(25 days)
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Not Found
No
The summary describes a mechanical safety syringe with a retraction mechanism, and there is no mention of AI or ML terms, image processing, or data-driven performance metrics.
No
The device is a syringe designed for administering medication and protecting healthcare workers, not for providing therapy itself.
No
The device is described as a safety syringe for injecting medication and fluids, not for diagnosing medical conditions. Its primary function is to safely deliver substances and protect healthcare workers, not to identify diseases or medical states.
No
The device description clearly indicates it is a physical syringe with a mechanical retraction mechanism, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for injecting medication and fluids into patients (subcutaneous and intramuscular use). This is a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body.
- Device Description: The device is a syringe designed for injecting substances and then retracting the needle. This is a delivery mechanism, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the living organism) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a tool for administering substances into the body.
N/A
Intended Use / Indications for Use
The device is intended to be used for subcutaneous and intramuscular use.
The function of the Futura® Safety Syringe is designed to provide safe and reliable method of injecting medication and fluids into patients and also helps protect the healthcare worker from potential needle sticks.
The Futura® Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle safely inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism.
Product codes
MEG
Device Description
The Futura® Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle safely inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2002
Mr. David Olmstead Vice President, RA/QA Futura Medical Technology 2025 W. 11" Street Upland. California 91786
Re: K023323
Trade/Device Name: Futura® Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: October 3, 2002 Received: October 4, 2002
Dear Mr. Olmstead:
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.
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.
1
Page 2 – Mr. Olmstead –
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy latowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K 023323
Confidential Futura Medical Futura Safety Syringc 510(k) Notification
Section 2
Indications for Use Statement
| 510(k) Number | Not applicable |
|---|---|
| Device Name: | Futura® Safety Syringe |
| Indications For Use | The device is intended to be used for subcutaneous and intramuscular use |
The function of the Futura® Safety Syringe is designed to provide safe and reliable method of injecting medication and fluids into patients and also helps protect the healthcare worker from potential needle sticks.
The Futura® Safety Syringe functions as a conventional hypodermic syringe except for its ability to retract the contaminated needle safely inside the syringe immediately after the completion of the patient injection. Complete delivery of the syringe contents activates the retraction mechanism.
(PLEAS DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) ______________________________________________________________________________________________________________________________________________________________________________
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801)
Viole Holland for Pat Cucinti
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K 0 23 3