The Reprocessed Hand-Activated Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.

Device Description

The Reprocessed Hand-Activated Ultrasonic Scalpels are hand held instruments which may be used to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with a functional length of 36cm. The instrument jaws are opened and closed using proximal ring handles, styled in a pistol-type grip. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. The Scalpel has a curved active blade. The proximal handle is designed for attachment to a compatible handpiece and microprocessor controller. Electrical outputs from the controller are converted by an ultrasonic transducer within the handpiece to mechanical vibrations that are transmitted through the instrument shaft to the distal scalpel blade. The proximal handle of the Hand-Activated Ultrasonic Scalpel has two integrated push buttons that allow hand control of the ultrasonic power level (minimum or maximum power level). Vanguard receives previously used Ultrasonic Scalpels from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use.

AI/ML Overview

The provided text is a 510(k) summary for a reprocessed medical device, specifically a Hand-Activated Ultrasonic Scalpel. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and biocompatibility testing of the reprocessed device itself, rather than a clinical study evaluating its performance against specific acceptance criteria.

As such, none of the requested information regarding acceptance criteria, study design, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies is present in the provided text. The document is about the reprocessing process validation and comparison of device characteristics to those of new predicate devices, not about a clinical performance study with AI.

However, I can extract the available information which primarily relates to the device itself and its regulatory clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for AI or clinical efficacy. The implicit acceptance criterion is that the reprocessed device performs "as intended" and is "safe and effective," demonstrating substantial equivalence to the original predicate devices without negative impact due to reprocessing. This is shown through the following:
- Technological Characteristics Equivalence: Device materials, specifications, and technological characteristics are equivalent to OEM devices.
- Performance and Test Data: Cleaning, sterilization, packaging validations, and performance and biocompatibility testing demonstrate the reprocessed devices perform as intended.
Reported Device Performance:
- Device Description: Functions to cut and coagulate tissue when connected to a compatible ultrasonic handpiece and generator. 5mm diameter, 36cm functional length, pistol-type grip, 360° rotation, curved active blade, integrated push buttons for power control.
- Equivalence Claim: Vanguard Reprocessed Hand-Activated Ultrasonic Scalpels are "essentially identical" and "substantially equivalent" to currently marketed Original Equipment Manufacturer (OEM) devices.

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 describes validation and testing of the reprocessed device itself (e.g., cleaning, sterilization, biocompatibility, performance), not a clinical study on patient data. Therefore, there is no "test set" in the context of patient data; instead, there are batches of reprocessed devices tested.
The sample sizes for these internal device validation tests are not specified in the provided text.
Data provenance: Not applicable in the context of clinical patient data. The testing is internal to Vanguard Medical Concepts, Inc. (later Ascent Healthcare Solutions).

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 document pertains to the regulatory clearance of a reprocessed medical device, not an AI or diagnostic study requiring expert-established ground truth on patient data.

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

Not applicable. As above, this is not a study assessing diagnostic performance where adjudication of ground truth would be needed.

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, an MRMC comparative effectiveness study was not done. This document does not describe any AI component or human-in-the-loop performance evaluation.

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

No. This document is about a reprocessed surgical instrument, not an algorithm or AI system.

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

Not applicable in the context of clinical AI performance. The "ground truth" for the device's performance is established through engineering and biological safety testing (e.g., sterility testing, material strength testing, biocompatibility assays) to ensure it meets specifications and performs equivalently to new devices.

8. The sample size for the training set

Not applicable. There is no AI component or "training set" of data described.

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

Not applicable. There is no AI component or "training set" of data described.

Summary

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K0433/5

510(k) Summary of Safety & Effectiveness

Submitter	Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815
Contact	Heather Crawford, RACDirector of Regulatory Affairs863-683-8680 [voice]863-683-8703 [facsimile]hcrawford@safe-reuse.com [email]
Date	November 24, 2004
Device	Trade Name: Vanguard Reprocessed Hand-Activated Ultrasonic ScalpelCommon Name: Ultrasonic Surgical Instrument21 CFR Section: UnclassifiedReprocessed - Class IIProduct Code: NLQ
PredicateDevices	Trade Names: Ethicon Endo-Surgery UltraCision® Harmonic Scalpel®510(k) numbers: K925699: Ultracision, Inc., Harmonic Scalpel Laparosonic Clamp CoagulatorK980099: Ethicon Endo-Surgery, Inc., UltraCision LaparoSonic Coagulating Shears LCS-5K993054: Ethicon Endo-Surgery, Inc., UltraCision Harmonic Scalpel LCS and CS Curved Shears
Indications forUse	The Reprocessed Hand-Activated Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.
Contra-indications	This instrument is not intended for contraceptive tubal ligation or for bone excision.
	Continued on next page

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510(k) Summary of Safety & Effectiveness, Continued

The Reprocessed Hand-Activated Ultrasonic Scalpels are hand held Device instruments which may be used to cut and coagulate tissue when connected Description to a compatible ultrasonic handpiece and generator. Scalpels are 5mm in diameter with a functional length of 36cm. The instrument jaws are opened and closed using proximal ring handles, styled in a pistol-type grip. The instrument tip and shaft can be rotated 360° in either direction using a knob on the handle. The Scalpel has a curved active blade. The proximal handle is designed for attachment to a compatible handpiece and microprocessor controller. Electrical outputs from the controller are converted by an ultrasonic transducer within the handpiece to mechanical vibrations that are transmitted through the instrument shaft to the distal scalpel blade. The proximal handle of the Hand-Activated Ultrasonic Scalpel has two integrated push buttons that allow hand control of the ultrasonic power level (minimum or maximum power level). Vanguard receives previously used Ultrasonic Scalpels from healthcare facilities; cleans, inspects, tests, packages, labels, and sterilizes the devices; and returns them to a healthcare facility for subsequent use. The Vanguard Reprocessed Hand-Activated Ultrasonic Scalpels are Technological essentially identical to the currently marketed Original Equipment Characteristics Manufacturer (OEM) devices. Device materials, specifications, and technological characteristics are equivalent. Cleaning, sterilization, and packaging validations, and performance and Test Data biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective.

Based upon the information provided herein and the 510(k) "Substantial Conclusion Equivalence" Decision Making Process Chart, we conclude that Vanguard Reprocessed Ultrasonic Scalpels are substantially equivalent to their predicate devices under the Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized symbol resembling a person embracing another, or a bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

NOV 2 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Ascent Healthcare Solutions % Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, Arizona 85044

Re: K043315 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Name: Ultrasonic Surgical Instrument Regulatory Class: Unclassified Product Code: NLQ Dated: February 24, 2005 Received: February 25, 2005

Dear Ms. Barton:

This letter corrects our substantially equivalent letter of March 22, 2005. The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on March 22, 2005. We have received your supplemental validation data as required for reprocessed singleuse devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the device listed in the enclosure accompanying this letter are 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 these devices, 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.

If your devices are classified (see above) into either class II (Special Controls) or class III (PMA) they may be subject to such 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 devices 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 devices comply 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 applicable requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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Page 2 - Ms. Moira Barton

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours

Ron Paulson

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

Enclosure

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Page 3 - Ms. Moira Barton

Indications for Use

510(k) Number (if known) : K043315

Vanguard Reprocessed Hand-Activated Ultrasonic Device Name: Scalpel

Indications For Use:

Reprocessed Hand-Activated Ultrasonic Scalpel is intended for use during minimally invasive laparoscopic and open surgical procedures where coagulation and incision of soft tissue is required.

Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Pele

Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K643315

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Page 4 – Ms. Moira Barton

. . . . . .

A 1998 - 1998 - 1999

List of Models:

Ethicon LCSB5HA 5mm Coagulating Shears, Pistol Grip with Integrated Push Buttons, 36mm, Curved Active Blade ,

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11:40

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Regulation Number and Section

N/A