(288 days)
The Single Use Endoscope Valves Set are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
The Single Use Endoscope Valves Set collects three types of valve products into one package unit, and which are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
This is single-use device and supplied sterile.
There are three main components included, which are Air/Water Valve, Suction Valve and Biopsy Valve.
The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
There are three models for fitting to varied endoscopes as AMH-EV-01; AMH-EV-02; AMH-EV-03. The main differences between models are physical size of components for varied endoscopes interface, but they share same indication for use, materials and components form.
This document is a 510(k) Premarket Notification from Anrei Medical (Hangzhou) Co., Ltd. for their "Single Use Endoscope Valves Set." It is a submission to the FDA seeking to demonstrate substantial equivalence to previously cleared predicate devices.
Based on the provided document, there is no clinical study or human subject testing described. The document explicitly states: "No clinical study is included in this submission." (Page 6)
Therefore, it is impossible to answer questions related to acceptance criteria proved by a study involving human subjects or AI performance. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices.
However, I can extract information regarding the non-clinical acceptance criteria and "performance" as it relates to demonstrating substantial equivalence for THIS device.
Acceptance Criteria and Reported Device Performance (Non-Clinical)
Since this submission is a 510(k) for a medical device (endoscope valves), the "acceptance criteria" and "performance" are primarily related to demonstrating substantial equivalence to predicate devices through a series of non-clinical tests, rather than clinical efficacy involving human patients or complex AI algorithm performance.
The document discusses various non-clinical tests conducted to prove the device meets design specifications and is substantially equivalent.
1. Table of Non-Clinical Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test / Standard | Acceptance Criteria (Implied by SE claim) | Reported Device Performance (as stated in document) |
|---|---|---|---|
| Biocompatibility | ISO 10993-5:2009 (Vitro cytotoxicity) | Device should not show cytotoxicity. | "the results shown that the proposed devices has same biocompatibility with predicate devices." |
| ISO 10993-10:2010 (Irritation and delay-type hypersensitivity) | Device should not cause irritation or hypersensitivity. | "the results shown that the proposed devices has same biocompatibility with predicate devices." | |
| Sterilization | ISO 11135:2014 (Ethylene oxide sterilization process) | Device must be sterile after the process. | "the results shown that the proposed devices has same sterilization performance with predicate devices." |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Residuals should be within acceptable limits. | "the results shown that the proposed devices has same sterilization performance with predicate devices." | |
| USP40 NF35<85> (Bacterial Endotoxins Test) | Device must pass bacterial endotoxin limits. | "the results shown that the proposed devices has same sterilization performance with predicate devices." | |
| Packaging Integrity | ASTM D 3078-02(2013) (Leaks in Flexible Packaging by Bubble Emission) | Packaging should be free of leaks. | "the results shown that the proposed devices has same package performance with predicate devices." |
| ASTM F 1929-15 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration) | Packaging seals should not allow dye penetration. | "the results shown that the proposed devices has same package performance with predicate devices." | |
| DIN 58953-6:2016 (Microbial barrier testing of packaging materials) | Packaging should provide an effective microbial barrier. | "the results shown that the proposed devices has same package performance with predicate devices." | |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Packaging seals should meet specified strength requirements. | "the results shown that the proposed devices has same package performance with predicate devices." | |
| ASTM F1140/F1140M-13 (Internal Pressurization Failure Resistance of Unrestrained Packages) | Packaging should withstand internal pressure without failure. | "the results shown that the proposed devices has same package performance with predicate devices." | |
| Shelf Life | ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems for Medical Devices) | Device should maintain performance stability for the claimed shelf life (3 years). Test results should show 3-year shelf life does not affect performance. | "the results shown that the proposed devices meet the requirements of claimed shelf life." and "The testing results shown that 3 years shelf life would not affect the performance of proposed device." |
| Device Performance | Tensile strength, water and gas flow rates, pressure maintenance, water and air flow leakage, backflow, insertion and removal, endoscope compatibility and insertion force, etc. | Performance should be comparable to predicate devices. | "The results shown that the proposed device has same performance with predicate device." This is a blanket statement for multiple functional performance aspects. Specific numerical results are not provided in this summary, but the claim is equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each non-clinical test. It generally states that "Non clinical tests were conducted to verify..." without providing the number of units tested.
- Data Provenance: The tests were conducted by Anrei Medical (Hangzhou) Co., Ltd. in China. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a non-clinical device performance and substantial equivalence study for a physical device, not an AI or diagnostic imaging study requiring expert radiologists or clinicians to establish ground truth for a test set. The "ground truth" for these tests are the objective measurements against established engineering and biological standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As above, this is not a study requiring human interpretation or multi-reader adjudication. The results are objective measurements from laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is typically performed for diagnostic devices (e.g., AI algorithms for image interpretation) to compare human performance with and without AI assistance. This submission is for a physical endoscope accessory, not an AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This question is also relevant to AI algorithms. This submission is for a physical medical device.
7. The Type of Ground Truth Used:
- Objective Test Standards and Predicate Device Performance. The "ground truth" for the non-clinical tests is established by recognized international standards (ISO, ASTM, DIN, USP) for biocompatibility, sterility, packaging, and shelf-life, and by direct comparison of the proposed device's functional performance against the performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set:
- Not Applicable. This question applies to machine learning models, not physical medical devices undergoing non-clinical testing for substantial equivalence.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, this pertains to machine learning models.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue and white.
May 14, 2020
Anrei Medical (Hangzhou) Co., Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. R912, B#15, XiYueHui, No.5, YiHe North Road FangShan District Beijing, 102401 CHINA
Re: K192048
Trade/Device Name: Single Use Endoscope Valves Set Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated: April 13, 2020 Received: April 15, 2020
Dear Ray Wang:
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.
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
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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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Indications for Use
510(k) Number (if known)
K192048
Device Name
Single Use Endoscope Valves Set
Indications for Use (Describe)
The Single Use Endoscope Valves Set are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Tab #3 510(k) 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: K192048
-
- Date of Preparation: 04/13/2020
-
- Sponsor Identification
Anrei Medical (HangZhou) Co., Ltd. No.3 Ave 8, HEDA, HangZhou City, ZheJiang, China 310018
Contact Person: Yang HuiBing Position: Regulations & Quality System Director Tel: +86-571-8691333 ext. 8658 Fax: +86-571-87603502 Email: huibing.yang@anrei.com.cn
- Designated Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10- 56335780 Email: ray.wang@believe-med.com
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4. Identification of Proposed Device
Trade Name: Single Use Endoscope Valves Set Common Name: Endoscope and Accessories Model(s): AMH-EV-01; AMH-EV-02; AMH-EV-03
Regulatory Information Classification Name: Endoscope and Accessories Classification: 2 Product Code: ODC Regulation Number: 21 CFR 876.1500 Review Panel: Gastroenterology/Urology;
Indications for Use Statement:
The Single Use Endoscope Valves Set are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
Device Description
The Single Use Endoscope Valves Set collects three types of valve products into one package unit, and which are used to fit to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
This is single-use device and supplied sterile.
There are three main components included, which are Air/Water Valve, Suction Valve and Biopsy Valve.
The Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Biopsy Valve is intended to accommodate various sizes of endoscopic accessory instruments while still providing a seal around the instrument channel inlet.
There are three models for fitting to varied endoscopes as AMH-EV-01; AMH-EV-02; AMH-EV-03. The main differences between models are physical size of components for varied endoscopes interface, but they share same indication for use, materials and components form.
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ર. Identification of Predicate Device(s)
510(k) Number: K102409 Product Name: DEFENDO Disposable Air/Water Valve for GI Endoscopes
510(k) Number: K102581 Product Name: DEFENDO Disposable Suction Valve for GI Endoscopes
510(k) Number: K090851 Product Name: DEFENDO Biopsy Valve (Model #100301 and I00302)
6. Non-Clinical Test Discussion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
Biological Testing was conducted as following standards, the results shown that the proposed devices has same biocompatibility with predicate devices.
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.
ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity;
Sterile Testing was conducted as following standards, the results shown that the proposed devices has same sterilization performance with predicate devices.
ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
USP40 NF35<85> Bacterial Endotoxins Test.
Package Testing was conducted as following standards, the results shown that the proposed devices has same package performance with predicate devices.
ASTM D 3078-02(2013) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
DIN 58953-6:2016 Sterilization-Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilizaed.
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
The shelf Life validation was conducted as following standard, the results shown that the proposed
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devices meet the requirements of claimed shelf life.
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
The performance testing was conducted for the performance of tensile strength, water and gas flow rates, pressure maintenance, water and air flow leakage, backflow, insertion and removal, endoscope compatibility and insertion force etc., this testing was a test that compares the proposed device with the predicate devices. The results shown that the proposed device has same performance with predicate device.
- Clinical Test Conclusion 7.
No clinical study is included in this submission.
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Substantially Equivalent (SE) Compariso ం
ble 1 Comparison of Technology Characteristic
| Item | Device name | Classification Name | Regulation Number | Predicate Device (K102409) | Predicate Device(K102581) | Predicate Device (K090851) | Remark |
|---|---|---|---|---|---|---|---|
| Proposed Device(s)Single Use Endoscope ValvesSet | Endoscope and accessories | 876.1500 | DEFENDO Disposable Air/WaterValve for GI Endoscopes | DEFENDO Disposable SuctionValve for GI Endoscopes | DEFENDO Biopsy Valve(Model #100301 and 100302) | / | |
| Endoscope and accessories | 876.1500 | Endoscope and accessories | Endoscope and accessories | SAME | |||
| 876.1500 | SAME | ||||||
| Indications for Use | The Single Use EndoscopeValves Set are used to fit tomultiple endoscope workingchannels/ports to enable anendoscope operator control thefunction of the workingchannels/ports and preventretrograde flow of the fluids,gases, and other materials. | The DEFENDO DisposableAir/Water Valve is intended to beused to control the air/waterfunction on an endoscope during aGI endoscopic procedure. | The DEFENDO DisposableSuction Valve is intended to beused to control the suctionfunction on an endoscopeduring a GI endoscopicprocedure. | DEFENDO Disposable BiopsyValve is indicated for coveringthe endoscope biopsy portduring an endoscopy procedure.The valve provides access forendoscopic device passage andexchange, helps maintainsufflation, and minimizesleakage of biomaterial from thebiopsy port throughout theendoscopic procedure. | SAME |
K192048
Page 5 of 9
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| endoscopic procedure.The Biopsy Valve is intendedto accommodate various sizesof endoscopic accessoryinstruments while stillproviding a seal around theinstrument channel inlet. | |||||
|---|---|---|---|---|---|
| Prescription/OTC | Prescription Use | Prescription Use | Prescription Use | Prescription Use | SAME |
| Components | Air/Water Valve, SuctionValve, Biopsy Valve | Air/Water Valve | Suction Valve | Biopsy Valve | SAME |
| Supplied Sterile | Yes | Yes | Yes | Yes | SAME |
| Single use | Yes | Yes | Yes | Yes | SAME |
| Feature | Sterile and single-use;Compatible with multipleendoscope workingchannels/ports;Enable an endoscope operatorcontrol the function of theworking channels/ports andprevent retrograde flow of thefluids, gases, and othermaterials; | Sterile and single-use;Compatible with multipleendoscope working channels/ports;Enable an endoscope operatorcontrol the function of the workingchannels/ports and preventretrograde flow of the fluids, gases,and other materials; | Sterile and single-use;Compatible with multipleendoscope channels/ports;Enable an endoscope operatorcontrol the function of theworking channels/ports andprevent retrograde flow of thefluids, gases, and othermaterials; | Compatible with multipleendoscope biopsy port during anendoscopy procedure | SAME |
| Materials | Air/Water Valve:ABS+Silica+SUS304Suction Valve:ABS+Silica+SUS304 | Not Available | Not Available | Not Available | Difference |
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K192048
Page 7 of 9
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| Summary | |
|---|---|
| ( | |
| 0(kl | |
| S |
| 140/160/180/240/260/290series;Fujinon 500 and 600 series;Pentax i10 and 90 series. | series endoscopes | series endoscopes | Endoscopes | ||
|---|---|---|---|---|---|
| The air/water valves, suctionvalve and biopsy valve arehoused in a single tray andpackaged in sealed initialpackage. | Suction and air/water valves arehoused in a single tray andpackaged in a sealed Tyvekpouch | ||||
| Packaging | Not Available | Not Available | SAME | ||
| Sterilization Method | EO | EO | Not Available | SAME | |
| Shelf Life | 3 year | 1 year | Not Available | Difference | |
| Biocompatibility | Cytotoxicity, Sensitization andIrritation | Cytotoxicity, Sensitization andIrritation | Not Available | SAME | |
| Difference Analysis |
atibility The proposed device has different on the for this differs, the performance estable to teacher and closes devices and fect the safety and effectiveness of proposed device
this different d fe: The proposed device has different shelf life than predicate device, the shelf life validation of 3 years has been conduced, which included perfo after accelerated aging. The testing results shown that 3 years shelf life would not affect the performance of proposed device. So, et the safety and effectiveness of proposed device
Materials: Beause the detail materials are not wailable, or could be onsidered as different the tiffers, the Bioompitility testing has betactives and oroposed device
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9. Substantially Equivalent (SE) Conclusion
The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.