(75 days)
Zimmer TransFx External Fixation Devices are indicated for fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and periarticular fractures.
The TransFx" External Fixation System is a modular system. Device description: The system design is designed to provide options in frame construction, simplicity in frame components, and ease of transition from one frame size to another.
This document describes a 510(k) submission for Reprocessed External Fixation Devices. The acceptance criteria and supporting study information are derived from the "Performance data" and "Technological characteristics" sections.
Here’s a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is safely reprocessed without introducing hazards. | "Validation of reprocessing" conducted. |
| Effectiveness: Device performs as originally intended. | "Function test(s)" conducted. "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." |
| Sterility: For sterile devices, sterility is maintained. | "Sterilization Validation (for sterile devices)" conducted. |
| Equivalence to Predicate: Design, materials, intended use, mechanism of action, claims, clinical applications, patient population, performance specifications, and method of operation are identical to predicate devices. | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices. The mechanism of action... is identical... 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." |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of a clinical study with human subjects. The performance testing appears to be primarily bench and laboratory-based. Therefore:
- Sample Size for Test Set: Not explicitly stated as a clinical "test set" in the traditional sense. The testing was conducted on "Reprocessed External Fixation Devices," implying a sample of these reprocessed devices was tested.
- Data Provenance: The studies were "Bench and laboratory testing." No information on country of origin or whether it was retrospective/prospective is provided, as these are typically applicable to clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the submitted data. The studies performed were bench and laboratory tests, not clinical evaluations requiring expert consensus for ground truth.
4. Adjudication method for the test set
This information is not applicable. No clinical test set or subjective evaluation requiring adjudication is described.
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
No multi-reader multi-case (MRMC) comparative effectiveness study was done. This device is a reprocessed medical device (external fixation devices), not an AI/imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical, reprocessed external fixation device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench and laboratory testing:
- Ground Truth for performance: The performance of the predicate (original) devices serves as the functional "ground truth." The reprocessed devices are evaluated against the expectation that they perform "as originally intended," meaning identically to the new, non-reprocessed versions. This would involve comparing mechanical properties, material integrity, and functional operation to established standards for new devices.
- Ground Truth for sterility: Sterility validation would be against recognized sterility assurance levels (e.g., ISO standards) for medical devices.
- Ground Truth for reprocessing validation: This would be against established procedures and standards for effective cleaning, disinfection, and sterilization to remove contaminants and pathogens.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.
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PART B: 510(k) SUMMARY
| Submitter: | Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044 | |
|---|---|---|
| Contact: | Amanda BabcockRegulatory Affairs Specialist(480) 763-5300 (o)(480) 763-5310 (f)ababcock@ascenths.com | SEP - 5 2006 |
| Date of preparation:Name of device: | June 6, 2006Trade/Proprietary Name: Reprocessed External FixationDevicesCommon or Usual Name: External Fixation Devices, FixationAppliance, Single/Multiple ComponentClassification Name: Single/Multiple Component Metallic BoneFixation Appliances and Accessories and Smooth or ThreadedMetallic Bone Fixation Fastener |
| Predicate Device | |
|---|---|
| 510(k) Title | Manufacturer |
| K984357 | TRANSFX EXTERNAL FIXATION SYSTEM |
| K990848 | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM |
| K991723 | TRANSFX MULTI PIN CLAMP IMMEDICA, INC |
| K001084 | TRANSFX ADJUSTABLE PIN TO BAR CLAMP |
The TransFx" External Fixation System is a modular system. Device description: The system design is designed to provide options in frame construction, simplicity in frame components, and ease of transition from one frame size to another. Intended use: Zimmer TransFx External Fixation Devices are intended to be
- used for fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and periarticular fractures.
- Indications Zimmer TransFx External Fixation Devices are indicated for fractures of the long bones and pelvis, joint fusion, limb statement: lengthening, osteotomies, and periarticular fractures.
CONFIDENTIAL
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Kc61759 (pg 2 of 2)
| 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. |
|---|---|
| Performance data: | These devices will be provided sterile and non-sterile dependingon customer preference.Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of Reprocessed ExternalFixation Devices. This included the following tests:Validation of reprocessing Sterilization Validation (for sterile devices) Function test(s)Performance testing demonstrates that Reprocessed ExternalFixation Devices perform as originally intended. |
| Conclusion: | Ascent Healthcare Solutions concludes that the modifieddevices (Reprocessed External Fixation Device) are safe,effective, and substantially equivalent to the predicate devicesas described herein. |
CONFIDENTIAL
:
Traditional 510(k)
:
10
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling human figures or birds, arranged in a row.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ascent Healthcare Solutions % Ms. Amanda Babcock Regulatory Affairs Specialist 10232 South 51st Street Phoenix, Arizona 85044
SEP - 5 2006
Re: K061759
Trade/Device Name: Reprocessed Zimmer TransFxTM External Fixation Devices (See enclosed list) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: June 20, 2006 Received: June 22, 2006
Dear Ms. Babcock:
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.
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Page 2 - Ms. Amanda Babcock
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 vours,
Barbara Buettner
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Ms. Amanda Babcock
Reprocessed Zimmer TransFx™ External Fixation Devices found to be substantially equivalent:
| Intermediate 8mm | |
|---|---|
| Name | Part Number |
| TransFx-Carbon Fiber Rod, 8mmx60mm | 4451-08-06 |
| TransFx-Carbon Fiber Rod, 8mmx80mm | 4451-08-08 |
| TransFx- Carbon Fiber Rod, 8mm x 100mm | 4451-08-10 |
| TransFx- Carbon Fiber Rod, 8mm x 120mm | 4451-08-12 |
| TransFx- Carbon Fiber Rod, 8mm x 140mm | 4451-08-14 |
| TransFx- Carbon Fiber Rod, 8mm x 160mm | 4451-08-16 |
| TransFx-Carbon Fiber Rod, 8mmx180mm | 4451-08-18 |
| TransFx-Carbon Fiber Rod, 8mm x 200mm | 4451-08-20 |
| TransFx-Carbon Fiber Rod, 8mm x 220mm | 4451-08-22 |
| TransFx-Carbon Fiber Rod, 8mm x 240mm | 4451-08-24 |
| TransFx- Carbon Fiber Rod, 8mm x 300mm | 4451-08-30 |
| TransFx- Carbon Fiber Rod, 8mm x 350mm | 4451-08-35 |
| TransFx-Protective Caps, 8mm | 4452-92-08 |
| TransFx-Protective Caps, 2.5/3.0mm | 4452-92-25 |
| TransFx-Protective Caps, 3./4.0mm | 4452-92-35 |
| TransFx-Rod to Rod Clamp 8mm to 8mm | 4452-10-08 |
| TransFx-Open Rod to Rod Transitional Clamp 4mm to 8mm | 4452-15-48 |
| TransFx-Open Rod to Rod Transitional Clamp, 8mm to 11mm | 4452-15-81 |
| TransFx-Open Rod to Rod clamp, 8mm to 8mm | 4452-15-88 |
| TransFx-Open Pin to rod Clamp, 2.5 to 4.5mm/8mm | 4452-25-28 |
| TransFx-Multi-Pin Clamp, 8mm, Single Connect | 4452-30-08 |
| TransFx-Multi-Pin Clamp, 8mm, End Connect | 4452-31-08 |
| TransFx-Multi-Pin Clamp, 8mm, Mid Connect | 4452-32-08 |
| Large 11mm | |
| Name | Part Number |
| TransFx-Carbon Fiber Rod, 11mmx100mm | 4451-01-10 |
| TransFx-Carbon Fiber Rod, 11mmx125mm | 4451-01-12 |
| TransFx-Carbon Fiber Rod, 11mmx150mm | 4451-01-15 |
| TransFx-Carbon Fiber Rod, 11mmx200mm | 4451-01-20 |
| TransFx-Carbon Fiber Rod, 11mmx250mm | 4451-01-25 |
| TransFx- Carbon Fiber Rod, 11mmx300mm | 4451-01-30 |
| TransFx-Carbon Fiber Rod, 11mmx350mm | 4451-01-35 |
| TransFx-Carbon Fiber Rod, 11mm x 400mm | 4451-01-40 |
| TransFx-Carbon Fiber Rod, 11mmx450mm | 4451-01-45 |
| TransFx-Carbon Fiber Rod, 11mmx500mm | 4451-01-50 |
| TransFx-Carbon Fiber Rod, 11mmx550mm | 4451-01-55 |
| TransFx-Carbon Fiber Rod, 11mmx600mm | 4451-01-60 |
| TransFx-Carbon Fiber Rod, 11mmx650mm | 4451-01-65 |
| TransFx-Aluminum Angled Rod, 11mm x 135mm | 4451-01-91 |
| TransFx-Aluminum Angled Rod, 11mm x 180mm | 4451-01-92 |
| TransFx-Protective Caps, 11mm | 4452-92-11 |
| TransFx-Protective Caps, 4.5/5.0mm | 4452-92-45 |
| TransFx-Rod to Rod Clamp 11mm to 11mm | 4452-10-11 |
| TransFx-Open Rod to Rod Clamp 11mm to 11mm | 4452-15-1 |
| TransFx-Open Pin to Rod Clamp, 4.0 to 6.0mm/11mm | 4452-25-5 |
| TransFx-Multi-Pin Clamp, 11 mm, Single Connect | 4452-30-1 |
| TransFx-Multi-Pin Clamp, 11 mm, End Connect | 4452-31-1 |
| TransFx-Multi-Pin Clamp, 11 mm, Mid Connect | 4452-32-1 |
| TransFx-Adjustable Clamp, 4.0 to 6.0mm/11 mm | 4452-35-5 |
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Page 4 – Ms. Amanda Babcock
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2. Indications for Use
510(k) Number (if known): K061759
Device Name: Ascent Healthcare Solutions Reprocessed External Fixation Devices
Indications for Use: Zimmer TransFx External Fixation Devices are indicated for fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and periarticular fractures.
Prescription Use (Part 21 CFR 801 Subpart D)
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)
barbare buchnofformxn
Division Sign Off
(Division Sign-Of Division of General, Restorative, and Neurological Devices
510(k) Number K061175
Ascent Healthcare Solutions Reprocessed External Fixation Device Traditional 510(k)
13
N/A