(161 days)
Not Found
No
The device description and performance studies focus on physical protection and compatibility, with no mention of AI/ML or related concepts.
No
The device is described as an endoscope tip guard intended to protect the endoscope during transport and storage, not for treating a disease or condition.
No
Explanation: The device is an endoscope tip guard, intended to protect the endoscope during transport and storage. It is not used to diagnose any medical condition or disease.
No
The device description clearly states it is a physical "tip guard" used to cover the distal end of an endoscope, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as protecting the tip of an endoscope during transport and storage. This is a physical protection function for a medical device, not a diagnostic test performed on a sample from the human body.
- Device Description: The description reinforces its function as a physical cover for the endoscope tip.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical accessory designed to protect another medical device (an endoscope).
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OCU
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and or clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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,
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.:
- 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@gahealth.net
Lam Wing Yu Senior Product Compliance Specialist Telephone: +852 2833 9010 Email: rainy@gahealth.net
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
Equivalence |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Product code | OCU | OCU | Identical |
| Regulatory
Classification | 2 | 2 | Identical |
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Regulation
Description | Endoscope and accessories | Endoscope and accessories | Identical |
| Endoscope
Sizes | Small: 2.7mm – 8mm
Large: 8.8mm – 14.7mm | 2.5mm - 14mm | Substantial
Equivalent |
| Indications for
Use | The Scope ProTech is a single-use, sterile endoscopic tip
protector that is intended to be
used during the transport and
storage of endoscopes for the
protection of these delicate
instruments. The Scope ProTech
is intended for the protection of
the distal tip and the bending
rubber of endoscopes with a
diameter of 2.7mm-8.0mm and
8.7mm-14.7mm. The Scope
ProTech will aid in the protection
of distal end, the lens and other
delicate components from
damage. It is not intended for
use during sterilization. | 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. | Substantial
Equivalent |
| Environment
of Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use or
Reusable | Single Use | Single Use | Identical |
| Material | Polypropylene | Silicone Rubber and High-Density Polyethylene | Substantial
Equivalent |
| Manufacturing
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-
sterile | Yes, EO gas | Substantial
Equivalent |
| Shelf Life | 3 years | 1 year | Substantial
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.