(100 days)
Not Found
No
The device description and performance testing focus on mechanical properties and sealing function, with no mention of AI/ML or data processing.
No.
The device is a biopsy valve that provides access for endoscopic instruments, helps maintain insufflation, minimizes leakage, and allows for irrigation during an endoscopic procedure. It does not treat or prevent any specific disease or condition, which is the primary characteristic of a therapeutic device.
No
The device description indicates that the Single-Use Biopsy Valve provides access for surgical instruments and maintains sufflation and minimizes leakage during endoscopic procedures. It does not mention any function related to identifying or analyzing medical conditions, which are characteristic of diagnostic devices.
No
The device description clearly outlines physical components (cylindrical base, cap, diaphragm seal, hollow body) and their mechanical functions (maintaining sufflation, minimizing leakage, providing access). It also mentions bench testing of performance and biocompatibility testing, which are typical for physical medical devices. There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during an endoscopic procedure to facilitate instrument passage, maintain insufflation, and minimize leakage. This is a functional accessory for a medical procedure performed in vivo (within the body).
- Device Description: The description details a mechanical valve designed to interact with an endoscope and surgical instruments. It focuses on physical properties like sealing and access.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information based on the analysis of biological samples.
- Reagents, calibrators, or controls typically associated with IVD tests.
The device's function is to support a medical procedure, not to perform a diagnostic test on biological samples.
N/A
Intended Use / Indications for Use
The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
Product codes
OCX
Device Description
The Seal Single-Use Biopsy valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Single-Use Biopsy Valve provides surgical instruments with sealable access to the working channel port of an endoscope. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.
The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal Is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.
The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.
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
Non-Clinical Testing:
The modified device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous injection test, and system injection test, in accordance with 21 CFR, Part 58. The modified Single-Use Biopsy Valve results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the modified device performs as well as the predicate in all testing performed.
Performance testing:
• 1 minute pressure test at 10 PSI – with device in biopsy valve - Pass
• 1 minute pressure test at 10 PSI – with device in biopsy valve - Pass
• 1 minute pressure test at 10 PSI after removing device from biopsy valve - Pass
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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K133734 Page1of4
510(k) Summary
Seal Single-Use Biopsy Valve
December 5, 2013
1. Company Identification
EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Telephone: 678-708-4773 Fax: 678-567-8218 Establishment Registration: 300759133
Contact Person 2.
Janna Babson Regulatory Affairs Associate
3. Device Name
| Commercial Name: | Seal Single-Use Biopsy Valve |
|---|---|
| Common/Usual Name: | Biopsy Valve |
| Classification Name: | Endoscopic, irrigation/suction system |
4. Device Classification
| Product Code: | OCX |
|---|---|
| Regulation Number: | 876.1500 |
| Class: | 11 |
| Review Panel: | Gastroenterology/Urology |
5. Intended Use:
The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.
1
6. Device Description:
The Seal Single-Use Biopsy valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Single-Use Biopsy Valve provides surgical instruments with sealable access to the working channel port of an endoscope. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.
The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal Is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.
The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.
7. Substantial Equivalence:
The device submitted for review is a modification of the Biopsy Valve (K111821). Changes to the device include a modification in material, and a change in dimensions. Both the modified and unmodified device is composed of thermoplastic elastomers. The modified device also has a reduction in overall height of the biopsy valve to provide an improved fit between the cap and body, as well as the valve to the instrument port.
The modified device is identical in terms of intended use, operating principle, performance, technology, energy used, and packaging.
| Characteristic | Single-Use Biopsy Valve
(Unmodified) | Single-Use Biopsy Valve
(Modified) |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K111821 | Pending |
| Indications for Use | Biopsy valves are intended to
provide access for endoscopic
device passage and exchange,
helps maintain sufflation,
minimizes leakage of biomaterial
from biopsy port throughout the
endoscopic procedure, and
provides access for irrigation. | Biopsy valves are intended to
provide access for endoscopic
device passage and exchange,
helps maintain sufflation,
minimizes leakage of biomaterial
from biopsy port throughout the
endoscopic procedure, and
provides access for irrigation. |
2
| Characteristic | Single-Use Biopsy Valve
(Unmodified) | Single-Use Biopsy Valve
(Modified) |
|-------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Material | Thermoplastic elastomer | Thermoplastic elastomer |
| Valve Inner Diameter | 7 mm | 7.1 mm |
| Endoscope
compatibility | Olympus
Fujinon
EndoChoice Fuse | Olympus series 160, 180, and 190
endoscopes.
Fujinon series 530, 590, and 600
endoscopes.
EndoChoice Fuse endoscopes. |
| Removable cap
with slit | Yes | Yes |
| Slit accommodate
devices | Up to 3.2 mm | Up to 3.2 mm |
| Packaging | Individually packaged plastic pouch | Individually packaged plastic pouch |
| Performance testing: | | |
| • 1 minute
pressure test at
10 PSI – with
device in biopsy
valve | Pass | Pass |
| • 1 minute
pressure test at
10 PSI – with
device in biopsy
valve | Pass | Pass |
| • 1 minute
pressure test at
10 PSI after
removing
device from
biopsy valve | Pass | Pass |
8. Non-Clinical Testing:
The modified device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous injection test, and system injection test, in accordance with 21 CFR, Part 58. The modified Single-Use Biopsy Valve results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the modified device performs as well as the predicate in all testing performed.
3
.
9. Conclusion:
The modified Single-Use Biopsy Valve is substantially equivalent to the unmodified predicate device listed above in performance, technical characteristics, biocompatibility, and intended use.
.
·
:
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, with flowing lines suggesting movement or support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2014
EndoChoice, Inc. Janna Babson Regulatory Affairs Associate 11810 Wills Road Alpharetta, GA 30009
Re: K133734
Trade/Device Name: Biopsy Valve Regulation Number: 21 CFR$ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: February 21, 2014 Received: February 24, 2014
Dear Janna Babson,
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 prodicate 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. 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.
5
Page 2 - Janna Babson
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K133734
Device Name Single-Use Biopsy Valve
Indications for Use (Describe)
The Single-Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from biopsy port throughout the endoscopic procedure, and provides access for irrigation.
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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