AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10

K993832 · Tandem Medical, Inc. · MEB · Feb 9, 2000 · General Hospital

Device Facts

• Record ID: K993832
• Device Name: AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
• Applicant: Tandem Medical, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Feb 9, 2000
• 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 delivers predetermined volumes of IV solutions in a specific sequence using a disposable bag and restrictor set. Designed for SASH (Saline, Administration, Saline, Heparin) regimen; eliminates need for repeated needle/syringe access to IVADs. Pharmacist fills AutoDose bag with saline/heparin; main medication added as administration solution. System operates via mechanical flow control; delivers fluids at consistent rates/pressures (max 25 psi). Used in clinical settings; operated by healthcare professionals. Benefits include reduced IVAD access frequency and standardized delivery of flush/medication sequences.

Clinical Evidence

Bench testing only. Compatibility and stability of 0.9% Sodium Chloride and Heparin Lock Flush solutions verified per USP 24/NF 19 monographs. Performance testing confirmed consistent delivery of fluids in predetermined volumes and order, with infusion pressures ≤ 25 psi. Biocompatibility testing performed on fluid-contact materials.

Technological Characteristics

Mechanical infusion system consisting of a pump, disposable bag, and restrictor set. Operates via gravity/pressure-based flow control. Materials are biocompatible. No electronic energy source or software algorithms described.

Indications for Use

Indicated for sequential infusion of predetermined volumes of IV solutions, including 0.9% Sodium Chloride and Heparin Lock Flush, in patients requiring IVAD access using the SASH (Saline, Administration, Saline, Heparin) regimen.

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

• AutoDose™ Infusion System (K990889)

Submission Summary (Full Text)

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9 2000 FEB

# SECTION 15: SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR807.92

#### 15.1 SUBMITTER INFORMATION

- Company Name: Tandem Medical, Inc. a. 15910 Bernardo Center Dr. b. Company Address: Company Phone: [phone] C. Company Facsimile [phone] d. Contact Person: Albert Misajon Director, Regulatory Affairs And Quality Assurance Date Summary Prepared: November 10, 1999 e. DEVICE IDENTIFICATION 15.2 AutoDose™ Infusion System - For Trade/Proprietary Name: a.
- Classification Name: b.

AutoDose Infusion System

- For use with
S.A.S.H.

Infusion Pump 21 CFR 880.5725

#### IDENTIFICATION OF PREDICATE DEVICES 15.3

| Company | Device | 510(k) No. | Date Cleared |
|---------------------------|---------------------------|------------|--------------|
| Tandem<br>Medical<br>Inc. | AutoDose™ Infusion System | K990889 | June 3, 1999 |

#### 15.4 DEVICE DESCRIPTION

The AutoDose Infusion System was designed to infuse Intravenous solutions of predetermined volumes in a predetermined order based on the configuration of the disposable bag. The system is capable of infusing Intravenous (IV) solutions of the following volumes in this order:

| Chamber | Volume |
|---------|---------------------|
| 1 | $\leq$ 10 mls. |
| 2 | $\sim$ 25 – 120 mls |
| 3 | $\leq$ 10 mls. |

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4 < 5 mls.

A Pharmacist may decide to use the AutoDose Infusion System with an AutoDose Bag filled with 0.9% Sodium Chloride Injection and Heparin Lock Flush Solutions, USP in conjunction with an Administration IV fluid. (Refer to figure 1). In this configuration, the AutoDose would deliver the IV fluids using the deliver regimen, commonly known as SASH: (Saline, Administration, Saline, Heparin) and eliminate the need to use needles, syringes and access the IVAD (Intravenous Access Device) multiple times.

When the Pharmacist chooses to use the AutoDose Infusion system in this manner, an empty AutoDose Bag is filled with Saline and Heparin solutions drawn and prepared from the Pharmacy stores. After the prescription is filled with the main medication (i.e. Administration solution), the solutions are administered to the patient using the AutoDose Infusion System following the Directions for Use.

#### ાર્ટે રે SUBSTANTIAL EQUIVALENCE

The AutoDose Infusion System used with 0.9% Sodium Chloride Injection and Heparin Lock Flush, USP solution is substantially equivalent to the original AutoDose Infusion System.

- 1. There is no change in the device Indications for Use, that is, the general use infusion of intravenous solutions.
- 2. There is no difference in the design of the unfilled AutoDose Bag and Restrictor Set. The design of the AutoDose Pump is unchanged. The materials used in the AutoDose Infusion System are unchanged.
- 3. The performance of the AutoDose Infusion System is the same in terms of infusion flow rates and pressures. The affect on the performance of the system due to the viscosity of either Sodium Chloride or Heparin solutions is insignificant. The compatibility and stability of the system with the two solutions have been verified.

#### 15.6 INTENDED USE

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

#### 15.7 PERFORMANCE

- 1. Device and Solution Compatibility and Stability The AutoDose™ Infusion System was tested to verify that both 0.9% Sodium Chloride, Injection and Heparin Lock Flush Solutions, USP are both compatible and stable. The AutoDose Bag and AutoDose Restrictor Set were

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filled with these solutions and tests were performed on the solutions per the applicable USP 24/NF 19 monographs. The results confirmed that the solutions meet all requirements over the storage periods and conditions.

- 2. Solution Infusion
The AutoDose System infuses IV fluids at consistent rates and pressures. Performance testing of the AutoDose Infusion System verified that the Saline and Heparin fluids would be consistently delivered in predetermined order and volumes, and generated infusion pressures no greater than 25 psi.

### SAFETY

- 1. Biocompatibility
Safety testing performed on the AutoDose Bag and AutoDose Restrictor Set materials in fluid contact demonstrate they are biocompatible.

### HAZARDS ANALYSIS

A Product Hazards Analysis was performed on the AutoDose Infusion System used with Sodium Chloride and Heparin solutions. The compatibility and stability of the solutions were tested and verified. No new or increased risk factors were identified.

S.A.S.H. is a widely used and accepted IV solution administration practice, especially in the intermittent administration of IV solutions using IVADs (Intravenous Access Devices). The solutions, Sodium Chloride and Heparin, proposed for use with the AutoDose Infusion System have previously been cleared for this purpose by FDA review. The performance testing of the AutoDose Infusion System verified safe consistent infusion times and pressures.

Therefore the use of the AutoDose Infusion System with 0.9% Sodium Chloride, Injection and Heparin Lock Flush Solutions, USP is deemed safe and effective based on the information presented.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a bird or abstract human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2000 FEB

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

Re: K993832 Trade Name: AutoDose™ Infusion System Requlatory Class: II Product Code: MEB Dated: November 120, 1999 November 12, 1999 Received:

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 reqistration, 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 Regulations, Title 21, Parts 800 to 895. ಗಿ 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

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Page 2 - Mr. Misajon

the Federal Register. 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.

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

thy A. Ulatowski Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE

| 510(k) Number: | K993832 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | <i>AutoDose</i> ^TM Infusion System - For Use With S.A.S.H. |
| Indications for Use: | The <i>AutoDose</i> Infusion system is intended for sequential infusion of predetermined volumes of intravenous solutions including 0.9% Sodium Chloride Injection, (NaCl), and Heparin Lock Flush Solution, USP solutions. |

(PLEASE DO NOT WRITE BELOW TILIS LINE - CONTINUE ON ANOTHER PAGF. II: NEUDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

______________________________________________________________________________________________________________________________________________________________________________

Patrice Cuscente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use V

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Over-The-Counter Use