(429 days)
Indications are widespread in the field of Surgery, Implantology and Endodontic treatment.
- Surgery: 1059, 5050, 5051, 5055, 5056, 5060, 5062, 5063, 5068, 5070, 5075
- . Endodontic treatment: 5057, 5059, 5061, 5066, 5067, 5069, 5071, 5076
- . Speed Increaser Contra-Angle: 5081 The device is intended for use where high speed such as 200'000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cuttin and/or finishing of dentures, denture bases, crowns, inlays and metal plates
All devices are driven by an electric micromotor handpiece that has the ISO-3964 Coupling.
All mentioned NOUVAG Contra-Angle Attachments Dental are attachments for surgical drive units. They are designed to transmit rotational movement of the motor axle of such drive units to the shank of a bur which will be inserted into the output end of the handpiece.
For this application, all these Contra-Angle Attachments contain a coupling part fittable to all surgical motors with a coupling according to ISO 3964.
The output end of the Contra-Angle Attachments contains chuck systems for accommondation of standardized bur shanks. All mentioned NOUVAG Contra-Angle Attachments Dental are designed for burs according to ISO 1797 shank-type 1.
The provided text is a 510(k) submission for NOUVAG Contra-Angle Attachments Dental. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way envisioned for a typical AI/software device.
The submission focuses on demonstrating substantial equivalence to existing legally marketed dental handpiece attachments. The "performance" aspect mentioned refers to compliance with established international standards for mechanical characteristics and usability, rather than performance in terms of diagnostic accuracy or clinical outcomes as would be relevant for an AI study.
Therefore, I cannot fulfill the request in the format provided because the information is not present in the input document.
Here's a breakdown of why and what information is available:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical or diagnostic performance. Instead, the submission implies acceptance criteria are met by conforming to existing international standards for dental instruments (ISO 7785-2, ISO 3964, ISO 10993-1/-5/-12).
- Reported Device Performance: The "Performance" row in the TABLE 1 TECHNOLOGICAL COMPARISON refers to compliance with ISO 7785-2 and ISO 3964. This indicates the device meets the mechanical and functional specifications outlined by these standards, making it comparable to the predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This document describes a traditional medical device (mechanical dental handpiece attachments), not an AI/software device. There is no "test set" of data in the AI sense for clinical validation. Testing would primarily involve mechanical and material property verification against the aforementioned ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No ground truth establishment for a diagnostic or clinical AI application. The "ground truth" for this device would be its adherence to engineering specifications and international standards, likely verified by engineers or quality control personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method for a clinical test set.
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:
- Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the AI sense. The "ground truth" for this device's safety and effectiveness is its compliance with established engineering standards (ISO) and its substantial equivalence to predicate devices already on the market.
8. The sample size for the training set:
- Not applicable. No training set for an AI model.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI model.
In summary: The provided 510(k) notification is for a mechanical medical device and therefore does not contain the types of information requested concerning AI acceptance criteria, studies, and data sets. The equivalence is demonstrated through comparison of material, design, intended use, and compliance with recognized performance standards to predicate devices.
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OCT - 1 2003
510(k) Notification July 23, 2002
SECTION 10
510(k) Summary
Submitter: NOUVAG AG St. Gallerstrasse 23-25 CH-9403 Goldach Switzerland
Contact Person: Benno Frei Technical Director, New Product Development Phone 0041 71 845 35 35 0041 71 845 35 36 Fax
Date Summary Prepared: July 23, 2002
Device Name:
Trade Name == Common Name Contra-Angle Attachments Dental Handpiece, Contra- and Right-Angle Attachments Dental Classification Name (per 21 CFR section 872.4200)
Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Company: | W & H Dentalwerk Buermoos GmbH |
|---|---|
| Device: | Surgical Contra-Angel Handpiece Attachments |
| 510(k) : | K011061 |
| Date Cleared: | June 21, 2001 |
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510(k) Notification July 23, 2002
| Company: | W & H Dentalwerk Buermoos GmbH |
|---|---|
| Device: | Surgical Contra-Angel Handpiece Attachments |
| 510(k) : | K984508 |
| Date Cleared: | June 25, 1999 |
| Company: | NSK, INC |
| Device: | E-Type Contra-Angle |
| 510(k) : | K962540 |
| Date Cleared: | September 12, 1996 |
| Company: | NSK, INC |
| Device: | E-Type Speed Increaser Contra-Angle |
| 510(k) : | K972569 |
| Date Cleared: | October 08, 1997 |
Device Description:
All mentioned NOUVAG Contra-Angle Attachments Dental are attachments for surgical drive units. They are designed to transmit rotational movement of the motor axle of such drive units to the shank of a bur which will be inserted into the output end of the handpiece.
For this application, all these Contra-Angle Attachments contain a coupling part fittable to all surgical motors with a coupling according to ISO 3964.
The output end of the Contra-Angle Attachments contains chuck systems for accommondation of standardized bur shanks. All mentioned NOUVAG Contra-Angle Attachments Dental are designed for burs according to ISO 1797 shank-type 1.
Intended us of the Devices: Indications are very widespread in the field of Dentistry.
Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device:
The NOUVAG Contra-Angle Attachments Dental are substantially equivalent to other legally marketed evices in the United States. The NOUVAG Contra-Angle Attachments Dental functions in a manner similar and are intended for the same use as the Surgical Contra-Angel Handpiece Attachments designed by W & H Dentalwerk Buermoos GmbH and NSK NAKANISHI INC.
{2}------------------------------------------------
510(k) Notification July 23, 2002
| Characteristics | NOUVAGContra-Angle Attachments Dental | Predicate Device W & HSurgical Contra-Angel Handpieces Types | Predicate Device NSKE-Type Contra-Angle |
|---|---|---|---|
| Indications for use | Indications are very widespread in thefield of implantology and surgery | Indications are very widespread in thefield of implantology and surgery | Indications are very widespread in the fieldof implantology and surgery |
| Target population | No restriction | No restriction | No restriction |
| Design | Contra-angle | Contra-angle | Contra-angle |
| Materials | Alloy coated with pure chromium | Stainless steel | Stainless steel |
| Performance | ISO 7785-2ISO 3964 | ISO 7785-2ISO 3964 | ISO 7785-2ISO 3964 |
| Sterility | Sterility by user / 134°C | Sterility by user / 134°C | Sterility by user / 134°C |
| Biocompatibility | Acc. ISO 10993-1 / -5 / -12 | Biocompatible material | Biocompatible material |
| Mechanical safety | ISO 7785-2 | ISO 7785-2 | ISO 7785-2 |
| Human factors | Gear ratio marked on the device | Gear ratio marked on the deviceColor coding | Gear ratio marked on the deviceColor coding |
| Compatibility withother devices | Coupling dimensions acc. ISO 3964For burs with shanks acc to ISO 1797(2.35 mm and 1.6 mm)Push button system and Latch type | Coupling dimensions acc. ISO 3964For burs with shanks acc to ISO 1797(2.35 mm and 1.6 mm)Push button system | Coupling dimensions acc. ISO 3964For burs with shanks acc to ISO 1797(2.35 mm and 1.6 mm)Latch Type |
| Where used | Dental | Dental | Dental |
TABLE 1 TECHNOLOGICAL COMPARISON
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510(k) Notification July 23, 2002
Brief summary of nonclinical tests and results:
The NOUVAG Contra-Angle Attachments Dental have been designed and tested to applicable safety standards. The NOUVAG Contra-Angle Attachments Dental do not raise any new issues of safety, effectiveness, or performance of the product.
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Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three abstract human figures, possibly representing individuals or families, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 2003
NOUVAG AG C/O Mr. Erich Forster INTRATest Systems GmbH Reusswehrstrasse 1 CH-5412 Gebenstorf, SWITZERLAND
Re: K022505
Trade/Device Name: Contra-Angle Attachments Dental Regulation Number: 872.4200 Regulation Name: Accessory to Dental Handpiece Regulatory Class: I Product Code: EGS Dated: June 30, 2003 Received: July 3, 2003
Dear Mr. Forster:
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.
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Page 2 - Mr. Forster
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 (OS) 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 vour 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,
Suan Ruisnro
Susan Runner, DDS, MA Interim 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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510(k) Notification November 29, 2002
510(k) Number (if known): K022505
Device Name: Contra- Angle Attachments Dental Types: 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, 5069, 5070, 5071, 5075, 5076, 5081
Indications for Use:
Indications are widespread in the field of Surgery, Implantology and Endodontic treatment.
- Surgery: 1059, 5050, 5051, 5055, 5056, 5060, 5062, 5063, 5068, 5070, 5075
- . Endodontic treatment: 5057, 5059, 5061, 5066, 5067, 5069, 5071, 5076
- . Speed Increaser Contra-Angle: 5081 The device is intended for use where high speed such as 200'000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cuttin and/or finishing of dentures, denture bases, crowns, inlays and metal plates
All devices are driven by an electric micromotor handpiece that has the ISO-3964 Coupling.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | kd22505 |
|---|---|
| ---------------- | --------- |
(Optional Format 3-10-98)
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.