Scissor instruments are used during minimally invasive surgery in conjunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue.

The instrument, model 5DCS, is validated with the US Surgical Force FX-C generator and is only to be used with this generator.

Device Description

Endoscopic instruments consist of a rigid plastic handpiece with loop handles connected to the distal end scissors or jaws by an elongated, narrow-diameter insulated barrel or shaft. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The handbiece loop handles operate the jaws. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. The blades or jaws of endoscopic instruments can deliver a cauterizing current that enters the instrument through the unipolar cautery connector on the handpiece, runs down the insulated shaft and through the tissue in the blades or jaws. Monopolar electrocautery is possible only with instruments equipped with a cautery pin in conjunction with a compatible electrosurgical unit and patient grounding pad.

AI/ML Overview

The provided documents do not contain the detailed information necessary to fully answer all aspects of your request, as they pertain to the 510(k) summary for a reprocessed medical device rather than a new device with AI components. The study described focuses on demonstrating the substantial equivalence of reprocessed endoscopic instruments to predicate devices through bench and laboratory testing.

Here's a breakdown of the available information and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used:

The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Endoscopic Instruments. This included the following tests:

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

The conclusion is: "Performance testing demonstrates that Reprocessed Endoscopic Instruments perform as originally intended."

However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum residual protein levels, specific electrical resistance ranges for cautery function) and the exact reported performance values for each of these tests are not provided in this summary. Therefore, a detailed table cannot be created. The ground truth for this type of testing is typically established by pre-defined engineering specifications, regulatory standards, and comparison to the performance of the original predicate device.

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

The document does not specify the sample sizes used for each of the bench and laboratory tests. It generally refers to "testing" without providing numerical details for the test sets.

The data provenance is from bench and laboratory testing of reprocessed medical devices, rather than clinical data from specific countries. It is inherently prospective in the sense that Ascent Healthcare Solutions performed these tests for this 510(k) submission.

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

This type of information is not applicable in the context of this 510(k) summary. The "ground truth" for the performance of a reprocessed medical device is established through objective physical, chemical, and biological testing against predefined engineering and regulatory standards, not through expert consensus on interpretations like with diagnostic imaging.

4. Adjudication Method for the Test Set:

This is not applicable to the type of bench and laboratory testing described. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints.

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:

This is not applicable. This submission is for reprocessed endoscopic instruments, which are physical surgical tools, not AI algorithms. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This is not applicable. This submission is for a physical medical device, not an algorithm.

8. The Sample Size for the Training Set:

This is not applicable as there is no AI or algorithm involved that would require a training set.

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

This is not applicable as there is no AI or algorithm involved that would require a training set.

In summary, the provided document is a 510(k) summary for a reprocessed physical medical device. It describes bench and lab tests to demonstrate substantial equivalence to a predicate device, focusing on safety and effectiveness. It does not involve AI, clinical data from human subjects for ground truth establishment, or multi-reader studies.

Summary

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SECTION 5: 510(k) SUMMARY

Submitter:

Contact:

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

Amanda Babcock Senior Regulatory Affairs Specialist (480) 763-5300 (o) (863) 904-2312 (f) ababcock@ascenths.com

Date of preparation:

Name of device:

Predicate Device

Device description:

· K012700

K984240

Trade/Proprietary Name: Reprocessed Endoscopic Instruments

Classification Name: Electrosurgical, cutting & coagulation. accessories, laparoscopic & endoscopic, reprocessed

510(k) Title Vanquard Reprocessed Electrosurgical Instruments ENDOPATH® Endoscopic Instruments

January 21, 2011

Manufacturer Ascent Healthcare Solutions Ethicon Endo-Surgery. Inc.

18 2011

Note: Only the Endoscopic Instrument (5DCS) is the subject of this submission, the electrosurgical unit and any other related equipment are not included in the scope of this submission.

Ascent Healthcare Solutions Reprocessed Endoscopic Instruments Traditional 510(k)

Page 14

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Indications for Use:

Technological characteristics:

Performance data:

Conclusion:

Scissor instruments are used during minimally invasive surgery. in coniunction with an appropriately sized trocar and a compatible electrosurgical unit for mobilization, transection and/or cauterization of tissue.

The design, materials, and intended use of Reprocessed Endoscopic Instruments are identical to the predicate devices The mechanism of action of Endoscopic Instruments is identical . to the predicate devices in that the same standard mechanical design and size and equivalent 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 Endoscopic Instruments includes removal of adherent visible soil and decontamination. Each individual Endoscopic Instrument is tested for appropriate function of its components prior to packaging and labeling operations.

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

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

Performance testing demonstrates that Reprocessed Endoscopic Instruments perform as originally intended.

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Endoscopic Instruments) are safe. effective, and substantially equivalent to the predicate devices as described herein.

Ascent Healthcare Solutions Reprocessed Endoscopic Instruments Traditional 510(k)

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.

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

Ascent Healthcare Solutions % Ms. Amanda Babcock Senior Regulatory Affairs Specialist 10232 South 51st Street Phoenix, Arizona 85044

Re: K110189

JUL 18 2011

Trade Name: Reprocessed Endoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: July 6, 2011 Received: July 7, 2011

Dear Ms. Babcock:

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 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.

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Page 2 - Ms. Amanda Babcock

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.

Sincerely yours,

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): K110189

Device Name: Reprocessed Endoscopic Instruments

Indications For Use:

The instrument, model 5DCS, is validated with the US Surgical Force FX-C generator and is only to be used with this generator.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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 of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110189

Ascent Healthcare Solutions Reprocessed Endoscopic Instruments Traditional 510(k)

Page 13

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The only reprocessed model cleared in this submission is the Curved Scissor with Unipolar Cautery, Model 5DCS.

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

510(k) Number K110189

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.