(57 days)
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).
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 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 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 <= 50 Watts, and provides monitoring of the patient return circuit for safety purposes.
The proposed single-use disposable accessory device, the PlasmaBlade T monopolar handpiece, provides the hemostatic capabilities of the Aquamantys SBS 5.0 Handpiece and the cutting and coagulative capabilities of the PEAK PlasmaBlade 4.0.
The proposed PlasmaBlade T Handpiece device is a monopolar, single use, disposable devices and is provided sterile. The devices are not intended for reuse or resterilization. The PlasmaBlade T handpieces consists of an enamel coated insulated blade electrode, an insulated telescoping shaft, handle with three integrated controls, and a co-extruded cable assembly to provide both power and saline. The seven-pin electrical connector is designed to be plugged into the proposed AEx Generator.
The proposed PlasmaBlade T Handpiece is a disposable device, that when connected to the AEX Generator, uses monopolar RF energy for the resection and coagulation of soft tissue and bone. The proposed PlasmaBlade T Handpiece device shares similar handpiece designand tip configuration as its predicate device, the PlasmaBlade 4.0 Monopolar Handpiece.
In addition to the monopolar cutting and coagulation capabilities the propsoed PlasmaBlade T Handpiece device also uses monopolar RF energy concurrent with saline delivery to provide a broader coagulative effect; similar to the predicate Aquamantys SBS 5.0 Handpiece, this result is trademarked as Transcollation® Technology by Medtronic. The proposed PlasmaBlade T Handpiece device also has a pump header tubing segment and saline bag spike tubing allowing the user to manually connect the device to saline source in the OR as well as the AEX Generator's peristaltic pump. This ensures the device is connected for saline delivery at the same time as the device is connected electrically to the proposed AEX Generator.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a structured table or numerical values for performance metrics. Instead, it relies on a comparison of the proposed device's performance to that of predicate devices, stating it is "comparable" or shows "no clinically significant difference."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Thermal Effects on Tissue | |
| Zone of thermal damage (AEx Generator vs. Predicates) | Comparable zone of thermal damage to predicate Aquamantys and Pulsar Generators. |
| Zone of thermal damage (PlasmaBlade T vs. Predicates) | Comparable zone of thermal damage to predicate Aquamantys SBS 5.0 and PlasmaBlade 4.0 Handpieces. |
| Software Verification | |
| Compliance with IEC 62304 Edition 1: 2006 | Software development and testing executed in compliance. |
| Electromagnetic Compatibility (EMC) | |
| Compliance with IEC 60601-1-2 Edition 3: 2007-03 | Tested in compliance. |
| Compliance with IEC 60601-2-2 Edition 5.0 2009-02 | Tested in compliance. |
| Electrical Safety | |
| Compliance with IEC 60601-1:2005 3rd Edition And A1:2012 | Tested in compliance. |
| Compliance with IEC 60601-2-2 Edition 5.0 2009-02 | Tested in compliance. |
| General Performance Characteristics | |
| Output characteristics | Verified. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "in-vivo, ex-vivo animal (porcine) studies" for thermal effects on tissue. However, it does not specify the number of animals or specific samples used in these studies.
- Data Provenance: The studies were animal (porcine) studies and were conducted as non-clinical testing. The document does not specify the country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for the animal studies in the context of human diagnosis or interpretation. The "ground truth" for the thermal effects appears to be directly measured or observed in the porcine tissue. For compliance with standards, the "ground truth" is adherence to the standard's requirements, which would typically be assessed by qualified engineers/testers, but no specific number or qualifications are provided.
4. Adjudication Method for the Test Set
Not applicable. The non-clinical testing and comparison against predicate devices do not involve an adjudication method in the context of human interpretation or diagnosis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document describes non-clinical testing (animal studies, software verification, EMC, electrical safety, bench-top performance) that compares the proposed device to predicate devices. It does not mention any clinical studies involving human readers or cases, nor a multi-reader multi-case (MRMC) comparative effectiveness study to assess human reader improvement with or without AI assistance. The device in question is an electrosurgical generator and handpiece, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The device is a physical electrosurgical system, not an algorithm or AI. The performance studies focus on the hardware's functional capabilities.
7. Type of Ground Truth Used
For the "Thermal Effects on Tissue" studies, the ground truth appears to be direct measurement or observation of thermal damage in porcine tissue. For the other tests (Software, EMC, Electrical Safety, Bench-top), the ground truth is compliance with recognized consensus standards and verification of output characteristics.
8. Sample Size for the Training Set
Not applicable. The device is an electrosurgical generator and handpiece, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is used for this type of device.
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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."
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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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 <= 50 Watts, and provides monitoring of the patient return circuit for safety purposes.
9.8.2 PLASMABLADE T HANDPIECE
The proposed single-use disposable accessory device, the PlasmaBlade T monopolar handpiece, provides the hemostatic capabilities of the Aquamantys SBS 5.0 Handpiece (Cleared under K111732, K132974) and the cutting and coagulative capabilities of the PEAK PlasmaBlade 4.0 (Previously cleared under K082786).
The proposed PlasmaBlade T Handpiece device is a monopolar, single use, disposable devices and is provided sterile. The devices are not intended for reuse or resterilization. The PlasmaBlade T handpieces consists of an enamel coated insulated blade electrode, an insulated telescoping shaft, handle with three integrated controls, and a co-extruded
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Image /page/5/Picture/0 description: The image shows the Medtronic logo. On the left side of the logo, there is a circular graphic with three figures in different positions, representing movement or transformation. To the right of the graphic, the word "Medtronic" is written in a bold, sans-serif font. The logo is simple and professional, conveying a sense of innovation and progress.
cable assembly to provide both power and saline. The seven-pin electrical connector is designed to be plugged into the proposed AEx Generator.
The proposed PlasmaBlade T Handpiece is a disposable device, that when connected to the AEX Generator, uses monopolar RF energy for the resection and coagulation of soft tissue and bone. The proposed PlasmaBlade T Handpiece device shares similar handpiece designand tip configuration as its predicate device, the PlasmaBlade 4.0 Monopolar Handpiece (Cleared under K082786).
In addition to the monopolar cutting and coagulation capabilities the propsoed PlasmaBlade T Handpiece device also uses monopolar RF energy concurrent with saline delivery to provide a broader coagulative effect; similar to the predicate Aquamantys SBS 5.0 Handpiece (Cleared under K111732, K132974), this result is trademarked as Transcollation® Technology by Medtronic. The proposed PlasmaBlade T Handpiece device also has a pump header tubing segment and saline bag spike tubing allowing the user to manually connect the device to saline source in the OR as well as the AEX Generator's peristaltic pump. This ensures the device is connected for saline delivery at the same time as the device is connected electrically to the proposed AEX Generator.
- ELECTROSURGICAL HANDPIECE DEVICES COMPATIBLE WITH THE AEX GENERATOR 9.8.3 The proposed AEX Generator will power the following proposed and the previously cleared hand-held disposable electrosurgical handpieces currently marketed by Medtronic:
| HANDPIECE | GENERATOR COMPATIBILITY | ||||
|---|---|---|---|---|---|
| 510(k) NUMBER | NAME | TYPE | AEX1 | PULSAR3 | AQM3 |
| Subject of this submission | PlasmaBlade T1 | Monopolar | ✓ | - | - |
| K082786 | PlasmaBlade 4.02 | Monopolar | ✓ | ✓ | - |
| K082786 | PlasmaBlade Needle | Monopolar | ✓ | ✓ | - |
| K083415 | PlasmaBlade Tonsil | Monopolar | ✓ | ✓ | - |
| K083415 | PlasmaBlade TnA | Monopolar | ✓ | ✓ | - |
| K083415 | PlasmaBlade Adenoid TIP | Monopolar | ✓ | ✓ | - |
| K093695 | PlasmaBlade 3.0S | Monopolar | ✓ | ✓ | - |
| K102709 | PlasmaBlade PLUS | Monopolar | ✓ | ✓ | - |
| K103775 | PlasmaBlade Suction Coagulator | Monopolar | ✓ | ✓ | - |
| K052859 | Aquamantys 6.0 | Bipolar | ✓ | - | ✓ |
| K052859, K111285, K132974 | Aquamantys 2.3 | Bipolar | ✓ | - | ✓ |
| K063639, K132974 | Aquamantys EVS 4.0 | Bipolar | ✓ | - | ✓ |
| K063639, K132974 | Aquamantys Mini EVS 3.4 | Bipolar | ✓ | - | ✓ |
| K073495 | Aquamantys MBS with Light | Bipolar | ✓ | - | ✓ |
| K101057 | Aquamantys 9.5XL | Bipolar | ✓ | - | ✓ |
| K111732, K132974 | Aquamantys SBS 5.02 | Bipolar | ✓ | - | ✓ |
| K123201 | Aquamantys Endo DBS 8.7 | Bipolar | ✓ | - | ✓ |
4Subject of this submission.
-Predicates for the proposed PlasmaBlade T Handpiece.
3Predicates for the proposed AEX Generator: AQM (K052859), Pulsar Generator (K082786)
Table 3: AEX Generator compatible Handpieces
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Image /page/6/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, sans-serif font on the right. The graphic depicts three human figures in different positions within a circle, suggesting movement or transformation. The word "Medtronic" is written in a clean, modern typeface, conveying a sense of professionalism and innovation.
9.9 INDICATIONS FOR USE
9.9.1 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 energy 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, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological, Thoracic, and Open Abdominal Surgery procedures. The device is not intended for contraceptive tubal coagulation (Permanent Female Sterilization).
9.9.2 PLASMABLADE T HANDPIECE
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 saline for hemostatic sealing and coagulation of soft tissue 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).
9.10 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The predicates and the proposed AEX generator and Plasmablade T are both intended for RF based resection and coagulation of soft tissue, and RF based hemostatic sealing concurrent with saline delivery for hemostatic sealing and coagulation of soft tissue and bone during various surgical procedures. The proposed devices share the same operational characteristics as the predicate platforms, comprised of a radio-frequency generator which supplies RF power to disposable electrode devices for electrosurgical procedures.
9.10.1 AEX GENERATOR
The AEx Generator applies the same fundamental technology as the predicate Aguamantys Generator (Previously cleared under K052859) and the Pulsar Generator (Previously cleared under K082786) in that it delivers bipolar and monpolar RF energy for resection and coagulation of soft tissue and bone, and RF based hemostatic sealing concurrent with saline delivery at the operative site.
9.10.2 PLASMABLADE T HANDPIECE
The proposed single-use disposable accessory device, the PlasmaBlade T monopolar handpiece, provides the hemostatic capabilities of the Aquamantys SBS 5.0 Handpiece (Cleared under K111732, K132974) and the cutting and coagulative capabilities of the PEAK PlasmaBlade 4.0 (Previously cleared under K082786).
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Image /page/7/Picture/0 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 depicts three human figures in different positions, arranged in a circular pattern. The word "Medtronic" is written in a bold, sans-serif font.
9.11 SUMMARY OF NON-CLINICAL TESTING
9.11.1 THERMAL EFFECTS ON TISSUE
The representative legally marketed Aguamantys and the PlasmaBlade Handpieces with the proposed AEX Generator were evaluated side by side against the predicate Aquamantys Generator (Cleared under K052859) and Pulsar Generator (Cleared under K082786) devices, in the in-vivo, ex-vivo animal (porcine) studies.
Thermal Effects on Tissue of the proposed PlasmBlade T Handpiece with the proposed AEX Generator was also evaluated side by side against the performance of the predicate Handpieces with the AEX Generator, in the in-vivo, ex-vivo animal (porcine) studies.
These studies demonstrated that the comparisons of the data show no clinically significant difference where the proposed AEX Generator exhibited a comparable zone of thermal damage as the predicate Aquamantys and Pulsar Generators. Furthermore, the proposed PlasmaBlade T tip assembly and performance exhibited a comparable zone of thermal damage as the predicate Aquamantys SBS 5.0 (Previously cleared under K111732, K132974) and PlasmaBade 4.0 (Previously cleared under K082786) Handpieces.
9.11.2 SOFTWARE VERIFICATION
The software development and testing was executed in compliance to the following FDA Recognized Consensus Standard:
| RECOGNITION NUMBER | STANDARD | TITLE OF STANDARD |
|---|---|---|
| 13-8 | IEC 62304 Edition 1: 2006 | Medical Device Software - Software Life CycleProcesses |
Table 4: Software Verification
9.11.3 ELECTOMAGNETIC COMPATIBILITY
The proposed AEX Generator was tested in compliance to the following FDA Recognized Consensus Standards:
| RECOGNITION NUMBER | STANDARD | TITLE OF STANDARD |
|---|---|---|
| 19-1 | IEC 60601-1-2 Edition 3: 2007-03 | Medical electrical equipment Part 1-2: General requirements for basic safetyand essential performance - Collateralstandard: Electromagnetic compatibility -Requirements and tests |
| 6-228 | IEC 60601-2-2 Edition 5.0 2009-02 | Medical electrical equipment Part 2-2: Particular requirements for the basicsafety and essential performance of highfrequency surgical equipment and highfrequency surgical accessories |
Table 5: Electromagnetic Compatibility
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Image /page/8/Picture/0 description: The image contains the Medtronic logo. The logo consists of a circular emblem on the left and the word "Medtronic" on the right. The emblem features three stylized human figures in different poses within a circle. The word "Medtronic" is written in a bold, sans-serif font.
9.11.4 ELECTRICAL SAFETY
The proposed AEX Generator and the PlasmaBlade T Handpiece devices were tested in compliance to the following FDA Recognized Consensus Standards:
| RECOGNITION NUMBER | STANDARD | TITLE OF STANDARD |
|---|---|---|
| 19-4 | IEC 60601-1:2005 3rd Edition AndA1:2012 | Medical electrical equipment-Part 1General requirements for safety andEssential Performance |
| 6-228 | IEC 60601-2-2 Edition 5.0 2009-02 | Medical electrical equipment Part 2-2Particular requirements for the basicsafety and essential performance of highfrequency surgical equipment and highfrequency surgical accessories |
Table 6: Electrical Safety of the AEX Generator and the PlasmaBlade T Handpiece
9.11.5 BENCH-TOP PERFORMANCE TESTING
General performance verification testing of the proposed AEX Generator and the PlasmaBlade T devices were also performed to verify the peformance and output characteristics.
9.12 CONCLUSION
Based on the various testing performed, including the ex-vivo, in-vivo animal study, sofware verification testing, electrical safety and electromagnetic compatibility testing, it can be concluded that the proposed devices do not introduce considerations for safety and efficacy different from the considerations of their predicate devices. The similar indications for use, technology and performance characteristics of the proposed AEX Generator and the PlasmaBlade T Handpiece are assessed to be substantially equivalent to the predicate devices.
§ 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.