The FMS Blades and Burrs are an accessory to the FMS Fluid Management Systems. FMS Blades and Burrs are intended to provide controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery.

Device Description

OMNICUT Blades are used with FMS™ Handpieces and Fluid Management Systems during arthroscopic surgery. OMNICUT Blades consist of stainless steel outer tube and a rotating inner tube connected to an inner and outer plastic hubs. Distal tips of the tubes contain sharp edges to facilitate the cutting.

AI/ML Overview

The provided document is a 510(k) summary for the OMNICUT™ Resection Blade, which is a medical device for arthroscopic surgery. This type of submission focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic performance (which would be expected for an AI/ML diagnostic device). Therefore, many of the requested categories related to AI/ML device studies (like "multi-reader multi-case study," "standalone performance," "training set size," and "ground truth establishment" via experts) are not applicable to this submission.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance for OMNICUT™ Resection Blade

This 510(k) summary proposes the OMNICUT™ Resection Blade to be substantially equivalent to predicate devices for use in arthroscopic surgery. The "acceptance criteria" here are based on comparative performance to predicate devices in pre-clinical tests, rather than diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Predicate Device Performance / Equivalence Accepted Criteria	Reported OMNICUT™ Device Performance
Soft Tissue Cutting	Performance equivalent to the K953695 predicate device (Dyonics Disposable Arthroscopic Blades - Full Radius Bonecutter blade).	Passed soft tissue cutting comparison tests and showed equivalent performance to the K953695 predicate.
Bone Cutting	Performance equivalent to the K953695 predicate device (Dyonics Disposable Arthroscopic Blades - Full Radius Bonecutter blade).	Passed bone cutting comparison tests and showed equivalent performance to the K953695 predicate.
Blade Particulate Generation (Shed Testing)	Particulate generation equivalent to the K953695 predicate device (Dyonics Disposable Arthroscopic Blades - Full Radius Bonecutter blade).	Passed blade shed testing comparison and showed equivalent performance to the K953695 predicate.
Suitability for Intended Use	Demonstrates suitability for controlled cutting, burring, shaving, and abrading of bone and tissue for use in arthroscopic surgery, consistent with predicate devices.	The OMNICUT blades passed all tests and demonstrated equivalent performance, indicating suitability for their intended use. The proposed devices are similar in intended use, design, and materials to the predicate devices, with modifications to the cutting window and lubrication status.

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

The document does not explicitly state the specific "sample size" for each test (e.g., number of blades tested, number of tissue samples). It refers to "Design verification activities" which implies a set of tests were performed. The data provenance is pre-clinical bench testing, likely conducted internally by the manufacturer (DePuy Mitek) or a contracted lab. The country of origin of the data is not specified but is implicitly associated with the submitter's location (Raynham, MA, USA). The studies are explicitly described as "Nonclinical Testing" and "preclinical studies."

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

Not applicable. This device is an arthroscopic blade, and the testing involves objective physical performance criteria (cutting efficiency, particulate generation), not a diagnostic assessment requiring expert interpretation or "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective pre-clinical measurements, not subjective evaluations requiring adjudication.

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

No. This document describes a 510(k) for a physical surgical tool, not an AI/ML diagnostic algorithm, so an MRMC comparative effectiveness study is not relevant or included.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the OMNICUT™ blade, the "ground truth" for the nonclinical testing is established by objective measurements against specified performance metrics (e.g., efficacy of cutting soft tissue/bone, amount of particulate generated). The predicate device performance serves as the benchmark against which the OMNICUT™ blade's performance is compared for demonstrating equivalence. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for a diagnostic device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set or ground truth for such a set.

Summary

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K130912 Page 1 of 2

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510(k) SUMMARY

JUN 1 4 2013

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Submitter'sName andAddress	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Tatyana KorsunskyRegulatory Affairs SpecialistDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-828-3122Facsimile: 508-977-6911e-mail: tkorsuns@its.jnj.com
Name ofMedical Device	Proprietary Name: OMNICUT™ Resection BladeCommon Name: Blade
SubstantialEquivalenceFacility	The OMNICUT™ blades are substantially equivalent to:K953695: Dyonics Disposable Arthroscopic Blades (Full Radius Bonecutter blade) K954465: FMS DUO® pump and shaver system (FMS blades) K041824: FMS NeXtra™ arthroscopic pump and shaver system (FMS blades)
DeviceClassification	Classification Name: ArthroscopeClassification Number: 21 CFR 888.1100 Class IIProduct Code: HRX
DeviceDescription	OMNICUT Blades are used with FMS™ Handpieces and Fluid Management Systemsduring arthroscopic surgery. OMNICUT Blades consist of stainless steel outer tubeand a rotating inner tube connected to an inner and outer plastic hubs. Distal tips ofthe tubes contain sharp edges to facilitate the cutting.
Indications forUse	The FMS Blades and Burrs are an accessory to the FMS Fluid Management Systems.FMS Blades and Burrs are intended to provide controlled cutting, burring, shavingand abrading of bone and tissue for use in arthroscopic surgery.
NonclinicalTesting	Design verification activities, such as soft tissue and bone tissue removal, as well asblade particulate generation testing, were performed on OMNICUT blades and theirpredicate devices.
Safety andPerformance	While there are no required tests for arthroscopy blades, the followingpreclinical studies were submitted to demonstrate substantial equivalence:Blade soft tissue cutting comparison with K953695 predicate. Blade bone cutting comparison with K953695 predicate. Blade shed testing comparison with K953695 predicate. The OMNICUT blades passed all tests and showed equivalent performance.

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Results of performance and safety testing have demonstrated that the proposed devices are suitable for their intended use. Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed OMNICUT Blades have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Comparison to The proposed OMNICUT Blades have the same intended use and are similar in the predicate design and materials to the predicate Smith & Nephew's Full Radius Bonecutter devices blades (K953695) and Mitek's FMS blades (K954465/ K041824). However, the proposed OMNICUT blades have a modified cutting window configuration and are provided lubricated. The proposed OMNICUT device can cut both bone and soft tissue, similar to a predicate Smith & Nephew's Full Radius Bonecutter blade.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

June 14, 2013

DePuy Mitek % Ms. Tatyana Korsunsky Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

Re: K130912

Trade/Device Name: OMNICUT Resection Blade Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: April 11, 2013 Received: April 12, 2013

Dear Ms. Korsunsky:

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

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Page 2 - Ms. Tatyana Korsunsky

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely vours. FOR

Peter Dinkumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation. Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K130912

Device Name: OMNICUT® Resection Blade

Indications for Use: The FMS Blades and Burrs are an accessory to the FMS Fluid Management Systems. FMS Blades and Burrs are intended to provide controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery.

Prescription Use	AND/OR
↓

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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DSD—DIVISION SIGN-OFF	Joshua C.
Division of Surgical Devices	Nipper-S
510(k) Number:	K130912

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.