(87 days)
Not Found
No
The device description focuses on mechanical components and operation, with no mention of AI, ML, or related concepts.
No
The device is described as a surgical tool used for resection of tissues, not for treating or curing a disease or condition. It is an instrument used during surgical procedures rather than a therapeutic device itself.
No
The device description indicates it is used for "resection of soft and osseous tissues," "cuts soft tissue," and connects to a "power device that is adjusted by the clinician to rotate the inner tubing." These actions are therapeutic (cutting/removing tissue) rather than diagnostic (identifying a condition).
No
The device description clearly details physical components made of stainless steel and plastic, and describes mechanical actions (rotation, cutting) and physical properties (straightness, absence of burs). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a surgical tool used for the resection of soft and osseous tissues within the body during arthroscopy and FESS procedures. It physically cuts tissue.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens outside of the body.
Therefore, this device falls under the category of a surgical instrument used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"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."
Product codes
HRX
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. The 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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
"large articular cavities, small articular cavities, and Functional Endoscopic Simus"
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"clinician"
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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. The
1
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.
2
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.
3
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:
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.
(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)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)