(156 days)
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.
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.
The provided document is a 510(k) summary for the CADD-MS™ 3 Ambulatory Infusion Pump, which is a medical device. It is not an AI/ML device, and therefore, many of the requested criteria (such as number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable or typically part of the submission for this type of device.
However, I can extract the relevant information regarding acceptance criteria and the studies performed to demonstrate equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" in a quantitative, tabular format as one might expect for an AI/ML device's performance metrics. Instead, the "acceptance criteria" are implied by the performance characteristics of the predicate device (CADD-Micro® Ambulatory Infusion Pump) and the CADD-MS™ 3's ability to demonstrate "substantial equivalence" through functional testing and comparison. The "reported device performance" is essentially that it met these equivalence standards.
| Acceptance Criteria (Implied by Equivalence to Predicate) | Reported Device Performance (CADD-MS™ 3) |
|---|---|
| Indications for Use: Subcutaneous, intravenous, intrathecal, and epidural delivery of medication. | Met: Designed for subcutaneous, intravenous, intrathecal, and epidural delivery of medication. |
| Performance Features: (e.g., flow rate accuracy, alarm functions, battery life, user interface functionality, safety features like occlusion sensors, programming capabilities). These are implicitly benchmarked against the CADD-Micro®. | Met: "performs to established specifications" and is "substantially equivalent... with respect to indications for use and performance features" to the CADD-Micro®. Specific functional tests were performed for software validation, verification of software-controlled programming functions, and proper pump operation. Biocompatibility testing was also performed for the 3-ml Cartridge. |
| Safety: Device operates safely without causing harm to the user or patient. | Met: "is safe, effective and performs to established specifications." Implied by functional testing, biocompatibility, and comparison to a legally marketed predicate device. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This device is an infusion pump, and the "test set" here refers to engineering and functional tests rather than a dataset of patient cases. The testing would involve a certain number of manufactured units, but the specific quantity is not disclosed in the summary.
- Data Provenance: Not applicable. The testing is primarily functional and engineering-based on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for AI/ML performance (e.g., expert consensus on medical images or diagnoses) is not relevant for this type of device submission. Performance is assessed through engineering tests and comparison to a predicate device, which would involve qualified engineers and regulatory specialists.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of data for AI/ML studies. This is not relevant for functional device testing.
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
- No. This is not an AI/ML device, and therefore, MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device with embedded software, not an AI/ML algorithm. Its "standalone performance" refers to its functional operation as a pump, which was assessed through validation and verification tests, as described in "Functional Testing."
7. The type of ground truth used
- Engineering Specifications and Predicate Device Performance: The "ground truth" for this device's performance is established by its design specifications and by demonstrating that it performs comparably or identically to the legally marketed predicate device (CADD-Micro® Ambulatory Infusion Pump) for its intended use and performance features. This would include verifying flow rates, alarm functions, programming accuracy, and safety features against predetermined engineering standards and the known performance of the predicate.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.
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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 RoadSt. Paul, MN 55112 |
|---|---|
| Contact Person: | Melanie HessRegulatory 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.
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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.
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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.
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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
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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
§ 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).