(85 days)
No
The device description details a purely mechanical device for bone distraction, with no mention of software, algorithms, or any components that would suggest AI/ML functionality. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is used for maxillary and midface osteodistraction in the reconstruction of congenital and acquired craniofacial anomalies, which is a therapeutic purpose.
No
The device is described as a "Distraction device" used for "Osteodistraction in the reconstruction of patients," indicating a therapeutic or reconstructive purpose rather than diagnostic.
No
The device description explicitly details physical components such as stainless steel crowns, precision attachments, hyraax screws, bone plates, and mini screws, which are hardware.
Based on the provided information, the Rod-4 Distraction device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Rod-4 Function: The Rod-4 Distraction device is a surgical implant used to physically move and reshape bone in the maxillary and midface region. It is a mechanical device that directly interacts with the patient's anatomy.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens. Its function is entirely focused on mechanical distraction of bone.
Therefore, the Rod-4 Distraction device falls under the category of a surgical device or implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.
Product codes
MQN
Device Description
The device consists of two to four preformed stainless steel crowns, which are cemented over maxillary first permanent molars and first permanent bicuspids. Stainless steel crowns have male and female precision attachments welded to them prior to cementation. Three Leone hyraax screws are also welded to the above-described attachments (two on the buccal and one on the palatal surfaces). The device is activated by a screwdriver, which is inserted in to the screwdriver slot of the hyraax screw and then rotated. The device is predominately - tooth bone, with KILS bone plates attached to the bone. Surgical mini screws are required to secure bone plates to the bone. Removal of the device requires removal of mini screws and removal of the crows.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and midface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Craniofacial Surgeon
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 Rigid External Distractor K972047, Oral Osteodistraction Rod Appliances (Rod 1,2,3) K014001
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
MAR 2 3 2004
510(K) SUMMARY (as required by 807.92(c)) K034045
| 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: | March 14, 2004 | | |
| Trade Name: | Oral Osteodistraction Distraction Rod Appliances (Rod 4) | | |
| Classification Name: | External Maxillary Fixator and/or Distractor - MQN | | |
| Predicate Device: | KLS Martin Rigid External Distractor K972047
Oral Osteodistraction Rod Appliances (Rod 1,2,3) K01400 | | |
Intended Use:
The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.
Device Description:
The device consists of two to four preformed stainless steel crowns, which are cemented over maxillary first permanent molars and first permanent bicuspids. Stainless steel crowns have male and female precision attachments welded to them prior to cementation. Three Leone hyraax screws are also welded to the above-described attachments (two on the buccal and one on the palatal surfaces). The device is activated by a screwdriver, which is inserted in to the screwdriver slot of the hyraax screw and then rotated. The device is predominately - tooth bone, with KILS bone plates attached to the bone. Surgical mini screws are required to secure bone plates to the bone. Removal of the device requires removal of mini screws and removal of the crows.
1
Comparison Chart
| | Oral Osteodistraction
ROD 1, 2, 3 -
K014001 | Oral Osteodistraction
Rod 4 | KLS Martin -
K972047 |
|---------------------------|---------------------------------------------------|--------------------------------|-----------------------------|
| Material | Stainless Steel 304 | Stainless Steel 304 | T1-6AL-4V Titanium
Alloy |
| Facial
Skeleton/Pins | Stainless Steel 301 | Stainless Steel 301 | T1-6AL-4V Titanium
Alloy |
| Distraction Rate | .5mm/day first 2 days
then 1mm/day after that | Same | 1 mm/day |
| Fixed to Patient
Bone | Screws | Screws | Screws |
| Completed
Distraction | Geared Rod | Geared Rod | Geared Rod |
| Distraction
Activation | Hex Key | Same | Same |
| Facial Bone
Distractor | Intraoral | Intraoral | Intraoral and External |
| Intended Use | Mandible Distraction | Maxillary | Maxillary |
| Device
Placement | Subcutaneous | Same | Same |
| User | Craniofacial Surgeon | Same | Same |
Rod 4 is essentially the same as Rods 1-3 except for the location of axis change.
Additional Comparison
| | Oral Osteodistraction
ROD 1, 2, 3 – K014001 | Oral
Osteodistraction
Rod 4 | KLS Martin -
K972047 |
|----------------------|------------------------------------------------|-----------------------------------|-----------------------------|
| Site of Distraction | Tooth-borne | Tooth-borne | Tooth-borne and
External |
| Latency Period | 5-7 Days | Same | Same |
| Distraction Period | 7-14 Days | Same | Same |
| Consolidation Period | 8-12 Weeks | Same | Same |
| Surgical Technique | Osteotomy | Same | Same |
| Placement | Internal | Internal | External |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird with three curved lines representing its wings or feathers.
Public Health Service
MAR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Oral Osteodistraction, L.P. C/O Mr. Arthur Ward RMS, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K034045
Trade/Device Name: Oral Osteodistraction Distraction Rod Appliance (Rod 4) Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: December 1, 2003 Received: December 29, 2003
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 - Ms. Rivkowich
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 (OS) 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 (301) 594-5613. 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/dsma/dsmamain.html
Sincerely yours,
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
034045 510(k) Number (if known):
Oral Osteodistraction Distraction Rod Appliance (Rod 4) Device Name:
Indications For Use:
The Rod-4 Distraction device is utilized for the purpose of maxillary and midface Osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies, narrow and underdeveloped maxilla.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use (Optional Format 1-2-96)
Swen
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: J