(24 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 a reprocessed medical device, specifically "Reprocessed External Fixation Devices."
For such devices, the "acceptance criteria" and "study" typically focus on demonstrating that the reprocessed device performs equivalently to the original, new device and the predicate device, especially after the reprocessing procedures (cleaning, disinfection/sterilization, functional testing).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance and Evidence |
|---|---|---|
| Functional Equivalence | Reprocessed devices must perform functionally as originally intended, comparable to new devices and predicate devices. | "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.""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.""Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices." |
| Material/Design Identity | Materials, design, shapes, and sizes of the reprocessed devices must remain identical to the original and predicate devices. | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices." |
| Intended Use Identity | The intended use and indications for use of the reprocessed devices must be identical to the original and predicate devices. | "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 quide 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.""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." (Note: this is a change in sterilization delivery, not intended use). |
| Safety and Effectiveness | The reprocessed devices must be safe and effective for their intended use. | "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices.""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." |
| No change in claims | There should be no changes to claims, clinical applications, patient population, or performance specifications. | "There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| Reprocessing Validation | The reprocessing procedures themselves must be validated to ensure the device performs as intended after reprocessing. | "Validation of reprocessing Function Testing" (This implicitly means the reprocessing process was validated such that the device maintains its function). |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices." and "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended."
- Sample Size: The specific sample size for the "bench and laboratory testing" is not explicitly mentioned in the provided text.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's pre-market testing for a reprocessed device, it would be prospective testing conducted by Alliance Medical Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable to this type of submission. For medical devices like reprocessed External Fixation Devices, the "ground truth" is typically defined by engineering specifications, material properties, and mechanical performance standards, not by expert clinical consensus on diagnostic accuracy. The testing involves physical and mechanical properties, not interpretation of clinical data by experts.
4. Adjudication Method for the Test Set
- This information is not applicable to this type of submission. Adjudication methods (like 2+1, 3+1) are used when establishing ground truth from multiple expert readings of diagnostic images or clinical assessments. For mechanical performance testing of a device, the results are typically quantitative measurements against predefined specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) and their performance with and without AI assistance is compared. This submission is for a reprocessed surgical implant (external fixation device), not a diagnostic tool requiring human interpretation of data where AI assistance would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For this device, the "ground truth" for performance testing is generally based on mechanical and material specifications derived from the original device design, relevant ASTM/ISO standards, and engineering performance requirements for external fixation devices. It involves quantifiable measurements of properties like strength, fatigue resistance, torsional stability, and material integrity, ensuring they meet the same standards as new, original devices. It's not based on expert consensus, pathology, or outcomes data in the traditional sense, but rather established engineering benchmarks.
8. The Sample Size for the Training Set
- Not applicable. As this is a physical reprocessed medical device, there is no "training set" in the context of machine learning. The "training" for the reprocessing process would involve establishing and validating specific cleaning, disinfection, and functional testing protocols based on engineering principles and regulatory guidelines.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As mentioned above, there's no "training set" in the AI/ML sense. The "ground truth" for the reprocessing process (which ensures the device meets performance criteria post-reprocessing) is established through rigorous validation protocols that demonstrate the ability to consistently clean, sterilize, and restore functional performance to predefined engineering specifications for external fixation devices. This involves chemistry, microbiology, and mechanical engineering testing rather than expert-derived ground truth.
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AUG 2 2 2005
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: July 20, 2005
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):
- K023714 Reprocessed Orthofix® 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 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 quide 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.
Alliance Medical Corporation Modified Reprocessed External Fixation Devices Special 510(k)
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| Indicationsstatement: | Reprocessed external fixation devices are indicated for use inpatients requiring external skeletal fixation and treatment offractures, osteotomy, arthrodesis, correction of deformities,fracture revision, bone reconstruction procedures, limblengthening, correction of bony or soft tissue deformities andsegmental bony or soft tissue defects. |
|---|---|
| Technologicalcharacteristics: | The design, materials, and intended use of the ReprocessedExternal Fixation Devices are identical to the predicate devices.The mechanism of action of the Reprocessed External FixationDevice is identical to the predicate devices in that the samestandard mechanical design, materials, shapes and sizes areutilized. There are no changes to the claims, intended use,clinical applications, patient population, performancespecifications, or method of operation. The only change is themodified 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 demonstrateperformance (safety and effectiveness) of the ReprocessedExternal Fixation Devices.Validation of reprocessing Function TestingPerformance testing demonstrates that Reprocessed ExternalFixation Devices perform as originally intended. |
| Conclusion: | Alliance Medical Corporation concludes that the modified device(the Reprocessed External Fixation Device) is safe, effectiveand substantially equivalent to the predicate devices, asdescribed herein. |
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is depicted with thick, black lines, giving it a bold and graphic appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
Ms. Moira Barton Regulatory Affairs Manager Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K052065
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: July 19, 2005 Received: July 29, 2005
Dear Ms. Barton:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave roviewed 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.
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Page 2 - Ms. Moira Barton
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and by of substantial equivalence of your device of your device to a legally promated 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 If you atent 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 other general 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,
Barbara Buehus
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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Indications for Use
510(k) Number (if known): K052065
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.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
Barbara Buehrle for MXM
(Division Sig Division of General, Restorati and Neurological Devices
510(k) Number K052065
§ 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.