(40 days)
TissueLink Bipolar Floating Ball
None
No
The 510(k) summary describes a standard electrosurgery device and makes no mention of AI, ML, image processing, or any related concepts.
Yes
The device is described as "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." This function of treating or alleviating a condition (hemostatic sealing and coagulation) in the body qualifies it as a therapeutic device.
No
The device description states it is an electrosurgery device used for hemostatic sealing and coagulation, which describes a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "sterile, single use electrosurgery device" and a "Bipolar Floating Ball device," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "hemostatic sealing and coagulation of soft tissue and bone at the operative site" during surgical procedures. This is a therapeutic and surgical application, not a diagnostic test performed on samples outside the body.
- Device Description: The description identifies it as an "electrosurgery device." Electrosurgery is a surgical technique, not an in vitro diagnostic method.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting analytes, or providing diagnostic information.
In vitro diagnostics are tests performed on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates directly on tissue within the body during surgery.
N/A
Intended Use / Indications for Use
The TissueLink BPS bipolar sealer 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
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 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)
TissueLink Bipolar 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
AUG 2 0 2003
Special 510(k): Device Modification -- TissueLink Medical, Inc. - Bipolar Floating Ball
K032132 P31/1
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 Bipolar Sealer 2.3 (Bipolar Floating Ball) device |
| Common Name: | Electrosurgery Bipolar Sealer |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories, 21CFR |
| 878.4400 |
Predicate Devices:
Claim of Substantial Equivalence of the TissueLink Bipolar Floating Ball (Bipolar Sealer 2.3) device is made to:
TissueLink Bipolar Floating Ball
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 name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, connected by flowing lines, and a star above the figures.
AUG 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vicki S. Anastasi Director Regulatory Affairs TissueLink Medical, Inc. One Washington Center, Suite 400 Dover, New Hampshire 03820
Re: K032132
Trade/Device Name: TissueLink Bipolar Sealer 2.3 (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: July 11, 2003 Received: July 28, 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 (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 - 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. 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 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 vours.
Sincerely yours,
Mark N Milken
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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Special 510(k): Device Modification – TissueLink Medical, Inc. – Bipolar Floating Ball
Indications for use Statement
Page
510(k) Number (if known):_KO32132
Device Name:
TissueLink Bipolar Sealer 2.3 (Bipolar Floating Ball) device
Indications for Use:
The TissueLink BPS bipolar sealer 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) OR Prescription Use Over-The-Counter Use Optional Format 1 -(Per 21 CFR 801.109) eral. Restorative
510(k) Number.
TissueLink Medical, Inc.
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