(323 days)
Intended to facilitate tissue grasping and control the bleeding of small vessel by bipolar coagulation
Reusable bipolar forceps
This document is a 510(k) clearance letter from the FDA for a Reusable Bipolar Forceps manufactured by Modern Medical Equipment Manufacturing Ltd. It states that the device is substantially equivalent to legally marketed predicate devices.
However, a 510(k) clearance letter does not typically contain the detailed acceptance criteria and study results you are asking for. This type of information is usually found in the original 510(k) submission document, which is a much more extensive technical file that sponsors submit to the FDA.
The provided document doesn't include:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes for test sets, data provenance, or the number/qualifications of experts.
- Adjudication methods.
- Details on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- The type of ground truth used or sample sizes/ground truth establishment for training sets.
The letter simply provides the regulatory decision that the device is substantially equivalent for the Indications For Use stated in the enclosure. The enclosure (Page 2 of the document) confirms the intended use: "Intended to facilitate tissue grasping and control the bleeding of small vessel by bipolar coagulation."
Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria and the study that proves the device meets them because that information is not present in this 510(k) clearance letter.
To get the information you're looking for, one would need to access the full 510(k) submission (K032327) that Modern Medical Equipment Manufacturing Ltd. submitted to the FDA.
{0}------------------------------------------------
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 an abstract symbol that resembles an eagle or a stylized human figure with three wing-like or arm-like extensions.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2004
Mr. David Lou Senior Project Engineer Modern Medical Equipment Manufacturing Ltd. 5F, Gold King Ind. Bldg. 35 Tai Lin Pai Road Kwai Chung, N.T. Hong Kong
Re: K032327
Trade/Device Name: Reusable Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 29, 2004 Received: April 1, 2004
Dear Mr. Lou:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreased of the enactment date of the Medical Device Amendments, or 10 commerce provide to they 20, 1978, in accordance with the provisions of the Federal Food, Drug, de vices that have been receive approval of a premarket approval application (PMA). allu Cosmette Act (110) that to hovice, subject to the general controls provisions of the Act. The r ou may, merchero, mains of the Act include requirements for annual registration, listing of general controls provisions and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clusion of or a croy of als. Existing major regulations affecting your device can thay be subject to sach additions, 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 r lease oc advised that I Dris issualite complies with other requirements of the Act that I DA has made a aoninistered by other Federal agencies. You must of any I edetal stututes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 form in the quality of events (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
Page 2 - Mr. David Lou
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin matically of substantial equivalence of your device to a legally premarket nothication. The FDA midnig of backandar equal evice 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), please if you desire specific advice for your act (301) 594-4659. Also, please note the regulation entitled, comact the Office of Complance at (301) of Crise Part 807.97). You may obtain Missianumy by reference to premainter.commibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Schess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indication for Use Statement KO32327
Modern Medical Equipment Mfg. Ltd. Applicant:
Not assigned yet 510(k) Number
Reusable bipolar forceps Device Name:
Indications For Use: Intended to facilitate tissue grasping and control the bleeding of small vessel by bipolar coagulation
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(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_________________________________________________________________________________________________________________________________________________________________
§ 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.