(77 days)
The intended use is for the gradual bone distraction of the facial bones that are deformed due to birth defects, disease, or trauma.
The indications for use are an uni-directional, intro-oral device for the distraction of facial bones.
Distractor similar to the KLS distractor approved as K973275
I apologize, but the provided text from the K991875 510(k) submission does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance.
Specifically, this document primarily constitutes the 510(k) summary and the FDA's clearance letter. It establishes the device's substantial equivalence to a predicate device (KLS Intraoral Distractor, K973275) based on its description and intended use.
Here's what I can extract from the provided text and what information is missing:
Information Present:
- Device Name: K-L-W Intraoral Distractor
- Intended Use: For the gradual bone distraction of the facial bones that are deformed due to birth defects, disease, or trauma. The Indications For Use document clarifies this as "an uni-directional, intro-oral device for the distraction of facial bones."
- Predicate Device: KLS Intraoral Distractor (K973275)
Information Not Present in the Provided Text:
- A table of acceptance criteria and the reported device performance: The document mentions the device is "similar" to the predicate, but it does not provide specific performance metrics, acceptance criteria, or a table detailing them.
- Sample size used for the test set and the data provenance: No information about a test set, sample size, or data origin is provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: Ground truth establishment and expert details are not discussed.
- Adjudication method for the test set: No information is available regarding adjudication.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No mention of such a study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a physical intraoral distractor, not a software algorithm, so this question is not applicable in its literal sense.
- The type of ground truth used: As no study is detailed, no ground truth is described.
- The sample size for the training set: Not applicable for this type of device, as it's not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
Why this information is missing:
For a 510(k) submission like K991875, particularly for a well-understood mechanical device like an intraoral distractor, the primary focus for clearance is demonstrating substantial equivalence to a previously cleared predicate device. This often relies on:
- Comparison of technological characteristics: Showing the new device has the same fundamental scientific technology and principles of operation as the predicate.
- Comparison of materials: Demonstrating similar or equivalent materials.
- Comparison of design and performance: Showing that any differences in design or materials do not raise new questions of safety and effectiveness, or if they do, that these differences are addressed through appropriate testing (e.g., mechanical strength, biocompatibility).
The provided text simply states the device is "similar to the KLS distractor approved as K973275" and does not detail the specific tests, performance data, or acceptance criteria that would have been submitted to demonstrate this similarity or the device's own standalone efficacy. These details would typically be found in the actual 510(k) submission document, which is much more extensive than the summary provided here.
Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or AI-specific performance metrics based solely on the provided K991875 summary and clearance letter.
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| AUG 18 1999 | ||
|---|---|---|
| 510(K) SUMMARY(as required by 807.92(c)) | ||
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)3234 Ella LaneNew Port Richey, FL 34655 | |
| Phone:Fax: | 727-376-4154727-376-7186 | |
| Contact Person: | Ed Ransom or Pat Lamb | |
| Date of Summary: | June 1,1999 | |
| Trade Name: | K-L-W Intraoral Distractor | |
| Classification Name: | Intraoral Distractor | |
| Predicate Device: | KLS Intraoral Distractor | |
| Device Description/Comparison: | Distractor similar to the KLS distractor approved asK973275 | |
| Intended Use: | The intended use is for the gradual bone distractionof the facial bones that are deformed due to birthdefects, disease, or trauma. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1999
KLS-Martin L.P. C/O Mr. Edward Ransom Regulatory & Marketing Services, Incorporated 3234 Ella Lane New Port Richey, Florida 34655
Re : K991875 K-L-W Intraoral Distractor Trade Name: Regulatory Class: II Product Code: MQN Dated: July 26, 1999 Received: July 28, 1999
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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Ransom
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cucurullo
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Intraoral Distractor
Indications For Use: The indications for use are an uni-directional, intro-oral device for the distraction of facial bones.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
. .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Susan Runne
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospity 510(k) Number
(Optional Format 1-2-96)
§ 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.