(355 days)
Not Found
No
The summary describes a traditional electrosurgical device using RF energy and saline for hemostasis and dissection. There is no mention of AI, ML, or any computational analysis of data for decision-making or control.
No
The device is described as a surgical tool for blunt dissection, hemostatic sealing, and coagulation of tissue and bone, which are direct interventions during a surgical procedure, not therapeutic treatments.
No
The device is described as a surgical tool used for blunt dissection and for hemostatic sealing and coagulation of soft tissue and bone, implying an operative or therapeutic function rather than diagnostic.
No
The device description clearly outlines a physical, single-use, sterile bipolar device with electrodes, saline lines, electrical connectors, and an on-off button. It is intended to be used in conjunction with a separate hardware generator. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "blunt dissection and for haemostatic sealing and coagulation of soft tissue and bone at the operative site." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical handpiece with electrodes and saline delivery, designed for use during surgery.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue samples, etc.) outside of the body to provide diagnostic information. IVDs are used to perform tests on these types of samples.
The device is a surgical tool used for therapeutic purposes (hemostasis and dissection) during an operation, not for diagnosing a condition by analyzing samples in a lab setting.
N/A
Intended Use / Indications for Use
The Aquamantys Double Cone Bipolar Sealer is a single use, sterile, bipolar device, intended to be used in conjunction with the Aquamantys 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).
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Aquamantys Double Cone Bipolar Sealer is a disposable, single-use, sterile, bipolar device. The device employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and for coagulation and blunt dissection. The device is equipped with a dual electrode tip. 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 a drip chamber or spike. The three-pin electrical connector is designed to be plugged into the Aquamantys Pump Generator.
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 (e.g., open abdominal, orthopaedic, and thoracic surgery).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Pre-Clinical Evaluation: Where applicable, non-clinical testing of the proposed device relied upon to determine substantial equivalence to the predicate were as follows:
- In-vivo porcine testing, including:
- Tissue resection showing depth versus fluence
- Stationary depth of effect on tissue versus time
- Moving depth and diameter of effect versus time
- Usability
- Angle of usage
- Various tissue usage states
- Compatibility with appropriate generator
- Finger switch
- Electromagnetic Compatibility per IEC 60601-1-2 as modified by IEC 60601-2-2
- Visual and Dimensional
Testing has confirmed the proposed device's performance for blunt dissection and for haemostatic sealing and coagulation is at least as safe and effective as that of the predicate devices.
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.
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
510(k) Summary of Safety and Effectiveness
APR - 5 2011
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, 21 CFR 807.87, 21 CFR 807.92, Format for Traditional and Abbreviated 510(k)s.
- ﺎ . Name of Submitter, Contact Person and Date Summary Prepared:
| Company Name: | Salient Surgical Technologies, Inc. |
|---|---|
| Address: | 180 International Drive |
| Portsmouth, NH 03801 | |
| Phone: | (603) 742-1515 |
| Fax: | (603) 742-5943 |
| Contact: | Tara N. Turney Urling, RAC |
| Senior Regulatory Affairs Specialist |
Date of Preparation: March 29, 2011
-
Device Trade Name and Common Name:
| Trade Name: | Aquamantys Double Cone Bipolar Sealer |
|---|---|
| Common/Usual Name: | |
| Classification Name: | |
| Accessories | Electrosurgery Bipolar Sealer |
| Electrosurgical, Cutting & Coagulation & | |
| Product Code: | GEI |
| 21CFR 878.4400 | |
| Device Class: | Class II |
- Legally Marketed Equivalent Device: TissueLink Solid Cylinder Monopolar Device 510(k) K014260
Aquamantys Pump Generator System (including AQM Bipolar Sealers 2.3 and 6.0) 510(k) K052859
1
- న. Performance Standards: None applicable
- Description of the Device: The Aquamantys Double Cone Bipolar Sealer is a 6. disposable, single-use, sterile, bipolar device. The device employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and for coagulation and blunt dissection. The device is equipped with a dual electrode tip. 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 a drip chamber or spike. The three-pin electrical connector is designed to be plugged into the Aquamantys Pump Generator.
-
- Intended Use of the Device: The Aquamantys Double Cone Bipolar Sealer is a single use, sterile, bipolar device, intended to be used in conjunction with the Aquamantys 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).
-
- Comparison of technological characteristics with Predicate Device: The device is similar to the TissueLink Solid Cylinder Monopolar device in that it is capable of blunt dissection as well as hemostatic sealing and coagulation. Physically, the device employs similar characteristics to the Aquamantys 6.0 Bipolar Sealer including connection to the Aquamantys Pump Generator.
-
- Pre-Clinical Evaluation: Where applicable, non-clinical testing of the proposed device relied upon to determine substantial equivalence to the predicate were as follows:
- . In-vivo porcine testing, including:
- o Tissue resection showing depth versus fluence
- o Stationary depth of effect on tissue versus time
- o Moving depth and diameter of effect versus time
- o Usability
- · Angle of usage
- . Various tissue usage states
- Compatibility with appropriate generator .
- a Finger switch
- Electromagnetic Compatibility per IEC 60601-1-2 as modified by IEC . 60601-2-2
- Visual and Dimensional .
2
Testing has confirmed the proposed device's performance for blunt dissection and for haemostatic sealing and coagulation is at least as safe and effective as that of the predicate devices.
-
- Conclusion: The proposed and predicate devices have similar intended uses, similar design, performance and functional features as well as the same fundamental scientific technology. The proposed device is found to be substantially equivalent to the named predicates. 1
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Salient Surgical Technologies, Inc. % Regulatory Technology Services LLC Mr. Mark Job 1394 25th Street NW Buffalo, MN 55313
APR - 5 2011
Re: K101057
Trade/Device Name: Aquamantys Double Cone 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 1, 2011 Received: April 4, 2011
Dear Mr. Job:
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
4
Page 2 - Mr. Mark Job
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse overse (CDFR 803); 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 100-1050.
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/ucm1158011, please
the Center for Devices and bodie DA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 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 tolli ine (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
edia.dps.mn.gov/KoreanServices/ResourcesforYourIndustry/default.htm
Sincerely yours,
Sincerely yours,
for Peter D. Rieman
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K101057
Device Name: Aquamantys Double Cone Bipolar Sealer
Indications for Use: The Aquamantys Double Cone Bipolar Sealer is a single use, sterile, bipolar device, intended to be used in conjunction with the Aquamantys 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 X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101057
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