(26 days)
Not Found
Not Found
No
The summary describes a standard bipolar electrosurgical device for tissue sealing and coagulation, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is used to coagulate, seal, and transect tissue in surgical applications, which are therapeutic procedures.
No.
The device is intended for "coagulating, sealing and transecting tissue" during surgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "bipolar electrosurgical device" and "bipolar forceps," which are hardware components used for surgical procedures. The summary does not mention any software-only functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The provided text clearly states the device's intended use is for "coagulating, sealing and transecting tissue" during surgical procedures. This is a direct intervention on the body, not a test performed on a sample outside the body.
- Device Description: The description is for "Bipolar Forceps," which are surgical instruments used for electrosurgery.
The information provided describes a surgical device used during a procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The TissueLink Sealing Forceps (Bipolar Forceps) is a sterile, single use bipolar electrosurgical device intended to be used in general and thoracic electrosurgical applications for coagulating, sealing and transecting tissue. It is intended for, but not limited to abdominal and thoracic surgery, laparoscopic procedures, endoscopic procedures and thoracoscopic procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)
Product codes
GEI
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TissueLink Bipolar Forceps
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Special 510(k): Device Modification – TissueLink Medical, Inc. – Sealing Forceps
KO30380
MAR 0 3 2003
510(k) Summary of Safety and Effectiveness
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Application Information:
| Date Prepared: | February 3, 2003 |
|---|---|
| Submitter: | TissueLink Medical Inc. |
| Address: | One Washington Center Suite 400 |
| Dover, NH 03820 | |
| Contacts: | Vicki S. Anastasi |
| Directory Regulatory Affairs | |
| Telephone Number: | (508) 922-1622 |
| FAX Number: | (508) 497-9925 |
| Roberta L. Thompson | |
| Vice President, Clinical, Regulatory and Quality | |
| Telephone Number: | (603) 742-1515 ext. 106 |
| Fax Number: | (603) 742-1488 |
| Device Information: | |
| Trade Name: | TissueLink Sealing Forceps |
| Common Name: | Electrosurgery Bipolar Forceps |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories, 21CFR 878.4400 |
Predicate Devices:
Claim of Substantial Equivalence of the TissueLink Sealing Forceps device is made to:
TissueLink Bipolar Forceps
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or a bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the central design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 3 2003
TissueLink Medical, Inc. Vicki S. Anastasi Director, Regulatory Affairs One Washington Center, Suite 400 Dover. New Hampshire 03820
Re: K030380
Trade/Device Name: TissueLink Sealing Forceps, Model 1 21-202-1 Regulation Number: 878.4400 Regulation Name: Electrosurgical device cutting and coagulation and accessories Regulatory Class: Class II Product Code: GEI Dated: February 3, 2003 Received: February 5, 2003
Dear Ms. Anastasi:
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
2
Page 2 - Ms. Vicki S. Anastasi
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in 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. 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), please contact the Office of Compliance at (301) 594-4659. 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,
Muriam 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
3
Special 510(k): Device Modification - TissueLink Medical, Inc. - Sealing Forceps
Indications for use Statement
Page
KO30380 510(k) Number (if known):
Device Name:
TissueLink Sealing Forceps device
Indications for Use:
The TissueLink Sealing Forceps (Bipolar Forceps) is a sterile, single use bipolar electrosurgical device intended to be used in general and thoracic electrosurgical applications for coagulating, sealing and transecting tissue. It is intended for, but not limited to abdominal and thoracic surgery, laparoscopic procedures, endoscopic procedures and thoracoscopic procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Optional Format 1-
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030380
TissueLink Medical, Inc.