CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400

K982838 · Sims Deltec, Inc. · FRN · Nov 4, 1998 · General Hospital

Device Facts

• Record ID: K982838
• Device Name: CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
• Applicant: Sims Deltec, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CADD-Legacy™ pump is suitable for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space, or subarachnoid space infusion.

Device Story

CADD-Legacy™ 1 Model 6400 is an ambulatory infusion pump for continuous drug delivery. Device provides measured therapy via intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, or subarachnoid routes. Used in hospital or outpatient settings; operated by healthcare professionals or patients. Pump stores one continuous delivery application. Healthcare providers program the device to manage infusion rates; output is the controlled delivery of medication. Benefits include portable, measured drug administration. Potential risks include over-infusion, under-infusion, or no infusion.

Clinical Evidence

No clinical data. Clinical studies were not deemed necessary for this device. Evidence consists of functional testing, including software validation and verification of software-controlled programming functions and pump operation.

Technological Characteristics

Ambulatory infusion pump for continuous delivery. Software-controlled programming. Designed for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, or subarachnoid administration. Standalone device.

Indications for Use

Indicated for patients requiring intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural, or subarachnoid space infusion therapy. Suitable for use in hospital or outpatient settings.

Regulatory Classification

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.

Predicate Devices

• CADD-1® Ambulatory Infusion Pump
• CADD-Prizm® VIP Model 6100 Ambulatory Infusion System

Submission Summary (Full Text)

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#### 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<br>Ambulatory Infusion System |
| Applicant's name and address: | SIMS Deltec, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
| Equivalence device comparison: | CADD-1® Ambulatory Infusion Pump and<br>CADD-Prizm® VIP Model 6100 Ambulatory<br>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.

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K982838

## 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.

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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.

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### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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# 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