(61 days)
Protego Air Water Connector: The single use Protego Air Water Connector is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures.
Protego Air Water Bottle Tubing: Protego Air Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.
Protego Hybrid Tubing: Protego Hybrid Tubing is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2, water and irrigation during endoscopic procedures in conjunction with an irrigation pump. It is a 24-hour multi-patient use device.
The Protego Air Water Connector is intended for single use then discarded. The Protego Air Water Bottle Tubing and Protego Hybrid Tubing are intended for 24-hour use then discarded. All Protego Air Water Connector, Protego Air Water Bottle Tubing and Protego Hybrid Tubing are provided sterile. The Air Water Connector is used in conjunction with air water bottle tubing or hybrid tubing, intended to supply air/CO2 and water during gastro-intestinal endoscopic procedure. It is connected to the air/water port of the endoscope to provide connection from the air/water bottle tubing to the endoscope. The Air Water Bottle Tubing is connected to the air/water port of the endoscope and the sterile water bottle to supply air/ CO2 or sterile water during the GI endoscopic procedure. The Hybrid Tubing is composed of air/water bottle tubing and irrigation tubing, which is intended to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastro-intestinal endoscopic procedure.
The provided text describes a 510(k) summary for medical devices (Protego Air Water Connector, Protego Air Water Bottle Tubing, and Protego Hybrid Tubing) and does not contain information about an AI-based diagnostic device. Therefore, it does not include details on acceptance criteria, a study proving AI device performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for such devices.
The document details the substantial equivalence of the subject devices to predicate devices based on:
- Intended Use: The devices are intended to connect air/CO2 and sterile water sources to an endoscope for gastrointestinal endoscopic procedures, with some variations in single-use vs. 24-hour multi-patient use.
- Technological Characteristics: Comparisons are made regarding product code, regulatory classification, regulation number, regulation description, environment of use, single-use/reusable nature, materials, manufacturing method, packaging, sterilization, and shelf life.
- Performance Testing: Bench testing was performed to support substantial equivalence.
Here's a breakdown of the information that is present in the document, which pertains to the physical medical devices, not an AI diagnostic system:
1. Acceptance Criteria and Reported Device Performance (as listed in the document for the physical devices):
| Acceptance Criteria (Bench Testing Performed) | Reported Device Performance (Summary) |
|---|---|
| Endoscope compatibility test | Met established specifications |
| Connector pulling force test | Met established specifications |
| Connector/tubing pulling force test | Met established specifications |
| Backflow prevention test (Air Water Connector) | Met established specifications |
| Air flow test (Air Water Bottle Tubing) | Met established specifications |
| Water flow test (Air Water Bottle Tubing) | Met established specifications |
| Water leak test (Air Water Bottle Tubing) | Met established specifications |
| Bottle cap compatibility test (Air Water Bottle Tubing) | Met established specifications |
| Air flow test (Hybrid Tubing) | Met established specifications |
| Water flow test (Hybrid Tubing) | Met established specifications |
| Air leak test (Hybrid Tubing) | Met established specifications |
| Flow clamp test (Hybrid Tubing) | Met established specifications |
| Backflow prevention test (Hybrid Tubing) | Met established specifications |
| Sterility Assurance Level (SAL) | 10^-6 (Validated EO sterilization cycle) |
| EO residuals | Below maximum levels defined in ANSI/AAMI/ISO 10993-7 |
| Shelf Life (Packaging Integrity) | Maintained for at least 3 years (based on accelerated aging and packaging tests) |
| Biocompatibility | Biocompatible (based on ISO 10993-5 and ISO 10993-10) |
2. Sample size used for the test set and the data provenance:
- The document mentions "bench testing was performed to support substantial equivalence on both the subject device and the predicate device" (Page 7, Section 9).
- It does not specify the precise sample sizes used for each of these bench tests, nor does it detail data provenance (country of origin, retrospective/prospective) as these are physical device tests, not clinical data sets in the diagnostic sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI diagnostic device where expert ground truth is established for image interpretation or similar. The "performance" here refers to physical and functional characteristics of the tubing/connectors.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, for the same reason as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. Its performance is measured directly through bench testing of its physical and functional properties.
7. The type of ground truth used:
- The "ground truth" for these devices is objective, measurable engineering and material specifications (e.g., flow rates, pulling forces, leakage, sterility, biocompatibility standards). It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI device would be.
8. The sample size for the training set:
- Not applicable. There is no AI training set for these devices.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
August 1, 2023
GA Health Company Limited Wing Yu Lam Assistant Regulatory Affairs Manager Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, HONG KONG
Re: K231602
Trade/Device Name: Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: June 1, 2023 Received: June 1, 2023
Dear Wing Yu Lam:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
ndications for Use (Describe)
Protego Air Water Connector
The single use Protego Air Water Connector is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures.
Protego Air Water Bottle Tubing
Protego Air Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.
Protego Hybrid Tubing
Protego Hybrid Tubing is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2. water and irrigation during endoscopic procedures in coniunction with an irrigation pump. It is a 24-hour multi-patient use device.
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)
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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: Submitter's Address:
Establishment Reqistration No.:
2. Sponsor Contact
GA Health Company Limited Unit 18, 21/F, Metropole Square 2 On Yiu Street, Shatin, N.T, Hong Kong. CHINA 3014749926
Cindy Ye Chief Executive Officer Telephone: +852 2833 9010 Email: cindy.ye@gahealth.com
Lam Wing Yu Assistant Requlatory Affairs Manager Telephone: +852 2833 9010 Email: rainy.lam@gahealth.com
3. Date Prepared
1 June 2023
4. Device Identification
Device Name: Common Name: Classification Number: Classification Name: Product Code: Product Code Name: Regulation Class: Device Panel:
Device Name: Common Name: Classification Number: Classification Name: Product Code: Product Code Name: Regulation Class: Device Panel:
Device Name: Common Name: Classification Number: Protego Air Water Connector Air Water Connector 21 CFR 876.1500 Endoscope and accessories OCX Endoscopic Irrigation/Suction System 2 Gastroenterology/Urology
Protego Air Water Bottle Tubing Air Water Bottle Tubing 21 CFR 876.1500 Endoscope and accessories OCX Endoscopic Irrigation/Suction System 2 Gastroenterology/Urology
Protego Hybrid Tubing Hybrid Tubing 21 CFR 876.1500
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| Classification Name: | Endoscope and accessories |
|---|---|
| Product Code: | OCX |
| Product Code Name: | Endoscopic Irrigation/Suction System |
| Regulation Class: | 2 |
| Device Panel: | Gastroenterology/Urology |
5. Predicate Device Identification
Primary Predicate Device 510(k) No.: Primarv Predicate Device Trade Name: Primary Predicate Device Product Code: Secondary Predicate Device 510(k) No .: Secondary Predicate Device Trade Name: Secondary Predicate Device Product Code:
K191366 Andorate Air Water Bottle Tubing OCX - Endoscopic Irrigation/Suction System K102855 Universal Irrigation Solution Hybrid
OCX - Endoscopic Irrigation/Suction System
6. Device Description:
The Protego Air Water Connector is intended for single use then discarded. The Protego Air Water Bottle Tubing and Protego Hybrid Tubing are intended for 24-hour use then discarded. All Protego Air Water Connector, Protego Air Water Bottle Tubing and Protego Hybrid Tubing are provided sterile. Table 1 shows the components included in the submission.
| Components | Qty | Product Code | RegulationNumber | RegulatoryClassification |
|---|---|---|---|---|
| Protego Air WaterConnector | 1 | OCX — EndoscopicIrrigation/SuctionSystem | 21 CFR 876.1500 | 2 |
| Protego Air Water BottleTubing | 1 | OCX — EndoscopicIrrigation/SuctionSystem | 21 CFR 876.1500 | 2 |
| Protego Hybrid Tubing | 1 | OCX — EndoscopicIrrigation/SuctionSystem | 21 CFR 876.1500 | 2 |
Table 1 - Components included in this Submission
The Air Water Connector is used in conjunction with air water bottle tubing or hybrid tubing, intended to supply air/CO2 and water during gastro-intestinal endoscopic procedure. It is connected to the air/water port of the endoscope to provide connection from the air/water bottle tubing to the endoscope. The Air Water Bottle Tubing is connected to the air/water port of the endoscope and the sterile water bottle to supply air/ CO2 or sterile water during the GI endoscopic procedure. The Hybrid Tubing is composed of air/water bottle tubing and irrigation tubing, which is intended to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastro-intestinal endoscopic procedure.
7. Indications for Use:
The single use Protego Air Water Connector is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures.
Protego Air Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.
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Protego Hybrid Tubing is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2, water and irrigation during endoscopic procedures in conjunction with an irrigation pump. It is a 24-hour multi-patient use device.
8. Technological Characteristics
Table 2.1 and Table 2.2 summarizes the subject devices technological characteristics as compared to the predicate devices.
Table 2.1 Summary of design, features and principles of operation and technological characteristics between the Air Water Connector, Air Water Bottle Tubing and predicate device
| Specification | Primary PredicateDevice | Subject Device | Subject Device | SubstantialEquivalence |
|---|---|---|---|---|
| Device name | Andorate Air Water BottleTubing(GAR025) | Protego Air WaterConnector(201001) | Protego Air Water BottleTubing(202001) | N/A |
| K number | K191366 | K231602 | K231602 | N/A |
| Manufacturer | GA Health CompanyLimited | GA Health CompanyLimited | GA Health CompanyLimited | N/A |
| Product code | OCX | OCX | OCX | Identical |
| RegulatoryClassification | 2 | 2 | 2 | Identical |
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| RegulationDescription | EndoscopicIrrigation/Suction System | EndoscopicIrrigation/Suction System | EndoscopicIrrigation/Suction System | Identical |
| Intended Use | The Air/Water BottleTubing is to connect anair/CO2 source, a sterilewater source (waterbottle), and an endoscopeto supply air/CO2 andwater duringgastrointestinalendoscopic procedures. Itis a 24-hour multi-patientuse device. | The single use Protego AirWater Connector isintended to connect anair/CO2 source, a sterilewater source and anendoscope to supplyair/CO2 and water duringgastrointestinalendoscopic procedures. | Protego Air Water BottleTubing is to connect anair/CO2 source, a sterilewater source (waterbottle), and an endoscopeto supply air/CO2 andwater duringgastrointestinalendoscopic procedures. Itis a 24-hour multi-patientuse device. | SubstantialEquivalent |
| Environmentof Use | Hospital and or clinics | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use orReusable | 24-hour Use | Single Use | 24-hour Use | Identical |
| Material | Acrylonitrile butadienestyrene, Silicone Rubber,Polyoxymethylene,Polyvinyl chloride,Thermoplastic elastomers, | Polycarbonate, SiliconeRubber | Acrylonitrile butadienestyrene, Silicone Rubber,Polyoxymethylene,Polyvinyl chloride,Polycarbonate,Polyethylene,Thermoplastic elastomers, | SubstantialEquivalent |
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| Specification | Primary PredicateDevice | Subject Device | Subject Device | SubstantialEquivalence |
|---|---|---|---|---|
| Device name | Andorate Air Water BottleTubing(GAR025) | Protego Air WaterConnector(201001) | Protego Air Water BottleTubing(202001) | N/A |
| K number | K191366 | K231602 | K231602 | N/A |
| Manufacturer | GA Health CompanyLimited | GA Health CompanyLimited | GA Health CompanyLimited | N/A |
| Polycarbonate,Polyethylene | ||||
| Manufacturingmethod | Injection molding,Compression molding,Extrusion | Injection molding,Compression molding | Injection molding,Compression molding,Extrusion | SubstantialEquivalent |
| Packaging | Packaged in a sealedpouch | Packaged in a sealedpouch | Packaged in a sealedpouch | SubstantialEquivalent |
| Sterilization | Yes | Yes | Yes | SubstantialEquivalent |
| Shelf Life | 3 years | 3 years | 3 years | SubstantialEquivalent |
Table 2.2 Summary of design, features and principles of operation and technological characteristics between the Hybrid Tubing and predicate device
| Specification | Secondary Predicate Device | Subject Device | SubstantialEquivalence |
|---|---|---|---|
| Device name | ENDOGATORTM Endoscopic DisposableTubing Kit(100602) | Protego Hybrid Tubing(203001) | N/A |
| K number | K102855 | K231602 | N/A |
| Manufacturer | BYRNE MEDICAL, INC. | GA Health Company Limited | N/A |
| Product code | OCX | OCX | Identical |
| RegulatoryClassification | 2 | 2 | Identical |
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| RegulationDescription | Endoscopic Irrigation/Suction System | Endoscopic Irrigation/Suction System | Identical |
| Intended Use | The Universal Irrigation Solution Hybrid(tubing and accessories toaccommodate various endoscopes andirrigation pumps) is intended to provideirrigation via sterile water and to supplyair (via an air pump) along with sterilewater during GI endoscopic procedureswhen used in conjunction with anirrigation pump or cautery unit. | Protego Hybrid Tubing is intended toconnect an air/CO2 source, a sterilewater source and an endoscope tosupply air/CO2, water and irrigationduring endoscopic procedures inconjunction with an irrigation pump. It isa 24-hour multi-patient use device. | SubstantialEquivalent |
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| Specification | Secondary Predicate Device | Subject Device | SubstantialEquivalence |
|---|---|---|---|
| Device name | ENDOGATOR™ Endoscopic DisposableTubing Kit(100602) | Protego Hybrid Tubing(203001) | N/A |
| K number | K102855 | K231602 | N/A |
| Manufacturer | BYRNE MEDICAL, INC. | GA Health Company Limited | N/A |
| Environmentof Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use orReusable | 24-hour Use | 24-hour Use | Identical |
| Material | Polycarbonate, ThermoplasticElastomer, Polyvinyl Chloride,Polyethylene, Methyl methacrylate-acrylonitrile-butadiene-styrenecopolymer | Polycarbonate, Silicone RubberPolyvinyl chloride, Polyoxymethylene,Polyethylene, Acrylonitrile butadienestyrene | SubstantialEquivalent |
| Manufacturingmethod | Injection molding, Compression molding,Extrusion | Injection molding, Compression molding,Extrusion | SubstantialEquivalent |
| Packaging | Packaged in a sealed pouch | Packaged in a sealed pouch | SubstantialEquivalent |
| Sterilization | Yes | Yes | SubstantialEquivalent |
| Shelf Life | 3 years | 3 years | SubstantialEquivalent |
9. Performance Test
The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The following bench testing was performed on the subject device - endoscope compatibility test, connector pulling force test, connector/tubing pulling force test and backflow prevention test for air water connector, air flow test, water flow test, water leak test and bottle cap compatibility test for air water bottle tubing and air flow test, water flow test, air leak test, flow clamp test and backflow prevention test for hybrid tubing. The performance data demonstrated that the subject devices met established specifications.
10. Sterilisation
All the subject devices are sold in a sterile package. The subject devices have been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10°, EO residuals on the components are below the maximum levels defined in ANSI/AAMI/ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals.
11. Shelf Life
The subject devices have a three (3) years shelf life, based on the design and existing sterile barrier data from the existing packaging integrity test in accordance with ASTM F88/F 88M-15, Standard test method for seal strength of flexible barrier materials, ASTM F1929-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by
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dye Penetration, ASTM D 3078-02, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission. DIN 58953-6. Sterilization - Sterile Supply - Part 6: Microbial Barrier Testing of Packaging Materials for Medical Devices Which Are to be Sterilized and ISO11737-2, Sterilization of Medical Devices – Microbiological Methods – Part 2: Tests of Sterility Performed in the Definition, Validation and Maintenance of a Sterilization Process and performance test were conducted after accelerated aging test according to ASTM F 1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The test result can imply that the subject devices can provide and maintain a sterile barrier and its intended performance for at least the claimed shelf life.
12. Biocompatibility
The biocompatibility of the subject device was conducted in accordance with the FDA quideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Biocompatibility testing is conducted on subject device in accordance with the ISO 10993 standard. The suction valve is non-patient contacting device while the biopsy valve is classified as an indirect patient contacting device and surface device with mucosal membrane contact for a limited duration (not more than 24 hours). The biocompatibility test was performed in accordance with the following standards - ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Test results show that all the subject devices are biocompatible.
13. Conclusion
The subject devices have the same intended use as the predicate device. Based on comparison of technological characteristics and evaluation of the characteristics through performance testing, the subject devices do not raise different questions of safety and effectiveness compared to the predicate. From a clinical perspective and comparing design specifications, the subject devices and the predicate device are substantially equivalent.
§ 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.