(51 days)
Administration of Intravenous fluids and drugs. The Tuta Healthcare Pty. Burette In Line (150ml) is a device used to administer fluids from a container to a patient's vascular system Through a cannula inserted into a vein.
The Tuta Healthcare Burette - In Line (150 mL) 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. The design of the Burette - In Line (150 mL) and Baxter Healthcare's In-Line Buretrol Extension Set are similar in terms of components of , PVC tubing, roller regulators and perforators.
The provided text describes a 510(k) submission for a medical device, the Tuta's Burette - In Line (150 mL). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This is typically done through a comparison of technological characteristics and performance data.
However, the provided document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML or diagnostic device. The device described is an "Administration Set, Intravascular," which is a physical burette for fluid administration, not a software algorithm or a diagnostic tool.
Therefore, I cannot provide the requested table and details because:
- Acceptance Criteria for a diagnostic/AI device: The document discusses equivalence to a predicate device, not specific performance metrics (like sensitivity, specificity, AUC) that would be relevant for an AI/ML or diagnostic device. The "acceptance criteria" here are implied by the demonstration of substantial equivalence in performance to the predicate device in terms of flow rate and biocompatibility.
- Study proving device meets acceptance criteria (for AI/ML): The study conducted was "Laboratory bench testing" to assess flow rate and "biocompatibility testing" for materials. These are engineering and material science tests, not clinical studies with patients, experts, ground truth, or statistical analysis typically associated with evaluating AI/ML models.
- Sample size and data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set information: These are all concepts relevant to the evaluation of AI/ML or diagnostic devices, which are not applicable to the physical burette described in the document.
In summary, the provided document describes a predicate device comparison for a fluid administration set, not an AI/ML or diagnostic device with performance metrics related to accuracy or human-in-the-loop improvements.
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11.0-510 (k) Summary
Summary of Safety and Effectiveness for Tuta's Burette - In Line (150 mL)
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
1
| 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: |
| 2. Device Name: | |
|---|---|
| Trade Name: | Burette - In Line (150 mL) |
| Proprietary Name: | Tuta Healthcare Burette - In Line (150 mL) |
| Classification Name: | Administration Set, Intravascular as Per CFR 21 880.5440 |
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- Legally Marketed Equivalent Device
The. Burette - In Line (150 mL) in the submission is substantially equivalent to Baxter Healthcare's In-Line Buretrol Extension Set (K984381).
- Legally Marketed Equivalent Device
The Tuta Burette - In Line (150 mL) and Baxter Healthcare's In-Line Buretrol Extension Set devices are designed to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
4. Description of the intended use of the Device
The Tuta Healthcare Burette - In Line (150 mL) is designed administer fluids from a container to a patient's vascular system through a needle catheter inserted
510 (k) Application - Burette - In Line (150 mL) Tuta Healthcare Pty. Limited
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into a vein. The pump helps to control the rate of flow of fluids from the container to the patient.
5. Summary of Similarities and Differences in Technological Characteristics, 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 Burette - In Line (150 mL) and Baxter Healthcare's In-Line Buretrol Extension Set have the same indications for use being "administration of fluicls 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 Burette - In Line (150 mL) and Baxter Healthcare's In-Line Buretrol Extension 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 Burette - In Line (150 mL) and Baxter Healthcare's In-Line Buretrol Extension 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 Burette - In Line (150 mL) and Baxter Healthcare's In-Line Buretrol Extension Set are enough to ensure equivalence.
5. Are performance data available to Assess Equivalence?
Yes. Laboratory bench 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 Burette - In Line (150 mL) as compared to Baxter Healthcare's In-Line Buretrol Extension Set.
Additionally, biocompatibility testing, performed in accordance with the General Program Memorandum #G95, has been conducted on all materials of the Burette - In Line (150 mL) which are utilized in the fluid path.
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6. Does the Performance data demonstrate equivalence?
Yes. Based upon the results of the laboratory testing, the performance of the Burette -In Line (150 mL) compares favourably to that of the current marketed Baxter Healthcare's In-Line Buretrol Extension Set.
Results from the biocompatibility testing have shown the materials of the Burette - In Line (150 mL) are suitable for limited contact.
CONCLUSION:
Based upon the above information, the Burette - In Line (150 mL) are substantially equivalent to Baxter Healthcare's In-Line Buretrol Extension Set.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Omid Souresrafil Ouality Assistance and Regulatory Affairs Manager Tuta Healthcare Pty. Limited 318-332 Burns Bay Road Lane Cove, Sydney NSW 2006 AUSTRALIA
Re: K023595
Trade/Device Name: Burette - In Line (150 mL) Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 24, 2002 Received: October 28, 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), 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,
Susan Runner
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
510(k) Number (if known):
Device Name: Burette - In Line (150 mL)
Indications For Use: Administration of Intravenous fluids and drugs.
The Tuta Healthcare Pty. Burette In Line (150ml) is a device used to administer fluids from a container to a patient's vascular system Through a cannula inserted into a vein.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use () (Per 21 CFR 801.109)
Palacue Cucente
Division of Anesthesiology, General Hospital, Infection Control, Denta
510(k) Number: X023595
510 (k) Application - Burette In-Line (150ml) Tuta Healthcare Pty. Limited
§ 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.