(41 days)
Not Found
No
The summary describes a mechanical external fixation system with no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes
The device is used for "reconstruction and corrections of bone segments of the human body" and "progressive realignment of the knee," which are therapeutic interventions.
No
The device is an external fixation system used for reconstruction and progressive realignment of bone segments, specifically for the knee after tibial osteotomy. It does not perform any diagnostic function.
No
The device description explicitly states it has multiple components of metallic bone fixation appliances and accessories, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "reconstruction and corrections of bone segments of the human body" and "progressive realignment of the knee." This describes a surgical device used on the body, not a device used to examine specimens from the body.
- Device Description: The description details metallic bone fixation appliances and accessories used for external fixation and osteotomy. This is consistent with a surgical implant/device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), performing tests in vitro (in a lab setting), or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The PTA (Progressive Tibial Alignment) external fixation system is a modular system with the components of: joints, bars, clamps or screws. Such components form a device indicated for reconstruction and corrections of bone segments of the human body.
The PTA is for progressive realignment of the knee.
Product codes (comma separated list FDA assigned to the subject device)
LXT, HWC
Device Description
The PTA has multiple components of metallic bone fixation appliances and accessories. It is designed for a progressive correction of the lower limb using tibial osteotomy. This device is composed of a main section of a bar and proximal distraction unit upon which are connected the clamps and grasping components. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316 LVM, ISO 5832-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone segments of the human body, knee
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)
Not Found
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.
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
5. 510(k) Summary
MAR 2 8 2006
MERIDIAN MEDICAL
1 30 : Avocado Avenos. Suite 220 Newport Beach CA 92660
| Submitter's name: | Meridian Medical |
|---|---|
| Address: | 1303 Avocado Ave., Suite 220 |
| Newport Beach, CA 92660 | |
| Phone: | 949-718-9220 |
| Fax number: | 949-718-9234 |
Name of contact person: Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821 grace@regulatoryspecialists.com
Date the summary was prepared: February 10, 2006
| Name of the device: | PTA (Progressive Tibial Alignment) |
|---|---|
| Trade or proprietary name: | PTA (Progressive Tibial Alignment) |
| Common or usual name: | External fixation system |
| Classification name: | Smooth or threaded metallic bone fixation fastener (per 21 CFR section 888.3040) |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
| K# | Device Name | Applicant |
|---|---|---|
| K032427 | FEP | Meridian Medical |
1
Description of the device:
The PTA has multiple components of metallic bone fixation appliances and accessories. It is designed for a progressive correction of the lower limb using tibial osteotomy. This device is composed of a main section of a bar and proximal distraction unit upon which are connected the clamps and grasping components. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316 LVM, ISO 5832-1.
Intended use of the device:
The PTA is for progressive realignment of the knee.
Summary of the technological characteristics of our device compared to the predicate device:
As can be seen in the Comparison section, the Meridian Medical devices and the FEP device have similar technological characteristics, the same design and materials and are equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wings, representing health, human services, and the department's commitment to serving the nation. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2006
Meridian Medical c/o Regulatory Specialists, Inc. Ms. Grace Holland 3722 Avenue Sausalito Irvine, California 92606
Re: K060403
Trade/Device Name: PTA (Progressive Tibial Alignment) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT, HWC Dated: February 10, 2006 Received: February 15, 2006
Dear Ms. Holland:
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
3
Page 2 - Ms. Gracc Holland
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. 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Herbert Lemon us
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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4. Indications for Use Statement Indications for Use
510(k) Number (if known):
Device Name: ____PTA (Progressive Tibial Alignment)
Indications for Use:
The PTA (Progressive Tibial Alignment) external fixation system is a modular system with the components of: joints, bars, clamps or screws. Such components form a device indicated for reconstruction and corrections of bone segments of the human body.
The PTA is for progressive realignment of the knee.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ullul
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Division of General, Restorative, and Neurological Devices
510(k) Number K060403