(28 days)
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.
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.
The provided text describes a 510(k) premarket notification for "Alliance Medical Corporation Reprocessed External Fixation Devices." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics for a novel device.
Therefore, many of the requested elements for a detailed study description are not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text, addressing what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating that the reprocessed devices "perform as originally intended" and are "safe and effective and substantially equivalent" to the predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Performance as "originally intended" (i.e., equivalent to new) | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Safety and Effectiveness (equivalent to predicate) | Alliance Medical Corporation concludes that the modified device (the Reprocessed External Fixation Device) is safe, effective and substantially equivalent to the predicate devices. |
| Reprocessing Validation | Validation of reprocessing performed. |
| Functionality | Function Testing performed. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the performance testing of the reprocessed devices. Details on data provenance (e.g., country of origin, retrospective/prospective) are also not provided. It is implied that the testing was conducted internally as part of the reprocessing validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not available in the provided text. The document refers to "bench and laboratory testing" rather than clinical expert evaluation for ground truth.
4. Adjudication Method for the Test Set:
Not applicable. The performance data described is based on bench and laboratory testing, not human-read interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through bench and laboratory testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a medical device (external fixation devices), not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance was established through bench and laboratory testing. This would involve comparing the mechanical and material properties and functional performance of the reprocessed devices against the specifications and expected performance of new, equivalent devices (the predicate).
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of reprocessed physical medical devices as described here. This concept is relevant for AI/ML models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
JUL 3 0 2003
Alliance Medical Corporation
3d058
page 1 of 2
PART B: 510(k) SUMMARY
| Submitter: | 10232 South 51 st StreetPhoenix, Arizona 85044 |
|---|---|
| Contact: | Moira BartonRegulatory Affairs Manager(480) 763-5300 (o)(480) 763-5310 (f)mbarton@alliance-medical.com |
| Date of preparation: | June 11, 2003 |
| Name of device: | Trade/Proprietary Name: Reprocessed External Fixation DevicesCommon or Usual Name: External Fixation Devices, Fixation Appliance, Single/Multiple ComponentClassification Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories and Smooth or Threaded Metallic Bone Fixation Fastener |
| Predicate device(s): | K012623 Reprocessed Synthes® External Fixation Devices |
| 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 |
Submitter:
s, sockets, connecting bars 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}------------------------------------------------
page 2 of 2
- Reprocessed external fixation devices are indicated for use in Indications 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. 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.
- Performance data: 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.
- Conclusion: Alliance Medical Corporation concludes that the modified device (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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized design of an abstract human figure with three wavy lines extending from the figure's head. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2003
Ms. Moira Barton Regulatory Affairs Manager Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K032058
Trade/Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: June 30, 2003 Received: July 2, 2003
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 (301) 594-4659. 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 yours,
Mark A. Milliman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
3wo58
Indications for Use Statement ll.
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.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milken
(Division Sign-Off) Division of General, Restorative and Neurological Devices
03 205 8 510(k) Number -
Prescription Use (per 21 CFR 801.109) Over-the-Counter Use
§ 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.