The INION CPS™ BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is intended 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.

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Inion CPS™ Baby 1.5 Bioabsorbable Fixation System). It focuses on establishing substantial equivalence to a predicate device and discusses product specifications, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a dataset analysis.

The document states:

"No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application." This suggests that the primary evaluation was against existing standards and predicate devices, rather than a specific performance study with acceptance criteria.
"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)." This highlights the reliance on equivalence to predicate devices, not a standalone performance study as described in your prompt's questions.

Therefore, I cannot extract the requested information based on the input document as it does not contain details about:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm only) performance study.
Type of ground truth used for a test set.
Sample size for the training set or how its ground truth was established.

This document is a regulatory submission focused on demonstrating substantial equivalence of a new design (large X plate) to an already cleared device and a predicate device under 510(k) regulations, rather than a clinical or performance study report with specific acceptance criteria as you've outlined.

Summary

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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).

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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.

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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.

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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

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K052444

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

Page 1 of 1

Regulation Number and Section

§ 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.