KLS-MARTIN INTRAORAL DISTRACTOR by KLS-MARTIN L.P.

The KLS-Martin Intraoral Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required. (Micrognathia, Hemifacial Microsomia, Congenital Craniofacial Syndromes)

Device Description

The KLS-Martin Intraoral Distractor is a subcutaneous bone distractor. It features two telescoping components activated by a jack screw, fixed to the bone via subcutaneous plates and secured with 1.5mm bone screws. A hex driver is used to activate the required distraction.

AI/ML Overview

The provided text is a 510(k) summary for the KLS-Martin Intraoral Distractor, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving device performance against specific acceptance criteria through a clinical study in the way modern AI/software as a medical device (SaMD) clearances would.

Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets them, especially in the context of AI/SaMD.

Here's why and what's missing:

Type of Device: The KLS-Martin Intraoral Distractor is a physical surgical implant (a bone distractor), not an AI/software device. Its clearance would typically rely on mechanical testing, biocompatibility, and comparison to a predicate device for safety and effectiveness, rather than performance metrics like sensitivity, specificity, or reader studies.
510(k) Pre-1997 Context: This 510(k) was submitted in 1997. The regulatory landscape for medical devices, particularly regarding clinical data requirements and performance metrics, was different from today, and certainly from what is expected for AI/SaMD.
Focus of the Document: The 510(k) summary focuses on device description, intended use, and comparison to a predicate device (Synthes Mandible Distractor K962272) to establish substantial equivalence. It confirms that the device is "substantially equivalent" to a legally marketed device, implying similar safety and effectiveness without necessarily requiring a new, extensive clinical trial demonstrating novel performance against defined metrics.

Therefore, I cannot populate the requested table or answer the specific questions because the provided text does not contain that type of information. This document clears a physical device based on equivalence, not through a performance study against acceptance criteria in the manner requested for AI/SaMD.

Summary

{0}------------------------------------------------

K 973275

NOV 20 1997

510(K) SUMMARY (as required by 807.92(c))

ﺎﺏ ﺍ

)

Submitter of 510(k):	Regulatory & Marketing Services, Inc. (RMS) P.O. Box 1108 Elfers, FL 34680
	Phone:813-376-4154Fax:813-376-7186	Phone:	813-376-4154	Fax:	813-376-7186
Phone:	813-376-4154
Fax:	813-376-7186
Contact Person:	Ed Ransom
Date of Summary:	August 26, 1997
Trade Name:	KLS-Martin Intraoral Distractor
Classification Name:	Mandible Distractor
Predicate Device:	Synthes Mandible Distractor K962272
Device Description/Comparison:	The KLS-Martin Intraoral Distractor is a subcutaneous bone distractor. It features two telescoping components activated by a jack screw, fixed to the bone via subcutaneous plates and secured with 1.5mm bone screws. A hex driver is used to activate the required distraction.
Intended Use:	The KLS-Martin Intraoral Distractor is intended to be used in the mandible for conditions such as mandibular deficiency or post-traumatic effects of the mandible, where gradual bone distraction is required.

{1}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997 Mr. Ed Ransom ·President KLS-Martin L.P. C/O Regulatory & Marketing Services, Incorporated 3234 Ella Lane New Port Richey, Florida 34655

Re : K973275 KLS-Martin Intraoral Distractor Trade Name: Requlatory Class: Uncalssified Product Code: MQN Dated: August 26, 1997 Received: September 2, 1997

Dear Mr. Ransom:

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 against 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) 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

{2}------------------------------------------------

Page 2 - Mr. Ransom

through 542 of the Act for devices under the Electronic enroagn sadiation Control provisions, or other Federal laws or requlations.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,

Timothy A. Ulatowski

Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

{3}------------------------------------------------

510(k) Number (if known): K973275

KLS-Martin Intraoral Distractor Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Om
Division of Dentel, Infection Control,
and General Hospital Devloge
510(k) Number K973275

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.