(337 days)
Not Found
No
The document describes an electro-mechanical device with a closed-loop flow control system based on sensors and pre-programmed settings derived from industry standards. There is no mention of AI or ML algorithms for decision-making, pattern recognition, or learning from data.
Yes
The device is an infusion pump system intended for the administration of fluids and medications, which directly relates to patient treatment and health management.
No
The device is described as an "electrical, external, volumetric drug compounder and infusion pump" intended for the "infusion (or administration) of fluids of medications" and "preparation (reconstitution, as required, and mixing) of single dose, intermittent, anti-infective and gastrointestinal medications." Its purpose is to deliver substances, not to diagnose conditions.
No
The device description explicitly states that the Sentry System includes an "electrical, external, volumetric drug compounder and infusion pump" and is an "electro-mechanical device incorporating a sterile disposable cassette." It also lists numerous hardware components like a bar code scanner, battery, and sensors. This clearly indicates it is not a software-only device.
Based on the provided text, the Bridge Sentry™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the system is for the "infusion (or administration) of fluids of medications" and the "preparation (reconstitution, as required, and mixing) of single dose, intermittent, anti-infective and gastrointestinal medications." This describes a system used for administering substances into a patient's body, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details an "electrical, external, volumetric drug compounder and infusion pump" with components for fluid delivery to a patient. This aligns with an infusion system, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring analytes (substances) in those samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device's function is to prepare and deliver medications to a patient, which falls under the category of therapeutic or drug delivery devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
The Bridge Sentry™ System is intended for the infusion (or administration) of fluids of medications. It is also intended for the preparation (reconstitution, as required, and mixing) of single dose, intermittent anti-infective and gastrointestinal medications. It is not intended for use with blood, blood products or lipids.
Product codes (comma separated list FDA assigned to the subject device)
FRN, FPA, LHI, FOX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test data has been included in the application to demonstrate substantial equivalence of the Sentry System.
Reconstitution: USP Constitution, USP Spectrophotometry. Manual reconstitution methods according to the drug manufacturers guidelines are used as the control to show that the Sentry System is equivalent or better. Result: Equivalent.
Mixing: USP Drug Assay High utilizing Performance Liquid Chromatography (HPLC) to measure the concentration accuracy of the mixture. Result: Concentration consistency is within 10 percent throughout a 50 ml mix cycle and mass balance of drug is ≥ 95 percent. Equivalent.
Delivery: ANSI/AAMI ID26-1992 guidelines for infusion devices. Result: The Sentry will conform to the ANSI/AAMI specification which is equivalent or better than the delivery performance of the predicates: Horizon Nxt and the OmniFlow 4000. Equivalent.
Rinse/Flush: USP Trace Drug Assay High Performance Liquid Chromatography (HPLC) to measure the residual drug concentration. Result: reduction in concentration is ≥ 97 percent. Equivalent.
Solution Materials Contact: ISO10993 Standard Physicochemical Tests: Elastomers and Physicochemical Tests: Plastics. Result: Acceptable results from standard tests. Equivalent.
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.
K820963, K946201, K933335, K900865, K904225, K852488, K900467, K904518
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
Image /page/0/Picture/0 description: The image shows the word "BRIDGE" with each letter separated from the others. Above the word is a series of vertical lines that are close together. The lines appear to be arranged in a circular or semi-circular pattern.
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
| /DEVICE NAME | 510(k) NUMBER |
|---|---|
| PRYOR Patient Pal IV | |
| Walker | K820963 procode FOX |
| Medical Specialties, Inc./ | |
| Infusion Stand | K946201 procode FOX |
| River Medical, Inc./ | |
| SmartDose Drug Vial | |
| Adapter | K933335 procode FRN |
| McGaw, Inc./ ADD-A-VIAL | |
| II Binary Connector | K900865 procode LHI |
| BAXA, Inc. / MicroMacro | |
| 12 Compounder | K904225 procode LHI |
Bridge Medical, Inc. 265 Santa Helena, Suite 210, Solana Beach, California 92075 Tel: 619 350 0100 Fax: 619 350 0115
1
| MANUFACTURER
| /DEVICE NAME | 510(K)NUMBER |
|---|---|
| IVAC, Inc. / Controlled | |
| Release Infusion | |
| System(CRIS) | K852488 procode FPA |
| Abbott Laboratories, Inc. / | |
| Therapist Infusion System | |
| 4000 (OmniFlow) | K900467 procode FRN |
| McGaw, Inc./ Volumetric | |
| 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:
-
- 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)
-
- Fluid Delivery The Bridge Sentry™ Administration Sets perform the fluid delivery. (21 CFR 880.5440 'Intravascular Administration Set'. Procode FPA)
-
- 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')
-
- 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')
-
- 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)
-
- 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')
125
2
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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3
| Table 1 - Solution Contact Components |
|---|
| Material Chemical Name |
| Monsanto LUSTRAN ABS 248-2002 White Resin, |
| Acrylonitrile-Butadiene-Styrene |
| BASF Terlux 2802 TR Transparent (equivalent |
| nomenclature 2802 TR Q161) ABS, Methyl |
| Methacrylate/ Acrylonitrile/Styrene/Butadiene |
| Polymer |
| Himont PROFAX PD-626 Polypropylene |
| Advanced Elastomer System's Santoprene |
| Thermoplastic Rubber, Medical Grade 281-64 |
| Advanced Elastomer System's Santoprene |
| Thermoplastic Rubber, Medical Grade 281-64 |
| Advanced Elastomer System's Santoprene |
| Thermoplastic Rubber, Medical Grade 281-64 |
| Advanced Elastomer System's Santoprene |
| Thermoplastic Rubber, Medical Grade 281-64 |
| Monsanto LUSTRAN ABS 248-2002 White Resin, |
| Acrylonitrile-Butadiene-Styrene |
| BASF Terlux 2802 TR Transparent (equivalent |
| nomenclature 2802 TR Q161) ABS, Methyl |
| Methacrylate/ Acrylonitrile/Styrene/Butadiene |
| Polymer |
| Dow Corning 360 Medical Fluid, 100 cs Viscosity, |
| 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
127
4
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
Mixing | pneumatic agitation
pneumatic agitation with
acoustic volume sensing (AVS)
volumetric control | manual - squeeze, shake
gravity, rotary peristaltic with
volumetric control |
|---------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Infusion Pump | Pneumatic actuation with AVS
volumetric control | Bellows actuated diaphragm
with volumetric control
(Horizon)
Piston Actuated with
volumetric control
(OmniFlow) |
| Rinse/Flush | pneumatic agitation with
acoustic volume sensing (AVS)
volumetric control | gravity with a known volume
(CRIS)
rotary peristaltic with control
volume (BAXA)
Piston Actuated with
volumetric control
(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 | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |||
| 的新闻 2019-08-19 11:15:14 10-03-20 11:15 11:15 11:15 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11:11 11 | |||
| Status Career States |
| Reconstitution | USP Constitution
USP
Spectrophotometry | Manual reconstitution
methods according to the
drug manufacturers
guidelines are used as the
control to show that the
Sentry System is equivalent
or better. | Equivalent |
|----------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
5
| Mixing | USP Drug Assay
High
utilizing
Performance Liquid
Chromatography
(HPLC) to measure the
concentration accuracy
of the mixture | Concentration consistency
is within 10 percent
throughout a 50 ml mix
cycle and mass balance of
drug is ≥ 95 percent. | Equivalent |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Delivery | AANSI/AAMI ID26-1992
guidelines for infusion
devices | The Sentry will conform to
the ANSI/AAMI specification
which is equivalent or better
than the delivery
performance of the
predicates: Horizon Nxt and
the OmniFlow 4000. | Equivalent |
| Rinse/Flush | USP Trace Drug Assay
High Performance
Liquid Chromatography
(HPLC) to measure the
residual drug
concentration | reduction in concentration is
≥ 97 percent | Equivalent |
| Solution
Materials
Contact | ISO10993 Standard
Physicochemical
Tests: Elastomers
and
Physicochemical
Tests: Plastics | Acceptable results from
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
6
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
7
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 (301) 594-4692. Additionally, for questions on Compliance at (3017 534-4022. "Ausur device, please contact Also, please note the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
8
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)
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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and the comments of