(16 days)
Not Found
No
The summary describes a mechanical external fixation device and its reprocessing, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is used for the "treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects," which are therapeutic applications.
No
The device description and intended use clearly state that external fixation devices are used for treatment and correction of fractures and deformities, not for diagnosis.
No
The device description explicitly lists various hardware components (frames, clamps, rods, pins, etc.) made of metal alloys, plastic, and composites, and the performance studies focus on bench and laboratory testing of these physical devices and their reprocessing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that this device is an external fixation device used for mechanical support and stabilization of bones in surgical procedures. It is applied directly to the patient's body and does not involve the analysis of biological specimens.
The information provided describes a surgical implant/device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Reprocessed External Fixation Devices are intended to be used for the fixation of supracondylar, or condylar fractures of the femur; for fusion of a joint; for surgical procedures that involve cutting the bone, for fixation of bone fractures; bone reconstruction; as a guide pin for insertion of other implants; or may be implanted through the skin so that a pulling force or traction may be applied to the skeletal system; and others may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Product codes (comma separated list FDA assigned to the subject device)
KTT, KTW, JEC
Device Description
External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices.
- Validation of reprocessing .
- Function Testing .
Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.
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
JUN 2 9 2005
KO515T4 p/2
PART B: 510(k) SUMMARY
- Alliance Medical Corporation Submitter: 10232 South 51st Street Phoenix, Arizona 85044 Moira Barton Contact: Regulatory Affairs Manager (480) 763-5300 (o) (480) 763-5310 (f)
June 11, 2003 Date of preparation:
Trade/Proprietary Name: Reprocessed External Fixation Name of device: Devices Common or Usual Name: External Fixation Devices, Fixation Appliance, Single/Multiple Component Classification Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories and Smooth or Threaded Metallic Bone Fixation Fastener
Predicate device(s):
Reprocessed Smith & Nephew® External Fixation K012634 Devices
- External fixation devices are specially designed frames, clamps, Device description: rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
- External Fixation Devices are intended to be used for the Intended use: fixation of supracondylar, or condylar fractures of the femur; for fusion of a joint; for surgical procedures that involve cutting the bone, for fixation of bone fractures; bone reconstruction; as a guide pin for insertion of other implants; or may be implanted through the skin so that a pulling force or traction may be applied to the skeletal system; and others may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
1
K051554 p²/₂
- Reprocessed external fixation devices are indicated for use in Indications patients requiring external skeletal fixation and treatment of statement: fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
- The design, materials, and intended use of the Reprocessed Technological External Fixation Devices are identical to the predicate devices. characteristics: The mechanism of action of the Reprocessed External Fixation Device is identical to the predicate devices in that the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. The only change is the modified external fixation devices will be provided non-sterile. Sterilization of the devices will occur in the hospital prior to use.
- Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of the Reprocessed External Fixation Devices.
- Validation of reprocessing .
- Function Testing .
Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.
- Alliance Medical Corporation concludes that the modified device Conclusion: (the Reprocessed External Fixation Device) is safe, effective and substantially equivalent to the predicate devices, as described herein.
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2005
Ms. Moira Barton Regulatory Affairs Manager Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K051554
Trade/Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices Regulation Numbers: 21 CFR 888.3030; 21 CFR 888.3040 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories; Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: KTT, KTW, JEC Dated: June 6, 2005 Received: June 13, 2005
Dear Ms. Barton:
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.
3
Page 2 - Ms. Moira Barton
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) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Stipt Rurdu
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement ll.
Image /page/4/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "K051554". The characters are written in a simple, clear style, making them easily readable. The string is underlined with a dark line.
Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices
Indications for Use: Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Image /page/4/Picture/4 description: The image shows the words "Prescription Use" followed by "(Part 21 CFR 801 Subpart D)". There is a symbol to the right of the text. The symbol is an X with a line underneath it.
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)
Stupt Surda
Division of General. Restorative. and Neurological Devices
510(k) Number K051554
Alliance Medical Corporation Modified Reprocessed External Fixation Devices Special 510(k)