The Tuta Healthcare Pty. Limited Blood Administration Set is a device used to administer fluids, blood and blood products from a container to a patient's vascular system Through a catheter or venous access system inserted into a vein.

Use of Needle-Free Access site may aide in the prevention of needlestick injury.

Device Description

The Tuta Healthcare Blood/Solution Administration Set is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted into a vein. The pump helps to control the rate of flow of fluids from the container to the patient.

AI/ML Overview

The provided text describes a 510(k) summary for the Tuta Healthcare Blood/Solution Administration Set, comparing it to the legally marketed Baxter Healthcare's Solution Administration Set (K924721). The submission aims to demonstrate substantial equivalence, focusing on design, materials, intended use, and performance.

However, the document does not contain the kind of detailed information typically found in studies for AI/ML-enabled medical devices or diagnostic devices, especially regarding acceptance criteria, specific performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or adjudication methods for ground truth, as these are not relevant to this type of device (an administration set) or the type of substantial equivalence submission presented.

The study referenced is a laboratory bench testing to assess the new device against the predicate device.

Here's a breakdown of the information that is available in the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Same indication statement as predicate device	Yes, "administration of fluids from a container to a patient's vascular system through a needle catheter inserted into a vein."
Same technological characteristics (design, materials, principle of operation) as predicate device	Yes, similar components (PVC tubing, roller regulators, perforators) and same principle of operation.
New characteristics do not affect safety or effectiveness	No new characteristics identified that would affect safety or effectiveness.
Descriptive characteristics precise enough to ensure equivalence	Yes.
Biocompatibility of fluid path materials	Materials suitable for limited contact (tested according to General Program Memorandum #G95).
Performance (e.g., Flow rate) compares favorably to predicate device	Flow rate testing of the Blood/Solution Administration Set "compares favourably" to the Baxter Healthcare's Solution Administration Set.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The document states "Laboratory beach testing has been performed," but does not provide details on the number of units or test repetitions.
Data Provenance: The testing was "Laboratory beach testing," implying it was conducted in a controlled environment. The manufacturer is based in Australia, but the testing location is not explicitly stated. It is a prospective study as tests were performed specifically for this submission.

3. 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. This device is an administration set, not a diagnostic device requiring expert interpretation of results or establishing ground truth based on clinical expert consensus. The "ground truth" here is the performance of the predicate device and established safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is an administration set. Adjudication methods are typically relevant for diagnostic studies where there's variability in interpretation or a need for consensus on clinical findings.

5. 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 not an AI-enabled diagnostic tool, and no human reader studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not have an algorithm or AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the performance of the legally marketed predicate device (Baxter Healthcare's Solution Administration Set K924721) and adherence to recognized safety and performance standards (e.g., biocompatibility testing per General Program Memorandum #G95).

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device and not an AI/ML model.

9. How the ground truth for the training set was established

Not applicable, as there is no training set. The "ground truth" for comparison is the predicate device's established performance and regulatory compliance.

Summary

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11.0-510 (k) Summary

Safety and Tuta's of Effectiveness for Summary Blood/Solution Administration Set

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Assigned 510(k) number K Od 3 o 3 9

1. Manufacturer's Name:	Tuta Healthcare Pty. Limited
Manufacturer's Address	318-332 Burnsbay RoadLane Cove , Sydney NSW 2066Australia
Contact Person:	Omid Souresrafil PhD
Telephone Number:	+ 61 2 94270300 (Switchboard)+ 61 2 9429 6381 (Direct)
Fax Number:	+61 2 9427 5017
Date:	10/09/02
2. Device Name:Trade Name:Proprietary Name:Classification Name:	Blood/Solution Administration SetTuta Healthcare Blood/Solution Administration SetAdministration Set, Intravascular as Per CFR 21 880.5440

1. Legally Marketed Equivalent Device
  The, Blood/Solution Administration Set in the submission is substantially equivalent to Baxter Healthcare's Solution Administration Set (K924721).

Use of Needle-Free Access site may aide in the prevention of needlestick injury.

Description of the intended use of the Device

510 (k) Application - Blood/Solution Administration Set Tuta Healthcare Pty. Limited

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Summary of Similarities and Differences in Technological Characteristics, ব Performance and intended use

The 510(k) "Substantial Equivalence Decision Making Process (Detailed)" decision tree was utilized to make a determination of the substantial equivalence.

1. Does the new device have the same indication statement?

Yes. The Blood/Solution Administration Set and Baxter Healthcare's Solution Administration Set have the same indications for use being "administration of fluids from a container to a patient's vascular system through a needle catheter inserted into a vein.

2. Does the new device have the same technological characteristics, e.g. Design Materials.

Yes, The design of the Blood/Solution Administration Set and Baxter Healthcare's Solution Administration Set are similar in terms of components of , PVC tubing, roller regulators and perforators.

There are no differences in the principle of operation of the Blood/Solution Administration Set and Baxter Healthcare's Solution Administration Set.

3. Could the new characteristics Affect Safety or effectiveness?

No new characteristics.

4. Are the descriptive characteristics precise enough to Ensure equivalence?

Yes. The descriptive characteristics of the Tuta Healthcare Blood/Solution Administration Set and Baxter Healthcare's Solution Administration Set are enough to ensure equivalence.

5. Are performance data available to Assess Equivalence?

Yes. Laboratory beach testing has been performed to assess the new device as compared to the devices proposed to be substantially equivalent, The testing included the following:

Flow rate testing of the Blood/Solution Administration Set as compared to . Baxter Healthcare's Solution Administration Set.

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Additionally, biocompatibility testing, performed in accordance with the General Program Memorandum #G95 , has been conducted on all materials of the Blood/Solution Administration Set which are utilized in the fluid path.

6. Does the Performance data demonstrate equivalence?

Yes. Based upon the results of the laboratory testing, the performance of the Blood/Solution Administration Set compares favourably to that of the current marketed Baxter Healthcare's Solution Administration Set.

Results from the biocompatibility testing have shown the materials of the Blood/Solution Administration Set are suitable for limited contact.

CONCLUSION:

Based upon the above information, the Blood/Solution Administration Set are substantially equivalent to Baxter Healthcare's Solution Administration Set.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 7 2002

Dr. Omid Souresrafil Tuta Healthcare Pty. Limited 318-332 Burns bay Road Lane Cove, Sydney NSW 2066 AUSTRALIA

Re: K023039

Trade/Device Name: Blood/Solution Administration Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: BRZ Dated: September 10, 2002 Received: September 12, 2002

Dear Dr. Souresrafil:

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 - Dr. Souresrafil

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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4. STATEMENT OF INDICTIONS FOR USE

K023039 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Blood/Solution Administration Set

Indications For Use: Administration of Intravenous fluids and drugs.

Use of Needle-Free Access site may aide in the prevention of needlestick injury.

(PLEASE DO NCT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use fi (Per 21 CFR 801.109)

510 (k) Application - Blood/Solution Administration Set Tuta Healthcare Pty. Limited

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Petura Church

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K023039

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.