AQUAMANTYS3 9.5 XL BIPOLAR SEALER
Device Facts
| Record ID | K120537 |
|---|---|
| Device Name | AQUAMANTYS3 9.5 XL BIPOLAR SEALER |
| Applicant | Medtronic, Inc. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | May 10, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Aquamantys3 9.5 XL Bipolar Sealer is a single use, sterile, bipolar device intended to be used in conjunction with the Aquamantys3 Pump Generator for delivery of radiofrequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, open abdominal, orthopaedic, and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Device Story
The Aquamantys3 9.5 XL Bipolar Sealer is a sterile, single-use electrosurgical device for blunt dissection and hemostatic sealing. It utilizes bipolar radio-frequency (RF) energy and saline, delivered via a dual-electrode tip with saline apertures. The device connects to the Aquamantys3 Pump Generator through a cassette interface, which simultaneously manages RF power and saline flow. Operated by surgeons in clinical settings such as open abdominal, orthopaedic, or thoracic surgery, the device provides active coagulation to soft tissue and bone. By combining RF energy with saline, the device facilitates tissue sealing, potentially reducing blood loss and improving surgical outcomes. The device is a line extension of the Aquamantys product family, differing from the predicate primarily in its integrated cassette connection mechanism.
Clinical Evidence
No clinical data. Substantial equivalence established through bench performance testing, including static/dynamic cord pulls, saline flow testing, air leak testing, hipot testing, continuity, and biocompatibility assessment.
Technological Characteristics
Bipolar electrosurgical device; RF energy and saline delivery; dual-electrode tip; cassette interface for generator connection; single-use; sterile. No specific material standards or software algorithm classes provided.
Indications for Use
Indicated for blunt dissection, hemostatic sealing, and coagulation of soft tissue and bone during open abdominal, orthopaedic, and thoracic surgery. Contraindicated for contraceptive tubal coagulation.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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## 510(k) Summary
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Submitter:
Medtronic Advanced Energy 180 International Drive Portsmouth, NH 03801
Contact Person: Tara N. Turney, RAC Senior Regulatory Affairs Specialist Phone: 603-742-5445 Fax: 603-742-1488 Email: tara.n.turney@medtronic.com
Date Prepared:
Aquamantys3 9.5 XL Bipolar Sealer
February 17th, 2012
Trade Name: Common Name:
Electrosurgical Bipolar Sealer
Electrosurgical Cutting and Coagulation Device and Classification Name: Accessories
Predicate Device:
Disposable Device Predicate: K101057, cleared April 5th, 2011
Cassette Predicate: K111285. cleared September 9th, 2011
Device Description:
Statement of Intended Use:
The Aquamantys3 9.5 XL Bipolar sealer represents a line extension to the predicate Aquamantys 9.5 XL Bipolar Sealer (cleared as the Double Cone Bipolar Sealer in K101057) and the Aquamantys product family. Similar to the predicate devices, it is a sterile, single-use hemostatic sealing device. The device employs bipolar radio-frequency (RF) energy and saline for blunt dissection and for hemostatic sealing and coagulation. The device is equipped with a dual electrode tip with saline apertures at its distal end. Saline and RF energy are supplied to the device from lines on the proximal end of the handpiece and connection to the Aquamantys3 Pump Generator via the distally attached cassette interface.
The Aquamantys3 9.5 XL Bipolar Sealer is a single use, sterile, bipolar device intended to be used in conjunction with the Aquamantys3 Pump Generator for delivery of radiofrequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, open
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K120537
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abdominal, orthopaedic, and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The modified single-use disposable accessory device, the Aquamantys3 9.5 XL Bipolar Sealer, is similar to the Aquamantys 9.5 XL Bipolar Sealer such that both devices provide concurrent delivery of bipolar RF energy with saline. The two devices share identical handpiece, shaft and tip configurations and differ only in how they connect to their respective, designated generators. The cord of the predicate Aquamantys 9.5 XL Bipolar Sealer terminates in a standard three-prong electrical connector and has saline tubing that is manually loaded as an additional step into the peristaltic pump. The cord of the proposed Aquamantys3 9.5 XL Bipolar Sealer terminates in a cassette that is designed to uniquely insert into the Aquamantys3 Pump Generator, providing simultaneous connection to both RF power and the peristaltic pump. This cassette interface is part of the predicate Aquamantys3 6.0 Bipolar Sealer device.
The Aquamantys3 9.5 XL Bipolar Sealer has undergone bench performance testing to verify and validate the performance features and specifications. The testing included:
- . static cable pulls,
- . dynamic cord pulls,
- static saline tube pulls. ●
- . air leak and flow,
- hipot testing, .
- saline flow testing, .
- . continuity
- biocompatibility assessment. .
All testing met the acceptance criteria.
Clinical testing was not required to establish substantial equivalence between the proposed and predicate devices.
Medtronic Advanced Energy has demonstrated that the Aquamantys3 9.5 XL Bipolar Sealer is substantially equivalent to the predicate device based upon indications for use, design, test results and fundamental scientific technology.
Summary of Technological Characteristics:
Summary of Nonclinical Data:
Summary of
Data:
Clinical Data:
Conclusion from
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 0 2012
Medtronic, Inc. % Tara N. Turney 180 International Drive Portsmouth, NH 03801
Re: K120537
Trade Name: Aquamantys3 9.5 XL Bipolar Sealer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 25, 2012 Received: April 26, 2012
Dear Ms. Turney:
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. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Drinas Internes and regulations administered by other Federal agencies. You must or any I odetar states and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K I all 607), laboring (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if applicable, the electronic form in and quand of on ontrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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## Page 2 - Ms. Tara N. Turney
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
Mark N. Mullen
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
## 510(k) Number (if known): K120537
Device Name: Aquamantys3 9.5 XL Bipolar Sealer
Indications for Use:
The Aquamantys3 9.5 XL Bipolar Sealer is a single use, sterile, bipolar device intended to be used in conjunction with the Aquamantys3 Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, open abdominal, orthopaedic, and thoracic surgery.
The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
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510(k) Number K120537
510(k) Number __
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