Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm Diameter Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection of tissue.

Device Description

Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm Diameter Endoscopic Instruments (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected packaged, labeled, and sterilize for an additional clinical use.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the Medline Renewal Reprocessed Endopath Endoscopic Instruments (K152313). The primary goal of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to establish novel performance criteria for a new AI device. Therefore, the information requested may not be fully available in the context of this specific regulatory document.

However, based on the provided text, I can extract the following information regarding the device's acceptance criteria and the study proving it meets these criteria:

This document describes the regulatory clearance of reprocessed surgical instruments, not an AI device. Therefore, many of the typical AI-specific questions (like effect size of AI assistance, standalone performance, ground truth for training sets, etc.) are not applicable here. The "acceptance criteria" here refer to demonstrating that the reprocessed devices perform equivalently to the original predicate devices and meet established safety and functional standards for surgical instruments.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these reprocessed devices are implicitly that they perform identically to the original, new Endopath Endoscopic Instruments manufactured by Ethicon Endo-Surgery, and maintain safety and sterility. The performance testing aims to confirm this equivalence.

Acceptance Criteria Category	Specific Criteria/Test	Reported Performance
Functional Equivalence	Simulated use	Found to be equivalent to predicate devices
	Grasping/pulling force	Found to be equivalent to predicate devices
	Cutting effectiveness/functionality	Found to be equivalent to predicate devices
	Device integrity	Found to be equivalent to predicate devices
	Coagulation evaluation	Found to be equivalent to predicate devices
Reprocessing Effectiveness	Cleaning	Found to be equivalent to predicate devices
	Protein, carbohydrates, visual inspection (under magnification)	Found to be equivalent to predicate devices
Biocompatibility	Cytotoxicity	Met standards
	Sensitization	Met standards
	Irritation	Met standards
	Acute systemic toxicity	Met standards
	Pyrogenicity	Met standards
Safety & Electrical	Electrical safety (IEC 60601-1)	Met standards
	Electrical safety (IEC 60601-1-2)	Met standards
	Electrical safety (IEC 60601-2-2)	Met standards
	Thermal analysis characterization	Met standards
Sterilization	Sterilization validation	Met standards
Device Stability	Product stability	Met standards
Overall Conclusion	Substantial Equivalence to predicate	Demonstrated substantial equivalence

Study Details (as inferable from the document):

Since this is a submission for reprocessed surgical instruments, not an AI device, the common terminology for AI studies doesn't directly apply. However, I can interpret the request in the context of this document:

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size (e.g., number of reprocessed devices tested for each functional or safety test).
- Provenance: Not specified in terms of country of origin for the data. The devices are reprocessed versions of Ethicon Endo-Surgery instruments, and the testing was performed by Medline ReNewal. It is a prospective evaluation in the sense that Medline performs these tests on their reprocessed devices to ensure quality and equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not directly applicable. "Ground truth" for these devices is typically established by comparing their performance to the known specifications and performance of original, new devices, and against recognized industry standards (e.g., ISO, ASTM, IEC). The testing itself provides the data, and expert interpretation occurs during the evaluation of these results against the predicate's performance and safety standards. There's no mention of a panel of experts for subjective assessment typical in AI evaluation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of this type of device and testing. Performance data from laboratory tests (e.g., force measurements, electrical readings) are quantitative and do not require expert adjudication in the same way clinical image interpretation might. Visual inspections would be performed according to established criteria, not consensus.
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 not an AI device or a diagnostic imaging study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is the performance specifications and safety profile of the original, new predicate devices (Ethicon Endopath Endoscopic Instruments), coupled with established engineering, biological, and sterilization standards (e.g., IEC 60601 series for electrical safety, biocompatibility standards, sterilization validation standards). The reprocessed device's performance is compared against these benchmarks.
The sample size for the training set:
- Not applicable. There is no machine learning "training set" for physical reprocessed instruments.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, connected by a flowing line that resembles a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

January 6, 2016

Surgical Instrument Services and Savings Incorporated Ms. Brandi Panteleon Acting Director, Quality Assurance and Regulatory Affairs 2747 Southwest 6th Street Redmond, Oregon 97756

Re: K152313

Trade/Device Name: Medline Renewal Reprocessed Endopath 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: December 8, 2015 Received: December 9, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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 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.

Joshua C. Nipper -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

Reprocessed Single-Use Device Models Included in Clearance:

{2}------------------------------------------------

Device Model	Device Name	Original Manufacturer
5DCD	Endopath 5 mm Diameter EndoscopicInstruments – Curved Dissector	Ethicon Endo-Surgery
5DCS	Endopath 5 mm Diameter EndoscopicInstruments - Curved Scissors	Ethicon Endo-Surgery

{3}------------------------------------------------

Indications for Use

510(k) Number (if known) K152313

Device Name

Medline ReNewal Reprocessed Endopath Endoscopic Instruments

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The word "Medline" is in black font with a blue star to the left of the word. To the right of the word "Medline" is the word "Renewal" in green and blue font, with the words "Full Circle Reprocessing" in a smaller font below the word "Renewal".

5.0 510(k) Summary)

Submitter/Owner	Medline ReNewal2747 SW 6th St.Redmond, OR 97756
Contact Name	Brandi PanteleonActing Director, Quality Assurance/Regulatory AffairsP: 541-923-3310F: 541-923-3375E: bpanteleon@medline.com
Date Prepared	August 13, 2015
Device Names	Proprietary Name: Reprocessed Medline ReNewal Endopath 5-mmDiameter Endoscopic Instruments
Classification	878: General and plastic surgery devices21 CFR §878.4400 - electrosurgical cutting and coagulation device andaccessories. Class II, product code NUJ
PredicateDevice	K984240 Endopath Endoscopic Instruments manufactured by EthiconEndo-Surgery, Inc.
DeviceDescription	Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mmDiameter Endoscopic Instruments (originally manufactured by EthiconEndo-Surgery) are cleaned, refurbished, tested, inspected packaged,labeled, and sterilize for an additional clinical use.
Statement ofIntended Use	Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mmDiameter Endoscopic Instruments have application in a variety of minimallyinvasive procedures to facilitate grasping, mobilization, dissection andtransection of tissue.
TechnologicalCharacteristics	The technological characteristics and the scientific technology of thesubject devices are identical to the predicate devices listed in thissubmission. The proposed devices are a reprocessed version of thepredicate devices.
PerformanceTesting	The functional characteristics of the subject devices have been evaluatedand found to be equivalent to the predicate devices based on the followingtests:• Simulated use; grasping/pulling force;• Cutting effectiveness/functionality;• Device integrity;• Coagulation evaluation;• Cleaning;• Protein, carbohydrates, visual inspection (under magnification)Biocompatibility:• Cytotoxicity, sensitization, irritation, acute systemic toxicity andpyrogenicity• Functional performance validation;
•	Electrical safety in accordance with IEC 60601-1;
•	Electrical safety in accordance with IEC 60601-1-2;
•	Electrical safety in accordance with IEC 60601-2-2;
•	Thermal analysis characterization;
•	Sterilization validation; and
•	Product stability.
Conclusion	Based on comparisons of the indications for use, intended use.Technological characteristics and performance data to the predicate devices, Reprocessed Medline ReNewal Endopath 5-mm Diameter Endoscopic Instruments are substantially equivalent to the predicate devices.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image contains the logos for Medline and ReNewal. The Medline logo is on the left and consists of the word "MEDLINE" in a sans-serif font with a stylized blue symbol next to it. To the right of the Medline logo is the ReNewal logo, with the word "ReNewal" in a bold, two-tone green and blue font. Below "ReNewal" is the text "Full Circle Reprocessing" in a smaller, sans-serif font.

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.