(77 days)
K#052859
Not Found
No
The summary describes a standard electrosurgical device for hemostatic sealing and coagulation, with no mention of AI or ML capabilities.
Yes
The device is intended for hemostatic sealing and coagulation of soft tissue and bone, which are therapeutic actions aimed at treating medical conditions or supporting surgical procedures.
No
The device is described as an electrosurgical device for hemostatic sealing and coagulation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "bipolar electrosurgical device" and a "bipolar sealer," indicating it is a physical hardware device used for surgical procedures, not software.
Based on the provided information, 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.
- Device Function: The description clearly states the device is a "bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site." This is a surgical tool used directly on the patient's tissue during a procedure.
- No Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to apply energy and saline to tissue in situ.
Therefore, the TissueLink SS4.0 bipolar sealer is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TissueLink SS4.0 bipolar sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein-sealling during 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; orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein-sealling.
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)
K#052859
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
Traditional 510(k) TissueLink Medical, Inc. – Aquamantys SS4.0
. I I
TISSUELINK
Simply Better Surgery
FEB 2 2 2007
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 6, 2006 |
|---|---|
| Submitter: | TissueLink Medical Inc. |
| Address: | One Washington Center Suite 400 |
| Dover, NH 03820 | |
| Contacts: | Vicki S. Anastasi |
| Director of Regulatory Affairs | |
| Telephone Number: | (603) 742-1515 ext. 210 |
| FAX Number: | (603) 742-1488 |
Device Information:
| Trade Name: | Aquamantys SS4.0 Bipolar Sealer |
|---|---|
| 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 Aquamantys SS4.0 Bipolar Sealer is made to:
| Name: | Aquamantys 2.3 Bipolar Sealer |
|---|---|
| 510(k) Number | K#052859 |
| Regulation Number | 878-4400 Device, Electrosurgical, Cutting & Coagulation & |
| Accessories | |
| Product Code | GEI |
| Decision Date | October 25, 2005 |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is drawn in black and white, and the text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TissueLink Medical, Inc. % Ms. Vicki S. Anastasi Director Regulatory Affairs One Washington Center, Suite 400 Dover, New Hampshire 03820
FEB 2 2 2007
Re: K063639
Trade/Device Name: TissueLink Aquamantys SS4.0 Bipolar Sealer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 6, 2006 Received: December 8, 2006
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.
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Traditional 510(k) TissueLink Medical, Inc. - Aquamantys SS4.0
| Indications for use Statement | |
|---|---|
| Page ___ of ___ | |
| 510(k) Number (if known): | K063639 |
| Device Name: | TissueLink Aquamantys SS4.0 Bipolar Sealer |
| Indications for Use: |
The TissueLink SS4.0 bipolar sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein-sealling during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)
Prescription Use Usé
OR
Over-The-Counter
(Per 21 CFR 801.109)
Optional Format 1-
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milken
(Division Sign-Division of General, Bestorative, and Neurologi 510(k) 1
TissueLink Medical, Inc.