(80 days)
CordCap™ is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means.
CordCap™ is a compression roll manufactured out of wicking paper and impregnated with natural salts.
The provided text is a 510(k) summary for the CordCap™ device. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics, sample sizes, and ground truth establishment methods.
Based on the provided text, there is no detailed study information available that describes acceptance criteria and how a device's performance meets those criteria in the way typically expected for a clinical trial or performance study of an AI/imaging device.
Here's an analysis of the submission in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The "criteria" for acceptance are implicitly that the device is "as safe and effective" as the predicate devices.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Summary from Submission) |
|---|---|
| Safety: | |
| - No adverse biological reactions | - CordCap™ is a mechanical device made of absorbent paper infused with sodium chloride and/or aluminum chloride salts. |
| - Low concentration of salts | - Salt level less than 6mg per 1" x ½" of paper, typically 0.06g - 0.09g of salt per device. |
| - Similar materials to predicate devices | - Materials (wicking paper, natural salts) are similar in nature to components or principles of retraction cords. |
| Effectiveness: | |
| - Temporary retraction of gingival margin | - Intended for temporary retraction of the gingival margin through mechanical means. Compression of gingival tissue over several minutes is commonly known to widen the sulcus. |
| - Hemostasis of gingival margin | - Intended for hemostasis of the gingival margin through mechanical means. Mechanical pressure on the tissue can effect hemostasis, enhanced through natural action of salts. |
| - Similar mechanism of action to predicate devices | - Functions in a physical manner similar to, and is intended for the same use as, predicate devices (Ultrapak NEHA, Stay-Put Impregnated). |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission does not describe a test set in the context of performance metrics for an AI/imaging device. It relies on a comparison of characteristics and intended use to predicate devices already on the market. There were no human subjects or data sets used for validating specific performance claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As there was no test set for performance evaluation, there were no experts used to establish ground truth. Substantial equivalence is determined by regulatory bodies based on documented device characteristics and comparison to predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process for performance was described.
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:
- No. An MRMC study is not relevant for this type of mechanical dental device. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implicit "Ground Truth" of Predicate Devices: The "ground truth" in a substantial equivalence claim is effectively the established safety and effectiveness of the legally marketed predicate devices (Ultrapak NEHA, Stay-Put Impregnated). The new device is deemed acceptable if it can demonstrate it shares the same intended use and technological characteristics, or is as safe and effective, as these predicates.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
In summary, the provided K091380 document is a 510(k) premarket notification for a mechanical dental device. Its acceptance relies on demonstrating substantial equivalence to already approved predicate devices, not on a detailed clinical study with performance metrics in the way an AI diagnostic device would be evaluated. Therefore, most of the specific questions about acceptance criteria and study details for an AI-like device are not applicable to this submission.
{0}------------------------------------------------
າງປະ ຊັ່ງປະ ຊົນ 2009
April 24, 2009
510(k) SUMMARY
-
- Submission Applicant & Correspondent:
Name: Centrix Incorporated Address: 770 River Road. Shelton, Connecticut 06484 USA Establishment Registration Number 1281412 Phone (203) 929-5582 Contact Person: John Discko, Executive VP Extension 206
- Submission Applicant & Correspondent:
-
- Name of Device: Cord, Retraction Trade/Proprietary/Model Name: CordCap™ Classification Product Code: MVL
-
- Device Description: CordCap™ is a compression roll manufactured out of wicking paper and impregnated with natural salts.
-
- Intended Use of the Device: The CordCap is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means. Compression of gingival tissue over several minutes is commonly known to widen the sulcus. In addition, mechanical pressure on the tissue can effect hemostasis, and is enhanced through the natural action of salts.
-
- Summary of Technological Characteristics of the Device Compared to the Predicate Devices:
CordCap is substantially equivalent to other legally marketed devices in the United States. CordCap™ functions in a physical manner similar to and is intended for the same use as the products Ultrapak NEHA (K010070) and Stay-Put Impregnated (K041023) cleared for marketing for Ultradent Products and Coltene/Whaledent, respectively.
{1}------------------------------------------------
510(k) Summary Page 2
In summary, CordCap ™ as described in this submission is, in our opinion, substantially equivalent to the predicate devices by meeting the following standards set by FDA:
It has the same intended use as the predicate devices; and
It has the same technological characteristics as the predicate devices; or >the sponsor demonstrates that the device is as safe and effective as the legally marketed device.
7) Tests and Conclusions:
CordCap™ is a mechanical device, made of absorbent paper, and infused with sodium chloride and/or aluminum chloride salts. Salt level is less than 6mg per 1" x ½" of paper. Typically, this amounts to .06g - .09g of salt per device, depending on size. Based on the low concentrations of the above common salts, the CordCap can be considered safe and effective for the temporary retraction of gingival tissue.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IJUL 3 0 2009
Mr. John Discko Executive, Vice President Centrix, Incorporated 770 River Road Shelton, Connecticut 06484
Re: K091380
Trade/Device Name: CordCap™ Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: April 24, 2009 Received: May 11, 2009
Dear Mr. Discko:
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 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.
{3}------------------------------------------------
Page 2 - Mr. Discko
(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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Runner
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Centrix Inc
510(k) Notification CordCap™
| Labels | Values |
|---|---|
| 510(k) number (if known) | K091380 |
CordCap™ Device Name:
Indications for Use: CordCap™ is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means.
(Please do not write below this line – continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ | or | Over-The-Counter Use | |
|---|---|---|---|---|
| --------------------------------------- | --------------------------------------------------------- | ---- | ---------------------- | -- |
| (Division Sign-Off) | Susan Runner |
|---|---|
| Division of Anesthesiology, General HospitalInfection Control, Dental Devices | |
| 510(k) Number: | K911380 |
N/A