(71 days)
Not Found
No
The description focuses on the electrosurgical technology (RF energy and saline) and does not mention any AI/ML components or functionalities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is used for hemostatic sealing and coagulation of soft tissue and bone, which are therapeutic medical interventions.
No
The device is intended for hemostatic sealing and coagulation during surgery, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "sterile, single-use bipolar electrosurgical device" and describes physical components like electrodes, a handpiece, and a saline fluid delivery line. It also mentions being used "in conjunction with the Aquamantys Pump Generator," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "hemostatic sealing and coagulation of soft tissue and bone at the operative site." This is a therapeutic and surgical application, not a diagnostic one.
- Mechanism of Action: The device uses RF energy and saline to achieve hemostasis during surgery. This is a direct intervention on the patient's tissue, not a test performed on a sample taken from the patient.
- Lack of Diagnostic Language: The description and intended use do not mention analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device operates directly on the patient during surgery for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Aquamantys 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, neurosurgical, spine, endoscopic procedures [except AQM 2.3], abdominal [open abdominal for AQM 2.3] and thoracic surgery, and epidural vein sealing [3.4, 4.0 & 5.0 only] during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Product codes
GEI
Device Description
The Aquamantys Bipolar Sealer is a sterile, single-use bipolar device. The device employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and coagulation. 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 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, orthopaedic, neurosurgical, spine, abdominal, thoracic, epidural vein
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
Comparative performance data was conducted on ex-vivo porcine brain tissue. Thermal zone damage of the Aquamantys Bipolar Sealers was comparable to the thermal zone damage of the Codman Irrigated Bipolar Forceps. Clinical studies were not required or conducted to support the proposed neurosurgical expanded indications.
Key Metrics
Not Found
Predicate Device(s)
K896541, K052859, K063639, K111732
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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510(k) Summary
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| Submitter: | Medtronic Advanced Energy
180 International Drive
Portsmouth, NH 03801 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gabriela Anchondo
Principal Regulatory Affairs Specialist
Phone: (904) 279-7550
Fax: (603) 742-1488
E-mail: gabby.anchondo@medtronic.com |
| Date Summary Prepared: | September 18, 2013
DEC 0 3 2013 |
| Device Trade Name: | Aquamantys® 2.3 Bipolar Sealer
Aquamantys® EVS 4.0 Epidural Vein Sealer
Aquamantys® Mini EVS 3.4 Epidural Vein Sealer
Aquamantys® SBS 5.0 Sheathed Bipolar Sealer |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Predicate Device: | (Codman Irrigated Bipolar Forceps)
K896541 Malis Bipolar Electrosurgical System CMC III
(Medtronic Advanced Energy Aquamantys Bipolar Sealers)
K052859 Aquamantys 2.3 Bipolar Sealer
K063639 Aquamantys EVS 4.0 Epidural Vein Sealer
K063639 Aquamantys Mini EVS 3.4 Epidural Vein Sealer
K111732 Aquamantys SBS 5.0 Sheathed Bipolar Sealer |
| Device Description: | The Aquamantys Bipolar Sealer is a sterile, single-use bipolar device.
The device employs radio-frequency (RF) energy and saline irrigation for
hemostatic sealing and coagulation. 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 drip chamber or spike. The three-pin electrical
connector is designed to be plugged into the Aquamantys Pump
Generator. |
| Intended Use: | The Aquamantys 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,
neurosurgical, spine, endoscopic procedures [except AQM 2.3],
abdominal [open abdominal for AQM 2.3] and thoracic surgery, and
epidural vein sealing [3.4, 4.0 & 5.0 only] during surgery. The device is
not intended for contraceptive tubal coagulation (permanent female
sterilization). |
| Technological
Characteristics: | The Aquamantys Bipolar Sealers have the same technological
characteristics as the Codman Irrigated Bipolar Forceps. Both devices
are bipolar electrosurgical instruments that employ radio-frequency (RF)
energy and saline irrigation for hemostatic sealing and coagulation. |
| Non-Clinical Tests: | Comparative performance data was conducted on ex-vivo porcine brain
tissue. Thermal zone damage of the Aquamantys Bipolar Sealers was
comparable to the thermal zone damage of the Codman Irrigated Bipolar
Forceps. |
| Clinical Tests: | Clinical studies were not required or conducted to support the proposed
neurosurgical expanded indications. |
| Conclusion: | The indications for use, technology and performance characteristics of
the Aquamantys Bipolar Sealers are the same as the Codman Irrigated
Bipolar Forceps. Based on this, Medtronic Advanced Energy claims
substantial equivalence to the predicate device. |
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K132974 Page 2 of 2
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and the control control of the control of
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Image /page/2/Picture/0 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 emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Advanced Energy Ms. Gabriela Anchondo Senior Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801
December 3, 2013
Re: K132974
Trade/Device Name: Aquamantys 2.3 Bipolar Sealer, Aquamantys EVS 4.0 Epidural Vein Sealer, Aquamantys Mini EVS 3.4 Epidural Vein Scaler, Aquamantys SBS 5.0 Sheathed Bipolar Scaler Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 15, 2013 Received: November 18, 2013
Dear Ms. Anchondo:
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 10 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 docs 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
3
Page 2 - Ms. Gabriela Anchondo
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours.
Radiological Health
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and
Enclosure
4
Indications for Use
510(k) Number (if known): K132974
Device Name:
Aquamantys 2.3 Bipolar Sealer
Indications for Use:
The Aquamantys 2.3 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, neurosurgical, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Device Name:
Aquamantys Epidural Vein Sealer & Aquamantys Mini Epidural Vein Sealer
Indications for Use:
The Aquamantys Epidural Vein 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, neurosurgical, 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 Name:
Aquamantys SBS 5.0 Sheathed Bipolar Sealer
Indications for 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, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not intended for contraceplive 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)
Lona H. Chen -A .
upped by Long H. Chen A.
Only Severament Bunlands
BurProple, Loo Long H. Chen A. 12-12-12-19200 JEC. 100. 1. 1-1100164054
Cizts: 2013.0 1.22 14-1 F. 19-05 DC
for BSA
(Division Sign-off) Division of Surgical Devices 510(k) Number_K132974