(295 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is also not available, but the intended use suggests a mechanical clipping device.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is used to create anastomoses, which is a surgical procedure to connect two structures. While this procedure may be part of a therapeutic intervention, the device itself is a surgical tool, not a therapeutic device in the sense of directly treating a condition.
No
The device is used for creating anastomoses (surgical connections) in blood vessels and other tubular structures, which is a therapeutic or procedural function, not a diagnostic one.
No
The intended use describes a device used for creating anastomoses in blood vessels, which strongly implies a physical, implantable, or surgical device, not a software-only device. The lack of any mention of software, algorithms, or data processing further supports this conclusion.
Based on the provided information, the AnastoClip GC is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating anastomoses (surgical connections) in blood vessels and other small tubular structures. This is a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description (Not Found): While the description is missing, the intended use strongly suggests a surgical device.
- No mention of samples, testing, or analysis: The provided text does not mention anything related to analyzing biological samples (blood, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The AnastoClip GC's function is clearly related to surgical intervention within the body.
N/A
Intended Use / Indications for Use
The AnastoClip GC is intended for use in the creation of everting anastomoses in blood vessels and other small tubular structures when tissue penetration is desired.
Product codes
FZP, HBT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels and other small tubular structures
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with a modern, abstract design. The seal is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR 2 3 2010
LeMaitre Vascular, Inc. c/o Mr. Andrew Hodgkinson Vice President, Clinical and Regulatory Affairs 63 Second Avenue Burlington, MA 01803
Re: K091987
Trade/Device Name: Secure Grip Vessel Closure System (GripClip) Regulation Number: 21 CFR 878.4300 Regulation Name: Clip, Implantable and Delivery System Regulatory Class: Class II (two) Product Code: FZP, HBT Dated: April 6, 2010 Received: April 7, 2010
Dear Mr. Hodgkinson:
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.
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.
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Page 2 - Mr. Andrew Hodgkinson
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATION FOR USE STATEMENT
510(k) Number (if known): K091987
Device Name: Secure Grip Vessel Closure System
Indications for Use:
The AnastoClip GC is intended for use in the creation of everting anastomoses in blood vessels and other small tubular structures when tissue penetration is desired.
Prescription Use______________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ID NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovas
ardiov Devices imber
K091987 Response 4-6-2010 Page 11 of 333