(158 days)
None
No
The description focuses on mechanical components and manual activation, with no mention of AI/ML terms or functionalities.
Yes
The device is described as a "Distraction device" intended for "distraction osteogenesis" to increase bone mass and height, which is a therapeutic intervention.
No
The device is described as a 'Rod-5 Distraction device' intended for increasing bone mass and height through distraction osteogenesis. Its function involves mechanical distraction to facilitate bone growth, not to diagnose a condition.
No
The device description clearly outlines physical components like bondable attachments, a horizontal rod, spring washers, detents, and a screwdriver, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description of the Rod-5 Distraction device clearly indicates it is a surgical device used in vivo (within the body) to facilitate bone growth through distraction osteogenesis. It is a physical device used to mechanically manipulate bone, not to analyze biological samples.
The device's function is entirely focused on a surgical procedure to correct bone deficiencies, which is outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.
Maxillo Mandibular deficiencies
Product codes
MQN
Device Description
The device consists of two bondable attachments and a horizontal rod that spans the distraction site. the rod is supported by these attachments which are bonded to the teeth and has holes for engagement of distraction wire. The spring washers and detents allow for activation of the device during distraction and provide a self-locking mechanism to prevent deactivation of the device. The device is activated by a screwdriver, which is inserted in to the screwdriver slot, pushed against the washer to disengage the detent, and then rotated. The device is predominately - tooth bone, with only a fixation wire attached to the bone; no screws are required. Removal of the device requires only cutting the fixation wire. The wire can then be pulled through the bone and soft tissue without the need for an incision.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cranio/Facial surgeons
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)
KLS-Martin Track Distractor K002152
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 (as required by 807.92(c))
JAN 2 8 2005
| Submitter of 510(k): | Oral Osteodistraction, L.P.
600 W. Lake Cook Rd., Suite 150
Buffalo Grove, IL 60089 | |
|-------------------------|-------------------------------------------------------------------------------------------|--|
| | Phone: 847-215-7554
Fax: 847-215-7563 | |
| Contact Person: | Yan Razdolsky | |
| Date of Summary: | July 1, 2004 | |
| Trade/Proprietary Name: | Oral Osteodistraction Distraction Rod Appliance
(ROD 5) | |
| Classification Name: | External Mandibular Fixator and/or Distractor | |
| Product Code: | MQN | |
| Predicate Device: | KLS-Martin Track Distractor K002152 | |
| Intended Use: | | |
The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.
Device Description:
The device consists of two bondable attachments and a horizontal rod that spans the distraction site. the rod is supported by these attachments which are bonded to the teeth and has holes for engagement of distraction wire. The spring washers and detents allow for activation of the device during distraction and provide a self-locking mechanism to prevent deactivation of the device. The device is activated by a screwdriver, which is inserted in to the screwdriver slot, pushed against the washer to disengage the detent, and then rotated. The device is predominately - tooth bone, with only a fixation wire attached to the bone; no screws are required. Removal of the device requires only cutting the fixation wire. The wire can then be pulled through the bone and soft tissue without the need for an incision.
1
Comparison Chart
| | Oral Osteodistraction
ROD - 5 | KLS Martin Track
Distractor - K002152 |
|------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Material | Polyurethane and Stainless
Steel | T1-6AL-4V Titanium Alloy |
| Distraction Rate | 1.0 mm/day | Same |
| Distraction Mechanism | Rod with holes for distraction
wire (.025") attached through
pt. bone | Threaded rod with attached
titanium plates fixed to one
with titanium screws |
| Distraction Activation | Screwdriver | Same |
| Site of Distraction | Tooth-borne, bone borne
(wire only) | Bone borne |
| Target Use | Cranio/Facial surgeons | Same |
| Latency Period | 3-7 Days | 5-7 Days |
| Distraction Period | 7-14 Days | Same |
| Retention Period | 3-6 Weeks | Same |
| Intended Use | Maxillo Mandibular
deficiencies | Same |
| Surgical Technique | Osteotomy | Same |
:
: 上
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
JAN 2 8 2005
ood and Drug Administratio 00 Corporate Boulevard Rockville MD 20850
Oral Osteodistraction, L.P. C/O Mr. Arthur J. Ward AJW Technology Consultants, Incorporated 962 Allegro Lane, Apollo Beach, Florida 33572
Re: K042278
Trade/Device Name: Oral Osteodistraction Distraction Rod Appliance (ROD 5) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: December 22, 2004 Received: January 21, 2005
Dear Mr. Ward:
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 - Mr. Ward
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,
Chiu, Lin, 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): _ | > 2 2 7 8
Device Name: Oral Osteodistraction Distraction Rod Appliance (ROD 5)
Indications for Use:
The Rod-5 Distraction device is intended for use in patients with bone loss due to periodontal disease, trauma or post tumor resection, Ankylosed teeth, or Atrophic boney areas inadequate for implant placements or restorative procedures which need to increase in bone mass and height by means of distraction osteogenesis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sun. Rur
Division Sign-Off) Olvision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K042278
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