K Number
K070710
Device Name
ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM
Date Cleared
2007-04-19

(36 days)

Product Code
Regulation Number
870.2850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Accutrans Disposable Pressure Transducer Kit provides the fluid pathway components that are intended to convert the hemodynamic waveform from the patient's catheter, through the disposable pressure transducer with integrated pressure sensor, into electrical signals which can be displayed using separate monitoring equipment. The whole kit is fully disposable and consists of pressure monitoring lines and the Accutrans Disposable Pressure Transducer. Accutrans Disposable Pressure Transducer: The disposable pressure transducer is provided with or without an integral 3cc/hr or 30cc/hr flush devices. Kits with Succhi flush devices are designed exclusively for use with a infusion pump for neonatal and infant applications. The disposable pressure transducer, with the integrated pressure sensor, is intended for direct coupling to sterile catheters with fluid (saline) flows in contact with the patient bloodstream. Accutrans Disposable Pressure Transducer Kits are available for modular assembly of an IV pole-mount transducer organizer system, or for portable on-patient mounting. AccuTrans Pressure Monitoring Kits and AccuTrans Disposable Transducer are indirectly in contact with the blood path and hence, are supplied sterile and is intended for single use only. Pole-mounts, backplates and transducer adapter cables are accessories that are to be used externally outside the human body, and hence supplied non-sterile but hygienically clean. Between surgical cases of patient, suitable cleaning instructions should be followed to minimize cross contamination between patient and health worker.
Device Description
Biosensors's Accutrans Disposable Pressure Transducer System consists of a pressure monitoring kit with pressure tubing connected to the single-use disposable transducer with an integrated pressure sensor. The transducer can come with or without an integral flush device. The complete configuration can be pole-mounted or patient mounted and is provided sterile and non-pyrogenic.
More Information

No
The device description and intended use focus on converting physical pressure into electrical signals. There is no mention of AI, ML, or any form of data analysis or interpretation that would typically involve these technologies. The performance studies are standard functional and biocompatibility tests, not related to AI/ML model validation.

No
This device is a pressure transducer system that converts hemodynamic waveforms into electrical signals for display on monitoring equipment; it does not directly treat or restore health.

No

Explanation: The device converts hemodynamic waveforms into electrical signals for display by separate monitoring equipment. It is a component that facilitates monitoring, but it does not perform the diagnosis itself. Diagnosis would be made by a healthcare professional interpreting the displayed information.

No

The device description clearly states it is a "Disposable Pressure Transducer Kit" and includes physical components like pressure monitoring lines, a disposable pressure transducer with an integrated pressure sensor, and potentially flush devices. It converts a hemodynamic waveform into electrical signals, which is a hardware function.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to convert hemodynamic waveforms from a patient's catheter into electrical signals for display on monitoring equipment. This is a direct measurement of physiological parameters within the body, not an analysis of samples taken from the body.
  • Device Description: The description focuses on the physical components and their function in measuring pressure within the patient's circulatory system.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a disease state based on such analysis. The device is directly connected to the patient's bloodstream via a catheter.

Therefore, the Accutrans Disposable Pressure Transducer Kit is a medical device used for physiological monitoring, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

Accutrans Disposable Pressure Transducer Kit is intended to convert the hemodynamic waveform from the patient's catheter, through the disposable pressure transducer with integrated pressure sensor, into electrical signals which can be displayed using separate monitoring equipment. Accutrans Disposable Pressure Transducer is provided with or without an integral 3cchr or 30cchr flush devices. Kits with 30cc/hr flush devices are designed exclusively for use with an infusion pump for neonatal and infant applications,

The disposable pressure transducer, with the integrated pressure sensor, is intended for direct coupling to sterile catheters with fluid (saline) flows in contact with the patient bloodstream.

Product codes

DRS

Device Description

Biosensors's Accutrans Disposable Pressure Transducer System consists of a pressure monitoring kit with pressure tubing connected to the single-use disposable transducer with an integrated pressure sensor. The transducer can come with or without an integral flush device. The complete configuration can be pole-mounted or patient mounted and is provided sterile and non-pyrogenic.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

neonatal and infant applications

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

Not Found

Summary of Performance Studies

Functional performance tests were performed on the Accutrans transducer to evaluate the performance and the reliability of the transducer in accordance to recommended performance standards, IEC 60601-1-34 and ANSI/AAMI BP22-1994. Based on the test results which meet the acceptance criteria, the transducer is concluded to be safe and effective for its intended use.

Biocompatibility tests were performed in accordance to ISO10993-1 Part 1: Evaluation & Testing and USP 27 Biological Reactivity Tests. In Vivo. Based on the test results. the Accutrans Pressure transducer is biocompatible and safe for its intended use.

Key Metrics

Not Found

Predicate Device(s)

K981747, K841788

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.2850 Extravascular blood pressure transducer.

(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).

0

K070710
P1/3

| BIOSENSORS
INTERNATIONAL | PREMARKET NOTIFICATION
SPECIAL 510K |
|-----------------------------|------------------------------------------|
| | DISPOSABLE PRESSURE
MONITORING SYSTEM |
| Page | 1 of 3 |

SECTION 5 510K SUMMARY [As required by section 807.92(c)]

APR 1 9 2007

Prepared on 19 December 2006

1. Applicant Information

| Company Address: | Biosensors USA
20280 Acacia Street, Suite 300
Newport Beach, CA 92660, USA | |
|-----------------------|----------------------------------------------------------------------------------|--|
| Establishment Number: | 2084493 | |
| Contact Person: | Sara Toyloy
Phone: (949) 553 8300
Facsimile: (949) 553 9129 | |

2. Device Identification

Common Name:Disposable Pressure Monitoring System
Trade Name:Accutrans Disposable Pressure Monitoring System
Classification Name:Transducer, Blood-Pressure, Extravascular

3. Predicate Devices

    1. BIOTRANS™ PRESSURE MONITORING KIT (K981747)
    1. UTAH DISPOSABLE PRESSURE TRANSDUCER (K841788)

4. Device Description

Biosensors's Accutrans Disposable Pressure Transducer System consists of a pressure monitoring kit with pressure tubing connected to the single-use disposable transducer with an integrated pressure sensor. The transducer can come with or without an integral flush device. The complete configuration can be pole-mounted or patient mounted and is provided sterile and non-pyrogenic.

5. Intended Use

Accutrans Disposable Pressure Transducer Kit is intended to convert the hemodynamic waveform from the patient's catheter, through the disposable pressure transducer with integrated pressure sensor, into electrical signals which can be displayed using separate monitoring equipment. Accutrans Disposable Pressure Transducer is provided with or without an integral 3cchr or 30cchr flush devices. Kits with 30cc/hr flush devices are designed exclusively for use with an infusion pump for neonatal and infant applications,

Prepared and Updated by Sylvia ER Dated 19 December 2006

TFAT-FDA-0001-NC

1

| BIOSENSORS
INTERNATIONAL | PREMARKET NOTIFICATION
SPECIAL 510K | DISPOSABLE PRESSURE
MONITORING SYSTEM |
|-----------------------------|----------------------------------------|------------------------------------------|
| Page | 2 of 3 | |

The disposable pressure transducer, with the integrated pressure sensor, is intended for direct coupling to sterile catheters with fluid (saline) flows in contact with the patient bloodstream.

6. Summary of Technological Characteristics of Device in relation to Predicate Devices(s)

Biosensors plans to introduce a fully disposable pressure monitoring kit. Accutrans models, in addition to the current Biotrans™ models already cleared by 510K (K981747). The materials used in Accutrans transducer are the same as Biotrans™ transducer, however the Accutrans transducer incorporates an in-built sensor. The technology of Accutrans pressure transducer is substantially equivalence to the Utah Deltrans™ pressure transducer, which is also cleared by 510K (K841788).

The subject Accutrans models have a similar intended use and design construction with equivalent components as the predicated Biotrans™ and Deltrans™ models. The safety and effectiveness of the subject device models have been assessed and discussed further in Section 7 below.

7. Assessment of Performance Data used to justify Substantial Equivalence

Test Summary, In-vitro

Functional performance tests were performed on the Accutrans transducer to evaluate the performance and the reliability of the transducer in accordance to recommended performance standards, IEC 60601-1-34 and ANSI/AAMI BP22-1994. Based on the test results which meet the acceptance criteria, the transducer is concluded to be safe and effective for its intended use.

Test Summary, Biocompatibility

Biocompatibility tests were performed in accordance to ISO10993-1 Part 1: Evaluation & Testing and USP 27 Biological Reactivity Tests. In Vivo. Based on the test results. the Accutrans Pressure transducer is biocompatible and safe for its intended use.

8. Conclusion:

The Functional performance Tests and Biocompatibility tests have demonstrated that the Biosensors Accutrans Disposable Pressure Monitoring System is substantially equivalent to the predicate devices and is safe and effective for its intended use.

2

| BIOSENSORS
INTERNATIONAL | PREMARKET NOTIFICATION
SPECIAL 510K |
|------------------------------------------|----------------------------------------|
| DISPOSABLE PRESSURE
MONITORING SYSTEM | Page 3 of 3 |

510K Substantial Equivalence Decision-Making Tree

Image /page/2/Figure/3 description: This image is a flowchart titled "510(k) "Substantial Equivalence" Decision-Making Process (Overview)". The flowchart starts with the question "New Device is Compared to Marketed Device". The flowchart then asks a series of questions, including "Does New Device Have Same Intended Use?" and "Does New Device Have Technological Characteristics That Raise New Types of Safety or Effectiveness Questions?". The flowchart ends with the determination of either "Not Substantially Equivalent" or "Substantially Equivalent".

Decision to substantial Equivalence is based on 510(k) Memorandum #K86-3. 510(k). Questions in the decision path are evaluated as follow:

Yes. The intended use of the new range of models of the Accutrans transducer is the same as the Blotrans transducer currently listed,

Q2. Does New Device have Technological Characteristics that raise new types of Safety or effectiveness questions?

No. The new models were designed to have a built-in sensor unlike the current models but the additional sensors housing material and gel were evaluated for biocompalibility and functional performance and demonstrated no new safety and effectiveness issue arises due to technological difference.

Q3. Does descriptive or Performance information demonstrate equivalence?

Yes. The product description and the intended use on the instruction for Use enclosed in Appendix A between the subject models and predicated models demonstrate the substantial equivalence. The physical and performance characteristics evaluated in Table 1 in Section 5 - Description of the device also showed substantial equivalence between the subject device and predicated device.

Conclusion:

As according to the decision path, the Accutrans Disposable Pressure Monitoring kit can be submitted using substantial Equivalence.

Prepared and Updated by Sylvia ER Dated 19 December 2006

TFAT-FDA-0001-NC

Q1. Does New Device have same intended use?

3

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2007

Biosensors International c/o Sara Toyloy 20280 Acacia St. Suite 300 Newport Beach, CA 92660

Re: K070710

Trade/Device Name: Accutrans Disposable Pressure Monitoring System Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular blood pressure transducer Regulatory Class: Class II Product Code: DRS Dated: March 9, 2007 Received: March 14, 2007

Dear Ms. Toyloy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

4

Page 2 - Ms. Toyloy

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Zimmerman Jr

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

K0707/0

| BIOSENSORS

INTERNATIONALPREI
-----------------------------------

MARKET NOTIFICATION

SPECIAL 510K

DISPOSABLE PRESSURE

Page

SECTION 4 INDICATIONS FOR USE

Common Name: Trade Name:

DISPOSABLE PRESSURE MONITORING SYSTEM ACCUTRANS PRESSURE MONITORING SYSTEM

  1. Intended Use / Indications for Use:

Accutrans Disposable Pressure Transducer Kit provides the fluid pathway components that are intended to convert the hemodynamic waveform from the patient's catheter, through the disposable pressure transducer with integrated pressure sensor, into electrical signals which can be displayed using separate monitoring equipment. The whole kit is fully disposable and consists of pressure monitoring lines and the Accutrans Disposable Pressure Transducer.

Accutrans Disposable Pressure Transducer: The disposable pressure transducer is provided with or without an integral 3cc/hr or 30cc/hr flush devices. Kits with Succhi flush devices are designed exclusively for use with a infusion pump for neonatal and infant applications. The disposable pressure transducer, with the integrated pressure sensor, is intended for direct coupling to sterile catheters with fluid (saline) flows in contact with the patient bloodstream. Accutrans Disposable Pressure Transducer Kits are available for modular assembly of an IV pole-mount transducer organizer system, or for portable on-patient mounting.

AccuTrans Pressure Monitoring Kits and AccuTrans Disposable Transducer are indirectly in contact with the blood path and hence, are supplied sterile and is intended for single use only. Pole-mounts, backplates and transducer adapter cables are accessories that are to be used externally outside the human body, and hence supplied non-sterile but hygienically clean. Between surgical cases of patient, suitable cleaning instructions should be followed to minimize cross contamination between patient and health worker.

Prescription Use

(Per 21CFR801.109)

Over-the-Counter Use

(Optional Format 1-2-96)

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

Or

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Ammerman

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Ka20710