(294 days)
Not Found
Not Found
No
The summary describes a reprocessed surgical tool (arthroscopic shapers) and the reprocessing procedures. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies focus on functionality testing and sterility validation, not algorithmic performance.
No
Explanation: A therapeutic device is designed to treat a medical condition. This device is described as an accessory for shaping bone and soft tissue during arthroscopic procedures, which are surgical interventions, not treatments themselves. While it's used in a medical procedure, its function is mechanical shaping, not direct therapy.
No
These reprocessed arthroscopic shapers are used as accessories for shaping bone and soft tissue during arthroscopic procedures. Their function is to physically alter tissue, not to diagnose conditions.
No
The device described is a physical medical device (arthroscopic shapers) that undergoes reprocessing, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are "accessories intended for use in arthroscopic procedures" for "shaping bone and soft tissue." This describes a surgical tool used directly on the patient's body.
- Device Description: The description reinforces this by explaining they are used "during arthroscopic procedures" for "shaping bone and soft tissue."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The devices that are the subject of this submission are used as accessories for shaping bone and soft tissue during arthroscopic procedures. They have a variety of names, such as shavers, burs, or trimmers, are made of a variety of materials, and come in many shapes and sizes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, refurbishing, testing, packaging, and sterilization. It allows the shapers to be used several times rather than just once.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bone and soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Each arthroscopic shaper is tested for functionality as part of the reprocessing procedures. Validation of the sterility protocol was also included in the submission. Comparative performance testing and clinical evaluations were not included as part of this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The predicate device for each reprocessed arthroscopic shaper is the same single use shaper as provided by the original manufacturer.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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510(k) SUMMARY
Surgical Instruments Servicing & Savings, Inc. Submitter's name: 723 Curtis Court Sisters. OR 97759 (541) 549-4164
Date summary prepared: August 10, 2001
Device name:
| Proprietary name: | Reprocessed Arthroscopic Shapers |
|---|---|
| Common or usual name: | Various arthroscopic shapers, such as shavers, burs, and trimmers. |
| Classification name: | Arthroscope (888.1100). Arthroscope and accessories (87 HRX). |
Legally marketed device for substantial equivalence comparison:
The predicate device for each reprocessed arthroscopic shaper is the same single use shaper as provided by the original manufacturer.
Description of the device:
The devices that are the subject of this submission are used as accessories for shaping bone and soft tissue during arthroscopic procedures. They have a variety of names, such as shavers, burs, or trimmers, are made of a variety of materials, and come in many shapes and sizes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning, refurbishing, testing, packaging, and sterilization. It allows the shapers to be used several times rather than just once.
Intended use of device:
The reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures.
Technological characteristics:
The device features of the reprocessed arthroscopic shapers and the single use shapers are very similar. The materials, dimensions, and geometry of individual shapers are identical. Both products are provided sterile. The technical characteristics, method of use, and compatibility with arthroscopic systems are also identical. The only difference is that the original products are sold for single use, while the reprocessed products can be used several times.
Testing conducted:
Each arthroscopic shaper is tested for functionality as part of the reprocessing procedures. Validation of the sterility protocol was also included in the submission.
Performance testing:
Comparative performance testing and clinical evaluations were not included as part of this 510(k).
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SECTION 3- INTENDED USE
Intended use of device:
Reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures. Each shaper can accomplish certain kinds of cutting based on its geometry and the intended uses of the arthroscope for which it is an accessory. Some are used on bone and others on soft tissue. The shapers that are the subject of this submission are single use items that will be reprocessed, sterilized, and then reused.
Intended use of predicate device:
The predicate devices are arthroscopic shapers that are accessories to arthroscopes and are used in the procedures for which the arthroscope is cleared. Each shaper can do certain types of cutting depending on its geometry. Some are used on bone and others are used on soft tissue. The predicate devices are single use devices that are used and then discarded.
Comparison:
The general intended use for arthroscopic shapers and reprocessed arthroscopic shapers is the same. In addition, the specific uses are the same for each shaper, whether it is single use or reprocessed, because these uses are dictated by the geometry of the shaper. The single use and reprocessed shapers have the same geometry.
Labeling:
Both sets of products are generically called "Arthroscopic shapers" thereby describing their use. The Surgical Instruments Servicing & Savings, Inc. (SISS) products state clearly on the label that they have been reprocessed. Sample SISS labels can be found in Appendix III. Labeling for the predicate devices is not included in this submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Surgical Instruments Servicing & Savings, Inc. c/o Mr. Robert S. McQuate R.S. McQuate & Associates, Inc. 3636 E. Columbine Drive Phoenix, AZ 85032
JUN 0 3 2002
Re: K012667
Trade/Device Name: Reprocessed Arthroscopic Shapers Regulation Number: 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: March 4, 2002 Received: March 5, 2002
Dear Mr. McQuate:
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.
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. Robert S. McQuate .
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 vou 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 vours.
s Slipt Rhodes
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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Reprocessed Arthroscopic Shapers 510(k) Notification Page 3 .
Indications for Use Statement
510(k) Number (if known):
Device name: Reprocessed Arthroscopic Shapers
Indications for Use: The reprocessed arthroscopic shapers are accessories intended for use in arthroscopic procedures.
(Please do not write below this line)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K012667 |
| Prescription Use | |
| OR | Over-The-Counter Use |
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