Andorate Universal Endoscope Tip Guard

K202838 · Ga Health Company Limited · OCU · Mar 5, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K202838
• Device Name: Andorate Universal Endoscope Tip Guard
• Applicant: Ga Health Company Limited
• Product Code: OCU · Gastroenterology, Urology
• Decision Date: Mar 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Universal Endoscope Tip Guard is intended to protect tip of the endoscope during transport and storage. It is not intended for use during sterilization.

Device Story

The Andorate Universal Endoscope Tip Guard is a single-use protective cover for the distal end of endoscopes. It is designed to prevent damage to delicate components, including the lens and bending rubber, during transport and storage in hospital or clinical settings. The device is manufactured via injection molding using silicone rubber and high-density polyethylene. It is supplied in a sealed pouch, available in both sterile (EO gas) and non-sterile configurations. The guard accommodates endoscopes with diameters ranging from 2.5mm to 14mm. It is applied manually by clinical staff to the endoscope tip before the device is moved or stored. By providing a physical barrier, it reduces the risk of mechanical damage to the endoscope, thereby maintaining instrument integrity and potentially reducing repair costs or clinical downtime.

Clinical Evidence

Bench testing only. Performance data included compression testing and endoscope compatibility testing to verify that the device meets established specifications. Biocompatibility testing was conducted in accordance with ISO 10993-1 for limited duration mucosal membrane contact, confirming the device is biocompatible.

Technological Characteristics

Materials: Silicone rubber and high-density polyethylene. Manufacturing: Injection molding. Form factor: Protective tip guard for endoscopes (2.5mm–14mm diameter). Sterilization: Ethylene oxide (EO) gas. Single-use. No software or electronic components.

Indications for Use

Indicated for the protection of the distal tip of endoscopes during transport and storage. Not intended for use during sterilization.

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.

Predicate Devices

• Scope ProTech (K191011)

Submission Summary (Full Text)

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March 5, 2021

GA Health Company Limited Cindy Ye Chief Executive Officer Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, China

Re: K202838

Trade/Device Name: Andorate Universal Endoscope Tip Guard Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCU Dated: January 15, 2021 Received: January 28, 2021

Dear Cindy Ye:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Shanil Haugen 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) K202838

Device Name Andorate® Universal Endoscope Tip Guard

Indications for Use (Describe)

The Universal Endoscope Tip Guard is intended to protect tip of the endoscope during transport and storage. It is not intended for use during sterilization.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

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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: [phone] Email: [e-mail]

Lam Wing Yu Senior Product Compliance Specialist Telephone: [phone] Email: [e-mail]

# 3. Date Prepared

5 Mar 2021

# 4. Device Identification

- Device Name: Common Name: Classification Number: Classification Name: Product Code: Product Code Name: Requlatory Class: Device Panel
Andorate® Universal Endoscope Tip Guard Tip guard for endoscope 21 CFR 876.1500 Endoscope and accessories. OCU Endoscopic Storage Cover 2 Gastroenterology/Urology

# 5. Predicate Device Identification

Predicate Device 510(k) No.: Predicate Device Trade Name: Predicate Device Product Code: K191011 Scope ProTech OCU - Endoscopic Storage Cover

# 6. Device Description:

The Andorate® Universal Endoscope Tip Guard is intended for single use. The universal endoscope tip guard is used to cover distal end of an endoscope prior to transportation and storage. The universal endoscope tip quard is individually packed in sealed package, and it is available both non-sterile and sterile.

### 7. Indications for Use:

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The Universal Endoscope Tip Guard is intended to protect tip of the endoscope during transport and storage. It is not intended for use during sterilization.

### 8. Technological Characteristics

Table 2 summarizes the universal endoscope tip guard technological characteristics as compared to the predicate devices.

Table 2 Summary of design, features and principles of operation and technological characteristics between the subject device and predicate devices

| Specification | Predicate Device | Subject Device | Substantial<br>Equivalence |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Product code | OCU | OCU | Identical |
| Regulatory<br>Classification | 2 | 2 | Identical |
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Regulation<br>Description | Endoscope and accessories | Endoscope and accessories | Identical |
| Endoscope<br>Sizes | Small: 2.7mm – 8mm<br>Large: 8.8mm – 14.7mm | 2.5mm - 14mm | Substantial<br>Equivalent |
| Indications for<br>Use | The Scope ProTech is a single-use, sterile endoscopic tip<br>protector that is intended to be<br>used during the transport and<br>storage of endoscopes for the<br>protection of these delicate<br>instruments. The Scope ProTech<br>is intended for the protection of<br>the distal tip and the bending<br>rubber of endoscopes with a<br>diameter of 2.7mm-8.0mm and<br>8.7mm-14.7mm. The Scope<br>ProTech will aid in the protection<br>of distal end, the lens and other<br>delicate components from<br>damage. It is not intended for<br>use during sterilization. | The Universal Endoscope Tip<br>Guard is intended to protect tip<br>of the endoscope during<br>transport and storage. It is not<br>intended for use during<br>sterilization. | Substantial<br>Equivalent |
| Environment<br>of Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use or<br>Reusable | Single Use | Single Use | Identical |
| Material | Polypropylene | Silicone Rubber and High-Density Polyethylene | Substantial<br>Equivalent |
| Manufacturing<br>method | Injection molding | Injection molding | Identical |
| Packaging | Packaged in a sealed pouch | Packaged in a sealed pouch | Identical |
| Sterilization | Yes, EO gas, also supplied non-<br>sterile | Yes, EO gas | Substantial<br>Equivalent |
| Shelf Life | 3 years | 1 year | Substantial<br>Equivalent |

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### 9. Performance Test

The bench testing was performed to support substantial equivalence on both the subject device and the predicate device. The performance data demonstrated that the subject devices met established specifications such as compression test and endoscope compatibility test.

## 10. Biocompatibility

The biocompatibility of the subject devices was 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". The subject devices are classified as non-patient contact device. Notwithstanding its nonpatient contact nature, biocompatibility testing is conducted on subject device GAR107-S in accordance with the ISO 10993 standard similar with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that both the subject devices are biocompatible.

## 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.