(74 days)
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
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
The provided text describes a 510(k) submission for a Reprocessed External Fixation Device by SterilMed, Inc. It claims substantial equivalence to the Stryker Hoffman II® External Fixation System.
However, the document does not contain the kind of detailed information requested about acceptance criteria and a study proving device performance in the context of diagnostic accuracy, which is typical for AI/ML devices or those with measurable performance metrics (e.g., sensitivity, specificity, AUC).
Instead, this submission focuses on the performance claims related to a reprocessed medical device, where the "performance" is more about functional integrity, sterility, and safety after reprocessing, rather than a diagnostic accuracy metric.
Here's a breakdown of what can be extracted based on the nature of this submission, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a reprocessed device, the "acceptance criteria" and "performance" are framed around maintaining the original device's functionality and safety after reprocessing. There are no specific numerical metrics like accuracy, sensitivity, or specificity.
| Aspect of Performance/Criteria | Reported Device Performance |
|---|---|
| Functional Characteristics | Representative samples of reprocessed external fixation constructs were tested to demonstrate appropriate functional characteristics. |
| Cleaning Procedure | Process validation testing was performed to validate the cleaning procedure. |
| Manufacturing Process Quality | The manufacturing process includes visual and validated functional testing of all products produced. |
| Substantial Equivalence | The Reprocessed External Fixation Devices are substantially equivalent to the Stryker Hoffman® II external fixation devices in functional design (principle of operation), materials, indications for use and methods of construction. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Representative samples" were used for functional testing and cleaning procedure validation. Specific numbers are not provided in this summary.
- Data Provenance: Not applicable in the context of data origin (e.g., country) as this pertains to the testing of the reprocessed physical device itself, not data collected from patients or diverse populations. The testing would have been conducted by SterilMed, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not present in the document. For device reprocessing, the "ground truth" would be established by validated engineering and quality control standards, rather than expert interpretation of medical images or patient data.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. Adjudication methods (like 2+1, 3+1) are typically used when human interpretation or consensus is required to establish ground truth for a diagnostic device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. This type of study is relevant for comparing diagnostic performance (e.g., of an AI system vs. human readers) and is not applicable to the reprocessing of a surgical fixation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not an algorithm or AI device. Hence, a standalone performance study in that context is not applicable.
7. The Type of Ground Truth Used
- The "ground truth" for this device would be established by engineering specifications, regulatory standards, and validated testing protocols to ensure the reprocessed device meets the functional and safety requirements of the original device and regulatory guidelines for reprocessing. This is based on physical and mechanical testing, not expert consensus on medical cases, pathology, or outcomes data in the usual sense for diagnostic devices.
8. The Sample Size for the Training Set
- Not applicable. There is no AI/ML algorithm requiring a training set mentioned in this document.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI/ML algorithm.
Conclusion on Document Suitability:
The provided document is a 510(k) summary for a reprocessed medical device. The information requested in points 2 through 9 (and parts of point 1) is typically relevant for evaluating diagnostic devices, especially those incorporating Artificial Intelligence or Machine Learning, which rely on large datasets, expert ground truth, and statistical performance metrics (e.g., sensitivity, specificity, ROC analysis). This document does not pertain to such a device, and therefore, most of the requested details are not present or applicable.
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SUMMARY AND CERTIFICATION II.
510(k) Summary A.
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Joshua Clarin11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 612-644-8402Fax: 763-488-3350 |
| Date Prepared: | June 3, 2008 |
| Trade Name: | Reprocessed External Fixation device |
| Classification Name: | Single/multiple component metallic bone fixation appliances andaccessories. |
| Classification Number: | Class II, 21 CFR 888.3030 |
KTT Product Code:
| PredicateDevices: | The reprocessed external fixation device is substantially equivalent to the Stryker Hoffman II®External Fixation System. | |
|---|---|---|
| DeviceDescription: | SterilMed's reprocessed external fixation devices consists of the standard bridge elements(rods, articulating and telescoping components), and connection elements (clamps) contained inthe 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 externalfixation frame. When used with sterile bone pins and Kirschner wires, this device is used toprovide stabilization of open and/or unstable fractures where soft tissue injury may preclude theuse of other fracture treatments such as IM rods, casts, or other means of internal fixation | |
| Functional andSafety Testing: | Representative samples of reprocessed external fixation constructs were tested to demonstrateappropriate functional characteristics. Process validation testing was performed to validate thecleaning procedure. In addition, the manufacturing process includes visual and validatedfunctional 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 ofoperation), materials, indications for use and methods of construction. |
AUG 1 8 2008
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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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. . . . . .
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.
§ 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.