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.

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.

AI/ML Overview

This 510(k) summary (K073444) for the Triton Medical TMed IV-Set indicates that the device is considered substantially equivalent to a predicate device (Dragon Heart Intravascular Administration Set, K043235) based on a comparison of technical characteristics and manufacturing processes. It does not describe a study that establishes acceptance criteria through performance testing with a specific test set.

Instead, the submission argues for substantial equivalence because:

The device is manufactured by the same manufacturer (Dragon Heart Medical Device Co., Ltd) as the predicate.
It is made from the same materials.
It is built to the same specifications as the predicate.
Therefore, any testing performed on the predicate would be identical for this device, and no new tests or clinical studies were deemed necessary.

Given this, the requested information elements related to performance criteria, test sets, ground truth establishment, expert review, MRMC studies, or standalone algorithm performance are not applicable to this specific 510(k) submission.

Here's a breakdown of the requested information based on the provided document:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics in this document. The implicit acceptance criterion is "substantial equivalence" to the predicate device, meaning it performs as safely and effectively as the predicate without raising new questions of safety or efficacy.
- Reported Device Performance: No quantitative performance metrics are reported. The document states, "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." This implies its performance is considered the same as the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Substantially Equivalent to predicate device (K043235) in terms of safety and efficacy.	Device is identical to the predicate in manufacturing, materials, and specifications. No new questions of safety or effectiveness are raised.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No new test set data was generated or used for this submission to demonstrate performance against acceptance criteria. The equivalence argument relies on the identity to the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No ground truth establishment was performed for a new test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set adjudication method was used.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an IV-set, not an AI-enabled diagnostic tool, and therefore no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is an IV-set, not an algorithm, and therefore standalone performance was not assessed in this context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth was established for the purpose of a new performance study.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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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:

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.

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6. Comparison to Predicate Devices:

Technical characteristics of the device compared to the predicate device:

	Triton Medical TMed IV-Set	Dragon Heart IntravascularAdministration SetK043235
Manufactured By	Dragon Heart Medical DeviceCo., Ltd	Dragon Heart Medical DeviceCo., Ltd
Intended Use	Administer fluids from acontainer to a patient through aneedle or catheter inserted into avein	Administer fluids from acontainer to a patient through aneedle or catheter inserted into avein
Device Class	II	II
Product Code	FPA	FPA
Components	Tubing, a flow regulator, dripchamber, backflow valve, anti-siphon valve, male Luer lock,0.22 micron filter or 1.2 micronfilter, connectors between partsof the set, needle free Y-site,spike, and medi-hook.	Tubing, a flow regulator, dripchamber, backflow valve, anti-siphon valve, male Luer lock,0.22 micron filter or 1.2 micronfilter, connectors between parts ofthe set. needle free Y-site, spike,and medi-hook
Sterilization	Ethylene Oxide according tostandard; ISO 11135, MedicalDevices- Validation and RoutineControl of Ethylene OxideSterilization, 1994.	Ethylene Oxide according tostandard; ISO 11135, MedicalDevices- Validation and RoutineControl of Ethylene OxideSterilization, 1994.
Packaging	According to Standard: ISO11607, Packaging for TerminallySterilized Medical Devices,2000.	According to Standard: ISO11607, Packaging for TerminallySterilized 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.

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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.

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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.

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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

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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 _____________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.