(74 days)
Not Found
No
The document describes a reprocessed external fixation device, which is a mechanical system for stabilizing fractures. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making. The focus is on the physical components and their function.
Yes
The device is described as "reprocessed external fixation device" used for "stabilization of open and/or unstable fractures," which is a therapeutic purpose.
No
The device is an external fixation device used for stabilization of fractures, which is a treatment, not a diagnostic, function.
No
The device description clearly states it consists of physical components like rods, clamps, and other hardware elements used in external fixation frames. It is a reprocessed physical medical device, not software.
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 device is used for the "construction of an external fixation frame" to "provide stabilization of open and/or unstable fractures." This is a therapeutic and structural function, not a diagnostic one performed on in vitro samples.
- Device Description: The description details the components of an external fixation frame (rods, clamps, etc.). These are physical components used externally on the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in these samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, this device falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This reprocessed external fixation device is indicated for use in the construction of an external fixation frame. When used with sterile bone pins and Kirschner wires, this device is used to provide stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation
Product codes
KTT
Device Description
SterilMed's reprocessed external fixation devices consists of the standard bridge elements (rods, articulating and telescoping components), and connection elements (clamps) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Note: Only the non-patient contact, external frame elements are the subject of this submission, the anchorage pins and wire elements are not included in the scope of this submission
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of reprocessed external fixation constructs were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning procedure. In addition, the manufacturing process includes visual and validated functional testing of all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The reprocessed external fixation device is substantially equivalent to the Stryker Hoffman II® External Fixation System.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
SUMMARY AND CERTIFICATION II.
510(k) Summary A.
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Joshua Clarin |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Ph: 612-644-8402 | |
| Fax: 763-488-3350 | |
| Date Prepared: | June 3, 2008 |
| Trade Name: | Reprocessed External Fixation device |
| Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories. | |
| Classification Number: | Class II, 21 CFR 888.3030 |
KTT Product Code:
| Predicate
Devices: | The reprocessed external fixation device is substantially equivalent to the Stryker Hoffman II®
External Fixation System. | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device
Description: | SterilMed's reprocessed external fixation devices consists of the standard bridge elements
(rods, articulating and telescoping components), and connection elements (clamps) contained in
the original manufacturer's system. Some of the components are MR safe and made of non-
magnetic materials. MR safe components are intended for use in the MR environment.
Note: Only the non-patient contact, external frame elements are the subject of this submission,
the anchorage pins and wire elements are not included in the scope of this submission | |
| Intended Use: | This reprocessed external fixation device is indicated for use in the construction of an external
fixation frame. When used with sterile bone pins and Kirschner wires, this device is used to
provide stabilization of open and/or unstable fractures where soft tissue injury may preclude the
use of other fracture treatments such as IM rods, casts, or other means of internal fixation | |
| Functional and
Safety Testing: | Representative samples of reprocessed external fixation constructs were tested to demonstrate
appropriate functional characteristics. Process validation testing was performed to validate the
cleaning procedure. In addition, the manufacturing process includes visual and validated
functional testing of all products produced. | |
| Conclusion: | The Reprocessed External Fixation Devices are substantially equivalent to the Stryker Hoffman®
II external fixation devices. | |
| | This conclusion is based upon the devices' similarities in functional design (principle of
operation), materials, indications for use and methods of construction. | |
AUG 1 8 2008
1
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2008
SterilMed, Inc. % Mr. Joshua Clarin Sr. Regulatory Affairs Specialist 11400 73rd Avenue North Maple Grove, Minnesota 55369
Received: July 16, 2008
Re: K081586 Trade/Device Name: Reprocessed External Fixation Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: July 15, 2008
Dear Mr. Clarin:
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
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Page 2 – Mr. Joshua Clarin
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for SterilMed, INC. Underneath the company name, it says "Medical Device Reprocessing" and "Small Equipment & Instrument Repair". The logo is in black and white and has a simple design.
. . . . . .
Indications for Use
·
510(k) Number (if known): KÖS 1586
Device Name: Reprocessed External Fixation Device
Indications for Use:
This reprocessed external fixation device is indicated for use in the construction of an external fixation frame. When used with sterile bone pins and Kirschner wires, this device is used to provide stabilization of open and/or unstable fractures where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation
Prescription Use X (Part 21 CFR 801 Subpart D)
: 1
AND/OR
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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K081586 |
|---|---|
| --------------- | --------- |
Page 1 of 1CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.