AUTODOSE INFUSION SYSTEM

K990889 · Tandem Medical, Inc. · MEB · Jun 3, 1999 · General Hospital

Device Facts

• Record ID: K990889
• Device Name: AUTODOSE INFUSION SYSTEM
• Applicant: Tandem Medical, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AutoDose Infusion System is intended for general use infusion of predetermined volumes of intravenous solutions.

Device Story

AutoDose Infusion System is a mechanical, spring-driven infusion pump for intravenous solutions. System components include a reusable mechanical roller device, a multi-chambered IV container (AutoDose Bag), and an administration set. Pharmacy fills the sterile, empty AutoDose Bag using a dedicated filling fixture; a clamp automatically seals the bag post-filling. End-user connects the administration set to the patient's indwelling access device and presses a start button. Flow rate is determined by the administration set size (50, 100, or 200 ml/hr). Device provides constant pressure to the IV bag; flow control is achieved via a fixed-diameter/length restrictor in the tubing. Used in clinical settings to simplify administration of multiple solutions by reducing steps and supplies. Benefits include automated, multi-solution infusion without continuous user interaction.

Clinical Evidence

Bench testing only. Evaluation performed at the conclusion of the Final Design Phase to verify product specifications. Metrics included average flow rate, flow rate accuracy, maximum infusion pressure, and residual volumes. Results confirmed the system met all specifications and was comparable to the predicate Sidekick system.

Technological Characteristics

Mechanically spring-driven infusion pump. Components: pressurization device, multi-chambered IV bag, and administration set with fixed-diameter/length flow restrictor. Sterilization: AAMI guidelines to 10^6 SAL. Pyrogenicity: LAL assessed per USP guidelines. No software or electronic components.

Indications for Use

Indicated for general use infusion of predetermined volumes of intravenous solutions in patients requiring intravenous therapy.

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

• SoloPak® Sidekick Infusion Pump & Administration Set (K962663)
• Sidekick™ Infusion System (K915646)

Submission Summary (Full Text)

{0}------------------------------------------------

# JUN ဒေသကြီး၊ မြို့နယ်၊ အမှတ်မြို့နယ်၊ အမှတ်မြို့နယ်၊ အမှတ်မြို့နယ်၊ အမှတ်မြို့နယ်၊ အမှတ်မြို့နယ်၊ အမှတ်မြို့နယ်၊ အမှတ်မြို့နယ်၊ အမှတ်မြို့နယ်၊ အမှတ်မြို့နယ်၊ အမှတ်မြို့နယ်၊ အမှတ

AutoDose Infusion System ORIGINAL PREMARKET 510(k) NOTIFICATION

K990889

# SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 15:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

#### 15.1 SUBMITTER INFORMATION

| a. Company Name: | Tandem Medical, Inc. |
|-----------------------------------------|-------------------------------------------------------------------------|
| b. Company Address: | 15190 Bernardo Center Drive<br>San Diego, CA 92127 |
| c. Company Phone:<br>Company Facsimile: | [phone]<br>[phone] |
| d. Contact Person: | Albert Misajon<br>Director, Regulatory Affairs<br>And Quality Assurance |
| e. Date Summary Prepared: | March 15, 1999 |

#### DEVICE IDENTIFICATION 15.2.

| a. Trade/Proprietary Name: | AutoDose Infusion System |
|----------------------------|----------------------------------|
| b. Classification Name: | Infusion Pump<br>21 CFR 880.5725 |

#### 15.3 IDENTIFICATION OF PREDICATE DEVICES

| Company | Device | 510(k) No. | Date Cleared |
|--------------------------------|------------------------------------------------------------|------------|--------------|
| Douglas<br>Medical<br>Products | SoloPak® Sidekick<br>Infusion Pump &<br>Administration Set | K962663 | 10/4/96 |
| I-Flow | Sidekick™ Infusion System | K915646 | 6/15/92 |

{1}------------------------------------------------

## DEVICE DESCRIPTION 15.4

The AutoDose Infusion System is a general use infusion system that is intended to infuse intravenous solutions of predetermined volumes in an order based on the AutoDose Bag configuration. It is intended that this system will infuse multiple intravenous solutions of predetermined volumes without user interaction. The system is comprised of the AutoDose, a mechanical roller device design in conjunction with the AutoDose Bag, a multiple chambered IV container, and the AutoDose Bag Administration Set. The single use multiple chambered IV container is designed to fit within the reusable AutoDose device with the end user pushing a start button once the AutoDose Bag Administration Set has been connected to the patient's indwelling access device. The AutoDose Bag Administration Set size will determine the system flow rate and will be offered in rates of 50 ml/hr, 100 ml/hr, and 200 ml/hr.

It is intended that the AutoDose Bag be provided empty and sterile to the end user. The AutoDose Bag can then be appropriately filled on the order of a physician by a pharmacy. The filling of the AutoDose Bag is performed using standard procedures, equipment and the AutoDose Filling Fixture. The AutoDose Filling Fixture is a tool developed to hold the AutoDose Bag for the pharmacist during the filling process. A clamp is automatically activated by the AutoDose Filling Fixture to securely close the bag after it has been filled.

The AutoDose Infusion System has been designed to simplify user interaction in the administration of multiple solutions safely with a reduction of a number of steps and a number of supplies typically used by healthcare providers.

The AutoDose Bag and the AutoDose Bag Administration Set will be sterilized per AAMI guidelines to a 10 6 sterility assurance level (SAL). Pyrogenicity will be LAL assessed per production lot in accordance with USP guidelines.

{2}------------------------------------------------

#### SUBSTANTIAL EQUIVALENCE 15.5

The Tandem AutoDose Infusion System is substantially equivalent to the SolaPak® Sidekick Infusion Pump and Administration Set and the I-Flow Sidekick™ in that each device is a mechanically spring driven infusion system intended for the infusion of general use intravenous solutions. The application of a constant pressure to the IV bag in conjunction with the fixed diameter and length of a restrictor in the administration tubing set achieve flow control in a similar manner. The flow rates (50, 100 and 200 ml/hr) for the AutoDose Infusion System are the same as those of the SoloPak® Sidekick Infusion Pump System and the I-Flow Sidekick™ Infusion System.

#### 15.6 INTENDED USE

The AutoDose Infusion System is intended for general use infusion of predetermined volumes of intravenous solutions.

#### TECHNOLOGICAL CHARACTERISTICS 15.7

A comparison of the technological characteristics of the AutoDose Infusion System with the predicate device is provided within this submission. The AutoDose Infusion System and the predicate device are composed of a pressurization device, IV bag, and administration set. The AutoDose Infusion System, as well as the predicate is a mechanically spring driven pump system where flow is achieved by the application of a constant pressure to the IV bag in conjunction with the fixed diameter and length of a restrictor in the administration set. The AutoDose has the capability of infusing predetermined volumes in an order based on the AutoDose Bag configuration; whereas, the predicate has the capacity to either infuse two volumes in sequence or in parallel. Both systems utilize standard pharmacy procedures and equipment for filling of the dedicated IV Bag.

{3}------------------------------------------------

# 15.8 PERFORMANCE DATA

The AutoDose Infusion System was evaluated at the conclusion of the Final Design Phase to verify that the system met the product specifications. The AutoDose, AutoDose Bag and AutoDose Administration Set was tested and the results compared to the following product specifications: Average Flow Rate; Flow Rate Accuracy; Maximum Infusion Pressure and Residual Volumes. The results indicated that the AutoDose Infusion System performed to the requirements in the specifications. When compared to the Sidekick, the AutoDose is comparable in all common performance characteristics.

## 15.9 510(k) CHECKLIST

This notification contains all information required by 21 CFR 807.87. A completed copy of the PreMarket Notification 510(k) Reviewer's Checklist is provided in this submission.

{4}------------------------------------------------

Image /page/4/Picture/10 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of three birds in flight, arranged in a row.

3 1939 JUN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Albert Misajon Director Regulatory Affairs and Quality Assurance Tandem Medical, Incorporated 15910 Bernardo Center Drive San Diego, California 92127

Re : K990889 Trade Name: AutoDose Infusion System Requlatory Class: II Product Code: MEB March 15, 1999 Dated: Received: March 17, 1999

Dear Mr. Misajon:

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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

{5}------------------------------------------------

Page 2 - Mr. Misajon

this response to your premarket notification Please note: 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.

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 regulation 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

Enclosure

{6}------------------------------------------------

# INDICATION FOR USE

| 510(k) Number: | To Be Assigned By FDA |
|----------------------|-------------------------------------------------------------------------------------------------------------------------|
| Device Name: | AutoDose Infusion System |
| Indications for Use: | The AutoDose Infusion System is intended for general use<br>infusion of predetermined volumes of intravenous solutions. |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

______________________________________________________________________________________________________________________________________________________________________________

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

24

______________________________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

______________________________________________________________________________________________________________________________________________________________________________

______________________________________________________________________________________________________________________________________________________________________________

| Prescription Use | <span></span> <span></span> |
|------------------|-----------------------------|
| | OR |
| | Over-The-Counter Use |

(Per 21 CFR 801.109)

| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | 1990889 |

CONFIDENTIAL