(69 days)
The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.
The Acetal material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
The provided document is a 510(k) summary for the Inovativ Acetal material, a thermoplastic resin used to fabricate dental prostheses, specifically preformed clasps. This summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the typical sense of a diagnostic or therapeutic medical device.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this type of submission. The "study" here is essentially the demonstration of substantial equivalence based on material characteristics and intended use.
Here's an attempt to address the request based on the available information:
Acceptance Criteria and Study Details for Inovativ Acetal
Given that this is a 510(k) submission for a material (thermoplastic resin) used in dental prostheses, the "acceptance criteria" are focused on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance thresholds for a diagnostic or interventional outcome.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| Similar Design | The Acetal thermoplastic resin is similar in design to the predicate device ("Acetal Dental" Acetal resin). |
| Similar Function | The Acetal thermoplastic resin is similar in function to the predicate device. |
| Similar Physical Properties | The Acetal thermoplastic resin is similar in physical properties to the predicate device. |
| Similar Material Characteristics | The Acetal thermoplastic resin is similar in material characteristics to the predicate device. A chemical analysis of Acetal is provided. |
| Similar Handling Characteristics | The Acetal thermoplastic resin is similar in handling characteristics to the predicate device. |
| Similar Intended Use | The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps, which is similar to the intended use of the predicate device. |
| Similar Functionality | The Acetal thermoplastic resin is similar in functionality to the predicate device. |
2. Sample Size for the Test Set and Data Provenance
This information is not applicable as there is no "test set" in the context of a clinical performance study for an AI/diagnostic device. The substantial equivalence is based on a comparison of the material itself and its intended use with a predicate device. The "data provenance" would refer to the characteristics of the material itself and the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. There is no "ground truth" established by experts in the context of evaluating a material's performance against clinical outcomes. The evaluation is primarily based on material science and comparison to an already cleared device.
4. Adjudication method for the test set
This information is not applicable. There was no "test set" requiring adjudication in the context of a clinical performance study.
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
This information is not applicable. The device is a material for dental prostheses, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a material, not an algorithm.
7. The type of ground truth used
This information is not applicable in the sense of expert consensus, pathology, or outcomes data for an AI/diagnostic device. For a material, the "ground truth" for substantial equivalence lies in the established characteristics of the predicate device.
8. The sample size for the training set
This information is not applicable. The device is a material, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is a material, not an AI model.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" presented in this 510(k) is a comparative analysis of the Inovativ Acetal material against a legally marketed predicate device: Pressing North America, Inc. material, "Acetal Dental" Acetal resin.
The conclusion of the "study" (as determined by the FDA's letter) is that the Inovativ Acetal device is substantially equivalent to the predicate device. This determination is based on the claim that:
- "The Acetal thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device."
- "Both the Acetal and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality."
- A chemical analysis of the Acetal material was provided within the submission to support these claims.
The FDA's August 29, 2002 letter (K022032) confirms this substantial equivalence, allowing the device to be marketed.
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INOVATIV, LLC.
KQa2o3a
1155 Twin Hills Drive JEFFERSON, OR. 97352 PHONE: 503-585-4362 Fax: 503-585-1188
510 (K) Summary
Submitter Name:
Submitter Address:
Submitter Telephone: Submitter Facsimile:
Contact Person:
Inovativ, LLC.
1155 Twin Hills Drive Jefferson, OR 97352
(503)585-4362 (503)585-1188
Bob Bowers Chief Operating Officer
June 10, 2002 Date Summary Prepared:
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Inovativ Acetal Original Premarket 510(K) Notification
SECTION 9: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR.807.92.
9.1 SUBMITTER INFORMATION
| a. Company Name: | Inovativ, LLC. |
|---|---|
| b. Company Address: | 1155 Twin Hills DriveJefferson, OR 97352 |
| c. Company Telephone:Company Facsimile: | (503)585-4362(503)585-1188 |
| d. Contact Person: | Bob BowersChief Operating Officer |
| e. Date Summary Prepared: | June 10, 2002 |
9.2 DEVICE IDENTIFICATION
| a. Trade/Proprietary Name: | Acetal |
|---|---|
| b. Classification Name: | Preformed Clasp21 CFR 872.3285 |
9.3 IDENTIFICATION OF PREDICATE DEVICES
The Acetal material is a thermoplastic resin used to prefabricate partial denture clasps. This material is substantially equivalent to the Pressing North America, Inc. material, "Acetal Dental" Acetal resin. This material is commercially available in the United States.
9.4 DEVICE DESCRIPTION
The Acetal material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
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Inovativ Acetal Original Premarket 510(K) Notification
9.5 SUBSTANTIAL EQUIVALENCE
This material is substantially equivalent to the Pressing North America, Inc. material, "Acetal Dental" Acetal resin. The fundamental characteristics are similar: the Acetal thermoplastic resin is similar in design, function, physical properties and intended use to the predicate device.
9.6 INDICATIONS FOR USE
The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.
9.7 TECHNOLOGICAL CHARACTERISTICS
A chemical analysis of the Acetal is provided within this submission. Both the Acetal and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality,
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services-URA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-URA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, with three curved lines above them. The profiles and lines are arranged to suggest a sense of movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2002
Mr. Robert Bowers Chief Operations Officer Inovativ, LLC 1155 Twin Hills Drive Jefferson, Oregon 97352
Re: K022032
Trade/Device Name: Acetal Regulation Number: 21 CFR 872.3285 Regulation Name: Preformed Clasp Regulatory Class: I Product Code: EHP Dated: June 10, 2002 Received: June 21, 2002
Dear Mr. Bowers:
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.
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Page 2 - Mr. Robert Bowers
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,
Tim A. Ulatowski
Timothy A. Ulatowski 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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Indications for Use
Page 1 of 1
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Device Name_ _________________________________________________________________________________________________________________________________________________________________
Indications for use:
The Acetal is intended for the fabrication of temporary dental prostheses like preformed clasps using Inovativ, LLC Acetal.
:
Do not write below this line - Continue on another page if needed
and the comments of the comments of the comments of the many of the comments of the comments of the comments of the comments of the contribution of the comments of the contra
Prescription Use سك (Per 21 CFR 801.109) OR
Over the counter _____________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
140000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 510(k) Number:_
§ 872.3285 Preformed clasp.
(a)
Identification. A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.