(169 days)
Not Found
No
The device description and performance studies focus on mechanical control of air, water, and suction, with no mention of AI or ML capabilities.
No
The device is described as an accessory to an echoendoscope designed to control air/water and suction functions. It does not directly treat, prevent, or diagnose a condition but rather facilitates the procedural operation of the endoscope.
No
The device description indicates that the BioGuard EUS Air/Water Valve and Suction Valve are accessories that control air/water and suction functions on an endoscope during a GI endoscopic procedure. These are functional control devices for an endoscope, not devices that perform diagnostic analysis or provide diagnostic information about a patient's condition.
No
The device description explicitly states that the devices are "accessories to an echoendoscope" and are "single use devices, supplied sterile," indicating they are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are used to "control the air/water function" and "control the suction function" on an endoscope during a GI endoscopic procedure. This describes a device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description reinforces this by explaining how the valves control air, water, and suction through the endoscope's channels and to a balloon. These are all actions performed directly on or within the patient during the procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide diagnostic information about a patient's health. IVDs are designed for testing samples to diagnose, monitor, or screen for diseases or conditions.
In summary, the BioGuard EUS Air/Water Valve and Suction Valve are accessories used to control functions of an endoscope during a medical procedure performed on a patient, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The BioGuard EUS Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The BioGuard EUS Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Product codes (comma separated list FDA assigned to the subject device)
ODC, FDF
Device Description
The BioGuard EUS Air/Water Valve and the BioGuard EUS Suction Valve are accessories to an echoendoscope. The EUS Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel, control water used to wash the lens of the endoscope and insufflate a balloon at the distal end of the echoendoscope.
The EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope.
Both devices are single use devices, supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional testing assessing the air/water valves ability to control the supply of air/CO2 and water to an endoscope was conducted via bench and simulated use testing. Functional testing assessing the suction valves ability to control the evacuation of air/CO2 and water through the endoscope was conducted via bench and simulated use testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
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January 13, 2021
Steris Corporation Carroll Martin Regulatory Affairs Director 5976 Heislev Road Mentor, OH 44060
Re: K202104
Trade/Device Name: BioGuard EUS Air/Water and Suction Valves Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC, FDF Dated: December 4, 2020 Received: December 7, 2020
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 controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202104
Device Name
BioGuard EUS Air/Water and Suction Valves
Indications for Use (Describe)
The BioGuard EUS Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The BioGuard EUS Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K202104 Page 1 of 4
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510(k) Summary For the BioGuard EUS Air/Water and Suction Valves
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Contact: Carroll Martin Regulatory Affairs Director Tel: 440-358-6259 Email: carroll_martin@steris.com
January 4, 2021 Summary Date:
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
STERIS Traditional 510(k) PREMARKET NOTIFICATION BioGuard EUS Air/Water and Suction Valves
1. Device Name
| Device Name: | BioGuard EUS Air/Water and Suction Valves, P/N 00711780 |
|---|---|
| Common Name: | Air/Water and Suction Valves |
| Regulation Name: | Endoscopic Channel Accessory |
Device Classification 2.
| Regulatory Class: | II |
|---|---|
| Regulation Number: | 21 CFR 876.1500 |
| Device Panel: | Gastroenterology/Urology |
| Product Code: | ODC and FDF |
| Product Code Name: | Endoscope Channel Accessory (ODC) |
| Colonoscope and Accessories, Flexible, Rigid | |
| (FDF) |
3. Predicate Device
K192059 BioGuard Air/Water Valve, BioGuard Suction Valve
4. Description of Device
The BioGuard EUS Air/Water Valve and the BioGuard EUS Suction Valve are accessories to an echoendoscope. The EUS Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel, control water used to wash the lens of the endoscope and insufflate a balloon at the distal end of the echoendoscope.
The EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope.
Both devices are single use devices, supplied sterile.
5. Intended Use
The BioGuard EUS Air/Water Valve is intended to be used to control the air/water function of an endoscope during a GI endoscopic procedure.
The BioGuard EUS Suction Valve is intended to be used to control the suction function of an endoscope during a GI endoscopic procedure.
5
6. Technological Characteristic Comparison Table
The BioGuard EUS Air/Water and Suction valves are similar in design to the predicate and have exactly the same intended use. The differences between the proposed and predicate devices are the design of the valves and the particular type of endoscope on which the devices are used. The design is different than the predicate (see table below) because the BioGuard EUS Air/Water and Suction valves are used on echoendoscopes that have different dimensions than the endoscopes that are used with the predicate device. The echoendoscopes also have a balloon channel to allow the inflation and deflation of a balloon with water. These differences do not raise any new concerns of safety and effectiveness when compared to the predicate device.
Table 1 summarizes the similarities/differences between the proposed device and the predicate.
| Feature | BioGuard EUS Air/Water and
Suction Valve
(Proposed) | BioGuard Air/Water and
Suction Valve
(Predicate K192059) | Comparison |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended use | The BioGuard EUS Air/Water
Valve is intended to be used to
control the air/water function on
an endoscope during a GI
endoscopic procedure. The
BioGuard EUS Suction Valve is
intended to be used to control
the suction function on an
endoscope during a GI
endoscopic procedure. | The BioGuard Air/Water
Valve is intended to be used
to control the air/water
function on an endoscope
during a GI endoscopic
procedure. The BioGuard
Suction Valve is intended to
be used to control the
suction function on an
endoscope during a GI
endoscopic procedure. | Same |
| Construction | Air/Water Valve:
Stem, gaskets, spring guide,
spring(s) and endcap with skirt | Air/Water Valve:
Stem, gaskets, spring and
valve base (skirt and
endcap) | Similar |
| | Suction Valve:
Stem, spring guide, spring(s)
and endcap with skirt | Suction Valve:
Stem, spring and valve base
(skirt and endcap) | |
| Sterile/Non-sterile | Sterile | Sterile | Same |
| Sterilization
Method | EtO | EtO | Same |
| Sterilization
Assurance Level | 10-6 | 10-6 | Same |
| Usage | Single use | Single use | Same |
Table 1. Proposed/Predicate Device Technological Characteristics Comparison Table
6
| Feature | BioGuard EUS Air/Water and
Suction Valve
(Proposed) | BioGuard Air/Water and
Suction Valve
(Predicate K192059) | Comparison |
|------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------|------------|
| Materials | Air/Water Valve: | Air/Water Valve: | |
| | PC-ABS, Stainless Steel, TPE | ABS Plastic, Stainless Steel,
Thermoplastic styrene
(Rabalon), TPE | Similar |
| | Suction Valve: | Suction Valve: | |
| | PC-ABS, Stainless Steel, Ultem
Plastic, TPE, Brass | ABS Plastic, Stainless Steel,
TPE, PC-ABS | Similar |
| Device
Dimensions
(lengths/widths) | Air/Water Valve:
Length: 46 mm
Diameter: 11 mm | Air/Water Valve:
Length: 45.9 mm
Diameter: 10 mm | Similar |
| | Suction Valve:
Length: 33 mm
Diameter: 3.8 mm | Suction Valve:
Length: 27.4 mm
Diameter: 5.6 mm | Similar |
| Target
Population | Patients undergoing an
endoscopic procedure | Patients undergoing an
endoscopic procedure | Same |
| Energy
Used/Delivered | None | None | Same |
| Method of
Application | Manual actuation | Manual actuation | Same |
| Compatible
Endoscopes | Olympus endoscope with a
balloon channel | Olympus endoscope without
a balloon channel | Similar |
| Packaging | Sealed thermoform tray | Sealed thermoform tray | Same |
STERIS Traditional 510(k) PREMARKET NOTIFICATION BioGuard EUS Air/Water and Suction Valves
7. Description of Safety and Substantial Equivalence
Functional testing assessing the air/water valves ability to control the supply of air/CO2 and water to an endoscope was conducted via bench and simulated use testing. Functional testing assessing the suction valves ability to control the evacuation of air/CO2 and water through the endoscope was conducted via bench and simulated use testing.
8. Conclusion
The proposed device, the BioGuard EUS Air/Water and Suction Valves, is substantially equivalent to its predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.