(53 days)
Not Found
No
The summary describes a system of titanium plates used as anchors for orthodontic procedures. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The description focuses solely on the physical implants.
Yes
The device is surgically implanted and used as an anchor for orthodontic procedures, which is a therapeutic intervention aimed at correcting dental and jaw irregularities.
No
The device is described as an implant used as an anchor for orthodontic procedures, not for identifying or investigating a medical condition.
No
The device description explicitly states that the device includes "several different designs of titanium plates," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implant intended for surgical placement in the mouth as an anchor for orthodontic procedures. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as titanium plates, which are physical implants.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a physical implant used to provide structural support for orthodontic treatment.
N/A
Intended Use / Indications for Use
The KLS-Martin Ortho Anchorage System is intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures.
The KLS-Martin Ortho Anchorage System (Plates) are implants intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients.
Product codes
DZE
Device Description
The KLS-Martin Ortho Anchorage System includes several different designs of titanium plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
palatal, maxilla or mandible region
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
长040891
MAY 2 8 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: | April 5, 2004 |
| Device Name: | KLS-Martin Ortho Anchorage System (Plates) |
| Trade Name: | Ortho Anchorage System |
| Common Name: | Bone Plate |
| Classification
Name and Number: | Endosseous Implant (CFR 872.3640) |
| Regulatory Class: | Class III |
| Predicate Devices: | KLS-Martin Micro Osteosynthesis System
(1.5mm) (K944565) |
| | Nobel Biocare Onplant Orthodontic System
(K980460) |
| Device
Description: | The KLS-Martin Ortho Anchorage System
includes several different designs of titanium
plates. |
| Intended Use: | The KLS-Martin Ortho Anchorage System is
intended to be surgically placed in the mouth
for use as
an anchor for orthodontic
procedures. |
1
Technological Characteristics:
Similarities to Predicate
are identical in materials and Plates manufacturing process to the KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565).
Differences to Predicate
KLS Martin Osteosynthesis System The (1.5mm) (K944565) is intended for bone fixation across fractures or osteotomies. The KLS Martin Ortho Anchorage System (Plates) is designed to aid in dental movement by providing a rigid skeletal fixation point. The KLS Martin Ortho Anchorage System (Plates) are different in shape to The KLS Martin Osteosynthesis System (1.5mm) (K944565).
The Nobel Biocare Onplant Orthodontic System (K980460) is a single threaded implant utilized as an anchor for orthodontic procedures in the palatal region. The KLS Martin Ortho Anchorage System (Plates) are titanium plates that are fixated with titanium screws utilized as an anchor for orthodontic procedures in the palatal, maxilla or mandible region.
Substantial Equivalence:
The KLS-Martin Ortho Anchorage System is substantially equivalent in application to the KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565)
The KLS-Martin Ortho Anchorage System is substantially equivalent in indications for use to the Nobel Biocare Onplant Orthodontic System (K980460)
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2004
Jennifer Damato KLS-Martin L.P. Director Regulatory Affairs Quality Assurance 11239-1 St. John Industrial Parkway South Jacksonville, Florida 32246
Re: K040891
Trade/Device Name: KLS Martin Ortho Anchorage System (Plates) Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: May 12, 2004 Received: May 14, 2004
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 cither 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. Damato
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 yours,
Ken Mulvey
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):
KLS Martin Ortho Anchorage System (Plates) Device Name:
Indications For Use:
The KLS-Martin Ortho Anchorage System (Plates) are implants intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients.
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 Runnes
on of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number:
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