FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
K063847 · Fujinon, Inc. · FDS · Mar 1, 2007 · Gastroenterology, Urology
Device Facts
Record ID
K063847
Device Name
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
Applicant
Fujinon, Inc.
Product Code
FDS · Gastroenterology, Urology
Decision Date
Mar 1, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
Observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas) using an Ultrasonic endoscope, observation and diagnosis of submucosal and perioheral organs using ultrasonic images, and endoscopic treatment.
Device Story
System comprises ultrasonic gastrointestinal endoscopes (EG-530UR, EG-530UT) and ultrasonic processor (SU-7000). Endoscopes feature integrated ultrasonic transducers; used with single-use balloons to maintain position. Processor drives transducer to emit ultrasound into body cavities; receives reflected signals; converts signals into ultrasonic images for display. Used in medical facilities by physicians for visualization of upper GI tract, submucosal, and peripheral organs. Output viewed by clinicians to guide diagnosis and endoscopic treatment. Benefits include enhanced visualization of internal structures and surrounding organs during endoscopic procedures.
Clinical Evidence
Bench testing only. No clinical data provided. Device passed electrical safety, thermal, and EMC testing requirements. Biocompatibility of materials confirmed.
Technological Characteristics
System includes ultrasonic endoscopes and SU-7000 processor. Endoscopes feature ultrasonic transducers for pulsed echo and pulsed Doppler imaging. Processor performs signal processing for B-mode, M-mode, PWD, and Color Doppler modes. Materials are biocompatible. Connectivity includes processor, light source, cart, and video printer. Sterilization/reprocessing not specified beyond biocompatibility.
Indications for Use
Indicated for observation and diagnosis of the upper digestive tract (esophagus, stomach, duodenum, underlying areas), submucosal and peripheral organs, and endoscopic treatment in medical facilities under physician management. Used for diagnostic ultrasound imaging or fluid flow analysis (B, M, PWD, Color Doppler modes) in abdominal, intraoperative (gastrointestinal tract and surrounding organs), and transesophageal (non-cardiac) 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.
Predicate Devices
Pentax EG-3630UR Ultrasound Video Gastroscope (K013640)
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Image /page/0/Picture/0 description: The image shows the word "FUJIFILM" in a bold, sans-serif font. The letters are black and the background is white. The letters are slightly distorted, giving the image a textured appearance.
Image /page/0/Picture/1 description: The image shows the word "FUJINON" in large, bold, black letters. Above the word, there is a handwritten inscription that appears to be "K063847". The text is clear and legible, with a simple, straightforward design.
MAR 0 1 2007
# 510 (k) Summary
Date Prepared [21 CFR 807.92(a)(1)] 12/18/06
#### Submitter's Information [21 CFR 807.92(a)(1)]
This 510(k) is being submitted by Joseph Azary on behalf of Fujinon Inc.
Contact: Joseph Azary 543 Long Hill Avenue Shelton, CT 06484 Tel: (203) 944-9320 Fax: (203) 944-9317.
.
Sponsor / U.S. Distributor: Fujinon Inc. 10 High Point Drive Wayne, NJ 07470 FDA Establishment Registration# 2431293.
Manufacturer: Fujinon Corporation 1-324 Uetake-Cho Kita-Ku, Saitama-Shi Saitama 331-9624, Japan FDA Establishment Registration# 9610875
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#### Trade Name, Common Name, Classification [21 CFR 807.92(2)(2)]
Device Trade Name: Fujinon Ultrasonic Endoscope & Processor, EG-530UR, EG-530UT, SU-7000 Device Common, Usual, or Classification Names: Ultrasonic gastrointestinal endoscope, ultrasonic processor
#### Classification:
| Product<br>Code | Regulation<br>Number | Description | Class |
|-----------------|----------------------|------------------------------------------|-------|
| FDS | 876.1500 | Gastroscope | II |
| IYN | 892.1550 | Ultrasonic Pulsed Doppler Imaging System | II |
| IYO | 892.1560 | Ultrasonic Pulsed Echo Imaging System | II |
| ITX | 892.1570 | Diagnostic Ultrasonic Transducer | II |
#### Predicate Device [21 CFR 807.92(a)(3)]
Ultrasonic Endoscopes
- Pentax EG-3630UR Ultrasound Video Gastroscope (K013640) .
- Olympus GF-UE160-AL5 Endoscope (K051541) .
The subject devices are substantially equivalent to the predicate devices. The indications for use are similar. There are only minor differences in field of view, viewing direction, diameter, and bending. The working length and total length are almost identical. Each endoscope uses different ultrasonic processors.
Ultrasound Processors
- Hitachi EUB-6000 (K994026 and K011252) .
The subject device is substantially equivalent to the predicate device. The indications for use are similar. There are some minor differences in size and frequency.. The display modes, scanning mode, and display are almost identical.
#### Description of the Device [21 CFR 807.92(a)(4)]
The EG-530UR and EG-530UT are medical ultrasonic gastrointestinal endoscopes. They are intended for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas) using an Ultrasonic endoscope, observation and diagnosis of submucosal and perioheral organs using ultrasonic images, and endoscopic treatment at medical facilities under the management of physicians.
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These endoscopes are used in combination with a processor, light source, cart, ultrasonic processor (SU-7000), and video printer.
The endoscopes are used with a single use balloon. The endoscopes have a groove on the tip to hold the balloon in place.
The SU-7000 is an ultrasonic processor that is used with a medical ultrasonic endoscope (EG-530UR or EG-530UT). The processor connects to the ultrasonic endoscope, which emits ultrasound in a body cavity by driving an ultrasonic transducer of the endoscope. It also processes the reflection ultrasonic signal received by the transducer and coverts it to an ultrasonic image.
#### Intended Use [21 CFR 807.92(a)(5)]
Observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas) using an Ultrasonic endoscope, observation and diagnosis of submucosal and perioheral organs using ultrasonic images, and endoscopic treatment
#### Technological Characteristics [21 CFR 807.92(a)(6)]
Fujinon, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device have similar indications for use.
#### Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to and passed electrical safety, thermal, and EMC testing requirements. The materials in the endoscope are biocompatible and are identical to the materials used in the predicate device.
#### Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 1 2007
Fujinon, Inc. % Mr. Joseph M. Azary Azary Technologies, Inc. 543 Long Hill Avenue SHELTON CT 06484
Re: K063847
Trade/Device Name: Fujinon Ultrasonic Endoscope & Processor (SU-7000 / EG-530UR / EG-530UT) Regulation Number: 21 CFR \$876.1500 Regulation Name: Endoscope and accessories Product Code: FDS Regulation Number: 21 CFR §892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: IYN Regulation Number: 21 CFR \$892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: IYO Regulation Number: 21 CFR 8892.1570 Regulation Name: Diagnostic ultrasonic transducer Product Code: ITX Regulatory Class: II Dated: December 18, 2006 Received: December 27, 2006
Dear Mr. Azary:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Fujinon Ultrasonic Endoscope & Processor SU-7000, as described in your premarket notification:
Transducer Model Number
EG-530UT EG-530UR
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### Page 2 - Mr. Joseph Azary
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may If your as not 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Andrew Kang, M.D., at (240) 276-3666.
Sincerely yours,
David le. Sgmm
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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### Indications for Use
510(k) Number (if known):
063847
Device Name: Fujinon Ultrasonic Endoscope & Processor (SU-7000 / EG-530UR / EG-530UT)
Indications For Use:
The EG-530UR and EG-530UT ultrasonic endoscopes are intended to be used with the SU-7000 ultrasound I ho system is used for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas), as well as observation and diagnosis of submucosal and peripheral organs using ultrasonic images, and endoscopic treatment.
Prescription Use X (Part 21 CFR 801 Subpart D)
Image /page/5/Picture/7 description: The image shows the text "AND/OR" in a bold, serif font. The letters are black against a white background. The slash between "AND" and "OR" is slightly tilted.
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number.
Page 1 of 1
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SU-700
K063847
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | | | | | | | | | | |
|---------------------------------------------------------------|-------------------------------|---|---|-----|-----|---------------|-------------------|------------------------|-----------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | | | See below | |
| Intraoperative (specify) | | N | N | N | | N | | | See below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | N | N | N | | N | | | See below | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | N | N | N | | N | | | See below non-cardiac | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N= new indication; P= previously cleared by FDA; | E= added under Appendix E | | | | | | | | | |
| Additional Comments: | Mixed mode includes B/M B/PWD | | | | | | | | | |
| Intraoperative: Gastro-intestinal tract & surrounding organs. | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergman
(Division Sign Off)
(Division Sign-Off) V Division of Reproductive, Abdominal, and Radiological Devices
Radiological Devices,
510(k) Number K063847
Prescription Use (Per 21 CFR 801.109)
{7}------------------------------------------------
#### Appendix F
# G-530UT
K063847
Diagnostic Ultrasound Indications for Use Form
Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | N | N | N | N | | N | | | See below | |
| Intraoperative (specify) | N | N | N | N | | N | | | See below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | N | N | N | | N | | | See below | Non-Cardiac |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode includes B/M B/PWD
Intraoperative: Gastro intestinal tract & surrounding abdominal organs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Gavin A. Ingram
(Division Sign-Off)
( = Fision Sign-Off)
Division of Reproductive, Abdominal, and Radiological Reproductive, and Radiological Devices
Prescription Use (Per 21 CFR 801.109)
510(k) Number _
F-3
Page VI
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# EG-530UR
Ko63847
### Diagnostic Ultrasound Indications for Use Form
## Fill out one form for each ultrasound system and each transducer.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | | | See below | |
| Intraoperative (specify) | | N | N | N | | N | | | See below | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | | N | | | See below | non cardiac |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Mixed mode includes B/M, B/PWD
Intraoperative: Gastro intestinal tract & surrounding abdominal organs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel M. Lyons
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K063847
Prescription Use (Per 21 CFR 801.109)
Page VII
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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.
