(101 days)
The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following:
- Post traumatic and degenerative arthritis involving both ankle and subtalar joints,
- Rheumatoid arthritis,
- Osteoarthritis,
- Pseudoarthrosis,
- Severe foot/ankle deformity, or
- Instability and skeletal defects after tumor resection.
These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.
The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials.
This Premarket Notification is to add 5.0mm Tibial Locking Screws in 20 to 24mm lengths, 5.0 mm Talar Screws with Threaded Head in 40 to 44mm lengths, and 6.0mm Calcaneal Locking Screws with Threaded Head in 50 to 68mm lengths to the system.
This 510(k) premarket notification is for a modification to an existing device, the SBi Anatomic Ankle Arthrodesis Interlocking Nail System. The submission is to add shorter lengths of existing screw types (5.0mm Tibial Locking Screws, 5.0 mm Talar Screws with Threaded Head, and 6.0mm Calcaneal Locking Screws with Threaded Head) to the system.
Given that this is a "Special 510(k)" submission for a modification to existing, substantially equivalent devices, the nature of the "acceptance criteria" and "study" described in the provided text focuses on demonstrating that the modified devices maintain substantial equivalence to the predicate devices. It's not a performance study of a novel AI device with specific accuracy or sensitivity metrics.
Here's an analysis based on the provided text, addressing your questions where applicable:
1. A table of acceptance criteria and the reported device performance
For a Special 510(k) seeking to modify an existing device, the "acceptance criteria" revolve around demonstrating that the modification does not negatively impact the safety and effectiveness of the device compared to its predicate. The "reported device performance" reflects that these criteria were met.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Equivalence: Modified screws use the same implantable grade material as predicate. | The shorter length screws being added... are made from implantable grade TiAl6V4 titanium (ASTM F136) which is the same material as the predicate screws. |
| Design Equivalence (functional aspects): Head designs, outer/inner diameters, and thread are the same as predicate screws. | The design of the shorter screws being added by this Special 510(k) are the same as the predicate screws in that the head designs of the outer and inner diameters and thread are the same. The only difference is that the modified screws are shorter in length. |
| Mechanical Performance Equivalence/Improvement: Shorter length does not compromise mechanical integrity; ideally, improves. | An Engineering Rationale is provided in the Bench Testing section which concludes that the bending loads will be lower if the screw is shorter while keeping the minor diameter the same. (This indicates an improvement in mechanical performance regarding bending loads, exceeding mere equivalence). |
| Sterilization Efficacy: The modification does not invalidate existing sterilization parameters. | Additionally the rationale concludes that the total mass of the new set configuration is decreasing (longer screws are being replaced by shorter screws); thus the existing sterilization parameters will still be valid. (This ensures that the sterilization process remains effective for the modified configuration, maintaining safety). |
| Intended Use: The modification does not change the intended use of the system. | The system's intended use remains unchanged and is explicitly stated: "The SBi Anatomic Ankle Arthrodesis Interlocking Nail System intended for tibiotalocalcaneal arthrodesis of the ankle following: Post traumatic and degenerative arthritis involving both ankle and subtalar joints, osteoarthritis, Rheumatoid arthritis, Pseudoarthrosis, Severe foot/ankle deformity, or Instability and skeletal defects after tumor resection..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not involve clinical studies with human test sets or data provenance in the way an AI diagnostic device would. The "study" here is a bench testing and engineering rationale.
- Test Set Sample Size: Not applicable in the traditional sense. The "test set" would be the modified screw components themselves, which are physically tested or analyzed through engineering principles. The document doesn't specify a number of screws fabricated and tested, but rather refers to an "Engineering Rationale" which implies calculations and potentially physical testing of representative samples.
- Data Provenance: Not applicable. The "data" comes from engineering analysis, material properties, and potentially physical bench testing conducted by the manufacturer.
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)
Not applicable. "Ground truth" for this type of modification is established by engineering principles, accepted material standards (ASTM F136), and regulatory requirements for medical devices. There are no radiologists or clinical experts involved in establishing "ground truth" for the mechanical properties or sterilization validity of the screws.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human interpretation or consensus. The "adjudication" is implicitly the regulatory review process by the FDA, where their experts evaluate the provided engineering rationale and bench test results against established standards to determine substantial equivalence.
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 device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this modification is based on:
- Engineering mechanics (e.g., bending load calculations)
- Materials science (e.g., ASTM F136 standard for TiAl6V4 titanium)
- Sterilization validation principles (e.g., impact of mass on sterilization parameters)
- Regulatory requirements for demonstrating substantial equivalence to a predicate device.
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. There is no training set for this device.
Summary of the Study:
The "study" in this context is an Engineering Rationale and Bench Testing (or analysis), rather than a clinical trial. The manufacturer submitted documentation demonstrating that the modified screws (shorter versions of existing screws) maintain or improve upon the safety and effectiveness of the predicate screws. This was achieved by providing:
- Material equivalence: Showing the new screws use the identical, implantable grade titanium as the predicate.
- Design equivalence: Confirming that the critical design features (head, diameters, thread) are identical, with only length being varied.
- Mechanical assessment: An engineering rationale that concluded shorter screws would experience lower bending loads (an improvement) compared to longer ones of the same minor diameter.
- Sterilization assessment: An engineering rationale that concluded the reduced total mass of the modified configuration ensured existing sterilization parameters remained valid.
Based on this engineering rationale and bench testing, the FDA determined the modified device (SBi Anatomic Ankle Arthrodesis Interlocking Nail System with the added shorter screws) was substantially equivalent to the predicate device (K112982).
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510(k) Premarket Notification Summary of Safety and Effectiveness
MAY 0 3 2013
Submission Information
| Manufacturer: | Small Bone Innovations, Inc. |
|---|---|
| 1380 South Pennsylvania Avenue | |
| Morrisville, PA 19067 | |
| Ph: 215-428-1791 | Fax: 215-428-1795 |
Submitted By:
Small Bone Innovations, Inc. Joseph Eble 1380 South Pennsylvania Avenue Morrisville, PA 19067
Date: January 24, 2013, Revised March 27, 2013
Proprietary Name: SBi Anatomic Ankle Arthrodesis Interlocking Nail System
Classification name/Identification: Class II, An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures
Product Code: HSB
Common/Usual Name and Reference Number: Intramedullary fixation rod - 21 CJFR 888.3020
Substantial Equivalence: Documentation is provided which demonstrates the modified devices are substantially equivalent to the devices of the SBi Anatomic Ankle Arthrodesis Interlocking Nail System.
Device Description: The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials.
This Premarket Notification is to add 5.0mm Tibial Locking Screws in 20 to 24mm lengths, 5.0 mm Talar Screws with Threaded Head in 40 to 44mm lengths, and 6.0mm Calcaneal Locking Screws with Threaded Head in 50 to 68mm lengths to the system.
Intended Use: The SBi Anatomic Ankle Arthrodesis Interlocking Nail System intended for tibiotalocalcaneal arthrodesis of the ankle following: Post traumatic and degenerative arthritis involving both ankle and subtalar joints, osteoarthritis, Rheumatoid arthritis, Pseudoarthrosis, Severe foot/ankle deformity, or Instability and skeletal defects after tumor resection. These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint
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replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.
The implants are intended for single use only and will be offered sterile and non-sterile.
The shorter length screws being added by this Special 510(k) are made from implantable grade TiAl6V4 titanium (ASTM F136) which is the same material as the predicate screws.
The design of the shorter screws being added by this Special 510(k) are the same as the predicate screws in that the head designs of the outer and inner diameters and thread are the same. The only difference is that the modified screws are shorter in length.
Current Devices: The modified devices are equivalent to the current devices of the SBi Anatomic Ankle Arthrodesis Interlocking Nail System (K112982).
An Engineering Rationale is provided in the Bench Testing section which concludes that the bending loads will be lower if the screw is shorter while keeping the minor diameter the same.
Additionally the rationale concludes that the total mass of the new set configuration is decreasing (longer screws are being replaced by shorter screws); thus the existing sterilization parameters will still be valid.
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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 & Human Services. The logo consists of a stylized depiction of an eagle with three legs, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is facing right, and its wings are represented by curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2013
Small Bone Innovations, Incorporated % Mr. John Minier 1380 South Pennsylvania Avenue Morrisville, Pennsylvania 19067
Re: K130147
Trade/Device Name: SBi Anatomic Ankle Arthrodesis Interlocking Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 1, 2013 Received: April 2, 2013
Dear Mr. Minier:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. John Minier
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4 Statement of Indications for Use
510(k) Number: K130147
Device Name: SBi Anatomic Ankle Athrodesis Interlocking Nail System
Indications For Use:
The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following:
-
Post traumatic and degenerative arthritis involving both ankle and subtalar joints,
-
Rheumatoid arthritis,
-
Osteoarthritis,
-
Pseudoarthrosis,
-
Severe foot/ankle deformity, or
-
Instability and skeletal defects after tumor resection.
These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.
Prescription Use V (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)
Page 1 of 1
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.