(60 days)
No
The summary describes a mechanical bone distraction system with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is used for gradual bone lengthening and bone transport, which are considered therapeutic interventions to address congenital deficiencies, mandibular hypoplasia, or post-traumatic defects.
No
The device is described as a "bone stabilizer and lengthening device" used for gradual bone lengthening and transport, which are treatment modalities, not diagnostic processes.
No
The device description explicitly states it is comprised of physical components like distraction arms, a central body, and pin clamps, indicating it is a hardware device.
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 for surgical intervention (bone stabilization and lengthening) directly on the patient's body.
- Device Description: The description details mechanical components designed to be implanted or attached externally to the bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside or on the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The KLS-Martin 3DX External Distraction System is a bone stabilizer and lengthening device when congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible require gradual bone lengthening, including bone transport.
Product codes
MON
Device Description
The device is comprised of two (2) interchangeable distraction arms, a central body which allows angular adjustment of the arms and pin clamps. The pin clamps will accept 2.0mm and 2.7mm Molina (K994154) pins. Bone stabilization can be achieved with carbon rods after distraction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible
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)
KLS Martin Molina Distractor (K994154), Howmedica Inc. Mandibular Bone Distractor II (K960297), Synthes External Multi Vector Mandible Distractor (K981362), Lorenz External Mandibular Distractor (K992873)
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
FEB 27 2004
510(K) SUMMARY
| Submitter: | KLS-Martin, L.P.
11239-1 St. Johns Industrial Parkway South
Jacksonville, FL 32246
Phone: 904-641-7746
Fax: 904-641-7378 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato
Director RA/QA |
| Date of Summary: | December 19, 2003 |
| Device Name: | KLS Martin 3DX External Distraction System |
| Trade Name: | 3DX External Distraction System |
| Common Name: | External Distraction System |
| Classification
Name and Number: | Plate, Bone (CFR 872.4760) |
| Regulatory Class: | Class II |
| Predicate Devices: | KLS Martin Molina Distractor (K994154)
Howmedica Inc. Mandibular Bone Distractor II (K960297)
Synthes External Multi Vector Mandible Distractor (K981362)
Lorenz External Mandibular Distractor (K992873) |
| Intended Use: | The KLS-Martin 3DX External Distraction System is a
bone stabilizer and lengthening device when
congenital deficiencies, mandibular hypoplasia or post
traumatic defects of the mandible require gradual
bone lengthening, including bone transport. |
| Device
Description: | The device is comprised of two (2) interchangeable
distraction arms, a central body which allows angular
adjustment of the arms and pin clamps. The pin |
1
clamps will accept 2.0mm and 2.7mm Molina (K994154) pins. Bone stabilization can be achieved with carbon rods after distraction.
Technological Characteristics:
Similarities to Predicate
The KLS Martin 3DX External Distraction System is the next generation in development based upon the KLS Martin Molina Distractor (K994154). The KLS Martin 3DX External Distraction System is similar to the Howmedica Inc. Mandibular Bone Distractor II (K960297), Synthes External Multi Vector Mandible Distractor (K981362) and the Lorenz External Mandibular Distractor (K992873)
Substantial Equivalence:
The KLS Martin 3DX External Distraction System is substantially equivalent in application and function to the KLS Martin Molina Distractor (K994154), the Howmedica Inc. Mandibular Bone Distractor II the Synthes External Multi Vector (K960297), Distractor (K981362) and the Lorenz Mandible External Mandibular Distractor (K992873).
Substantial equivalence is based on comparison of performance, method of distraction, bone stabilization and clinical literature assessment.
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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines. The logo is black and white.
FEB 27 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer Damato Director Regulatory Affairs Quality Assurance KLS-Martin, L.P. 11239-1 Saint Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K034027
Trade/Device Name: KLS Martin 3DX External Distraction System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MON Dated: December 19, 2003 Received: December 29, 2003
Dear Ms. Damato:
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. Falk
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 (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 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 vours.
Ques
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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Indications for Use
510(k) Number (if known): K > 34027
KLS Martin 3DX External Distraction System Device Name:
Indications For Use:
The KLS Martin 3DX External Distraction System is a bone stabilizer and lengthening device when congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible require gradual bone lengthening, including bone transport.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ryan
(Division Sign-Off) on of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: