← Product Code [FMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF) · K972900 # ULTRASAFE MODEL T200 INJECTOR (K972900) _Safety Syringes, Inc. · FMF · Feb 26, 1998 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K972900 ## Device Facts - **Applicant:** Safety Syringes, Inc. - **Product Code:** [FMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF.md) - **Decision Date:** Feb 26, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5860 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic, Pediatric ## Indications for Use The UltraSafe® Model T200 Injector with Needle Guard is designed to hold a TUBEX® Sterlie Cartridge-Needle Unit 2.5 ml. in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit. The UltraSafe® Model T200 Injector is used with a Tubex® Sterile Cartinge-Needle Unit 2.5 ml. to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for parenteral methods of administration. ## Device Story The UltraSafe® Model T200 is a manual, disposable injection system designed to hold 2.5 ml TUBEX® sterile cartridge-needle units. It functions as a mechanical injector for delivering medication into patient tissue. The device features an integrated needle guard that the clinician manually snaps into place over the needle after use. This mechanism eliminates the need for recapping, thereby reducing the risk of accidental needle stick injuries during disposal. The device is operated by healthcare professionals in clinical settings. It provides the same usable needle length as standard unguarded needles, allowing for equivalent hypodermic procedures. The primary benefit is enhanced caregiver safety through passive/active needle shielding. ## Clinical Evidence Bench testing only. No clinical data provided. Testing confirmed structural strength and functional equivalence to predicate devices for hypodermic procedures. ## Technological Characteristics Manual, disposable injection system. Materials: K-Resin (KR01, KR03) and ABS Resin. Mechanical needle guard mechanism requiring two-handed activation. Compatible with 2.5 ml TUBEX® cartridge-needle units. Non-powered, mechanical device. ## 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 - Safety Syringes UltraSafe® Aspirating Syringe ([K944425](/device/K944425.md)) - Wyeth TUBEX® Injector (Pre-amendment) ## 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}------------------------------------------------ FEB 2 6 1998 # UltraSafe® Injection System Model T200 Injector with Needle Guard 510(k) Premarket Notification K 97290 0 # 9.0 Summary of Safety and Effectiveness # Safety Syringes Contact Person 9.1 David Mitchell Safety Syringes, Inc. 250 West Colorado Blvd. Suite # 101 Arcadia, CA 91007 (626) 821.1121 Phone (626) 821.1009 Fax #### 9.2 Device Name UltraSafe® Injection System, Model T200 Injector with Needle Guard #### 9.3 Predicate Devices Safety Syringes UltraSafe® Aspirating Syringe - K944425 Wyeth TUBEX® Injector - Pre-amendment #### 9.4 Product Description and Function The UltraSafe® Model T200 Injector with Needle Guard is a product which is intended to be used with a TUBEX® Sterile Cartridge-Needle Units 2.5 ml to deliver medication from the cartridge into the tissues of the patient. The device is totally disposable and is equipped with a needle shield which can be snapped into place after use of a syringe, thus protecting the caregiver by eliminating the need to recap the needle, and minimizing accidental needle stick injuries during disposal of the syringe/needle. ### Comparison to Predicate Devices/Equivalence વે.ર # Descriptive Comparison to Legally Marketed Devices Model T200 Injector with Needle Guard is intended to be used to deliver medication from a cartridge. The guard Safety Syringes, Inc. UltraSafe T200 Injector 510(k) Submission {1}------------------------------------------------ requires a two-handed action in order to cover the needle point after use. The Model T200 Injector with Needle Guard has been tested and found to have considerably greater strength than the predicate device. The T200 Injector is as easy to assemble and use as the Wyeth Injector. With the Model T200 in the "ready-to-use" position, it provides the same useable needle length as an unguarded needle. The user can perform typical hypodermic procedures equivalently to standard, unguarded needles. ## 9.6 Comparison of Materials The UltraSafe® Injection System, Model T200 Injector with Needle Guard is made of K-Resin KR01, KR03, and ABS Resin which are the same materials as the Safety Syringes predicate device. ## Safety and Efficacy Information 9.7 Biocompatibility: The UltraSafe® Injection System, Model T200 Injector uses the same materials as the Safety Syringes predicate device. The materials have passed biocompatibility tests. Labeled Warning Statements: Hands must remain behind the needle at all times during use and disposal. Safety Syringes, Inc. UltraSafe T200 Injector 510(k) Submission {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 6 1998 Mr. Anthony R. Perez CEO & President Safety Syringes, Incorporated 250 West Colorado Boulevard, Suite 101 Arcadia, California 91007 Re : K972900 UltraSafe® Injection System Model T200 Trade Name: Injector with Needle Guard Requlatory Class: II Product Code: FMF Dated: January 6, 1998 Received: January 7, 1998 Dear Mr. Perez: 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal - Requlations, Title 21, Parts 800 to 895 - A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does {3}------------------------------------------------ Page 2 - Mr. Perez 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 requlations. 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) 594-4618. 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" (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.qov/cdrh/dsmamain.html". Sincerely yours Timo thy A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known): K972900 UltraSafe® Injection System Model T200 Injector With Needle Guard Device Name: Indications For Use: The UltraSafe® Model T200 Injector with Needle Guard is designed to hold a TUBEX® Sterlie Cartridge-Needle Unit 2.5 ml. in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit. The UltraSafe® Model T200 Injector is used with a Tubex® Sterile Cartinge-Needle Unit 2.5 ml. to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to adults and for parenteral methods of administration. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Patricia Encente Concurrence of CDRH Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K972900 Prescription Use (Per.21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K972900](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K972900) **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. 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