K200481 · Ga Health Company Limited · ODC · Jun 18, 2020 · Gastroenterology, Urology
Device Facts
Record ID
K200481
Device Name
Andorate Biopsy Valve, Andorate Biopsy Irrigator
Applicant
Ga Health Company Limited
Product Code
ODC · Gastroenterology, Urology
Decision Date
Jun 18, 2020
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
3rd-Party Reviewed
Indications for Use
The Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure. The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.
Device Story
Andorate Disposable Biopsy Valve and Biopsy Irrigator are single-use, sterile endoscopic accessories. The valve covers the endoscope biopsy port, facilitating device passage/exchange while maintaining insufflation and preventing biomaterial leakage. The irrigator enables simultaneous irrigation and instrumentation within the biopsy channel, featuring a backflow valve to prevent fluid/biomaterial backflow into irrigation tubing. Used in hospitals and clinics by medical professionals during endoscopic procedures. Devices are manufactured via injection molding; sterilized via EO gas. The valve is made of silicone; the irrigator is made of polycarbonate and silicone. These devices function as mechanical seals and fluid conduits to support standard endoscopic workflows, improving procedural efficiency and maintaining sterile/clean environments during instrumentation.
Clinical Evidence
Bench testing only. No clinical data was required. Performance testing included assembly integrity, endoscope compatibility, vacuum/squeegee leak tests, water flow tests, backflow performance, and biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity). Sterility was validated per ISO 10993-7.
Technological Characteristics
Single-use, sterile, EO-sterilized endoscopic accessories. Biopsy valve: silicone, injection molded. Biopsy irrigator: polycarbonate and silicone, injection molded. Compatibility: Fujifilm and Olympus GI endoscopes. Mechanical principle: sealing and fluid flow regulation. Shelf life: 1 year (valve), 3 years (irrigator).
Indications for Use
Indicated for use during endoscopic procedures to cover the biopsy port, provide access for device passage/exchange, maintain insufflation, minimize biomaterial leakage, and enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.
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.
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June 18, 2020
GA Health Company Limited % Rafael Aguila Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, Florida 33155-3708
Re: K200481
Trade/Device Name: Andorate Biopsy Valve Andorate Biopsy Irrigator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: June 5, 2020 Received: June 9, 2020
Dear Rafael Aguila:
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-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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, 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
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known)
K200481
#### Device Name
Andorate® Disposable Biopsy Valve and Andorate® Biopsy Irrigator
#### Indications for Use (Describe)
The Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.
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.
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FORM FDA 3881 (7/17)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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510(k) Premarket Notification: Traditional Biopsy Valve and Biopsy Irrigator GA Health Company Limited
# 510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
## 1. Submission Sponsor
| Submitter's Name: | GA Health Company Limited |
|---------------------------------|--------------------------------------------------------------------------------------|
| Submitter's Address: | Unit 18, 21/F, Metropole Square<br>2 On Yiu Street, Shatin, N.T,<br>Hong Kong, CHINA |
| Establishment Registration No.: | 3014749926 |
### 2. Sponsor Contact
Contact Person:
Cindy Ye – Chief Executive Officer
| Telephone: | +852 2833 9010 |
|------------|---------------------------------------------------------------------|
| Email: | <span style="text-decoration: underline;">cindy@andorate.com</span> |
## 3. Date Prepared
5.
29 May 2020
## 4. Device Identification
| Trade Device Name: | Andorate® Disposable Biopsy Valve |
|-----------------------------------------------------------------|---------------------------------------|
| Regulation Name: | Endoscope and accessories |
| Product Code: | ODC |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | 2 |
| Trade Device Name: | Andorate® Disposable Biopsy Irrigator |
| Regulation Name: | Endoscope and accessories |
| Product Code: | ODC |
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | 2 |
| Predicate Device Identification<br>Predicate Device 510(k) No.: | K090851 |
| Predicate Device Trade Name: | DEFENDO™ Disposable Biopsy V |
| Predicate Device Product Code: | ODC |
Predicate Device 510(k) No.: Predicate Device Trade Name: Predicate Device Product Code:
alve
K110088 DEFENDO™ Y-Opsy Irrigator ODC
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## 6. Device Description:
Table 1 shows the components included in the application.
| Components | Qty | Classification Name | Regulation<br>Number | Classification |
|------------------------------------------|-----|--------------------------------------|----------------------|----------------|
| Andorate® Disposable<br>Biopsy Valve | 1 | ODC – Endoscope<br>Channel Accessory | 876.1500 | 2 |
| Andorate® Disposable<br>Biopsy Irrigator | 1 | ODC – Endoscope<br>Channel Accessory | 876.1500 | 2 |
The biopsy valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The biopsy irrigator is intended to cover the endoscope biopsy port for sealing and endoscopic device passage/ exchange, at the same time use in conjunction with irrigation tubing. consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the irrigation tubing.
The biopsy irrigator and biopsy valve are packed individually in a sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate devices.
According to the Medical Device Recalls database in FDA website, no product recall was found for the predicate device. According to the FDA MAUDE database, safety issues on fluid leakage and backflow were identified. In the performance test, the leakage test and backflow test were conducted for verification.
There were no prior submissions for the subject devices.
# 7. Intended Use:
The Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.
# 8. Technological Characteristics
The following table (Table 2 - 3) is summaries of the subject devices technological characteristics as compared to the predicate devices.
Table 2 Summary of design, features and principles of operation and technological characteristics between the subject and predicate devices (Biopsy valve)
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| Specification | Predicate Device | Subject Device | Substantial<br>Equivalence |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Device name | DEFENDO™ Disposable<br>Biopsy Valve | ANDORATE® Disposable<br>Biopsy Valve | N/A |
| K number | K090851 | / | N/A |
| Manufacturer | Medivators, Inc | GA Health Company Limited | N/A |
| Product code | ODC | ODC | N/A |
| Classification | 2 | 2 | Identical |
| Regulation No | 876.1500 | 876.1500 | Identical |
| Regulation<br>Name | Endoscope and accessories | Endoscope and accessories | Identical |
| Supplied Sterile | Yes | Yes | Identical |
| Compatibility | Fujifilm GI endoscopes | Fujifilm GI endoscopes | Identical |
| Intended Use | The DEFENDO™ Disposable<br>biopsy valve is intended to be<br>cover the endoscope biopsy port<br>during an endoscopy procedure.<br>In addition, the valve provides<br>access for endoscopic device<br>passage and exchange, helps<br>maintain insufflation and<br>minimizes leakage of biomaterial<br>from the biopsy port throughout<br>the endoscopic procedure. | The Andorate® Disposable<br>biopsy valve is used to cover the<br>endoscope biopsy port during an<br>endoscopy procedure. In<br>addition, the valve provides<br>access for endoscopic device<br>passage and exchange, helps<br>maintain insufflation and<br>minimizes leakage of biomaterial<br>from the biopsy port throughout<br>the endoscopic procedure. | Substantial<br>Equivalent |
| Environment of<br>Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,<br>Disposable | Yes | Yes | Identical |
| Material | Thermoplastic Elastomer | Silicone | Substantial<br>Equivalent |
| Packaging | Packaged in a sealed pouch<br>individually | Packaged in a sealed pouch<br>individually | Identical |
| Manufacturing<br>method | Injection moulding | Injection moulding | Substantial<br>Equivalent |
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | One year | N/A |
Table 3 Summary of design, features and principles of operation and technological characteristics between the subject and predicate devices (biopsy irrigator)
| Specification | Predicate Device | Subject Device | Substantial<br>Equivalence |
|---------------|---------------------------|------------------------------------------|----------------------------|
| Device name | DEFENDO™ Y-Opsy Irrigator | ANDORATE® Disposable<br>Biopsy Irrigator | N/A |
| K number | K110088 | / | N/A |
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K200481 Page 14of 510(k) Premarket Notification: Traditional Biopsy Valve and Biopsy Irrigator GA Health Company Limited CONFIDENTIAL
| Manufacturer | Medivators, Inc | GA Health Company Limited | N/A |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product code | ODC | ODC | N/A |
| Classification | 2 | 2 | Identical |
| Regulation No | 876.1500 | 876.1500 | Identical |
| Regulation<br>Name | Endoscope and accessories | Endoscope and accessories | Identical |
| Supplied Sterile | Yes | Yes | Identical |
| Compatibility | Olympus and Fujinon GI<br>endoscopes | Olympus and Fujifilm GI<br>endoscopes | Identical |
| Intended Use | The DEFENDO™ Y-Opsy<br>Irrigator is intended to enable<br>simultaneous irrigation<br>and<br>instrumentation<br>in<br>the<br>endoscope's biopsy channel. | The Andorate® Disposable Biopsy<br>Irrigator is intended to enable<br>simultaneous irrigation<br>and<br>instrumentation<br>in<br>the<br>endoscope's biopsy channel. | Substantial<br>Equivalent |
| Environment of<br>Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,<br>Disposable | Yes | Yes | Identical |
| Material | Polycarbonate, silicone | Polycarbonate, silicone | Similar |
| Packaging | Packaged in a sealed pouch<br>individually | Packaged in a sealed<br>pouch<br>individually | Identical |
| Manufacturing<br>method | Injection moulding | Injection moulding | Substantial<br>Equivalent |
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | N/A |
# 9. Non-Clinical Performance Data
The bench testing was performed to support substantial equivalence. The following testing were performed on subject devices from initial production lots, including sterilization.
#### 9.1 Performance Test
# 9.1.1 Andorate® Disposable Biopsy Valve
- 9.1.1.1 Assembling Integrity
- 9.1.1.2 Endoscope Compatibility
- 9.1.1.3 Vacuum Leak Test
- 9.1.1.4 Squeegee Leak Test
### 9.1.2 Andorate® Disposable Biopsy Irrigator
- 9.1.2.1 Compatibility with irrigation tubing
- 9.1.2.2 Compatibility with endoscope
- 9.1.2.3 Water Flow Test
- 9.1.2.4 Vacuum Leak Test
- 9.1.2.5 Water Leakage Test
- 9.1.2.6 Squeegee Leak Test
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#### 9.1.2.7 Backflow Performance Test
#### 9.2 Sterilization
All the subject devices are sold in sterile package, like the Medivators predicate devices. The subject devices have been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 106. EO residuals on the components are below the maximum levels defined in ANSI/AAMI/ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The subiect and the predicate devices, are not labeled as pvrogen-free because thev do not have any blood or cerebrospinal fluid contact.
#### 9.3 Shelf Life
The Andorate® Disposable Biopsy Irrigator has a three (3) year expiration date and the Andorate® Disposable Biopsy Valve has a one (1) year expiration date. The subject devices are packaged in a paper/film pouch respectively. These pouches have been tested by Sanitation Environment Technology Institute, Soochow University. The tests conducted including accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test and the sterility test. The performance test was conducted for the subject devices after the accelerated aging process. The test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance before the expiration date.
#### 9.4 Biocompatibilitv
The biocompatibility of the subject devices were conducted in accordance with the FDA guideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process"". It included the following tests.
- Acute Systemic Toxicity Test -
- -In Vitro Cytotoxicity
- । Skin sensitization
- -Irritation
The subject devices are classified as surface devices with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that the subject devices are biocompatible.
# 10. Clinical Testing
Similar devices have been on the market for many years with proven safety and efficacy for the use of the device. These devices have no direct patient contact. Based on this history and the use of the device, clinical testing was not necessary to support substantial equivalence data. The non-clinical testing performed supports safety and efficacy of the devices and provides data to show substantial equivalence to the predicate devices.
# 11. Conclusion
The subject devices have the same intended use as the predicate devices. Based on the technological characteristics and overall performance of the devices in bench testing, there are no significant differences exist between the subject devices and the predicate devices. The subject devices do not raise any new issues of safety and effectiveness. From a clinical perspective and comparing design specifications, the subject devices and the predicate device are substantially equivalent.
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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.
