(100 days)
this device is to be used as a heavy body material for:
- · Two step putty/wash technique
- · Sigle step putty/wash technique
- · Functional peripheries
- Crown/bridge work
Vinyl polysiloxane is an addition-reaction silicone elastomer (an addition silicone). It is a viscous liquid that cures quickly into a rubber-like solid, taking the shape of conforming to tooth's shape surface it was lying against while curing. As with 2-part epoxy, its package keeps its 2 component liquids in separate container until the moment they are mixed and applied, because once mixed, they cure (harden) rapidly.
To create the material, the user mixes the base with the catalyst, and the chemical reaction begins. Once the impression material is set and modified, it is taken to patient"s mouth for use in the transfer bonding process.
The provided text is a 510(k) summary for a dental impression material (PEAK NS033CF, PEAK NS017CF). It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a diagnostic medical device.
Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment cannot be found in this document because the premarket notification for this type of device does not typically require such detailed clinical study information.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on compliance with international standards for dental impression materials and biocompatibility. The "reported device performance" section primarily states that the new device meets these standards, rather than providing specific numerical performance metrics.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ISO 10993-5 (Cytotoxicity) | Compliant (Biocompatible) |
| ISO 10993-10 (Skin Irritation, Sensitization) | Compliant (Biocompatible) |
| ISO 4823:2015 (Dentistry - Elastomeric Impression Materials) | Compliant (Technological characteristics including setting time, consistency, elastic recovery, strain-in-compression are similar to predicate and meet standard). |
2. Sample Size for the Test Set and Data Provenance
Not provided in the document. The document states that performance and biocompatibility tests were carried out, but it does not specify the sample sizes or the provenance of the data (e.g., country of origin, retrospective/prospective nature). These tests would typically be laboratory-based rather than involving human subjects for effectiveness testing in the way a diagnostic AI would.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided in the document. For a dental impression material, "ground truth" would relate to its physical and chemical properties and biocompatibility as measured in laboratory settings against established standards, not interpretation by human experts in a diagnostic context.
4. Adjudication Method for the Test Set
Not applicable/Not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for clinical diagnostic studies where multiple readers interpret cases and their consensus defines ground truth. This is not relevant for the type of testing described for an impression material.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable/Not done. An MRMC study is relevant for diagnostic devices that assist human readers (e.g., AI for radiology). This device is a dental impression material, not a diagnostic AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
Not applicable/Not done. This concept applies to AI algorithms. The device in question is a physical material.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by international standards (ISO 4823:2015 for physical properties and ISO 10993-5, ISO 10993-10 for biocompatibility). This involves objective measurements and tests according to the methodologies defined by these standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set
Not applicable/Not provided in the document. The concept of a "training set" applies to machine learning algorithms. This device is a physical product, not an AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided in the document. As stated above, this device does not involve a training set for an AI algorithm.
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Neosil Co., Ltd. Yang Ho Dong CEO Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu Seoul, 06523 Kr
Re: K180565
Trade/Device Name: PEAK NS033CF, PEAK NS017CF Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: February 26, 2018 Received: March 19, 2018
Dear Yang Ho Dong:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
June 13, 2018
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180565
Device Name PEAK NS033CF PEAK NS017CF
Indications for Use (Describe)
this device is to be used as a heavy body material for:
- · Two step putty/wash technique
- · Sigle step putty/wash technique
- · Functional peripheries
- Crown/bridge work
| 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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510(k) SUMMARY K180565
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 8807.92.
| Submitter Information: | Neosil Co., Ltd.63,Gongdanseo-ro 18beon-gil, Geumjeong-guBusan, 46332, KoreaTel. +82-51-265-5144 |
|---|---|
| Contact Person: | Ho Dong, YangOnbix Corporation#821 Samil Plaza, 14 Dogokro 1-gilGangnam-gu, Seoul, Korea (06253)Tel: *82-2-566-3360 / Fax: *82-2-6280-3360Email: onbix@naver.com |
| Date Summary Prepared: | Mar 23, 2018 |
Device Information:
Trade Name(s): PEAK NS033CF / PEAK NS017CF Classification Name: impression material Panel: dental Product Code & Regulation: ELW
Predicate Device Information:
K152180 - PEAK NS033C / PEAK NS017C
Device Description:
Vinyl polysiloxane is an addition-reaction silicone elastomer (an addition silicone). It is a viscous liquid that cures quickly into a rubber-like solid, taking the shape of conforming to tooth's shape surface it was lying against while curing. As with 2-part epoxy, its package keeps its 2 component liquids in separate container until the moment they are mixed and applied, because once mixed, they cure (harden) rapidly.
To create the material, the user mixes the base with the catalyst, and the chemical reaction
begins. Once the impression material is set and modified, it is taken to patient"s mouth for use in the transfer bonding process.
Indications for Use:
this device is to be used as a heavy body material for:
- Two step putty/wash technique
- · Sigle step putty/wash technique
- · Functional peripheries
- = Crown/bridge work
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
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-
- indications for use
-
- raw material
-
- technological characteristics including setting time, consistency, elastic recovery, strain-in compression etc in accordance with ISO 4823.
-
- performance properties
-
- biocompatibility in accordance with ISO 10993-1
Summary of the technological characteristics compared to the predicate device
The device chemical composition is slightly different than listed in the predicate and therefore the following performance and biocompatibility tests were carried out to show substantial equivalence.
Non-Clinical performance test
To be in compliance with electromagnetic safety and compatibility, appropriate study has been applied to the new device in accordance with the following standard
ISO 10993-5 cytotoxicity
ISO 10993-10 skin irritation, sensitization
ISO 4823:2015 dentistry - elastomeric impression materials
Conclusion
The subject and predicate devices have similar material properties . characteristics and performance and therefore is substantially equivalent to the K152180 predicate device.
§ 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).