AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER

K111732 · Salient Surgical Technologies, Inc. · GEI · Dec 5, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111732
• Device Name: AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER
• Applicant: Salient Surgical Technologies, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 5, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aquamantys SBS 5.0 Sheathed 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 sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Story

Aquamantys SBS 5.0 is a sterile, single-use bipolar electrosurgical handpiece used with the Aquamantys Pump Generator. It delivers RF energy and saline to tissue; saline couples electrical energy to tissue, maintaining consistent temperatures (~100°C) to achieve hemostatic sealing and coagulation without charring. The device features dual stainless steel electrodes in a two-position insulating polymer sheath, manually adjusted by the surgeon via mechanical detents. 'Sheath open' exposes electrodes for broad tissue planes; 'sheath closed' exposes only tips for delicate structures or small areas. An on-off button on the handpiece activates both RF and saline flow. Used by surgeons in OR settings (orthopaedic, spine, endoscopic, abdominal, thoracic). Benefits include reduced vessel lumen diameter and effective bleeding control, aiding surgical hemostasis.

Clinical Evidence

No clinical data was necessary to support substantial equivalence. Evidence consists of bench testing and in vivo animal data. Testing confirmed compliance with standards including ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), and IEC 60601-2-2 (high-frequency surgery equipment).

Technological Characteristics

Bipolar electrosurgical device; dual stainless steel electrodes; two-position insulating polymer sheath; RF energy source; saline irrigation system; manual activation; sterile, single-use. Compliant with ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-2, and ISO 10993 series. Sterilized via ethylene oxide.

Indications for Use

Indicated for hemostatic sealing and coagulation of soft tissue and bone in orthopaedic, spine, endoscopic, abdominal, and thoracic surgeries, and for epidural vein sealing. 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

• Aquamantys 2.3 Bipolar Sealer (K052859)
• Aquamantys SS4.0 Bipolar Sealer (K063639)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Salient Surgical Technologies. The logo consists of a stylized eye-like symbol on the left, followed by the word "SALIENT" in bold, sans-serif font. Below "SALIENT" is the phrase "SURGICAL TECHNOLOGIES" in a smaller, sans-serif font. The logo has a slightly distressed or textured appearance.

ري Salient Surgical Technologies, Inc. 180 International Drive Portsmouth, NH 03801 Tel: [phone] Fax: [phone]

## 510(K) SUMMARY AS REQUIRED BY SECTION 807.92(C)

K11732

## Aquamantys SBS 5.0 Sheathed Bipolar Sealer - 510(k) Summary

| 510(k) owner: | Salient Surgical Technologies, Inc.,<br>180 International Drive,<br>Portsmouth, NH 03801 USA<br>Tel. [phone]<br>Fax. [phone] |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Martin J. Leighton |
| Date Summary Prepared: | November 23, 2011 |
| Device Trade Name: | Aquamantys SBS 5.0 Sheathed Bipolar Sealer |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Code: | 21 CFR §878.4400 |
| Product Code | GEI |
| Equivalent Device(s): | Aquamantys 2.3 Bipolar Sealer (K052859)<br>Aquamantys SS4.0 Bipolar Sealer (K063639) marketed as the Aquamantys<br>Epidural Vein Sealer (EVS) |
| Device Description: | The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is a sterile, single-use<br>bipolar electrosurgical device intended to be used in conjunction with the<br>Aquamantys Pump Generator for delivery of RF energy and saline for<br>hemostatic sealing and coagulation of soft tissue and bone and epidural vein<br>sealing at the operative site. Its indications for use include but are not limited to,<br>orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery,<br>and epidural vein sealing during surgery.<br><br>The device employs radio-frequency (RF) energy and saline irrigation for<br>hemostatic sealing and coagulation. The effect of RF energy applied to tissues<br>concurrent with a flow of saline results in hemostatic sealing and coagulation of<br>soft tissue and bone without charring; this result has been trademarked<br>"Transcollation® Technology" by Salient Surgical Technologies.<br><br>The saline helps couple the electrical energy output from the electrosurgical<br>generator to the tissue, increasing the contact area and limiting the surface to a<br>consistent temperature range. (approximately 100 degrees C). |
| | The vascular system is primarily made up of collagen types I and III. The effect<br>of heat on these fibrous collagens has been well studied. (1, 8) When regularly<br>oriented collagen shrinks along a direction parallel to the dominant direction of<br>fiber orientation, the shrinkage is accompanied by swelling in a direction |
| | perpendicular to the fiber orientation. (5, 6) This effectively results in reduction of<br>the vessel lumen diameter and in most cases closure of the vessel lumen. (7-8)<br>References cited follow below. |
| | The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is equipped with dual<br>polished stainless steel electrode tips. The electrodes are housed in a two<br>position insulating polymer sheath. The two positions of the sheath are manually<br>established by the surgeon's hand and defined by positive mechanical detents<br>that are detected by the touch. In the sheath open position, the electrodes are<br>fully exposed allowing the surgeon to make use of a majority of their area to<br>contact incised tissue in order to deliver hemostatic sealing and coagulation<br>therapy to broad tissue planes. In the sheath closed position the electrodes are<br>surrounded by the insulating sheath along their length and only exposed at their<br>tips. The closed position allows the surgeon to work adjacent delicate structures<br>while delivering therapy to small areas of incised tissue, or preventing or<br>stopping epidural veins from bleeding. Regardless of sheath position, when the<br>electrodes are activated saline is concurrently delivered from apertures located<br>within the electrode sheath housing. Saline and electrical lines exit the opposite<br>end of the handpiece from the electrodes. The handpiece is equipped with an<br>on-off button that simultaneously activates both RF and saline flow. A saline fluid<br>delivery line is provided with the device, and includes a section of pump tubing<br>and drip chamber with spike. The three-pin electrical connector is designed to<br>be plugged into the Aquamantys Pump Generator. |
| Intended and Indications for<br>Use: | The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is a sterile, single-use<br>bipolar electrosurgical device intended to be used in conjunction with the<br>Aquamantys Pump Generator for delivery of RF energy and saline for<br>hemostatic sealing and coagulation of soft tissue and bone at the operative site.<br>It is intended for, but not limited to orthopaedic, spine, endoscopic procedures,<br>abdominal and thoracic surgery, and epidural vein sealing during surgery. The<br>device is not intended for contraceptive tubal coagulation (permanent female<br>sterilization). |
| Summary of the technological<br>characteristics of the<br>Aquamantys SBS 5.0<br>Sheathed Bipolar Sealer<br>device compared to the<br>predicate devices: | In order to establish substantial equivalence of the Aquamantys SBS 5.0<br>Sheathed Bipolar Sealer to the predicate devices, characteristics including but<br>not limited to the following were assessed and compared.<br>• Intended and indications for use<br>• Construction (including structure and component materials)<br>• Principles of operation and mechanisms of action<br>• Performance of intended and indications for use on live tissues (as<br>conducted per GLP requirements in GLP certified facilities)<br>The results of these comparative assessments found the Aquamantys SBS 5.0<br>Sheathed Bipolar Sealer substantially equivalent to the equivalent devices<br>(predicates) identified above. |
| Non-clinical<br>Performance<br>Data: | Performance testing per standardized methods and Salient Surgical's test<br>protocols, including bench testing and <i>in vivo</i> animal data collection, was<br>conducted and provides support that the Aquamantys SBS 5.0 Sheathed<br>Bipolar Sealer is substantially equivalent to currently marketed predicate<br>devices.<br>Non-clinical performance test protocols and reports of results are identified in<br>Sections 14 through 19 of this 510(k) submission.<br>Test protocols and reports of results demonstrate that, in consideration of its<br>intended and indications for use, the design, labeling, packaging and sterilization<br>of the Aquamantys SBS 5.0 Sheathed Bipolar Sealer is compliant with the<br>following standards: |
| K114732 | Aquamantys SBS 5.0 Sheathed Bipolar Sealer - 510(k) Summary<br>Page 2 of 3 |
| ANSI/AAMI ISO 11135-1:2007: Sterilization of health care products -<br>Ethylene Oxide - Part 1: Requirements for the development, validation<br>and routine control of a sterilization process for medical devices ISO 11607-1:2006, Packaging for terminally sterilized medical devices<br>-Part 1: Requirements for materials, sterile barrier ISO 11607-2:2006: Packaging for terminally sterilized medical devices<br>-Part 2: Validation requirements for forming, sealing and assembly<br>processes, including Annex B (informative) listing of standardized test<br>methods and procedures ASTM F1980-07; Shelf-life and accelerated aging techniques for<br>standard evaluation of packaging performance ISO 10993-4:2002, Biological evaluation of medical devices - Part 4:<br>Selection of tests for interactions with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part 5:<br>Tests for In Vitro Cytotoxicity ISO 10993-7:2008, Biological evaluation of medical devices - Part 7:<br>Ethylene oxide sterilization residuals ISO 10993-10:2002 (A1:2006), Biological evaluation of medical devices<br>- Part 10: Tests for irritation and delayed-type hypersensitivity. ISO 10993-11:2006, Biological evaluation of medical devices -- Part 11:<br>Tests for systemic toxicity ANSI/AAMI ST72:2002/(R)2010 - Bacterial endotoxins— Test<br>methodologies, routine monitoring, and alternatives to batch testing AAMI / ANSI ES 60601-1:2005, Medical electrical equipment - Part 1:<br>General requirements for basic safety and essential performance. IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2: General<br>Requirements For Safety Collateral Standard Electromagnetic<br>Compatibility Requirements And Tests IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular<br>requirements for the basic safety and essential performance of high<br>frequency surgery equipment and high frequency surgical accessories | |
| Clinical Performance Data: | Clinical data was not necessary to support that the Aquamantys SBS 5.0<br>Sheathed Bipolar Sealer is substantially equivalent to currently marketed<br>predicate devices. |
| Cited References | 1. Tanzer ML. Cross-linking of collagen. Science. 1973; 180(86):561-566.<br>2. Sigel B, Hatke FL. Physical factors in electrocoaplation of blood vessels. Arch<br>Surg. 1967; 95(1):54-58.<br>3. Gorisch W, Boergen KP. Heat-induced contraction of blood vessels. Lasers<br>Surg Med. 1982; 2( 1): 1-13.<br>4. Miles CA, Bailey Al. Thermally labile domains in the collagen molecule.<br>Micron. 2001; 32(3):325-332.<br>5. Arnoczky AP, Aksan A. Thermal modification of connective tissues: basic<br>science considerations and clinical implications. JAm Aead Orthop Surg. 2000;<br>8(5):305-313.<br>6. Chen SS, Wright NT, Humphrey JD. Heat-induced changes in the mechanics<br>of a collagenous tissue: isothermal, isotonic shrinkage. J Biomech Eng. 1998;<br>120(3):382-388.<br>7. Sigel B and Dunn M. The mechanism of blood vessel closure by high<br>frequency electrocoagulation. Sugary, Gynecology & Obstetrics 1965; 821-831.<br>8. Sigel B, Hatke FL. Physical factors in electrocoagulation of blood vessels. Arch<br>Surg 1967; 95: 54-58. |

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Salient Surgical Technologies, Incorporated % Mr. Martin Leighton Director of Regulatory Affairs & Quality Assurance 180 International Drive Portsmouth, New Hampshire 03801

DEC - 5 2011

Re: K111732

Trade/Device Name: Aquamantys SBS 5.0 Sheathed 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: November 14, 2011 Received: November 17, 2011

Dear Mr. Leighton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Mr. Martin Leighton

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.

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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ely yours,

N. Mc

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

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## 4. INDICATIONS FOR USE STATEMENT

510(k) Number if known:

Device Name: Aquamantys SBS 5.0 Sheathed Bipolar Sealer

The Aquamantys SBS 5.0 Sheathed 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 sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use ___ (Per 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

Divisi (Division Signical, Orthopedic, and Restorative Devices

510(k) Number K111732