(4 days)
No
The summary describes a bioabsorbable fixation system (plates and screws) for surgical procedures. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The focus is on the physical implants and their material composition.
Yes
The device is described as a fixation system intended for use in trauma and reconstructive procedures, which are medical treatments designed to alleviate or cure a condition, thus making it a therapeutic device.
No
Explanation: The device is a bioabsorbable fixation system used for trauma and reconstructive procedures, such as fixing fractures and supporting bones after osteotomies. It is a treatment device, not one used for diagnosis.
No
The device description clearly states it is a "Bioabsorbable Fixation System" and mentions "plates," indicating it is a physical implantable device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used in surgical procedures for trauma and reconstruction of the craniofacial skeleton, mid-face, and maxilla. This involves direct intervention on the patient's body.
- Device Description: The description reinforces that it's a fixation system (plates and screws) used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body. This device is a surgical implant used to fix bones.
N/A
Intended Use / Indications for Use
The INION CPSTM BABY 1.5 BIOABSORBABLE FIXATION A. SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla.
B. Specific indications:
- Fractures of the cranium, mid-face and maxilla
- Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations)
- LeFort (1, II, III) osteotomies
- Pediatric reconstructive procedures
- Orthopgnathic or reconstructive procedures of the cranium, mid-face, or maxilla
- Craniotomy flap fixation
Product codes
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 40-hole plate and 64-hole plate are identical with the other implants in the previously 510(k) cleared Inion CPS™ 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 and maxilla, cranium, mandible (contraindicated)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K05134/Page 1 of 2
MAY 2 7 2005
Image /page/0/Picture/2 description: The image shows a logo with the word "NION" in large, bold letters. Below "NION" are the words "e t Solutio" in a smaller font. The background of the logo appears to be a series of vertical lines, possibly representing a barcode or a similar pattern. The image quality is somewhat degraded, with some pixelation and noise visible.
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: 40-hole plate, 64-hole 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
LactoSorb Trauma Plating System 1.5 38 hole plate (K992355, K971870)
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 designs to Inion CPSTM Baby 1.5 Bioabsorbable Fixation System (K010351).
1
Image /page/1/Picture/0 description: The image shows a close-up of a logo or text, primarily in black and white. The word "INION" is prominently displayed in a bold, sans-serif font, with the letters appearing to be white against a black background. Below "INION", there is smaller text that reads "Inter ent Solution", also in white. The image has some visual artifacts, such as spots and vertical lines, which may be due to the quality of the image or the printing process.
Page 2 of 2
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 40-hole plate and 64-hole plate are identical with the other implants in the previously 510(k) cleared Inion CPS™ 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 40 hole plate and 64 hole plate are substantially equivalent with the other Inion CPSTM Baby 1.5 Bioabsorbable Fixation system (K010351) implants as well as the predicate device LactoSorb Trauma Plating System 1.5 38 hole plate (K992355, K971870).
Inion CPS™ Baby 1.5 Bioabsorbable Fixation system 40 hole plate and 64 hole plate are 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 40 hole plate and 64 hole 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a series of lines representing people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2005
Ms. Hanna Marttila Regulatory Affairs Director Inion Limited Lääkärinkatu 2, FIN-33520 Tampere FINLAND
Re: K051341
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: May 19, 2005 Received: May 23, 2005
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 (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,
Chris Liu, 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 CPSTM Baby 1.5 Bioabsorbable Fixation System
Indications for Use:
- General indications: The INION CPSTM BABY 1.5 BIOABSORBABLE FIXATION A. SYSTEM is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, mid-face and maxilla.
- B. Specific indications:
- · Fractures of the cranium, mid-face and maxilla
- · Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations)
- · LeFort (1, II, III) osteotomies
- · Pediatric reconstructive procedures
- · Orthognathic or reconstructive procedures of the cranium, mid-face, 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 of bone; and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse). DO NOT use in the mandible.
Prescription Use (Part 21 CFR 801 Subpart D)
. . . . . . . . .
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
and the comments of the comments of the comments of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swag Runne
(Division Sian-Off) Division of Anesthesiology. General Hospital, Intection Control, Dental Devices
Page 1 of 1
510(k) Number: K051341