The PEAK PlasmaBlade™ TnA Tonsil and Adenoid Tissue Dissection Device is only 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 Tonsil and Adenoid Tissue Dissection Device consists of a handpiece with integrated controls and cable, a shaft with a suction cannula, and two interchangeable tips. The tonsil tip consists of a curved and tapered insulated blade electrode with an opening in the center to allow for the evacuation of smoke and fluids. The adenoid tip consists of a flat, straight insulated blade electrode housed in a plastic tip with a bendable suction lumen that allows for the evacuation of tissue, fluids and smoke. Both tips connect to the suction cannula of the handpiece.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving the device meets said criteria. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for bringing a new device to market.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes and data provenance for a test set.
Number of experts and qualifications for ground truth establishment.
Adjudication method.
MRMC comparative effectiveness study or effect size.
Standalone algorithm performance.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The text does mention:

Performance Data: "Preclinical laboratory and performance tests were executed to ensure the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." However, it does not provide details about these tests, the specific criteria, or the results.
Study Type: The device's clearance is based on proving substantial equivalence to existing predicate devices (PEAK PlasmaBlade™ Tissue Dissection Device (K073057) and ArthroCare® ENT Plasma Wands™ (K070374)). This typically involves comparing technological characteristics, intended use, and safety/effectiveness profiles rather than a new clinical efficacy or performance study against predefined quantitative acceptance criteria.

Summary

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083415 p. 1 of 2

510(k) Summary for the PEAK PlasmaBlade™ TnA Tonsil and Adenoid Tissue Dissection Device

1. Submitter name and address:

PEAK Surgical, Inc. 2464 Embarcadero Way Palo Alto, CA 94303 Phone: 650-331-3020 Fax: 650-331-3293

Contact: Lois Nakayama

Date Prepared: June 5, 2009

2. Device Name:

Trade Name:	PEAK PlasmaBlade TM TnA Tonsil and Adenoid TissueDissection Device
Common Name:	Electrosurgical Device and Accessories
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR 878.4400)

3. Predicate Devices:

PEAK PlasmaBlade™ Tissue Dissection Device (K073057) ArthroCare® ENT Plasma Wands™ (K070374)

4. Device description:

ੱ . Intended Use:

The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is only intended to be used for the cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectorny (Pharyngeal, Tubal, Palatine).

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K083415 8::20

Technological Characteristics: 6.

The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is similar to the predicate devices in that they are all electrosurgical instruments used to cut tissue and coagulate soft tissue, utilizing RF powered distal ends.

7. Performance Data:

Preclinical laboratory and performance tests were executed to ensure the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria.

Sterilization: 8.

The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is provided sterile. The device is not intended for reuse or resterilization.

の Conclusions:

By virtue of design, materials, function, and intended use, the PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is substantially equivalent to FDA-cleared devices currently marketed in the United States. In establishing substantial equivalence to the predicate devices, PEAK Surgical evaluated the indications for use, materials incorporated, product specification and energy requirements of those systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized eagle emblem, which is the symbol of the department. The eagle is depicted with its wings spread, and its body is formed by a series of curved lines.

Public Health Service

JUN - 5 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PEAK Surgical, Incorporated % Ms. Lois Nakayama Manager, Regulatory Affairs 2464 Embarcadero Way Palo Alto, California 94303

Re: K083415

Trade/Device Name: PEAK PlasmaBlade™ TnA Tonsil And Adenoid Tissue Dissection Device

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: II

Product Code: GEI

Dated: June 1, 2009 Received: June 3, 2009

Dear Ms. Nakayama:

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.

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

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Page 2-Ms. Lois Nakayama

(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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For

Mark N. Melkerson

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K083415, 1.of

Indications for Use

510(k) Number (if known): K083415

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

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of C Office of Device Evaluation (ODE) tof the Kin (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083415

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.