The Endoscopic Seal is mounted to the proximal port of the endoscope working channel and intended to resist the backflow of distention fluid when the channel is not being used or when instruments are passed through the working channel.

The Endoscopic Seal consists of a silicone seal, an introducer, and an adapter with sealing ring (optional). The Introducer is used to enable improved access during endoscopic procedures. The Adapter and Sealing Ringare optional for Endoscopic Seal. They are used with the non-standard Luer endoscopes.

The silicone seal combined with introducer can be used with all endoscopes with the proximal port of the working channel between 6 mm to 9 mm in its largest outside diameter. Mount the silicone seal onto the working channel of the Endoscope. Make sure the connection is tight. Insert the introducer into the silicone seal.If using the WOLF endoscope, mount the adapter with sealing ring onto the endoscope working channel port first and then place the silicone seal and introducer onto the adapter.

AI/ML Overview

The provided text is a 510(k) Summary for the Endoscopic Seal. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing and comparisons, rather than providing details of a clinical study with acceptance criteria and device performance metrics in the way you've outlined for a typical AI/software device.

Therefore, for aspects related to clinical performance, ground truth, expert involvement, and AI-specific studies (MRMC, standalone), the information is not applicable as this device is a physical medical device (an endoscopic seal), not an AI/software as a medical device (SaMD).

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various bench tests conducted to demonstrate the safety and performance of the Endoscopic Seal. It does not explicitly state "acceptance criteria" in a quantitative format for most tests, but rather implies that the device "meets the requirements" or is "identical to the predicated device."

Performance Test / Element of Comparison	Acceptance Criteria (Implied)	Reported Device Performance
Physical/Mechanical Tests:
Seal Leaks (ASTM F1929)	Meets standard requirements	Tested, presumably met
Seal Strength (ASTM F88)	Meets standard requirements	Tested, presumably met
Seal Integrity (ASTM F1886)	Meets standard requirements	Tested, presumably met
Accelerated Aging (ASTM F1980-16)	Meets standard requirements for sterile barrier systems	Tested, presumably met
Small-bore connectors (ISO 80369-20)	Meets common test methods	Tested, presumably met
Fastness of connection	Identical to predicated device	Identical to predicated device
Smoothness	Identical to predicated device	Identical to predicated device
Sealing performance (Leakage)	Identical to predicated device	Identical to predicated device (tested "together with subject device" for predicate)
Biocompatibility Tests:
Cytotoxicity (ISO 10993-5: 2009)	Meets standard requirements	Meets requirements of ISO 10993-5
Sensitization (ISO 10993-10:2010)	Meets standard requirements	Meets requirements of ISO 10993-10
Skin irritation (ISO 10993-10:2010)	Meets standard requirements	Meets requirements of ISO 10993-10
Material-Mediated Pyrogenicity (ISO 10993-11: 2017)	Meets standard requirements	Meets requirements of ISO 10993-11
Acute Systemic Toxicity (ISO 10993-11: 2017)	Meets standard requirements	Meets requirements of ISO 10993-11

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated. The tests are bench tests on the device hardware itself, not clinical data.
Data Provenance: Not applicable in the context of clinical data. The tests were performed in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical device, and the "ground truth" is established by adhering to established engineering and biocompatibility standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. This is a physical device.

5. If a multi-reader multicase (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:

No. This is a physical device, not an AI/software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the physical and biocompatibility testing, the "ground truth" is defined by the acceptance criteria and methodologies specified in the cited ASTM and ISO international standards. Successful completion of these tests according to the standards serves as the evidence of compliance.

8. The sample size for the training set:

Not Applicable. This device does not involve a training set for an algorithm.

9. How the ground truth for the training set was established:

Not Applicable. This device does not involve a training set for an algorithm.

Summary

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January 14, 2022

Well Lead Medical CO., LTD. Caroline Gong RA Specialist No. 47 Guomao Avenue South. Hualong, Panyu Guangzhou, Guangdong 511434 China

Re: K211814 Trade/Device Name: Endoscopic Seal Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODC Dated: December 10, 2021 Received: December 14, 2021

Dear Caroline Gong:

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.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology 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) K211814

Device Name Endoscopic Seal

Indications for Use (Describe)

Endoscopic Seal is a self-sealing cap that is intended to prevent the backflow of fluid through the working channel of an endoscope.

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

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Welllead Medical CO., LTD �
Address: No.47, Guomao Avenue South, Hualong, Panyu, Guangzhou, China 511434 �
Tel: 86 20 8475 8878-6531 �
Contact Person (including title): Ms. Caroline Gong (RA Specialist) �
� E-mail: gongyoushan@welllead.com.cn

Subject Device Information 2.

Type of 510(k) submission: Traditional �
� Common Name: Endoscopic Seal
� Trade Name: Wellead Endoscopic Seal
Device: Endoscope Channel Accessory �
Regulation Description: Endoscope and accessories �
� Regulation Medical Specialty: Gastroenterology/Urology
Review Panel: Gastroenterology/Urology �
Product Code: ODC �
Regulation Number: 876.1500 �
� Regulation Class: 2

Predicate Device Information 3.

Sponsor	OBP Corporation
Device Name	OBP Self-Sealing Endoscopic Seal with Luer Lock
510(k) Number	K091838
Product Code	HIH, ODC, HET

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RegulationNumber	21 CFR 876.1500 and 884.1690
Regulation Class	2

4. Device Description

5. Indications for Use

Endoscopic Seal is a self-sealing cap that is intended to prevent the backflow of fluid through the working channel of an endoscope..

6. Test Summary

Endoscopic Seal has been evaluated the safety and performance by lab bench testing as following:

ASTM F1929 Standard Test Method for Detecting Seal Leaks in Po-rous Medical � Packaging by Dye Penetration
ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials �

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� ASTM F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
� ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
� ISO 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
� ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Eval-uation And Testing Within A Risk Management Process
� ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
� ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
� ISO 10993-11: 2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

Elements ofComparison	Subject Device	Predicate Device	Remark
Device Nameand Model	Endoscope Seal(Type: I)	OBP Self-Sealing EndoscopicSeal with Luer Lock	--
510 (K)Number	Applying	K091838	--
Regulationnumber	21 CFR 876.1500	21 CFR 876.1500 and884.1690	SE
Regulationdescription	Endoscope and accessories	Endoscope and accessories	SE
Product code	ODC	HIH, ODC, HET	SE
Class	II	II	SE
Indication forUse	Endoscopic Seal is a self-sealing capthat is intended to prevent the backflowof fluid through the working channel ofan endoscope.	The OBP Self-SealingEndoscopic Seal is a singleuse, sterile endosopicintroducer seal. It is afficed tothe proximal port of theendoscope working channel. Itprevents efflux of distention	SE
Elements ofComparison	Subject Device	Predicate Device	Remark
		fluid when the channel is notbeing used or wheninstruments are passedthrough the working channel ofthe endoscope. The seal maybe used with following types ofendoscopes:● Hysteroscope● Laparoscope● Cystoscope● Colonoscope
Prescriptionuse	Yes	Yes	SE
Sterility	Sterile	Sterile	SE
Use	Single Use	Single Use	SE
Model	Type I	The 4 different seals aremarked with different coloredbands: yellow (0.6mm seal),light pink (1.2mm seal), green(1.6mm seal), and blue(2.0mm seal).	SE
Materials ofEndoscopicSeal	Silicone	Silicone	SE
Materials ofComponents	Introducer (POM), Adapter (PC), SealingRing (Silicone)	N/A	SE
Components	Introducer, Adapter, Sealing Ring	N/A, predicate device hasfunnel guided entry and Luer-Lock fitting.
Performance test result
Fastness ofconnection	Identical to predicated device
Smoothness	Identical to predicated device	Predicate device is tested	SE
Sealingperformance(Leakage)	Identical to predicated device	together with subject device
Elements ofComparison	Subject Device	Predicate Device	Remark
Biocompatibility	Cytotoxicity test - ISO 10993-5: 2009,Sensitization - ISO 10993-10:2010,Skin irritation - ISO 10993-10:2010Material-Mediated Pyrogenicity – ISO10993-11: 2017Acute Systemic Toxicity - ISO 10993-11: 2017	Unknown

7. Comparison to predicate device and conclusion

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Comparison in Detail(s):

The description of indication for use for subject device is different from predicate device. However, both of them are indicated to resist the backflow of fluid around an instrument inserted through the working channel. Therefore, this difference does not affect substantially equivalence.

Although the materials of subject device is different from predicate device, we can find that the subject devices all meet the requirements of ISO 10993-5, ISO 10995-10, ISO 10993-11. So the differences of the materials will not raise any safety or effectiveness concern.

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Finial Conclusion:

The technological characteristics, features, specifications, materials, and indication for use of Endoscopic Seal is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Date of the summary prepared: January 7, 2022

Regulation Number and Section

§ 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.