(218 days)
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No
The document describes a standard infusion pump and medication safety software for creating protocols. There is no mention of AI, ML, or any technology that learns or adapts based on data. The software appears to be rule-based for safety protocols.
Yes.
The device is an ambulatory infusion pump intended for delivering drug therapy, including continuous infusion, patient-controlled analgesia, and clinician bolus, to patients. These applications are directly involved in treating medical conditions or alleviating symptoms, qualifying it as a therapeutic device.
No
The device is an ambulatory infusion pump and associated software, intended for delivering medication, not for diagnosing conditions.
No
The device description clearly states that the submission includes both the CADD-Solis ambulatory infusion pump (hardware) and the CADD-Solis Medication Safety Software. While the software is a component, the overall device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The CADD-Solis ambulatory infusion pump and its associated software are designed to deliver medication to a patient's body through various routes (intravenous, subcutaneous, etc.). They are not used to analyze samples taken from the body.
- Intended Use: The intended use clearly describes the delivery of therapies and medication, not the analysis of biological samples.
- Device Description: The description focuses on the pump's ability to provide measured drug therapy and the software's function in creating protocols for medication delivery.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the CADD-Solis ambulatory infusion pump and its software fall under the category of infusion pumps and medication delivery systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CADD® Solis ambulatory infusion pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion, patient controlled PCA doses, or both.
The CADD®-Solis Medication Safety Software – Administrator allows you to establish a therapy-based protocol library that will be used by the CADD®-Solis Ambulatory Infusion Pump or by the CADD® -Solis Medication Safety Software -Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).
Product codes (comma separated list FDA assigned to the subject device)
MEA
Device Description
CADD®-Solis Ambulatory Infusion Pump
The CADD® -Solis ambulatory infusion pump ("Solis Pump") provides measured drug therapy to patients in the hospital setting. The pump can be programmed to deliver medication at a continuous rate, patient controlled analgesia (PCA), clinician bolus, continuous rate plus PCA, and continuous rate plus clinician bolus.
CADD®-Solis Medication Safety Software – Administrator
The Smiths Medical MD, Inc. CADD® -Solis Medication Safety Software -Administrator ("Solis Safety Software - Administrator"), a server based software program that operates on commercially available computers, is designed to establish user defined therapy based protocols for use by the Solis Pump or for use by use CADD®-Solis Medication Safety Software – Point of Care (POC) to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The Solis Safety Software - Administrator does not allow duplicative Drug, Protocol or User identification entries.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Functional Testing
The Solis Pump and Solis Safety Software – Administrator were subjected to verification and validation testing. The verification and validation testing performed demonstrate the devices function as intended and perform to specification.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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) Summary
MAR - 7 ZUUn
GENERAL INFORMATION
| Applicant's Name and Address: | Smiths Medical MD, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Phil Neururer
Sr. Regulatory Affairs Specialist |
| Common/Usual Name: | Ambulatory Infusion Pump
Pump Communications System |
| Proprietary Name: | CADD®-Solis Ambulatory Infusion Pump
CADD®-Solis Medication Safety Software |
| Equivalence Device Comparison: | CADD-Prizm® PCS II Model 6101 Ambulatory Infusion
System
CADD-Sentry Pro® Medication Safety |
II. DEVICE DESCRIPTION
CADD®-Solis Ambulatory Infusion Pump
The CADD® -Solis ambulatory infusion pump ("Solis Pump") provides measured drug therapy to patients in the hospital setting. The pump can be programmed to deliver medication at a continuous rate, patient controlled analgesia (PCA), clinician bolus, continuous rate plus PCA, and continuous rate plus clinician bolus.
CADD®-Solis Medication Safety Software – Administrator
The Smiths Medical MD, Inc. CADD® -Solis Medication Safety Software -Administrator ("Solis Safety Software - Administrator"), a server based software program that operates on commercially available computers, is designed to establish user defined therapy based protocols for use by the Solis Pump or for use by use CADD®-Solis Medication Safety Software – Point of Care (POC) to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The Solis Safety Software - Administrator does not allow duplicative Drug, Protocol or User identification entries.
072144
1
INTENDED USE OF THE DEVICE III.
CADD®-Solis Ambulatory Infusion Pump
The CADD® Solis ambulatory infusion pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion, patient controlled PCA doses, or both.
CADD®-Solis Medication Safety Software – Administrator
The CADD®-Solis Medication Safety Software – Administrator allows you to establish a therapy-based protocol library that will be used by the CADD®-Solis Ambulatory Infusion Pump or by the CADD® -Solis Medication Safety Software -Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).
SUMMARY OF STUDIES V.
A. Functional Testing
The Solis Pump and Solis Safety Software – Administrator were subjected to verification and validation testing. The verification and validation testing performed demonstrate the devices function as intended and perform to specification.
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2008
Mr. Phil Neururer Senior Regulatory Affairs Specialist Smiths Medical MD, Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112
Re: K072144
Trade/Device Name: CADD® -Solis Ambulatory Infusion Pump CADD® - Solis Medication Safety Software - Administrator Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: February 20, 2008 Received: February 21, 2008
Dear Mr. Neururer:
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. Mr. Neururer
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chih Lin, 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
SMITHS MEDICAL MD, INC. 510(k) Premarket Notification
CADD®-Solis Ambulatory Infusion Pump CADD®-Solis Medication Safety Software
Indications for Use
510(k) Number: K072144
Device Name: CADD®-Solis Ambulatory Infusion Pump
Indications for Use:
"The CADD -Solis ambulatory infusion pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both (such as patientcontrolled analgesia)."
Prescription Use
Over-The Counter Use ---------
Per 21 CFR 801.109)
Device Name: CADD®-Solis Medication Safety Software - Administrator
OR
Indications for Use:
"The CADD®-Solis Medication Safety Software consists of the Administrator and the Point of Care software applications. This software allows you to create a set of standard pump Protocols to be used with the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump. The Point of Care software application is used for the CADD-Prizm® PCS II Ambulatory Infusion pump (with software revision H or higher) only."
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony D. Morton
OR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K$\phi$7a,44