(92 days)
Not Found
Not Found
No
The summary describes a reprocessed external fixation device and its intended use, focusing on mechanical components and reprocessing procedures. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is described as a "reprocessed fixation device" intended for "fracture fixation" and addressing conditions like "joint contractures," "pseudoarthrosis or non-union of long bones," and "limb lengthening." These are therapeutic interventions designed to treat or alleviate a disease or condition.
No
The device is a fixation device intended for fracture fixation and limb lengthening, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like rods, clamps, and other bridge elements, which are hardware. The submission is for reprocessed external fixation devices, which are physical medical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for fracture fixation, joint contracture correction, limb lengthening, and joint arthrodesis. These are all procedures performed on the patient's body to treat musculoskeletal conditions.
- Device Description: The device is described as an external fixation device consisting of rods, clamps, and other components that form a frame outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant/external support used directly on the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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
adults and pediatric patients
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): 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.
Not Found
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
§ 888.3030 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
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 |
| Predicate
| Devices: | The reprocessed external fixation device is substantially equivalent to the Smith & Nephew Jet-X® 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: | 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 or loss of range and fractures requiring distraction; post-traumatic joint contracture | |
| which has resulted in loss of range of motion; pseudoarthrosis or non-union of long bones; limb | |
| lengthening by epiphyseal or metaphyseal distraction; joint arthrodesis; correction of segmental | |
| bony or soft tissues; and management of comminuted intra-articular fractures of the distal | |
| radius. | |
| 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 Smith & |
| Nephew Jet-X® 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. |
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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.
2
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