(161 days)
Not Found
No
The device description and intended use clearly describe a standard manual syringe with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is used for the injection of insulin or fluids into the body, which is a therapeutic action.
No
The device description states its intended use is for "injection of insulin into the body" and "to inject fluids into, or withdraw fluids from, the body," which are therapeutic or functional uses, not diagnostic.
No
The device description clearly outlines physical components made of materials like polypropylene and Kraton IR, indicating it is a hardware device (a syringe).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "injection of insulin into the body" and to "inject fluids into, or withdraw fluids from, the body." This describes a device used for direct interaction with the human body for therapeutic or diagnostic purposes in vivo (within the living organism).
- Device Description: The description details a standard syringe used for injecting or withdrawing fluids. This is a common medical device used for administering medications or collecting samples from the body, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are designed for testing these types of samples in vitro (outside the living organism).
Therefore, the DuoPross Insulin Syringe is a medical device, but it falls under the category of devices used for direct patient care rather than in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The DuoProSS Syringes device is intended to be used to inject fluids into, or withdraw fluids from, the body.
The 1ml DuoPross Insulin Syringe is intended for the injection of insulin into the body.
The DuoPross Syringes device is used to inject fluids into, or withdraw fluids from, the body.
Product codes
FMF
Device Description
The DuoProSS Syringes device is a sterile, single use, standard piston syringe, designed for manual use. The device is available in 1, 1 (insulin), 2, 5, 10, 20 and 60 cc/ml volumes with luer slip or luer lock configurations. Each syringe consists of a calibrated hollow barrel and movable plunger. At the distal end of the syringe is a male connector nozzle for fitting the female connector hub of a single lumen needle. Configurations are supplied with and without the needle already attached to the syringe. The DuoProSS Syringes device consists of 3 parts: a barrel, a plunger, a piston and a needle. The barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The piston is made from Kraton IR, a highly inert isoprene rubber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020623, K022806, K031594, K034031, K980987
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
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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
Piston Syringe
CLASSIFICATION NUMBER
21 CFR 880.5680/Procode 80 FMF
PROPRIETARY DEVICE NAME
DuoProSS Syringes
DEVICE DESCRIPTION
The DuoProSS Syringes device is a sterile, single use, standard piston syringe, designed for manual use. The device is available in 1, 1 (insulin), 2, 5, 10, 20 and 60 cc/ml volumes with luer slip or luer lock configurations.
1
Each syringe consists of a calibrated hollow barrel and movable plunger. At the distal end of the syringe is a male connector nozzle for fitting the female connector hub of a single lumen needle. Configurations are supplied with and without the needle already attached to the syringe.
2 - 2
DESIGN AND MATERIALS
The DuoProSS Syringes device consists of 3 parts: a barrel, a plunger, a piston and a needle. The barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The piston is made from Kraton IR, a highly inert isoprene rubber. Please see List of Components and Materials table.
INTENDED USE
The DuoProSS Syringes device is intended to be used to inject fluids into, or withdraw fluids from, the body.
SUBSTANTIAL EQUIVALENCE
K020623 DuoPro Safety Syringe
K022806 Modified DuoPro Safety Syringe
K031594 1 ml Bak'Snap DuoPro Safety Syringe
K034031 10 ml Bak'Snap DuoPro Safety Svringe
K980987 Becton-Dickinson (BD) Single-Use Hypodermic and Insulin Syringes and others
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings and body. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
FEB 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DuoProSS Meditech Corporation C/O Mr. Frank Ferguson Official Corespondent Ferguson Medical 12200 Academy Road NE #931 Albuquerque, New Mexico 87111
Re: K042500
Trade/Device Name: DUOPROSS SYRINGES-1ml Insulin Syringe and Duopross Syring (General USE) Regulation Number: 880.5680 Regulation Name: Pediatric Position Holder Regulatory Class: II Product Code: FMF Dated: December 28, 2004 Received: December 13, 2004
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 enclosurc) 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 Ecderal Register.
3
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 vour 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 vours,
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
4
K0412500
Indications For Use
K042500 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
DUOPROSS SYRINGES – 1ml Insulin Syringe Device Name:
Indications For Use:
The 1ml DuoPross Insulin Syringe is intended for the injection of insulin into the body.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use XX (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)
Anton D. luc
. Bion Sign-Off) ision of Anesthesiology, General Hospital, rection Control. Dental Devices
11:4) Number__________________________________________________________________________________________________________________________________________________________________
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5
Indications For Use
510(k) Number (If known): K042500
Device Name: DUOPROSS SYRINGES
Indications For Use:
The DuoPross Syringes device is used to inject fluids into, or withdraw fluids from, the body.
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)
.............................................................................................................................................................................. -25
:) sion Sign-Off) : Ision of Anesthesiology, General Hospital, Traction Control, Dental Devices
(k) Number ___________________________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________
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