(28 days)
General indications: The Inion CPS" Baby 1.5 Bioabsorbable Fixation System is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface and maxilla.
Specific indications:
- Fractures of the cranium, midface 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, midface or ● maxilla.
- . Craniotomy flap fixation.
Not Found
This is a 510(k) premarket notification for a medical device (Inion CPS™ Baby 1.5 Bioabsorbable Fixation System), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, experts, and comparison to AI performance is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K010351) for the same intended use. It describes the device, its intended use, classifications, and the FDA's clearance.
There is no information within this document that describes:
- Acceptance criteria for an AI/ML model's performance.
- Any study proving a device meets such criteria through a performance evaluation using a test set.
- Data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for ONION Intelligent Solution. The logo features the word "ONION" in bold, sans-serif font, with the first "O" stylized as a solid circle. Below the word "ONION" is the tagline "Intelligent Solution" in a smaller, italicized font. The logo is presented in white against a black background.
033194
510(k) SUMMARY For the Inion CPS™ Baby 1.5 Bioabsorbable Fixation System September/25/2003
ADMINISTRATIVE INFORMATION
Manufacturer´s Name:
Inion Ltd. Lääkärinkatu 2 FIN-33520 Tampere
Contact Person: Hanna Marttila Regulatory Affairs Manager Phone: +358 3 230 6600 Fax:
DEVICE NAME
Common/Usual Name: bone plating system Classification Name: bone plates and screws
ESTABLISHMENT REGISTRATION NUMBER
9710629
DEVICE CLASSIFICATION AND PRODUCT CODE
As shown in 21 CFR 888.3040 bone fixation fasteners are classified as Class II. Screws have been assigned Product Code HWC.
As shown in 21 CFR 872.4760 bone plates are classified as Class II. Bone plates have been assigned Product Code 76 JEY
PREDICATE DEVICE
(1) Inion CPS™ Baby 1.5 Bioabsorbable Fixation System (K010351)
{1}------------------------------------------------
INTENDED USE
Indications for use remain identical with the previously cleared Inion CPSTM Baby Bioabsorbable Fixation System (K010351) and are as follows:
General indications: The Inion CPS" Baby 1.5 Bioabsorbable Fixation System is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface and maxilla.
Specific indications:
- Fractures of the cranium, midface 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, midface or ● maxilla.
- . Craniotomy flap fixation.
Contraindications:
The Inion CPS 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.
EQUIVALENCE TO MARKETED PRODUCTS
The Inion CPS" Baby 1.5 Bioabsorbable Fixation System is identical to the previously cleared Inion CPS™ Baby 1.5 Bioabsorbable Fixation System (K010351). Devices itself have not been modified.
Based on 80 weeks data in vitro degradation data Inion has up to date, we believe, it is justified to claim implants to loose their strength over 9-16 weeks in vivo with complete strength loss and resorption within one to two years. This change does not raise any new questions on safety and effectiveness.
{2}------------------------------------------------
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 stripes forming its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
OCT 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Hanna Marttila Regulatory Affairs Manager Inion Limited Lääkärinkatu 2 FIN-33520, Tampere FINLAND
Re: K033194
Trade/Device Name: Inion CPS™ Baby 1.5 Bioabsorbable Fixation System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 25, 2003 Received: October 3, 2003
Dear Ms. Marttila:
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.
{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 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.
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 (301) 594- 4613. 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/dsma/dsmamain.html
Sincerely yours,
R. Carlos
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}------------------------------------------------
D STATEMENT OF INDICATIONS FOR USE
Applicant: Inion Ltd. 510(k) Number: Device Name: Inion CPS ™ Baby 1.5 Bioabsorbable Fixation System
Indications for Use:
Indications:
- A. General indications: The Inion CPS" Baby 1.5 Bioabsorbable Fixation System is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface and maxilla.
- B. Specific indications:
- Fractures of the cranium, midface 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, midface or ● maxilla.
- Craniotomy flap fixation. .
Contraindications:
The Inion CPS 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 3. bone; and where patient cooperation cannot be guaranteed. (e.g., alcoholism, drug abuse)
-
- DO NOT USE in the mandible.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
SuvelRung (Optional Format 1-2-96)
Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number:
§ 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.