(83 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of the device for cutting and coagulation, with no mention of AI or ML capabilities. The performance studies are based on bench and animal testing, not AI/ML model validation.
Yes
The device is indicated for "cutting and coagulation of soft tissue," which are direct therapeutic interventions.
No
The device is described as being for "cutting and coagulation of soft tissue," which are treatment functions, not diagnostic ones. There is no mention of it being used to gather information about a patient's condition.
No
The device description clearly details physical hardware components (single-use devices, shafts, nose pieces, hand switches, footswitches, suction lumen) and their interaction with qualified Generators, indicating it is a hardware-based medical device system.
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 "cutting and coagulation of soft tissue during General, Plastic and Reconstructive... procedures." This describes a surgical tool used directly on a patient's body.
- Device Description: The description details a "single-use-only device designed for use with qualified Generators as a System (Surgery System)" and mentions features like a "bendable shaft," "rotatable nose piece," "integrated hand switch control," and "suction lumen for the evacuation of smoke and fluids." These are characteristics of a surgical instrument, not a device used to test samples outside the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
PlasmaBlade X 4.0
The PlasmaBlade™ X 4.0 is a single-use- only device designed for use with qualified Generators as a System (Surgery System). The PlasmaBlade™ X has integrated hand switch control, or alternatively, may be controlled with a qualified Footswitch, supplied as an optional accessory to the Generator. The PlasmaBlade™ X 4.0 consists of a single bendable shaft and rotatable nose piece that can be adjusted by hand. The system components are designed to be used together and operated as a single unit.
PlasmaBlade X 3.0S
The PlasmaBlade™ X 3.0S is a single-use, monopolar RF device. It is designed to be used with the qualified Generators as part of the Surgery System. It can be operated with the integrated hand switch or a qualified Footswitch. The PlasmaBlade™ X 3.0S consists of a single bendable blade and telescoping shaft that can be configured in both standard and extended length. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Design and material changes were verified through bench testing.
Comparative performance testing was conducted in an in-vivo/ex-vivo animal model to determine thermal effect of the X series against the predicates. The thermal effect of the X series of products was found to be substantially equivalent to that of the predicate devices.
Clinical Testing was not required for these products.
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 4.0 (K073057 Original Submission, K082786 Expanded Indications), 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
August 2, 2018
Medtronic Advanced Energy Heather Valley Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801
Re: K181257
Trade/Device Name: PlasmaBlade X 3.0S, PlasmaBlade X 4.0 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 9, 2018 Received: May 11, 2018
Dear Heather Valley:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer Stevens For Binita S. Ashar, M.D., M.B.A., F.A.C Director Division of Surgical Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181257
Device Name
PlasmaBlade X 4.0 and PlasmaBlade X 3.0S
Indications for Use (Describe)
The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.
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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Medtronic
510(k) Summary K181257
| Submitter: | Medtronic Advanced Energy
180 International Drive
Portsmouth, NH 03801 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Heather Valley, RAC
Principal Regulatory Affairs Specialist
Phone: (603) 294-5447
Fax: (603) 742-1488
Email: heather.a.valley@medtronic.com |
| Date Summary Prepared: | May 09, 2018 |
| Device Trade Name: | PlasmaBlade X 4.0
PlasmaBlade X 3.0S |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and
accessories (21 CFR 878.4400) |
| Product Code: | GEI |
| Predicate Devices: | PlasmaBlade 4.0 (K073057 Original Submission, K082786
Expanded Indications)
PlasmaBlade 3.0S (K093695) |
| Device Description: | PlasmaBlade X 4.0
The PlasmaBlade™ X 4.0 is a single-use- only device
designed for use with qualified Generators as a System
(Surgery System). The PlasmaBlade™ X has integrated
hand switch control, or alternatively, may be controlled with a
qualified Footswitch, supplied as an optional accessory to the
Generator. The PlasmaBlade™ X 4.0 consists of a single
bendable shaft and rotatable nose piece that can be adjusted
by hand. The system components are designed to be used
together and operated as a single unit.
PlasmaBlade X 3.0S
The PlasmaBlade™ X 3.0S is a single-use, monopolar RF
device. It is designed to be used with the qualified
Generators as part of the Surgery System. It can
be operated with the integrated hand switch or a qualified
Footswitch. The PlasmaBlade™ X 3.0S consists of a single
bendable blade and telescoping shaft that can be configured |
4
in both standard and extended length. The finger grip also
incorporates a suction lumen for the evacuation of smoke and fluids.
| Indications for Use: | Device Name: PlasmaBlade X 4.0 |
|---|---|
| Indications: The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures. | |
| Device Name: PlasmaBlade X 3.0S | |
| Indications: The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures. | |
| Technological Characteristics: | The predicate PlasmaBlade devices and proposed PlasmaBlade X family of devices are intended for RF based cutting and coagulation. 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. |
| Summary of Non-Clinical Testing: | Design and material changes were verified through bench testing. |
| Comparative performance testing was conducted in an in-vivo/ex-vivo animal model to determine thermal effect of the X series against the predicates. The thermal effect of the X series of products was found to be substantially equivalent to that of the predicate devices. | |
| Summary of Clinical Tests: Conclusion: | Clinical Testing was not required for these products. The indications for use, technology and performance characteristics of the PlasmaBlade X devices are equivalent to the predicate devices, as such, Medtronic Advanced Energy claims substantial equivalence to the predicates. |