(253 days)
Not Found
No
The 510(k) summary describes a mechanical bone transport system and does not mention any AI or ML components or functionalities.
Yes
The device is used to correct bone deficiencies and defects through gradual distraction, which is a therapeutic intervention.
No
The device description clearly states its intended use is for bone stabilization, lengthening, and transport, not for diagnosing medical conditions.
No
The device description explicitly lists physical components made of titanium alloy and stainless steel, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for bone stabilization, lengthening, and transport. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information about a person's health.
- Device Description: The device components (reconstruction plate, screws, bone transport unit) are all designed for surgical implantation and manipulation within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with IVD devices.
This device is a surgical implant used for orthopedic reconstruction, not a diagnostic tool used on biological specimens.
N/A
Intended Use / Indications for Use
The Craniotech Bone Transport Reconstruction Plate (BTRP) system includes devices intended as a bone stabilizer, lengthening and/or transport device when correction of congenital or developmental bone deficiencies or post-traumatic or post-surgical defects of the mandible (including ramus, body, alveolar ridge, symphisis) and mid-face bones require gradual distraction.
Product codes
MQN
Device Description
The device contains a reconstruction plate and screws of TiAl6V4 titanium alloy, and a stainless steel bone transport unit, activation screw and flexible cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible (including ramus, body, alveolar ridge, symphisis) and mid-face bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
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.
0
510(k) SUMMARY
| MAY 1 1 2007 | ||||||
|---|---|---|---|---|---|---|
| Submitter Name: | Custom Scientific | |||||
| Submitter Address: | 7021 Haverford Drive | |||||
| Dallas, TX 75214 | ||||||
| Contact Person: | Mr. Timothy Mulone | |||||
| Phone Number: | 214.343.3688 | |||||
| Fax Number: | 214.503.8192 | |||||
| Date Prepared: | August 31, 2006 | |||||
| Device Trade Name: | Craniotech Bone Transport Reconstruction Plate (BTRP) | |||||
| Device Common Name: | External Mandibular Fixator and/or Distractor | |||||
| Classification Number: | 21 CFR 872.4760 | |||||
| Classification Name: | Bone Plate | |||||
| Product Code: | MQN | |||||
| Predicate Device: | K010139; Zurich Distraction System; KLS-Martin L.P. | |||||
| Statement of Intended | ||||||
| Use: | The Craniotech Bone Transport Reconstruction Plate (BTRP) system includes devices intended as a bone stabilizer, lengthening and/or transport device when correction of congenital or developmental bone deficiencies or post-traumatic or post-surgical defects of the mandible (including ramus, body, alveolar ridge, symphisis) and mid-face bones require gradual distraction. | |||||
| Device Description: | The device contains a reconstruction plate and screws of TiAl6V4 titanium alloy, and a stainless steel bone transport unit, activation screw and flexible cable. | |||||
| Comparison to the | ||||||
| Predicate Devices: | Based upon the intended use, design, materials, and the testing conducted, it can be concluded the BTRP is substantially equivalent to the predicate device in terms of intended use, safety and effectiveness. |
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Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 2007
Craniotech ACR Device, LLC C/O Ms. Patsy J. Trisler 5600 Wisconsin Avenue, # 509 Chevy Chase, Maryland 20815
Re: K062572
Trade/Device Name: Craniotech Bone Transport Reconstruction Plate Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: May 4, 2007 Received: May 7, 2007
Dear Ms. Trisler:
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.
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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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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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510(k) Number (if known):
Device Name:
Craniotech Bone Transport Reconstruction Plate
Indications for Use:
The Craniotech Bone Transport Reconstruction Plate (BTRP) system includes devices intended as a bone stabilizer, lengthening and/or transport device when correction of congenital or developmental bone deficiencies or post-traumatic or post-surgical defects of the mandible (including ramus, body, alveolar ridge, symphisis) and mid-face bones require gradual distraction.
Prescription Use X (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)
(Posted November 13, 2003)
Susan Runner
on of Anesthesiology, General Hospital
K Number: K062572