(29 days)
The single-use BioShield biopsy valve is used to cover the biopsy/suction channel of gastrointestinal endoscopes. 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 BioShield Irrigator – extension tubing is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with the BioShield Irrigator.
The BioShield Irrigating Adaptor is intended to be used with the biopsy valve to provide access for irrigation.
The BioShield biopsy valve is a single-use disposable cap that is used to cover the biopsy/suction channel of endoscopes during endoscopic procedures and other procedures. It provides access to the endoscope's working channel, minimizes leakage of biomaterial and other fluids during insufflation and instrument exchange and allows for irrigation. The device consists of a valve body and a cap. The device is made from thermoplastic elastomer. There are a total of 10 versions of the BioShield biopsy valve. All 10 versions of the BioShield Biopsy valve are subject to the major change of removing the skirt that aided in maintaining insufflation in the predicate device and two of these 10 versions have had an irrigation line added. Seven versions of the biopsy valve that are compatible with Olympus and Fujinon endoscopes and three versions of the valve that are compatible with Pentax endoscopes. Also, of these 10 versions, there are two versions that have an irrigation line to provide another irrigation option for the user. All valves, with the exception of one version, are supplied non-sterile.
There are two irrigation devices provided with the BioShield biopsy valve. These devices were not previously cleared under the 510(k) process. Their product code is OCX. They are the BioShield Irrigator and the BioShield Irrigator Extension Tubing. The BioShield Irrigating Adaptor consists of a luer connection attached to a stainlesssteel tip. The Bioshield Irrigating Adaptor is used for intraprocedural gastrointestinal endoscopic irrigation when attached to a luer-lock or slip-tip syringe directly through the BioShield biopsy valve. The BioShield Irrigator Extension Tubing is a 180 cm long piece of irrigation tubing that has connectors on both ends. The tubing can be connected to a BioShield Irrigator biopsy valve on one end and to an irrigation system (irrigation tubing connected to an irrigation source used with an auxiliary water pump) on the other end in order to provide hands-free foot pedal irrigation control. Both of these irrigation devices are provided non-sterile.
This document describes the premarket notification (510(k)) for the BioShield Biopsy Valve, Irrigator, and Irrigating Adaptor. The focus of the provided text is primarily on the regulatory submission and does not detail a study proving device performance against acceptance criteria in the typical sense of a clinical or non-clinical performance study with detailed methodologies, sample sizes, or ground truth establishment.
Instead, the document states: "Based on the intended use, technological characteristics and non-clinical performance data, the subject device is shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use." This implies that the 'study' to prove the device meets acceptance criteria is primarily a non-clinical performance testing suite designed to demonstrate equivalence to a predicate device and compliance with material and functional safety standards.
Here's the information extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Leakage Testing | The BioShield Irrigating Adaptor must not spray or experience geyser type leaks. | Pass |
| Biocompatibility Testing | The BioShield Irrigating Adaptor patient-contacting materials must be non-cytotoxic, a non-sensitizer, a non-irritant, and non-pyrogenic. | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the leakage or biocompatibility testing. The data provenance is non-clinical, meaning it's likely conducted in a laboratory setting. There is no information regarding country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on medical images or pathology reports) is not relevant for non-clinical performance tests like leakage or biocompatibility. These tests rely on predefined technical standards and measurements.
4. Adjudication method for the test set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert disagreement on ground truth might occur. For non-clinical performance tests, results are usually objective measurements against established criteria.
5. If a multi reader multi case (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 document describes a medical device (biopsy valve, irrigator, adaptor), not an AI/software device. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This document describes a medical device, not an algorithm or AI.
7. The type of ground truth used
For the non-clinical performance testing:
- Leakage Testing: The ground truth is the absence of spraying or geyser-type leaks, which would be objectively observed during the test.
- Biocompatibility Testing: The ground truth is established by adherence to recognized biocompatibility standards (e.g., ISO 10993 series), which involve laboratory assays and tests to determine cytotoxicity, sensitization, irritation, and pyrogenicity. The 'Pass' result indicates compliance with these established biological safety criteria.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 20, 2023
Steris Carroll Martin Director, Regulatory Affairs 5976 Heisley Rd Mentor, Ohio 44060
Re: K232951
Trade/Device Name: BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: ODC, OCX Dated: September 18, 2023 Received: September 21, 2023
Dear Carroll Martin:
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 (the 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 available 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
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Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devicereporting-mdr-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/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
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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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen -S
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) K232951
Device Name
BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711139); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711 133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134)
Indications for Use (Describe)
The single-use BioShield biopsy valve is used to cover the biopsy/suction channel of gastrointestinal endoscopes. 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 BioShield Irrigator - extension tubing is intended to provide irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with the BioShield Irrieator.
The BioShield Irrigating Adaptor is intended to be used with the BioShield Biopsy Valve to provide access for irrigation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K232951 Page 1 of 4
Image /page/4/Picture/1 description: The image shows the logo for STERIS. The logo consists of the word "STERIS" in a serif font, with the registered trademark symbol to the right of the word. Below the word is an image of several horizontal wavy lines in blue.
510(k) Summary for the BioShield Biopsy Valve BioShield Irrigator – extension tubing BioShield Irrigating Adaptor
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
| Contact: | Carroll Martin |
|---|---|
| Regulatory Affairs Director | |
| Tel: 440-358-6259 | |
| Email: Carroll_Martin@steris.com |
Submission Date: September 18, 2023
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | BioShield Biopsy Valve |
|---|---|
| BioShield Irrigator – Extension Tubing | |
| BioShield Irrigating Adaptor | |
| Device Class: | Class II |
| Regulation Name: | Endoscope channel accessory |
| Endoscopic irrigation/suction system | |
| Common/usual Name: | Biopsy Valve |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | ODC, OCX |
2. Predicate Device
BioShield - ERCP Biopsy Valve, K210342 BioShield Irrigator - Extension Tubing, K210342 BioShield Irrigating Adaptor, K210342
3. Device Description
The BioShield biopsy valve is a single-use disposable cap that is used to cover the biopsy/suction channel of endoscopes during endoscopic procedures and other procedures. It provides access to the endoscope's working channel, minimizes leakage of biomaterial and other fluids during insufflation and instrument exchange and allows for irrigation. The device consists of a valve body and a cap. The device is made from thermoplastic elastomer. There are a total of 10 versions of the BioShield biopsy valve. All 10 versions of the BioShield Biopsy valve are subject to the major change of removing the skirt that aided in maintaining insufflation in the predicate device and two of these 10 versions have had an irrigation line added. Seven versions of the biopsy valve that are compatible with Olympus and Fujinon endoscopes and three versions of the valve that are compatible with Pentax endoscopes. Also, of these 10 versions, there are two versions that have an irrigation line to provide another irrigation option for the user. All valves, with the exception of one version, are supplied non-sterile.
There are two irrigation devices provided with the BioShield biopsy valve. These devices were not previously cleared under the 510(k) process. Their product code is OCX. They are the BioShield Irrigator and the BioShield Irrigator Extension Tubing. The BioShield Irrigating Adaptor consists of a luer connection attached to a stainlesssteel tip. The Bioshield Irrigating Adaptor is used for intraprocedural gastrointestinal endoscopic irrigation when attached to a luer-lock or slip-tip syringe directly through the BioShield biopsy valve. The BioShield Irrigator Extension Tubing is a 180 cm long piece of irrigation tubing that has connectors on both ends. The tubing can be connected to a BioShield Irrigator biopsy valve on one end and to an irrigation system (irrigation tubing connected to an irrigation source used with an auxiliary water pump) on the other end in order to provide hands-free foot pedal irrigation control. Both of these irrigation devices are provided non-sterile.
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| Product Name | Part Number | SterilityStatus |
|---|---|---|
| BioShield – biopsy valve | 00711124 | Non-sterile |
| BioShield – biopsy valve | 00711125 | Non-sterile |
| BioShield – biopsy valve | 00711126 | Non-sterile |
| BioShield – biopsy valve | 00711127 | Non-sterile |
| BioShield – biopsy valve-sterile | 00711128 | Sterile |
| BioShield – biopsy valve | 00711129 | Non-sterile |
| BioShield Irrigating Adaptor | 00711131 | Non-sterile |
| BioShield – irrigator | 00711133 | Non-sterile |
| BioShield Irrigator – extensiontubing (180 cm) | 00711134 | Non-sterile |
| BioShield – biopsy valve | 00711135 | Non-sterile |
| BioShield – biopsy valve | 00711136 | Non-sterile |
| BioShield – irrigator | 00711137 | Non-sterile |
BioShield Biopsy Valves and Irrigation Devices
4. Indications for Use
The single-use BioShield biopsy valve is used to cover the opening to the biopsy/suction channel of gastrointestinal endoscopes. 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 BioShield Irrigator – extension tubing is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with the BioShield Irrigator.
The BioShield Irrigating Adaptor is intended to be used with the biopsy valve to provide access for irrigation.
ನ. Technological Characteristics Comnarison Table
A comparison of technical characteristics between the proposed BioShield Irrigating Adaptor and its predicate can be found in Table 1. There are no modifications to the BioShield Biopsy valves or the BioShield Irrigation Extension Tubing.
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| Features | BioShield IrrigatingAdaptor, K210342(Predicate Device) | Modified BioShieldIrrigating Adaptor(Proposed Device) | Comparison |
|---|---|---|---|
| Intended Use | The BioShield IrrigatingAdaptor is intended to beused with the biopsy valveto provide access forirrigation. | The BioShield IrrigatingAdaptor is intended tobe used with the biopsyvalve to provide accessfor irrigation. | Identical |
| Construction | Hollow metal tube withstandard plastic luer lockconnector. No colorant. | Hollow metal tube(stainless steel) withstandard plastic(polypropylene) luerlock connector. The luerlock has an ambercolorant. | Similar. Testing hasshown that the additionof the amber coloranthas no impact on safety,effectiveness or deviceperformance. |
Table 1. Technological Characteristics Comparison Table
6. Summarv of Non-Clinical Performance Testing
| Testing | Acceptance Criteria | Results |
|---|---|---|
| Leakage Testing | The BioShield Irrigating Adaptor must notspray or experience geyser type leaks | Pass |
| BiocompatibilityTesting | The BioShield Irrigating Adaptor patient-contacting materials must be non-cytotoxic, a non-sensitizer, a non-irritantand non-pyrogenic. | Pass |
Non-clinical testing consisted of the following:
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use.
§ 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.