BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5

K973593 · Bridge Medical, Inc. · FRN · Aug 25, 1998 · General Hospital

Device Facts

• Record ID: K973593
• Device Name: BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5
• Applicant: Bridge Medical, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Aug 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bridge Sentry™ System is intended for the infusion (or administration) of fluids or medications. It is also intended for the preparation (reconstitution, as required, and mixing) of single dose, intermittent, anti-infective and gastrointestinal drugs. The system is not intended for use with blood, blood products or lipids.

Device Story

Sentry System is an electro-mechanical volumetric drug compounder and infusion pump; includes bedside unit, pharmacy utility, and sterile disposable administration sets. Inputs: patient, user, and drug identification via bar code scan or menu selection; pharmacy presets downloaded to device. Operation: proprietary Acoustic Volume Sensor (AVS) and precision fluid impedance form closed-loop flow control; pneumatic actuation manages fluid transfer, reconstitution, mixing, and rinsing/flushing. Output: accurate, continuous fluid delivery to patient. Used in clinical settings by healthcare providers. System detects occlusions and air-in-line; minimizes medication errors by cross-referencing patient/drug data with pharmacy presets. Benefits: automated, accurate drug preparation and delivery; reduced risk of drug interactions via sequential flushing.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via: USP reconstitution protocols; HPLC drug assay for mixing concentration accuracy (within 10% consistency, mass balance ≥ 95%); ANSI/AAMI ID26-1992 guidelines for infusion delivery; HPLC trace drug assay for rinse/flush efficacy (residual concentration reduction ≥ 97%); and ISO 10993 physicochemical testing for solution contact materials.

Technological Characteristics

Electro-mechanical volumetric pump; pneumatic actuation; Acoustic Volume Sensor (AVS) for closed-loop flow control. Materials: ABS (Monsanto Lustran, BASF Terlux), Polypropylene (Himont Profax), Thermoplastic Rubber (Santoprene 281-64), Polydimethylsiloxane (Dow Corning 360). Flow rate: 1.0-1000.0 ml/hr; accuracy +/- 5%. Connectivity: bar code scanner, data acquisition computer, pharmacy utility download. Power: 12V sealed lead acid battery. Sterilization: sterile disposable cassettes.

Indications for Use

Indicated for the infusion of fluids or medications and the preparation (reconstitution and mixing) of single dose, intermittent, anti-infective, and gastrointestinal drugs. Contraindicated for use with blood, blood products, or lipids.

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

• PRYOR Patient Pal IV Walker (K820963)
• Medical Specialties, Inc. Infusion Stand (K946201)
• River Medical, Inc. SmartDose Drug Vial Adapter (K933335)
• McGaw, Inc. ADD-A-VIAL II Binary Connector (K900865)
• BAXA, Inc. MicroMacro 12 Compounder (K904225)
• IVAC, Inc. Controlled Release Infusion System (CRIS) (K852488)
• Abbott Laboratories, Inc. Therapist Infusion System 4000 (OmniFlow) (K900467)
• McGaw, Inc. Volumetric Infusion Pump and IV Set (K904518)

Submission Summary (Full Text)

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## 510(K) SUMMARY

## 1. Submitter Information

09/09/97

Bridge Medical, Inc. 265 Santa Helena Suite 210 Solana Beach, CA 92075

Contact Person: Donald V. Canal Dolfalu V. Ganal
Director Product Development and Manufacturing Phone: (972) 964 - 6740 (972) 964 - 7524 FAX:

### 2. Name of Device

| Trade/Proprietary Name: | Bridge Sentry™ Bedside Unit, Bridge Sentry Pharmacy Utility and Bridge Sentry Administration Sets (collectively referred to as the Sentry System). |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | External Infusion Pump and Administration Set |
| Classification Name: | Infusion Pump; Intravascular Administration, Set, Compounder |

#### 3. Predicate Devices

The predicate devices are shown in the table below:

| MANUFACTURER<br>/DEVICE NAME | 510(k) NUMBER |
|--------------------------------------------------------|---------------------|
| PRYOR Patient Pal IV<br>Walker | K820963 procode FOX |
| Medical Specialties, Inc./<br>Infusion Stand | K946201 procode FOX |
| River Medical, Inc./<br>SmartDose Drug Vial<br>Adapter | K933335 procode FRN |
| McGaw, Inc./ ADD-A-VIAL<br>II Binary Connector | K900865 procode LHI |
| BAXA, Inc. / MicroMacro<br>12 Compounder | K904225 procode LHI |

Bridge Medical, Inc. 265 Santa Helena, Suite 210, Solana Beach, California 92075 Tel: [phone] Fax: [phone]

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| MANUFACTURER<br>/DEVICE NAME | 510(K)NUMBER |
|-----------------------------------------------------------------------------|---------------------|
| IVAC, Inc. / Controlled<br>Release Infusion<br>System(CRIS) | K852488 procode FPA |
| Abbott Laboratories, Inc. /<br>Therapist Infusion System<br>4000 (OmniFlow) | K900467 procode FRN |
| McGaw, Inc./ Volumetric<br>Infusion Pump and IV Set. | K904518 procode FRN |

The Bridge Sentry™ Bedside Unit includes six functions which are listed below with the appropriate product code:

- 1) Infusion Pump The Bridge Sentry Bedside Unit has the capability to control the delivery of IV drugs to the patient. These drugs may be standard IV drugs and solutions, pharmacy admixtures and drugs that require reconstitution, and dilution. (21 CFR 880.5725 'Infusion Pump'. Procode FRN)
- 2) Fluid Delivery The Bridge Sentry™ Administration Sets perform the fluid delivery. (21 CFR 880.5440 'Intravascular Administration Set'. Procode FPA)
- 3) Vial access/Reconstitution The Bridge Sentry Bedside Unit provides access for fluid to transfer from a diluent source to a drug vial. Reconstitution is the process of dissolving a lyophilized or powdered drug into a diluent. (21 CFR 880.5440 'Intravascular Administration Set'. Procode LHI - 'Fluid Transfer Device')
- 4) Mixing The Sentry performs fluid transfer in order to mix two fluids into a homogeneous concentration. (21 CFR 880.5440 'Intravascular Administration Set'. Procode LHI - 'Fluid Transfer Device')
- 5) Rinse/Flush The Sentry has the capability to rinse/flush the fluid path to allow sequential rinsing/flush and delivery of multiple drug doses through the same disposable to minimize the possibility of drug interactions. (21 CFR 880.5440 'Intravascular Administration Set'. Procode FPA)
- 6) Infusion Stand The Sentry contains an IV pole to be used for mounting and transporting IV pumps. (unclassified pre-amendment product. Procode FOX 'Infusion Stand')

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#### 4. Description of the Subject Device

The Bridge Sentry™ Bedside Unit. The Bridge Sentry Pharmacy Utility and the Bridge Sentry™ Administration Sets are collectively referred to as the Sentry System. The Sentry System includes an electrical, external, volumetric drug compounder and infusion pump. The administration sets contain a dedicated cassette that is compatible with the Bridge Seotry Bedside Unit.

The Sentry is an electro-mechanical device incorporating a sterile disposable cassette with ancillary fluid delivery tubing and components. The Sentov stores drug delivery preset information for reconstitution, dilution and delivery. These presets are based on industry standards derived from drug labeling. The preset information is downloaded into each Sentry device. The Sentry requires identification of the patient, the user, the drug, and the dillo oching part of the setup operation. The identification may be accomplished via bar code scan or menu selection. The Sentry uses the identification information in conjunction with the pharmacy presets to minimize emars and capture drig event information.

The Sentry System provides accurate and continuous flow of fluids to the patient. The device operates using a proprietary Acoustic Volume Sensor, a form of actuation pressure and a precision fluid impedance in the set to for a closed loop flow control system. The system detect occlusions in the patient line downstream and determines if sufficient fluid can be drawn from an upstream source to continue patient delivery. The system also detects air in line and when possible eliminates the air.

The administration sets are sterile, and for single patient use. The Administration Sets are composed of a unique cassette and various combinations of other standard administration set components including tubing, filters, spikes, drip chambers, injection sites, clamps, caps or protectors, and luer connectors.

The Sentry Cassette contains 10 valves to control fluid flow, a precision control orifice for flow control, a front cover, rear cover, mid-body, an inlet port, outlet port, a luer connection, and three drug vial spikes.

The Sentry device contains a System Management Module, a Fluid Delivery Module, bar code scanner, infusion stand base and pole(s), vial attachment mechanism, battery, pharmacy utility, air in line sensor, and a data acquisition computer.

The solution contact materials are listed in Table 1 below:

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| Table 1 - Solution Contact Components |
|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Material Chemical Name |
| Monsanto LUSTRAN ABS 248-2002 White Resin,<br>Acrylonitrile-Butadiene-Styrene |
| BASF Terlux 2802 TR Transparent (equivalent<br>nomenclature 2802 TR Q161) ABS, Methyl<br>Methacrylate/ Acrylonitrile/Styrene/Butadiene<br>Polymer |
| Himont PROFAX PD-626 Polypropylene |
| Advanced Elastomer System's Santoprene<br>Thermoplastic Rubber, Medical Grade 281-64 |
| Advanced Elastomer System's Santoprene<br>Thermoplastic Rubber, Medical Grade 281-64 |
| Advanced Elastomer System's Santoprene<br>Thermoplastic Rubber, Medical Grade 281-64 |
| Advanced Elastomer System's Santoprene<br>Thermoplastic Rubber, Medical Grade 281-64 |
| Monsanto LUSTRAN ABS 248-2002 White Resin,<br>Acrylonitrile-Butadiene-Styrene |
| BASF Terlux 2802 TR Transparent (equivalent<br>nomenclature 2802 TR Q161) ABS, Methyl<br>Methacrylate/ Acrylonitrile/Styrene/Butadiene<br>Polymer |
| Dow Corning 360 Medical Fluid, 100 cs Viscosity,<br>Polydimethylsiloxane |

#### Device Specifications:

Flow Rates: 1.0 - 1000.0 ml/hr Volume To Be Infused: 0.1 to 9999.9 ml Volumetric Accuracy: +/- 5 percent Battery: 12 Volt - 10 amp hour sealed lead acid Battery Infusion Time: 4 hour at 100 ml/hr Occlusion Pressure: 150 mmHg and 500 mmHg Fluid Types: All standard IV drugs (Excluding Blood, Blood Products and Medications containing Lipids)

#### 5. Intended Use

The Bridge Sentry™ System is intended for controlled intravenous delivery and mixing (as required) of drugs. The Bridge Sentry System is also intended for the preparation (reconstitution, as required, and mixing) of single dose, intermittent, anti-infective and gastrointestinal drugs.

#### 6. Technological Characteristics

The Sentry System is substantially equivalent to the predicate devices. The differences are in the areas of the fluid movement and monitoring, and

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electronic control of processes that are performed manually by the predicate devices. Refer to Table 2 for a list of differences between the subject device and the predicate devices.

| Vial Access/ Reconstitution<br>Mixing | pneumatic agitation<br>pneumatic agitation with<br>acoustic volume sensing (AVS)<br>volumetric control | manual - squeeze, shake<br>gravity, rotary peristaltic with<br>volumetric control |
|---------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Infusion Pump | Pneumatic actuation with AVS<br>volumetric control | Bellows actuated diaphragm<br>with volumetric control<br>(Horizon)<br>Piston Actuated with<br>volumetric control<br>(OmniFlow) |
| Rinse/Flush | pneumatic agitation with<br>acoustic volume sensing (AVS)<br>volumetric control | gravity with a known volume<br>(CRIS)<br>rotary peristaltic with control<br>volume (BAXA)<br>Piston Actuated with<br>volumetric control<br>(OmniFlow) |
| Fluid Contact Materials | Refer to Table 1 | Refer to Table 1 |

| Table 2 Technological Differences | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| and the country of the country of the country of the first of the first of the first and the first and the first and the first and the first and the first and the first and t | |

### 7. Performance Test Data Summary

Test data has been included in the application to demonstrate substantial equivalence of the Sentry System. Table 3 contains a summary of the test method, criteria and test results.

| | | Table 3 - Performance Testing to Support Substantial Equivalence | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | |
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| Reconstitution | USP<1> Constitution<br>USP<851><br>Spectrophotometry | Manual reconstitution<br>methods according to the<br>drug manufacturers<br>guidelines are used as the<br>control to show that the<br>Sentry System is equivalent<br>or better. | Equivalent |
|----------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|

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| Mixing | USP Drug Assay<br>High<br>utilizing<br>Performance Liquid<br>Chromatography<br>(HPLC) to measure the<br>concentration accuracy<br>of the mixture | Concentration consistency<br>is within 10 percent<br>throughout a 50 ml mix<br>cycle and mass balance of<br>drug is ≥ 95 percent. | Equivalent |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Delivery | AANSI/AAMI ID26-1992<br>guidelines for infusion<br>devices | The Sentry will conform to<br>the ANSI/AAMI specification<br>which is equivalent or better<br>than the delivery<br>performance of the<br>predicates: Horizon Nxt and<br>the OmniFlow 4000. | Equivalent |
| Rinse/Flush | USP Trace Drug Assay<br>High Performance<br>Liquid Chromatography<br>(HPLC) to measure the<br>residual drug<br>concentration | reduction in concentration is<br>≥ 97 percent | Equivalent |
| Solution<br>Materials<br>Contact | ISO10993 Standard<br>Physicochemical<br>Tests: Elastomers<br>and<br>Physicochemical<br>Tests: Plastics | Acceptable results from<br>standard tests | Equivalent |

## 8. Substantial Equivalence Conclusion

The substantial equivalence claim between the Sentry System and the 1110 Substantial on supported by the descriptive information and predioute devices to cappens the system, which met the criteria for predicate equivalence for all functional areas.

#### 9. SIgnature of Applicant

Bridge Medical, Inc. Donald V. Canal Director Product Development and Manufacturing

Signature: All V. Cul Date: 9/9/97

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure, represented by three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1998

Mr. Donald V. Canal Director of Manufacturing and Product Development Bridge Medical, Incorporated 265 Santa Helena, Suite 210 Solana Beach, California 92075

Re : K973593

> Trade Name: Bridge Sentry Bedside Unit, Bridge Sentry™ Administration Set Regulatory Class: II Product Code: ERN Dated: July 21, 1998 Received: July 23, 1998

Dear Mr. Logan:

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 interetate 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 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 (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. ਰ 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Canal

the Act for devices under the Electronic Product Radiation the Act for devices under the becoment of regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your 510\x7 premaince of your device to a legally
finding of substantial equivalence of classification for your marketed predicate device results in a classification for your marketed predicate device resures in a claboration.
device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling If you debire apective active active additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on Compliance at (3017 534-4022. "Ausur device, please contact Also, please note the Office of Compliance at [phone]. the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be Information on your respon 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,

S. Antman for

Timothy A. Ulatowski 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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# Indications For Use Statement

K973593 510(k) Number (if known):

Device Name: Bridge Sentry™ System

#### Indications For Use:

The Bridge Sentry™ System is intended for the infusion (or administration) of fluids of The Bridge Sentry'' System is intended for the preparation (reconstitution, as required, and medications. It is also intended for the preparation (resemblication) in thended for use with blood, blood products or lipids.

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Proscription Use __

510(k) Number __

Over-The-Counter Use_

Lalauria Cuscenita
Whirlen Star, S.C.

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