K Number
K990140
Device Name
NORMED BONE TRANSPORT
Date Cleared
1999-03-25

(65 days)

Product Code
Regulation Number
872.4760
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical Indications are as follows: - · Tumor Resections - Severe trauma which make continuous bone segments no longer possible - · Bone grafting defects - · Severe open mandibular fractures - · Facial deformity corrections
Device Description
The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.
More Information

Not Found

Not Found

No
The description focuses on a mechanical device for bone distraction and does not mention any software, algorithms, or data processing that would indicate AI/ML.

Yes
The device is described as being used to increase bone height and mass by means of distraction osteogenesis, and for correcting various clinical indications such as tumor resections, trauma, and facial deformities, which are therapeutic applications.

No

The device is described as a "Transport Distraction Device" used to increase bone height and mass through distraction osteogenesis, which is a therapeutic treatment. It does not mention diagnosing conditions.

No

The device description explicitly refers to a "transitory monofocal or bifocal distraction device," which is a physical medical device used in surgical procedures. The summary does not mention any software component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Function: The ACE/Normed Transport Distraction Device is a surgical implant used to physically increase bone height and mass through distraction osteogenesis. It is used in the body, not to test samples from the body.
  • Intended Use: The intended use clearly describes a surgical procedure and the device's role in that procedure, not a diagnostic test.
  • Device Description: The description reinforces its function as a physical device for bone manipulation.

Therefore, this device falls under the category of a surgical or implantable device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

Indications: The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical Indications are as follows: · Tumor Resections · Severe trauma which make continuous bone segments no longer possible · Bone grafting defects · Severe open mandibular fractures · Facial deformity corrections Contraindications: The ACE/Normed Transport Distraction Device is contraindicated in patients with insufficient available bone, poor bone quality, and generalized diseases, allergies or habits (uncontrolled diabetes, blood dvcrasias, hyperthyroidism, AIDS, alcohol addiction, psychiatric disorders, oral infections, malignancies, myocardial infarction within the last 12 months, heavy smoking, use of chewing tobacco, poor oral hygiene, etc.) that may contribute to poor healing or osteogenesis formation of bone. The patient's good medical health status and history is mandatory. In addition, a radiographic evaluation to examine the anatomical condition of the patient for proper use of the defined surgical protocol is required.

Product codes

JEY

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillofacial alveolar and small craniofacial skeletal bones, mandibles, maxillae

Indicated Patient Age Range

Not Found

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)

Not Found

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

J. Edward Carchidi, D.D.S. President Ace Surgical Supply Company, Incorporated 1034 Pearl Street P.O. Box 1710 Brockton, Massachusetts 02403

Re : K990140 Normed Bone Transport Trade Name: Regulatory Class: II Product Code: JEY January 15, 1999 Dated: Received: January 19, 1999

Dear Dr. Carchidi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

1

Page 2 - Dr. Carchidi

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patriaux Cusenite ffe

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

510(k) NUMBER (IF KNOWN): K990140

ACE/NORMED TRANSPORT DISTRACTION DEVICE DEVICE NAME:

INDICATIONS FOR USE:

Indications:

The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.

Clinical Indications are as follows:

  • · Tumor Resections
  • Severe trauma which make continuous bone segments no longer possible
  • · Bone grafting defects
  • · Severe open mandibular fractures
  • · Facial deformity corrections

Contraindications:

The ACE/Normed Transport Distraction Device is contraindicated in patients with insufficient available bone, poor bone quality, and generalized diseases, allergies or habits (uncontrolled diabetes, blood dvcrasias, hyperthyroidism, AIDS, alcohol addiction, psychiatric disorders, oral infections, malignancies, myocardial infarction within the last 12 months, heavy smoking, use of chewing tobacco, poor oral hygiene, etc.) that may contribute to poor healing or osteogenesis formation of bone. The patient's good medical health status and history is mandatory. In addition, a radiographic evaluation to examine the anatomical condition of the patient for proper use of the defined surgical protocol is required.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) Susan
(Division Sign-Off)
Over-The-Counter-Use
(Optional Format 1-2-1
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 9901411