The PowerBlade Plus HC is a sterile 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The proposed device is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a mechanical sharp blade. The LiNA PowerBlade Plus HC includes a rotation wheel on the handle that rotates the grasper jaws at the tip to improve positioning and ergonomics during the surgical procedure. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet. Two types of connectors are provided: the two pin connector is for use with most standard electrosurgical generators with a bipolar outlet, and a 3-pin connector that is attached to the cable of the LiNA PowerBlade Plus HC for use with ValleyLab™ generators with a LigaSure™ outlet. When the 3-pin connector is used, the control button on the hand piece can be used to activate the coagulation. When using the 2pin connector the coagulation function of the PowerBlade Plus HC is foot pedal controlled.

AI/ML Overview

This document describes an FDA 510(k) premarket notification for a medical device and does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically associated with AI/ML-based medical devices or diagnostic tools.

Instead, this submission is for a traditional medical device (an electrosurgical cutting and coagulation device) and focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "acceptance criteria" here implicitly refer to the regulatory requirements for showing substantial equivalence, and the "study" is the non-clinical performance data and comparison to the predicate.

Given this, I will reframe the requested information in the context of this specific regulatory submission.

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

Acceptance Criteria (based on substantial equivalence)	Reported Device Performance
Intended Use: Same as predicate.	The LiNA PowerBlade Plus™ HC is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated, which is identical to the predicate device.
Indications for Use: Same as predicate.	Indications for Use for the LiNA PowerBlade Plus™ HC are identical to the predicate device.
Energy Type: Same as predicate.	Energy type (bipolar electrosurgical current) is unchanged from the predicate.
Materials: No changes.	Materials are unchanged from the predicate.
Sterilization Method: No changes.	Sterilization method (ethylene oxide) is unchanged from the predicate.
Fundamental Scientific Technology: No changes.	The fundamental scientific technology (bipolar electrosurgery with mechanical transection) is unchanged from the predicate.
Safety and Effectiveness: No new questions raised by changes.	The differences (added hand control activation button, 3-pin connector adapter for ValleyLab™ / LigaSure™ outlet) do not raise any new questions regarding safety and effectiveness.
Compliance with Recognized Standards: (IEC60601-1, IEC60601-2-2)	Verification testing was performed to demonstrate compliance with recognized standards IEC60601-1 and IEC60601-2-2.
Performance Characteristics: Similar to predicate after changes.	Verification testing, including functionality testing, was performed as part of design controls to verify functionality of the proposed device and its compliance with standards, ensuring performance akin to the predicate with the added features.
Mechanical Integrity/Functionality of new features: Hand control and new connector	Verification testing confirmed the functionality of the added hand control activation button and the 3-pin connector adapter.

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

This submission does not detail a "test set" in the sense of patient data or a specific clinical study with a defined sample size for statistical analysis of a diagnostic or predictive algorithm. Instead, the "testing" refers to non-clinical performance data and verification testing of the device's engineering and functionality.

Sample Size for Non-Clinical Testing: Not explicitly stated (e.g., number of devices tested, number of cycles). This typically involves engineering benches and lab testing.
Data Provenance: Not applicable in the context of patient data. The non-clinical testing would have been conducted by the manufacturer (LINA Medical ApS in Denmark) or contracted labs, adhering to recognized international standards.

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)

Not applicable. This is a submission for an electrosurgical instrument, not a diagnostic device requiring expert interpretation of medical images or patient data to establish ground truth. The "ground truth" for this device's performance would be objective measurements of coagulation, cutting, and mechanical function in a lab setting, against predefined specifications and recognized standards.

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

Not applicable. As there is no human interpretation of data requiring adjudication, this concept does not apply to the non-clinical verification testing mentioned.

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

Not applicable. This device is not an AI/ML diagnostic tool, and no MRMC study was conducted or required. The device is an electrosurgical instrument.

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

Not applicable. This device does not involve an algorithm. It is a manually operated surgical instrument.

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

The "ground truth" for this type of device would be established through:

Engineering specifications.
Objective measurements obtained during mechanical and electrical testing (e.g., power output, temperature, tissue effects on surrogate materials, tip rotation, activation reliability).
Compliance with recognized international standards (IEC60601-1, IEC60601-2-2).

8. The sample size for the training set

Not applicable. This device is not an AI/ML-based device and does not involve a "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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

October 23, 2014

LINA Medical ApS % Ms. Christine E. Nichols RAC Boston Biomedical Associates 100 Crowley Drive, Suite 216 Marlborough, Massachusetts 01752

Re: K142757

Trade/Device Name: LiNA PowerBlade Plus™ HC Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 24, 2014 Received: September 25, 2014

Dear Ms. Nichols:

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

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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 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/Resourcesfor You/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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K142757

Device Name LiNA PowerBlade Plus™ HC

Indications for Use (Describe)

The LiNA PowerBlade Plus™ HC is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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5 510(k) Summary

1. Submission Sponsor

LINA Medical ApS Formervangen 5 2600 Glostrup Denmark Phone: +45 43 29 66 66 Fax: -45 43 29 66 99 Contact: Louisa Memborg, Regulatory Affairs Officer

Submission Correspondent

Christine E. Nichols RAC Boston Biomedical Associates 100 Crowley Dr., Suite 216 Marlborough, MA 01752

Date Prepared

September 24, 2014

2. Device Identification

Trade/Proprietary Name: Common/Usual Name:

Classification Name:

Classification Regulation:

Product Code: Device Class: Classification Panel:

3. Predicate Device

LiNA PowerBlade Plus™ K132837

4. Device Description

LiNA PowerBlade Plus™ HC

electrosurgical, cutting & coagulation & accessories Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400

GEI Class II General & Plastic Surgery

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blade. The LiNA PowerBlade Plus HC includes a rotation wheel on the handle that rotates the grasper jaws at the tip to improve positioning and ergonomics during the surgical procedure. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet. Two types of connectors are provided: the two pin connector is for use with most standard electrosurgical generators with a bipolar outlet, and a 3-pin connector that is attached to the cable of the LiNA PowerBlade Plus HC for use with ValleyLab™ generators with a LigaSure™ outlet. When the 3-pin connector is used, the control button on the hand piece can be used to activate the coagulation. When using the 2pin connector the coagulation function of the PowerBlade Plus HC is foot pedal controlled.

5. Intended Use

The LiNA PowerBlade Plus HC is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated.

6. Comparison of Technological Characteristics

This special 510(k) is a modification to the LiNA PowerBlade Plus previously cleared by the FDA via 510(k) K132837. No changes were made to the intended use, indications for use, energy type, materials, sterilization method or fundamental scientific technology. The LiNA PowerBlade Plus HC has the following differences from the predicate: Added hand control activation button for coagulation when device is used with the ValleyLab Generators with a LigaSure outlet, and the addition of a 3 pin connector adapter to allow connection with the ValleyLab Generators that have the LigaSure outlet. The three pin connector adapter can be easily removed from the cable so that the cable is compatible with most ESUs.

Non-Clinical Performance Data

Verification testing was performed as part of design controls to verify functionality of the proposed device and compliance with the same recognized standards as the predicate (IEC60601-1, and IEC60601-2-2).

Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The descriptive information detailed in this submission supports the substantial equivalence of the device.

7. Conclusion Statement of Substantial Equivalence

The differences between the LiNA PowerBlade Plus HC and the predicate LiNA PowerBlade Plus do not raise any new questions regarding its safety and effectiveness. Verification testing and compliance with voluntary recognized standards, demonstrate that the LiNA PowerBlade Plus is substantially equivalent to the predicate device LiNA PowerBlade Plus in terms of design, components, principals of operation, sterilization, performance characteristics, and intended use. The LiNA PowerBlade Plus, as designed is determined to be substantially equivalent to the referenced predicate device.

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.