The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears 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 Coagulating 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). An audible and tactile mechanism is integrated into the handle housing to indicate full closure. The Ultrasonic Coagulating Shears is 18 cm long, shaft diameter of 8.5 mm, with an active blade length of 18 mm. The blade and clamp arm are straight allowing them to function through an incision without the use of a trocar. The Ultrasonic Coagulating Shears allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. The Ultrasonic Coagulating Shears is designed to operate with the Harmonic TM Generator 300 (GEN04) and the Hand Piece (HP054).

AI/ML Overview

The provided document describes the 510(k) summary for Reprocessed Ultrasonic Coagulating Shears. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving a new device meets specific acceptance criteria through a clinical study. The performance data presented focuses on verifying that the reprocessed device performs as originally intended, matching the predicate device.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance that a new device would need to meet. Instead, the submission relies on demonstrating substantial equivalence to an existing predicate device (Harmonic Wave Coagulating Shears, K062000). The "acceptance criteria" are implied to be that the reprocessed device performs identically to the predicate device in terms of design, materials, intended use, mechanism of action, claims, clinical applications, patient population, and performance specifications.

Acceptance Criteria (Implied for Reprocessed Device)	Reported Device Performance (Reprocessed Ultrasonic Coagulating Shears)
Identical design, materials, and intended use as predicate device.	"The design, materials, and intended use of Reprocessed Technological Ultrasonic Coagulating Shears are identical to the predicate characteristics: device."
Identical mechanism of action as predicate device.	"The mechanism of action of Ultrasonic Coagulating Shears is identical to the predicate device in that the same standard mechanical design, size, and materials are utilized."
No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation compared to predicate device.	"There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation."
Safe and effective.	"Performance testing demonstrates that Reprocessed Ultrasonic Coagulating Shears perform as originally intended. Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Ultrasonic Coagulating Shears) are safe, effective, and substantially equivalent to the predicate device as described herein."
Biocompatibility requirements met.	"Biocompatibility" test conducted. (Specific results not detailed in summary, but implied to be successful).
Reprocessing is validated.	"Validation of reprocessing" test conducted. (Specific results not detailed in summary, but implied to be successful). This also includes "removal of adherent visible soil and decontamination."
Sterilization is validated.	"Sterilization Validation" conducted. (Specific results not detailed in summary, but implied to be successful).
Components function appropriately.	"Function test(s)" conducted. "Each individual Ultrasonic Coagulating Shear is tested for appropriate function of its components prior to packaging and labeling operations." (Specific results not detailed in summary, but implied to be successful).
Packaging is validated.	"Packaging Validation" conducted. (Specific results not detailed in summary, but implied to be successful).

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

The document explicitly states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultrasonic Coagulating Shears." However, it does not specify the sample sizes used for these tests.

The data provenance is from bench and laboratory testing, not human clinical data. There is no information about country of origin, retrospective, or prospective nature of this "test set" in the context of clinical trials, as it's not a clinical trial.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and therefore not provided in the document. The study described is a series of bench and laboratory tests to confirm the physical and functional characteristics of a reprocessed device compared to its original specifications, not a study involving human or image-based ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document, as it's not a study involving human reader interpretation or adjudication. The "test set" here refers to physical items undergoing laboratory testing, not clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the substantial equivalence of a reprocessed medical device through bench and laboratory testing, not on the comparative effectiveness of human readers with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done

No, a standalone algorithm performance study was not done. This document concerns a reprocessed physical medical device (ultrasonic shears), not a software algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is the original specifications and performance of the new (predicate) ultrasonic coagulating shears. The reprocessed device is tested against these established standards to demonstrate that it performs "as originally intended." This includes:

Biocompatibility standards.
Validated reprocessing protocols.
Sterilization efficacy.
Appropriate function of components (mechanical, electrical, etc.).
Packaging integrity.

8. The Sample Size for the Training Set

This information is not applicable. There is no training set in the context of machine learning or AI involved in this submission.

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

This information is not applicable. Since there is no training set mentioned, there is no ground truth established for it in this context.

Summary

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MAR - 4 2010 K093709 SECTION 5: 510(k) SUMMARY

ﺎ ﻳﺎﺭ ﺍﻟﻌ

・・

Submitter:	Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044
Contact:	Moira Barton-VartySenior Director Regulatory Affairs480.763.5300 (o)480.763.5350 (f)mbarton@ascenths.com
Date of preparation:	November 30, 2009
Name of device:	Trade/Proprietary Name: Reprocessed Ultrasonic CoagulatingShearsClassification Name: Scalpel, Ultrasonic, Reprocessed
Predicate DeviceK062000	510(k) TitleHarmonic Wave Coagulating ShearsWith Scissor Handle and HandControl, Model Wave18S; HarmonicDisposable Torque Wrench	ManufacturerEthicon Endo-Surgery,Inc.
Device description:	The Ultrasonic Coagulating Shears is an instrument consistingof a scissor handle housing assembly with hand control buttons(MIN for minimum power level and MAX for maximum powerlevel). An audible and tactile mechanism is integrated into thehandle housing to indicate full closure. The UltrasonicCoagulating Shears is 18 cm long, shaft diameter of 8.5 mm,with an active blade length of 18 mm. The blade and clamp armare straight allowing them to function through an incision withoutthe use of a trocar. The Ultrasonic Coagulating Shears allowsfor the cutting and coagulation of vessels up to and including 5mm in diameter.
	The Ultrasonic Coagulating Shears is designed to operate withthe Harmonic TM Generator 300 (GEN04) and the Hand Piece(HP054).
	Note: Only the Ultrasonic Coagulating Shears is the subject ofthis submission, the reusable hand piece, generator, and anyother related equipment are not included in the scope of this

submission.

other related equipment are not included in the scope of this

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093702

ﮩ

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Indications for Use: The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears 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.

The design, materials, and intended use of Reprocessed Technological Ultrasonic Coagulating Shears are identical to the predicate characteristics: device. The mechanism of action of Ultrasonic Coagulating Shears 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 Coagulating Shears includes removal of adherent visible soil and decontamination. Each individual Ultrasonic Coaqulating Shear 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 Coaqulating Shears. This included the following tests:

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

Performance testing demonstrates that Reprocessed Ultrasonic Coagulating Shears perform as originally intended.

Ascent Healthcare Solutions concludes that the modified Conclusion: devices (Reprocessed Ultrasonic Coagulating Shears) 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR - 4 2010

Ascent Healthcare Solutions % Ms. Moira Barton-Varty Senior Director of Regulatory Affairs 10232 South 51st Street Phoenix, Arizona 85044

Re: K093702

Trade/Device Name: Reprocessed Ultrasonic Coagulating Shears Regulatory Class: Unclassified Product Code: NLQ Dated: February 23, 2010 Received: February 24, 2010

Dear Ms. Barton-Varty:

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 - Mr.

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/ReportalProblem/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 N. Melkerson

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

93702 510(k) Number (if known):

Device Name: Reprocessed Ultrasonic Coagulating Shears

Indications For Use:

Prescription Use × (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)

Neil RP Ogilvie for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093702

Page 12

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Reprocessor	Model Number	Description
Ascent Healthcare Solutions	Wave18S	Reprocessed UltrasonicCoagulating ShearsScissor Handle with HandControl
		8.5 mm diameter / 18 cm long

Image /page/5/Picture/1 description: The image shows a medical device, specifically a Harmonic scalpel. The device has a long, thin shaft with a grasping mechanism at the end. The handle is white and has the words "I-harmonic wave" printed on it.

Figure 1 Reprocessed Ultrasonic Coagulating Shears

YhilRP Oglin for mxm

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

510(k) Number K093702

Regulation Number and Section

N/A