The PEAK PlasmaBlade UPPP is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including, uvulopalatopharyngoplasty (UPPP) and tonsillectomy (Pharyngeal, Tubal, Palatine).
The PEAK PlasmaBlade Suction Coagulator device is intended for use in surgical procedures such as general and otolaryngology (ENT) including, uvulopalatopharyngoplasty (UPPP), tonsillectomy, and adenoidectomy, where coagulation of tissue and suction of fluids are desired. It is not intended to be used as a dissection instrument.

Device Description

The PEAK PlasmaBlade® UPPP and Suction Coagulator is a single-use, disposable, electrosurgical instrument consisting of two PlasmaBlade tips (UPPP tip and Suction Coagulator tip) designed to be attached to the Plasmablade ENT handpiece (cleared as the PEAK Plasmablade TnA handpiece via K083415). These devices are used with Pulsar I (K073057) and Pulsar II (K102029) Electrosurgical Generators. The devices provide radio-frequency energy for cutting (UPPP tip only) and coagulation of soft tissue and contain integrated suction for the evacuation of smoke and fluids from the surgical site. The PEAK Plasmablade ENT handpiece has integrated buttons for Cut and Coag, which may be used to operate the device, or it may be activated with an optional footswitch supplied with the Pulsar Generators.

AI/ML Overview

This document, K150297, is a 510(k) premarket notification for the PEAK PlasmaBlade UPPP and Suction Coagulator. It describes the device and its intended use, and argues for its substantial equivalence to previously marketed predicate devices.

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the acceptance criteria are primarily related to electrical safety and performance equivalence to predicate devices. The reported device performance is that these criteria were met through non-clinical testing.

Acceptance Criteria	Reported Device Performance
Electrical Safety	Verified through testing in accordance with FDA recognized consensus standards: - IEC 60601-1:2005 3rd Edition And A1:2012 (Medical electrical equipment-Part 1: General requirements for safety and Essential Performance) - IEC 60601-2-2 Edition 5.0 2009-02 (Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories)
Performance and Thermal Effect (in-vivo)	Equivalent to that of the predicate device, demonstrated in an in-vivo animal model utilizing GLP.
Device Validation for Intended Use	Further validated through cadaveric testing.

2. Sample sized used for the test set and the data provenance

Sample Size: The document does not specify the exact sample size for the in-vivo animal model or the cadaveric testing. It only states that these tests were conducted.
Data Provenance:
- In-vivo animal model: Utilized GLP (Good Laboratory Practice), suggesting controlled experimental conditions. No specific country of origin is mentioned.
- Cadaveric testing: Conducted to validate intended use. No specific country of origin is mentioned.
- Electrical Safety testing: Performed in accordance with international standards (IEC), implying laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the document describes a medical device (electrosurgical instrument) and its safety and functional equivalence, not an AI/ML-based diagnostic or prognostic device requiring expert-established ground truth on a test set. The validation is through engineering tests and performance comparison to established predicate devices.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. There is no mention of human subjectivity or expert review in the "test set" described (animal and cadaveric performance, electrical safety).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. This submission is for an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool or an imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. The device is an electrosurgical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context refers to established standards and observable physical outcomes:

Electrical Safety: Defined by compliance with international consensus standards (IEC 60601-1 and IEC 60601-2-2).
Performance and Thermal Effect: Demonstrated by equivalence to the predefined performance characteristics and thermal effects of the predicate device in a biological model (in-vivo animal model).
Intended Use Validation: Confirmed through cadaveric testing, ensuring the device functions as expected in a simulated surgical environment.

8. The sample size for the training set

This section is not applicable. The PEAK PlasmaBlade UPPP and Suction Coagulator is a physical medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that creates a sense of depth and unity. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 21, 2015

Medtronic Advanced Energy Lydia Sakakeeny, Ph.D. Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801

Re: K150297

Trade/Device Name: PEAK PlasmaBlade UPPP and Suction Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 24, 2015 Received: April 28, 2015

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

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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/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 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.

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

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Indications for Use

510(k) Number (if known): K150297

Device Name: PEAK PlasmaBlade UPPP

Indications for Use:

Prescription Use X (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)

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Indications for Use

510(k) Number (if known): K150297

Device Name: PEAK PlasmaBlade Suction Coagulator

Indications for Use:

The PEAK PlasmaBlade Suction Coagulator device is intended for use in surgical procedures such as general and otolaryngology (ENT) including, uvulopalatopharyngoplasty (UPPP), tonsillectorny, and adenoidectomy, where coagulation of tissue and suction of fluids are desired. It is not intended to be used as a dissection instrument.

Prescription Use X (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)

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Image /page/4/Picture/0 description: The image is the logo for Medtronic. The logo features a circular graphic on the left with three figures in different positions, suggesting movement or transformation. To the right of the graphic is the company name, "Medtronic," in a bold, blue sans-serif font. Below the name is the tagline, "Alleviating Pain • Restoring Health • Extending Life," also in blue.

510(k) Summary

Submitter:	Medtronic Advanced Energy180 International DrivePortsmouth, NH 03801
Contact Person:	Lydia Sakakeeny, PhDPrincipal Regulatory Affairs SpecialistPhone: (603) 294-5482Fax: (603) 742-1488E-mail: lydia.sakakeeny@medtronic.com
Date Summary Prepared:	March 13, 2015
Device Trade Name:	PEAK PlasmaBlade UPPP and Suction CoagulatorPEAK PlasmaBlade Suction Coagulator
Common Name:	Electrosurgical Instrument
Classification Name:	Electrosurgical cutting and coagulation device and accessories(21 CFR 878.4400)
Product Code:	GEI
Predicate Device:	K083415 PEAK PlasmaBlade TnA (Tonsil Tip PS300-001)K014290 (Original) Arthrocare ENT Plasma WandsK103775 PEAK PlasmaBlade Suction Coagulator
Device Description:	The PEAK PlasmaBlade® UPPP and Suction Coagulator is a single-use,disposable, electrosurgical instrument consisting of two PlasmaBladetips (UPPP tip and Suction Coagulator tip) designed to be attached to thePlasmablade ENT handpiece (cleared as the PEAK Plasmablade TnAhandpiece via K083415). These devices are used with Pulsar I(K073057) and Pulsar II (K102029) Electrosurgical Generators. Thedevices provide radio-frequency energy for cutting (UPPP tip only) andcoagulation of soft tissue and contain integrated suction for theevacuation of smoke and fluids from the surgical site. The PEAKPlasmablade ENT handpiece has integrated buttons for Cut and Coag,which may be used to operate the device, or it may be activated with anoptional footswitch supplied with the Pulsar Generators.
Intended Use:	The PEAK PlasmaBlade UPPP is indicated for cutting and coagulation ofsoft tissue during otolaryngology (ENT) surgery including,uvulopalatopharyngoplasty (UPPP) and tonsillectomy (Pharyngeal,Tubal, Palatine).The PEAK PlasmaBlade Suction Coagulator device is intended for use insurgical procedures such as general and otolaryngology (ENT) including,uvulopalatopharyngoplasty (UPPP), tonsillectomy, and adenoidectomy,where coagulation of tissue and suction of fluids are desired. It is notintended to be used as a dissection instrument.

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Image /page/5/Picture/0 description: The image is the logo for Medtronic. On the left is a circular graphic with three figures in different positions. To the right of the graphic is the name "Medtronic" in a large, bold, blue font. Below the name is the slogan "Alleviating Pain - Restoring Health - Extending Life" in a smaller, blue font.

Technological Characteristics:

The PEAK PlasmaBlade UPPP and Suction Coaqulator are similar to the predicate devices in that they are single use, sterile, electrosurgical instruments used to cut (UPPP only) and coagulate soft tissue utilizing RF powered distal ends. Both enable the suction of fluid and smoke from the surgical site.

Summary of Non-Clinical Testing:

The design and performance of the PEAK PlasmaBlade UPPP device were verified and validated through bench testing.

Electrical Safety of the PEAK PlasmaBlade UPPP was conducted in accordance with the following FDA recognized consensus standards:

RecognitionNumber	Standard	Title of Standard
19-4	IEC 60601-1:2005 3rdEdition And A1:2012	Medical electricalequipment-Part 1: Generalrequirements for safety andEssential Performance
6-228	IEC 60601-2-2 Edition 5.02009-02	Medical electricalequipment Part 2-2:Particular requirements forthe basic safety andessential performance ofhigh frequency surgicalequipment and highfrequency surgicalaccessories

Comparative performance testing was conducted in an in-vivo animal model utilizing GLP. Performance and thermal effect of the PEAK PlasmaBlade UPPP and Suction Coagulator in the in-vivo model was equivalent to that of the predicate device.

Cadaveric testing was also conducted to further validate the devices for their intended use.

Summary of Clinical Tests: Clinical testing was not required for this product.

Conclusion: The indications for use, technology and performance characteristics of the PEAK PlasmaBlade UPPP and Suction Coagulator are equivalent to the predicate devices' and therefore Medtronic Advanced Energy claims Substantial equivalence to the predicate devices.

Regulation Number and Section

§ 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.