(14 days)
The Aquamantys™ Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is intended for 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.
The Aquamantys Pump Generator is a shelf top unit consisting of a sheet metal housing, front control panel and side mounted pump. Within the housing resides a main circuit board, a display board and a power supply. The software integrates the flow to the desired power setting and flow level selected. The pump 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. The Aquamantys BPS 6.0 and the Aquamantys BPS 2.3 are hand held "wand" like devices that consist of a plastic handle with two needle electrodes at one end that interface with the operative site. The other end of the handle has a cable that 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 bipolar devices are unique in that they provide simultaneous fluid delivery, as well as the treatment of tissue that is based on simultaneous irrigation and low power density RF energy delivery to tissue that is oozing blood at a slow but steady rate.
The provided text is a 510(k) summary for the TissueLink Aquamantys Pump Generator System. It focuses on demonstrating substantial equivalence to predicate devices and describes the device's function and intended use. However, it does not contain the specific information required to answer your questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what's missing:
- No Acceptance Criteria: The document does not list any specific performance acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or other quantitative measures).
- No Performance Study Results: While it mentions the device, its function, and comparisons to predicate devices for substantial equivalence, it does not present data from a study designed to measure the device's performance against any set criteria.
- No Details on Test Sets, Ground Truth, Training Sets, or Expert Adjudication: These are all elements typically found in studies evaluating the diagnostic or functional performance of a medical device, especially those involving AI or image analysis. This document is a regulatory submission for substantial equivalence based on device description and intended use, not a clinical or performance study report.
Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.
To answer your questions, I would need a document that presents the results of a performance study for the TissueLink Aquamantys Pump Generator System, including details on its evaluation metrics and the methodology used.
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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 400Dover, NH 03820 |
| Contacts: | Vicki S. AnastasiDirector 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 - 21CFR878.4400 |
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
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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.
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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.
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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
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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
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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
§ 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.