(196 days)
K#020574
Not Found
No
The summary describes a standard electrosurgery device for hemostasis and coagulation, with no mention of AI, ML, image processing, or data-driven performance metrics. The predicate device is also described as an "Identical device," further suggesting no new AI/ML technology is incorporated.
Yes.
The device is used for hemostatic sealing and coagulation of soft tissue and bone, which are therapeutic actions to treat or ameliorate a condition.
No
This device is described as an electrosurgery device used for hemostatic sealing and coagulation of soft tissue and bone, which are therapeutic functions, not diagnostic. Its intended use does not involve assessing or identifying medical conditions.
No
The device description clearly states it is a "TissueLink Bipolar Floating Ball device," which is a physical electrosurgery device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "hemostatic sealing and coagulation of soft tissue and bone at the operative site" using radiofrequency current and saline. This is a surgical procedure performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples.
- Device Description: The description is of a surgical tool, not a diagnostic test kit or instrument.
The device is an electrosurgical device used during surgery, which falls under the category of medical devices used for treatment or intervention, not diagnosis.
N/A
Intended Use / Indications for Use
The TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and bone at the operative site, endoscopic and open abdominal, orthopaedic, spine 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#020574
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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. –
Expanded indications Bipolar Floating Ball device
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters and numbers. The sequence reads 'KO22532', with a horizontal line drawn underneath the entire sequence. The characters are written in a cursive style, and the numbers are slightly stylized.
510(k) Summary of Safety and Effectiveness
FEB 1 2 2003
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: | July 31, 2002 |
|---|---|
| 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 Bipolar Floating Ball device |
| Common Name: | Electrosurgery Cauterizing Pen |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories. 21CFR. |
Predicate Devices:
Claim of Substantial Equivalence of the TissueLink Bipolar Floating Ball device is made to:
Identical device, TissueLink Bipolar Floating Ball, K#020574
878.4400
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 the department's emblem, which is a stylized representation of a human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2003
Ms. Vicki S. Anastasi Director, Regulatory Affairs TissueLink Medical, Inc. One Washington Center, Suite 400 Dover, New Hampshire 03820
Re: K022532
Trade/Device Name: TissueLink Bipolar Floating Ball Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 13, 2002 Received: November 14, 2002
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 mav 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.
2
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), 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) you may obtain. 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
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
3
Expanded indications Bipolar Floating Ball device
13
Indications for use Statement
Page _____ of ________________________________________________________________________________________________________________________________________________________________
K022532 510(k) Number (if known):
Device Name:
TissueLink Bipolar Floating Ball device
Indications for Use:
The TissueLink Bipolar Floating Ball device is a sterile, single use electrosurgery device intended to be used in conjunction with an electrosurgical generator for delivery of radiofrequency current and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. 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 | |
|---|---|
| (Per 21 CFR 801.109) |
| OR | Over-The-Counter Use | |
|---|---|---|
| -- | ---- | ---------------------- |
| Optional Format 1 - | |
|---|---|
| -- | --------------------- |
| | Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices |
| -- | ---------------------------------------------------------------------------------------------------------- |
|---|
| TissueLink Medical, Inc. | 510(k) Number | KO22532 |
|---|---|---|
| -------------------------- | --------------- | --------- |