This IDA-4 or IPT-MC is designed to be used by manufacturers, BioMedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices. It is not intended to be used as an infusion device calibrator. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Steady and non-steady flow rate pumps can be analyzed. The device is designed to operate using water or saline only. It incorporates an RS232 serial port for computer control/data output and a Centronics type parallel printer port.

Device Description

The "IDA-4 & IPT-MC" incorporate one to four self reading calibrated micro-burettes (transducers)which measure the volume of fluid flowing from one to four infusion devices into the device. Flow rates from 1 to 1000 mL per hour can be administered independently in each channel. This device is designed to be used by manufacturers, BioMedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Non steady flow rate pumps can also be analyzed. The device is designed to operate using water or saline only. The device can be used to determine flow rates, flow volume, average flow rate (with from -100 mmHg to +300 mmHg), average bolus volume with total delivery, occlusion pressure.

AI/ML Overview

The Bio-Tek IDA-4 & IPT-MC are infusion device analyzers. The provided text details their performance testing and specifications rather than a clinical study with human patients. As such, many of the requested categories for clinical study analysis are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature / Acceptance Criteria	Reported Device Performance
Average Flow Rate	Range: 0.5 to 1000 mL/hr Accuracy: ± 1% of reading ± 1 Least Significant Digit (LSD) for rates of 50 -100 mL/hr for delivery volumes over 20 mL. Otherwise ± 2% of reading ± 1 LSD after delivery of 5 mL. (Specifications are with water at 15 to 25° C.)
Delivered Volume	Range: 0 to 9999 mL Accuracy: ± 1% of reading ± 1 Least Significant Digit (LSD) for rates of 50 -100 mL/hr for delivery volumes over 20 mL. Otherwise ± 2% of reading ± 1 LSD after delivery of 5 mL. (Specifications are with water at 15 to 25° C.)
Flow and Accuracy Under Back Pressure	Accuracy: Same accuracies as average flow rate and delivered volume. Range: -100 mmHg to +300 mmHg
Occlusion Pressure	Accuracy: - 0 to 9 psi (0-465 mmHg): ± 5% of Reading ± 0.1 psi or 6 mmHg - 9 to 34 psi (465 to 1762 mmHg): ±5% of Reading ± 0.2 psi or 12 mmHg Maximum Reading: 2326 mmHg; or 45 psi; or 310 kPa
Multi-channel Capability	One to four test channels each with independent operation.
Display	Larger display (240 by 128 Supertwist LCD with backlight) capable of showing graphics or multiple lines of text. (Compared to predicate single display line).
Flow Height Sensors	18 flow height "sensors" in the transducer. (Compared to predicate 4 "sensors").
Cross Talk between channels	No cross talk between channels.
Air-in-line detection	Monitor with error messages utilized to minimize believable but incorrect results.
Blockage detection	If valve is blocked or partially blocked and value is outside of a range, an error message is displayed and printed.

2. Sample size used for the test set and the data provenance

The document describes performance testing (verification and validation) for an infusion device analyzer, not a clinical study on human subjects or clinical data. Therefore, the concept of "test set" in the context of patient data, data provenance (country, retrospective/prospective), or sample size (in terms of patients/cases) is not applicable here. The testing was conducted internally by Bio-Tek Instruments, Inc. on the device itself and various infusion pumps.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as this is performance testing of a medical device analyzer, not a study involving human experts establishing ground truth for diagnostic accuracy. The "ground truth" for the device's performance would be established by reference standards or calibrated equipment used to test the analyzer.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically relevant for human expert assessments in clinical studies, which is not the nature of this submission.

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 is a submission for a medical device analyzer, not an AI or diagnostic imaging device involving human readers.

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

The device itself is a standalone analyzer. Its performance was verified and validated "using a controlled written plan." The testing established that the device "meets its marketing specifications." This indicates standalone performance testing of the device's metrological capabilities.

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

For this type of device (an analyzer), the ground truth is established by reference measurements from known, calibrated sources (e.g., precise flow rates and volumes from external calibrated pumps/systems) and adherence to engineering specifications. The document states accuracy specifications are with "water at 15 to 25° C," implying controlled laboratory conditions and standard fluid properties.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device that requires a training set. The device operates based on physical principles (sensors, micro-burettes) and established engineering parameters.

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

Not applicable, as no training set is relevant to this device's functioning.

Summary

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K973609

C. BIO-TEK INSTRUMENTS, INC.

BIO-TEK 510(k) Infusion Device Analyzer IDA-4 & IPT-MC APPENDIX G

510(k) SUMMARY 1-

2- Contact Person:	Michael N. Sevigny Quality Assurance Manager
	802-655-4040 ext 336
	Establishment Registration Number: Bio-Tek 1217454 Filing
	Establishment will be marketing IDA-4 versions
	2921581 DNI Nevada will be marketing
	IPT-MC versions
	Preparation date September 19, 1997

3- Classification Name:	Pump, infusion, tester, MRZ, Class II
Common Name:	Infusion Pump Analyzer or Tester
Proprietary Name:	IDA-4 and IPT-MC

4- Substantially Equivalent to: The device family is equivalent to the legally marketed predicate devices: Bio-Tek Instruments, Inc. IDA-2Plus K961862 -predicate with the most similarity and some identical features; Dynatech Nevada, Model 404A, 510(k) # K897096.

IDA-4 & IPT-MC and the predicate Pulse Oximeter testers have an identical intended use and there are no new technological features or issues which would raise concern of safety and effectiveness.

5 & 6- Description of Device and Intended Use: The device family is intended for use as a infusion device tester or analyzer. It is not intended to be an infusion device calibrator.

The device can be used to determine flow rates, flow volume, average flow rate (with from -100 mmHg to +300 mmHg), average bolus volume with total delivery, occlusion pressure,

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7- Summary of technological characteristics of devices compared to predicate:

The IDA-4 & IPT-MC are multi-channel devices capable of testing from 1 to 4 infusion pumps (or up to four outputs from 1 pump) simultaneously and independently. The predicate IDA-2Plus is a single channel device.

The IDA-4 & IPT-MC has a larger display (240 by 128 Supertwist LCD with backlight) capable of showing graphics or multiple lines of text at one time. The predicate IDA-2Plus has a single display line.

The IDA-4 & IPT-MC utilize 18 flow height "sensors" in the transducer thus giving better accuracy than the IDA-2Plus which had 4 "sensors". The transducer design is patented under US Patent No. 4,938,072

IDA-4 & IPT-MC and the predicate infusion pump testers/analyzers have a similar intended use and there are no new technological features or issues which would raise concern of safety and effectiveness.

8- Performance Testing: (Verification and Validation):

The device was extensive verified and validated using a controlled written plan. Each feature was determine to work correctly per the written specifications. Testing was successfully completed for: Flow Rate Accuracy, Volume Delivered Accuracy; Bolus delivery testing accuracy: Accuracy of Flow Rate under negative and positive backpressure; no cross talk between channels, and other features.

In summary the testing established that the IDA-2Plus meets its marketing specifications and is similar to the other devices as claimed in this submission.

9- Clinical Testing: Clinical testing was not required since the devices comprise test equipment, and are never in contact with a patient nor do they have any therapeutic or diagnostic patient function. As stated above they are not intended to be used as calibrators and should not be used for clinical "calls".

10- Conclusions from testing: The testing conducted to date and that will be conducted prior to release will support all product claims for intended use including accuracy and full feature operation.

11. Other Information of Interest to FDA:

Potential System Hazards: are classified as those which could affect the functionality of the system. The primary system function hazards which were reviewed and addressed were: a) To minimize the possibility of believable but incorrect results being displayed when measuring flow " and air-in-line detection monitor with error messages is utilized. b) Another potential hazard is from incorrect behavior of the device when the valve is blocked or partially blocked. If the value is outside of a range an error message is displayed and printed.

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BIO-TEK 510(k) Index 2 E, F, EF & CardioSat 100 E, F, EF APPENDIX G

User Safety Considerations: The device has been designed to meet the user safety Oser Safety Collinerally 11990)/ EN61010-1 "Safety requirements for electronic equipment for measurement, control and laboratory use. Part 1 General requirements". Features such as the sturdy drip proof plastic case were chosen with user safety in mind.

The above information is certified to be truthful and accurate to the best of my knowledge.

Michael Vi. Angny.

Michael N. Sevigny Quality Assurance Manager

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 18 1997

Mr. Michael N. Sevigny Quality Assurance Manager Bio-Tek Instruments, Incorporated Highland Park, Box 998 Winooski, Vermont 05404-0998

Re : K973609 Trade Name: IDA-4 and IPT-MC Requlatory Class: II Product Code: FRN Dated: September 19, 1997 Received: September 22, 1997

Dear Mr. Sevigny:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Sevigny

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. I 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 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" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdg.gov/cdrh/dsmanain.html .

Sincerely yours

Timothy A. Ulatowski

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

Enclosure

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510(k) Number (if known):

IDA-4 & IPT-MC, Infusion Device Analyzer Device Name:

Indications For Use:

Specifications:

· One to four test channels each with independent operation.
· Average Flow Rate:

Range: 0.5 to 1000 mL/hr

Accuracy: ± 1% of reading ± 1 Least Significant Digit (LSD) for rates of 50 -100 mL/hr for delivery volumes over 20 mL. Otherwise ± 2% of reading ± 1 LSD after delivery of 5 mL. Specifications are with water at 15 to 25° C.

· Instantaneous flow rate is read from device display graph or PC screen:
· Delivered Volume:

. .

Range 0 to 9999 mL

· Flow and Accuracy Under Back Pressure:
Same accuracies as those listed above Range - 100 mmHg to +300 mmHg

(continued on page 2)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrica Cuccerote
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital, Intrection C 510(k) Number _

سا Prescription Use (Per 21 CFR §801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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510(k) Number (if known):

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Device Name:

Indications For Use: Page 2

· Occlusion Pressure:

Accuracy: 0 to 9 psi or 0-465 mmHg ± 5% of Reading ± 0.1 psi or 6 mmHg; 9 to 34 psi or 465 to 1762 mmHg ±5% of Reading ± 0.2 psi or 12 mmHg Maximum Reading: 2326 mmHg; or 45 psi; or 310 kPa

· Bar Code Wand and Gun capable, reads device under test ID for record storage purposes

• IDA-4 Graphics Software: Windows based, allows viewing of multiple graphs per screen, analyze review pump performance for: instantaneous flows; average flows; delivered volume; bolus volume.

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).