The LiNA PowerBlade Plus is a 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The LiNA PowerBlade Plus is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a sharp blade. LiNA PowerBlade Plus 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the LiNA PowerBlade Plus, a bipolar forceps device. This submission focuses on demonstrating substantial equivalence to a predicate device, the LiNA PowerBlade (K063025), rather than proving that the device meets specific performance acceptance criteria through a standalone study with defined metrics.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Predicate Equivalence	Compliance to IEC60601-1:2006 (General Medical Electrical Equipment)	Device complies	Non-Clinical Performance Testing
	Compliance to IEC60601-2-18 (Endoscopic equipment)	Device complies	Non-Clinical Performance Testing
	Compliance to IEC60601-2-2 (High-frequency surgical equipment)	Device complies	Non-Clinical Performance Testing
	Biocompatibility (ISO10993-1)	Device complies	Non-Clinical Performance Testing
	Sterilization (ISO1135-1)	Device complies	Non-Clinical Performance Testing
	Biocompatibility (ISO10993-7)	Device complies	Non-Clinical Performance Testing
Functionality	Grasping performance comparable to predicate	Demonstrated comparable performance	Comparative Functionality Testing
	Cutting performance comparable to predicate	Demonstrated comparable performance	Comparative Functionality Testing
	Coagulation performance comparable to predicate	Demonstrated comparable performance	Comparative Functionality Testing

Note: The document does not provide specific numerical acceptance limits (e.g., "cutting force must be > X Newtons") nor detailed quantitative results for the LiNA PowerBlade Plus. Instead, it states that the device "complies" with standards and that comparative functionality testing "demonstrated that the grasping, cutting and coagulation performance of the proposed device was comparable to the predicate device." The acceptance criteria are largely implied to be "being equivalent to the predicate device" and "compliance with relevant standards."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for the comparative functionality testing. It only mentions "testing" was performed.
The data provenance is non-clinical testing, performed by the manufacturer (implied to be in Denmark, where the sponsor is located) as part of a premarket submission. It is by definition retrospective in the context of the device's development cycle.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is not applicable as the described performance testing is non-clinical and does not involve human expert assessment for "ground truth" in the way a clinical study or diagnostic AI validation would. The "ground truth" for the non-clinical tests would be the established methods and measurements defined by the standards and functional comparisons, not expert human opinion.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. There is no mention of expert adjudication in the context of the non-clinical performance and functionality testing described.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical instrument (bipolar forceps), not an AI diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

No, a standalone algorithm-only performance study was not done. This device is a physical surgical instrument, not an algorithm or AI.

7. The Type of Ground Truth Used

For standards compliance, the ground truth is the requirements laid out in the specified international standards (IEC60601 series, ISO10993 series, ISO1135-1).
For comparative functionality testing (grasping, cutting, coagulation), the ground truth is the performance of the predicate device, the LiNA PowerBlade (K063025). The proposed device's performance was compared to that of the predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical instrument, not an AI or machine learning model that requires a training set.

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

Not applicable. (See #8).

Summary

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510(k) Summary 6.

1. Submission Sponsor
  LiNA Medical ApS

Formervangen 5

2600 Glostrup

Denmark

Phone: +45 4329 6666

Fax: +45 4329 6699

Contact: Louisa Memborg, Regulatory Affairs Officer

2. Submission Correspondent

Christine Nichols RAC Boston Biomedical Associates 386West Main Street Suite 7 Northborough. MA 01532 Phone: 508-351-8632 Ext 252 cnichols@boston-biomedical.com

3. Date Prepared

September 9, 2013

4. Device Identification

Trade/Proprietary Name: LiNA PowerBlade Plus

Bipolar forceps Common/Usual Name:

Electrosurgical, Cutting and Coagulation device and accessories. Classification Name:

Class. Regulation:	21 CFR 878.4400
Product Code:	GEI
Device Class:	Class II
Classification Panel:	General & Plastic Surgery

REV A

DEC 1 9 2013

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Traditional 510(k) Premarket Notification Submission: LiNA Medical ApS PowerBlade Plus

5. Predicate Device

LiNA PowerBlade (K063025)

Device Description 6.

7. Intended Use

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

8. Comparison of Technological Characteristics

The LiNA PowerBlade Plus is substantially equivalent to the predicate device with respect to technological characteristics. The devices have similar materials and principal of use, dimensions, as well as the same energy type, performance specifications and fundamental scientific technology.

9. Non-Clinical Performance Data

Testing was performed to demonstrate that the LiNA PowerBlade Plus complies with the same testing requirements as the predicate device which includes compliance to IEC60601-1:2006, IEC60601-2-18, and IEC60601-2-2, as well as Biocompatibility and sterilization requirements as shown by compliance to ISO10993-1, ISO1135-1, and ISO10993-7.

In addition, comparative functionality testing was performed which demonstrated that the grasping, cutting and coagulation performance of the proposed device was comparable to the predicate device.

The LiNA PowerBlade Plus testing demonstrates that the proposed and predicate devices are substantially equivalent.

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Traditional 510(k) Premarket Notification Submission: LiNA Medical ApS PowerBlade Plus

10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

Performance testing and compliance with voluntary standards, demonstrate that the LiNA PowerBlade Plus is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, sterilization, biocompatibility, performance characteristics, and intended use. The LiNA PowerBlade Plus, as designed and manufactured, is be substantially equivalent to the referenced predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms, possibly representing care or support.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

LiNA Medical ApS % Ms. Christine E. Nichols Boston Biomedical Associates 386 West Main Street, Suite 7 Northborough, Massachusetts 01532 December 19, 2013

Re: K132837

Trade/Device Name: LiNA PowerBlade 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 20, 2013 Received: November 21, 2013

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Christine E. Nichols

forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Radiological Health

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and

Enclosure

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Traditional S10(k) Premarket Notification Submission: LiNA Medical ApS PowerBlade Plus

5. Indications for Use Statement

510(k) Number (if known): K132837

Device Name: LiNA PowerBlade Plus

Indications for Use:

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

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)

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(Division Sign-off) Division of Surgical Devices 510 (k) Number: K132837

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.