(144 days)
Not Found
Not Found
No
The summary describes a mechanical syringe with a locking mechanism and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a syringe used for fluid aspiration/injection, not for treating or rehabilitating a medical condition. Its locking mechanism is for preventing accidental reuse, not for therapeutic purposes.
No
Explanation: The device description states its purpose is for general fluid aspiration/injection and to prevent accidental reuse via a locking mechanism. There is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device description clearly states it is a physical syringe with a locking mechanism, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general purpose fluid aspiration/injection" by healthcare professionals. This describes a device used directly on or with a patient for therapeutic or diagnostic procedures, not for testing samples in vitro (outside the body).
- Device Description: The description details a hypodermic syringe with a locking feature. This is a medical device used for administering or withdrawing fluids from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are specifically designed for testing biological samples (like blood, urine, tissue) to diagnose diseases, monitor health, or determine compatibility. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection. The devices contain a piston locking mechanism which aids in the prevention of the accidental reuse of the syringe.
Product codes
MEG
Device Description
The SOLOGARD® LOCKING PLUS Syringe is a sterile, single-use, disposable hypodermic syringe with a plunger locking feature to prevent the accidental reuse of the syringe. It is manufactured in sizes of 1, 2.5, 3, 5, & 10 ml with a LuerLock connector and is supplied without needle.
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
health care professionals
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)
In order to demonstrate that the locking feature did not effect the safety and efficacy of the device design, engineering analyses of the fluid flow and dynamometer and simulated use testing of the locking feature were conducted. Results indicated that the device performance was equivalent to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Becton Dickinson Single Use Hypodermic Syringes
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).
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MAR 1 7 2000
510(k) Summary of Safety and Effectiveness For SOLOGARD® LOCKING PLUS Syringe
October 20, 1999
CONTACT PERSON:
Patrick Grant, Jr. SafeGard Medical Products, Inc. 52 Dragon Court Woburn, MA 01801 Phone: (781) 935-2275 Fax: (781) 935-8424
DEVICE NAME:
Trade name: SOLOGARD® LOCKING PLUS Syringe Common & Classification name: Piston Syringe
PREDICATE DEVICE:
Becton Dickinson Single Use Hypodermic Syringes
PRODUCT DESCRIPTION:
The SOLOGARD® LOCKING PLUS Syringe is a sterile, single-use, disposable hypodermic syringe with a plunger locking feature to prevent the accidental reuse of the syringe. It is manufactured in sizes of 1, 2.5, 3, 5, & 10 ml with a LuerLock connector and is supplied without needle.
INTENDED USE:
The syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
COMPARISON TO PREDICATE DEVICE:
The SOLOGARD® LOCKING PLUS Syringe is designed with a locking feature which detains the plunger after it is depressed and prevents the plunger withdrawal for a subsequent accidental reuse. All other aspects of the design do not vary significantly from the predicate device.
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EQUIVALENCE:
In order to demonstrate that the locking feature did not effect the safety and efficacy of the device design, engineering analyses of the fluid flow and dynamometer and simulated use testing of the locking feature were conducted. Results indicated that the device performance was equivalent to that of the predicate device.
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular pattern around the bird image. The text is in all capital letters.
MAR 1 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Patrick Grant, Jr Chief Financial Officer SafeGuard Products, Incorporated 52 Dragon Court Woburn, Massachusetts 01801
Re : K993609 Trade Name: SOLOGARD® LOCKING PLUS Syringe Regulatory Class: II Product Code: MEG Dated: February 15, 2000 February 17, 2000 Received:
Dear Mr. Grant, Jr.:
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 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 reqistration, listing of devices, good manufacturing practice, labelinq, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (GMP) GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Grant, Jr.
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 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 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" (21 CFR 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/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
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Indications for Use Statement
510(k) Number (if known):
Device Name: _SOLOGARD® Locking Plus Syringe
Indications For Use:
These syringes are intended for use by health care professionals for general purpose fluid aspiration/injection. The devices contain a piston locking mechanism which aids in the prevention of the accidental reuse of the syringe.
(PLEASE 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 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Patricio Cuenca
(Division Sign-Off) Division of Denial, Infection Control, and General Hospital Devices
(Optional Format 1-2-96)
General Hospital Devices:
510(k) Number K993609
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