(12 days)
Dental impression material for: Impressions for inlay, onlay, crown, and bridge restorations Functional impressions Fixation impressions Implant impressions
The modified IMPREGUM® F is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth. ESPE is submitting this Special 510(k) for modifications of its polyether based impression material IMPREGUM® F. In particular one ingredient will be exchanged by a chemical compound with comparable character and another one will be added. The modified IMPREGUM® F has the same fundamental scientific technology and the same intended use, therefore, we believe these modifications are eligible for the Special 510(k) process.
This document is a 510(k) summary for a modified dental impression material, IMPREGUM® F. It does not contain information about acceptance criteria or a study proving that a device meets those criteria in the way a medical AI/software device would.
The document describes a "Special 510(k)" submission for modifications to an existing polyether-based impression material. In this context, "acceptance criteria" and "study" refer to the comparison of the modified device's chemical composition, physical, and mechanical properties to the predicate device to demonstrate substantial equivalence, rather than performance metrics for an AI or software device.
Therefore, most of the requested information regarding AI/software performance criteria (e.g., sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.
Here's an attempt to answer the relevant questions based on the provided text, while acknowledging its limitations for an AI software context:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table with quantitative acceptance criteria for performance metrics (like sensitivity, specificity, etc.) nor reported performance in a typical clinical study outcome. Instead, the acceptance criteria for this Special 510(k) are based on demonstrating "substantial equivalence" to the predicate device by showing that the modified device has comparable characteristics, fundamental scientific technology, and the same intended use.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (as stated in comparison) |
|---|---|
| Same intended use | IMPREGUM® F (modified) has the same intended use. |
| Same operating principle | IMPREGUM® F (modified) is used by the same operating principle. |
| Same basic chemical design | IMPREGUM® F (modified) incorporates the same basic chemical design (with one ingredient exchanged for a comparable one, and another added). |
| Same shelf life | IMPREGUM® F (modified) has the same shelf life. |
| Same manufacturing and packaging materials/processes | IMPREGUM® F (modified) is manufactured and packaged using the same materials and processes. |
The study described is the comparison of the modified IMPREGUM® F with the unmodified IMPREGUM® F regarding:
- Chemical composition
- Physical properties
- Mechanical properties
- Indications for use
The text states that these comparisons led the submitter to believe the modifications are "eligible for the Special 510(k) process" and that the modified device is "substantially equivalent to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "chemical composition, the physical and mechanical properties" being compared, but no details on sample sizes or data provenance (e.g., how many batches were tested, where the testing was done) are given. This is typical for a Special 510(k) for material modifications, where the focus is on comparative testing against the predicate rather than a clinical trial.
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)
This is not applicable to this type of device and submission. "Ground truth" in the context of material properties is established through standardized laboratory testing methods, not expert consensus in the way clinical diagnostic AI works.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this type of device and submission. Adjudication methods are typically used for establishing ground truth in clinical imaging or diagnostic studies involving human interpretation.
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 is not applicable. This document describes a dental impression material, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This document describes a dental impression material, not an AI or software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "study" described (comparison of material properties), the "ground truth" would be the objective measurements and specifications of the predicate device, against which the modified device's properties were compared using scientific and engineering test methods.
8. The sample size for the training set
This is not applicable. There is no "training set" in the AI/machine learning sense for this device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" for this device.
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SEP 8 1999
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IV.
Submitter
| Name: | ESPE Dental AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas Petermann, Manager of U.S.Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| Andreas_Petermann@ESPE.de | |
| Date: | August 25, 1999 |
| Name of Device | |
| Proprietary Name: | IMPREGUM® F |
| Classification Name: | Impression material |
| Common Name: | Polyether based impression material |
Predicate Device
IMPREGUM® F ..................................................................................................................................................................
Description for the Premarket Notification
The modified IMPREGUM® F is classified as an impression material (21 C.F.R. § 872.3660) because it is a device intended to reproduce the structure of a patient's teeth.
ESPE is submitting this Special 510(k) for modifications of its polyether based impression material IMPREGUM® F. In particular one ingredient will be exchanged by
Image /page/0/Picture/10 description: The image shows the text "Special 510(k) IMPREGUM® F" above the logo for ESPE. The ESPE logo is a square with a tree inside of it, next to the word ESPE in large, bold letters. The text and logo are all in black and white.
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a chemical compound with comparable character and another one will be added. The modified IMPREGUM® F has the same fundamental scientific technology and the same intended use, therefore, we believe these modifications are eligible for the Special 510(k) process.
In this Special 510(k) Device Modification submission the chemical composition, the physical and mechanical properties, and the indications for use of both the unmodified IMPREGUM® F and the modified IMPREGUM® F are compared. Furthermore, ESPE's design control activities are shortly explained.
The modified impression material IMPREGUM® F has the following similarities to the unmodified IMPREGUM® F:
- IMPREGUM® F (modified) has the same intended use .
- IMPREGUM® F (modified) is used by the same operating principle
- . IMPREGUM® F (modified) incorporates the same basic chemical design
- . IMPREGUM® F (modified) has the same shelf life
- IMPREGUM® F (modified) is manufactured and packaged using the same . materials and processes
In summary the modified IMPREGUM® F described in this submission is, in our opinion, substantially equivalent to the predicate device.
Image /page/1/Picture/9 description: The image shows the text "Special 510(k) IMPREGUM® F" above the logo for ESPE. The ESPE logo consists of a stylized tree inside of a square, followed by the text "ESPE" in a large, bold font. The logo is black and white.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 8 1999
Dr. Andreas Petermann Requlatory Affairs ESPE Dental AG ESPE Plaza D-82229 Seefeld, Bavaria Germany
K992895 Re: Impregum® F Trade Name: Requlatory Class: II Product Code: ELW Dated: Auqust 25, 1999 Received: August 27, 1999
Dear Dr. Petermann:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 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 through 542 of
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Page 2 -Dr. Petermann
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4690. 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
imothy A. Ulatowsk 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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Statement of Indications for Use
Device Name:
Impregum®F
Indications for use:
Dental impression material for:
Impressions for inlay, onlay, crown, and bridge restorations
Functional impressions
Fixation impressions
Implant impressions
Prescription use:区
Over-the counter use □
Suza Rums
(Division Sign-Off)
:
Division of Digit-Off)
Division of Dental, Infection Control, and General Hospital Device 510(k) Number _
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).