(80 days)
Not Found
No
The device description and performance studies indicate a purely mechanical and chemical mechanism of action, with no mention of AI or ML.
Yes
The device is intended for the temporary retraction and hemostasis of the gingival margin, which are therapeutic actions.
No
The device is described as a medical device for temporary retraction and hemostasis of the gingival margin through mechanical means, not for diagnosing a condition.
No
The device description clearly states it is a physical compression roll made of wicking paper and impregnated with salts, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- CordCap™ Function: The description clearly states that CordCap™ is a mechanical device used for the temporary retraction and hemostasis of the gingival margin. It works by physical compression and absorption, not by analyzing biological samples.
- Intended Use: The intended use is for a physical action on tissue (retraction and hemostasis), not for analyzing a sample to gain diagnostic information.
- Device Description: The description of the materials (wicking paper, natural salts) and how it functions (compression roll) aligns with a mechanical/absorbent device, not an IVD.
Therefore, based on the provided information, CordCap™ falls under the category of a medical device used for a physical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
MVL
Device Description
CordCap™ is a compression roll manufactured out of wicking paper and impregnated with natural salts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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 Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K911380 |