(315 days)
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation oand 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) submission for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. This submission focuses on demonstrating substantial equivalence to predicate devices, not on a new, AI-powered diagnostic or therapeutic device. As such, many of the requested criteria (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, AI improvement effect size) are not applicable to this type of submission.
The core of this submission is about proving that reprocessing existing external fixation devices does not alter their safety and effectiveness compared to new, predicate devices.
Here's an analysis of the available information based on your request:
Description of Acceptance Criteria and Study to Prove Device Meets Them
The acceptance criteria for the "Reprocessed External Fixation Devices" are implicitly tied to demonstrating that the reprocessed devices perform identically to their original, new counterparts, and to the predicate devices, in terms of safety and effectiveness. The study described focuses on proving that the reprocessing procedure maintains these critical performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance: Reprocessed devices must perform functionally equivalent to new 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. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| Biocompatibility: Reprocessing must not introduce unacceptable biocompatibility risks. | "Biocompatibility Validation of reprocessing" (mentioned as conducted to demonstrate performance). |
| Sterility/Cleanliness: Reprocessing must ensure proper sterilization and removal of contaminants. | While not explicitly detailed in the provided text, "Biocompatibility Validation of reprocessing" would inherently include aspects of cleanliness and sterilization efficacy to ensure patient safety. |
| Material Integrity: Reprocessing must not degrade the materials of the device. | "The design, materials, and intended use of the Reprocessed External Fixation Device s are identical to the predicate devices." Implies that reprocessing does not fundamentally alter these. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the devices tested as part of the "bench and laboratory testing."
- Data Provenance: The data comes from "bench and laboratory testing" conducted by Alliance Medical Corporation. No country of origin is specified for the data itself, but the submitter is based in Phoenix, Arizona, USA. The testing is retrospective in the sense that it evaluates the performance of reprocessed versions of already existing devices. It is not prospective clinical trial data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This submission does not involve a diagnostic device or a study requiring expert readers to establish ground truth for a test set in the traditional sense (e.g., radiology interpretation). The "ground truth" here is the established performance and safety of the original, new devices and the predicate devices. The study aims to show the reprocessed device meets these existing standards, rather than defining a new ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. There is no mention of an adjudication method as it relates to expert reader interpretation. The testing is bench and laboratory-based.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-powered device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-powered device or algorithm.
7. The type of ground truth used
- The "ground truth" for this submission is implicitly the established performance specifications, material properties, biocompatibility, and intended use of the original, new, and predicate external fixation devices. The study aims to demonstrate that the reprocessed devices meet these existing, well-defined standards. This is akin to using established engineering standards and material science data as a basis for comparison.
8. The Sample Size for the Training Set
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. This is not a machine learning or AI device.
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K012645
1 OF 2
510(k) Summary of Safety and Effectiveness
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 |
|---|---|
| Contact: | Don SelveyVice President, Regulatory Affairs and Quality Assurance(480) 763-5300 |
| Date of preparation: | 8 August 2001 |
| Name of device: | Reprocessed External Fixation Devices |
| Common Name: | External Fixation Devices, Fixation Appliance, Single/MultipleComponent and Invasive Traction Component |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances andAccessories |
Reprocessed device(s):
| MANUFACTURER | MODELNUMBER | DESCRIPTION |
|---|---|---|
| EBI | 01001 | EXTERNAL FIXATOR |
| EBI | 01300 | DFS T-CLAMP |
| EBI | 01520 | STEEL ROD |
| EBI | 03110 | 2 SIDED HEX HEAD WRENCH |
| EBI | 03125 | T-HANDLE HEX HEAD WRENCH |
| EBI | 04300 | DISTAL RADIUS FIXATOR |
| EBI | 13020-EBI | 1/4 STEEL RING |
| EBI | 13035 | 1/4 STEEL RING |
| EBI | 13040 | 3/4 STEEL RING |
| EBI | 1505 | TUBE TO TUBE CLAMP |
| EBI | 2200-EBI | EXTERNAL FIXATOR |
| EBI | 4003 | EXTERNAL FIXATOR |
| EBI | R00096 | EXTERNAL FIXATOR |
Predicate device(s):
EBI XFIX® DFS® Rail System K010437 K951357 EBI Small External Fixator EBI X Fix DynaFix System K953406 K970290 EBI X Fix DynaFix Mini External Fixator
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KO12645 20 F 2
...
| Device description: | External fixation devices are specially designed frames, clamps, rods,rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixationbolts, washers, nuts, hinges, sockets, connecting bars and screwsused for the management of bone fractures and reconstructive, aswell as corrective, orthopedic surgery. Materials used include metalalloys, plastic and composites. These materials are chosen to addressa wide range of fractures and applications as well as to allow for theappropriate amount of rigidity and stability. |
|---|---|
| Intended use: | External Fixation Devices are intended to be used for the fixation ofsupracondylar, or condylar fractures of the femur; for fusion of a joint;for surgical procedures that involve cutting the bone, for fixation ofbone fractures; bone reconstruction; as a guide pin for insertion of otherimplants; or may be implanted through the skin so that a pulling forceor traction may be applied to the skeletal system; and others may beused for fixation of bone fractures, for bone reconstructions, as a guidepin for insertion of other implants, or it may be implanted through theskin so that a pulling force (traction) may be applied to the skeletalsystem. |
| Indications statement: | Reprocessed external fixation devices are indicated for use inpatients requiring external skeletal fixation oand treatment offractures, osteotomy, arthrodesis, correction of deformities, fracturerevision, bone reconstruction procedures, limb lengthening,correction of bony or soft tissue deformities and segmental bony orsoft tissue defects. |
| Technological characteristics: | The design, materials, and intended use of the Reprocessed ExternalFixation Device s are identical to the predicate devices. Themechanism of action of the Reprocessed External Fixation Device isidentical to the predicate devices in that the same standardmechanical design, materials, shapes and sizes are utilized. There areno changes to the claims, intended use, clinical applications, patientpopulation, performance specifications, or method of operation. |
| Performance data: | Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of the Reprocessed ExternalFixation Devices.Biocompatibility Validation of reprocessingPerformance testing demonstrates that Reprocessed External FixationDevices perform as originally intended. |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21CFR Part 807 and based on the information provided in thispremarket notification, Alliance Medical Corporation concludes thatthe modified device (the Reprocessed External Fixation Device) issafe, effective and substantially equivalent to the predicate devices asdescribed herein. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird-like figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2002
Mr. Don Selvey Vice President Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K012623, K012634, K012645, K012648 Trade Name: 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, KTW, JEC Dated: April 3, 2002 Received: April 4, 2002
Dear Mr. Selvey:
We have reviewed your Section 510(k) premarket notifications of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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 - Mr. Don Selvey
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notifications. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices . to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
. Merle N. Millerson
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
Enclósure
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Indications for Use Statement
510(k) Number (if known):
KO12645
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 oand 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.
| MANUFACTURER | MODELNUMBER | DESCRIPTION |
|---|---|---|
| EBI | 01001 | EXTERNAL FIXATOR |
| EBI | 01300 | DFS T-CLAMP |
| EBI | 01520 | STEEL ROD |
| EBI | 03110 | 2 SIDED HEX HEAD WRENCH |
| EBI | 03125 | T-HANDLE HEX HEAD WRENCH |
| EBI | 04300 | DISTAL RADIUS FIXATOR |
| EBI | 13020-EBI | 1/4 STEEL RING |
| EBI | 13035 | 1/4 STEEL RING |
| EBI | 13040 | 3/4 STEEL RING |
| EBI | 1505 | TUBE TO TUBE CLAMP |
| EBI | 2200-EBI | EXTERNAL FIXATOR |
| EBI | 4003 | EXTERNAL FIXATOR |
| EBI | R00096 | EXTERNAL FIXATOR |
to Mark N. Milliken
Division of General, Restorative and Neurological Devices
510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109) CONFIDENTIAL
OL
Over-the-Counter Use
Alliance Medical Corporation Reprocessed External Fixation Devices Traditional 510(k)
60
§ 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.