(156 days)
RTR® SYRINGE is designed for the replacement of bone losses, after being impregnated with the patient's blood or with a physiological solution for craniofacial indications in the dental practice such as filling tooth sockets.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for a medical device called "RTR® Syringe." It does not contain information about acceptance criteria, device performance studies, or clinical trial data. The document primarily focuses on regulatory approval and the device's indications for use.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
- Information on MRMC comparative effectiveness studies or standalone performance.
- Type of ground truth, training set sample size, or how ground truth was established for a training set.
This document is a regulatory approval, not a scientific study report.
{0}------------------------------------------------
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The text is in all caps and is written in a simple, sans-serif font.
SEP 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Septodont C/O Mr. Wayne H. Matelski Arent Fox, PLLC 1050 Connecticut Avenue, NW Washington, District of Columbia 20036-5339
Re: K063634 Trade/Device Name: RTR® Syringe Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: May 10, 2007 Received: May 10, 2007
Dear Mr. Matelski:
This letter corrects our substantially equivalent letter of May 11, 2007.
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 (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.
{1}------------------------------------------------
Page 2 - Mr. Matelski
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA $ Issuance or a subscription with other requirements
mean that FDA has made a determination that your device Federal agencies mean that FDA has made a decemmance that Joan inistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by registrati of the Act or any Federal statues and reginations including, but not limited to: registration
You must comply with all the Act 's requirements, including bractice You must comply with an the Act 3 requirements and 0 ); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing (21 CFR Part and listing (21 CPR Part 807), labeling (21 CFR Part 820) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulations (21 -542 of t requirements as set forth in the quality systems (20) regulable (2010) 10) in Act);
applicable, the electronic product radiation control provisions (sections 531-542 of the A 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section This letter will allow you to continue marketing your users and equivalence of your device to
510(k) premarket notification. The FDA finding of substantial equivalerice and 510(K) premarket nothleation. The 1 DA Initially of Same of Same of Source and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), and n you desire specific as . of Compliance at (240) 276-0115 please contact the Office of Comphanes at (210) = 1 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 2 = 1 = = (http://www.lda.gov/curmorgam2.html/> by reference to premarket notification" (21CFR
note the regulation entitled, "Misbranding by reference are responsibilities under the note the regulation entitled, "Misoranding of responsibilities under the Part 807.97). You may obtain outcr general minutational and Consumer Assistance at its
Act from the Division of Small Manufacturers, International and Consumer and consumer Act from the Drvision of Binan Nati(240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Carls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
STATEMENT OF INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): K063634
Device Name: RTR® SYRINGE
Indications for Use:
RTR® SYRINGE is designed for the replacement of bone losses, after being impregnated with RTR® SYRINGE is designed for the replacement of one roads, and the program.
the patient's blood or with a physiological solution for craniofacial indications in the dental practice such as filling tooth sockets.
AND/OROver-the-Counter Use Prescription Use X Prescription OSC
(Part 2) CFR 801 Subpart D)(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)
Susan Runne/
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . of Anesthesiology, General Hospital, Control, Dental Devices
", k) Number ___
RPP/211310.1
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.