(102 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects and reprocessing of external fixation devices, with no mention of AI or ML.
Yes
The device is used for the treatment of fractures, osteotomy, arthrodesis, correction of deformities, and other bone reconstruction procedures, which clearly indicates a therapeutic purpose.
No
The device description and intended use clearly state that it is for skeletal fixation and treatment of fractures and deformities, which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly lists various hardware components (frames, clamps, rods, pins, etc.) made of metal alloys, plastic, and composites, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, etc. These are all procedures performed directly on the patient's body to treat musculoskeletal conditions.
- Device Description: The device description details components like frames, clamps, rods, pins, and screws made of metal alloys, plastic, and composites. These are all physical components used to stabilize bones externally.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples or analysis of bodily fluids or tissues.
Therefore, this device falls under the category of a surgical or orthopedic device used for external fixation, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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
Skeletal system (bones). Specific indications mention supracondylar or condylar fractures of the femur.
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 Reprocessed External Fixation Devices. This included the following tests:
- Validation of reprocessing
- Sterilization Validation (for sterile devices)
- Function test(s)
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.
K021933, K875022, K875012, K910986
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
K052918 (pg 1 of 2)
JAN 27 2006
PART B: 510(k) SUMMARY
| Submitter: | Alliance Medical Corporation
10232 South 51st Street
Phoenix, Arizona 85044 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Moira Barton
Regulatory Affairs Manager
(480) 763-5300 (o)
(480) 763-5310 (f)
mbarton@alliance-medical.com |
| Date of preparation: | August 2, 2005 |
| Name of device: | Trade/Proprietary Name: Reprocessed External Fixation
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 | 510(k) Title | Manufacturer |
|---|---|---|
| K021933 | TempFix™ External Fixation System | |
| K875022 | TempFix™ External Fixation System, MR Safe | |
| K875012 | DePuy ACE AIM® Titanium Supracondylar Nail | |
| K910986 | Hoffmann Dynamic Wrist Fixator |
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.
Intended use: 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 pulling force (traction) may be applied to the skeletal system.
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K052918 (pg 2 of 2)
- Indications Reprocessed external fixation devices are indicated for use in statement: 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.
- Technological The design, materials, and intended use of the Reprocessed 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.
- Performance data: These devices will be provided sterile and non-sterile depending on customer preference.
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed External Fixation Devices. This included the following tests:
- Validation of reprocessing ●
- Sterilization Validation (for sterile devices) .
- . Function test(s)
Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.
- Conclusion: Alliance Medical Corporation concludes that the modified devices (Reprocessed External Fixation Device) are safe, effective, and substantially equivalent to the predicate devices as described herein.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized eagle with three lines representing its wings, and the eagle's head is facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2006
Ms. Moira Barton Manager, Regulatory Affairs Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K052918
Trade/Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices (See enclosed list) Regulation Number: 21 CFR 888.3030 and 21 CFR 888.3040 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories, Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: KTT, KTW, JEC Dated: December 21, 2005 Received: January 5, 2006
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, I'DA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination docs 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 - Ms. Barton
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) 276-0210. 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 vours.
Sincerely yours,
Barbara BuchmuD
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| System | Part | Description |
|---|---|---|
| Ace-Fisher® Fixator | ||
| System | FC-10027 | Composite 2/3 Ring, Small (6" diam.) |
| FC-10028 | Composite 1/3 Ring, Small (6" diam.) | |
| FC-10029 | Composite 2/3 Ring, Medium (8" diam.) | |
| FC-10030 | Composite 1/3 Ring, Medium (8" diam.) | |
| FC-10031 | Composite 2/3 Ring, Large (10" diam.) | |
| FC-10032 | Composite 1/3 Ring, Large (10" diam.) | |
| 8180-04-008 | Ring Foot Medium | |
| 8180-04-011 | Medium Foot Frame | |
| 8180-04-013 | Foot Frame Crossbar | |
| FA-10000-3 | Long Rod | |
| FA-10000-2 | Medium Rod | |
| FA-10000-1 | Short Rod | |
| FA-10000-0 | Extra Short Rod | |
| FA-10355 | 1 Pin Holder | |
| FA-10360 | 2 Pin Holder | |
| FA-10365 | 3 Pin Holder | |
| FA-10054-2 | 90° Pin Holder Adapter | |
| FF-10605 | 90° Adapter Rod | |
| FF-10023 | Ring Connector | |
| FF-10610 | Articulation | |
| Hoffman Classic | ||
| Sterile Wrist Kit | A13 | Articulation 8/8 mm |
| A14 | Articulation 8/5 mm | |
| A16 | Compression/Distraction Bar | |
| A18/150 | Connecting Rod 150mm | |
| A18/200 | Connecting Rod 200mm | |
| A18/250 | Connecting Rod 250mm | |
| A18/300 | Connecting Rod 300mm | |
| A18/350 | Connecting Rod 350mm | |
| A18/400 | Connecting Rod 400mm | |
| AC11 | Ball Joint w/ Rod | |
| AC10 | Ball Joint | |
| AC16 | Washer | |
| 8082-00-000 | Classic Sterile Wrist Kit | |
| (AMC does not reprocess the pins) |
Reprocessed External Fixation Device Models found to be Substantially Equivalent:
: :
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2. Indications for Use Statement
510(k) Number (if known): K052918
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 bory or soft tissue defects. ·
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tartian Meehim
(Division Sign-Of Division of General, Restorative, and Neurological Devices
Alliance Medical Corporation Reprocessed External Fixation Device Traditional 510(k)
510(k) Number K052918
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