(109 days)
The INION FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
The Inion FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of appropriate immobilization. The INION FreedomPin™ products are made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The pins are dyed green for better visualization during the surgical procedure by a minimal amount of Drug and Cosmetic (D&C) Green No. 6, which is used in several biodegradable sutures and implants. Inion FreedomPins have nominal dimensions ranging from 1.5 - 3.2 mm in diameter and 30 - 70 mm in length. In addition, sterile Pin Kits are offered which contain 2-3 pins and the required sterile, single use instruments needed for the insertion. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be resterilized. Inion FreedomPins provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing. Inion FreedomPins are designed to be used with customized instrumentation consisting of drill bits. K-wires, applicators. and arthroscopic pistons and tips.
The provided text describes a 510(k) summary for the Inion FreedomPin™. It details the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not contain the level of detail typically found in a clinical study report or a statistical analysis plan for an AI/ML device.
Therefore, many of the requested categories cannot be fully addressed. The information below reflects what is available in the provided text.
Acceptance Criteria and Study Details for Inion FreedomPin™
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Inion FreedomPin™ does not explicitly state numerical acceptance criteria in the format typically seen for AI/ML performance metrics (e.g., sensitivity, specificity thresholds). Instead, the performance testing aimed to demonstrate "substantial equivalence" to a predicate device in terms of mechanical properties and degradation profile.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as numerical thresholds for AI/ML) | Reported Device Performance |
|---|---|---|
| Mechanical Properties | "Sufficient strength to fulfil their intended function during the healing period." | "Mechanical testing in shear, bending, pull-out and torsion was performed to verify the strength and fixation properties of Inion FreedomPin™ and to compare them to the predicate devices.""The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion FreedomPin™ are substantially equivalent with the predicate device Inion OTPS Biodegradable Pin (K050275)." |
| Degradation Profile | "Degrade gradually thereafter. Bioresorption takes place within two to four years." | "In vitro degradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over healing period as the polymer degrades during in vitro degradation and to ensure the degradation of the Inion FreedomPin™.""The data demonstrates that... degradation profile... of Inion FreedomPin™ are substantially equivalent with the predicate device." |
| Functionality & Handling | "Functioning together as intended, and conform to the defined user needs and intended uses." | "Functional and handling test and simulated clinical use test were performed... The devices have passed the tests for functionality and handling in simulated clinical use settings." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text describes mechanical and in vitro degradation testing, as well as functional and handling tests and simulated clinical use tests. These are not clinical studies with "test sets" in the context of an AI/ML device's performance evaluation on patient data.
- Sample Size for Testing: Not specified in terms of number of pins, but implied to be sufficient for mechanical and degradation tests. It does not refer to patient samples.
- Data Provenance: The tests are described as in vitro and simulated clinical use, meaning they were conducted in a laboratory setting. There is no mention of patient data, geographical origin, or retrospective/prospective nature as this is a physical medical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a physical bone fixation pin, not an AI/ML diagnostic or predictive system that requires expert-established ground truth from medical images or patient records. The "ground truth" for this device would be its physical properties and degradation characteristics, measured through established engineering and chemical testing methods.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation of data for "adjudication" in the context of the described physical and mechanical tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, this was not done. An MRMC study is relevant for AI-powered diagnostic or screening tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Inion FreedomPin™ is a physical implant, not a diagnostic or image-analysis device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The Inion FreedomPin™ is a physical medical device that is implanted surgically and supports bone healing. It does not involve an algorithm that operates "standalone" in the typical sense of AI/ML performance evaluation. Its "performance" is its mechanical integrity and biodegradation profile.
7. The Type of Ground Truth Used
For the Inion FreedomPin™, the "ground truth" for the performance testing refers to:
- Standardized Mechanical Test Results: Measurements of shear strength, bending strength, pull-out strength, and torsion using established engineering test methods.
- In Vitro Degradation Data: Measurements of material and mechanical property changes over time in a controlled laboratory environment mimicking physiological conditions.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence was the known and accepted performance of the predicate device (Inion OTPS Biodegradable Pin K050275), against which the new device's performance was compared.
8. The Sample Size for the Training Set
Not applicable. The Inion FreedomPin™ is a physical device, and its development and testing did not involve a "training set" in the context of AI/ML model development.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reasons as point 8.
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APR 1 1 2014
510(k) SUMMARY Inion FreedomPin™
Image /page/0/Picture/2 description: The image shows the word "INION" in white letters against a black background. The letters are bold and slightly fuzzy, giving them a textured appearance. The word is horizontally oriented and centered in the image.
K133932 page 1 of 2
| Manufacturer and submitter: | Inion Oy,Lääkärinkatu 2,FIN-33520 Tampere, FINLAND |
|---|---|
| Date: | December 16, 2013 |
| Contact person | Kati Marttinen, Quality and Regulatory Director |
| Phone: +358 10 830 6600 | |
| Fax: +358 10 830 6691 | |
| kati.marttinen@inion.com | |
| Establishment registrationnumber | 9710629 |
| Trade name of the device | Inion FreedomPin™ |
| Device classification andproduct code | Class II |
| Classification Panel: Orthopaedic | |
| Product Code: HTY | |
| Common name: Bone fixation pin | |
| Regulation number: 888.3040 | |
| Predicate device | Inion OTPS Biodegradable Pin (K050275) |
| Conformance with performancestandards | Compliance to voluntary consensus standards is listed in theapplication. |
Device description and principles of operation
The Inion FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of appropriate immobilization.
The INION FreedomPin™ products are made of degradable co-polymers composed of Llactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The pins are dyed green for better visualization during the surgical procedure by a minimal amount of Drug and Cosmetic (D&C) Green No. 6, which is used in several biodegradable sutures and implants.
Inion FreedomPins have nominal dimensions ranging from 1.5 - 3.2 mm in diameter and 30 - 70 mm in length. In addition, sterile Pin Kits are offered which contain 2-3 pins and the required sterile, single use instruments needed for the insertion. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be resterilized.
Inion FreedomPins provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.
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510(k) SUMMARY Inion FreedomPin™
INION
K133932 page 2 of 2
Inion FreedomPins are designed to be used with customized instrumentation consisting of drill bits. K-wires, applicators. and arthroscopic pistons and tips.
Indications for use
The Inion FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Performance testing for substantial equivalence determination
Mechanical testing in shear, bending, pull-out and torsion was performed to verify the strength and fixation properties of Inion FreedomPin™ and to compare them to the predicate devices. Testing was conducted initially and during in vitro degradation.
In vitro degradation testing was carried out to determine the degradation profile (i.e., change in material and mechanical properties) and verify the sufficiency of the mechanical stability over healing period as the polymer degrades during in virro degradation and to ensure the degradation of the Inion FreedomPin™.
Functional and handling test and simulated clinical use test were performed to verify that the implants, accessory instruments, packaging and instructions for use are functioning together as intended, and conform to the defined user needs and intended uses.
The data demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion FreedomPin™ are substantially equivalent with the predicate device Inion OTPS Biodegradable Pin (K050275). The devices have passed the tests for functionality and handling in simulated clinical use settings.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11. 2014
Inion Ov Ms. Kati Marttinen Quality and Regulatory Director Lääkärinkatu 2 FIN-33520 Tampere Finland
Re: K133932
Trade/Device Namc: Inion FreedomPin"M Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: March 3. 2014 Received: March 6. 2014
Dear Ms. Marttinen:
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 docs 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
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Page 2 - Ms. Kati Marttinen
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.
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wigqins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K133932
Statement of Indications for Use
K133932 510(k) Number:
Device Name:
Inion FreedomPin™
The INION FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth南極rank -S
Division of Orthopedic Devices
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It 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.(b)
Classification. Class II.