(153 days)
The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate).
The subject device includes several different designs of implantable distractors intended for bone lengthening or stabilization. The subject device is not supplied sterile. The subject device consists of: Transpalatal Distractor TPB (Module Size #1 (1 - 21mm), Module Size# 2 (16 - 31mm), Module Size# 3 (22 - 49mm), Module Size# 4 (26 - 59mm), Abutment Plate, Osteosynthesis Screws); Transmandibular Distractor TMD (Vertical Footplates with rods, Osteosynthesis Screws); Mandibular Distraction Dynamic Osteosynthesis MD-DOS (Posterior Fixation Unit (PFU), Fixation Screws, Distraction Unit (DU), Anterior Fixation Unit (AFU), Spacer). The subject device requires patient activation at specified times post-operatively using a provided spanner. The device is composed of Titanium Allov Grade 2 and 5 per ASTM F-67 and ASTM F-136 requirements.
The provided FDA 510(k) Premarket Notification for the Surgi-Tec - Bruges Distraction - Anchoring - Osteosynthesis System does not contain a study that proves the device meets specific quantitative acceptance criteria in terms of performance metrics.
Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because it is essentially the same as a legally marketed device that does not require premarket approval.
Here's how the information provided relates to your request, with the understanding that a traditional performance study with quantitative acceptance criteria is not presented:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary "acceptance criterion" in this 510(k) submission is substantial equivalence to the listed predicate devices (Howmedica Leibinger Guerrero-Bell Distractor, Martin Zurich Distraction System, Medartis MODUS Mandibular Reconstruction System). This is evaluated based on:
- Identical Indications for Use: The devices can be used for the same medical conditions and purposes.
- Similar Technological Characteristics: The devices operate on similar principles and have similar design features.
- Identical Material Composition: The devices are made of the same materials.
- Safety and Effectiveness: The device does not raise new issues of safety or effectiveness compared to the predicate.
- Reported Device Performance:
- Material Composition: "The device is composed of Titanium Alloy Grade 2 and 5 per ASTM F-67 and ASTM F-136 requirements." This matches the material used in predicate devices.
- Intended Use: "The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate)." This is identical to the predicate devices.
- Technological Approach: "The subject device is based on a similar technological approach by using intra-oral bone-borne titanium components to stabilize and/or lengthen the oral cavity (mandible, ramus, ridge, and palate)."
- Clinical Usage (Historical): "Additionally, this device has been successfully used in Europe for several years." and "Lastly, clinical usage has found the subject device to produce satisfactory results and function safely as a medical device." This refers to real-world experience, though no specific data or metrics are provided.
2. Sample size used for the test set and the data provenance
- Not applicable. This submission does not include a formal test set with a specific sample size as would be found in a performance study with quantitative metrics. The evaluation is based on a comparison to predicate devices and general clinical experience.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for a test set was established by experts in the context of this 510(k) as there was no such study performed.
4. Adjudication method for the test set
- Not applicable. No test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI/software device, but a physical implantable device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implantable device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" implicitly used is the historic safety and effectiveness of the predicate devices in clinical practice, and the clinical experience with the subject device in Europe. This is not a formally collected "ground truth" data set in the typical sense of a clinical trial.
8. The sample size for the training set
- Not applicable. As this is not an AI/machine learning device, there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth for it.
In summary:
This 510(k) submission successfully established substantial equivalence by comparing the device's materials, intended use, and technological characteristics to legally marketed predicate devices, and by citing prior clinical usage in Europe. It does not contain data from a formal performance study with predefined quantitative acceptance criteria and a test set involving expert ground truth, as would typically be seen for a novel device or diagnostic algorithm.
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FDA 510(k) Premarket Notification
Surgi-Tec - Bruges Distraction - Anchoring - Osteosynthesis System
510 (k) Summary [as required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(1)]
November 1, 2001
Submitter's Information [21 CFR 807.92(a)(1)]
Surgi-Tec S.A. C/o Joseph Azary Azary Technologies LLC P.O. Box 2156 Huntington, CT. 06484
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are:
- Bruges Distraction Anchoring Osteosynthesis System �
Predicate Device [21 CFR 807.92(a)(3)]
The subject device is substantially equivalent to the following devices:
| Subject Device Name | 510k |
|---|---|
| Howmedica Leibinger Guerrero-Bell Distractor (or Dynaform) | K972166 |
| Martin Zurich Distraction System | K010139 |
| Medartis MODUS Mandibular Reconstruction System | K992682 |
Description of the Device [21 CFR 807.92(a)(4)]
The subject device includes several different designs of implantable distractors intended for bone lengthening or stabilization. The subject device is not supplied sterile. The subject device consists of:
| Transpalatal Distractor TPB | Transmandibular DistractorTMD | Mandibular Distraction Dy-namic Osteosynthesis MD-DOS |
|---|---|---|
| Module Size #1 (1 - 21mm) | Vertical Footplates with rods | Posterior Fixation Unit (PFU) |
| Module Size# 2 (16 - 31mm) | Osteosynthesis Screws | Fixation Screws |
| Module Size# 3 (22 - 49mm) | Distraction Unit (DU) | |
| Module Size# 4 (26 - 59mm) | Anterior Fixation Unit (AFU) | |
| Abutment Plate | Spacer | |
| Osteosynthesis Screws |
The subject device requires patient activation at specified times post-operatively using a provided spanner.
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The device is composed of Titanium Allov Grade 2 and 5 per ASTM F-67 and ASTM F-136 requirements.
Intended Use [21 CFR 807.92(a)(5)]
The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate).
Technological Characteristics [21 CFR 807.92(a)(6)] and Performance Data [21 CFR 807.92(b)(1))
The subject device has identical material composition and indications for use as the predicate devices. The subject device is based on a similar technological approach by using intra-oral bone-borne titanium components to stabilize and/or lengthen the oral cavity (mandible, ramus, ridge, and palate). Additionally, this device has been successfully used in Europe for several years.
Conclusion [21 CFR 807.92(b)(3)]
The subject device has identical indications for use and similar technological characteristics as the predicate devices. The subject device is composed of Titanium, which is a material used in the predicate devices, as well as a material that has been used successfully in a variety of dental and medical implants over the last several decades. Lastly, clinical usage has found the subject device to produce satisfactory results and function safely as a medical device.
We conclude that the subject device is as safe and effective as the predicate device and does not raise any new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph M. Azary Azary Technologies LLC P.O. Box 2156 Huntington, Connecticut 06484
Re: K013672
Trade/Device Name: Surgi-Tec S.A. Bruges Distraction-Anchoring-Osteosynthesis Systems Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: February 25, 2002 Received: May 14, 2002
Dear Mr. Azary:
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.
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.
BB
Image /page/2/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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Page 2 - Mr. Azary
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski
Time 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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FDA 510(k) Premarket Notification
Surgi-Tec - Bruges Distraction - Anchoring - Osteosynthesis System
5 10(k) Number (if known): KOJ3672
Device Name: Surgi-Tec S.A. Bruges Distraction - Anchoring - Osteosynthesis Systems
Indications For Use: The subject device is intended to be used as a bone stabilizer and lengthening device for the correction of congenital deficiencies or post-traumatic defects of the oral cavity (mandible, ramus, ridge, and palate).
(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 Riance
(Division Sign-Off) Division of Dental, Infection Control, and Gsneral Hospital Devices 10156 F10tk) Number __
1-1
§ 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.