Wellead Endoscopic Seal

K211814 · Well Lead Medical Co., Ltd. · ODC · Jan 14, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K211814
• Device Name: Wellead Endoscopic Seal
• Applicant: Well Lead Medical Co., Ltd.
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Jan 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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

Device Story

Endoscopic Seal is a single-use, sterile accessory mounted to the proximal port of an endoscope working channel (6-9 mm diameter). It consists of a silicone seal, an introducer (POM), and an optional adapter (PC) with a sealing ring. The device functions as a physical barrier to prevent backflow of distention fluid when the channel is idle or when instruments are passed through. It is used by clinicians in endoscopic settings. The device benefits the patient by maintaining the integrity of the endoscopic field and preventing fluid loss during procedures.

Clinical Evidence

Bench testing only. Performance evaluated via ASTM F1929 (seal leaks), ASTM F88 (seal strength), ASTM F1886 (seal integrity), and ISO 80369-20 (connectors). Biocompatibility testing performed per ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity).

Technological Characteristics

Materials: Silicone seal, POM introducer, PC adapter. Dimensions: Compatible with 6-9 mm proximal port diameters. Connectivity: Mechanical interface. Sterilization: Sterile. Standards: ASTM F1929, F88, F1886, F1980-16; ISO 80369-20, ISO 10993-1, -5, -10, -11.

Indications for Use

Indicated for use as a self-sealing cap to prevent fluid backflow through the working channel of an endoscope during endoscopic procedures.

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

• OBP Self-Sealing Endoscopic Seal with Luer Lock (K091838)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone]-6531 �
- Contact Person (including title): Ms. Caroline Gong (RA Specialist) �
- � E-mail: [e-mail]

#### 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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| Regulation<br>Number | 21 CFR 876.1500 and 884.1690 |
|----------------------|------------------------------|
| Regulation Class | 2 |

#### 4. Device Description

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.

#### 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 of<br>Comparison | Subject Device | Predicate Device | Remark |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Device Name<br>and Model | Endoscope Seal<br>(Type: I) | OBP Self-Sealing Endoscopic<br>Seal with Luer Lock | -- |
| 510 (K)<br>Number | Applying | K091838 | -- |
| Regulation<br>number | 21 CFR 876.1500 | 21 CFR 876.1500 and<br>884.1690 | SE |
| Regulation<br>description | Endoscope and accessories | Endoscope and accessories | SE |
| Product code | ODC | HIH, ODC, HET | SE |
| Class | II | II | SE |
| Indication for<br>Use | Endoscopic Seal is a self-sealing cap<br>that is intended to prevent the backflow<br>of fluid through the working channel of<br>an endoscope. | The OBP Self-Sealing<br>Endoscopic Seal is a single<br>use, sterile endosopic<br>introducer seal. It is afficed to<br>the proximal port of the<br>endoscope working channel. It<br>prevents efflux of distention | SE |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark |
| | | fluid when the channel is not<br>being used or when<br>instruments are passed<br>through the working channel of<br>the endoscope. The seal may<br>be used with following types of<br>endoscopes:<br>● Hysteroscope<br>● Laparoscope<br>● Cystoscope<br>● Colonoscope | |
| Prescription<br>use | Yes | Yes | SE |
| Sterility | Sterile | Sterile | SE |
| Use | Single Use | Single Use | SE |
| Model | Type I | The 4 different seals are<br>marked with different colored<br>bands: yellow (0.6mm seal),<br>light pink (1.2mm seal), green<br>(1.6mm seal), and blue<br>(2.0mm seal). | SE |
| Materials of<br>Endoscopic<br>Seal | Silicone | Silicone | SE |
| Materials of<br>Components | Introducer (POM), Adapter (PC), Sealing<br>Ring (Silicone) | N/A | SE |
| Components | Introducer, Adapter, Sealing Ring | N/A, predicate device has<br>funnel guided entry and Luer-<br>Lock fitting. | |
| Performance test result | | | |
| Fastness of<br>connection | Identical to predicated device | | |
| Smoothness | Identical to predicated device | Predicate device is tested | SE |
| Sealing<br>performance<br>(Leakage) | Identical to predicated device | together with subject device | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Remark |
| Biocompatibilit<br>y | Cytotoxicity test - ISO 10993-5: 2009,<br>Sensitization - ISO 10993-10:2010,<br>Skin irritation - ISO 10993-10:2010<br>Material-Mediated Pyrogenicity – ISO<br>10993-11: 2017<br>Acute Systemic Toxicity - ISO 10993-<br>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.

8. Date of the summary prepared: January 7, 2022