BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor

Q: Who is the manufacturer of BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

STERIS Corporation filed the 510(k) submission for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor (K210342).

Q: What is the FDA product code for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

ODC. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

BioShield - ERCP Biopsy Valve (K070420); Irrigation System (K103239); Medovations BullDog Biopsy Valve Irrigating Adaptor Accessory (K142068).

Q: Who can help prepare an FDA 510(k) submission like BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K210342 · STERIS Corporation · ODC · Sep 3, 2021 · Gastroenterology, Urology

Device Facts

Record ID	K210342
Device Name	BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
Applicant	STERIS Corporation
Product Code	ODC · Gastroenterology, Urology
Decision Date	Sep 3, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

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.

Device Story

BioShield system comprises single-use biopsy valves, irrigators, and extension tubing for GI endoscopes. Valves cover biopsy/suction channels; provide access for instrument passage/exchange; maintain insufflation; minimize biomaterial leakage. Irrigators and extension tubing facilitate delivery of irrigation fluids (e.g., sterile water) during procedures. Used in clinical settings by physicians/endoscopy staff. Device transforms manual input from clinician (attaching syringe or irrigation source) to deliver fluid through valve port. Benefits include improved procedural efficiency, reduced leakage, and simplified irrigation access. No electronic or software components; purely mechanical operation.

Clinical Evidence

Bench testing only. Testing included retention force, leakage, device exchange, backflow, and irrigation flow rate testing. All tests passed acceptance criteria.

Technological Characteristics

Materials: Thermoplastic elastomer (valve body/cap), Polyvinyl chloride (irrigation line/tubing), Polycarbonate (housing/connectors), Silicone (diaphragm), ABS plastic (connectors), Stainless steel (irrigator tip). Manual operation; no energy source. Dimensions: 180 cm extension tubing. Sterilization: Ethylene Oxide (for sterile versions). Connectivity: None. Software: None.

Indications for Use

Indicated for patients undergoing gastrointestinal endoscopic procedures requiring biopsy/suction channel access, insufflation maintenance, and/or irrigation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

BioShield - ERCP Biopsy Valve (K070420)
Irrigation System (K103239)
Medovations BullDog Biopsy Valve Irrigating Adaptor Accessory (K142068)

Reference Devices

Pure Vu System (K210981)

Related Devices

K142068 — BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON;PENTAX COMPATIBLE;DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE · Medovations, Inc. · Mar 10, 2015
K232951 — 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) · Steris · Oct 20, 2023
K070420 — BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138 · United States Endoscopy Group, Inc. · Mar 19, 2007
K192048 — Single Use Endoscope Valves Set · Anrei Medical (Hangzhou) Co., Ltd. · May 14, 2020
K220884 — Disposable Endoscope Valve Sets · Sml Med-Tech Solutions Limited · Jan 17, 2023

Submission Summary (Full Text)

{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 ">– extension tubing (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 Biopsy Valve Predicate Device K070420 | BioShield Biopsy Device (Proposed Device) | Comparison | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | 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. | 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. | Similar. This change does not impact how the device is used. The modified device has the same fundamental technology as the predicate. The terms "sufflation" and "insufflation have the same meaning. | | Construction | Valve Body Valve Body Insert Valve Cap | Valve Body Valve Cap Irrigation Line | Similar. The valve body insert helped the valve maintain insufflation and mitigate leakage. Testing has shown that removal of the insert did not affect these features of the device. The addition of the irrigation line gives the user another option to irrigate through the valve. | | Sterile/Non- sterile | Sterile and Non-sterile | Sterile and Non-sterile (only the 00711128 valve is supplied sterile) | Identical | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical | | Sterilization Assurance Level | 10-6 | 10-6 | Identical | | Usage | Single use | Single use | Identical | | Materials (by component) | Valve Body and valve cap Thermoplastic elastomer | Valve Body and valve cap: Thermoplastic elastomer Irrigation Line: Polyvinyl chloride Check valve Housing - Polycarbonate Diaphragm: Silicone Irrigation line: Polyvinyl chloride | The same material for the valve. Different materials for the components. Testing of the components shows no effect on safety or effectiveness of the proposed valves themselves. | | Target Population | Patients undergoing an endoscopic procedure | Patients undergoing an endoscopic procedure | Identical | {7}------------------------------------------------ | Energy Used/Delivered | None | None | Identical | |---------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Method of Application | Manual | Manual | Identical | | Compatible Endoscopes | Olympus and G5 and newer Fujinon gastrointestinal endoscopes | Pentax, Olympus and G5 and newer Fujinon gastrointestinal endoscopes | Similar. The addition of using the valve on Pentax endoscopes is similar to the predicate in that the fundamental technology and the use of the valve on Pentax endoscopes is identical to the predicate. | | Number of Devices/Box | 25 | 50, 100, 200 depending on SKU | Similar. This change is similar to the predicate in that the packaging of the device has not changed, only the number of devices in a box. | | Irrigation Accessories | None | The BioShield Irrigating Adaptor consisting of a polypropylene luer lock connected to a stainless-steel tip. The BioShield Irrigation Extension tubing consists of a 180cm piece of polyvinyl chloride tubing with a female connector made of polycarbonate on one end and a male connector made of ABS plastic on the other end | This is different than the predicate device in that these accessories were not offered for use. But testing has shown that use of these accessories does not impact the safety or effectiveness of the BioShield Biopsy valves. | {8}------------------------------------------------ | Features | US Endoscopy's | BioShield Irrigator - | Comparison | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Irrigation System, K103239 | extension tubing, K210342 | | | Intended Use | The Irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit. | 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. | Similar. The BioShield Irrigator - extension tubing is not connected directly to an irrigation pump or electrosurgical unit but can be connected to irrigation tubing providing the same exact purpose of US Endoscopy's Irrigation System, that is to provide irrigation fluids to the endoscope. Whereas the intended use of the two devices is not exactly the same, the differences do not alter the intended therapeutic effect of the device. The fundamental technology of attaching to a water source and providing irrigation fluids to an endoscope are exactly the same. | | Construction | Irrigation Tubing Set: Consists of 110 in (279.4cm) irrigation tubing that has a connector on one end (to connect to the scope connector) and a vented bottle cap on the other end that goes into a water bottle. Scope Connector: Consists of two connectors, one on each end and a check valve in the middle. | BioShield Irrigator - extension tubing: Consists of a 70.9 in (180cm) piece of irrigation tubing with connectors on both ends that allow for connection to the BioShield Biopsy valve with the built-in irrigation line and to a water source. | Similar. Both devices have irrigation tubing as a component. This irrigation tubing serves the same purpose; to connect a water source to the endoscope for the purpose of providing irrigation fluids. The US Endoscopy Irrigation system has a scope connector with a check valve to protect against backflow. This check valve connects directly to the endoscope. The BioShield Irrigator - extension tubing does not have a check valve, it is connected to the | | | | | BioShield Biopsy valve with irrigation line that does have a check valve. Both devices connect to an irrigation source and to the endoscope. | | Materials of Construction | Irrigation tubing: PVC Cap: PVC Scope Connector: Polyetherimide | BioShield Irrigator – extension tubing: PVC Male connector: ABS plastic Female connector: polycarbonate | Similar. The irrigation tubing portion of both devices are made of PVC. | | Sterility | Sterile | Non-sterile | Different. The Pure Vu System, K210981 is a similar reference device that is provided in a non-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 BullDog Biopsy Valve Irrigating Adaptor Accessory, K142068 | BioShield Biopsy Valve Irrigating Adaptor Accessory, K210342 | Comparison | |--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Intended Use | The BullDog Biopsy Valve Irrigating Adaptor Accessory is intended to be used with the biopsy valve to provide access for irrigation. | The BioShield Biopsy Valve Irrigating Adaptor Accessory is intended to be used with the biopsy valve to provide access for irrigation. | Same | | Construction | Hollow metal tube with standard plastic luer lock connector | Hollow metal tube with standard plastic luer lock connector | Same | {10}------------------------------------------------ #### Summarv of Non-Clinical Performance Testing 6. | Testing | Acceptance Criteria | Results | |---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Retention Force Testing | 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 | The BioShield biopsy valves must not spray or experience geyser type leaks while the endoscope is pressurized | Pass | | Device Exchange Testing | 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 | 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.