(43 days)
No
The summary describes a standard electrosurgical device that uses RF energy and saline. There is no mention of AI, ML, or any computational processing that would suggest the use of such technologies. The testing described is standard for electrosurgical devices and does not involve AI/ML performance metrics.
Yes
The device is described as a monopolar RF energy device intended for use in various surgical procedures, performing cutting, coagulation, and sealing of soft tissue and bone, which are therapeutic functions.
No
Explanation: The device is described as a surgical tool that delivers RF energy for cutting, sealing, and coagulation of soft tissue and bone. Its purpose is therapeutic (surgical intervention), not diagnostic (identifying a disease or condition).
No
The device description clearly outlines a physical, disposable handpiece with a blade electrode, shaft, handle, controls, and cable assembly. It connects to a generator and delivers RF energy and saline, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures involving cutting and coagulation of soft tissue and bone. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details a surgical handpiece that delivers RF energy and saline directly to tissue during surgery. This is consistent with a surgical tool, not a device used to analyze samples like blood or urine in a lab setting.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples outside the body).
- Detecting or measuring specific substances (analytes) in samples.
- Providing diagnostic information about a patient's health status based on sample analysis.
The device is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
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 PlasmaBlade T should not be used on small appendages or body parts, as in circumcision. 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 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 3.0S (Previously cleared under K093695).
The proposed PlasmaBlade T Handpiece device is a monopolar, single use, disposable device and is provided sterile. The devices are not intended for reuse or resterilization. The PlasmaBlade T handpiece consists of an enamel coated insulated blade electrode with an uncoated circular 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 AEx Generator (Cleared under K143175).
The proposed PlasmaBlade T Handpiece is a disposable device, that when connected to the AEX Generator (K143175), uses monopolar RF energy for the resection and coagulation of soft tissue and bone. The proposed PlasmaBlade T Handpiece device provides similar resection and coagulative effect to the predicate device, the PlasmaBlade 3.0S Monopolar Handpiece (Cleared under K093695).
In addition to the monopolar cutting and coagulation capabilities the proposed 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and bone, 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.
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)
Summary of Non-Clinical Testing: In-vivo testing on an animal model was completed to confirm that the proposed device performed adequately to its predicates for its intended use. The testing met the criteria outlined in the FDA Guidance Document, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff" issued on August 15, 2016. The in-vivo testing determined the zone of thermal damage imparted on the tissue by the proposed devices was comparable to the predicates.
The bench and animal testing demonstrated that the performance and tissue effect of the proposed devices are substantially equivalent to that of the predicate devices and do not raise any concerns of device safety or efficacy.
Summary of Clinical Tests: Clinical testing was not required for this product.
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.
PlasmaBlade T and AEX Generator (K143175), Aquamantys SBS 5.0 (K111732, K132974), PlasmaBlade 3.0S (K093695)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2017
Medtronic Advanced Energy Lydia Sakakeeny, Ph.D. Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801
Re: K170610 Trade/Device Name: 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: February 28, 2017 Received: March 1, 2017
Dear Dr. Sakakeeny:
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 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jennifer R. Stevenson -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
2
Indications for Use
510(k) Number (if known) K170610
Device Name PlasmaBlade T
Indications for Use (Describe)
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 PlasmaBlade T should not be used on small appendages or body parts, as in circumcision. 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)
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510(k) Summary
| Submitter: | Medtronic Advanced Energy
180 International Drive
Portsmouth, NH 03801 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lydia Sakakeeny, PhD
Principal Regulatory Affairs Specialist
Phone: (603) 294-5482
Fax: (603) 742-1488
E-mail: lydia.sakakeeny@medtronic.com |
| Date Summary Prepared: | February 28, 2017 |
| Device Trade Name: | PlasmaBlade T |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories
(21 CFR 878.4400) |
| Product Code: | GEI |
| Predicate Device: | PlasmaBlade T and AEX Generator (K143175)
Aquamantys SBS 5.0 (K111732, K132974)
PlasmaBlade 3.0S (K093695) |
| Device Description: | 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
3.0S (Previously cleared under K093695). |
| | The proposed PlasmaBlade T Handpiece device is a monopolar, single
use, disposable device and is provided sterile. The devices are not
intended for reuse or resterilization. The PlasmaBlade T handpiece
consists of an enamel coated insulated blade electrode with an uncoated
circular 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 AEx Generator (Cleared under K143175). |
| | The proposed PlasmaBlade T Handpiece is a disposable device, that
when connected to the AEX Generator (K143175), uses monopolar RF
energy for the resection and coagulation of soft tissue and bone. The
proposed PlasmaBlade T Handpiece device provides similar resection
and coagulative effect to the predicate device, the PlasmaBlade 3.0S
Monopolar Handpiece (Cleared under K093695). |
| | In addition to the monopolar cutting and coagulation capabilities the
proposed 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 |
4
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.
Indications for use: The PlasmaBlade T is a monopolar, single use, sterile, disposable device intended for use with the AEX Generator (K143175). The device delivers RF energy concurrent with saline for hemostatic sealing 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 PlasmaBlade T should not be used on small appendages or body parts, as in circumcision. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Technological Characteristics:
The predicates and PlasmaBlade T are intended for RF based resection and coagulation of soft tissue, as well as 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.
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 3.0S (Previously cleared under K093695).
Summary of Non-Clinical Testing:
The design and performance of the modified PlasmaBlade T were verified and validated through bench testing. Medtronic product development processes and the finalized FDA Guidance Document, Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff issued on August 15, 2016, were utilized to determine applicable bench testing requirements.
Bench testing included the following:
- . Sterilization
- Transit ●
- Shelf Life ●
- . Biocompatibility
- Electrical Safety/EMC
- Mechanical Testing
- Activation Testing
5
| | In-vivo testing on an animal model was completed to confirm that the proposed device performed adequately to its predicates for its intended use. The testing met the criteria outlined in the FDA Guidance Document, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff" issued on August 15, 2016. The in-vivo testing determined the zone of thermal damage imparted on the tissue by the proposed devices was comparable to the predicates.
The bench and animal testing demonstrated that the performance and tissue effect of the proposed devices are substantially equivalent to that of the predicate devices and do not raise any concerns of device safety or efficacy. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Clinical Tests: | Clinical testing was not required for this product. |
| Conclusion: | The indications for use, technology and performance characteristics of the modified PlasmaBlade T are equivalent to the predicate devices' and therefore Medtronic Advanced Energy claims substantial equivalence to the predicate devices. |