(90 days)
Not Found
Not Found
No
The summary describes a standard electrosurgery device and makes no mention of AI or ML.
Yes
The device is described as an electrosurgery device used for blunt dissection and hemostasis of soft tissue, which are therapeutic medical procedures.
No
Explanation: The device is an electrosurgery device used for blunt dissection and hemostasis, which are treatment functions, not diagnostic ones.
No
The device description clearly identifies it as a physical electrosurgery device ("TissueLink Solid Cylinder monopolar device") used for delivering radio frequency current and saline, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgery for blunt dissection and hemostasis of soft tissue. This is a therapeutic and surgical function, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description is of a surgical electrosurgery device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on tissue within the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The TissueLink Solid Cylinder monopolar device is a sterile, single use electrosurgery device intended to be used in conjunction with a like insurgical generator for delivery of radio is current and saline for blunt dissection, hemostation of soft tissue at the operative site. It is intended for, but not limited to, endoscopic and open abdominal and thoracic surgery. 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
soft tissue at the operative site (abdominal and thoracic surgery)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
TissueLink Monopolar Floating Ball
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
510(k) Premarket Submission - TissueLink Medical, Inc. - Solid Cylinder monopolar device
MAR 2 7 2002
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: | December 21, 2001 |
|---|---|
| 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 Solid Cylinder monopolar device |
| Common Name: | Electrosurgery Cauterizing Pen |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories, 21CFR 878.440 |
Claim of Substantial Equivalence of the TissueLink Solid Cylinder monopolar device is made to:
TissueLink Monopolar Floating Ball
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2002
Ms. Vicki S. Anastasi Director, Regulatory Affairs TissueLink Medical, Inc. Suite 400 One Washington Center Dover. NH 03820
Re: K014260
Trade/Device Name: TissueLink Solid Cylinder Monopolar Device Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 21, 2001 Received: December 27, 2001
Dear Ms. Anastasi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally in the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use Stated in the enorosale) to tegans and the Medical Device Amendments, or to connineres prior to May 20, 1976, the excordance with the provisions of the Federal Food. Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, dicierole, thanker the act include requirements for annual registration, listing of general volurola provisions 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 If your device is olassinod (600 as 10) of the major regulations affecting your device can may be subject to such 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 Dri brounder over device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I oderall the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Fee orequirements) ; good manufacturing practice requirements as set CI It Fart 6077, adoling (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 - Ms. Vicki S. Anastasi
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,
Muriam C. Provost
for 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
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510(k) Premarket Submission – TissueLink Medical, Inc. – Solid Cylinder monopolar device
Indications for use Statement
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