(92 days)
The reprocessed fixation device is indicated for use with adults and pediatric patients and intended for fracture fixation (open and closed) fractures and disease generally resulting in joint contractures of loss of range and fractures requiring distraction; post-traumatic joint contracture which has resulted in loss of rantion; pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraor joint athrodosis, correction of segmental bony of soft tissues; and management of committed intra-articular fractures of the distal radius.
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) premarket notification for a Reprocessed External Fixation Device (K081342) by SterilMed, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with human subjects or an AI-based algorithm.
Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types for AI) are not applicable to this type of device and submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This submission does not provide a table with specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic device, nor does it report device performance in that way. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device (Smith & Nephew Jet-X® External Fixation System) through functional and safety testing.
| Acceptance Criterion (Demonstration of Equivalence) | Reported Device Performance |
|---|---|
| Functional Design (Principle of Operation) | The reprocessed external fixation device consists of standard bridge elements (rods, articulating and telescoping components) and connection elements (clamps) contained in the original manufacturer's system. Substantially equivalent to the Smith & Nephew Jet-X® external fixation devices based on similar functional design. |
| Materials | Some components are MR safe and made of non-magnetic materials, intended for use in the MR environment. No specific material differences from the predicate device that would impact equivalence are noted, implying comparable materials. |
| Indications for Use | The reprocessed device is indicated for use with adults and pediatric patients for fracture fixation, joint contractures, limb lengthening, joint arthrodesis, correction of segmental bony or soft tissues, and management of comminuted intra-articular fractures of the distal radius. These indications are stated to be equivalent to the predicate. |
| Methods of Construction | The conclusion of substantial equivalence is based on similarities in methods of construction. The document mentions process validation testing for cleaning and visual/validated functional testing of all products. |
| 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. Manufacturing process includes visual and validated functional testing of all produced products. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is not a study assessing diagnostic performance on a test set of data. The "test set" here refers to representative samples of the reprocessed physical devices used for functional and safety testing.
- The document states "Representative samples of reprocessed external fixation constructs were tested." The specific number of samples is not provided.
- Data Provenance: Not applicable in the context of data for an AI/diagnostic device. The "data" here refers to the results of physical device testing. The testing was conducted by SterilMed, Inc. (Maple Grove, MN, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission does not involve establishing ground truth from expert consensus for a diagnostic test. The testing involves physical properties and functionality of a medical device.
4. Adjudication method for the test set
- Not Applicable. No expert adjudication method is relevant for this type of device and submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a reprocessed external fixation device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- For Physical Device Testing: The "ground truth" for the functional and safety testing would be established by validated engineering specifications, performance standards, and comparisons against the original manufacturer's specifications and the predicate device's known performance characteristics. The document mentions "appropriate functional characteristics" and "validated functional testing."
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device.
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K081342 (pg 1/1)
II. SUMMARY AND CERTIFICATION
Contact Person:
- A. 510(k) Summary Submitter:
AUG 1 3 2008
| SterilMed, Inc. |
|---|
| Joshua Clarin |
| 11400 73rd Avenue North |
| Maple Grove, MN 55369 |
| Ph: 612-644-8402 |
| Fax: 763-488-3350 |
| Date Prepared: | May 12, 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 |
| Product Code: | KTT |
| PredicateDevices: | The reprocessed external fixation device is substantially equivalent to the Smith & Nephew Jet-X® 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: | The reprocessed fixation device is indicated for use with adults and pediatric patients andintended for fracture fixation (open and closed) fractures and disease generally resulting in jointcontractures or loss of range and fractures requiring distraction; post-traumatic joint contracturewhich has resulted in loss of range of motion; pseudoarthrosis or non-union of long bones; limblengthening by epiphyseal or metaphyseal distraction; joint arthrodesis; correction of segmentalbony or soft tissues; and management of comminuted intra-articular fractures of the distalradius. |
| 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 Smith &Nephew Jet-X® external fixation devices. |
| This conclusion is based upon the devices' similarities in functional design (principle ofoperation), materials, indications for use and methods of construction. |
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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 stylized eagle-like symbol with flowing lines, representing the department's mission of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SterilMed, Inc. % Mr. Joshua Clarin Sr. Regulatory Affairs Specialist 11400 73rd Avenue North Maple Grove, Minnesota 55369
AUG 1 3 2008
Re: K081342
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: II Product Code: KTT Dated: July 16, 2008 Received: July 18, 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 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. Joshua Clarin
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 entitled, "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 Assistances of at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millerson
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. The logo is in a bold, serif font. Below the company name, it says "Medical Device Reprocessing" and "Small Equipment & Instrument Repair" in a smaller, sans-serif font. The text is black and the background is white.
Indications for Use 510(k) Number (if known): |(081342 (pq | / | )
Device Name: Reprocessed External Fixation Device
Indications for Use:
The reprocessed fixation device is indicated for use with adults and pediatric patients and intended for fracture fixation (open and closed) fractures and disease generally resulting in joint contractures of loss of range and fractures requiring distraction; post-traumatic joint contracture which has resulted in loss of rantion; pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraor joint athrodosis, correction of segmental bony of soft tissues; and management of committed intra-articular fractures of the distal radius.
Prescription Use (Part 21 CFR 801 Subpart D)
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)
louise Brielund for MXM
(Division Sign Off)
Division of General, Restorative
Page 1 of 1
CONFIDENTIAL & PROPRIETARY INFORMATION OF STERRAMED MECULTO
AND/OR
Page 7 of 49
510(k) Number K081542
§ 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.