(43 days)
Permits the safe and simple removal of scalpel blades from most commonly used scalpel handles
Safely contains the blade immediately upon removal, eliminating the need for further handling prior to disposal
The counter allows the user to monitor its use to see when it is becoming full and will need changing
Scalpel handles compatible with the QLICKSMART® include: Swann Morton Blade sizes 3, 4, 7 and 9 Lawton Blade sizes 3 and 4 Martin Blade sizes 3, 4 and 7 Smic Blade sizes 3 and 4 Aesculap Blade sizes 3, 3L, 4 and 7 Sayco Blade sizes 3, 4 and 5 Nopa Blade sizes 3 and 4 Lance Blade sizes 3 and 4 Conqueror Blade size 3 Pro-Med Blade sizes 3 and 4 Paragon Blade sizes 3 and 4 Feather Blade size 7 Rocket Blade size 5 Generic Blade size 4 ab stainless Blade size 4 LRI Blade size 4 Jakobi Blade Size 4
Scalpel handles known to be incompatible with the QLICKSMART® include: Barron Handle Beaver Type Handles Disposable Handles.
Not Found
This document is a marketing authorization letter for the QLICKSMART® scalpel blade remover, not a study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or has different technological characteristics but these do not raise new questions of safety and effectiveness.
Therefore, this document does not contain the information requested regarding specific acceptance criteria, device performance metrics, study designs, sample sizes, or ground truth establishment. The FDA letter is a regulatory approval based on demonstrating equivalence, not on the presentation of a de novo clinical or performance study with detailed acceptance criteria and results.
{0}------------------------------------------------
Image /page/0/Picture/1 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 coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 6 1998
Robert T. Handren, Jr., M.S. President Handren Associates, Incorporated 5818 Princess Caroline Place Leesburq, Florida 34748
Re: K983367 QLICKSMART® Trade Name: Requlatory Class: II Product Code: MMK Dated: September 23, 1998 September 24, 1998 Received:
Dear Mr. Handren:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
{1}------------------------------------------------
Page 2 - Mr. Handren
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known): K983367
Device Name: QLICKSMART®
Indications For Use:
"Permits the safe and simple removal of scalpel blades from most 1. commonly used scalpel handles"
"Safely contains the blade immediately upon removal, eliminating 2. the need for further handling prior to disposal"
"The counter allows the user to monitor its use to see when it is 3. becoming full and will need changing"
"Scalpel handles compatible with the QLICKSMART® include: ধ:
Swann Morton Blade sizes 3, 4, 7 and 9 Lawton Blade sizes 3 and 4 Martin Blade sizes 3, 4 and 7 Smic Blade sizes 3 and 4 Aesculap Blade sizes 3, 3L, 4 and 7 Sayco Blade sizes 3, 4 and 5 Nopa Blade sizes 3 and 4 Lance Blade sizes 3 and 4 Conqueror Blade size 3 Pro-Med Blade sizes 3 and 4 Paragon Blade sizes 3 and 4 Feather Blade size 7 Rocket Blade size 5 Generic Blade size 4 ab stainless Blade size 4 LRI Blade size 4 Jakobi Blade Size 4"
"Scalpel handles known to be incompatible with the QLICKSMART® ഗ് include:
Barron Handle Beaver Type Handles Disposable Handles."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Prescription Use | OR | |||||||||||
| Over-The-Counter Use | ||||||||||||
| 1-2-96)(Division Sign-Off)Division of De Infection Control,and General Hospital Devices510(k) Number | 1-2-96) | (Division Sign-Off) | Division of De Infection Control, | and General Hospital Devices | 510(k) Number | (Optional Format | ||||||
| 1-2-96) | ||||||||||||
| (Division Sign-Off) | ||||||||||||
| Division of De Infection Control, | ||||||||||||
| and General Hospital Devices | ||||||||||||
| 510(k) Number |
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).