K Number
K211814
Device Name
Wellead Endoscopic Seal
Date Cleared
2022-01-14

(217 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
More Information

Not Found

No
The device description and performance studies focus on the mechanical properties and sealing function of a physical component, with no mention of AI or ML.

No
The device is described as a self-sealing cap intended to prevent the backflow of fluid through an endoscope's working channel. This is a mechanical function within a medical procedure, not a treatment or therapy for a disease or condition. Its purpose is to facilitate the use of an endoscope, not to provide therapy itself.

No

This device is described as a self-sealing cap for preventing fluid backflow in an endoscope's working channel. Its function is mechanical (sealing), not diagnostic (identifying or characterizing a disease or condition).

No

The device description clearly states it consists of physical components: a silicone seal, an introducer, and an optional adapter with sealing ring. The performance studies also focus on physical properties like seal strength and leakage.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "prevent the backflow of fluid through the working channel of an endoscope." This is a mechanical function related to the operation of an endoscope during a procedure.
  • Device Description: The description details a physical seal, introducer, and adapter designed to be mounted on an endoscope. It describes how it works to resist fluid backflow.
  • Performance Studies: The performance studies listed are primarily focused on the physical integrity, sealing performance, and biocompatibility of the device. These are typical tests for a medical device that interacts with the body or medical equipment, but not for a device that analyzes biological samples in vitro.
  • Lack of IVD Characteristics: There is no mention of:
    • Analyzing biological samples (blood, urine, tissue, etc.).
    • Providing diagnostic information about a patient's health status.
    • Using reagents or assays.
    • Measuring analytes or biomarkers.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and related to the operation of an endoscope during a procedure.

N/A

Intended Use / 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.

Product codes

ODC

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.

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

Not Found

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

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
  • 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

Key Results:
Fastness of connection: Identical to predicated device
Smoothness: Identical to predicated device
Sealing performance (Leakage): Identical to predicated device
Biocompatibility: Cytotoxicity test - ISO 10993-5: 2009, Sensitization - ISO 10993-10:2010, Skin irritation - ISO 10993-10:2010, Material-Mediated Pyrogenicity – ISO 10993-11: 2017, Acute Systemic Toxicity - ISO 10993-11: 2017

Key Metrics

Not Found

Predicate Device(s)

K091838

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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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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.

1

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

2

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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3

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.

SponsorOBP Corporation
Device NameOBP Self-Sealing Endoscopic Seal with Luer Lock
510(k) NumberK091838
Product CodeHIH, ODC, HET

4

| Regulation

Number21 CFR 876.1500 and 884.1690
Regulation Class2

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 �

5

  • � 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

ComparisonSubject DevicePredicate DeviceRemark
Device Name
and ModelEndoscope Seal
(Type: I)OBP Self-Sealing Endoscopic
Seal with Luer Lock--
510 (K)
NumberApplyingK091838--
Regulation
number21 CFR 876.150021 CFR 876.1500 and
884.1690SE
Regulation
descriptionEndoscope and accessoriesEndoscope and accessoriesSE
Product codeODCHIH, ODC, HETSE
ClassIIIISE
Indication for
UseEndoscopic Seal is a self-sealing cap
that is intended to prevent the backflow
of fluid through the working channel of
an endoscope.The OBP Self-Sealing
Endoscopic Seal is a single
use, sterile endosopic
introducer seal. It is afficed to
the proximal port of the
endoscope working channel. It
prevents efflux of distentionSE
Elements of
ComparisonSubject DevicePredicate DeviceRemark
fluid when the channel is not
being used or when
instruments are passed
through the working channel of
the endoscope. The seal may
be used with following types of
endoscopes:
● Hysteroscope
● Laparoscope
● Cystoscope
● Colonoscope
Prescription
useYesYesSE
SterilitySterileSterileSE
UseSingle UseSingle UseSE
ModelType IThe 4 different seals are
marked with different colored
bands: yellow (0.6mm seal),
light pink (1.2mm seal), green
(1.6mm seal), and blue
(2.0mm seal).SE
Materials of
Endoscopic
SealSiliconeSiliconeSE
Materials of
ComponentsIntroducer (POM), Adapter (PC), Sealing
Ring (Silicone)N/ASE
ComponentsIntroducer, Adapter, Sealing RingN/A, predicate device has
funnel guided entry and Luer-
Lock fitting.
Performance test result
Fastness of
connectionIdentical to predicated device
SmoothnessIdentical to predicated devicePredicate device is testedSE
Sealing
performance
(Leakage)Identical to predicated devicetogether with subject device
Elements of
ComparisonSubject DevicePredicate DeviceRemark
Biocompatibilit
yCytotoxicity test - ISO 10993-5: 2009,
Sensitization - ISO 10993-10:2010,
Skin irritation - ISO 10993-10:2010
Material-Mediated Pyrogenicity – ISO
10993-11: 2017
Acute Systemic Toxicity - ISO 10993-
11: 2017Unknown

7. Comparison to predicate device and conclusion

6

7

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.

8

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.

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