Single-use Video Pancreaticobiliary Scope, PB Digital Controller
Applicant
Micro-Tech (Nanjing) Co., Ltd.
Product Code
FBN · Gastroenterology, Urology
Decision Date
Feb 16, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Single-use Video Pancreaticobiliary Scope is used in combination with the PB digital controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories. The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.
Device Story
System comprises sterile single-use flexible video pancreaticobiliary scope and reusable PB digital controller; scope features distal CMOS sensor and LED light source (via glass fiber) for visualization; scope provides working channel for diagnostic/therapeutic accessories; physician operates scope via maneuverable tip; controller processes CMOS image data for display on external monitor; system used in clinical settings for ERCP/PTC procedures; provides direct visualization to guide accessory devices; benefits include improved diagnostic/therapeutic access to pancreaticobiliary system.
Clinical Evidence
No clinical data or animal studies included. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), electrical safety (ANSI AAMI ES60601-1, IEC 60601-2-18), sterilization validation (ISO 11135), and performance testing (resolution, field of view, articulation, leakage, and accessory compatibility).
Technological Characteristics
System includes single-use flexible scope and reusable controller. Scope features CMOS sensor, LED illumination, and 4-way articulation. Materials comply with ISO 10993-1. Electrical safety per ANSI AAMI ES60601-1, IEC 60601-2-18, and IEC 60601-1-2. Sterilization via Ethylene Oxide (ISO 11135). Connectivity includes DVI/CVBS video output.
Indications for Use
Indicated for adults undergoing endoscopic surgery of the pancreaticobiliary system, including hepatic ducts, for diagnostic and therapeutic applications.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
February 16, 2023
Micro-Tech (Nanjing) Co., Ltd Sally He RA Engineer No. 10 Gaoke Third Road Nanjing National Hi-tech Industrial Development Zone Nanjing, Jiangsu 210032 CHINA
Re: K221784
Trade/Device Name: Single-use Video Pancreaticobiliary Scope, PB Digital Controller Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBN, NTN, KQM Dated: August 26, 2022 Received: January 17, 2023
Dear Sally He:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known)
K221784
Device Name Pancreaticobiliary Video System
Indications for Use (Describe)
The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.
The Single-use Video Pancreaticobiliary Scope is used in combination with the PB digital controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.
The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks, giving them a bold and modern look. A registered trademark symbol (®) is positioned in the upper right corner of the logo. The logo is simple, clean, and easily recognizable.
# 510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K221784
### 1. Date of Preparation: 2023-02-08
### 2. Sponsor Identification
# Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC
Establishment Registration Number: 3004837686
Contact Person: Sally He
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
# Email: RA.Micro-Tech@outlook.com
### 3. Identification of Proposed Device
Trade Name: Single-use Video Pancreaticobiliary Scope, PB Digital Controller
Common Name: Pancreaticobiliary Video System
## Regulatory Information
Device Classification Name: Endoscope and accessories
Classification regulation: 876.1500(FBN, NTN, FET), 874.4160(KQM)
Class and Review Panel: Class II, Gastroenterology/Urology (FBN, NTN, FET)
Class I, General and plastic surgery (KQM)
Product code: FBN, KQM, NTN, FET
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, blocky font. The letters are interconnected and have a three-dimensional appearance, suggesting depth and solidity. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
### 4. Identification of Predicate Device and Reference Device
Predicate Device:
510(k) Number: K142922
Product Name: SpyGlass DS Direct Visualization System
Manufacturer: Boston Scientific Corporation.
Reference Device:
510(k) Number: K200483
Product Name: SpyGlass Discover Digital System
Manufacturer: Boston Scientific Corporation.
#### 5. Indications for Use
The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope.
The Single-use Video Pancreaticobiliary Scope is used in combination with the PB Digital Controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories.
The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.
### Device Description 6.
Pancreaticobiliary Video System consists of:
Single-Use Video Pancreaticobiliary Scope:
- CDS11001
- CDS11002
- CDS11003
- CDS11004
- CDS11005
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a clean and modern design.
- CDS22001 ●
- CDS22002
- CDS22003
- CDS22004
- CDS22005
PB Digital Controller:
- BS-W-100
The Single-Use Video Pancreaticobiliary Scope is a sterile single use flexible scope and PB Digital Controller is a reusable device.
The Single-Use Video Pancreaticobiliary Scope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Insertion port
- Suction port
- Camera at the distal tip and LED light source in the handle of the pancreaticobiliary scope
The light emitted by the cold light source located in the handle is transmitted to the distal end of the pancreaticobiliary scope through the glass fiber, and irradiates the human tissue from the distal end. CMOS and glass fiber are located at the same position at the distal end. CMOS transmits the collected image information to the PB Digital Controller through cable, and the PB Digital Controller displays the image on the display after processing.
CMOS and optical components are identical for all specifications of products.
- Working channel port
- Lever which can lock the control
The Single-Use Video Pancreaticobiliary Scope have different size as follows:
- Maximum insertion portion width
- Effective working length
- Minimum accessories channel width
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A registered trademark symbol (®) is located in the upper right corner of the logo.
The PB Digital Controller has the following physical and performance characteristics:
- Displays the image from The Single-Use Video Pancreaticobiliary Scope on the screen
- Can record screenshots or video of image from the Single-Use Video Pancreaticobiliary Scope
- Can connect to an external monitor
- Reusable device
### 7. Comparison of Technological Characteristics
The Pancreaticobiliary Video System substantially equivalent device materials, design, configuration,
sterilization process and intended use as those featured in the predicate device SpyGlass DS Direct
Visualization System (K142922) and SpyGlass Discover Digital System (K200483).
# Comparison to Predicate Device and Reference Device:
Table 1 Substantial Equivalence Comparison between Proposed Single-Use Video Pancreaticobiliary
| | Proposed Device | Predicated Device | Reference Device | |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Characteristics | Single-Use<br>Video<br>Pancreaticobiliary Scope | SpyGlass DS Access<br>and Delivery Catheter<br>(K142922) | SpyGlass Discover<br>Digital Catheter<br>(K200483) | Remark |
| Product Code | FBN, KQM, NTN | FBN, KQM, NTN | FBM,KQM, NTN | Same |
| Class | II | II | II | Same |
| Regulation<br>Description | Pancreaticobiliary Scope<br>(flexible or rigid) and<br>accessories | Pancreaticobiliary Scope<br>(flexible or rigid) and<br>accessories | Pancreaticobiliary<br>Scope (flexible or rigid)<br>and accessories | Same |
| Regulation<br>number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Illumination<br>Source | LED | LED | LED | Same |
| Indication<br>for<br>Use | The Single-use Video<br>Pancreaticobiliary Scope<br>is used in combination<br>with the PB Digital<br>Controller, which is<br>designed to provide<br>imaging for the diagnosis<br>and treatment application<br>of endoscopic surgery<br>process of pancreatic<br>biliary system, and | Intended to provide<br>direct visualization and<br>to guide both optical and<br>accessory devices for<br>diagnostic and<br>therapeutic applications<br>during endoscopic<br>procedures in the<br>pancreatico-biliary<br>system including the<br>hepatic ducts. | The Spyglass Discover<br>Digital Catheter is<br>intended to provide<br>direct visualization and<br>to guide both optical and<br>accessory devices for<br>diagnostic and<br>therapeutic applications<br>during endoscopic<br>procedures in the<br>pancreatico-biliary | Similar |
| | Proposed Device | Predicated Device | Reference Device | |
| Characteristics | Single-Use<br>Video<br>Pancreaticobiliary Scope | SpyGlass DS Access<br>and Delivery Catheter<br>(K142922) | SpyGlass Discover<br>Digital Catheter<br>(K200483) | Remark |
| | provide working channel<br>for other diagnosis and<br>treatment accessories. | | system including the<br>hepatic ducts. | |
| Operating<br>method | ERCP, PTC | ERCP | LCBDE, PTC, Open<br>Surgical procedure | Similar |
| Working length | 2200mm<br>800mm<br>650mm<br>600mm<br>400mm | 2140mm | 650mm | Similar |
| Images Sensor | CMOS | CMOS | CMOS | Same |
| Reusability | Single-Use | Single-Use | Single-Use | Same |
| Sterile | Yes | Yes | Yes | Same |
| Anatomic sites | Pancreatic biliary system | Pancreatic biliary system | Pancreatic<br>biliary<br>system | Same |
| Target<br>population | Adults | Adults | Adults | Same |
| Rx-only | Yes | Yes | Yes | Same |
| Tip Diameter | 3.7mm<br>3.1mm | 3.5mm | 3.5mm | Similar |
| Shaft Diameter | 3.9mm<br>3.2mm | 3.6mm | 3.6mm | Similar |
| Working<br>Channel<br>Diameter | 2.0mm<br>1.2mm | 1.2mm | 1.2mm | Similar |
| | Proposed Device | Predicated Device | Reference Device | |
| Characteristics | Single-Use<br>Video<br>Pancreaticobiliary Scope | SpyGlass<br>DS Access<br>and Delivery Catheter<br>(K142922) | SpyGlass<br>Discover<br>Digital<br>Catheter<br>(K200483) | Remark |
| Minimum<br>Duodenoscope<br>Working<br>channel | 4.2mm<br>3.7mm | 4.2mm | Not<br>used<br>through<br>duodenoscope | Similar |
| Minimum<br>Sheath Working<br>Channel | 4.0mm<br>3.3mm | Not used through sheath | 3.6mm | Similar |
| Deflection | 4way<br>≥45° | 4way<br>≥30 ° | 4way<br>≥30 ° | Greater |
| Direction<br>of<br>View | 0 | 0 | 0 | Same |
| Field of view | 120 | 120 | 120 | Same |
| Resolution | 12.7lines/mm<br>@5mm<br>object distance | 7.13 lines/mm<br>@5mm<br>object distance | Unknown | Greater |
| Biocompatibilit<br>y | Comply with ISO 10993-1 | Comply with ISO 10993-<br>1 | Comply with ISO 10993-1 | Same |
| Shelf Life | 2 Years | 2 Years | 2 Years | Same |
| Electrical<br>Performance | Comply with<br>ANSI AAMI ES60601-1<br>IEC60601-1-2<br>IEC 60601-2-18 | Comply with<br>ANSI AAMI ES60601-1<br>IEC60601-1-2<br>IEC 60601-2-18 | Comply with<br>ANSI AAMI ES60601-1<br>IEC60601-1-2<br>IEC 60601-2-18 | Same |
Scope and Predicate/Reference Device
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional design. The letters are white and stand out against a blue background. A registered trademark symbol is located in the upper right corner of the logo.
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right, creating a sense of depth. A small 'R' in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
# Table 2 Substantial Equivalence Comparison between Proposed PB Digital Controller and
| Characteristics | Proposed Device | Predicate/Reference Device | | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| | PB Digital Controller | Predicated Device | Reference Device | Remark |
| | | SpyGlass DS Digital<br>Controller(K142922) | SpyGlass Discover<br>Digital<br>Controller(K200483) | |
| Product Code | FBN,FET | FBN | FBN | PB Digital<br>Controller is |
| Characteristics | Proposed Device | Predicated Device | Reference Device | Remark |
| | PB Digital Controller | SpyGlass DS Digital<br>Controller(K142922) | SpyGlass Discover<br>Digital<br>Controller(K200483) | |
| Class | II | II | II | a video<br>processor<br>regulated<br>under FET. |
| Regulation<br>Description | Pancreaticobiliary Scope<br>(flexible or rigid) and<br>accessories<br>Endoscopic Video<br>Imaging<br>System/Component,<br>Gastroenterology-Urology | Pancreaticobiliary Scope<br>(flexible or rigid) and<br>accessories | Pancreaticobiliary<br>Scope (flexible or rigid)<br>and accessories | Same<br>PB Digital<br>Controller is<br>one<br>component<br>of<br>endoscopic<br>Video<br>Imaging<br>System |
| Regulation<br>number | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Indication<br>for<br>Use | The PB Digital Controller<br>can be used together with<br>the Single-use Video<br>Pancreaticobiliary Scope<br>of Micro-Tech to process<br>the image collected by the<br>scope and transmit it to the<br>display. | The SpyGlass DS Digital<br>Controller is intended to<br>provide illumination and<br>receive, process, and<br>output images from the<br>SpyScope DS Access and<br>Delivery Catheter for<br>diagnostic and<br>therapeutic applications<br>during endoscopic<br>procedures in the<br>pancreaticobiliary<br>system including the<br>hepatic ducts. | The Spyglass Discover<br>Digital Controller is<br>intended to provide<br>illumination and receive,<br>process, and output<br>images from the<br>Spyglass Discover<br>Digital Catheter for<br>diagnostic and<br>therapeutic applications<br>during endoscopic<br>procedures in the<br>pancreaticobiliary<br>system including the<br>hepatic ducts. | Similar |
| | Proposed Device | Predicated Device | Reference Device | |
| Characteristics | PB Digital Controller | SpyGlass DS Digital<br>Controller(K142922) | SpyGlass Discover<br>Digital<br>Controller(K200483) | Remark |
| Video Formats | PAL and NTSC | PAL and NTSC | PAL and NTSC | Same |
| Video Outputs | DVI, CVBS | S-Video, VGA, DVI | S-Video, VGA, DVI | Similar |
| Characteristics | Proposed Device | Predicated Device | Reference Device | |
| | PB Digital Controller | SpyGlass DS Digital<br>Controller(K142922) | SpyGlass<br>Discover<br>Digital<br>Controller(K200483) | Remark |
| White<br>Balancing | Automatic | Automatic | Automatic | Same |
| Brightness<br>Control | 5 settings | 5 settings | 5 settings | Same |
| Separate<br>monitor | Yes | Yes | Yes | Same |
| Energy<br>used/Power<br>source | Yes | Yes | Yes | Same |
| Reusability | Reusable | Reusable | Reusable | Same |
| Rx-only | Yes | Yes | Yes | Same |
| Shelf Life | 5 Years | 5 Years | 5 Years | Same |
| Electrical<br>Performance | Comply with<br>ANSI AAMI ES60601-1<br>IEC60601-1-2<br>IEC 60601-2-18 | Comply with<br>ANSI AAMI ES60601-1<br>IEC60601-1-2<br>IEC 60601-2-18 | Comply with<br>ANSI AAMI ES60601-1<br>IEC60601-1-2<br>IEC 60601-2-18 | Same |
# Predicate/Reference Device
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be part of a single, solid shape. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A small registered trademark symbol is visible in the upper right corner of the logo. The logo has a clean and modern design.
### 8. Performance Data
Performance testing was conducted to demonstrate the essential performance of the proposed device Pancreaticobiliary Video System and confirmed that the proposed device works as intended with the compatible devices.
The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
- > Diameter
- > Working length
- > Working channel diameter
- > Liquid injection and aspiration
- > Field of view
- > Resolution
- > Articulation direction
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly, giving the logo a dynamic look. A registered trademark symbol (®) is positioned in the upper right corner of the logo.
- Articulation angle A
- > Surface and edges
- > Leakage
- > Attachment to duodenoscope reliability
- A Duodenoscope compatibility
- > Irrigation pump compatibility
- > Accessory compatibility
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. A oneyear aging test was performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices"
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of international Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
Electrical performance was performed in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", IEC 60601-2-18:2009 "Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment", IEC 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests"
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
### 9. Animal Study
No animal study is included in this submission.
## 10. Clinical Study
No clinical study is included in this submission.
## 11. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Pancreaticobiliary Video System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device SpyGlass DS Direct Visualization System under K142922 and reference device SpyGlass Discover Digital System under K200483, the subject device is as safe, as effective, and performs as well as the predicate/reference device.
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
