(319 days)
Shasta Logic - Clinicalc, A Mixed Bag Corp - Infusion Calculator, Harvard Apparatus - Harvard 2 Syringe Pump
Not Found
No
The summary describes a computer program for managing drug libraries on a syringe pump, with no mention of AI or ML technologies or related concepts like training/test sets or performance metrics associated with AI/ML.
No
The Harvard Library is a computer program designed to manage drug information for a syringe pump, aiming to reduce operator errors. It is not directly involved in treating or diagnosing medical conditions, but rather serves as a tool to facilitate the accurate operation of a separate medical device (the syringe pump).
No
The device is a computer program designed to manage drug name and parameter libraries for a syringe pump, aiming to reduce operator errors. It does not perform any diagnostic functions on patients.
Yes
The device is described as a "computer program" that runs on a personal computer and is intended to create and download a library of drug names and parameters to a separate hardware device (the Harvard 2 Syringe Pump). It does not appear to include any hardware components itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create and download a library of drug names and parameters to a syringe pump. This is related to drug delivery and pump operation, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: It's a computer program for managing drug information for a syringe pump.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
The device is a software tool designed to support the operation of a medical device (a syringe pump), not to perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
MRZ
Device Description
The Harvard Library is a computer program which runs on MSDOS based personal computers under Microsoft Windows V3.1 or higher.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Shasta Logic - Clinicalc, A Mixed Bag Corp - Infusion Calculator, Harvard Apparatus - Harvard 2 Syringe Pump
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
Technological Characteristics
The Harvard Library is a computer program which runs on MSDOS based personal computers under Microsoft Windows V3.1 or higher.
1
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:
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.
(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 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
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