(57 days)
No
The summary describes a standard electrosurgical generator and handpiece system with a peristaltic pump for saline delivery. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device's functionality. The performance studies focus on thermal damage and electrical safety, not AI/ML performance metrics.
Yes
The device, an AEx Generator and PlasmaBlade T, is intended for delivering RF energy for cutting, coagulation, and hemostatic sealing of soft tissue and bone in various surgical procedures, performing a direct therapeutic function.
No
The device is described as an electrosurgical generator and a monopolar electrosurgical instrument intended for cutting and coagulation of soft tissue and bone, which are therapeutic functions, not diagnostic.
No
The device description clearly outlines hardware components including a generator, handpiece, housing, LCD control panel, peristaltic pump, and electrical connectors. While software is mentioned for verification and testing, the device is fundamentally a hardware system with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures on soft tissue and bone within the human body. This involves direct interaction with the patient during surgery.
- Device Description: The description details an electrosurgical generator and handpiece that deliver RF energy and saline to the patient's tissues for cutting and coagulation. This is an in vivo application (within a living organism).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) outside the body.
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or assays.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device operates directly on the patient's tissues during surgery.
N/A
Intended Use / Indications for Use
AEx Generator:
The AEx Generator is a radio frequency (RF) electrosurgical generator capable of simultaneously powering specified monopolar and bipolar electrosurgical instruments. It is intended to be used for delivery of RF energy to instruments indicated for cutting and coagulation of soft tissue and for delivery of RF encrgy concurrent with saline to instruments indicated for hemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to. General. Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gyneologic, Orthopaedic. Arthroscopic, Spinal and Neurological, Thoracic, and Open Abdominal Surgery procedures. The device is not intended for contraceptive tubal coagulation (Permanent Female Sterilization).
PlasmaBlade T:
The PlasmaBlade T is a monopolar, single use, sterile, disposable device intended for use with the AEX Generator. The device delivers RF energy concurrent with saling and coagulation of soft tissue and bone and RF energy for cutting and coagulation of soft tissue. It is intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal, Thoracic, and Open abdominal surgery procedures. 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
Currently included as part of the system in this 510(k) submission are the AEX Generator, and the PlasmaBlade T Handpiece which is a one hand-held disposable, sterile, single use disposable electrosurgical device that is compatible only with the AEX Generator.
The information on the previously cleared hand-held disposable electrosurgical handpieces that are compatible with the AEX Generator is provided in section 9.8.3.
9.8.1 AEX GENERATOR
In one compact generator, the proposed AEX system provides the functional capabilities available in two separate previously marketed generators: the Medtronic Pulsar Generator (Previously cleared under K082786) and the Aguamantys Generator (Previously cleared under K052859). The AEX Generator applies similar fundamental technologies and methods of operation as the predicate Generators, delivering bipolar and monopolar RF energy for resection and coagulation of soft tissue, and RF based hemostatic sealing concurrent with saline delivery for hemostatic and coagulation sealing of soft tissue and bone at the operative site.
The AEX Generator is a line powered, electrosurgical generator with monopolar and bipolar RF that is intended for use only with specific compatible Medtronic electrosurgical Handpieces; the AEX compatible Handpieces are identified in Section 9.8.3. The AEX Generator is a shelf-top unit consisting of a plastic, metal housing and a front LCD control panel. The Generator has a peristaltic pump outside the generator's housing, which is capable of transferring saline through the disposable accessory device concurrent with the generator's provision of RF energy. The LCD control panel is a touchscreen and serves as the user interface for power and saline settings. The AEX Generator has three-pin and seven-pin receptacles in its front panel that provides for the monopolar PlasmaBlade and bipolar Aquamantys disposable Handpieces connection to the Generator's RF power.
The proposed PlasmaBlade T Handpiece connection to the AEX Generator pump is configured to interface with the AEX Generator peristaltic pump. The AEX Generator accepts designated, commercially available, split-pad and single foil patient return electrode pads (neutral electrodes), non-REM neutral electrodes for monopolar applications
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 31, 2014
Medtronic Advanced Energy Mr. Deep Pal Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801
Re: K143175 Trade/Device Name: AEx Generator PlasmaBlade T Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 4, 2014 Received: November 5, 2014
Dear Mr. Pal:
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
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Page 2 - Mr. Deep Pal
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 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows the Medtronic logo. On the left side of the logo is a circle with three figures inside. The figures are in different positions, suggesting movement. To the right of the circle is the word "Medtronic" in a bold, sans-serif font.
SECTION 8: INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K143175 Device Name
AEx Generator PlasmaBlade T
Indications for Use (Describe)
AEx Generator:
The AEx Generator is a radio frequency (RF) electrosurgical generator capable of simultaneously powering specified monopolar and bipolar electrosurgical instruments. It is intended to be used for delivery of RF energy to instruments indicated for cutting and coagulation of soft tissue and for delivery of RF encrgy concurrent with saline to instruments indicated for hemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to. General. Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gyneologic, Orthopaedic. Arthroscopic, Spinal and Neurological, Thoracic, and Open Abdominal Surgery procedures. The device is not intended for contraceptive tubal coagulation (Permanent Female Sterilization).
PlasmaBlade T:
The PlasmaBlade T is a monopolar, single use, sterile, disposable device intended for use with the AEX Generator. The device delivers RF energy concurrent with saling and coagulation of soft tissue and bone and RF energy for cutting and coagulation of soft tissue. It is intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal, Thoracic, and Open abdominal surgery procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6748 171
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Image /page/3/Picture/1 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" on the right. The graphic shows three figures in a circle, with one figure standing upright and the other two figures lying horizontally. The word "Medtronic" is written in a bold, sans-serif font.
SECTION 9: 510(k) SUMMARY
This summary of substaintial equivalence is submitted in accordance with the requirements of 21CFR807.92.
DATE PREPARED 9.1
November 3, 2014
9.2 NAME AND ADDRESS OF THE 510(k) OWNER
Medtronic Advanced Energy 180 International Drive Portsmouth, NH 03801
9.3 CONTACT PERSON
Deep Pal
Principal Regulatory Affairs Specialist Telephone: 817.788.6685 Facsimile: 817.788.6222 E-Mail: deep.pal@medtronic.com
9.4 PROPRIETARY NAME OF THE PROPOSED DEVICES
AEX Generator (Device Catalog Number: 40-405-1); and PlasmaBlade T Handpiece (Device Catalog Number: 27-101-1)
COMMON/USUAL NAME 9.5
Electrosurgical Device and Accessories
9.6 DEVICE CLASSIFICATION NAME
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400, Product Code GEI, Class II)
9.7 PREDICATE DEVICE IDENTIFICATION
The devices that are within the scope of this 510(k) Submission, the proposed AEX Generator and PlasmaBlade T Handpiece devices, are substantially equivalent to the following predicates:
| PROPOSED DEVICE | CLAIMING SUBSTANTIAL EQUIVALNCE TO | ||
|---|---|---|---|
| AEX | PlasmaBlade T | PREDICATE DEVICE | 510(k) NUMBER |
| ✓ | N/A | Aquamantys System |
- Aquamantys Generator and Aquamantys Handpieces | K052859 |
| ✓ | ✓ | PEAK Surgery System - PULSAR Generator and PlasmaBlade Handpieces | K082786 |
| N/A | ✓ | Aquamantys SBS 5.0 Handpiece | K111732, K132974 |
| D DEVICE CLAIMING SUBSTANTIAL EQUIVALNCE TO | |
|---|---|
| --------------------------------------------- | -- |
Table 2: Predicate device claiming equivalence to
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Image /page/4/Picture/0 description: The image shows the Medtronic logo. On the left side of the logo is a circular graphic with a person in three different positions, showing movement. To the right of the graphic is the company name, "Medtronic," in a bold, sans-serif font.
9.8 DEVICE DESCRIPTION
Currently included as part of the system in this 510(k) submission are the AEX Generator, and the PlasmaBlade T Handpiece which is a one hand-held disposable, sterile, single use disposable electrosurgical device that is compatible only with the AEX Generator.
The information on the previously cleared hand-held disposable electrosurgical handpieces that are compatible with the AEX Generator is provided in section 9.8.3.
9.8.1 AEX GENERATOR
In one compact generator, the proposed AEX system provides the functional capabilities available in two separate previously marketed generators: the Medtronic Pulsar Generator (Previously cleared under K082786) and the Aguamantys Generator (Previously cleared under K052859). The AEX Generator applies similar fundamental technologies and methods of operation as the predicate Generators, delivering bipolar and monopolar RF energy for resection and coagulation of soft tissue, and RF based hemostatic sealing concurrent with saline delivery for hemostatic and coagulation sealing of soft tissue and bone at the operative site.
The AEX Generator is a line powered, electrosurgical generator with monopolar and bipolar RF that is intended for use only with specific compatible Medtronic electrosurgical Handpieces; the AEX compatible Handpieces are identified in Section 9.8.3. The AEX Generator is a shelf-top unit consisting of a plastic, metal housing and a front LCD control panel. The Generator has a peristaltic pump outside the generator's housing, which is capable of transferring saline through the disposable accessory device concurrent with the generator's provision of RF energy. The LCD control panel is a touchscreen and serves as the user interface for power and saline settings. The AEX Generator has three-pin and seven-pin receptacles in its front panel that provides for the monopolar PlasmaBlade and bipolar Aquamantys disposable Handpieces connection to the Generator's RF power.
The proposed PlasmaBlade T Handpiece connection to the AEX Generator pump is configured to interface with the AEX Generator peristaltic pump. The AEX Generator accepts designated, commercially available, split-pad and single foil patient return electrode pads (neutral electrodes), non-REM neutral electrodes for monopolar applications