← Product Code [FMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF) · K053413 # TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES (K053413) _Terumo Europe N.V. · FMF · Apr 6, 2006 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K053413 ## Device Facts - **Applicant:** Terumo Europe N.V. - **Product Code:** [FMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF.md) - **Decision Date:** Apr 6, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5860 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The Terumo Syringe for administration of UV sensitive medicines is a sterile hypodernic syringe for single use, intended for the aspiration of fluids and blood, or for the injectior. of fluids immediately after filling. The opaque color of the barrel allows the administration of UV sensitive medicines. ## Device Story Manual, single-use, 20 mL hypodermic piston syringe; features opaque barrel to prevent UV light transmission; used for aspiration of fluids/blood or injection of fluids. Operated by clinicians; provides protection for UV-sensitive medications during administration. Benefits patient by maintaining integrity of light-sensitive drugs. ## Clinical Evidence Bench testing only. Performance verified per EN ISO 7886-1 (1997). Biocompatibility testing conducted per EN ISO 10993-1. Sterilization validated per EN 550/ISO 11135. ## Technological Characteristics 20 mL piston syringe; plastic barrel with opaque coloring; synthetic rubber gasket; eccentric luer taper tip. Sterilized via ethylene oxide (ISO 11135). Biocompatible materials (ISO 10993). Manual operation. ## 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 - Terumo Disposable Hypodermic Syringe ([K980181](/device/K980181.md)) ## 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}------------------------------------------------ ## 510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information 6 2006 APR - 1. Device Name ## Proprietary Name Terumo® Syringe for administration of UV sensitive medicines ## Classification Name Piston syringe (80FMF) 21CFR, Section 880.5860 Classification: Class II ## Common Name Sterile hypodermic syringe for single use - 2. Reason for Submission New Device #### 3. Intended Use The Terumo Syringe for administration of UV sensitive medicines is a sterile hypodernic syringe for single use, intended for the aspiration of fluids and blood, or for the injectior. of fluids immediately after filling. The opaque color of the barrel allows the administration of UV sensitive medicines. #### 4. Description & Materials The Terumo Syringe for administration of UV sensitive medicines is a hypodermic standard piston syringe, available in 20 ml volume, with an eccentric luer taper tip for single use, made of plastic material and a synthetic rubber gasket. The barrel of the syringe has an opaque color to avoid the transmission of UV light. #### 5. Technology/Principles of operation The Terumo Syringe is operated manually. - 6. Performance The Terumo syringe was tested in accordance with EN ISO 7886-1 (1997). Other testing included barrel transmission and UV protection of the opaque barrel. None of the data raises any new issues of safety and effectiveness. {1}------------------------------------------------ #### 7. Substantial Equivalence The "Terumo Syringe for administration of UV sensitive medicines", manufactured by Terumo Europe N.V., submitted in this 510(k) file is substantially equivalent in intended description/specifications, technology/principles of operation, materials and use. performance to the cleared "Terumo Disposable Hypodermic Syringe", manufactured by Terumo Medical Corporation in which is the subject of K980181, with the exception that the opaque colored Terumo Syringe manufactured by Terumo Europe N.V. additionally allows the administration of UV sensitive medicines. #### 8. Additional Safety Information The sterility of the Terumo Syringe for administration of UV sensitive medicines is assured by using a validated sterilization method qualified in accordance with EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide" and ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" to a sterility assurance level (SAL) of 10° as required by EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices". Ethylene oxide residual levels and Ethylene Chlorohydrin residual levels resulting from EtO sterilization are in compliance with ISO 10993-7: " Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals". The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard EN ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing. Results of the testing demonstrate that the blood contacting materials are biocompatible. The expiration dating for the Terumo Syringe for administration of UV sensitive medicines has been established at 5 years. #### 9. Conclusion The Terumo Syringe for administration of UV sensitive manufactured by Terumo Europe N.V. and submitted in this 510(k) file is substantially equivalent in intended use, description, specifications, technology/principles of operation, materials and performance to the cleared Terumo Disposable Hypodermic Syringe manufactured by Terumo Medical Corporation which is the subject of K980181, with the exception that the opaque colored Terumo Syringe manufactured by Terumo Europe N.V. additionally allows the administration of UV sensitive medicines. Differences between the devices do not raise any new or different issues of safety or effectiveness. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in capital letters. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 6 2006 APR Ms. M.J. Aerts Manager Regulatory Affairs TERUMO EUROPE N.V. Researchpark Zone 2 Interleuvenlaan 40 Leuven, Belgium 3001 Re: K053413 Trade/Device Name: Terumo® Syringe for Administration of UV Sensitive Medicines Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: February 20, 2006 Received: February 23, 2006 Dear Ms. Aerts: 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. {3}------------------------------------------------ Page 2 - Ms. Aerts 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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/industry/support/index.html. Sincerely yours. Susie Y. Michaux Davis Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a black and white picture of a triangle. The triangle is oriented so that one of the points is facing down. The triangle is made up of many small dots. # Indications for Use 510(k) Number (if known): K053413 Device Name: Terumo® Syringe for administration of UV sensitive medicines ### Indications for Use: The Terumo Syringe for administration of UV sensitive medicines is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. The opaque color of the barrel allows the administration of UV sensitive medicines. | Prescription Use | X | |-----------------------------|--------| | (Part 21 CFR 801 Subpart D) | AND/OR | S.N 4/5/06 Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) driny, General Hospit ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 453 412 ---------------------------------------------------------------------------------------------------------------------------------------------------------------------- Page __ of ___________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K053413](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K053413) **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