(87 days)
Not Found
No
The device description and performance studies focus on the mechanical function and reprocessing of surgical accessories, with no mention of AI or ML.
No
The device is described as surgical instruments used for cutting tissue and bone during arthroscopic procedures and FESS. These are tools used during a surgical procedure, not devices that provide therapy themselves.
No
The device description clearly states its purpose is for "resection of soft, osseous and cartilaginous tissue, and bone" during arthroscopic procedures and FESS, which are surgical interventions, not diagnostic processes.
No
The device description explicitly states that the device consists of "surgical instruments" which are physical accessories with rotating blades. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "operative large and small Joint arthroscopic procedures and Functional Endoscopic Sinus Surgery (FESS)" and is indicated for "resection of soft, osseous and cartilaginous tissue, and bone". This describes a surgical instrument used in vivo (within the body) for a therapeutic or diagnostic procedure performed directly on the patient.
- Device Description: The description details surgical instruments with rotating blades used for cutting tissue and bone. This aligns with a surgical tool, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (like blood, urine, tissue samples) to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is designed to be used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
Reprocessed powered arthroscopic accessories are intended for use in operative large and small Joint arthroscopic procedures and Functional Endoscopic Sinus Surgery (FESS). These accessories are indicated for resection of soft, osseous and cartilaginous tissue, and bone in large and small articular cavities and FESS.
Product codes
HRX
Device Description
SterilMed's reprocessed powered arthroscopic accessories consist of surgical instruments which run at variable speeds and are used for cutting soft tissue, cartilage and bone. These accessories are straight or angled, and have rotating blades that are used with irrigation and suction. Their diameters range from 2.0 to 6.0 mm and come in burr, shaver, and cutter designs. These accessories are designed to run in conjunction with a control console, motor drive unit, foot or hand switch, and a suction /irrigation system under endoscopic/video visualization. However, this submission only pertains to the accessories and not the other system components, such as the control console or motor drive unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large and small joint, small articular cavities, Sinus
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
Representative samples of reprocessed powered arthroscopic accessories underwent bench testing to demonstrate substantially equivalent functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
SECTION 2. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | NOV 0 2 2001
SterilMed, Inc. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick Fleischhacker
11400 73 rd Avenue North
Minneapolis, MN 55369
Ph: 888-856-4870
Fax: 763-488-3350 |
| Date Prepared: | August 6, 2001 |
| Trade Name: | SterilMed Reprocessed Powered Arthroscopic Accessories |
| Classification Name
and Number: | Arthroscope, Class II, 21 CFR 888.1100 |
| Product Code: | HRX |
| Predicate Device(s): | The reprocessed powered arthroscopic accessories are
substantially equivalent to:
The powered arthroscopic accessories included in the
Linvatec Universal Drive System (K971059);The Smith & Nephew Dyonics Disposable Endoscopic
Surgery Blades (K970511);The Smith & Nephew Dyonics Disposable
Arthroscopic Blades (K953695); andTheir counterparts from the original manufacturers. |
| Device Description: | SterilMed's reprocessed powered arthroscopic accessories
consist of surgical instruments which run at variable speeds
and are used for cutting soft tissue, cartilage and bone.
These accessories are straight or angled, and have rotating
blades that are used with irrigation and suction. Their
diameters range from 2.0 to 6.0 mm and come in burr,
shaver, and cutter designs. These accessories are designed
to run in conjunction with a control console, motor drive
unit, foot or hand switch, and a suction /irrigation system
under endoscopic/video visualization. However, this
submission only pertains to the accessories and not the
other system components, such as the control console or
motor drive unit. |
1
Reprocessed powered arthroscopic accessories are intended Intended Use: for use in operative large and small joint arthroscopic procedures and Functional Endoscopic Sinus Surgery (FESS). These accessories are indicated for resection of soft, osseous and cartilaginous tissue, and bone in large and small articular cavities and FESS.
Representative samples of reprocessed powered Safety Testing: arthroscopic accessories underwent bench testing to demonstrate substantially equivalent functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
The powered arthroscopic accessories reprocessed by Conclusion: SterilMed are substantially equivalent to the powered arthroscopic accessories included in the Linvatec Universal Drive System (K971059), the Smith & Nephew Dyonics Disposable Endoscopic Surgery Blades (K970511), the Smith & Nephew Dyonics Disposable Arthroscopic Blades (K953695), and their counterparts from the original manufacturers. This conclusion is based upon the fact that these devices' are essentially identical to their predicate devices in terms of functional design, materials, indications for use, and principles of operation.
Functional and
Premarket Notification
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a person embracing another, or a bird in flight. The symbol is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 2 2001
Mr. Patrick Fleischhacker Vice President Regulatory and Quality Control SterilMed, Inc. 11400 73rd Avenue North Minneapolis, Minnesota 55369
Re: K012536
K012530
Trade/Device Name: SterilMed Reprocessed Powered Arthroscopic Accessories Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: August 6, 2001 Received: August 7, 2001
Dear Mr. Fleischhacker:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section >10(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars manned to the Medical Device Amendments, or to commerce prior to May 26, 1776, the enacenture with the provisions of the Federal Food. Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that to hot require subject to the general controls provisions of the Act. The Act. The You may, therefore, market the dovice, belyer to the most
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the 110 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 ( If your device is classified (see above) the exist on a consequentions affecting your device can
may be subject to such additional controls. Existing major and the collected this be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Regarities in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuation of a backed complies with other requirements of the Act
that FDA has made a determination that your device complies with on anyat that I DA has made a determination administered by other Federal agencies. You must or any regeral statutes and regulations annualing, but not limited to: registration and listing (21 Comply with an the 71et 31equirements, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFRT art 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Patrick Fleischhacker
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with anow you to begin mainting of substantial equivalence of your device to a legally prematicated 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 IT you desire specific authoritor for your witto diagnostic devices), please contact the Office of additionally 21 CHT Fur 007.10 for questions on the promotion and advertising of Compination at (301) 591-1899 - 1854 - 15 - 15 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - - 1 - - - - - - - - - - - - - - - - - - - - - - - - your do roo, prodo combronding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general information on your responsional 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, m
Image /page/3/Picture/5 description: The image shows a close-up of a handwritten letter. The letter is written in black ink on white paper. The handwriting is cursive and appears to be a signature. The signature is illegible.
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
4
NOV 0 2 2001
Indications for use Page
Device Name: Reprocessed Powered Arthroscopic Accessories
Indications for Use:
Reprocessed powered arthroscopic accessories are intended for use in operative large and Reprocessed powered antinoscopic accessors and Functional Endoscopic Sinus Surgery (FESS). small Joint arthroscopic procedures and I and Laster in
These accessories are indicated for resection of soft, osseous and cartilaginous tissue, and These accessorres are large and articular cavities and FESS.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Walker
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012536
Premarket Notification