(84 days)
Not Found
No
The summary describes a standard infusion pump with no mention of AI or ML capabilities, image processing, or data sets for training/testing.
Yes
The device is an infusion pump that delivers measured drug therapy to patients, which is a form of medical treatment.
No
The device description and intended use clearly state that it is an "ambulatory infusion pump" used for "measured drug therapy" and "infusion." There is no mention of it being used to diagnose a condition or disease.
No
The device description explicitly states it is an "ambulatory infusion pump," which is a hardware device. The summary also mentions "software controlled programming functions" and "software related to proper pump operation," indicating software that controls hardware, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the delivery of drugs to various anatomical sites within the patient's body (intravenous, intra-arterial, subcutaneous, etc.). This is a therapeutic function, not a diagnostic one.
- Device Description: The description reinforces that the pump provides "measured drug therapy."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is used to administer substances directly into the body for treatment.
N/A
Intended Use / Indications for Use
"The CADD-Legacy™ pump is suitable for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion."
Product codes (comma separated list FDA assigned to the subject device)
FRN
Device Description
The CADD-Legacy™ 1 Model 6400 ambulatory infusion pump is similar in design, function, and intended use to Deltec's CADD-1 " Ambulatory Infusion Pump and the CADD-Prizm® VIP Model 6100 Ambulatory Infusion System . The Model 6400 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings. The pump is capable of storing one delivery application. The delivery application resident in the Model 6400 pump and the subject of this 510(k) Notification is the continuous delivery application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients in hospital or outpatient settings.
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 pump operation were certified for the CADD-Legacy™ 1 Model 6400 Ambulatory Infusion System.
Clinical Studies: Clinical studies were not deemed necessary regarding the use of the CADD-Legacy™ 1 Model 6400 Ambulatory Infusion System.
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.
Not Found
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 4 1998 NOY for the CADD-Legacy™ 1 MODEL 6400 AMBULATORY INFUSION SYSTEM
GENERAL INFORMATION I.
| Common/Usual Name: | Ambulatory Infusion Pump |
|---|---|
| Proprietary Name: | CADD-Legacy™ 1 Model 6400 |
| Ambulatory Infusion System | |
| Applicant's name and address: | SIMS Deltec, Inc. |
| 1265 Grey Fox Road | |
| St. Paul, MN 55112 | |
| Equivalence device comparison: | CADD-1® Ambulatory Infusion Pump and |
| CADD-Prizm® VIP Model 6100 Ambulatory | |
| Infusion System |
DEVICE DESCRIPTION II.
The CADD-Legacy™ 1 Model 6400 ambulatory infusion pump is similar in design, function, and intended use to Deltec's CADD-1 " Ambulatory Infusion Pump and the CADD-Prizm® VIP Model 6100 Ambulatory Infusion System . The Model 6400 pump provides measured drug therapy for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space delivery to patients in hospital or outpatient settings. The pump is capable of storing one delivery application. The delivery application resident in the Model 6400 pump and the subject of this 510(k) Notification is the continuous delivery application.
Ш. ALTERNATIVES
Alternatives to the CADD-Legacy™ 1 Model 6400 pump include the use of other commercially available ambulatory infusion pumps, such as Deltec's CADD-1® and CADD-Prizm® VIP Ambulatory Infusion Pumps.
POTENTIAL ADVERSE EFFECTS IV.
The potential direct adverse effects that may occur when using the CADD-Legacy™ 1 Model 6400 pump, as well as other commercially available non-implantable ambulatory infusion pumps, include the possibility of overinfusion, under-infusion, or no infusion.
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for the CADD-Legacy™ 1 MODEL 6400 AMBULATORY INFUSION SYSTEM
SUMMARY OF STUDIES V.
Functional Testing A.
Test plans associated with software validation, verification of software controlled programming functions, and software related to proper pump operation were certified for the CADD-Legacy™ 1 Model 6400 Ambulatory Infusion System.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the use of the CADD-Legacy™ 1 Model 6400 Ambulatory Infusion System.
CONCLUSIONS DRAWN FROM THESE STUDIES VI.
Based upon the information provided above, the CADD-Legacy™ 1 Model 6400 Ambulatory Infusion System is substantially equivalent to other commercially available ambulatory infusion systems.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird or eagle with three lines forming the wings and head. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1998 NOV
Mr. Edward W. Numainville Vice President, Regulatory Affairs and Quality Systems SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
K982838 Re : CADD-Legacy™ 1 Ambulatory Infusion Trade Name: System, Model 6400 Requlatory Class: II Product Code: FRN Dated: August 12, 1998 August 12, 1998 Received:
Dear Mr. Numainville:
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, qood 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 regulations 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Reqister. Please note: 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 regulations.
3
Page 2 - Mr. Numainville
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation 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
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
i.
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
CADD-Legacy™ 1 Model 6400 Ambulatory Infusion Pump Device Name:
Indications For Use:
"The CADD-Legacy™ pump is suitable for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use L (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1/2/96)
Palace Crescenta
(Division Sign-On)
Division of Denal, Infection Control, and General Hospital Devices
510(k) Number 4982858
M:\510(k)ISDSubmissions1998\CADD-LegacyNIndicationsLegacy1