(210 days)
No
The device description and intended use focus on mechanical components and fluid management during endoscopic procedures, with no mention of AI or ML capabilities.
No.
The device components are used to cover an endoscope channel, provide access for device passage, maintain insufflation, minimize leakage, and provide irrigation during endoscopic procedures, rather than directly treating a condition or disease.
No
The device is described as a biopsy valve and accessories for endoscopes, used for access, insufflation, leakage minimization, and irrigation during gastrointestinal procedures. Its function is descriptive and procedural assistance, not diagnostic analysis or information gathering.
No
The device description clearly outlines physical components made of thermoplastic elastomer and stainless steel, and the performance studies focus on physical properties like retention force and leakage. There is no mention of software as a component or function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as an accessory for gastrointestinal endoscopes, facilitating access, maintaining insufflation, minimizing leakage, and providing irrigation during endoscopic procedures. This is a procedural aid, not a device used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description reinforces the device's role as a physical component used during an endoscopic procedure. It covers the biopsy/suction channel and provides access for instruments and irrigation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples, detect markers, or provide any information for diagnosis. Its function is purely mechanical and procedural.
- Performance Studies: The performance studies focus on physical characteristics and functionality (retention force, leakage, device exchange, backflow, irrigation flow rate), not on diagnostic accuracy or analytical performance related to biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for 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 Irrieator.
The BioShield Irrigating Adaptor is intended to be used with the BioShield Biopsy Valve to provide access for irrigation.
Product codes (comma separated list FDA assigned to the subject device)
ODC, OCX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
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)
Non-clinical performance testing was conducted.
Study type: Retention Force Testing, Leakage Testing, Device Exchange Testing, Backflow testing (through check valve attached to irrigation line), Irrigation Testing using the BioShield Irrigating Adaptor, Irrigation Testing Using the Irrigation Extension Tubing (Flow Rate Testing).
Key results: All tests passed their acceptance criteria.
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.
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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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)
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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.