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.

AI/ML Overview

Here are the acceptance criteria and the study details for the Accutrans Disposable Pressure Monitoring System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
IEC 60601-1-34 (Performance Standards)	Meets the acceptance criteria based on functional performance tests.
ANSI/AAMI BP22-1994 (Performance Standards)	Meets the acceptance criteria based on functional performance tests.
ISO10993-1 Part 1: Evaluation & Testing (Biocompatibility)	Accutrans Pressure transducer is biocompatible.
USP 27 <88> Biological Reactivity Tests (Biocompatibility)	Accutrans Pressure transducer is safe for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size (number of devices) used for the functional performance and biocompatibility tests. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The tests seem to be performed against established technical standards (IEC, ANSI/AAMI, ISO, USP) rather than by human expert consensus or adjudication.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the evaluation relies on meeting established technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study was mentioned. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical performance and biocompatibility testing. There is no information about human readers or AI assistance.

6. If Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable as the device is a physical medical device (pressure transducer system), not an AI algorithm. Its performance is intrinsic to the device itself.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance was in the form of established performance standards (IEC 60601-1-34, ANSI/AAMI BP22-1994) for functional performance and biocompatibility standards (ISO10993-1 Part 1, USP 27 <88>) for safety.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reason as point 8.

Summary

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K070710
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BIOSENSORSINTERNATIONAL	PREMARKET NOTIFICATIONSPECIAL 510K
	DISPOSABLE PRESSUREMONITORING 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 USA20280 Acacia Street, Suite 300Newport Beach, CA 92660, USA
Establishment Number:	2084493
Contact Person:	Sara ToyloyPhone: (949) 553 8300Facsimile: (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

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

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BIOSENSORSINTERNATIONAL	PREMARKET NOTIFICATIONSPECIAL 510K	DISPOSABLE PRESSUREMONITORING 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 <88> 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.

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BIOSENSORSINTERNATIONAL	PREMARKET NOTIFICATIONSPECIAL 510K
DISPOSABLE PRESSUREMONITORING 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?

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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

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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

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K0707/0

BIOSENSORSINTERNATIONAL	PREI
-----------------------------	------

MARKET NOTIFICATION

SPECIAL 510K

DISPOSABLE PRESSURE

Page

SECTION 4 INDICATIONS FOR USE

Common Name: Trade Name:

DISPOSABLE PRESSURE MONITORING SYSTEM ACCUTRANS PRESSURE MONITORING SYSTEM

Intended Use / Indications for Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Ammerman

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

Regulation Number and Section

§ 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).