(84 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI/ML. The device description is minimal and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic performance.
No
This device is described for use in trauma and reconstructive procedures, which are surgical interventions, not therapeutic treatments.
No
The 'Intended Use / Indications for Use' states that the device is "indicated for use in trauma and reconstructive procedures." This suggests a surgical or treatment device, not one used for diagnosis. There is no mention of identifying, classifying, or predicting disease.
No
The summary describes a device intended for trauma and reconstructive procedures in the midface and craniofacial skeleton, which strongly suggests a physical implant or surgical tool, not a software-only device. There is no mention of software, image processing, or AI.
Based on the provided information, the BONAMATES® series is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "trauma and reconstructive procedures in the midface and craniofacial skeleton." This describes a surgical or procedural use within the body, not a diagnostic test performed on samples taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description is simply "BONAMATES® Series," which doesn't suggest a diagnostic function.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
Therefore, the BONAMATES® series appears to be a medical device used for surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BONAMATES® series are indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
midface and craniofacial skeleton
Indicated Patient Age Range
adults and children
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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.
Not Found
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 2004
BioTech One, Incorporated C/O Ms. Karen Uyesugi U.S. Consultant Uyesugi & Associates 92 Costa Brava Laguna Niguel, California 92677
Re: K040650
Trade/Device Name: BONAMATES® Series Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 29, 2004 Received: March 11, 2004
Dear Ms. Uyesugi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the relefenced above and nave acternialsoure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to activelic Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Connenay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 If your device is classified (boo acc iditional controls. Existing major regulations affecting (1 MA), it hay of subject to tax of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 -Ms. Uyesugi
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be act rised that 1 D a determination that your device complies with other requirements modi that I Dri mas made statutes and regulations administered by other Federal agencies. of the Act of ally I ederal bane Act's requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT rate 007), abstitus (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadisation 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) This letter will anow your even finding of substantial equivalence of your device to a premarket notification. - Indevice 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), If you desire specific at 100 % pliance 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 may obtain 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,
Carl 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
2
BioTech One, Inc. 510(k) Notification
・・
BONAMATES® Series
:
: : : : :
510(k) number (if known):
BONAMATES® Series Device Name:
: : :
Indications for Use:
BONAMATES® Series:
The BONAMATES® series are indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton in adults and children.
Susan Ryan
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthoulors.
510(k) Number:
(PLEASE DO NOT WRITE BFILOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use ________