The Reprocessed Ultrasonic Curved Shears is indicated for soft tissue incisions when bleeding control and minimal thermal injury is desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures and other open procedures.

Device Description

The Ultrasonic Curved Shears is an instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The instrument has a working length of 9cm, an active blade length of 16mm, and utilizes a curved blade and clamp arm. The Ultrasonic Curved Shears device allows for the cutting and coagulation of vessels up to and including 5mm in diameter. The Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are designed to operate with the Harmonic™ Generator 300 (GEN04) and Harmonic™ Blue Hand Piece (HPBLUE).

AI/ML Overview

The provided documentation describes the reprocessing of an Ultrasonic Curved Shears device and its substantial equivalence to a predicate device. The information details the acceptance criteria through performance testing, but not a specific study with a quantitative measure against criteria in a table format as requested.

Here's an analysis of the provided information, addressing your points:

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

The document lists categories of performance testing but does not provide specific quantitative acceptance criteria or detailed reported performance values. It states generally that "Performance testing demonstrates that Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist perform as originally intended."

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Demonstrated performance (safety and effectiveness)
Validation of reprocessing	Demonstrated performance (safety and effectiveness)
Sterilization Validation	Demonstrated performance (safety and effectiveness)
Function test(s)	Demonstrated performance (safety and effectiveness)
Packaging Validation	Demonstrated performance (safety and effectiveness)

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

The document does not specify the sample size used for any of the performance tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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)

This information is not provided in the document. The performance tests appear to be laboratory and bench testing, not clinical studies involving human observers for establishing ground truth.

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

This information is not applicable and not provided. The testing described is technical performance testing, not a clinical trial with expert adjudication.

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

An MRMC comparative effectiveness study was not conducted. This document describes the reprocessing of a surgical instrument, not an AI-assisted diagnostic or therapeutic device that would involve human reader performance.

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

This is not applicable to the device described. The device is a reprocessed surgical instrument, not an algorithm.

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

For the "Function test(s)," the ground truth would likely be the original design specifications and performance characteristics of the predicate device. For "Biocompatibility," "Validation of reprocessing," "Sterilization Validation," and "Packaging Validation," the ground truth is established by adherence to recognized standards and protocols for reprocessing, sterilization, and packaging of medical devices. No clinical outcomes data or pathology is mentioned for establishing ground truth in this context.

8. The sample size for the training set

This is not applicable as the device is a reprocessed physical instrument, not an AI model.

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

This is not applicable as the device is a reprocessed physical instrument, not an AI model.

Summary of the Study:

The study described is a series of bench and laboratory tests designed to demonstrate that the Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist performs as originally intended by the manufacturer of the predicate device (Harmonic Focus Curved Shears and Torque Wrench, K063192). The core of the argument for substantial equivalence relies on:

Identical Design and Materials: The reprocessed device is stated to have identical design, materials, intended use, mechanism of action, mechanical design, size, and materials as the predicate device.
Reprocessing Validation: Ascent Healthcare Solutions' reprocessing procedure includes removal of soil, decontamination, and individual functional testing of each reprocessed unit.
Performance Testing Categories: The testing covered Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), and Packaging Validation.

The conclusion is that these tests demonstrate safety, effectiveness, and substantial equivalence to the predicate device. The document does not provide the granular details of the specific acceptance criteria (e.g., a specific force requirement for a function test) or the quantitative results of these tests, but rather states that performance was "demonstrated."

Summary

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K 100 537

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SECTION 5: 510(k) SUMMARY

Submitter:	Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044	MAY 12 2010
Contact:	Ramona KulikRegulatory Affairs Engineer480.763.5300 (o)480.763.2952 (f)rkulik@ascenths.com
Date of preparation:	February 24, 2009
Name of device:	Trade/Proprietary Name: Reprocessed Ultrasonic CurvedShears with torque wrench and grip assist
	Classification Name: Scalpel, Ultrasonic, Reprocessed
Predicate DeviceK063192	510(k) TitleHarmonic Focus Curved Shears andTorque Wrench	ManufacturerEthicon Endo-Surgery,Inc.
Device description:	The Ultrasonic Curved Shears is an instrument consisting of ascissor handle housing assembly with hand control buttons (MINfor minimum power level and MAX for maximum power level).The instrument has a working length of 9cm, an active bladelength of 16mm, and utilizes a curved blade and clamp arm. TheUltrasonic Curved Shears device allows for the cutting andcoagulation of vessels up to and including 5mm in diameter.
	The Reprocessed Ultrasonic Curved Shears with torque wrenchand grip assist are designed to operate with the Harmonic™Generator 300 (GEN04) and Harmonic™ Blue Hand Piece(HPBLUE).
	Note: Only the Ultrasonic Curved Shears with torque wrenchand grip assist is the subject of this submission, the reusablehand piece, generator, and any other related equipment are notincluded in the scope of this submission.
Indications for Use:	The Reprocessed Ultrasonic Curved Shears is indicated for softtissue incisions when bleeding control and minimal thermalinjury is desired. The device can be used as an adjunct to orsubstitute for electrosurgery, lasers, and steel scalpels ingeneral, plastic, pediatric, gynecologic, urologic, exposure toorthopedic structures and other open procedures.

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K1 00 537

Page 2 of (2)

Technological characteristics:

The design, materials, and intended use of Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are identical to the predicate device. The mechanism of action of Ultrasonic Curved Shears with torque wrench and grip assist is identical to the predicate device in that the same standard mechanical design, size, and materials are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition. Ascent Healthcare Solutions' reprocessing of Ultrasonic Curved Shears with torque wrench and grip assist includes removal of adherent visible soil and decontamination. Each individual Ultrasonic Curved Shear with torque wrench and grip assist is tested for appropriate function of its components prior to packaging and labeling operations.

Performance data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultrasonic Curved Shears. This included the following tests:

Biocompatibility �
Validation of reprocessing .
Sterilization Validation ●
Function test(s) �
Packaging Validation .

Performance testing demonstrates that Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist perform as originally intended.

Conclusion:

Ascent Healthcare Solutions concludes that the Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are safe, effective, and substantially equivalent to the predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. 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

MAY 1 2 2010

Ascent Healthcare Solutions % Ms. Ramona Kulik Regulatory Affairs Engineer 10232 South 51st Street Phoenix, Arizona 85044

Re: K100537

Trade/Device Name: Reprocessed Ultrasonic Curved Shears with Torque Wrench And Grip Assist

Regulatory Class: Unclassified Product Code: NLQ Dated: February 24, 2010 Received: February 25, 2010

Dear Ms. Kulik:

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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Page 2 - Ms. Ramona Kulik

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/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.

Mark A. Millman

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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SECTION 4: INDICATIONS FOR USE STATEMENT

K100 537 510(k) Number (if known):

Device Name: Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist

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 CDRH, Office of Device Evaluation (ODE)

Detkrogh for max

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

510(k) Number K100537

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Reprocessor	Model Number	Description
Ascent Healthcare Solutions	FCS9	Reprocessed Ultrasonic CurvedShears (9cm long/16mm bladelength) with
	TWBLUE	Torque wrench
	GABLUE	Grip Assist

Image /page/5/Picture/1 description: The image shows a Harmonic Focus scalpel. The scalpel is white and has a black handle. The scalpel is lying on a table. The scalpel has the words "Harmonic Focus" printed on the side.

Figure 1 Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist

Neil R. Ode for man
(Division Sign-Off)

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

510(k) Number K100537

Regulation Number and Section

N/A