(106 days)
RETRACT is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
RETRACT is a dental product capable of controlling gingival bleeding, temporarily displacing the marginal gingiva and temporarily drying the gingival sulcus around a tooth. The paste allows the dental clinician to perform operative procedures without interference from moisture or excess soft tissue. RETRACT is supplied in 0.5 ml syringes with a hand plunger, intra-oral tips, Instructions for Use & MSDS.
This Preamarket Notification (510(k)) is for the RETRACT Gingival Retraction/Hemostatic Paste.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct performance study to meet those criteria. Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that the device is deemed acceptable if it has similar indications, principles of operation, and technological characteristics to legally marketed devices, and the minor differences do not raise new questions of safety or effectiveness.
Table of Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence):
| Acceptance Criterion (Inferred from Substantial Equivalence) | Reported Device Performance (Comparison to Predicates) |
|---|---|
| Indications for Use | "similar indications" to predicate devices (TRAXODENT, EXPASYL, RACEGEL). |
| Principles of Operation | "similar principles of operation" to predicate devices. |
| Technological Characteristics | "similar technological characteristics" to predicate devices. |
| Aluminum Chloride Concentration | Approximately 22% aluminum chloride, which falls within the range of predicate devices (15% - 25%). |
| Primary Fillers/Thickening Agent | Uses "clay or similar materials" as primary fillers/thickening agent, similar to TRAXODENT and EXPASYL. |
| Safety and Effectiveness | "minor differences in the device do not raise any new questions of safety or effectiveness." |
| Biocompatibility | "biocompatible based on the directed usage, the known material profiles, and the extensive usage history of the constituents." Other ingredients are "food grade (or better)". |
2. Sample Size and Data Provenance
The document does not describe a specific clinical or performance study with a defined sample size for a test set. The evaluation is based on comparing the device's characteristics and ingredients to existing predicate devices already on the market. Therefore, there is no mention of a "test set" in the traditional sense, or data provenance.
3. Number of Experts and Qualifications for Ground Truth
Since no independent study with a test set was conducted to establish ground truth, there is no information provided on the number or qualifications of experts used for this purpose.
4. Adjudication Method
As there was no specific test set requiring ground truth establishment, there is no adjudication method mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted, as the device approval pathway was based on substantial equivalence and not a comparative effectiveness study involving human readers or AI assistance. The device is a paste, not an imaging or diagnostic AI system.
6. Standalone Performance Study
A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not conducted. This device is a dental material, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context is implicitly the established safety and effectiveness profile of the predicate devices. The new device is deemed acceptable because its characteristics align with or are similar to those already proven safe and effective in the market. It's an expert judgment based on prior approvals and material science, rather than a new "ground truth" derived from patient outcomes or pathology for this specific device.
8. Sample Size for the Training Set
The document does not mention a training set in the context of an algorithm or machine learning. The "training" for this type of device development would involve research and development to formulate the paste and ensure its chemical and physical properties are suitable, often based on existing knowledge of similar materials.
9. How Ground Truth for the Training Set Was Established
Since there is no explicit "training set" as understood in algorithm development, there's no information on how its "ground truth" was established. The development of the device would rely on established scientific principles for material formulation, chemical compatibility, and efficacy of known hemostatic and gingival retraction agents, guided by regulatory requirements and industry standards.
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1 KI | 3839 | Tags: 1 | 3839 | Times
510(k) SUMMARY
| Submitter: | Parkell, Inc.300 Executive DriveEdgewood, NY 11717TEL: 631-249-1134FAX: 631-249-1242 |
|---|---|
| Contact: | Daniel R. Schechter, Esq.VP, Regulatory AffairsParkell, Inc.300 Executive DriveEdgewood, NY 11717 |
| Submission Date: | 16 December 2011 |
| Trade Name: | RETRACT |
| Common Name: | Gingival Retraction/Hemostatic Paste |
| Classification Name: | None |
| Classification Product Code: | MVL |
| Predicate Devices: | TRAXODENT (K083695), EXPASYL (K050180), RACEGEL(K093711) |
| Device Description: | RETRACT is a dental product capable of controlling gingivalbleeding, temporarily displacing the marginal gingiva andtemporarily drying the gingival sulcus around a tooth. The pasteallows the dental clinician to perform operative procedureswithout interference from moisture or excess soft tissue.RETRACT is supplied in 0.5 ml syringes with a hand plunger,intra-oral tips, Instructions for Use & MSDS. |
| Intended Use: | RETRACT is a paste containing aluminum chloride which is usedfor the temporary retraction and hemostasis of the gingivalmargin during dental procedures such as dental impressions. |
| Tech. Characteristics: | RETRIEVE gingival retraction/hemostatic paste is a single partpaste and is typically supplied in a single-barrel syringe. Thepaste is dispensed by hand into and around the sulcular area ofa prepared tooth for retraction and hemostasis and is then easilywashed away with water. The material is biocompatible basedon the directed usage, the known material profiles, and theextensive usage history of the constituents. Other than thealuminum chloride, the remaining ingredients are all food grade(or better) materials. |
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Substantial Equivalence:
Parkell's RETRACT gingival retraction/hemostatic paste has similar indications, principles of operation, and technological characteristics as the predicate devices. The minor differences in the device do not raise any new questions of safety or effectiveness. Thus, RETRACT is substantially equivalent to its predicate devices. For example, the three predicate devices contain aluminum chloride in concentrations ranging from 15% -25%. RETRACT has approximately 22% aluminum chloride. In addition, RETRACT, TRAXODENT and EXPASYL all use clay or similar materials as the primary fillers/thickening agent in the mixture with aluminum chloride.
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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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Daniel R. Schechter, Esq. Vice President, Regulatory Affairs Parkell, Inc. 300 Executive Drive Edgewood, New York 11717
APR 1 2 2012
Re: K113839
Trade/Device Name: RETRACT Gingival Retraction/Hemostatic Paste Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MVL Dated: March 20, 2012 Received: March 26, 2012 -
Dear Mr. Schechter:
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 - Mr. Schechter
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 (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/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,
hu 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):
Device Name: RETRACT Gingival Retraction/Hemostatic Paste
Indications for Use:
RETRACT is a paste containing aluminum chloride which is used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
Prescription Use X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quinn
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
(1)3734 510(k) Number:
N/A