The PEAK PlasmaBlade® PLUS Tissue Dissection Device 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 surgical procedures.

Device Description

The PEAK PlasmaBlade® PLUS consists of a single insulated bendable blade, telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip incorporates a suction lumen for the evacuation of smoke and fluids. A ball electrode attaches to the finger grip to allow a broader application of energy. The PlasmaBlade PLUS is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, PlasmaBlade EXT and PlasmaBlade 3.0S.

AI/ML Overview

The provided text is a 510(k) Summary for the PEAK PlasmaBlade® PLUS, an electrosurgical device. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting detailed performance from a study in the format typically used for AI/ML device submissions.

Based on the content provided, here's an attempt to answer your questions, highlighting where information is absent or not applicable:

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

The document does not explicitly present a table of acceptance criteria and device performance in numerical terms for the PEAK PlasmaBlade® PLUS. Instead, it states that the device "functioned as intended and met design specifications" and "complies with" various electrical safety, sterilization, and biocompatibility standards. It also mentions "Histological studies comparing thermal effects of the device to the predicate devices demonstrated that the PlasmaBlade PLUS is substantially equivalent to the predicate devices and meets safety and effectiveness criteria."

Acceptance Criteria (Inferred)	Reported Device Performance
Function as intended and meet design specifications	Device "functioned as intended and met design specifications."
Compliance with IEC 60601-1 (Medical Electrical Equipment: General Requirements for Safety)	Device "complies with" IEC 60601-1.
Compliance with IEC 60601-1-2 (Medical Electrical Equipment: Electromagnetic Compatibility)	Device "complies with" IEC 60601-1-2.
Compliance with IEC 60601-2-2 (Medical Electrical Equipment: Particular Requirements for the Safety of High Frequency Surgical Equipment)	Device "complies with" IEC 60601-2-2.
Compliance with ISO 11135-1 (Sterilization of Healthcare Products - Ethylene Oxide)	Device "complies with" ISO 11135-1.
Compliance with ISO 10993-1 (Biological evaluation of medical devices: Guidance on selection of tests)	Device "complies with" ISO 10993-1.
Compliance with ISO 10993-7 (Biological Evaluation of Medical Devices: Ethylene Oxide Sterilization Residuals)	Device "complies with" ISO 10993-7.
Substantial equivalence in thermal effects to predicate devices	"Histological studies comparing thermal effects of the device to the predicate devices demonstrated that the PlasmaBlade PLUS is substantially equivalent to the predicate devices and meets safety and effectiveness criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Laboratory and performance tests were executed" and "Histological studies," but does not specify sample sizes for these tests or studies. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document mentions "Histological studies," which implies microscopic examination, likely performed by pathologists. However, it does not specify the number of experts used, their specific qualifications, or how ground truth was established regarding the "thermal effects" in these histological studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for the tests or studies conducted.

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

No MRMC comparative effectiveness study was conducted or reported. This device is an electrosurgical tool, not an AI/ML diagnostic aid. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

This question is not applicable. The PEAK PlasmaBlade® PLUS is a physical surgical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "histological studies," the ground truth was presumably based on pathology (microscopic examination of tissue samples to assess thermal effects). The exact nature of the assessment (e.g., specific measurements of thermal damage zones) is not detailed.

8. The sample size for the training set

This question is not applicable. As this is not an AI/ML device, there is no concept of a "training set" in the context of machine learning model development.

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

This question is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten string of characters, "Ki02709". The characters are written in a simple, somewhat blocky style, with varying stroke thicknesses. The "K" is capitalized and the rest of the characters are numbers. The numbers are all similar in size and spacing.

Image /page/0/Picture/2 description: The image shows the logo for Peak Surgical. The logo consists of a stylized lightning bolt inside of a circle on the left, and the word "PEAK" in bold letters on the right. Below the word "PEAK" is the word "surgical" in a smaller, non-bold font.

510(k) Summary: PEAK PlasmaBlade® PLUS

DEC 1 7 2010

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: December 3, 2010

2. Device Name:

PEAK PlasmaBlade® PLUS Trade Name:

Common Name: Electrosurgical Device and Accessories

Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories

Regulation Number: 21 CFR § 878.4400

Product Code: GEI

Regulatory Class: Class II

3. Predicate Devices:

PEAK PlasmaBlade® 3.0S (K093695) PEAK PlasmaBlade® TnA (K083415) ConMed Ball Electrode (K780976)

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4. Device Description:

The PlasmaBlade PLUS is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, PlasmaBlade EXT and PlasmaBlade 3.0S.

5. Intended Use:

The PEAK PlasmaBlade® PLUS 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 surgical procedures.

Technological Characteristics 6.

The PEAK PlasmaBlade® PLUS is similar to the predicate devices in output energy, delivery system (PlasmaBlade 3.0S) and blade specifications (ConMed Ball Electrode). The PlasmaBlade 3.0S and PlasmaBlade PLUS are both electrosurgical instruments used to cut and coagulate soft tissue, utilizing RF powered distal ends.

7. Non-clinical Performance Data:

Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Data demonstrated that the PlasmaBlade PLUS 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)

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. 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 1: Guidance on selection of tests (Third Edition, 2003)
ISO 10993-7; Biological Evaluation of Medical Devices -- Part 7: Ethylene Oxide . Sterilization Residuals (First Edition, 1995)

Histological studies comparing thermal effects of the device to the predicate devices demonstrated that the PlasmaBlade PLUS is substantially equivalent to the predicate devices and meets safety and effectiveness criteria.

8. Sterilization

The PEAK PlasmaBlade® PLUS 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 PlasmaBlade® PLUS is substantially equivalent to the predicate devices. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a clean and official appearance.

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

DEC 1 7 2010

Re: K102709

Trade/Device Name: PEAK PlasmaBlade® PLUS Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 16, 2010 Received: November 17, 2010

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 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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Page 2 - Ms. Lois Nakayama

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/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.

Sincerely yours,

AZ-B-RA
p.

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):

Device Name: PEAK PlasmaBlade® PLUS

Indications for Use:

. .

Yvonne L. Perry

(Bivision Sign-Off) Division of Surgical, Ofthopedic, and Restorative Devices

510(k) Number K102709

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.