(68 days)
The Reprocessed External Fixation Device is intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
LARGE: Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components are used for: Stabilization of soft tissues and fractures, Polytrauma/multiple orthopedic trauma, As treatment adjunct for vertically unstable pelvic fractures, Arthrodeses and osteotomies with soft tissue problems; failures of total joints, Treatment of fractures stabilized with limited internal fixation, Non-unions/septic non-unions, Intra-operative reductions/stabilization tool to assist with indirect reduction, Unilateral rectilinear bone segment transport or leg lengthening.
MEDIUM: Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
SMALL: Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, and foot. Specifically, the components can be used for: Preliminary fixation before ORIF, Unstable fractures of the distal radius (both intra and extra-articular), Open and/or comminuted bilateral fractures, Open and or combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement, Fracture dislocations, Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations), Pediatric open fractures with bone loss and osteotomies.
MINI: Stabilizes and provides treatment for fractures of the hand and foot. Specifically, the components can be used for: Comminuted fractures of phalanges and metacarpals, Displaced intra-articular fractures, Segmental bone loss, Fractures that do not allow stable internal fixation, Fractures with associated complex soft tissue injuries, Tumor resections.
The Reprocessed External Fixation Device consists of the standard bridge elements (rods, articulating and telescoping components), and connection elements (clamps) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Anchorage elements are not included in the Reprocessed External Fixation Device.
The provided document describes a 510(k) premarket notification for a Reprocessed External Fixation Device. This is a regulatory filing for a medical device that aims to demonstrate its substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through extensive clinical trials.
As such, the document does not contain the typical information regarding acceptance criteria and a study design that demonstrates the device meets those criteria in the way a new device would. Instead, the "study" described is primarily focused on demonstrating functional equivalence to existing devices through bench testing and process validation.
Here's an analysis of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Characteristics: Reprocessed devices must demonstrate appropriate functional characteristics. | "Functional and Representative samples of Reprocessed External Fixation Devices underwent bench testing to demonstrate appropriate functional characteristics." (No specific quantitative metrics or results are provided, simply that they "demonstrate appropriate functional characteristics.") |
| Cleaning Procedure Validation: The reprocessing cleaning procedure must be validated. | "Process validation testing was done to validate the cleaning procedure." (No specific validation criteria or results are provided.) |
| Visual and Functional Testing: All reprocessed products must pass visual and functional inspection prior to release. | "In addition, the manufacturing process includes visual and functional testing of all products prior to release." (This describes an internal quality control step rather than specific performance data from a study.) |
| Substantial Equivalence: The reprocessed device must be substantially equivalent to the predicate device in functional design, materials, and indications for use. | "The External Fixation Device reprocessed by SterilMed is substantially equivalent to counterpart devices originally manufactured by Synthes. This conclusion is based upon the devices' similarities in functional design, materials and indications for use." (This is the overarching conclusion of the 510(k) submission, not a specific performance outcome against a metric.) The predicate devices are listed as Synthes Reprocessed External Fixation Devices (K033158), Synthes Large External Fixation Clamps MR Safe (K031428) and Synthes Medium External Fixation System MR Safe (K040258). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states "Functional and Representative samples" were used for bench testing. The exact number of samples is not specified.
- Data Provenance: The data is likely from retrospective bench testing conducted by SterilMed, Inc. (Minneapolis, MN, USA) on their reprocessed devices. The country of origin of the data would therefore be the USA. This is not a clinical study involving patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The concept of "ground truth" as typically understood in AI/medical imaging studies (e.g., pathology, expert consensus on disease presence) does not apply directly here. The "ground truth" for this type of submission is the functional and material specifications of the original, new devices and established regulatory standards for reprocessing.
- The document does not mention any external experts establishing ground truth for the test set. The validation would have been performed by SterilMed's internal engineering and quality personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This concept is not applicable here. Adjudication methods like 2+1 are used in clinical studies where conflicting expert opinions need to be resolved for ground truth labeling. This submission relies on objective bench test results and process validation.
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 MRMC comparative effectiveness study was done. This is a submission for a physical medical device (external fixation device, reprocessed), not an AI algorithm for diagnostic imaging. Therefore, the question of human readers improving with AI assistance is not relevant to this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. Again, this is for a physical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the functional and material testing, the "ground truth" would be considered the established engineering specifications and performance characteristics of the originally manufactured (new) devices, as well as relevant industry standards for mechanical properties and material integrity, and regulatory requirements for device reprocessing and sterility. This is not ground truth in the sense of a medical diagnosis.
8. The sample size for the training set
- This device is a reprocessed physical medical device, not an AI model. Therefore, the concept of a "training set" for an algorithm is not applicable.
9. How the ground truth for the training set was established
- As mentioned above, there is no training set for an AI algorithm in this context.
In summary:
This 510(k) submission establishes substantial equivalence for a reprocessed external fixation device. The "study" involves bench testing of representative samples to confirm functional characteristics and process validation for the cleaning procedure. The core argument is that the reprocessed device performs comparably to the original, new device and other legally marketed reprocessed predicate devices. It does not involve clinical trials, expert consensus on patient data, or AI algorithm validation.
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K051957 (pg 1 of 2)
SEP 2 1 2005
SECTION 2. SUMMARY AND CERTIFICATION
2.A. 510(k) Summary
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Thomas A. Dold MBA, RACDirector of Regulatory AffairsSterilMed, Inc.11400 73 rd Ave. NMinneapolis, MN 55369Ph: 763-488-3400Fax: 763-488-3350 |
| Date Prepared: | July 18, 2005 |
| Trade Name: | Reprocessed External Fixation Device |
| Classification Name:And Number: | External Fixation DeviceClass II, 21 CFR 888.3030 |
| Product Code: | KTT |
| Predicate Device(s): | The Reprocessed External Fixation Device is substantiallyequivalent to the Synthes Reprocessed External FixationDevices (K033158), Synthes Large External FixationClamps MR Safe (K031428) and Synthes Medium ExternalFixation System MR Safe (K040258). |
| Device Description: | The Reprocessed External Fixation Device consists of thestandard bridge elements (rods, articulating and telescopingcomponents), and connection elements (clamps) containedin the original manufacturer's system. Some of thecomponents are MR safe and made of non-magneticmaterials. MR safe components are intended for use in theMR environment. Anchorage elements are not included inthe Reprocessed External Fixation Device. |
| Intended Use: | The Reprocessed External Fixation Device is intended foruse in the construction of an external fixation frame fortreatment of various fracture types that require externalfixation. |
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K051957 (pg 2 of 2)
Functional and Representative samples of Reprocessed External Fixation Safety Testing: Devices underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning procedure. In addition, the manufacturing process includes visual and functional testing of all products prior to release. The External Fixation Device reprocessed by SterilMed is Conclusion: substantially equivalent to counterpart devices originally manufactured by Synthes. This conclusion is based upon the devices' similarities in functional design, materials and indications for use.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). 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 representation of three human figures, depicted as flowing, interconnected lines.
Public Health Service
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas A. Dold, MBA, RAC Director of Regulatory Affairs SterilMed, Inc. 11400 73td Avenue North Minneapolis, Minnesota 55369
Re: K051957 Trade/Device Name: Reprocessed External Fixation Device (See enclosed list) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: July 18, 2005 Received: July 19, 2005
Dear Mr. Dold:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section - 10(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate, to regars mannent date of the Medical Device Amendments, or to commerce prior to May 26, 1776, the enacified in accordance with the provisions of the Federal Food. Drug, devices that have been reclassince in accessaries while in a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval and Cosmelle Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, dicierore, market the act nelude requirements for annual registration, listing of general controls provisions of the fiel 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 If your device is classified (see abore) into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and device of D fifay be subject to such additional connounce and to 898. In addition, FDA may be found in the Overning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean I lease oc advised that I Dri 3 issualled or with other requirements of the Act that TDA has made a dolorimiation administered by other Federal agencies. You must or any receral statutes and regulations administer on registration and listing (21 Comply with an the For s requirements, and manufacturing practice requirements as sch CFN Fatt 607), labeling (21 CFR Part 800), good if applicable, the electronic forth in the quality byetems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2- Mr. Thomas A. Dold, MBA, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin marketing your arrantial equivalence of your device to a legally premarket hourication. The PDA maing of backannal sor 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 desire specific advice for your ac now to the regulation entitled, and office of contact the Office of Comphanee at (210) 216 of 807.97). You may obtain ' Misolanding by reference to premation in the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or and index birds Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson, M.S.
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3– Mr. Thomas A. Dold, MBA, RAC
Reprocessed External Fixation Device Models found to be Substantially Equivalent:
| Manufacturer # | Description | |
|---|---|---|
| 1. | 390.002 | Large 6 Position Multi-Pin Clamp, MR Safe |
| 2. | 390.003 | Rod Attachment for Large Multi-Pin Clamp, MR Safe |
| 3. | 390.004 | Large 4 Position Multi-Pin Clamp, MR Safe |
| 4. | 390.005 | Large Combination Clamp, MR Safe |
| 5. | 390.006 | Dynamization Clip for Large Combination Clamp, MR Safe |
| 6. | 390.007 | Tube-to-Tube Clamp, MR Safe |
| 7. | 390.008 | Large Open Adjustable Clamp, MR Safe |
| 8. | 394.80 | 11.0mm Carbon Fiber Rod, 100mm length |
| 9. | 394.81 | 11.0mm Carbon Fiber Rod, 125mm length |
| 10. | 394.82 | 11.0mm Carbon Fiber Rod, 150mm length |
| 11. | 394.83 | 11.0mm Carbon Fiber Rod, 200mm length |
| 12. | 394.84 | 11.0mm Carbon Fiber Rod, 250mm length |
| 13. | 394.85 | 11.0mm Carbon Fiber Rod, 300mm length |
| 14. | 394.86 | 11.0mm Carbon Fiber Rod, 350mm length |
| 15. | 394.87 | 11.0mm Carbon Fiber Rod, 400mm length |
| Manufacturer # | Description | |
| 390.031 | Medium Combination Clamp, MR Safe | |
| 390.032 | Dynamization Clip for Medium Combination Clamp, MR Safe | |
| 390.033 | Medium 4 Position Multi-Pin Clamp, MR Safe | |
| 390.034 | Rod Attachment for Medium Multi-Pin Clamp, MR Safe | |
| 390.035 | Medium Open Adjustable Clamp, MR Safe | |
| 390.036 | Medium 6 Position Multi-Pin Clamp, MR Safe | |
| 390.037 | 8.0mm/11.0mm Combination Clamp, MR Safe | |
| 395.779 | 8.0mm Carbon Fiber Rod, 160mm length | |
| 395.780 | 8.0mm Carbon Fiber Rod, 180mm length | |
| 395.782 | 8.0mm Carbon Fiber Rod, 200mm length | |
| 395.784 | 8.0mm Carbon Fiber Rod, 220mm length | |
| 395.786 | 8.0mm Carbon Fiber Rod, 240mm length | |
| 395.788 | 8.0mm Carbon Fiber Rod, 280mm length | |
| 395.792 | 8.0mm Carbon Fiber Rod, 320mm length | |
| 394.796 | 8.0mm Carbon Fiber Rod, 360mm length | |
| 394.797 | 8.0mm Carbon Fiber Rod, 400mm length |
I arge External Fixation Device Components
Medium External Fixation Device Components
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Page 4– Mr. Thomas A. Dold, MBA, RAC
| Manufacturer # | Description | |
|---|---|---|
| 32. | 390.041 | Small Combination Clamp, MR Safe |
| 33. | 390.051 | 4.0mm Adjustable Clamp for Distal Radius Fixator, MR Safe |
| 34. | 395.54 | 4.0mm/2.5mm Open Clamp |
| 35. | 395.55 | 4.0mm/4.0mm Open Clamp |
| 36. | 395.56 | 4.0mm/2.5mm Clamp |
| 37. | 395.57 | 4.0mm/4.0mm Clamp |
| 38. | 395.597 | 4.0mm Adjustable Clamp for Distal Radius Fixator |
| 39. | 395.60 | 4.0mm Carbon Fiber Rod, 60mm length |
| 40. | 395.61 | 4.0mm Carbon Fiber Rod, 80mm length |
| 41. | 395.62 | 4.0mm Carbon Fiber Rod, 100mm length |
| 42. | 395.63 | 4.0mm Carbon Fiber Rod, 120mm length |
| 43. | 395.64 | 4.0mm Carbon Fiber Rod, 140mm length |
| 44. | 395.65 | 4.0mm Carbon Fiber Rod, 160mm length |
| 45. | 395.66 | 4.0mm Carbon Fiber Rod, 180mm length |
| 46. | 395.67 | 4.0mm Carbon Fiber Rod, 200mm length |
:
Small External Fixation Device Components
Mini External Fixation Device Components
| Manufacturer # | Description | |
|---|---|---|
| 47. | 395.105 | 3.0mm Carbon Fiber Rod, 25mm length |
| 48. | 395.107 | 3.0mm Carbon Fiber Rod, 45mm length |
| 49. | 395.109 | 3.0mm Carbon Fiber Rod, 60mm length |
| 50. | 395.111 | 3.0mm Carbon Fiber Rod, 75mm length |
| 51. | 395.125 | Mini Holding Clamp, 1.25mm |
| 52. | 395.126 | Mini Holding Clamp, 1.6mm |
| 53. | 395.133 | 3.0mm/3.0mm Connecting Clamp |
| 54. | 395.134 | 3.0mm/4.0mm Connecting Clamp |
.
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Indications for Use
(pg 1 of 2) 510(k) Number (if known):
Device Name: Reprocessed External Fixation Device
Indications for Use:
The Reprocessed External Fixation Device is intended for use in the construction of an I he Reprocessed External I mation Dollar is a learnet types that require external fixation.
LARGE
LAKGE
Provide treatment for long bone and pelvic fractures that require external fixation Specifically, the components are used for:
- Stabilization of soft tissues and fractures .
- Polytrauma/multiple orthopedic trauma .
- r of traumannuluipte orthopours as treatment adjunct for vertically unstable . pelvic fractures
- pervic fractures
Arthrodeses and osteotomics with soft tissue problems; failures of total joints . - Archited of tractures stabilized with limited internal fixation ●
- Non-unions/septic non-unions .
- Intra-operative reductions/stabilization tool to assist with indirect reduction .
- I Inilateral rectilinear bone segment transport or leg lengthening .
MEDIUM
MEDIUM
Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
SMALL
Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, Stabilizes and provided aspecifically, the components can be used for:
- Preliminary fixation before ORIF .
- Unstable fractures of the distal radius (both intra and extra-articular) .
- Open and/or comminuted bilateral fractures .
- Open and or combination with extensive soft tissue injury, bone loss, and vascular ● and/or neural involvement
- Fracture dislocations .
- Failed closed reduction with casting resulting in secondary deformity (radial . shortening and angulations)
- shortening and angulations)
Pediatric open fractures with bone loss and osteotom Division Sign-Off) .
Division of General, Restorative. and Neurological Devices
510(k) Notification - Reprocessed External Fixation Device July 18, 2005 SterilMed, Inc. CONFIDENTIAL
510/k) Numher K05 957 r. /:
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K051957 (pg 2 of 2)
MINI
MINI
Stabilizes and provides treatment for fractures of the hand and foot Specifically, the components can be used for:
- Comminuted fractures of phalanges and metacarpals .
- Displaced intra-articular fractures .
- Segmental bone loss .
- Segmental other of that do not allow stable internal fixation .
- Fractures with associated complex soft tissue injuries .
- Tumor resections .
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K051957 4.2/2
§ 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.