Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.

Device Description

Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are sterile single use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. The Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are originally manufactured by OLYMPUS/Gyrus ACMI.

AI/ML Overview

This document is a 510(k) premarket notification for Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that defines and proves acceptance criteria for a novel device or AI algorithm.

Therefore, most of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment is not present in this document. This document primarily describes the regulatory process for reprocessed medical devices.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results. Instead, it states that "The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices after the specified number of reprocessing cycles." The "acceptance criteria" appear to be that the reprocessed blades perform equivalently to the new predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (in accordance with ISO 10993-1:2009)	Testing performed and results were acceptable.
Cleaning validation	Testing performed and results were acceptable.
Product stability	Testing performed and results were acceptable.
Product performance (bench tests, including device integrity)	Testing found devices equivalent to predicate after reprocessing.
Use and operation using simulated clinical use and artificial test soil	Testing found devices equivalent to predicate after reprocessing.
Blade sharpness	Testing found devices equivalent to predicate after reprocessing.
Irrigation function	Testing found devices equivalent to predicate after reprocessing.
Outflow function	Testing found devices equivalent to predicate after reprocessing.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the various tests (biocompatibility, cleaning validation, product stability, product performance). The data provenance is not mentioned, but given it's a 510(k) submission to the US FDA, the testing would typically be conducted to US regulatory standards. It would be considered prospective for the reprocessed device, as tests are conducted on the reprocessed products.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The testing described (biocompatibility, cleaning validation, bench tests for device function) does not typically involve "experts establishing ground truth" in the same way an AI algorithm for medical imaging would. It involves laboratory testing and comparison to manufacturing specifications or predicate device performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where consensus among multiple reviewers is needed to establish ground truth or evaluate performance. The tests described are laboratory-based and objective performance measurements.

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 and not provided. This device is a reprocessed surgical blade, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

This is not applicable. This device is a physical surgical tool and does not involve any algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the performance specifications of a new, original equipment manufacturer (OEM) device (the predicate device) and accepted industry standards (e.g., ISO 10993-1 for biocompatibility). The reprocessed device's performance is compared against these established benchmarks.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This is not applicable. There is no "training set."

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces overlapping to suggest community and support. The logo is presented in black and white.

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

December 18, 2014

Medline Renewal Mr. Richard D. Wynkoop Vice President Quality Assurance & Regulatory Affairs 2747 SW 6th Street Redmond, Oregon 97756

Re: K142022

Trade/Device Name: Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades Regulation Number: 21 CFR 874.4140 Regulation Name: Ear, nose, and throat bur Regulatory Class: Class I Product Code: NLY Dated: November 12, 2014 Received: November 17, 2014

Dear Mr. Wynkoop:

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

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

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 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/Resourcesfor You/Industry/default.htm. 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 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,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page 3 – Mr. Richard D. Wynkoop

List of models cleared in K142022:

7013-8000 Serrated Sinus Application Blade ●
7013-8001 Serrated Sinus Application Blade ●
7013-8002 Smooth, Round Tip Sinus Application Blade ●
7013-8003 Smooth, Square Tip Sinus Application Blade .
7013-8033 Serrated Sinus Application Blade ●
7013-8034 Turbinate Sinus Application Blade ●
7013-8035 Serrated Sinus Application Blade ●
7013-8100 Aggressive Sinus Application Blade ●

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

Indications for Use

510(k) Number (if known) K142022

Device Name

Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades

Indications for Use (Describe)

Medline ReNewal Reprocessed Gyus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 blue, with a blue star-like symbol to the right of it. 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.

K142022 Medline ReNewal Reprocessed Gyrus-Diego Sinus Application
K142022 Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades

5.0 510(k) Summary

Submitter/Owner	Medline ReNewal2747 SW 6th St.Redmond, OR 97756
Contact Names	Brandi PanteleonDirector, Regulatory AffairsP: 541-923-3310F: 541-923-3375E: bpanteleon@medline.com	Richard D. WynkoopVP, Quality Assurance & RegulatoryAffairsP: 541-923-3310F: 541-923-3375E: rwynkoop@medline.com
Date Prepared	December 15, 2014
Device Names	Proprietary Name: Medline ReNewal Reprocessed Gyrus-Diego SinusApplication BladesCommon Name: ear, nose, and throat shaver, reprocessed
Classification	§ 874.4140 - ear, nose, and throat burClass I, nonexemptProduct Code NLY
PredicateDevice	K020594 Sinus Application Blades of the Diego Powered Dissector andDrill System manufactured by OLYMPUS/Gyrus ACMI.
DeviceDescription	Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades aresterile single use devices that have been cleaned, disinfected, inspected,refurbished, tested, packaged, labeled, and sterilized. The MedlineReNewal Reprocessed Gyrus-Diego Sinus Application Blades are originallymanufactured by OLYMPUS/Gyrus ACMI.
Statement ofIntended Use	Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades aredesigned for use in limited sinus applications involving soft tissue and thinbone such as lamina papyracea.
TechnologicalCharacteristics	The technological characteristics of the proposed devices are substantiallyequivalent to the predicate devices listed in this submission. The proposeddevices are a reprocessed version of the predicate devices.
PerformanceTesting	The functional characteristics of the proposed devices have been evaluatedand found to be equivalent to the predicate devices after the specifiednumber of reprocessing cycles. Testing included:biocompatibility testing performed in accordance with ISO 10993-1:2009, cleaning validation, product stability, product performance (bench) tests included: device integrity, use and operation using simulated clinical use and artificial test soil,

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

Image /page/5/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.

K142022 Medline ReNewal Reprocessed Gyrus-Diego Sinus Application
K142022 Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades

	blade sharpness, irrigation function, and outflow function.
Conclusion	Based on comparisons of the indications for use, intended use, technological characteristics, and performance data to the predicate devices, Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are substantially equivalent to the predicate devices.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in large font, with "Re" in green and "newal" in blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font. To the left of the text is the Medline logo, which is a blue star-like shape with the word "MEDLINE" next to it.

	Predicate	Proposed	Comparison
DeviceCharacteristics	Sinus Application Blades of theDiego Powered Dissector and DrillSystem	Medline ReNewal ReprocessedGyrus-Diego Sinus ApplicationBlades	Same device; different manufacturer
Predicate 510(k)	K020594	TBD	N/A
Product Name	Gyrus-Diego Sinus ApplicationBlades	Reprocessed Gyrus-Diego SinusApplication Blades	N/A
Intended Use	Gyrus Sinus Application Blades areintended to be used with the poweredreusable hand piece of the PoweredDiego Dissector and Drill System andare designed for use in sinusapplications.	Medline ReNewal ReprocessedGyrus-Diego Sinus ApplicationBlades are intended to be used withthe powered reusable hand piece ofthe Powered Diego Dissector andDrill System and are designed foruse in sinus applications.	Same intended use
Indications forUse	Gyrus Sinus Application Blades aredesigned for use in sinusapplications. Sinus applicationsinclude ethmoidectomy/sphenoehtmoidectomy, polypectomy,septoplasty, transsphenoidalprocedures, and procedures such asthe removal of septal spurs,antrostomy, and endoscopicdacryocystorhinostomy (DCR).	Medline ReNewal ReprocessedGyrus-Diego Sinus ApplicationBlades are designed for use inlimited sinus applications involvingsoft tissue and thin bone such aslamina papyracea.	Only the sinus application bladesindicated for soft tissue and thin bonesuch as lamina papyracea will bereprocessed by Medline ReNewal. Thepredicate indications for use is for thewhole system, not just the sinusapplication blades. Thus, the MedlineReNewal Reprocessed Gyrus-DiegoSinus Application Blades have a morefocused indications for use than thepredicate system.
Configuration	Insertable blades for powereddissector and drill system	Insertable blades for powereddissector and drill system	Same configuration

Predicate and Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades device comparison chart. Table 1:

Regulation Number and Section

§ 874.4140 Ear, nose, and throat bur.

(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.