The single use BioShield® biopsy valve EUS is used to cover the opening to the biopsy/suction channel of flexible echoendoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.

Device Description

The BioShield® biopsy valve EUS - Linear is an accessory to a linear echoendoscope. The EUS biopsy valve allows the end user to cover the accessory port of a linear echoendoscope. The BioShield® biopsy valve EUS - Linear consists of tether and cap. The biopsy valves' cap can be removed from the accessory port while being held on the echoendoscope via the tether to the cap. The biopsy valve is a single-use, disposable device that is supplied sterile or nonsterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BioShield® biopsy valve EUS - Linear, based on the provided document:

This document is a 510(k) summary for a medical device called the "BioShield® biopsy valve EUS - Linear." It describes the device's technical characteristics, indications for use, and a summary of performance testing conducted to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Testing Category	Acceptance Criteria	Reported Device Performance
Retention Force Testing	The retention force of the BioShield EUS biopsy valve - Linear (sterile & non-sterile) must be equal to or greater than the predicate device.	"Testing for the proposed biopsy valves, both sterile and non-sterile showed they were comparable to the predicate devices in maintaining insufflation, allowing for device exchange and minimizing leakage from the biopsy port. The proposed devices met all acceptance criteria of the verification testing." (implies this criterion was met)
Leakage Testing	The BioShield biopsy valve EUS - Linear (sterile & non-sterile) must be comparable to or better than the predicate device. The device(s) shall not spray or experience geyser type leaks while pressurized.	"Testing for the proposed biopsy valves, both sterile and non-sterile showed they were comparable to the predicate devices in maintaining insufflation, allowing for device exchange and minimizing leakage from the biopsy port. The proposed devices met all acceptance criteria of the verification testing." (implies this criterion was met)
Device Exchange Testing	The BioShield biopsy valve EUS - Linear should allow device passage and should not become detached during instrument usage and exchange.	"Testing for the proposed biopsy valves, both sterile and non-sterile showed they were comparable to the predicate devices in maintaining insufflation, allowing for device exchange and minimizing leakage from the biopsy port. The proposed devices met all acceptance criteria of the verification testing." (implies this criterion was met)
Shelf Life Testing	The proposed devices were accelerated aged for a period equal to one year of real-time aging prior to conducting the testing provided in this submission.	Conducted (based on the description). Further details on specific results or whether acceptable aging was achieved are not explicitly stated but are implied by the overall statement that "The proposed devices met all acceptance criteria of the verification testing."
Biocompatibility Testing	Tested in accordance with ISO 10993-5:2009 (Cytotoxicity) and ISO 10993-10: 2010 (Irritation and Sensitization).	Tested (based on the description). No specific results are provided, but compliance with standards is indicated.
Sterilization	Tested in accordance with AAMI/ANSV/ISO 11135-1:2014. Sterilization Assurance Level (SAL) of 10-6.	Tested (based on the description). An SAL of 10-6 is reported in the comparison table, and method is Ethylene Oxide.

2. Sample Sizes Used for the Test Set and Data Provenance

Retention Force Testing:
- 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
- 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).
Leakage Testing:
- 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
- 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).
Device Exchange Testing:
- 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
- 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).

Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, this testing would typically be prospective bench testing conducted by the manufacturer (Steris Corporation, located in Mentor, OH, USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. The testing described is bench testing of physical device performance (e.g., retention force, leakage, device passage), not a clinical study involving experts establishing ground truth for diagnostic or interpretative tasks.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. There wasn't a subjective assessment by experts that required adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This document describes bench testing of a physical accessory, not a diagnostic or interpretative AI-powered device that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical biopsy valve, not an algorithm or software. The "performance" being evaluated is the mechanical functionality of the valve itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on measurable physical properties and functional criteria as defined by the acceptance criteria. For example:

Retention Force: Measured force in pounds.
Leakage: Visual observation of spraying or geyser-type leaks.
Device Exchange: Observation of successful passage and non-detachment during instrument usage.
Biocompatibility/Sterilization: Adherence to established ISO/AAMI standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As mentioned above, there is no training set for this device.

Summary

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November 6, 2020

Steris Corporation Jacqueline Oliver Regulatory Affairs Specialist 5976 Heisley Rd Mentor, OH 44060

Re: K202583 Trade/Device Name: BioShield biopsy valve EUS - Linear Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODD Dated: September 3, 2020 Received: September 8, 2020

Dear Jacqueline Oliver:

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 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

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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 medical devices and radiation-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 P. Haugen, Ph.D. 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)

K202583

Device Name BioShield® biopsy valve EUS - Linear

Indications for Use (Describe)

The single use BioShield® biopsy valve EUS is used to cover the biopsy/suction channel of flexible echoendoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.

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 For the BioShield® biopsy valve EUS - Linear

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact: Jackie Oliver Regulatory Affairs Specialist Tel: 440-358-6289 Email: Jackie_oliver@steris.com

September 1, 2020 Summary Date:

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade/Device Name:	BioShield biopsy valve EUS - Linear
Regulation Number:	21 CFR 876.1500
Regulation Name:	Endoscope and accessories
Regulatory Class:	Class II
Product Code:	ODD

Predicate Device 2.

K070420 BioShield ERCP Biopsy Valve

3. Description of Device

The biopsy valve is a single-use, disposable device that is supplied sterile or nonsterile.

4. Indications for Use

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Technological Characteristic Comparison Table 5.

The BioShield® biopsy valve EUS - Linear is similar in design to the predicate and has similar intended uses. The differences between the proposed and predicate devices are the design of the valves and the particular type of endoscope on which the devices are used. The design is different than the predicate (see table below) because the BioShield® biopsy valve EUS - Linear is used on linear echoendoscopes that have different dimensions than the endoscopes that are used with the predicate device. These differences do not raise any new concerns of safety and effectiveness when compared to the predicate device.

Table 1 summarizes the similarities/differences between the proposed device and the predicate.

Feature	BioShield® biopsy valve EUS -Linear (Proposed)	BioShield ERCP Valve(Predicate K070420)	Comparison
Indications for use	The single use BioShield®biopsy valve EUS is used tocover the opening to thebiopsy/suction channel offlexible echoendoscopes. Itprovides access for endoscopicdevice passage and exchange,helps maintain insufflation,minimizes leakage ofbiomaterial from the biopsyport throughout the endoscopicprocedure and provides accessfor irrigation.	The single use BioShield®-ERCP biopsy valve is used tocover the opening to the biopsy/suction channel of Olympus andG5 and newer Fujinongastrointestinal endoscopes. Itprovides access for endoscopicdevice passage and exchange,helps maintain sufflation,minimizes leakage of biomaterialfrom the biopsy port throughoutthe endoscopic procedure, andprovides access for irrigation.	Similar
Construction	Valve BodyValve Cap	Valve BodyValve Body InsertValve Cap	Similar
Sterile/Non-sterile	Sterile & Non-sterile	Sterile & Non-sterile	Same
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Same
SterilizationAssurance Level	10-6	10-6	Same
Usage	Single use	Single use	Same
Materials	Thermoplastic Elastomer	Thermoplastic Elastomer	Same

Table 1. Proposed/Predicate Device Technological Characteristics Comparison Table

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STERIS Traditional 510(k) PREMARKET NOTIFICATIONBioShield® biopsy valve EUS – Linear	K202583Page 4 of 7
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Feature	BioShield® biopsy valve EUS -Linear (Proposed)	BioShield ERCP Valve(Predicate K070420)	Comparison
DeviceDimensions	Length: 0.52"Width: 0.52"Height: 0.77"	Length: 0.87"Width w/side-tabs 0.88"Height: 0.86"	Similar
TargetPopulation	GI Endoscopic procedures	GI Endoscopic procedures	Same
EnergyUsed/Delivered	None	None	Same
Method ofApplication	Manual application	Manual application	Same
CompatibleEndoscopes	Linear Echoendoscopes	Olympus & G5 and newerFujinon gastrointestinalendoscopes	Similar
Packaging	Polybag (non-sterile)Peel Pouch (sterile)	Polybag (non-sterile)Peel Pouch (sterile)	Same

Description of Safety and Substantial Equivalence 6.

Testing for the proposed biopsy valves, both sterile and non-sterile showed they were comparable to the predicate devices in maintaining insufflation, allowing for device exchange and minimizing leakage from the biopsy port. The proposed devices met all acceptance criteria of the verification testing. Performance testing includes:

Bench Testing Summary

Performance testing was conducted to demonstrate that the proposed BioShield biopsy valve EUS are comparable to the predicate K070402 devices.

A summary of the testing conducted is provided in the table below:

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Testing	AcceptanceCriteria
Retention ForceTesting	The retention force of the BioShield EUS biopsy valve -Linear (sterile & non-sterile) must be equal to or greater thanthe predicate device.
Leakage Testing	The BioShield biopsy valve EUS - Linear (sterile & non-sterile) must be comparable to or better than the predicatedevice. The device(s) shall notspray or experience geyser type leaks while pressurized.
DeviceExchangeTesting	The BioShield biopsy valve EUS - Linear should allowdevice passage and should not become detached duringinstrument usage and exchange.
Shelf Life Testing	The proposed devices were accelerated aged for a periodequal to one year of real-time aging prior to conducting thetesting provided in this submission.

Summary of Tests Conducted for the BioShield biopsy valve EUS - Linear

Provided below is a detailed summary of the testing activities.

Retention Force Testing

Objective: This test was intended to determine the force required to remove the proposed devices, the BioShield Biopsy Valves EUS - Linear (sterile & nonsterile) from the echoendoscope and compare those results to the predicate device.

Sample: Fifteen BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot) and 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot) were used for testing.

Procedure: The testing procedure included the use of a calibrated force gauge to measure tensile force in pounds. The BioShield biopsy valve EUS - Linear (nonsterile) was attached to the inlet port of an echoendoscope. The valve was pulled off the endoscope and the force required to remove the biopsy valve from the linear echoendoscope was measured. This procedure was repeated for the remaining non-sterile valves and the sterile valves.

Standards utilized: None

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Leakage Testing

Objective: To establish that the proposed devices, the BioShield Biopsy Valves EUS - Linear (sterile & non-sterile), do not leak when attached to a pressurized echoendoscope.

Procedure: Attach the BioShield biopsy valve EUS - Linear (non-sterile) to the inlet port of the echoendoscope. Affix a pressure tube assembly at the end of the linear echoendoscope and introduce 5 psi of water pressure up the accessory channel. Verify that leaks do not occur at the biopsy valve cap while the accessory channel is pressurized. Repeat this procedure for the remaining nonsterile valves and the sterile valves.

Standards Utilized: None

Device Exchange Testing

Objective: To establish that the proposed devices, the BioShield Biopsy Valves EUS - Linear (sterile & non-sterile), allow for the passage of endoscopic devices of varying sizes.

Procedure: Secure a linear echoendoscope to the lab bench in a tortuous configuration. Attach the BioShield Biopsy Valve EUS – Linear (non-sterile) to the inlet port of the echoendoscope. Insert and remove the below listed devices. Test insertion and removal of the following device types: biopsy forceps and injection needles.

Standards Utilized: None

Shelf Life Testing (Accelerated aging)

Tested in accordance with Standard: ASTM F1980-16 - Standard Guide For Accelerated Aging Of Sterile Barrier Systems for Medical devices.

Biocompatibility Testing:

Cytotoxicity: Tested in accordance with ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity

Irritation: Tested in accordance with ISO 10993-10: 2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

Sensitization: Tested in accordance with ISO 10993- 10: 2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization

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Sterilization

Tested in accordance with AAMI/ANSVISO 11135-1:2014, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical device

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.