(73 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 described as a general-purpose fluid aspiration/injection syringe, which is a delivery device and not a therapeutic device. Its function is to administer or withdraw fluids, not to treat a condition itself.
No
The device is a syringe intended for general purpose fluid aspiration/injection, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical syringe with a locking mechanism and needle, indicating it is a hardware medical device. There is no mention of software as the primary or sole 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." This describes a device used for administering or withdrawing fluids from the body, which is a clinical procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a hypodermic syringe with a needle and a locking mechanism. This is consistent with a device used for injecting or aspirating fluids directly from a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, etc.) in vitro (outside the body) to diagnose a condition or provide information about a patient's health status.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This syringe is designed for direct interaction with the patient's body for fluid management.
N/A
Intended Use / Indications for Use
The syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
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 (comma separated list FDA assigned to the subject device)
FMF, FMI
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 and is supplied with a G29 x ½" or G29 x 5/8" 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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).
0
OCT = 1 2001
510(k) Summary of Safety and Effectiveness For SOLOGARD® LOCKING PLUS Syringe with Needle
July 18, 2001
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 with Needle Common & Classification name: Piston Syringe
PREDICATE DEVICES:
Becton Dickinson Single Use Hypodermic Syringes and SafeGard Medical Products, Inc. SOLOGARD® LOCKING PLUS Syringe without Needle
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 and is supplied with a G29 x ½" or G29 x 5/8" needle.
INTENDED USE:
The syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
COMPARISON TO PREDICATE DEVICES:
The SOLOGARD® LOCKING PLUS Syringe with needle is designed with a locking feature which detains the plunger after it is depressed and prevents the plunger withdrawal for a subsequent accidental reuse. In this aspect it is similar to the predicate SOLOGARD® LOCKING PLUS Syringe without Needle.
1
All other aspects of the design do not vary significantly from the predicate Becton Dickinson device.
EQUIVALENCE:
The performance and use of this device do not differ significantly from the predicate devices. Therefore, SafeGard Medical Products, Inc. believes that this device is equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
OCT - 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Patrick Grant, Jr. President Safegard Medical Products, Incorporated 52 Dragon Court Woburn, Massachusetts 01801
Re: K012283
Trade/Device Name: Sologard Locking Plus Syringe with Needle Regulation Number: 880.5860 and 880.5570 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF and FMI Dated: July 18, 2001 Received: July 20, 2001
Dear Mr. Grant:
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.
3
Page 2 - Mr. Grant
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 und instills (21 CF Partier 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 aller reville) over 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,
L. Alatorre
A. Ulatowski Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): _ K 0 1 22 8 3
Device Name: _SOLOGARD® Locking Plus Syringe with Needle
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 _________________________________________________________________________________________________________________________________________________________
Patricia Cescente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 4 012
(Optional Format 1-2-96)