(210 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 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 BioShield 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 option to the user to irrigate. All valves, with the exception of one version, are supplied non-sterile.
There are two accessories 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 Irrigator consists of a luer connection attached to a stainless-steel tip. The Bioshield Irrigator 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 accessories are provided non-sterile.
Here's an analysis of the provided text, extracting the acceptance criteria and study details as requested. It's important to note that this document is a 510(k) summary for a medical device and therefore focuses on non-clinical performance testing (bench and simulated use), not clinical studies involving human patients or complex AI algorithms requiring ground truth establishment through expert consensus.
The document discusses devices related to gastrointestinal endoscopes (BioShield Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor). The testing described is primarily focused on the mechanical and fluid dynamic performance of these physical devices, not on diagnostic performance or interpretation of medical images.
Acceptance Criteria and Reported Device Performance
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Retention Force Testing (BioShield Biopsy Valves) | The retention force of the BioShield Biopsy valves must be equal to or greater than the predicate device as documented in K070420 (3.2 lbs.). | Pass |
| Leakage Testing (BioShield Biopsy Valves) | The BioShield biopsy valves must not spray or experience geyser type leaks while the endoscope is pressurized. | Pass |
| Device Exchange Testing (BioShield Biopsy Valves) | The BioShield Biopsy valves should allow device passage and should not become detached during instrument usage and exchange. | Pass |
| Backflow testing (through check valve attached to irrigation line) | The BioShield Biopsy Valve Irrigator Olympus/Fuji and Pentax must not leak through the check valve located on the irrigation line while the endoscope is pressurized. | Pass |
| Irrigation Testing (using the BioShield Irrigating Adaptor) | During irrigation, the biopsy valve should not experience spraying geyser type leaks. | Pass |
| Irrigation Testing (Using the Irrigation Extension Tubing - Flow Rate Testing) | The average amount of water displaced when using the BioShield Irrigation Extension tubing must be equal to ± 15% of the average amount of water displaced when the BioShield Irrigation tubing was not used. Also, water flow should not occur when the pinch clamp is closed. | Pass |
Study Details (Based on the provided text)
Given that this is a 510(k) summary for physical medical devices and not an AI/software device, many of the requested categories related to AI performance, human readers, and image interpretation are not applicable (N/A) to this document. The testing described is "Non-clinical performance testing" which "consisted of ... bench and simulated use testing."
1. Sample sized used for the test set and the data provenance:
* Sample Size: Not explicitly stated for each test, but the nature of bench and simulated use testing implies a sample size sufficient to demonstrate consistent performance across different models/versions of the device and against the predicate.
* Data Provenance: The document does not specify country of origin for the test data for these non-clinical tests. The tests are "bench and simulated use testing," implying laboratory-based evaluations rather than patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* N/A. Ground truth in the context of expert review for diagnostic/AI performance is not applicable here. The "ground truth" for these mechanical tests is based on measurable physical properties (e.g., force, flow rate, or visual observation of leakage/spraying) and comparison to a predicate device's established performance.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* N/A. Adjudication methods are typically used in clinical studies or AI performance evaluations involving subjective human assessment. For these mechanical/fluid dynamic tests, results are objective (Pass/Fail based on quantitative and qualitative criteria).
4. 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:
* N/A. This applies to AI-assisted diagnostic tools, not to physical endoscope accessories.
5. Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* N/A. This applies to AI algorithms. The device itself is a physical accessory.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Bench and Simulated Use Data / Objective Measurements / Predicate Device Performance. The ground truth for evaluating these devices is their ability to meet defined physical and functional criteria, often compared directly to a legally marketed predicate device's known performance characteristics (e.g., retention force = 3.2 lbs).
7. The sample size for the training set:
* N/A. No "training set" in the context of machine learning is applicable. Device development would involve iterative design and testing, but not a formally defined AI training set.
8. How the ground truth for the training set was established:
* N/A. As no AI training set is involved, this question is not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
September 3, 2021
STERIS Corporation Carroll Martin Regulatory Affairs Director 5976 Heislev Rd Mentor, OH 44060
Re: K210342
Trade/Device Name: BioShield- ERCP Biopsy Valve, BioShield Irrigator -Extension Tubing, BioShield Irrigating Adaptor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC, OCX Dated: August 2, 2021 Received: August 4, 2021
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general control's 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
{1}------------------------------------------------
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-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 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,
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) K210342
Device Name BioShield Biopsy Valve BioShield Irrigator - Extension Tubing BioShield Irrigating Adaptor
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the first page of a document, labeled "K210342 Page 1 of 8". The page features the STERIS logo in large, bold, sans-serif font. Below the company name is an image of several horizontal wavy lines in blue, resembling water.
510(k) Summary for the BioShield Biopsy Valve
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
| Contact: | Carroll Martin |
|---|---|
| Regulatory Affairs Director | |
| Tel: 440-358-6259 | |
| Email: Carroll_Martin@steris.com |
March 15, 2021 Submission Date:
{4}------------------------------------------------
1. Device Name
| Trade Name: | BioShield Biopsy Valve |
|---|---|
| BioShield Irrigator – Extension Tubing | |
| BioShield Irrigating Adaptor | |
| Device Class: | Class II |
| Regulation Name: | Endoscope and Accessories |
| Common/usual Name: | Biopsy Valve |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | OCX, ODC |
2. Predicate Device
BioShield - ERCP Biopsy Valve, K070420 Irrigation System, K103239 Medovations BullDog Biopsy Valve Irrigating Adaptor Accessory, K142068
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 option to the user to irrigate. All valves, with the exception of one version, are supplied non-sterile.
There are two accessories 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 Irrigator consists of a luer connection attached to a stainless-steel tip. The Bioshield Irrigator 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 accessories are provided non-sterile.
{5}------------------------------------------------
| Product Name | Part Number | Sterility Status |
|---|---|---|
| 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 Accessories
Indications for Use 4.
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 Biopsy Valve Irrigating Adaptor Accessory is intended to be used with the biopsy valve to provide access for irrigation.
ട്. Technological Characteristics Comparison Table
A comparison of technical characteristics between the proposed BioShield Biopsy Valve and its predicate can be found in Table 1. A comparison of technical characteristics between the proposed accessory, the BioShield Irrigation Extension Tubing and its predicate can be found in Table 2. A comparison of technical characteristics between the proposed accessory, the BioShield Irrigating Adaptor and its predicate can be found in Table 3.
{6}------------------------------------------------
| Features | BioShield - ERCP BiopsyValvePredicate Device K070420 | BioShield Biopsy Device(Proposed Device) | Comparison |
|---|---|---|---|
| Intended Use | The single-use BioShield -ERCP biopsy valve is used tocover the opening to thebiopsy/suction channel ofOlympus and G5 and newerFujinon gastrointestinalendoscopes. It provides accessfor endoscopic device passageand exchange, helps maintainsufflation, minimizes leakage ofbiomaterial from the biopsy portthroughout the endoscopicprocedure and provides accessfor irrigation. | The single-use BioShieldbiopsy valve is used to coverthe opening to thebiopsy/suction channel ofgastrointestinal endoscopes.It provides access forendoscopic device passageand exchange, helps maintaininsufflation, minimizesleakage of biomaterial fromthe biopsy port throughoutthe endoscopic procedure andprovides access for irrigation. | Similar. This changedoes not impact howthe device is used. Themodified device has thesame fundamentaltechnology as thepredicate. The terms"sufflation" and"insufflation have thesame meaning. |
| Construction | Valve BodyValve Body InsertValve Cap | Valve BodyValve CapIrrigation Line | Similar. The valvebody insert helped thevalve maintaininsufflation andmitigate leakage.Testing has shown thatremoval of the insertdid not affect thesefeatures of the device.The addition of theirrigation line gives theuser another option toirrigate through thevalve. |
| Sterile/Non-sterile | Sterile and Non-sterile | Sterile and Non-sterile (onlythe 00711128 valve is suppliedsterile) | Identical |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide | Identical |
| SterilizationAssurance Level | 10-6 | 10-6 | Identical |
| Usage | Single use | Single use | Identical |
| Materials (bycomponent) | Valve Body and valve capThermoplastic elastomer | Valve Body and valve cap:Thermoplastic elastomerIrrigation Line: PolyvinylchlorideCheck valveHousing - PolycarbonateDiaphragm: SiliconeIrrigation line: Polyvinylchloride | The same material forthe valve. Differentmaterials for thecomponents. Testing ofthe components showsno effect on safety oreffectiveness of theproposed valvesthemselves. |
| Target Population | Patients undergoing anendoscopic procedure | Patients undergoing anendoscopic procedure | Identical |
{7}------------------------------------------------
| EnergyUsed/Delivered | None | None | Identical |
|---|---|---|---|
| Method ofApplication | Manual | Manual | Identical |
| CompatibleEndoscopes | Olympus and G5 and newerFujinon gastrointestinalendoscopes | Pentax, Olympus and G5 andnewer Fujinongastrointestinal endoscopes | Similar. The addition ofusing the valve onPentax endoscopes issimilar to the predicatein that the fundamentaltechnology and the useof the valve on Pentaxendoscopes is identicalto the predicate. |
| Number ofDevices/Box | 25 | 50, 100, 200 depending onSKU | Similar. This change issimilar to the predicatein that the packaging ofthe device has notchanged, only thenumber of devices in abox. |
| IrrigationAccessories | None | The BioShield IrrigatingAdaptor consisting of apolypropylene luer lockconnected to a stainless-steeltip.The BioShield IrrigationExtension tubing consists of a180cm piece of polyvinylchloride tubing with a femaleconnector made ofpolycarbonate on one end anda male connector made ofABS plastic on the other end | This is different thanthe predicate device inthat these accessorieswere not offered foruse. But testing hasshown that use of theseaccessories does notimpact the safety oreffectiveness of theBioShield Biopsyvalves. |
{8}------------------------------------------------
| Features | US Endoscopy's | BioShield Irrigator - | Comparison |
|---|---|---|---|
| Irrigation System,K103239 | extension tubing,K210342 | ||
| Intended Use | The Irrigation System(tubing and accessories toaccommodate variousendoscopes and irrigationpumps) is intended toprovide irrigation viairrigation fluids, such assterile water, duringgastrointestinal endoscopicprocedures when used inconjunction with anirrigation pump orelectrosurgical unit. | The BioShield Irrigator- extension tubing isintended to provideirrigation via irrigationfluids, such as sterilewater, duringgastrointestinalendoscopic procedureswhen used inconjunction with theBioShield Irrigator. | Similar. The BioShieldIrrigator - extensiontubing is not connecteddirectly to an irrigationpump or electrosurgicalunit but can beconnected to irrigationtubing providing thesame exact purpose ofUS Endoscopy'sIrrigation System, thatis to provide irrigationfluids to the endoscope.Whereas the intendeduse of the two devicesis not exactly the same,the differences do notalter the intendedtherapeutic effect of thedevice. Thefundamental technologyof attaching to a watersource and providingirrigation fluids to anendoscope are exactlythe same. |
| Construction | Irrigation Tubing Set:Consists of 110 in(279.4cm) irrigation tubingthat has a connector on oneend (to connect to thescope connector) and avented bottle cap on theother end that goes into awater bottle.Scope Connector:Consists of twoconnectors, one on eachend and a check valve inthe middle. | BioShield Irrigator -extension tubing:Consists of a 70.9 in(180cm) piece ofirrigation tubing withconnectors on both endsthat allow for connectionto the BioShield Biopsyvalve with the built-inirrigation line and to awater source. | Similar. Both deviceshave irrigation tubing asa component. Thisirrigation tubing servesthe same purpose; toconnect a water sourceto the endoscope for thepurpose of providingirrigation fluids. TheUS EndoscopyIrrigation system has ascope connector with acheck valve to protectagainst backflow. Thischeck valve connectsdirectly to theendoscope. TheBioShield Irrigator -extension tubing doesnot have a check valve,it is connected to the |
| BioShield Biopsy valvewith irrigation line thatdoes have a checkvalve. Both devicesconnect to an irrigationsource and to theendoscope. | |||
| Materials ofConstruction | Irrigation tubing: PVCCap: PVCScope Connector:Polyetherimide | BioShield Irrigator –extension tubing: PVCMale connector: ABSplasticFemale connector:polycarbonate | Similar. The irrigationtubing portion of bothdevices are made ofPVC. |
| Sterility | Sterile | Non-sterile | Different. The Pure VuSystem, K210981 is asimilar reference devicethat is provided in anon-sterile state. |
Table 2. BioShield Irrigator Extension Tubing Technological Characteristics Comparison Table
{9}------------------------------------------------
Table 3. BioShield Biopsy Valve Irrigating Adaptor Technological Characteristics Comparison Table
| Features | Medovations BullDogBiopsy Valve IrrigatingAdaptor Accessory,K142068 | BioShield Biopsy ValveIrrigating AdaptorAccessory, K210342 | Comparison |
|---|---|---|---|
| Intended Use | The BullDog Biopsy ValveIrrigating AdaptorAccessory is intended tobe used with the biopsyvalve to provide access forirrigation. | The BioShield BiopsyValve Irrigating AdaptorAccessory is intended tobe used with the biopsyvalve to provide accessfor irrigation. | Same |
| Construction | Hollow metal tube withstandard plastic luer lockconnector | Hollow metal tube withstandard plastic luer lockconnector | Same |
{10}------------------------------------------------
Summarv of Non-Clinical Performance Testing 6.
| Testing | Acceptance Criteria | Results |
|---|---|---|
| Retention ForceTesting | The retention force of the BioShieldBiopsy valves must be equal to or greaterthan the predicate device as documented inK070420 (3.2 lbs.). | Pass |
| Leakage Testing | The BioShield biopsy valves must notspray or experience geyser type leakswhile the endoscope is pressurized | Pass |
| Device ExchangeTesting | The BioShield Biopsy valves should allowdevice passage and should not becomedetached during instrument usage andexchange. | Pass |
| Backflow testing(through check valveattached to irrigationline) | The BioShield Biopsy Valve IrrigatorOlympus/Fuji and Pentax must not leakthrough the check valve located on theirrigation line while the endoscope ispressurized. | Pass |
| Irrigation Testingusing the BioShieldIrrigating Adaptor | During irrigation, the biopsy valve shouldnot experience spraying geyser type leaks. | Pass |
| Irrigation TestingUsing the IrrigationExtension Tubing(Flow Rate Testing) | The average amount of water displacedwhen using the BioShield IrrigationExtension tubing must be equal to ± 15%of the average amount of water displacedwhen the BioShield Irrigation tubing wasnot used. Also, water flow should notoccur when the pinch clamp is closed. | Pass |
Non-clinical testing consisted of the following:
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data (bench and simulated use testing), the subject device has 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.