Disposable Arthroscopy Surgery Blades are indicated for resection of soft and osseous tissues in large articular cavities, small articular cavities, and Functional Endoscopic Simus Surgery (FESS). The FESS application is limited to those small blades, which are appropriate for the procedure.

Device Description

The arthroscopic blade is composed of stainless steel tubing with plastic connectors. A small tube is fitted within a larger tube. The distal ends of the tubes are serrated and/or sharpened. The proximal end of each stainless steel tube is insertion molded into plastic connectors. The inner tube is fitted into the outer tube. The inner tube rotates within the outer tube and creates a scissor action that cuts soft tissue in the arthroscopy procedure. The assembled arthroscopic blade is connected to a power device that is adjusted by the clinician to rotate the inner tubing during use at the selected RPMs. Depending on the size and configuration of the device, the inner tube may be fitted with a plastic sheathing, or copper bearings, may be plated with an alloy such as nickel/tin and may be lubricated to facilitate rotation within the outer shaft. In addition the inner and outer tubes must be straight with no bends or kinks to ensure adequate rotation of the shafts during use. Burs must be absent from the cutting edges to prevent inadequate rotation and freezing up of the inner shaft during use.

AI/ML Overview

Reprocessed Arthroscopic Blade

Note: The provided text describes the regulatory submission for a reprocessed medical device, not an AI/ML powered device. Therefore, many standard AI/ML study components (like expert ground truth, MRMC studies, training set details) are not applicable and will be marked as "Not Applicable". The study focuses on demonstrating substantial equivalence through performance and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" are implied by showing the reprocessed device performs "equal to, or better than" the predicate device in specific tests.

Test	Acceptance Criteria (Implied: Equal to or better than predicate)	Reported Device Performance (Reprocessed device vs. Predicate)
Free-spin test	Must perform equal to or better than predicate	Performed equal to or better than predicate (specifically, replacement sheathing acts as a better friction barrier)
Cut-test	Must perform equal to or better than predicate	Performed equal to or better than predicate
Shed test	Must perform equal to or better than predicate	Performed equal to or better than predicate
TOC test	Must demonstrate substantial biocompatibility	Passed, demonstrating substantial biocompatibility
ETO residual test	Must demonstrate substantial biocompatibility	Passed, demonstrating substantial biocompatibility

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

The document does not explicitly state the sample sizes for each test (free-spin, cut, shed, TOC, ETO residual). It refers to "the reprocessed devices" and "predicate devices" generically.

Sample Size: Not explicitly stated for each test.
Data Provenance: Not explicitly stated, but the tests were performed by "MIT" (Medical Instruments Technology, Inc.), suggesting internal testing. The submission does not specify country of origin for test data, nor if it was retrospective or prospective, though it would logically be prospective testing conducted for this submission.

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

Not Applicable. This is not an AI/ML study involving human expert interpretation for ground truth. Performance was assessed through objective physical and chemical tests.

4. Adjudication Method for the Test Set

Not Applicable. This is not an AI/ML study involving human interpretation or adjudication. Test results would be quantitative measurements.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study was not done. This is a submission for a physical medical device, not an AI/ML diagnostic or assistive tool.

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

Yes, in the context of device performance. The tests (free-spin, cut, shed, TOC, ETO residual) were performed on the devices themselves to assess their inherent physical and chemical properties and performance, without human "in-the-loop" interpretation as would be relevant for an AI algorithm.

7. The Type of Ground Truth Used

Benchmark Performance: The ground truth for performance tests (free-spin, cut, shed) was based on the performance of the legally marketed predicate device (Dyonics Shavers K833587).
Established Standards: For biocompatibility tests (TOC, ETO residual), the ground truth would be established safety and biocompatibility standards and acceptable limits for residual ethylene oxide and total organic carbon.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML study; there is no "training set" in the conventional sense. The "training" for their reprocessing procedure would involve process development and validation, not a data-driven model.

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

Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for the reprocessing method itself would have been established through process validation studies to ensure consistent and effective reprocessing.

Summary

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Medical Instruments Technology, Inc's.

Reprocessed Arthroscopic Blade Premarket Notification

Medical Instruments Technology Inc.
NOV 0 8 2001	K012624

Quality Reprocessing and Surgical Cost Containment Systems

Section 12: 510(K) Summary

Name of Submitter

Medical Instruments Technology, Inc. 385 North 3050 East Saint George, UT 84790 Tel: (435) 674-4010 Fax: (435) 674-9819

Contact persons

Tom Haueter, RA/QA Manager Crystal Batcabe, Assistant RA/QA Manager

Summary Prepared August 10, 2001

Device Name and Classification

Common Name: Arthroscopic Instruments, Reprocessed Arthroscopic Instruments, Arthroscopic Shavers, Shavers, Arthroscopic Blades, Burs

Classification: Class II per 21CFR 888.1100

Predicate Device

MIT's reprocessed arthroscopic shavers are substantially equivalent to: Dyonics Shavers K833587

Description of Device

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Medical Instruments Technology, Inc's. Reprocessed Arthroscopic Blade Premarket Notification

arthroscopic blade from the surgical site.

Depending on the size and configuration of the device, the inner tube may be fitted with a plastic sheathing, or copper bearings, may be plated with an alloy such as nickel/tin and may be lubricated to facilitate rotation within the outer shaft. In addition the inner and outer tubes must be straight with no bends or kinks to ensure adequate rotation of the shafts during use. Burs must be absent from the cutting edges to prevent inadequate rotation and freezing up of the inner shaft during use.

Intended Use

MIT's mechanized reprocessing of arthroscopy blades does not change their intended use. The arthroscopy blades are inserted into hand pieces to allow cutting of soft tissue in arthroscopy procedures. The blades are designed for use in a range of surgical procedures. They are supplied sterile.

Technological Characteristics

MIT's reprocessed arthroscopic devices have the same technological characteristics as the predicate devices. MIT does not change any of the design characteristics or materials during reprocessing. The only material change, that MIT does make, is that of the sheathing. The sheathing is replaced, because the original sheathing would be damaged in the reprocessing procedures. The replacement sheathing is substantially equivalent to the original sheathing, and actually acts as a better friction barrier than the new sheathing (as shown in free-spin test.)

MIT has shown that the reprocessed shavers are substantially equivalent to the predicate devices by performance of the freespin test, the cut-test, and the shed test. Additionally, we have tested the device for substantial biocompatibility by performing the TOC test and the ETO residual test. In all tests, the reprocessed devices have been equal to, or better than, the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 82001

Mr. Jack Speer President Medical Instruments Technology, Inc. 385 North 3050 East Suite B St. George, Utah 84790

Re: K012624

Trade Name: Reprocessed Arthroscopic Blades Regulation Number: 888.1100 Regulation Name: Arthroscope and Accessories Regulatory Class: II Product Code: HRX Dated: August 10, 2001 Received: August 13, 2001

Dear Mr. Speer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 & Mr. Jack Speer

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Walker, ms

Image /page/3/Picture/5 description: The image shows a signature. The signature is in black ink and appears to be a stylized version of the letters 'fa'. The 'f' is formed with a large loop and a downward stroke, while the 'a' is smaller and connected to the 'f'. The signature has a simple, flowing design.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 0 82001

Page 4 of 5

510(k) Number (if known):	K012 624
Device Name:	Arthroscopy Blades

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lisa Walke

(Division Sign-Off) -(Division of General, Restorative and Neurological Devices

510(k) Number K012624

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.