← Product Code [MEG](/productcode/MEG) · K993609 # SOLOGUARD LOCKING PLUS SYRINGE (K993609) _Safeguard Medical Products, Inc. · MEG · Mar 17, 2000 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K993609 ## Device Facts - **Applicant:** Safeguard Medical Products, Inc. - **Product Code:** [MEG](/productcode/MEG.md) - **Decision Date:** Mar 17, 2000 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5860 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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. ## Device Story SOLOGARD® LOCKING PLUS Syringe is a sterile, single-use, disposable hypodermic syringe; features integrated plunger locking mechanism to prevent accidental reuse. Available in 1, 2.5, 3, 5, and 10 ml sizes with LuerLock connector; supplied without needle. Used by healthcare professionals in clinical settings for general fluid aspiration and injection. Locking feature detains plunger after depression, preventing withdrawal. Device benefits patient by reducing risk of needle-stick injuries or cross-contamination associated with syringe reuse. ## Clinical Evidence Bench testing only. Engineering analyses of fluid flow, dynamometer testing, and simulated use testing of the locking feature were conducted to demonstrate performance equivalence to the predicate device. ## Technological Characteristics Sterile, single-use, disposable piston syringe. Sizes: 1, 2.5, 3, 5, 10 ml. Features LuerLock connector and integrated plunger locking mechanism. Mechanical operation; no energy source or software. ## Regulatory 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. ## Predicate Devices - Becton Dickinson Single Use Hypodermic Syringes ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ MAR 1 7 2000 K993609 # 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. {1}------------------------------------------------ ### 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ ## 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 7 --- **Source:** [https://fda.innolitics.com/device/K993609](https://fda.innolitics.com/device/K993609) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com