The Harvard Library is intended to provide a vehicle to create and download a library of drug names and parameters to the Harvard 2 Syringe Pump. It is designed to lessen the likelihood of operator errors when entering drug information into the Harvard 2 Syringe Pump.

Device Description

The Harvard Library is a computer program which runs on MSDOS based personal computers under Microsoft Windows V3.1 or higher.

AI/ML Overview

This document refers to the Harvard Library computer program, designed to create and download drug libraries to the Harvard 2 Syringe Pump to reduce operator errors. The document is a 510(k) summary, which typically does not include detailed study results or acceptance criteria in the format requested. Therefore, much of the requested information cannot be extracted directly from the provided text.

Based on the provided text, here is what can be inferred:

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

The document does not explicitly state acceptance criteria or provide specific performance metrics in a table format. The intended use focuses on "lessen[ing] the likelihood of operator errors," implying that the performance would be measured by a reduction in such errors. However, there are no reported numbers for this.

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

This information is not provided in the 510(k) summary.

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):

This information is not provided in the 510(k) summary. As it's a software for drug library management, "experts" in the context of ground truth would likely be pharmacists or clinicians knowledgeable in drug administration and error prevention.

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

This information is not provided in the 510(k) summary.

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:

This is not applicable as the Harvard Library is not an AI-assisted diagnostic tool involving human readers or interpretation of medical images. It's a software for reducing data entry errors. There is no mention of an MRMC study.

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

The device itself is a "computer program" that "creates and downloads" data. Its intended function is to work with a human operator using the syringe pump to reduce errors during data entry. Therefore, a purely standalone performance without any human interaction would likely not be the primary focus for evaluating its intended use. Any evaluation would inherently involve the human-in-the-loop interacting with the software to demonstrate its ability to reduce errors. However, the document does not specify any study design.

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

The document does not specify the type of ground truth used. For a device intended to reduce operator errors during drug information entry, ground truth would likely involve:

Correct drug names and parameters for a given set of drugs.
Correctly entered data into the Harvard 2 Syringe Pump by operators, compared against the intended drug information.
Assessment of whether the "Library" effectively prevented common types of data entry errors.

8. The sample size for the training set:

This information is not provided in the 510(k) summary.

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

This information is not provided in the 510(k) summary.

Summary of Device and Regulatory Status:

Device Name: Harvard Library
Common Name: Computer Program
Classification Name: Infusion Pump (though the device itself is software for an infusion pump)
Intended Use: To create and download a library of drug names and parameters to the Harvard 2 Syringe Pump, designed to lessen the likelihood of operator errors when entering drug information.
Technological Characteristics: Computer program running on MS-DOS based personal computers under Microsoft Windows V3.1 or higher.
Predicate Devices: Shasta Logic - Clinicalc, A Mixed Bag Corp - Infusion Calculator, Harvard Apparatus - Harvard 2 Syringe Pump.
Regulatory Status: The FDA determined the device to be substantially equivalent to predicate devices, allowing it to be marketed under general controls provisions.

The provided document is primarily a regulatory notification (510(k) summary) for market clearance, focusing on substantial equivalence and intended use. Detailed study designs, acceptance criteria with specific performance metrics, and in-depth clinical validation data are typically not fully elaborated in these summary documents, but would have been part of the full 510(k) submission.

Summary

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Harvard

I N C O R P O R A T E D

Appendix E

Summary of Safety and Efficacy

Harvard Medical Inc.

JAN - 9 1998

6970678

22 Pleasant Street South Natick MA 01760 (508)-655-2000

Contact Person: Eric J. Flachbart, Vice President, Research and Development Date Prepared: 6 February, 1997

Trade Name: Harvard Library Common Name: Computer Program Classification Name: Infusion Pump

Predicate Devices

Shasta Logic - Clinicalc A Mixed Bag Corp - Infusion Calculator Harvard Apparatus - Harvard 2 Syringe Pump

Intended Use

Technological Characteristics

The Harvard Library is a computer program which runs on MSDOS based personal computers under Microsoft Windows V3.1 or higher.

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Image /page/1/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 image of an eagle with its wings spread, symbolizing strength and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 1998

Mr. Eric J. Flachbart Vice President, Research and Development Harvard Apparatus Incorporated 22 Pleasant Street 01760 South Natick, Massachusetts

Re : K970678 The Harvard Library Trade Name: Requlatory Class: II Product Code: MRZ Dated: October 14, 1997 October 14, 1997 Received:

Dear Mr. Flachbart:

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 requlation (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:

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Page 2 - Mr. Flachbart

this response to your premarket notification submission does not affect any obligation you might have under sections 531 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. The FDA findinq 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 requlation (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 general 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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Indications For Use Statement

K970678 510(k) Number if known): TO BE ASSIGNED

The Harvard Library Device Name:

Indications For Use:

(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 Dental, Infection Control,
and General Hospital Devices

510(k) Number	K970678
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Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

000000

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).