(164 days)
Administration of fluids from a container to a patient's vascular system through a cannula inserted into a vein.
The AutoStart Burette is an in-line burette used for intravenous administration of fluids (either gravitational or via an infusion pump) from a container to a patient's vascular system through a cannula inserted into a vein. This is a sterile, single-use device. The device is fitted with a float system which that allows the primary infusion to restart following addition to and dispensation of medication from the burette. There is no need to manually restart the infusion as is the case with conventional in-line burettes.
1. Acceptance Criteria and Reported Device Performance
The provided document (K092965) for the Analytica AutoStart Burette does not contain a specific table of acceptance criteria and reported device performance in the format typically seen for algorithm-based devices. Instead, it demonstrates substantial equivalence based on adherence to an FDA recognized standard and risk assessment.
Here's a breakdown of the information that can be extracted or inferred regarding performance and acceptance based on the submission:
| Acceptance Criteria (Inferred from regulatory compliance) | Reported Device Performance |
|---|---|
| Compliance with ISO 8536-5:2004 | The AutoStart Burette complies with ISO 8536-5:2004 Infusion equipment for medical use Part 5 – Burette infusion sets for single use, gravity feed – the FDA recognized safety and performance standard for these devices. |
| Equivalence of Indications for Use | Identical indications for use as the predicate device (Tuta Healthcare In-Line Burette 150mL, K023595). |
| Equivalent Materials and Components | Manufactured from medical grade polymers, equivalent to the predicate device. |
| Equivalence of Operation | Both devices are 150mL capacity, graduated, flow regulated in-line burettes. |
| No Significant New Safety Concerns | Risk assessment performed in conformance with ISO 14971:2007, and no significant new safety concerns raised by the design. |
| AutoStart Flotation Feature Functionality | The device is fitted with a float system which allows the primary infusion to automatically restart following addition to and dispensation of medication. This is a key distinguishing feature and implies performance in this aspect. |
2. Sample Size for Test Set and Data Provenance
This document is for a medical device (burette) and not an AI/algorithm-based device that would typically involve test sets of data (e.g., medical images, patient records). Therefore, the concepts of "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in this context. The evaluation is based on physical device testing and compliance with established standards, not analysis of clinical data in the traditional sense for AI.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. As this is not an AI/algorithm-based device, there is no need for experts to establish ground truth from a test set of data. The "ground truth" for this device's performance is its adherence to engineering specifications and regulatory standards.
4. Adjudication Method
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted device, so there would be no human readers improving with or without AI assistance.
6. Standalone Performance Study
Yes, in a way, standalone testing of the device's physical and functional characteristics was performed to demonstrate compliance with ISO 8536-5:2004. This standard outlines tests for various aspects of infusion sets, including:
- Flow rate consistency: Ensuring the device delivers fluids at regulated rates.
- Capacity and Graduation Accuracy: Verifying the 150mL capacity and the accuracy of markings.
- Material Biocompatibility: Assessed implicitly through the use of "medical grade polymers."
- Leakage and Integrity: Implied by meeting a safety standard.
- Functionality of the AutoStart feature: Although specific test results are not detailed, the description of the feature implies it underwent testing to ensure it works as intended.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Engineering Specifications and Design Documents: The design of the Analytica AutoStart Burette.
- Regulatory Standards: ISO 8536-5:2004 ("Infusion equipment for medical use Part 5 – Burette infusion sets for single use, gravity feed").
- Predicate Device Characteristics: The performance and safety profile of the Tuta Healthcare In-Line Burette (K023595).
8. Sample Size for Training Set
Not applicable. This is not an AI/machine learning device that requires a training set of data.
9. How Ground Truth for Training Set Was Established
Not applicable.
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510(k) Summary
| Contact Person: | Elaine DuncanPaladin Medical Inc.PO Box 560Stillwater MN 55082Tel: (715) 549 6035Fax:(715) 549 5380duncan@paladinmedical.com | MAR - 4 2010 |
|---|---|---|
| Brand Name: | Analytica AutoStart Burette | |
| Common Name: | In-Line Burette | |
| Classification Name: | (21CFR 880.5540) Set, Administration, Intravascular | |
| Product Code: | FPA | |
| Predicate Device: | Tuta Healthcare In-Line Burette 150mL (K023595) | |
| Date Prepared: | 31 August 2009 | |
| Device Description: | The AutoStart Burette is an in-line burette used for intravenousadministration of fluids (either gravitational or via an infusionpump) from a container to a patient's vascular system through acannula inserted into a vein. This is a sterile, single-use device.The device is fitted with a float system which that allows theprimary infusion to restart following addition to and dispensation ofmedication from the burette. There is no need to manually restartthe infusion as is the case with conventional in-line burettes. | |
| Indications for Use: | Administration of fluids from a container to a patient's vascularsystem through a cannula inserted into a vein. |
Summary of Basis for Substantial Equivalence:
The Analytica AutoStart Burette is substantially equivalent to the Tuta Healthcare In-Line Burette (K023595). Equivalence is based on equivalence of indications, design features and properties and supported by compliance with an FDA Guidance and an FDA recognized performance standard.
With the exception of the AutoStart flotation feature, both the AutoStart Burette and the predicate device have:
ldentical indications for use .
Both devices are indicated to be used in the administration of fluids from a container to a patient's vascular system through a cannula inserted into the vein.
Equivalent materials and components .
Both devices are manufactured from medical grade polymers.
Equivalence of operation .
Both devices are 150mL capacity, graduated, flow regulated in-line burettes.
The AutoStart Burette complies with ISO 8536-5:2004 Infusion equipment for medical use Part 5 – Burette infusion sets for single use, gravity feed – the FDA recognized safety and performance standard for these devices.
Risk assessment has been performed in conformance with ISO 14971:2007 and there are no significant new safety concerns raised by the design of the AutoStart Burette.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR ~ 4 2010
Analytic PTY, Limited C/O Ms. Elaine Duncan President Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082
Re: K092905
Trade/Device Name: Analytica AutoStart Burette Regulation Number: 21CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 8, 2010 Received: February 12, 2010
Dear Ms. Duncan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Duncan
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 l'ederal 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
f
unper Anthony D. Watson, B.S., M.S., M.B.A.
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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510(k) Number (if known):
Device Name:
Analytica AutoStart Burette
Indications for Use: Administration of fluids from a container to a patient's vascular system through a needle catheter inserted into a vein.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092905
§ 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.