(63 days)
Stela Primer: - Dentin and enamel bonding
Stela Capsule - Direct Class I, II, III and V cavities. Ideally Class I and II - Base or liner - Core build-ups.
The Stela Capsule System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:
- Stela Capsule - a capsule consisting of powder and liquid components which are mixed and activated when the capsule is pushed down. After mixing with a triturator (amalgamator) an applicator is used to dispense the paste.
- Stela Primer an adhesive liquid packaged in a bottle. A bendable disposable brush applicator is used to apply Stela Primer.
The combination of Stela Primer and Stela Capsule will bond to both enamel and dentin without scrubbing or light curing.
This is a 510(k) premarket notification for a dental device, specifically the Stela Capsule System. The provided text describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not contain the detailed acceptance criteria for a study and the specific performance reported against those criteria in the format you requested for AI/algorithm performance.
The document discusses bench testing for physical and chemical properties of the dental material, and biocompatibility testing. These are not studies that define acceptance criteria or performance for an "AI/algorithm" device in the manner you've described.
Therefore, I cannot populate the table or answer questions 2 through 9 as they pertain to AI/algorithm performance in medical image analysis or similar AI-driven diagnostic/therapeutic applications.
The document indicates:
- The device is not an AI/algorithm-based device. It's a dental restorative material (capsule system and primer).
- No standalone or human-in-the-loop performance studies directly related to AI/algorithm performance were conducted or reported.
- No ground truth derived from experts or pathology for AI training/testing is mentioned.
- No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned.
However, I can extract information regarding the bench testing performance for the Stela Capsule System and how it met ISO standards, which serves as a form of "acceptance criteria" for this type of medical device.
Based on the provided text, here's what can be extracted regarding the material performance and acceptance criteria for the Stela Capsule System:
The Stela Capsule System underwent biocompatibility testing and non-clinical performance data (bench testing) to demonstrate its safety and effectiveness relative to predicate devices and relevant ISO standards.
1. Table of Acceptance Criteria and Reported Device Performance (for Bench Testing):
| Acceptance Criteria (ISO Standard Requirement, where applicable) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO 7405:2018, ISO 10993-5:2009) | Low potential for unacceptable adverse biological response |
| Delayed-type hypersensitivity (ISO 10993-10:2010) | Low potential for unacceptable adverse biological response |
| Irritation/intracutaneous reactivity (ISO 10993-10:2010) | Low potential for unacceptable adverse biological response |
| Systemic toxicity (ISO 10993-11:2017) | Low potential for unacceptable adverse biological response |
| Genotoxicity (ISO 10993-3:2014) | Low potential for unacceptable adverse biological response |
| Non-clinical Performance (Bench Testing): | |
| Working time (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Setting time (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Flexural strength (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Shade (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Colour stability (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Radio-opacity (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Shear bond strength to dentin (ISO 29022:2013) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Shear bond strength to enamel (ISO 29022:2013) | Met relevant ISO standard requirement; performed comparably to predicate devices |
Regarding the other questions (AI/Algorithm specific):
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/algorithm study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/algorithm study. Ground truth in this context refers to chemical/physical measurements and biological reactions, not expert interpretations of data.
- Adjudication method for the test set: Not applicable.
- 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, an MRMC study was not done as this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI device.
- The type of ground truth used: For biocompatibility, the "ground truth" is the universally accepted biological response measures defined by ISO 10993 series. For bench testing, the "ground truth" is the physical and chemical properties measured against ISO 4049 and ISO 29022 standards.
- The sample size for the training set: Not applicable. This device does not involve a training set for an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
October 28, 2022
SDI Limited Quynh Jewell Regulatory Affairs Manager 3-15 Brunsdon Street, Bayswater Melbourne, Victoria 3153 Australia
Re: K222583
Trade/Device Name: Stela Capsule System Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF, KLE Dated: August 26, 2022 Received: August 26, 2022
Dear Quynh Jewell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K22583
Device Name Stela Capsule System
Indications for Use (Describe) Stela Primer: - Dentin and enamel bonding
Stela Capsule
- Direct Class I, II, III and V cavities. Ideally Class I and II
- Base or liner
- Core build-ups.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the letters "SDI" in a black box on the left side of the image. To the right of the black box are the letters "SDI" in a larger font. The letters are in a sans-serif font and are white in color. The background of the image is white.
SDI Limite
Establishment Registration No: 3004140838
PIN: MD6132520
510(k) NOTIFICATION (Traditional): Stela Capsule System – Summary – August 2022
K222583
Submitter Information 1.
SDI Limited 3-15 Brunsdon Street Bayswater, Victoria 3153 Australia
| Contact Person: | Quynh Jewell |
|---|---|
| Position: | Regulatory Affairs Manager |
| Company: | SDI Limited |
| Phone: | +61 3 8727 7111 |
| Email: | Quynh.Jewell@sdi.com.au |
Date Prepared: 9 September 2022
Device Details 2.
The Stela Capsule System comprises the following components:
| Proprietary Name: | Stela Capsule | |
|---|---|---|
| Common Name: | Dental restorative material | |
| Regulation Name: | Tooth shade resin material | |
| Regulation Number: | 872.3690 | |
| Product Code: | EBF | |
| Regulatory Class: | II | |
| Proprietary Name: | Stela Primer | |
| Common Name: | Dental adhesive | |
| Regulation Name: | Resin tooth bonding agent | |
| Regulation Number: | 872.3200 | |
| Product Code: | KLE | |
| Regulatory Class: | II | |
| Proprietary Name: | Application brush | |
| Common Name:Application brush | ||
| Regulation Name: | Resin applicator | |
| Regulation Number: | 872.3140 | |
| Product Code: | KXR | |
| Regulatory Class: | I |
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510(k) NOTIFICATION (Traditional): Stela Capsule System - Summary - August 2022
Proprietary Name: Common Name: Regulation Name: Regulation Number: Product Code: Regulatory Class:
SDI Applicator Applicator/Dispenser Dental hand instruments 872.4565 DZN |
Predicate Device 3.
| Submitter's Device | Primary Predicate Device | Secondary Predicate Device |
|---|---|---|
| Stela Primer | Name: ParaBond¹Manufacturer: Coltene510(k) Number: K053040 | Name: Scotchbond Universal Adhesive²Manufacturer: 3M ESPE510(k) Number: K110302 |
| Stela Capsule | Name: Fill-Up!Manufacturer: Coltene510(k) Number: K150218 | Name: Filtek Supreme Ultra UniversalRestorativeManufacturer: 3M ESPE510(k) Number: K083610 |
1 ParaBond was originally cleared in ParaCem Universal DC 510(k) based on the National Library of Medicine GUDID database noting ParaBond's 510(k) number as K053040.
2 Scotchbond Universal Adhesive was originally cleared as Adhesive EXL 759
No reference devices were used in this submission.
It is noted the application brush is exempt from the premarket notification procedure under Regulation 872.3140. The applicator is exempt from the 510(k) procedure under Regulation 872.4565
Device Description 4.
The Stela Capsule System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:
- Stela Capsule - a capsule consisting of powder and liquid components which are mixed and activated when the capsule is pushed down. After mixing with a triturator (amalgamator) an applicator is used to dispense the paste.
- Stela Primer an adhesive liquid packaged in a bottle. A bendable disposable brush ● applicator is used to apply Stela Primer.
The combination of Stela Primer and Stela Capsule will bond to both enamel and dentin without scrubbing or light curing.
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Image /page/5/Picture/0 description: The image shows the logo for SDI. On the left side of the image, the letters "SDI" are in white font on a black square. To the right of the square, the letters "SDI" are in black font, followed by the word "Limited".
510(k) NOTIFICATION (Traditional): Stela Capsule System – Summary – August 2022
Indications of Use 5.
The indications for each component of the Stela Capsule System are below.
| Stela Primer | Stela Capsule |
|---|---|
| 1) Dentin and enamel bonding | 1) Direct restoration of Class I, II, III and Vcavities. Ideally Class I and II, |
| 2) Base or liner, | |
| 3) Core build-ups |
For Stela Primer, the indications are identical to the primary predicate. In comparison to the secondary predicate, Stela Primer's indications are phrased in a broad sense whereas the predicate specifies each use. This difference in wording is not expected to alter the intended use nor affect the safety or effectiveness of Stela Primer compared to the secondary
For Stela Capsule, the indications are nearly identical to the primary predicate with the exception of the direct restoration of Class III and IV cavities which are indicated by the secondary predicate according to its Instructions for Use.
Comparison of Technological Characteristics with the Predicate 6. Device
The Stela Capsule System is based on well-established existing self-cure resin technology. The System's two components consist of a 1) combined primer plus bonding agent (Stela Primer) and 2) restorative bulk-fill resin-based material (Stela Capsule).
Stela Primer binds to tooth structure through ionic bonds. Bonding of Stela Primer to Stela Capsule occurs in situ upon contact via polymerisation.
At a high level, the Stela Capsule System has the same technological characteristics as the predicate devices. Where differences exist these are as follows:
- . Stela Primer number of steps
- Similar to Scotchbond Universal Adhesive in that it consists of one bottle O containing the necessary elements to prime and bond; whereas ParaBond consists of three bottles: a conditioner, adhesive A and adhesive B.
- Stela Primer curinq ●
- Self-cure like ParaBond; whereas Scotchbond Universal Adhesive is light O cured.
- Stela Capsule material and curing
- radiopaque bulk-fill composite like both predicates. Stela Capsule is self- O curing while Fill-Up and Filtek Supreme Ultra Universal Restorative are dualcure and light-cure, respectively.
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Image /page/6/Picture/0 description: The image shows the logo for SDI Limited. On the left side of the logo, the letters "SDI" are displayed in white on a black square. To the right of the black square, the words "SDI Limited" are displayed in black on a white background.
510(k) NOTIFICATION (Traditional): Stela Capsule System – Summary – August 2022
7. Performance Data
Biocompatibility testing
The Stela Capsule System is considered an external communicating device in long term contact with tissue/bone/dentin. A biological risk assessment and testing were conducted to assess the biocompatibility of the Stela Capsule System:
- Cytotoxicity tests (ISO 7405:2018, ISO 10993-5:2009) ●
- Delayed-type hypersensitivity (ISO 10993-10:2010)
- Irritation/intracutaneous reactivity (ISO 10993-10:2010) ●
- Systemic toxicity (ISO 10993-11:2017) ●
- Genotoxicity (ISO 10993-3:2014).
The results of the biocompatibility testing and risk assessment demonstrates a low potential for an unacceptable adverse biological response from contact of the component materials of the device with the body.
Non-clinical performance data
Bench testing was conducted to determine the performance of the Stela Capsule System compared to the primary and secondary predicate devices. Testing was conducted on the system where Stela Primer was used in conjunction with Stela Capsule and compared to the equivalent system for the primary and/or secondary predicate device(s). The tests performed were:
- Working time (ISO 4049) ●
- Setting time (ISO 4049)
- Flexural strength (ISO 4049) ●
- Shade (ISO 4049) ●
- Colour stability (ISO 4049) ●
- Radio-opacity (ISO 4049) ●
- Shear bond strength to dentin (ISO 29022:2013) .
- . Shear bond strength to enamel (ISO 29022:2013).
Bench testing demonstrated the Stela Capsule System met the relevant ISO standard requirement, where applicable, and performed comparably to the predicate devices for the parameters tested.
Clinical performance data
This section is not applicable.
Electrical safety and electromagnetic compatibility (EMC)
This section is not applicable.
Software verification and validation testing
This section is not applicable.
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Image /page/7/Picture/0 description: The image shows the logo for SDI Limited. The logo consists of the letters "SDI" in white on a black square. To the right of the square, the words "SDI Limited" are written in black text.
510(k) NOTIFICATION (Traditional): Stela Capsule System – Summary – August 2022
Mechanical and acoustic testing
This section is not applicable.
Conclusion Regarding Substantial Equivalence 8.
A suite of bench and biocompatibility tests shows Stela Capsule System performs comparably to the predicate devices (when used on a system basis) and possesses a low likelihood of an unacceptable adverse biological response from contact of the component materials of the device with the body. The Stela Capsule System's indications for use are identical or very similar to the predicate devices and they are all based on the same restorative materials technology. On this basis, the Stela Capsule System is substantially equivalent to the predicate devices.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.