(14 days)
Not Found
No
The description focuses on the electrosurgical generator's hardware, software for integrating flow and power settings, and the mechanism of simultaneous fluid delivery and RF energy. There is no mention of AI, ML, or any learning or adaptive capabilities based on data.
Yes
The device is intended for "hemostatic sealing of soft tissue and bone at the operative site" which is a therapeutic intervention.
No.
The device is described as an electrosurgical generator intended for hemostatic sealing of soft tissue and bone, not for diagnosing a medical condition.
No
The device description clearly states it is a "shelf top unit consisting of a sheet metal housing, front control panel and side mounted pump" and includes a "main circuit board, a display board and a power supply." It also describes "hand held 'wand' like devices" and a "cart," indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hemostatic sealing of soft tissue and bone at the operative site." This is a therapeutic procedure performed directly on the patient's body during surgery.
- Device Description: The device is an electrosurgical generator with a pump and hand-held "wand" like devices that interface with the operative site. This describes a surgical tool used for treatment.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device is clearly intended for surgical intervention and treatment, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Aquamantys™ Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is intended for electrosurgical hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, use in orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). For use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Aquamantys Pump Generator is a shelf top unit consisting of a sheet metal housing, front control i he Aqualifantys i unip Generator is a show top until consing resides a main circuit board, a displayers of the panel and side mounted purific within the neasing reasure would more on any more any software integrates the flow to the desired power setting and flow level selected. The punip generator can be set from 20 to 200 watts and has high, medium and low flow rate settings.
The Aquamantys system includes the pump generator, cart and specified Aquamantys disposable devices of The Aquamantys BPS 6.0 and the Aquanantys BPS 2.3 are hand held "wand" like devices that consist of The Aqualifaniys DF S o.o allo the Aqualiantys DF B 2.5 art one end that interface with the operative a plastic handle with two need they of the plugs into the pump generator and have a section of pump tubing that clamps into the peristaltic pump.
Compared to most conventional electrosurgical devices and generators. TissueLink bipotent that in Compared to most conventional clectrosurgiour delivery, as well as the reatment of tissue that is based on simulaticous same in gation and ter pover detroity are oozing blood at a slow but steady rate.
A complete Aquamantys System diagram is shown on the following page.
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
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.
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#024059, K20574, K022532, K032132
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
Image /page/0/Picture/1 description: The image shows the logo for TissueLink. The logo consists of the word "TissueLink" in a bold, sans-serif font, with a stylized graphic to the right. Below the word "TissueLink" is the tagline "Simply Better Surgery" in a smaller, sans-serif font. The graphic to the right of the word "TissueLink" appears to be a stylized representation of two interlocking shapes.
OCT 25 2005
Page 1 of 2
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: | September 29, 2005 |
|---|---|
| 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 Pump Generator System, Aquamantys 6.0 Bipolar Sealer,
and Aquamantys 2.3 Bipolar Sealer |
|----------------------|-------------------------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Bipolar Generator |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories - 21CFR
878.4400 |
Predicate Devices:
Claim of Substantial Equivalence of the Aquamantys Pump Generator System is made to:
| Name: | Söring GmbH MBCTM Series |
|---|---|
| 510(k) Number | K#024059 |
| Regulation Number | 878-4400 Device, Electrosurgical, Cutting & Coagulation & Accessories |
| Product Code | GEI |
| Decision Date | January 8, 2003 |
Claim of Substantial Equivalence of the Aquamantys 6.0 and 2.3 Bipolar Sealer devices are made to:
TissueLink BPS 6.0 K20574 and K022532 TissucLink BPS 2.3 K032132
1
Special 510(k): Part A TissueLink Medical, Inc. – Aquamantys Pump Generator System
Device Description-Pump Generator
Page 2 of 2
The Aquamantys Pump Generator is a shelf top unit consisting of a sheet metal housing, front control i he Aqualifantys i unip Generator is a show top until consing resides a main circuit board, a displayers of the panel and side mounted purific within the neasing reasure would more on any more any software integrates the flow to the desired power setting and flow level selected. The punip generator can be set from 20 to 200 watts and has high, medium and low flow rate settings.
The Aquamantys system includes the pump generator, cart and specified Aquamantys disposable devices of The Aquamantys BPS 6.0 and the Aquanantys BPS 2.3 are hand held "wand" like devices that consist of The Aqualifaniys DF S o.o allo the Aqualiantys DF B 2.5 art one end that interface with the operative a plastic handle with two need they of the plugs into the pump generator and have a section of pump tubing that clamps into the peristaltic pump.
Compared to most conventional electrosurgical devices and generators. TissueLink bipotent that in Compared to most conventional clectrosurgiour delivery, as well as the reatment of tissue that is based on simulaticous same in gation and ter pover detroity are oozing blood at a slow but steady rate.
A complete Aquamantys System diagram is shown on the following page.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
OCT 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vicki S. Anastasi Director of Regulatory Affairs TissueLink Medical, Inc. One Washington Center, Suite 400 Dover, New Hampshire 03820
Re: K052859
Trade/Device Name: TissueLink Aquamantys Pump Generator System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 7, 2005 Received: October 11, 2005
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 cnactment 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.
3
Page 2- 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Curbare Prelud
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Part A TissueLink Medical, Inc. - Aquamantys Pump Generator System
| K052859 | |
|---|---|
| Indications for use Statement | |
| Page ______ of ______ | |
| 510(k) Number (if known): | K0528859 |
Device Name:
TissueLink Aquamantys Pump Generator System
Indications for Use:
The Aquanantys™ Bigolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump whic I he Aquamantys a jor assethly with rightmastatic sealing of soft tissue and hone at the operative site. It is intended for, but not encier with same join tembrant beating of orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). for contraceptive land coaghtause only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.
Preseription Use
( )|ર
Over-The-Counter Use
(Per 21 CFR 801.109)
Optional Format 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE TH NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Barbara Oneill
and Neurological Devices
510(k) Number K052857
Tissuel mi, Miedical Inc