(89 days)
The DuoProSS Needle device is a sterile hypodermic needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
The DuoProSS Needle device is a sterile, single use, standard hypodermic needle. The device is available in various Gauges and lengths. Each needle device consists of a stainless steel cannula sealed with epoxy glue into a polypropylene hub. The assembly has a protective polypropylene needle shield. The device is packaged in a peal-back pouch and sterilized by ethylene oxide. The DuoProSS Needle device consists of 4 parts or materials: a stainless steel cannula, a polypropylene hub, epoxy glue and a polypropylene needle guard.
The provided text describes a hypodermic needle (DuoProSS Needle) and its 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating similarity to existing devices rather than extensive clinical efficacy studies typically associated with novel or high-risk devices.
Therefore, the information you're requesting regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth establishment (as typically applied to AI/ML or diagnostic devices) is not applicable to this particular 510(k) submission for a standard hypodermic needle.
The "study" that proves the device meets acceptance criteria in this context is the submission itself, which primarily focuses on:
- Substantial Equivalence: Demonstrating that the DuoProSS Needle has the same intended use, technological characteristics, and safety/effectiveness profiles as a predicate device (Terumo Disposable Hypodermic Needle K771203 and others).
- Design and Materials: Providing details on the components and materials used, which are standard for hypodermic needles.
- Sterilization: Stating that the device is sterilized by ethylene oxide.
- Compliance with General Controls: Acknowledging adherence to general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, etc.).
There is no mention of a clinical trial, performance study with acceptance criteria in the typical sense (e.g., sensitivity, specificity, accuracy), or any data requiring expert adjudication, multi-reader multi-case studies, or standalone algorithm performance for this device.
In summary, the provided document does not contain the information requested in your numbered points because it pertains to a traditional medical device submission (510(k) for a hypodermic needle) that does not require such performance data for market clearance.
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page 1 of 2
DEC 5 2005
510(k) SUMMARY
K NUMBER
SPONSOR
DuoProSS Meditech Corporation 27 Sarah Drive Farmingdale, NY 11735 Phone: 631.249.0100 Fax: 631.249.0700
SUBMITTED BY
Ferguson Medical Consultant to DuoProSS
CLASSIFICATION NAME
Needle, Hypodermic, Single Lumen
CLASSIFICATION NUMBER
21 CFR 880.5570/Procode 90 FMI
PROPRIETARY DEVICE NAME
DuoProSS Needle
DEVICE DESCRIPTION
The DuoProSS Needle device is a sterile, single use, standard hypodermic needle. The device is available in various Gauges and lengths.
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K052445 page 2 of 2
Each needle device consists of a stainless steel cannula sealed with epoxy glue into a polypropylene hub. The assembly has a protective polypropylene needle shield. The device is packaged in a peal-back pouch and sterilized by ethylene oxide.
DESIGN AND MATERIALS
The DuoProSS Needle device consists of 4 parts or materials: a stainless steel cannula, a polypropylene hub, epoxy glue and a polypropylene needle guard. Please see List of Components and Materials table.
INTENDED USE
The DuoProSS Needle device is a sterile hypodermic needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
SUBSTANTIAL EQUIVALENCE
Terumo Disposable Hypodermic Needle (K771203) and others.
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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 is a circular seal with the words "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
DEC 5 2005
DuoProSS Meditech Corporation C/O Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road N.E. # 931 Albuquerque, New Mexico 87111
Re: K052445
Trade/Device Name: DUOPROSS NEEDLE Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 23, 2005 Received: November 28, 2005
Dear Mr. Ferguson:
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 such 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. Ferguson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276- 0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Smitie Y. Michie, M.D.
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
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Indications For Use
510(k) Number (If known):
14052445
Device Name: DUOPROSS NEEDLE
Indications For Use:
The DuoProSS Needle device is a sterile hypodermic needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Prescription Use XX (Part 21 CFR 801 Subpart D) And/Or
Over-The- Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
William M. Burdick
For Anthony D. Watson
12/5/05
f Anesthesiology, General Hospital,
Section Control, Dental Devices
Page 1 of 1
§ 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).