(285 days)
The Patton Tripol™ is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated.
The Patton Tripol™ is a forceps that grasps, coagulates, and transects tissue, utilizing electrical current. The device is compatible with available bipolar generators.
This document is a 510(k) summary for the Patton Tripol™ Bipolar Forceps. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
The document describes a medical device (bipolar forceps) that grasps, coagulates, and transects tissue using electrical current. The submission is focused on demonstrating substantial equivalence to existing predicate devices (Dexide Bipolar Forceps II+ Device and Bicoag Coagulating Forceps).
Therefore, I cannot provide the requested information from the provided text, as it pertains to a traditional medical device submission and not to an AI/ML device study.
Here's why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: Not present. Substantial equivalence claims for traditional devices often rely on material properties, design comparisons, and functional testing, not statistical performance metrics like sensitivity/specificity against a ground truth.
- Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of an AI/ML model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. There is no training set for an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
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APR 3 0 2002
510(k) Summary as required by 807.92(c) for Patton Tripol™ Prepared July 5, 2001
K012279
Patton Medical Corporation Submitted by: 1000 Westbank Drive, Suite 5A200 Austin, Texas 78746 Fax 512 328-9113 512 329-0469
Michael T. Patton Contact Person: President
Patton Tripol™ Bipolar Forceps Device Trade Name:
Bipolar Forceps Common Name:
DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACC Classification:
DEXIDE BIPOLAR FORCEPS II+ DEVICE (K993055), manufactured Predicate Devices: United States Surgical, 150 Glover Avenue, Norwalk, CT 06856.
BICOAG COAGULATING FORCEPS (K971565) manufactured by Everest Medical Corp., 13755 First Avenue, North, Suite 500, Minneapolis, MN 55441.
000N1000E
Description of Device:
The Patton Tripol™ is a forceps that grasps, coagulates, and transects tissue, utilizing electrical current. The device is compatible with available bipolar generators.
Intended Use of Device:
The Patton Tripo!™ is intended for use in open and laparoscopic surgeries where grasping, coagulating, and transecting of tissue is indicated .
Substantial Equivalence to Predicate Device:
The Patton Tripol™ is substantially equivalent to the Dexide Bipolar Forceps II** Device (K993055), manufactured by United States Surgical, 150 Glover Avenue, Norwalk, CT 06856, and the Bicoag Coagulating Forceps (K971565), manufactured by Everest Medical Corp., 13755 First Avenue, North, Suite 500, Minneapolis, MN 55441.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2002
Mr. Michael Patton President Patton Medical Corporation 1000 Westbank Drive, Suite 5A200 Austin, TX 78746
Re: K012279
Trade/Device Name: Patton Tripol Bipolar Forceps Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 26, 2002 Received: March 26, 2002
Dear Mr. Patton:
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 such 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); 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.
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Page 2 - Mr. Michael Patton
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if.known):_____________________________________________________________________________________________________________________________________________________
Patton Tripol Bipolar Forceps Device Name:
Indications For Use:
The Patton Tripol is intended for use in open and laparoscopic The Patcon Tripor Is Incended 101 as on transecting of tissue is indicated.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012279
OR Over-The-Counter Use
Prescription Use_ (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.