The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).

Device Description

The PEAK PlasmaBlade® TnA is a single-use, disposable, electrosurgical instrument consisting of two PlasmaBlade tips (Tonsil tip and Adenoid tip) designed to be attached to the PlasmaBlade ENT handpiece (cleared as the PEAK PlasmaBlade TnA handpiece via K083415). The device also includes a wire cleaning brush designed to remove eschar build up and maintain a clear channel for suction.

The Adenoid Tip consists of a wire electrode housed in a plastic tip with a bendable suction lumen that allows for the evacuation of tissue, fluids, and smoke. It connects to the suction shaft of the handpiece.

These device is used with PULSAR I (K073057), PULSAR II (K102029) and AEX (K143175) Electrosurgical Generators. It provides radio-frequency energy for cutting and coagulation of soft tissue. 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 Generators.

AI/ML Overview

This FDA document is a 510(k) summary for the Medtronic PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Acceptance Criteria and Device Performance (as implied by the document):

The document does not explicitly state "acceptance criteria" in a quantitative table format with specified thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices. The implicit acceptance criteria are that the modifications to the device (specifically the Adenoid Tip) do not raise new issues of safety or effectiveness compared to the predicate devices.

The reported device performance is that it is "substantially equivalent" to predicate devices. The summary claims this equivalence based on characteristics, intended use, technology, and non-clinical testing.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
No new issues of safety raised	Confirmed through bench and pre-clinical testing that different technological characteristics do not raise new issues of safety or effectiveness.
No new issues of effectiveness raised	Confirmed through bench and pre-clinical testing that different technological characteristics do not raise new issues of safety or effectiveness.
Equivalent thermal effect	Comparative performance testing in an in-vivo animal model showed the thermal effect of the PEAK PlasmaBlade Adenoid Tip was substantially equivalent to the predicate device.
Functions for intended use	Designed for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy, similar to predicate.

Study Details:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "comparative performance testing conducted in an in-vivo animal model." It doesn't specify the number of animals or trials.
- Data Provenance: The "in-vivo animal model" suggests animal data, likely pre-clinical, rather than human clinical data. The location of the testing (country of origin) is not mentioned. It is a prospective study as it was conducted to verify and validate the modified device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was an in-vivo animal model study focused on thermal effects, not an expert-based clinical review or diagnostic accuracy study which would typically involve expert consensus. The "ground truth" here would relate to measurements of thermal tissue damage, which would be objectively measured using scientific methods.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical imaging or diagnostic studies. For an in-vivo animal study measuring thermal effects, the "ground truth" would be determined by direct physical or biological measurements.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required for this product." MRMC studies typically involve human readers interpreting cases to assess diagnostic performance or impact on clinical decision-making.
- Effect size of human readers improvement: Not applicable, as no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a medical device for surgical intervention (electrosurgical instrument). The concept of "standalone algorithm performance" typically applies to AI/software as a medical device (SaMD) for diagnostic or predictive purposes. For an electrosurgical instrument, its performance is inherently "standalone" in mechanical/electrical function, but it always operates with a surgeon (human-in-the-loop). The non-clinical and pre-clinical testing assesses the device's physical performance characteristics (e.g., cutting, coagulation, thermal effect) independent of human variability in interpretation, but not in a "standalone algorithm" sense.
The type of ground truth used:
- For the in-vivo animal model, the "ground truth" for comparative thermal effect likely involved direct measurement or histological assessment of tissue damage (e.g., depth of necrosis, adjacent tissue effects) caused by the device and the predicate device. For bench testing, it would involve objective physical measurements (e.g., power output, temperature, tissue cutting characteristics).
The sample size for the training set:
- Not applicable. This device is a physical electrosurgical instrument, not an AI/machine learning algorithm that requires a "training set" of data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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

July 8. 2016

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

Re: K152703

Trade/Device Name: PlasmaBlade TnA Tonsil and Adenoid Dissection Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 7, 2016 Received: June 8, 2016

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.

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Page 2 - Lydia Sakakeeny, Ph.D.

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 devicerelated 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/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 yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PEAK PlasmaBlade TnA (Adenoid Tip)

Indications for Use

510(k) Number (if known): K152703

Device Name: PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device

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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Medtronic

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:	September 10, 2015
Device Trade Name:	PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device
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 and Adenoid Tissue DissectionDeviceK014290 (Original) Arthrocare ENT Plasma Wands
Device Description:	The PEAK PlasmaBlade® TnA is a single-use, disposable,electrosurgical instrument consisting of two PlasmaBlade tips (Tonsil tipand Adenoid tip) designed to be attached to the PlasmaBlade ENThandpiece (cleared as the PEAK PlasmaBlade TnA handpiece viaK083415). The device also includes a wire cleaning brush designed toremove eschar build up and maintain a clear channel for suction.
	The Adenoid Tip consists of a wire electrode housed in a plastic tip witha bendable suction lumen that allows for the evacuation of tissue, fluids,and smoke. It connects to the suction shaft of the handpiece.
	These device is used with PULSAR I (K073057), PULSAR II (K102029)and AEX (K143175) Electrosurgical Generators. It provides radio-frequency energy for cutting and coagulation of soft tissue. 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 Generators.
Intended Use:	The PEAK PlasmaBlade TnA device is only indicated for cutting andcoagulation of soft tissue during otolaryngology (ENT) surgery includingadenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).
Technological Characteristics:	The PEAK PlasmaBlade TnA, Adenoid Tip is similar to the predicatedevices in that they are single use, sterile, electrosurgical instrumentsused to cut and coagulate soft tissue utilizing RF powered distal ends. Aenable the suction of fluid and smoke from the surgical site.
Summary of Non-Clinical Testing:	The design and performance of the modified Adenoid Tip were verifiedand validated through bench testing.
	Comparative performance testing was conducted in an in-vivo animalmodel. Thermal effect of the PEAK PlasmaBlade Adenoid Tip in the in-vivo model was substantially equivalent to that of the predicate device.
	All bench and pre-clinical testing that testing confirmed that the differenttechnological characteristics of the subject device and the respectivepredicates do not raise any new issues of safety or effectiveness.
Summary of Clinical Tests:	Clinical testing was not required for this product.
Conclusion:	The indications for use, technology and performance characteristics ofthe modified PEAK PlasmaBlade TnA (specifically the Adenoid Tip) areequivalent to the predicate devices' and therefore Medtronic AdvancedEnergy claims substantial equivalence to the predicate devices.

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Technological differences between the modified adenoid tip and its predicates exist however they do not adversely impact the safety or efficacy of the devices.

For example, the modified adenoid tip and the original PEAK PlasmaBlade Adenoid tip are monopolar electrosurgical instruments with same operating principle, the modified tip utilizes a wire electrode while the predicate utilizes a blade electrode.

Similarly, while ENT Plasma Wands provide bipolar RF energy coupled with saline to the operatvie site and the PEAK PlasmaBlade adenoid tip delivers monopolar RF energy to the operative site, in vivo pre-clinical testing has confirmed that the thermal damage imparted by the two technologies are equivalent and does not raise concerns over safety or efficacy.

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.