(71 days)
Not Found
No
The description focuses on a mechanical valve for endoscopic procedures and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device's description indicates it facilitates the passage and exchange of endoscopic devices, forming a seal and supporting their position, rather than providing a direct therapeutic effect on the patient.
No.
The "Intended Use" clearly states that the device is "intended to provide access for endoscopic device passage and exchange," and the "Device Description" explains how it forms a seal and maintains position. There is no mention of it being used to diagnose conditions or process data for diagnostic purposes.
No
The device description clearly describes a physical valve intended to be used with endoscopes and endoscopic devices. It mentions physical characteristics, compatibility with biopsy port valves, and bench testing related to physical and simulated use. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the Boa Endoscopic Valve™ is to "provide access for endoscopic device passage and exchange throughout the endoscopic procedure." This describes a device used during a medical procedure to facilitate the use of other instruments.
- Device Description: The description details how the valve is used with endoscopes and endoscopic devices to create a seal and support instruments. This is a mechanical function within a procedure.
- Lack of Diagnostic Function: An IVD is a device used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Boa Endoscopic Valve™ does not perform any such examination or analysis of biological samples.
- No Mention of Biological Samples: The description focuses on the interaction with endoscopes and endoscopic devices, not with biological specimens.
The Boa Endoscopic Valve™ is a medical device used in conjunction with endoscopic procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Boa Endoscopic Valve™ is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.
Product codes (comma separated list FDA assigned to the subject device)
OCX
Device Description
The Boa Endoscopic Valve™ is used with endoscopes and endoscopic devices with a maximum outer diameter up to 0.167 in. Endoscopic devices are inserted through the Boa Endoscopic Valve™ and through the endoscope. The Boa Endoscopic Valve™ forms a seal around endoscopic devices, supports the endoscopic device, and maintains the position relative to the endoscope biopsy channel port. It is compatible with biopsy port valves and is positioned against the biopsy valve of the endoscope. The Boa Endoscopic Valve™ is non-sterile and is designed for single patient use.
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
Used in hospitals, sub-acute care institutions, surgery centers, or doctor's office . where endoscopic procedures may be performed
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was performed in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process.
Bench Testing
Design verification and validation testing were performed on the Boa Endoscopic Valve™ to evaluate physical, simulated use, reliability, and safety specifications.
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.
EndoChoice Seal Biopsy Valve, K111821
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 13, 2015
C2 Therapeutics, Inc. Theresa Brandner-Allen VP of Regulatory Affairs and Quality Assurance 303 Convention Way, Suite 1 Redwood City, CA 94063
Re: K152140 Trade/Device Name: Boa Endoscopic Valve Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: September 24, 2015 Received: September 25, 2015
Dear Theresa Brandner-Allen,
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Herbert P. Lerner -S
for 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
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Indications for Use
510(k) Number (if known) K152140
Device Name
Boa Endoscopic Valve™M
Indications for Use (Describe)
The Boa Endoscopic Valve™ is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
SUBMITTER I.
Submitter Name: C2 Therapeutics, Inc.
- Address: 303 Convention Way, Suite 1 Redwood City, CA 94063 Phone Number: 650-521-5921 Fax Number: 650-556-1145
Contact Person: Theresa Brandner-Allen VP of Regulatory Affairs and Quality Assurance
July 30, 2015 Date Prepared:
II. DEVICE
Name of Device: Boa Endoscopic Valve™ Common Name: Endoscopic valve Classification Name: Endoscope and accessories, 21 CFR§876.1500 Regulatory Class: Class II Product Code: OCX
III. PREDICATE DEVICE
EndoChoice Seal Biopsy Valve, K111821 This predicate device has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Boa Endoscopic Valve™ is used with endoscopes and endoscopic devices with a maximum outer diameter up to 0.167 in. Endoscopic devices are inserted through the Boa Endoscopic Valve™ and through the endoscope. The Boa Endoscopic Valve™ forms a seal around endoscopic devices, supports the endoscopic device, and maintains the position relative to the endoscope biopsy channel port. It is compatible with biopsy port valves and is positioned against the biopsy valve of the endoscope. The Boa Endoscopic Valve™ is non-sterile and is designed for single patient use.
V. INDICATIONS FOR USE
The Boa Endoscopic Valve™ is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Boa Endoscopic Valve™ has similar technological characteristics to the legally marketed predicate. The subject device and predicate device are based on the following same technological elements:
- · Attached to the proximal biopsy channel port of an endoscopic device to provide endoscopic device passage and exchange
- Aids in the insertion, use, and removal of the endoscopic accessories during . endoscopic procedures
- . Minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure
- Used in hospitals, sub-acute care institutions, surgery centers, or doctor's office . where endoscopic procedures may be performed
- . Used in a single patient (disposable) undergoing endoscopic procedures
The following technological differences exist between the modified device and predicate device:
- The top of the modified device is rotated during use, and the top of the predicate . device is pulled up during use
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was performed in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing and ISO 10993-1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process.
Bench Testing
Design verification and validation testing were performed on the Boa Endoscopic Valve™ to evaluate physical, simulated use, reliability, and safety specifications.
VIII. CONCLUSION
The Boa Endoscopic Valve™ has the same clinical attributes, technological characteristics, and expected performance as the legally marketed predicate, EndoChoice Seal Biopsy Valve (K111821). The design verification and validation test results demonstrate that the Boa Endoscopic Valve™ should perform as intended in the specified use conditions and should perform comparably to the legally marketed predicate that is currently marketed for the same intended use.