(59 days)
Not Found
No
The device description and performance studies focus on mechanical properties and functionality of a physical valve, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device is a biopsy valve that covers the opening to the biopsy/suction channel of flexible echoendoscopes and provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial, rather than directly treating a disease or condition.
No
The device is described as a biopsy valve accessory for echoendoscopes, used to cover the biopsy channel, maintain insufflation, and minimize leakage. Its function is to facilitate the biopsy procedure, not to diagnose a condition.
No
The device description clearly states it consists of a tether and cap, which are physical components, not software. The performance studies also focus on bench testing of physical properties like retention force and leakage.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an accessory used during an endoscopic procedure to cover a biopsy/suction channel. It facilitates device passage, maintains insufflation, and minimizes leakage. This is a surgical/procedural accessory, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description confirms it's an accessory to an echoendoscope, consisting of a tether and cap. This aligns with a procedural accessory.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the BioShield® biopsy valve EUS is a medical device used during an endoscopic procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ODD
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing Summary:
Performance testing was conducted to demonstrate that the proposed BioShield biopsy valve EUS are comparable to the predicate K070402 devices.
Tests conducted:
- Retention Force Testing: Objective was to determine the force required to remove the proposed devices from the echoendoscope and compare to predicate. 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). Procedure: Used a calibrated force gauge to measure tensile force. Valve was attached to the inlet port of an echoendoscope, pulled off, and force measured.
- Leakage Testing: Objective was to establish that the proposed devices do not leak when attached to a pressurized echoendoscope. 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). Procedure: Valve attached to echoendoscope, pressure tube affixed, and 5 psi water pressure introduced. Verified no leaks at biopsy valve cap.
- Device Exchange Testing: Objective was to establish that the proposed devices allow passage of endoscopic devices of varying sizes. 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). Procedure: Linear echoendoscope secured in tortuous configuration, valve attached. Inserted and removed biopsy forceps and injection needles.
- Shelf Life Testing (Accelerated aging): Tested in accordance with ASTM F1980-16.
- Biocompatibility Testing:
- Cytotoxicity: Tested in accordance with ISO 10993-5:2009.
- Irritation: Tested in accordance with ISO 10993-10: 2010.
- Sensitization: Tested in accordance with ISO 10993- 10: 2010.
- Sterilization: Tested in accordance with AAMI/ANSVISO 11135-1:2014.
Key results:
The proposed devices met all acceptance criteria of the verification testing. Testing showed the proposed biopsy valves (sterile and non-sterile) were comparable to the predicate devices in maintaining insufflation, allowing for device exchange and minimizing leakage from the biopsy port.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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
1
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
2
Indications for Use
510(k) Number (if known)
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 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.
4. Indications for Use
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.
5
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 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. | The single use BioShield®-
ERCP biopsy valve is used to
cover the opening to the biopsy/
suction channel of Olympus and
G5 and newer Fujinon
gastrointestinal endoscopes. It
provides access for endoscopic
device passage and exchange,
helps maintain sufflation,
minimizes leakage of biomaterial
from the biopsy port throughout
the endoscopic procedure, and
provides access for irrigation. | Similar |
| Construction | Valve Body
Valve Cap | Valve Body
Valve Body Insert
Valve Cap | Similar |
| Sterile/Non-sterile | Sterile & Non-sterile | Sterile & Non-sterile | Same |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Sterilization
Assurance 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 NOTIFICATION
BioShield® biopsy valve EUS – Linear | K202583
Page 4 of 7 |
| ------------------------------------------------------------------------------------------ | ------------------------ |
|---|
| Feature | BioShield® biopsy valve EUS -
Linear (Proposed) | BioShield ERCP Valve
(Predicate K070420) | Comparison |
|--------------------------|----------------------------------------------------|------------------------------------------------------------------|------------|
| Device
Dimensions | Length: 0.52"
Width: 0.52"
Height: 0.77" | Length: 0.87"
Width w/side-tabs 0.88"
Height: 0.86" | Similar |
| Target
Population | GI Endoscopic procedures | GI Endoscopic procedures | Same |
| Energy
Used/Delivered | None | None | Same |
| Method of
Application | Manual application | Manual application | Same |
| Compatible
Endoscopes | Linear Echoendoscopes | Olympus & G5 and newer
Fujinon gastrointestinal
endoscopes | 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 | Acceptance
Criteria |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| 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. |
| Device
Exchange
Testing | The BioShield biopsy valve EUS - Linear should allow
device passage and should not become detached during
instrument usage and exchange. |
| 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. |
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.
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: 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.
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: 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