(79 days)
All indications for displacement of the marginal gingiva and to provide for a dry sulcus when the periodontium is healthy.
CoSP2, manufactured by 3M ESPE, is a retraction paste for the displacement of marginal gingiva and to provide for a dry sulcus. Any suitable, commonly available dispensers, e.g., the Capsule Applicator, manufactured for 3M ESPE, can be used for application of the retraction paste. The paste is applied directly from the retraction capsule into the sulcus. A CoSP2 retraction capsule may not be used on more than one patient.
I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria in the way you've outlined for AI/ML device evaluation.
The provided document is a 510(k) summary for a medical device called "CoSP2," which is a retraction paste used in dentistry. The document focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against a set of quantitative acceptance criteria through a specific performance study as would be typical for an AI/ML device.
Here's why I cannot fulfill your request based on the given text:
- Type of Device: CoSP2 is a physical dental paste, not an AI/ML device or software. Therefore, the evaluation methodology and criteria are fundamentally different.
- Safety and Effectiveness Claims: The document states, "In this 510(k) premarket notification chemical composition, performance data (e.g. extrusion force, flow resistance, and rinsing time), and indications for use of CoSP2 have been compared to its predicate devices." and "To provide evidence for safety biocompatibility testing was carried out. The results show that CoSP2 is a safe device." It concludes: "In summary, it can be concluded that safety and effectiveness requirements for CoSP2 are completely met."
- "Performance Data" Context: The "performance data" mentioned (extrusion force, flow resistance, and rinsing time) are physical properties of the paste, not clinical efficacy or diagnostic accuracy metrics related to AI.
- No "Acceptance Criteria" Table: There is no table of acceptance criteria or reported device performance metrics in the way you've requested (e.g., sensitivity, specificity, AUC) for an AI/ML device.
- No ML-Specific Study Information: The document does not mention anything about:
- Sample sizes for test sets (beyond general product testing).
- Data provenance for clinical images/data.
- Number or qualifications of experts establishing ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or comparative effectiveness with human readers.
- Standalone AI algorithm performance.
- Types of ground truth (e.g., pathology, outcomes data).
- Training set sample size or how its ground truth was established.
In essence, the 510(k) submission for CoSP2 focuses on demonstrating that the device is as safe and effective as existing legally marketed predicate devices, primarily through comparison of chemical composition, physical performance characteristics, and biocompatibility testing. It doesn't involve the kind of performance study or acceptance criteria relevant to an AI/ML diagnostic or assistive device.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
FEB 1 9 2010
Submitter Information
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Desi W. Soegiarto,Regulatory Affairs Specialist |
| Phone: | 011-49-8152-700 1169 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| Date: | February 17, 2010 |
Name of Device
| Proprietary Name: | CoSP2 |
|---|---|
| Common Name: | Retraction paste |
| Classification Name: | Unclassified |
| Product code | MVL |
Predicate Devices
| Expasylby Produits Dentaires Pierre Rolland | K050180 |
|---|---|
| Hemostasyl Pasteby Produits Dentaires Pierre Rolland | K082116 |
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Description for the Premarket Notification
CoSP2, manufactured by 3M ESPE, is a retraction paste for the displacement of marginal gingiva and to provide for a dry sulcus. Any suitable, commonly available dispensers, e.g., the Capsule Applicator, manufactured for 3M ESPE, can be used for application of the retraction paste. The paste is applied directly from the retraction capsule into the sulcus. A CoSP2 retraction capsule may not be used on more than one patient.
Predicate devices to which CoSP2 has been compared are Expasyl by Produits Dentaires Pierre Rolland for Kerr (K050180) and Hemostasyl Paste by Produits Dentaires Pierre Rolland (K082116).
Like its predicate devices, CoSP2 has been design as a pasty alternative to the most common retraction devices which are cords.
Like its predicate devices, CoSP2 is a retraction paste containing aluminum chloride. It is known that aluminum chloride constrics or occludes blood vessels, causing denaturation, producing a physical meshwork (in contrast to epinephrine which is a pharmacological active substance that causes decreasing blood pressure).
CoSP2 is intended to be used for all indications for displacement of the marginal gingiva and to provide for a dry sulcus when the periodontium is healthy, such as:
Taking impressions, either with impression material or as digital impression Preparation of temporary casts
Preparation of Class II and V fillings
The intended use of CoSP is comparable the area of the intended use of the predicate devices of CoSP2.
In this 510(k) premarket notification chemical composition, performance data (e.g. extrusion force, flow resistance, and rinsing time), and indications for use of CoSP2 habe been compared to its predicate devices.
The comparison for chemistry, performance data and indications for use shows that CoSP2 is substantially equivalent to the predicate devices.
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To provide evidence for safety biocompatibility testing was carried out. The results show that CoSP2 is a safe device.
In summary, it can be concluded that safety and effectiveness requirements for CoSP2 are completely met.
Indications for use:
All indications for displacement of the marginal gingiva and to provide for a dry sulcus when the periodontium is healthy.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue. Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M ESPE AG Dental Products ESPE Platz D-82229 Seefeld GERMANY
FEB 1 9 2010
Re: K093721
Trade/Device Name: CoSP2 Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: November 27, 2009 Received: December 2, 2009
Dear Dr. Soegiarto:
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.
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Page 2- Dr. Soegiarto
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. 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):
K093.721
Device Name:
Indications For Use:
CoSP2
All indications for displacement of the marginal gingiva and to provide for a dry sulcus when the periodontium is healthy.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBetzoms for Dr. K.P. Muluy
(Richland Ctr. OH)
(Divlaion Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K093721
N/A