(71 days)
A. General indications: In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures.
B. Specific indications:
- Craniofacial skeleton, cranium, mid-face, maxilla, and mandible
- Metacarpus, proximal and middle phalangeal bones
- Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax
Inion CPS/OTPS FreedomPlate™ implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers and they are provided in sizes typical to this application. Inion CPS/OTPS FreedomPlate 1.5 implants gradually lose their strength during 18-36 weeks in vivo. Bioresorption takes place within two to four years.
Inion CPS/OTPS FreedomPlate™ implants are provided sterile to the user. The shelf life of the device is 3 years.
The provided text is a 510(k) summary for the Inion® CPS/OTPS FreedomPlate™. This document establishes substantial equivalence to predicate devices, rather than outlining a study that proves the device meets specific acceptance criteria in the way a medical AI/software device would.
Therefore, many of the requested categories are not applicable to this type of medical device submission. The device is a physical bone fixation plate, not a software algorithm that performs a diagnostic or predictive task.
Here's an attempt to address the questions based on the provided text, indicating "Not Applicable" where the information is not present or relevant to this type of device.
1. Table of acceptance criteria and the reported device performance
For substantial equivalence, acceptance criteria are typically met by demonstrating that the new device has the same intended use, similar technological characteristics, and no new questions of safety or effectiveness compared to predicate devices. The "performance" is primarily defined by its material properties and degradation profile being comparable.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use: Maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses, bone grafts, maintenance of relative position of weak bony tissue (etc.), in trauma/reconstructive procedures, and cement restriction in total joint arthroplasty procedures. | Substantially equivalent to predicate devices: The intended use of Inion CPS/OTPS FreedomPlate™ is the same as the predicate devices. |
| Material Composition: Biodegradable polymers (polylactic acid / trimethylenecarbonate copolymers). | Made of: resorbable polylactic acid / trimethylenecarbonate copolymers. |
| Technological Characteristics: Loss of strength, bioresorption timeline. | Gradually lose strength: during 18-36 weeks in vivo. Bioresorption: within two to four years. |
| Mechanical Properties: (Not explicitly detailed in numerical values, but implied to be comparable to predicates). | Substantially equivalent to predicate devices: Based on performance data and specifications presented, mechanical properties are substantially equivalent. |
| Degradation Profile: (Not explicitly detailed in numerical values, but implied to be comparable to predicates). | Substantially equivalent to predicate devices: Based on performance data and specifications presented, degradation profile is substantially equivalent. |
| Safety and Effectiveness: No new questions raised compared to predicates. | Conclusion: Differences with predicate devices do not raise new questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a physical medical device (bone fixation plate) being submitted for substantial equivalence, not a software device or diagnostic test. The evaluation is based on material properties, design, and comparison to existing devices, not a clinical trial or AI test set.
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 as typically understood for an AI/software device does not apply here. The evaluation is based on engineering principles, material science, and regulatory comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 device is a physical bone fixation plate, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the typical sense. The "ground truth" for this submission is regulatory in nature: the established safety and effectiveness of the predicate devices based on their material properties, mechanical performance, and clinical history. The new device demonstrates "substantial equivalence" to this established "truth."
8. The sample size for the training set
Not applicable. This is a physical medical device.
9. How the ground truth for the training set was established
Not applicable.
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K063410 pg 42
Image /page/0/Picture/2 description: The image shows a logo with the letters 'ON' in a bold, sans-serif font. Below the letters, there is some text that appears to say 'nt Solution'. The background is divided into two sections, with the right side being a solid black color and the left side being a lighter color with some vertical lines.
Inion® CPS/OTPS FreedomPlate™
JAN 2 3 2007
Indications for use
A. General indications: In the presence o appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures.
- B. Specific indications:
-
- Craniofacial skeleton, cranium, mid-face, maxilla, and mandible
-
- Metacarpus, proximal and middle phalangeal bones
-
- Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax
Substantial equivalence to marketed products
Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion CPS/OTPS FreedomPlate™ are substantially equivalent with the predicate devices Inion® CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352), Inion® OTPS™ Biodegradable "Mini Plating System (K023887) and Inion® OTPS™ Biodegradable Mesh Plating System (K031961).
Inion CPS/OTPS FreedomPlate™ is sulvstantially equivalent to predicate Class II devices, when used, in the presence of appropriate additional immobilization or fixation. for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures, because the differences between Inion CPS/OTPS FreedomPlate™ and the predicate devices do not raise new questions of safety and effectiveness.
{1}------------------------------------------------
510(k) SUMMARY
Image /page/1/Picture/1 description: The image shows a logo with the word "ION" in large, bold letters. Below the word "ION" is the phrase "ent Solution" in a smaller font. The left side of the image has a textured, speckled appearance, while the right side is mostly black with some vertical white lines.
Inion® CPS/OTPS FreedomPlate™
page 2 of 2
Manufacturer and submitter Inion Oy, Lääkärinkatu 2, FIN-33520 Tampere, FINLAND
Contact Person
Kati Marttinen, Regulatory Affairs Specialist Phone: +358 3 2306 600 Fax: +358 3 2306 691 kati.marttinen@inion.com
Establishment registration number 9710629
Trade name of the device Inion® CPS/OTPS FreedomPlate™
Device classification and product code
Class II Classification Panel: Orthopedic Product Code: HRS Common name: Plate, fixation, bone Regulation number: 21 CFR 888.3030
Predicate devices
Inion® CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352) Inion® OTPS™ Biodegradable Mini Plating System (K023887) Inion® OTPS™ Biodegradable Mesh Plating System (K031961)
Conformance with performance standards
No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.
Device description and principles of operation
Inion CPS/OTPS FreedomPlate™ implants are made of resorbable polylactic acid / trimethylenecarbonate copolymers and they are provided in sizes typical to this application. Inion CPS/OTPS FreedomPlate 1.5 implants gradually lose their strength during 18-36 weeks in vivo. Bioresorption takes place within two to four years.
Inion CPS/OTPS FreedomPlate™ implants are provided sterile to the user. The shelf life of the device is 3 years.
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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 eagle with three bars representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inion Oy % Ms. Kati Marttinen Regulatory Affairs Specialist Lija akiarinkatu 2 33520 Tampere, FINLAND
JAN 2 3 2007
Re: K063410 Trade/Device Name: Inion® CPS/OTPS Freedom Plate™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 10, 2006 Received: November 13, 2006
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.
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.
{3}------------------------------------------------
Page 2 - Ms. Kati Marttinen
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
1/22/07
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Statement of Indications for Use
510(k) Number:
Ko63410
Device Name:
Inion® CPS/OTPS Freedor::Plate™
INDICATIONS
A. General indications: In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures, and cement restriction in total joint arthroplasty procedures.
B. Specific indications:
-
- Craniofacial skeleton, cranium, mid-face, maxilla, and mandible
-
- Metacarpus, proximal and middle phalangeal bones
-
- Long bones, flat bones, short bones, irregular bones, appendicular skeleton, and thorax
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | ---------- |
AND/OR
| Over-The-Counter Use(21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | LC63410 |
|---|---|
| --------------- | --------- |
Page 1 of 1
§ 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.