TRITON MEIDCAL TMED IV-SET

{0}------------------------------------------------ K073444 AUG 1 8 2008 ## Section 5 510(K) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMVDA 1990 and 21 CFR §807.92. 510(k) number: K043235 Submitter's Identification: Submitter Address: Submitter Phone: Submitter Fax: Submitter Contact: Triton Medical, LLC 9810 South Dorchester Avenue Chicago, IL 60628 646.723.6907 212.697.0806 Ross Kurz Vice-President rkurz@tritonmed.com (email) ### 2. Name of the Device: Triton Medical TMed IV-Set ## 3. Predicate Device Information: Dragon Heart Intravascular Administration Set 510(k) Number: K043235 Dragon Heart Medical Devices Co., Ltd. Kaiping, Guangdong, 529375 Peoples Republic of China #### 4. Intended Use: The Triton Medical TMed IV-Set is used to administer fluids from a container to a patient through a needle or catheter inserted into a vein. ## 5. Device Description: Depending on configuration, the device may include the following; protective cap(s), drip chamber, tubing, back check valve(s), anti-siphon valve, needle free Y-site, roller clamp, 0.22 micron filter or 1.2 micron filter, male Luer lock, spike, and medi-hook. Schematics representations of the various configurations of the Triton Medical TMed IV-Set are exhibited in Appendix 3 - Device Drawings and Configurations. The Triton Medical TMed IV-Set is supplied sterile. {1}------------------------------------------------ # 6. Comparison to Predicate Devices: # Technical characteristics of the device compared to the predicate device: | | Triton Medical TMed IV-Set | Dragon Heart Intravascular<br>Administration Set<br>K043235 | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufactured By | Dragon Heart Medical Device<br>Co., Ltd | Dragon Heart Medical Device<br>Co., Ltd | | Intended Use | Administer fluids from a<br>container to a patient through a<br>needle or catheter inserted into a<br>vein | Administer fluids from a<br>container to a patient through a<br>needle or catheter inserted into a<br>vein | | Device Class | II | II | | Product Code | FPA | FPA | | Components | Tubing, a flow regulator, drip<br>chamber, backflow valve, anti-<br>siphon valve, male Luer lock,<br>0.22 micron filter or 1.2 micron<br>filter, connectors between parts<br>of the set, needle free Y-site,<br>spike, and medi-hook. | Tubing, a flow regulator, drip<br>chamber, backflow valve, anti-<br>siphon valve, male Luer lock,<br>0.22 micron filter or 1.2 micron<br>filter, connectors between parts of<br>the set. needle free Y-site, spike,<br>and medi-hook | | Sterilization | Ethylene Oxide according to<br>standard; ISO 11135, Medical<br>Devices- Validation and Routine<br>Control of Ethylene Oxide<br>Sterilization, 1994. | Ethylene Oxide according to<br>standard; ISO 11135, Medical<br>Devices- Validation and Routine<br>Control of Ethylene Oxide<br>Sterilization, 1994. | | Packaging | According to Standard: ISO<br>11607, Packaging for Terminally<br>Sterilized Medical Devices,<br>2000. | According to Standard: ISO<br>11607, Packaging for Terminally<br>Sterilized Medical Devices, 2000. | # 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows: The device is the same device as the predicate. It is manufactured by the same manufacturer, from the same materials, and to the same specifications as the predicate. Any testing is identical. {2}------------------------------------------------ # 8. Discussion of Clinical Tests Performed: Not applicable ## 9. Conclusions: The subject device has the same intended use, manufacturer, and technical characteristics as the predicate device. Similarly, there are no differences in materials used to fabricate the subject device and the predicate device. Therefore no new questions of safety or effectiveness are raised by this submission. Thus, the Triton Medical TMed IV-Set is substantially equivalent to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Triton Medical LLC AUG 1 8 2008 C/O Mr. Ian P. Gordon Senior Vice President Emergo Group 1705 South Capitol of Texas Highway, Suite 500 Austin, Texas 78746 K073444 Trade/Device Name: Triton Medical TMed IV-Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: August 7, 2008 Received: August 11, 2008 Dear Mr. Gordon: Re: 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. {4}------------------------------------------------ Page 2 - Mr. Gordon 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. 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 {5}------------------------------------------------ ## Section 4 Indications for Use Indications for Use 510(k) Number: K073444 Device Name: Triton Medical TMed IV-Set Indications for Use: The Triton Medical TMed IV-Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a ven. The device is for prescription use only. Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off Office of Device Evaluation and Safety Cinting Omm 510(k) Number: _ K�ワ3444 _____________________________________________________________________________________________________________________________________________________