The Reprocessed Hand Activated Sealer/Divider can be used during open procedures to seal vessels up to and including 7mm, lymphatics and tissue bundles. The Hand Activated Sealer/Divider can also be used to seal pulmonary vasculature but only when used with the ForceTriad™ energy platform.

The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

Device Description

The Hand Activated Sealer/Divider is an instrument that works exclusively with the ForceTriad™ energy platform (not within the scope of this submission) to seal vessels up to and including 7 mm. seal pulmonary vasculature, lymphatics and tissue bundles. The instrument's shaft diameter is 13.5 mm (oval), length is 18 cm and shaft rotation is 180 degrees.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Reprocessed Hand Activated Sealer/Divider:

Summary of Acceptance Criteria and Study Findings for Reprocessed Hand Activated Sealer/Divider

This submission is for a reprocessed device, thus the "acceptance criteria" and "device performance" are primarily focused on demonstrating that the reprocessed device performs identically to its predicate device and original intent, and that the reprocessing itself is safe and effective.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Conducted	Reported Device Performance
Equivalence to Predicate	Design, materials, intended use, mechanism of action, claims, clinical applications, patient population, performance specifications, method of operation.	"The design, materials, and intended use of the Reprocessed Hand Activated Sealer/Divider are identical to the predicate device." "The mechanism of action... 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."
Reprocessing Effectiveness	Removal of adherent visible soil and decontamination.	"Ascent Healthcare Solutions' reprocessing of the Hand Activated Sealer/Divider includes removal of adherent visible soil and decontamination."
Functionality Testing	Appropriate function of components.	"Each individual Hand Activated Sealer/Divider is tested for appropriate function of its components prior to packaging and labeling operations."
Performance (Safety & Effectiveness Demonstration)	Bench and laboratory testing covering: - Biocompatibility - Validation of reprocessing - Sterilization Validation - Function test(s) - Packaging Validation	"Performance testing demonstrates that Reprocessed Hand Activated Sealer/Divider perform as originally intended." "Conclusion: Ascent Healthcare Solutions concludes that the Reprocessed Hand Activated Sealer/Divider are safe, effective, and substantially equivalent to the predicate device as described herein."

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

The document does not explicitly state a specific numerical sample size for the "test set" in terms of how many reprocessed devices were tested for each performance criterion.

Sample Size: Not explicitly stated as a numerical value (e.g., "N=X devices"). The text mentions "Each individual Hand Activated Sealer/Divider is tested for appropriate function," suggesting every unit undergoes some functional testing. For other tests like biocompatibility or sterilization, it's implied that a sufficient, representative sample was used according to regulatory standards for validation, but the exact number is not provided.
Data Provenance: The studies were conducted as "Bench and laboratory testing" by Ascent Healthcare Solutions. There is no mention of country of origin for the data or whether it was retrospective or prospective in the sense of clinical studies. Given it's a reprocessed device and the tests are focused on material, functional, and reprocessing validation, these are typical laboratory-based studies.

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

N/A. This type of submission (510(k) for a reprocessed electrosurgical device) focuses on engineering and material science testing, rather than interpretation of medical images or clinical outcomes by medical experts to establish a "ground truth." The "ground truth" here is adherence to engineering specifications and performance within established safety and effectiveness parameters, which would be assessed by engineers, quality control specialists, and possibly microbiologists. The document does not describe the use of medical experts for establishing ground truth for these tests.

4. Adjudication Method for the Test Set

N/A. As with point 3, this is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation tasks (e.g., radiology reads) where there's subjectivity and potential disagreement. The performance tests described (biocompatibility, sterilization, function, etc.) are typically objective, pass/fail criteria and do not involve human adjudication in this context.

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

No. An MRMC study is completely irrelevant for this device and type of submission. MRMC studies are used to evaluate the diagnostic performance of imaging devices or algorithms where multiple readers interpret cases. This submission is for a reprocessed surgical instrument.

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

N/A. This is not an AI algorithm or a diagnostic device. It's a reprocessed surgical instrument. The device itself operates as designed (without "human-in-the-loop" once it's in use, other than being operated by the surgeon) and its performance is assessed against its original specifications and the predicate device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is multifaceted, rooted in engineering specifications, established regulatory standards, and the performance characteristics of the original (predicate) device.

Predicate Device Performance: The primary ground truth is that the reprocessed device must perform "identically" and "as originally intended" compared to the new, predicate device.
Safety Standards: Ground truth for biocompatibility relates to accepted material safety standards.
Sterilization Standards: Ground truth for sterilization validation relates to established industry and regulatory standards for achieving sterility (e.g., sterilization assurance level, SAL).
Functional Specifications: Ground truth for function tests would be the original engineering specifications for force, sealing ability (e.g., vessel seal strength), electrical integrity, etc., of the new device.

8. The Sample Size for the Training Set

N/A. There is no "training set" in the context of this device. A training set is used for machine learning models. This submission describes the testing and validation of a reprocessed medical device through traditional engineering and quality control methods.

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

N/A. As mentioned in point 8, there is no training set for this device.

Summary

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K111600

SECTION 5: 510(k) SUMMARY

NOV 1 5 2011

Submitter:	Ascent Healthcare Solutions
	10232 South 51st Street
	Phoenix, Arizona 85044

Contact: Ramona Kulik Regulatory Affairs Engineer 480.763.5300 (o) 480.763.2952 (f) rkulik@ascenths.com

Date of preparation: June 7, 2011

Name of device: · Trade/Proprietary Name: Reprocessed Hand Activated Sealer/Divider

Classification Name: Electrosurgical cutting and coagulation device and accessories

Predicate Device 510/k) Title Manufacturer K070162 Forcetriad Electrosurgical Generator; Ligasure Instruments

Valleylab A division of Tyco Healthcare Group

Device description: The Hand Activated Sealer/Divider is an instrument that works exclusively with the ForceTriad™ energy platform (not within the scope of this submission) to seal vessels up to and including 7 mm. seal pulmonary vasculature, lymphatics and tissue bundles. The instrument's shaft diameter is 13.5 mm (oval), length is 18 cm and shaft rotation is 180 degrees.

Indications for Use: The Reprocessed Hand Activated Sealer/Divider can be used during open procedures to seal vessels up to and including 7mm, lymphatics and tissue bundles. The Hand Activated Sealer/Divider can also be used to seal pulmonary vasculature but only when used with the ForceTriad™ energy platform. The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

ﻌﺪ ﻋﻠﻰ

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Technological The design, materials, and intended use of the Reprocessed characteristics: Hand Activated Sealer/Divider are identical to the predicate device. The mechanism of action of Reprocessed Hand Activated Sealer/Divider 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 the Hand Activated Sealer/Divider includes removal of adherent visible soil and decontamination. Each individual Hand Activated Sealer/Divider 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 Hand Activated Sealer/Divider. This included the following tests:

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

Performance testing demonstrates that Reprocessed Hand Activated Sealer/Divider perform as originally intended.

Conclusion:

Ascent Healthcare Solutions concludes that the Reprocessed Hand Activated Sealer/Divider are safe, effective, and substantially equivalent to the predicate device as described herein.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

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

NOV 1 5 2011

Re: K111600

Trade/Device Name: Reprocessed Hand Activated Sealer/Divider Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: November 09, 2011 Received: November 14, 2011

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. Iisting 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

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Page 2 - Ms. Ramona Kulik

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 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/CDRH0ffices/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/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

urs,

For Pete

elkerson
i) 2

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

510(k) Number (if known): K1) |600

Device Name: Reprocessed Hand Activated Sealer/Divider

Indications For Use:

The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

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)

Division Sign-Off

(Division Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111600

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.