(168 days)
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).
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 and epidural vein sealing at the operative site. Its indications for use include but are not limited to, orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery.
The device employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and coagulation. The effect of RF energy applied to tissues concurrent with a flow of saline results in hemostatic sealing and coagulation of soft tissue and bone without charring; this result has been trademarked "Transcollation® Technology" by Salient Surgical Technologies.
The saline helps couple the electrical energy output from the electrosurgical generator to the tissue, increasing the contact area and limiting the surface to a consistent temperature range. (approximately 100 degrees C).
The vascular system is primarily made up of collagen types I and III. The effect of heat on these fibrous collagens has been well studied. (1, 8) When regularly oriented collagen shrinks along a direction parallel to the dominant direction of fiber orientation, the shrinkage is accompanied by swelling in a direction perpendicular to the fiber orientation. (5, 6) This effectively results in reduction of the vessel lumen diameter and in most cases closure of the vessel lumen. (7-8) References cited follow below.
The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is equipped with dual polished stainless steel electrode tips. The electrodes are housed in a two position insulating polymer sheath. The two positions of the sheath are manually established by the surgeon's hand and defined by positive mechanical detents that are detected by the touch. In the sheath open position, the electrodes are fully exposed allowing the surgeon to make use of a majority of their area to contact incised tissue in order to deliver hemostatic sealing and coagulation therapy to broad tissue planes. In the sheath closed position the electrodes are surrounded by the insulating sheath along their length and only exposed at their tips. The closed position allows the surgeon to work adjacent delicate structures while delivering therapy to small areas of incised tissue, or preventing or stopping epidural veins from bleeding. Regardless of sheath position, when the electrodes are activated saline is concurrently delivered from apertures located within the electrode sheath housing. Saline and electrical lines exit the opposite end of the handpiece from the electrodes. The handpiece is equipped with an on-off button that simultaneously activates both RF and saline flow. A saline fluid delivery line is provided with the device, and includes a section of pump tubing and drip chamber with spike. The three-pin electrical connector is designed to be plugged into the Aquamantys Pump Generator.
The provided text describes the Aquamantys SBS 5.0 Sheathed Bipolar Sealer and its 510(k) summary (K111732). However, it does not contain explicit acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or specific thresholds for hemostatic sealing efficacy) nor a detailed study that directly proves the device meets such criteria for a specific AI-driven task.
Instead, the document focuses on establishing substantial equivalence to predicate devices through non-clinical performance data, primarily bench testing and in vivo animal data. It explicitly states that clinical data was not necessary for this 510(k) submission. Therefore, many of the requested items related to clinical studies, ground truth establishment, expert adjudication, and AI-specific metrics are not applicable or not present in this document.
Here's an analysis based on the provided information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance, nor does it provide a table of performance metrics meeting those criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests. The "performance" assessment is qualitative, focusing on proving the device's functionality and safety are comparable to existing, legally marketed devices.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to predicate devices in: | Assessed through: Construction (structure, materials), Principles of operation, Mechanisms of action, Performance on live tissues (GLP-compliant in vivo animal studies). |
| - Intended and Indications for Use | Found "substantially equivalent" to predicate devices (Aquamantys 2.3 Bipolar Sealer (K052859) and Aquamantys SS4.0 Bipolar Sealer (K063639)). |
| - Construction | Not specifically detailed, but "assessed and compared." |
| - Principles of Operation and Mechanisms of Action | Not specifically detailed, but "assessed and compared." |
| - Performance of intended and indications for use on live tissues | Conducted per GLP requirements in GLP certified facilities, using in vivo animal data. |
| Compliance with relevant standards: (e.g., sterilization, packaging, biocompatibility, electrical safety) | "Test protocols and reports of results demonstrate that...the design, labeling, packaging and sterilization of the Aquamantys SBS 5.0 Sheathed Bipolar Sealer is compliant with the following standards:" (followed by a comprehensive list of ISO, ASTM, and AAMI standards). |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated in terms of number of cases or animals, but refers to "bench testing and in vivo animal data collection." No human test set was used for this stage of approval.
- Data provenance: In vivo animal data and bench testing. The country of origin for the animal studies is not specified, but they were conducted in "GLP certified facilities."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is not an AI/diagnostic device that relies on expert interpretation for ground truth.
- For the in vivo animal studies, the "ground truth" would be established by direct observation of hemostatic sealing effectiveness by the study investigators/veterinarians, following established protocols. The number and qualifications of these individuals are not specified in this summary.
4. Adjudication method for the test set
- Not applicable in the context of an AI device requiring expert adjudication for ground truth. The performance in animal studies would be assessed directly against predefined endpoints in the test protocols.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a surgical device, not an AI diagnostic/assistance system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a conventional medical device; there is no AI algorithm involved.
7. The type of ground truth used
- For the in vivo animal data, the ground truth would be direct observational evidence of hemostatic sealing and coagulation of soft tissue and bone in the operative site, evaluated by study personnel based on predefined criteria within the study protocols. Macroscopic and microscopic evaluation of tissue effects might also be part of this.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable.
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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: 603.742.1515 Fax: 603.742.1488
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.,180 International Drive,Portsmouth, NH 03801 USATel. (603) 294-5446Fax. (603) 742-1488 |
|---|---|
| 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)Aquamantys SS4.0 Bipolar Sealer (K063639) marketed as the AquamantysEpidural Vein Sealer (EVS) |
| Device Description: | The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is a sterile, single-usebipolar electrosurgical device intended to be used in conjunction with theAquamantys Pump Generator for delivery of RF energy and saline forhemostatic sealing and coagulation of soft tissue and bone and epidural veinsealing at the operative site. Its indications for use include but are not limited to,orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery,and epidural vein sealing during surgery.The device employs radio-frequency (RF) energy and saline irrigation forhemostatic sealing and coagulation. The effect of RF energy applied to tissuesconcurrent with a flow of saline results in hemostatic sealing and coagulation ofsoft tissue and bone without charring; this result has been trademarked"Transcollation® Technology" by Salient Surgical Technologies.The saline helps couple the electrical energy output from the electrosurgicalgenerator to the tissue, increasing the contact area and limiting the surface to aconsistent temperature range. (approximately 100 degrees C). |
| The vascular system is primarily made up of collagen types I and III. The effectof heat on these fibrous collagens has been well studied. (1, 8) When regularlyoriented collagen shrinks along a direction parallel to the dominant direction offiber orientation, the shrinkage is accompanied by swelling in a direction | |
| perpendicular to the fiber orientation. (5, 6) This effectively results in reduction ofthe vessel lumen diameter and in most cases closure of the vessel lumen. (7-8)References cited follow below. | |
| The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is equipped with dualpolished stainless steel electrode tips. The electrodes are housed in a twoposition insulating polymer sheath. The two positions of the sheath are manuallyestablished by the surgeon's hand and defined by positive mechanical detentsthat are detected by the touch. In the sheath open position, the electrodes arefully exposed allowing the surgeon to make use of a majority of their area tocontact incised tissue in order to deliver hemostatic sealing and coagulationtherapy to broad tissue planes. In the sheath closed position the electrodes aresurrounded by the insulating sheath along their length and only exposed at theirtips. The closed position allows the surgeon to work adjacent delicate structureswhile delivering therapy to small areas of incised tissue, or preventing orstopping epidural veins from bleeding. Regardless of sheath position, when theelectrodes are activated saline is concurrently delivered from apertures locatedwithin the electrode sheath housing. Saline and electrical lines exit the oppositeend of the handpiece from the electrodes. The handpiece is equipped with anon-off button that simultaneously activates both RF and saline flow. A saline fluiddelivery line is provided with the device, and includes a section of pump tubingand drip chamber with spike. The three-pin electrical connector is designed tobe plugged into the Aquamantys Pump Generator. | |
| Intended and Indications forUse: | The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is a sterile, single-usebipolar electrosurgical device intended to be used in conjunction with theAquamantys Pump Generator for delivery of RF energy and saline forhemostatic 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. Thedevice is not intended for contraceptive tubal coagulation (permanent femalesterilization). |
| Summary of the technologicalcharacteristics of theAquamantys SBS 5.0Sheathed Bipolar Sealerdevice compared to thepredicate devices: | In order to establish substantial equivalence of the Aquamantys SBS 5.0Sheathed Bipolar Sealer to the predicate devices, characteristics including butnot limited to the following were assessed and compared.• Intended and indications for use• Construction (including structure and component materials)• Principles of operation and mechanisms of action• Performance of intended and indications for use on live tissues (asconducted per GLP requirements in GLP certified facilities)The results of these comparative assessments found the Aquamantys SBS 5.0Sheathed Bipolar Sealer substantially equivalent to the equivalent devices(predicates) identified above. |
| Non-clinicalPerformanceData: | Performance testing per standardized methods and Salient Surgical's testprotocols, including bench testing and in vivo animal data collection, wasconducted and provides support that the Aquamantys SBS 5.0 SheathedBipolar Sealer is substantially equivalent to currently marketed predicatedevices.Non-clinical performance test protocols and reports of results are identified inSections 14 through 19 of this 510(k) submission.Test protocols and reports of results demonstrate that, in consideration of itsintended and indications for use, the design, labeling, packaging and sterilizationof the Aquamantys SBS 5.0 Sheathed Bipolar Sealer is compliant with thefollowing standards: |
| K114732 | Aquamantys SBS 5.0 Sheathed Bipolar Sealer - 510(k) SummaryPage 2 of 3 |
| ANSI/AAMI ISO 11135-1:2007: Sterilization of health care products -Ethylene Oxide - Part 1: Requirements for the development, validationand routine control of a sterilization process for medical devices ISO 11607-1:2006, Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier ISO 11607-2:2006: Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing and assemblyprocesses, including Annex B (informative) listing of standardized testmethods and procedures ASTM F1980-07; Shelf-life and accelerated aging techniques forstandard evaluation of packaging performance ISO 10993-4:2002, Biological evaluation of medical devices - Part 4:Selection of tests for interactions with blood ISO 10993-5:2009, Biological evaluation of medical devices - Part 5:Tests for In Vitro Cytotoxicity ISO 10993-7:2008, Biological evaluation of medical devices - Part 7:Ethylene oxide sterilization residuals ISO 10993-10:2002 (A1:2006), Biological evaluation of medical devices- Part 10: Tests for irritation and delayed-type hypersensitivity. ISO 10993-11:2006, Biological evaluation of medical devices -- Part 11:Tests for systemic toxicity ANSI/AAMI ST72:2002/(R)2010 - Bacterial endotoxins— Testmethodologies, routine monitoring, and alternatives to batch testing AAMI / ANSI ES 60601-1:2005, Medical electrical equipment - Part 1:General requirements for basic safety and essential performance. IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2: GeneralRequirements For Safety Collateral Standard ElectromagneticCompatibility Requirements And Tests IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particularrequirements for the basic safety and essential performance of highfrequency surgery equipment and high frequency surgical accessories | |
| Clinical Performance Data: | Clinical data was not necessary to support that the Aquamantys SBS 5.0Sheathed Bipolar Sealer is substantially equivalent to currently marketedpredicate devices. |
| Cited References | 1. Tanzer ML. Cross-linking of collagen. Science. 1973; 180(86):561-566.2. Sigel B, Hatke FL. Physical factors in electrocoaplation of blood vessels. ArchSurg. 1967; 95(1):54-58.3. Gorisch W, Boergen KP. Heat-induced contraction of blood vessels. LasersSurg Med. 1982; 2( 1): 1-13.4. Miles CA, Bailey Al. Thermally labile domains in the collagen molecule.Micron. 2001; 32(3):325-332.5. Arnoczky AP, Aksan A. Thermal modification of connective tissues: basicscience considerations and clinical implications. JAm Aead Orthop Surg. 2000;8(5):305-313.6. Chen SS, Wright NT, Humphrey JD. Heat-induced changes in the mechanicsof a collagenous tissue: isothermal, isotonic shrinkage. J Biomech Eng. 1998;120(3):382-388.7. Sigel B and Dunn M. The mechanism of blood vessel closure by highfrequency electrocoagulation. Sugary, Gynecology & Obstetrics 1965; 821-831.8. Sigel B, Hatke FL. Physical factors in electrocoagulation of blood vessels. ArchSurg 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 (800) 638-2041 or (301) 796-7100 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
§ 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.