Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Device Description

Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected, packaged, and sterilized for an additional clinical use.

AI/ML Overview

The provided text describes the substantial equivalence of a reprocessed surgical device, not an AI or diagnostic device, so many of the requested categories (like number of experts for ground truth, MRMC study effect size, sample size for training set, etc.) are not applicable and cannot be answered from the provided document.

However, I can extract the relevant acceptance criteria and performance information:

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

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds matched to reported performance data for each criterion. Instead, it describes various performance tests conducted to demonstrate equivalence to the predicate device. The general acceptance criterion is that the reprocessed device performs equivalently to the original predicate device across these tests.

Acceptance Criteria (General)	Reported Device Performance (Summary)
Functional Equivalence to Predicate Device	The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices based on the following tests: simulated use; grasping/pulling force; cutting effectiveness/functionality; drop test; device integrity; cutting/coagulation evaluation for a prolonged period of time; thermal analysis characterization; tissue sticking; vessel burst pressure, seal quality and histopathology; electrical safety in accordance with IEC 60601-1; cleaning; protein, carbohydrates, and endotoxins and visual inspection; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability.
Safety and Cleaning (absence of harmful residues/pyrogens)	Cleaning; protein, carbohydrates, and endotoxins and visual inspection; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity.
Sterilization Efficacy and Device Stability	Sterilization validation; and product stability.
Electrical Safety (as per recognized standards)	Electrical safety in accordance with IEC 60601-1.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test set. It describes types of tests performed (e.g., simulated use, grasping/pulling force, cutting effectiveness). The "data provenance" is implied to be from laboratory testing conducted on the reprocessed devices, comparing them to the predicate devices. The document does not specify country of origin or whether the data was retrospective or prospective, though performance testing is inherently prospective for the reprocessed device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to a reprocessed surgical instrument. The "ground truth" for these tests relates to measurable physical and functional properties, as well as biological safety, compared against the predicate device and established standards, rather than expert interpretation of images or clinical data.

4. Adjudication method for the test set
Not applicable for this type of device and testing. Test results are based on objective measurement against established specifications or predicate device performance.

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
Not applicable. This is for a surgical instrument, not an AI or diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a surgical instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly refers to the established performance characteristics and safety profile of the legally marketed predicate device, as well as recognized industry standards for safety (e.g., electrical safety, biocompatibility, sterilization efficacy) and functionality. For example, "cutting effectiveness" would be compared to a benchmark established by the new predicate device, and "vessel burst pressure" would have a defined acceptable range.

8. The sample size for the training set
Not applicable. This is a reprocessed surgical instrument, not a machine learning algorithm.

9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this type of device submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human figure.

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

January 26, 2016

Surgical Instrument Services and Savings (dba Medline Renewal) Ms. Brandi Panteleon Director, Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756

Re: K151405

Trade/Device Name: Medline Renewal Reprocessed Harmonic Ace + Shears without Adaptive Tissue Technology

Regulatory Class: Unclassified Product Code: NLO Dated: December 23, 2015 Received: December 28, 2015

Dear Ms. Panteleon:

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 of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Model	Device Name	Device Size
HAR23M	Medline ReNewal Reprocessed ACE+Shears without Adaptive TissueTechnology	5 x 23 cm
HAR36M	Medline ReNewal Reprocessed ACE+Shears without Adaptive TissueTechnology	5 x 36 cm

Reprocessed Single-Use Device Models Included in Clearance:

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Indications for Use

510(k) Number (if known) K151405

Device Name

Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The word "Medline" is in blue, with a blue star-like symbol to the right. To the right of the Medline logo is a vertical line, followed by the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.

510(k) Summary — K151405

Submitter/Owner	Medline ReNewal2747 SW 6th St.Redmond, OR 97756
Contact Names	Brandi PanteleonDirector, QA/RAP: 541-923-3310F: 541-923-3375E: bpanteleon@medline.com
Date Prepared	May 20, 2015
Device Names	Proprietary Name: Medline ReNewal Reprocessed Harmonic ACE+ Shearswithout Adaptive Tissue Technology, models HAR23M and HAR36MCommon Name: Unclassified/scalpel, ultrasonic reprocessed
Classification	Unclassified/scalpel ultrasonic, reprocessedProduct code: NLQ
PredicateDevice	K120729 Ethicon Endo-Surgery Harmonic ACE® Shears+ Adaptive TissueTechnology
DeviceDescription	Medline ReNewal Reprocessed Harmonic ACE+ Shears without AdaptiveTissue Technology (originally manufactured by Ethicon Endo-Surgery) arecleaned, refurbished, tested, inspected, packaged, and sterilized for anadditional clinical use.
Intended Use	Medline ReNewal Reprocessed Harmonic ACE+ Shears without AdaptiveTissue Technology are indicated for soft tissue incisions when bleedingcontrol and minimal thermal injury are desired. The instruments can beused as an adjunct to, or substitute for, electrosurgery, lasers and steelscalpels in general, plastic, pediatric, gynecologic, urologic, exposure toorthopedic structures (such as spine and joint space) and other open andendoscopic procedures.
TechnologicalCharacteristics	The technological characteristics and the fundamental scientific technologyof the subject devices are identical to the predicate device. The proposeddevices are a reprocessed version of the predicate devices.

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Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The word "Medline" is in blue, with a blue star-like symbol to the right. To the right of the Medline logo is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in a smaller font below.

	The functional characteristics of the proposed devices have been evaluatedand found to be equivalent to the predicate devices based on the followingtests:
PerformanceTesting	simulated use; grasping/pulling force; cutting effectiveness/functionality; drop test; device integrity; cutting/coagulation evaluation for a prolonged period of time; thermal analysis characterization; tissue sticking; vessel burst pressure, seal quality and histopathology; electrical safety in accordance with IEC 60601-1; cleaning; protein, carbohydrates, and endotoxins and visual inspection; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability.
Conclusion	Based on comparisons of the indications for use, intended use,technological characteristics, and performance data to the predicatedevices, Medline ReNewal Reprocessed Harmonic ACE+ Shears withoutAdaptive Tissue Technology are substantially equivalent to the predicatedevices.

Regulation Number and Section

N/A