(14 days)
No
The summary describes a bioabsorbable fixation system for surgical procedures and does not mention any AI or ML components.
Yes
The device is described as a "Fixation System" intended for use in "trauma and reconstructive procedures" for various conditions like "fractures," "craniosynostosis," and "congenital malformations," all of which aim to treat or alleviate a medical condition.
No
The device is a bioabsorbable fixation system intended for use in trauma and reconstructive surgical procedures, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Bioabsorbable Fixation System," which are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device used in vivo (within the body) for surgical procedures to fix fractures and perform reconstructive procedures on the craniofacial skeleton. IVDs are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description reinforces the use of the device as an implantable fixation system for surgical procedures.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical functions of an IVD.
This device is a surgical implant used for mechanical fixation, not for diagnostic testing.
N/A
Intended Use / Indications for Use
- General indications: The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION A. SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla.
- в. Specific indications:
- · Fractures of the cranium, mid-face and maxilla
- · Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations)
- · LeFort (I, II, III) osteotomies
- · Pediatric reconstructive procedures
- · Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla
- · Craniotomy flap fixation
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
The Inion CPS™ Baby 1.5 Bioabsorbable Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. Specific indications:
- . Fractures of the cranium, mid-face and maxilla
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations) .
- LeFort (I, II, III) osteotomies .
- . Pediatric reconstructive procedures
- Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla .
- . Craniotomy flap fixation.
The new large X plate is identical with the other implants in the previously 510(k) cleared Inion CPSTM Baby 1.5 Bioabsorbable Fixation System (K010351) in terms of copolymer composition, intended use and indications for use as described in the device labelling, manufacturing method, sterilization method and packaging solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton, mid-face, maxilla, cranium, mandible
Indicated Patient Age Range
Infant, Pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
K052 444
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Image /page/0/Picture/2 description: The image shows a logo with the word "INION" in large, bold white letters against a black background. Below the word "INION", there is the phrase "Intelligent Solution" in a smaller, white font. The logo appears to be for a company or product named INION, emphasizing its focus on intelligent solutions.
SEP 2 0 2005
SPECIAL 510(k) SUMMARY for the line extension of INION CPS ™ Baby 1.5 Bioabsorbable Fixation System (K010351)
MANUFACTURER Inion Ltd., Lääkärinkatu 2, FIN-33520 Tampere, FINLAND
Contact Person
Hanna Marttila, Regulatory Affairs Director Lääkärinkatu 2, FIN-33520 Tampere Phone: +358 3 2306 600 Fax: +358 3 2306 691 hanna.marttila@inion.com
DEVICE NAME
Trade name: Large X plate Common/Usual Name: Bone plate
ESTABLISHMENT REGISTRATION NUMBER 9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
Classification Panel: Dental Regulation Number: 21 CFR 872.4760 Regulation Name: Bone plate Regulatory Class: Class II Product Code: JEY
PREDICATE DEVICE
Howmedica Leibinger Resorbable Fixation System (K982531)
CONFORMANCE WITH PERFORMANCE STANDARDS
No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application.
THE REASON FOR SCPECIAL 510(k)
Additional plate design to Inion CPS™ Baby 1.5 Bioabsorbable Fixation System (K010351).
1
Image /page/1/Picture/1 description: The image shows the logo for INION Intelligent Solution. The logo is white text on a black background. The word INION is in large, bold letters, and the words Intelligent Solution are in smaller letters below.
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The Inion CPS™ Baby 1.5 Bioabsorbable Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla. Specific indications:
- . Fractures of the cranium, mid-face and maxilla
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations) .
- LeFort (I, II, III) osteotomies .
- . Pediatric reconstructive procedures
- Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla .
- . Craniotomy flap fixation.
The new large X plate is identical with the other implants in the previously 510(k) cleared Inion CPSTM Baby 1.5 Bioabsorbable Fixation System (K010351) in terms of copolymer composition, intended use and indications for use as described in the device labelling, manufacturing method, sterilization method and packaging solution.
Similar design from other manufacturers is currently commercially available and in clinical use.
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™ Baby 1.5 Bioabsorbable Fixation system large X plate are substantially equivalent with the other Inion CPS™ Baby 1.5 Bioabsorbable Fixation system (K010351) implants as well as the predicate device Howmedica Leibinger Resorbable Fixation System (K982531).
Inion CPS™ Baby 1.5 Bioabsorbable Fixation system large X plate is substantially equivalent to predicate Class II devices used in maintaining accurate alignment of bone fractures and osteotomies in the cranium and mid-face because the differences between Inion CPS™ Baby 1.5 Bioabsorbable Fixation system large X plate and the predicate devices do not raise new questions of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the logo.
SEP 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Hanna Marttila Regulatory Affairs Director Inion Limited Laakarinkatu 2 Tampere, FINLAND 33520
Re: K052444
R022444
Trade/Device Name: Inion CPS™ Baby 1.5 Bioabsorbable Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 25, 2005 Received: September 6, 2005
Dear Ms. Marttila:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becales or child 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 Interstate continered prior to that have been reclassified in accordance with the provisions of Amendinents, or to do rooms and tic Act (Act) that do not require approval of a premarket the roderal I ood, Drug, and Ocentraly, therefore, market the device. subject to the general approval uppressions of the Act. The general controls provisions of the Act include confors providens of an 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 (1 MA), it may of subject to tach adala f Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the beach nouncements concerning your device in the Federal Register.
3
Page 2 -- Ms. Marttila
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 modifine and Federal statutes and regulations administered by other Federal agencies. or the Act of all , eath all the Act's requirements, including, but not limited to: registration r ou intist contpry wart 807); labeling (21 CFR Part 801); good manufacturing practice alle fishing (21 CF rate of 1), and 10 the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quarity sion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will are n Jourse of Substantial equivalence of your device to a premarket notification - 11 - 11 - 11 - 11 - 11 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you desire specific at Compliance at (240) 276-0115. 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 yours,
Clive
Shia-Lian, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Inion CPS1M Baby 1.5 Bioabsorbable Fixation System
Indications for Use:
- General indications: The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION A. SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla.
- в. Specific indications:
- · Fractures of the cranium, mid-face and maxilla
- · Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations)
- · LeFort (I, II, III) osteotomies
- · Pediatric reconstructive procedures
- · Orthognathic or reconstructive procedures of the cranium, mid-face, or maxilla
- · Craniotomy flap fixation
Contraindications:
The INION CPSIM BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is not intended for use in and is contraindicated for mandibular tumor resection; active or potential infection; patient conditions including limited blood supply, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse). DO NOT use in the mandible.
V Prescription Use (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)
Susan Runne
n of Anesthesiology, General Hospital Infection Control, Dental D
510(k) Number
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