The Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils and adenoids.

Device Description

The PEAK Suction Coagulator consists of of an active suction lumen, a bendable shaft, and a finger grip for attachment to the TnA handpiece and is to be used for the coagulation of tissues and aspiration of fluids during electrosurgical procedures. The device is activated by pressing the coag button (blue) on the TnA handpiece.

AI/ML Overview

The provided text describes the 510(k) submission for the PEAK Suction Coagulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in the manner typically seen for novel diagnostic or AI-driven devices.

Therefore, the information required to populate most of the acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not available in the provided document.

Instead, the submission relies on:

Comparison to a predicate device (Valleylab Suction Coagulator): The primary claim is that the PEAK Suction Coagulator is "substantially equivalent" due to similar output energy, delivery system, blade specifications, and the use of monopolar electrosurgery for tissue coagulation.
Compliance with recognized standards: The device met various IEC and ISO standards related to electrical safety, electromagnetic compatibility, surgical equipment safety, sterilization, and biocompatibility.
Histological studies: These were conducted to compare the thermal effects of the PEAK Suction Coagulator to the predicate device, aiming to show similar safety and effectiveness. The specific acceptance criteria for these histological studies are not detailed, nor are the number of samples, ground truth establishment, or expert involvement.

Here's a breakdown of what can be gathered from the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as inferred/stated)	Reported Device Performance
Substantial Equivalence	Similar output energy	Similar to predicate device
	Similar delivery system	Similar to predicate device
	Similar blade specifications	Similar to predicate device
	Monopolar electrosurgical device	Similar to predicate device
	RF powered distal ends	Similar to predicate device
Safety (Thermal Effects)	Thermal effects comparable to predicate device	Histological studies demonstrated substantial equivalence to predicate device.
Functionality	Function as intended (coagulation of tissue, aspiration of fluids)	Laboratory and performance tests executed to ensure function as intended.
Electromedical Standards	IEC 60601-1 (General Safety)	Complies with standard
	IEC 60601-1-2 (EMC)	Complies with standard
	IEC 60601-2-2 (HF Surgical Eq.)	Complies with standard
Sterilization	ISO 11135-1 (EO Sterilization)	Complies with standard
Biocompatibility	ISO 10993-1 (Guidance on Tests)	Complies with standard
	ISO 10993-7 (EO Residuals)	Complies with standard

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not specified for the histological studies or laboratory/performance tests.
Data Provenance: Implied to be laboratory tests and histological studies, conducted for this regulatory submission. No information on country of origin or whether it's retrospective/prospective.

3. Number of Experts Used to Establish Ground Truth & Qualifications

Number of Experts: Not specified.
Qualifications: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of histological comparisons, it would typically involve expert pathologist review, but the method isn't described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, this type of study is not mentioned. The device is a surgical instrument, not a diagnostic imaging AI, so an MRMC study comparing human readers with and without AI assistance is not applicable here. The comparison is between the device and a predicate device/standards.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable in the context of an electrosurgical device. The device itself is a tool used by a human surgeon. Its performance is evaluated through its physical and electrical characteristics, and its effects on tissue.

7. The Type of Ground Truth Used

For the "Safety (Thermal Effects)" criterion, the ground truth was likely derived from histological examination by qualified personnel (e.g., pathologists) comparing tissue effects between the PEAK Suction Coagulator and the predicate device.
For other criteria, the "ground truth" would be established by compliance with published international standards (IEC, ISO) and internal design specifications.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This document describes a medical device requiring regulatory clearance based on substantial equivalence, not an AI/ML algorithm that undergoes "training."

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment: Not applicable, as there is no "training set" in this context.

Summary

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K103775 Pg 1 of 3

510(k) Summary: PEAK Suction Coagulator

MAY 2 7 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

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 Sr. Manager, Regulatory Affairs

Date prepared: April 29, 2011

2. Device Name:

Trade Name:	PEAK Suction Coagulator
Common Name:	Electrosurgical Device and Accessories
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories
Regulation Number:	21 CFR § 878.4400
Product Code:	GEI
Regulatory Class:	Class II

3. Predicate Devices:

Valleylab Suction Coagulator (K091223) PEAK PlasmaBlade® TnA (K083415)

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Device Description: 4.

2.4 2

<103775

న్. Intended Use:

The PEAK Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils or adenoids.

6. Technological Characteristics

The PEAK Suction Coagulator is similar to the predicate device, the Valleylab Suction Coagulator in output energy, delivery system and blade specifications. They are both monopolar electrosurgical devices coagulate tissue, utilizing RF powered distal ends.

Non-clinical Performance Data: 7.

Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Data demonstrated that the PEAK Suction Coagulator complies with the following standards:

IEC 60601-1; Medical Electrical Equipment Part 1: General Requirements for . ● Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
. IEC 60601-1-2; Medical Electrical Equipment - Part 1-2: General Requirements for Safety: Electromagnetic Compatibility, 2001, Amendment 1: 2004.
. IEC 60601-2-2; Medical Electrical Equipment -- Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment (Fourth Edition, 2006)
ISO 11135-1; Sterilization of Healthcare Products - Ethylene Oxide - Part1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (First Edition, 2007)
. ISO 10993-1; Biological evaluation of medical devices - Part I: Guidance on selection of tests (2009)
. ISO 10993-7; Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (2008)

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Histological studies comparing thermal effects of the device to the predicate device demonstrated that the PEAK Suction Coagulator is substantially equivalent to the predicate device and meets safety and effectiveness criteria.

8. Sterilization

The PEAK Suction Coagulator is provided sterile. The device is not intended for reuse or resterilization.

9. Conclusion:

By virtue of design, materials function and intended use, the PEAK Suction Coagulator is substantially equivalent to the predicate device. In establishing substantial equivalence to the predicate device, PEAK Surgical evaluated the indications for use, materials incorporated, product specification and energy requirements of the device.

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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

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

MAY 27 2011

Re: K103775

Trade/Device Name: PEAK 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 29, 2011 Received: May 02, 2011

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. 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

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Page 2 - Ms. Lois Nakayama

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. 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/CDRHQffices/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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm.

Sincerely yours,

Eric S. Keith

for

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

Enclosure

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Indications for Use

510(k) Number (if known): K103775

Device Name: PEAK Suction Coagulator

Indications for Use:

Signature

(Dision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103775

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 CDRH, Office of Device Evaluation (ODE)

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.