(156 days)
Not Found
Not Found
No
The description focuses on microprocessor-based control, user-programmed profiles, and sensor-based features, with no mention of AI or ML algorithms for decision-making or data analysis.
Yes.
The device is designed for the infusion of medication, which is a therapeutic intervention.
No
The device is an infusion pump designed for delivering medication, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components such as a microprocessor, battery, display, keypad, buttons, sensors, and a physical pump mechanism. While it contains software for programming and control, it is fundamentally a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The CADD-MS™ 3 Ambulatory Infusion Pump is designed to deliver medication into the body (subcutaneously, intravenously, epidurally, and intrathecally). It is a drug delivery device, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states the purpose is for "infusion of medication." There is no mention of analyzing biological samples or providing diagnostic information.
- Device Description: The description focuses on the mechanical and electronic aspects of the pump for controlled drug delivery. It does not describe any components or processes related to analyzing biological specimens.
Therefore, based on the provided information, the CADD-MS™ 3 Ambulatory Infusion Pump falls under the category of a drug delivery device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
"The CADD-MS™ 3 Ambulatory Infusion Pump is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication."
"The Smiths Medical MD, Inc. 3-ml Cartridge Reservoir is designed for use with the CADD-MS™ 3 for delivering medication."
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The Smiths Medical MD, Inc. CADD-MS™ 3 Ambulatory Infusion Pump, a microprocessor based electronic syringe pump with a 3-ml cartridge reservoir, is designed for low volume syringe-based infusion therapy allowing continuous, automatic dose and demand dose delivery profiles for subcutaneous, intravenous, epidural and intrathecal delivery.
The pump operates on one (1) AAA alkaline battery. The user-interface of hardware features include a backlit liquid crystal display, 4-key front keypad, separate bolus button, audible or vibratory alarm, battery cap and cartridge cap. The pump is waterproof and features a cartridge sensor and downstream occlusion sensor.
Based on user code-entry and an internal real-time clock, a user will be able to program multiple basal (continuous), bolus (demand) dosing and automatic dosing delivery profiles within programmed maximum limits.
The pump accommodates the Smiths Medical MD, Inc. 3ml cartridge reservoir.
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)
A. Functional Testing
Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were performed.
Biocompatibility testing for the 3-ml Cartridge was performed and found to be biocompatible
B. Clinical Studies
Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the CADD-MS™ 3 Ambulatory Infusion Pump.
C. Conclusions Drawn from the Studies
Based upon the information provided through verification and validation test reports, the CADD-MS™ 3 Ambulatory Infusion Pump is safe, effective and performs to established specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
CADD-Micro® Ambulatory Infusion Pump
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.
Not Found
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).
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) SUMMARY OF SAFETY AND EFFECTIVENESS CADD-MSTM 3 Ambulatory Infusion Pump June 13, 2005 K051568
GENERAL INFORMATION
NOV 1 7 2005
| Applicant's Name and Address: | Smiths Medical MD, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|---------------------------------------------------------------------|
| Contact Person: | Melanie Hess
Regulatory and Clinical Affairs Associate |
| Common/Usual Name: | Ambulatory Syringe Pump |
| Proprietary Name: | CADD-MS™ 3 Ambulatory Infusion Pump |
| Equivalence Device Comparison: | CADD-Micro® Ambulatory Infusion Pump |
II. DEVICE DESCRIPTION
The Smiths Medical MD, Inc. CADD-MS™ 3 Ambulatory Infusion Pump, a microprocessor based electronic syringe pump with a 3-ml cartridge reservoir, is designed for low volume syringe-based infusion therapy allowing continuous, automatic dose and demand dose delivery profiles for subcutaneous, intravenous, epidural and intrathecal delivery.
The pump operates on one (1) AAA alkaline battery. The user-interface of hardware features include a backlit liquid crystal display, 4-key front keypad, separate bolus button, audible or vibratory alarm, battery cap and cartridge cap. The pump is waterproof and features a cartridge sensor and downstream occlusion sensor.
Based on user code-entry and an internal real-time clock, a user will be able to program multiple basal (continuous), bolus (demand) dosing and automatic dosing delivery profiles within programmed maximum limits.
The pump accommodates the Smiths Medical MD, Inc. 3ml cartridge reservoir.
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CADD-MS™ 3 Ambulatory Infusion Pump
June 13, 2005
KOS1568
INTENDED USE OF THE DEVICE III.
The CADD-MS™ 3 is a syringe infusion pump designed for subcutaneous, intravenous, intrathecal and epidural delivery of medication.
The Smiths Medical MD, Inc. 3ml Cartridge is designed for use with the CADD-MS™ 3 for delivering medication
IV. DEVICE COMPARISON
The CADD-MS™ 3 Ambulatory Infusion Pump was compared to and found to be substantially equivalent to the following commercially available predicate device: CADD-Micro® Ambulatory Infusion Pump.
The CADD-MS™ 3 Ambulatory Infusion Pump is substantially equivalent to the CADD-Micro Ambulatory Infusion Pump 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 pump operation were performed.
Biocompatibility testing for the 3-ml Cartridge was performed and found to be biocompatible
B. Clinical Studies
Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the CADD-MS™ 3 Ambulatory Infusion Pump.
C. Conclusions Drawn from the Studies
Based upon the information provided through verification and validation test reports, the CADD-MS™ 3 Ambulatory Infusion Pump is safe, effective and performs to established specifications.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of an eagle with three wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. The text is in a sans-serif font and is oriented to follow the curve of the circle.
Public Health Service
NOV 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Melanie Hess Regulatory and Clinical Affairs Associate Smith Medical MD, Incorporated 1265 Grev Fox Road St. Paul. Minnesota 55112
Re: K051568
Trade/Device Name: CADD-MS™ 3 Ambulatory Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 31, 2005 Received: November 1, 2005
Dear Ms. Hess:
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 - Ms. Hess
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 (OS) 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) 276-0120. 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,
Smette y. Michin ons.
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. Indications for Use Statement 510(k) Number: K051568
Device Name: CADD-MS'" 3 Ambulatory Infusion Pump
Indications for Use:
"The CADD-MS™ 3 Ambulatory Infusion Pump is designed for subcutaneous, intravenous, epidural and intrathecal infusion of medication."
Prescription Use x 21 CFR 801.109)
OR
OR
Over-The Counter Use Per
Device Name: Smiths Medical MD, Inc. 3-ml Cartridge Reservoir
Indications for Use:
"The Smiths Medical MD, Inc. 3-ml Cartridge Reservoir is designed for use with the CADD-MS™ 3 for delivering medication."
Prescription Use _____________________________________________________________________________________________________________________________________________________________ 21 CFR 801 109)
Over-The Counter Use -------Per
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton Wang
Siston (Sign-Off) Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510(k) Number. K051568