(117 days)
Not Found
No
The description focuses on software for managing and sending pre-defined therapy protocols to an infusion pump, with no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML.
No
The device is medication safety software designed to program an infusion pump, not to directly provide therapy itself. It manages therapy-based protocols for another device.
No
The device is described as "Medication Safety Software" that allows for programming of an infusion pump and managing therapy-based protocols. Its purpose is to control and manage medication delivery, not to diagnose a medical condition.
Yes
The device is described as a "software program that operates on commercially available personal computers or similar hardware platforms such as tablets." While it interacts with a hardware device (the infusion pump), the 510(k) focuses solely on the software's function in creating, managing, and transmitting protocols, and the performance studies described are functional testing related to software validation. There is no indication that the submission includes hardware components or hardware-specific verification/validation.
Based on the provided information, the CADD-Sentry Pro™ Medication Safety Software is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CADD-Sentry Pro™ Function: The CADD-Sentry Pro™ software is designed to program and manage ambulatory infusion pumps (specifically the CADD-Prizm® PCS II). Its purpose is to facilitate the safe and accurate delivery of medications to a patient.
- No Specimen Analysis: The software does not interact with or analyze any biological specimens from the patient. It deals with programming and managing the delivery of substances into the body, not analyzing substances from the body.
Therefore, the CADD-Sentry Pro™ Medication Safety Software falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The CADD-Sentry Pro"" Medication Safety Software – Administrator allows you to establish a therapy-based protocol library that will be used by the CADD-Sentry Pro Medication Safety Software - Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher)."
AND
"The CADD-Sentry Pro" Medication Safety Software – Point of Care allows use of a personal computer to send CADD-Sentry Pro "Medication Safety Software --Administrator established therapy-based protocols to the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher)."
Product codes
MRZ
Device Description
The Smiths Medical MD, Inc. CADD-Sentry Pro™ Medication Safety Software, a software program that operates on commercially available personal computers or similar hardware platforms such as tablets, is designed for pump programming of the CADD-Prizm" PCS II Ambulatory Infusion Pump (software revision H or higher) through a therapy-based protocol database defined by the user. The CADD-Sentry Pro™ Medication Safety Software consists of an Administrator and a Point-of-Care (POC) software module that employs serial communications to send and receive pump information. Both modules are compatible with barcode scanners (or similar input devices) through various PC connections. Barcode format is determined by the user; but is limited to 20 alphanumerical characters. The CADD-Sentry Pro™ Medication Safety Software does not allow duplicative Drug, Protocol or User identification entries.
The CADD-Sentry Pro™ Medication Safety Software - Administrator module allows the user to create and save therapy-based protocols, including pump settings. The Administrator module allows therapy-based protocols to be stored and edited within user-defined protocol libraries. The Administrator user determines POC user access and editing capabilities of these libraries. Other Administrator module features include barcode printing, reports, and sending and receiving pump identification.
The CADD-Sentry Pro™ Medication Safety Software - Point-of-Care module allows the user to send and receive pump settings via serial communication sourced from protocol libraries established using the Administrator module. Additional features include storing and printing pump programs and reports, verifying pump settings to established protocols and viewing history logs in the easier view of the PC monitor.
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)
Functional Testing: Test plans associated with software validation, verification of software controlled programming functions, and software related to proper software and pump operation were performed.
Clinical Studies: Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD-Sentry Pro" Medication Safety Software.
Conclusions Drawn from the Studies: Based upon the information provided, the CADD-Sentry Pro Medication Safety Software is safe, effective and performs to established specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CADD-Sentry Pro™ Medication Safety Software
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
510(k) Premarket Notification 510(k) Summary
| GENERAL INFORMATION | K472955 (P.1242) | |
|---|---|---|
| Applicant's Name and Address: | Smiths Medical MD, Inc. | |
| 1265 Grey Fox Road | ||
| St. Paul, MN 55112 | FEB 13 2008 | |
| Contact Person: | David H. Short | |
| Director Regulatory Affairs and Design | ||
| Assurance | ||
| Common/Usual Name: | Pump Communications System | |
| Proprietary Name: | CADD-Sentry Pro™ Medication Safety Software | |
| Classification Name: | 21 CFR 880.5725, Accessories, Pump, Infusion | |
| Product Code | MRZ | |
| Equivalence Device Comparison: | CADD-Sentry Pro™ Medication Safety Software | |
| Date Prepared | February 7, 2008 |
II. DEVICE DESCRIPTION
CADD-Sentry Pro™ Medication Safety Software
The Smiths Medical MD, Inc. CADD-Sentry Pro™ Medication Safety Software, a software program that operates on commercially available personal computers or similar hardware platforms such as tablets, is designed for pump programming of the CADD-Prizm" PCS II Ambulatory Infusion Pump (software revision H or higher) through a therapy-based protocol database defined by the user. The CADD-Sentry Pro™ Medication Safety Software consists of an Administrator and a Point-of-Care (POC) software module that employs serial communications to send and receive pump information. Both modules are compatible with barcode scanners (or similar input devices) through various PC connections. Barcode format is determined by the user; but is limited to 20 alphanumerical characters. The CADD-Sentry Pro™ Medication Safety Software does not allow duplicative Drug, Protocol or User identification entries.
The CADD-Sentry Pro™ Medication Safety Software - Administrator module allows the user to create and save therapy-based protocols, including pump settings. The Administrator module allows therapy-based protocols to be stored and edited within user-defined protocol libraries. The Administrator user determines POC user access and editing capabilities of these libraries. Other Administrator module features include barcode printing, reports, and sending and receiving pump identification.
1
510(k) Premarket Notification 510(k) Summary
K47a155 (P.202a)
The CADD-Sentry Pro™ Medication Safety Software - Point-of-Care module allows the user to send and receive pump settings via serial communication sourced from protocol libraries established using the Administrator module. Additional features include storing and printing pump programs and reports, verifying pump settings to established protocols and viewing history logs in the easier view of the PC monitor.
INTENDED USE OF THE DEVICE III.
CADD-Sentry Pro™ Medication Safety Software
The CADD-Sentry Pro " Medication Safety Software -- Administrator allows you to establish a therapy-based protocol library that will be used by the CADD-Sentry Pro"" Medication Safety Software - Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).
The CADD-Sentry Pro" Medication Safety Software - Point of Care allows use of a personal computer to send CADD-Sentry Pro " Medication Safety Software - Administrator established therapy-based protocols to the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).
IV. DEVICE COMPARISON
CADD-Sentry Pro™ Medication Safety Software
The CADD-Sentry Pro " Medication Safety Software was compared to and found to be substantially equivalent to the following commercially available predicate device: CADD-Sentry Pro " Medication Safety Software with respect to indications for use and performance features.
V. SUMMARY OF STUDIES
A. Functional Testing
Test plans associated with software validation, verification of software controlled programming functions, and software related to proper software and pump operation were performed.
B. Clinical Studies
Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD-Sentry Pro" Medication Safety Software.
C. Conclusions Drawn from the Studies
Based upon the information provided, the CADD-Sentry Pro Medication Safety Software is safe, effective and performs to established specifications.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
FEB 13 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David H. Short Director Regulatory Affairs and Design Assurance Smiths Medical MD, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
Re: K072955
Trade/Device Name: CADD-Sentry Pro™ Medication Safety Software – Administrator CADD-Sentry Pro™ Medication Safety Software – Point of Care Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: January 17, 2008 Received: January 18, 2008
Dear Mr. Short:
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.
3
Page 2 - Mr. Short
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ches. Lins, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification Indications for Use
510(k) Number: TBD
Device Name: CADD-Sentry Pro " Medication Safety Software - Administrator
Indications for Use:
"The CADD-Sentry Pro"" Medication Safety Software – Administrator allows you to establish a therapy-based protocol library that will be used by the CADD-Sentry Pro Medication Safety Software - Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher)."
| Prescription Use | X |
|---|---|
| OR | |
| Over-The Counter Use | |
| Per 21 CFR 801.109 |
Device Name: CADD-Sentry Pro™ Medication Safety Software - Point of Care
Indications for Use:
"The CADD-Sentry Pro" Medication Safety Software – Point of Care allows use of a personal computer to send CADD-Sentry Pro "Medication Safety Software --Administrator established therapy-based protocols to the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher)."
OR Over-The Counter Use Per 21 CFR 801.109 Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cinton Vrant
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:__ Ko7295S
CADD-Sentry Pro™ Medication Safety Software Smiths Medical MD, Inc.
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