The BSI BIOTRANS Pressure Monitoring Kits are designed for use with BIOTRANS Sensor Bases. Kits containing integral 3- and 40 cc/hr flush device are designed for use in physiologic pressure measurements where continuous flow is required to maintain catheter patency. The 40 cchr flush devices are included in Kits designed for neonatal applications in conjunction with a properly calibrated fluid delivery purnp.

Device Description

The BIOTRANS Pressure Monitoring Systems consist of the sterile, single-use BIOTRANS Pressure Monitoring Kits and reusable BIOTRANS Reusable Sensor Bases and Monitor Adapter Cables. The single-use BIOTRANS Pressure Monitoring Kits provide the sterile fluid pathway components that deliver IV solution to maintain catheter patency via the administration set components. transducer dome assembly and extension set, and convey the hemodynamic waveform from the patient's catheter to the reusable sensor (provided separately). The pressure waveform is conveyed to the sensor via two compliant diaphragms which are brought into intimate contact during set up of the device by the end-user. All fluid contact occurs within the sterile single-use kit components.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Meet American National Standard for Blood Pressure Transducers (ANSI/AAMI BP22-1994) performance and safety requirements.	The BIOTRANS domes, when affixed to the BIOTRANS reusable sensor bases, meet American National Standard for Blood Pressure Transducers (ANSI/AAMI BP22-1994) performance and safety requirements. After exposure to pressures up to 4000 mm Hg, as required, BIOTRANS sensors meet accuracy and safety requirements, indicating adequate protection from overpressure.
Meet FDA and ISO biocompatibility requirements (ISO-10993-1 and G95-1).	All dome assembly materials meet the FDA and ISO biocompatibility requirements listed in ISO-10993-1 and G95-1. All other materials are either currently employed in legally marketed products with identical blood exposure, or are used in the fabrication of devices with a long history of safe and effective use for identical applications.
Meet tensile and leak test requirements listed in International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use.	All bonded joints meet tensile and leak test requirements listed in International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use.
History of complaints for administration sets (comparable to those marketed in US).	BSI's administration sets have been marketed in Asia and Europe for over 5 years with no history of complaints. They are of identical design to administration sets currently marketed in the US.

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

The document does not explicitly state the sample sizes used for testing each individual criterion (e.g., number of domes tested for pressure performance, number of materials tested for biocompatibility, number of bonded joints tested for tensile/leak).

Provenance: The document implies that parts of the testing were conducted to meet US (ANSI/AAMI) and international (ISO) standards. The administration sets' performance history is cited for "Asia and Europe." The testing appears to be retrospective in the sense that it evaluates the manufactured device against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. The performance data is based on engineering testing against established performance and safety standards (ANSI/AAMI, ISO) for medical devices, rather than expert interpretation of a test set.

4. Adjudication Method for the Test Set:

Not applicable. The evaluation is based on meeting predefined technical specifications and standards, not on expert consensus or adjudication of interpretations.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes a technical evaluation of the device's performance against established industry standards.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:

Yes, the study describes a standalone evaluation of the device's physical and functional performance (e.g., meeting pressure requirements, biocompatibility, leak tests) without human interaction influencing the core performance metrics.

7. The Type of Ground Truth Used:

The ground truth used consists of established performance and safety standards for medical devices, specifically:

American National Standard for Blood Pressure Transducers (ANSI/AAMI BP22-1994)
FDA and ISO biocompatibility requirements (ISO-10993-1 and G95-1)
International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical monitoring kit, not an AI/algorithm-based device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

AUG 20 1998

BSI BIOTRANS™ Pressure Monitoring Kits Premarket Notification

510k Summary BIOTRANS Pressure Monitoring Kits Prepared May 4, 1998

K981747

10 of 26

1. Submitted by

John Shulze Sunscope International, Inc. 20250 Acacia St., Suite 115 Newport Beach, CA 92660 Tel: (714) 553-8300 Fax: (714) 553-9129

2. Contact Person

John Shulze

3. Device Identification:

Trade Name	BIOTRANS Pressure Monitoring Kits
Common Name	Physiologic Pressure Monitoring Kits
Classification Name	Transducer, Blood Pressure, Extravascular

4. Predicate Device(s)

Medex, Inc.'s Medex MX-960, Medex MX-860; Utah Medical Products Inc.'s Pressure Monitoring Kits: Ohmeda's DTX Disposable Transducer Kits.

5. Device Description

The BIOTRANS Pressure Monitoring Systems consist of the sterile, single-use BIOTRANS Pressure Monitoring Kits and reusable BIOTRANS Reusable Sensor Bases and Monitor Adapter Cables.

The single-use BIOTRANS Pressure Monitoring Kits provide the sterile fluid pathway components that deliver IV solution to maintain catheter patency via the administration set components. transducer dome assembly and extension set, and convey the hemodynamic waveform from the patient's catheter to the reusable sensor (provided separately). The pressure waveform is conveyed to the sensor via two compliant diaphragms which are brought into intimate contact during set up of the device by the end-user.

All fluid contact occurs within the sterile single-use kit components.

6. Intended Use:

The BSI BIOTRANS Pressure Monitoring Kits are designed for use with the BIOTRANS Sensor Bases.

Kits containing integral 3- and 40 cc/hr flush devices are designed for use in physiologic pressure measurements where continuous flow is required to maintain catheter patency. The 40 cc/hr flush devices are included in Kits designed for neonatal applications in coniunction with a properly calibrated fluid delivery pump. Kits supplied without flush devices are intended for use in monitoring applications where no saline flush is required.

The predicate Medex Disposable Pressure Monitoring Kits are designed for use with the Medex Reusable Transducers.

The predicate Ohmeda and Utah Medical Products' Pressure Monitoring Kits which include 3cc flush devices are intended for use in physiologic pressure measurements which require continuous flow to maintain catheter patency. Those kits that employ a

{1}------------------------------------------------

BSI BIOTRANS™ Pressure Monitoring Kits Premarket Notification

30cc/hr flush device are intended for use in neonatal applications. This 30 cc flush device requires the use of a properly calibrated infusion pump.

Ohmeda's DTX Disposable Transducer Kit, Model TNF-R, does not include a flush device. No indications for use are indicated in its labeling for this model. The tacit assumption is that these kits are intended for pressure monitoring purposes where continuous flow is not required, or in conjunction with a stand-alone flush device.

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

The BIOTRANS Pressure Monitoring Kit domes incorporate a snap-fit configuration to ensure intimate mechanical contact of the dome diaphragm with the reusable sensor base diaphragm. The predicate Medex domes employ a bayonet mechanism for this purpose.

The BIOTRANS Kits are available in configurations that employ the silicone rubber component of the flush control device as a pressure relief mechanism. This mechanism is only available as an integral part of fast flush and flow control devices of the predicate devices.

Atthough the same generic materials and components are used for BIOTRANS and predicate devices, different formulations and vendors are used.

8. Assessment of Performance Data used to justify Substantial Equivalence Claim

The BIOTRANS domes, when affixed to the BIOTRANS reusable sensor bases, meet American National Standard for Blood Pressure Transducers (ANSI/AAMI BP22-1994) performance and safety requirements. These requirements are also met by the predicate Medex reusable pressure transducers.

After exposure to pressures up to 4000 mm Hg, as required in ANSI/AAMI BP22-1994, BIOTRANS sensors meet accuracy and safety requirements, indicating that the pressure relief mechanism provides the sensor with adequate protection from overpressure.

All dome assembly materials meet the FDA and ISO biocompatibility requirements listed in ISO-10993-1 and G95-1. respectively. All other materials are either currently employed in legally marketed products with identical blood exposure, or are used in the fabrication of devices with a long history of safe and effective use for applications identical to those indicated for the BIOTRANS Pressure Monitoring Kits.

All bonded ioints meet tensile and leak test requirements listed in International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use.

BSI's administration sets have been marketed in Asia and Europe for over 5 years with no history of complaints. They are of identical design to administration sets currently marketed in the US.

9. Conclusion:

The BIOTRANS Pressure Monitoring Kits meet performance and safety standards listed in American National Standard for Blood Pressure Transducers and are safe and effective for their intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are connected by flowing lines that resemble hair or fabric. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1998

Mr. John E. Shulze Directing Manager Sunscope International, Inc. 20250 Acacia Street, Suite 115 Newport Beach, CA 92660

Re: K981747 Biotrans™ Pressure Monitoring Kits Regulatory Class: II (two) Product Code: 74 DRS Dated: August 11, 1998 Received: August 11, 1998

Dear Mr. Shulze:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, and 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS

{3}------------------------------------------------

Paqe 2 - Mr. John E. Shulze

inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for guestions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Blake

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page__________________________________________________________________________________________________________________________________________________________________________

Kits

510(k) Number (if known):	K981747
Device Name:	BIOSENSORS INTERNATIONAL'S BIOTRANS TM PRESSURE MONITORING

Indications For Use:

The BSI BIOTRANS Pressure Monitoring Kits are designed for use with BIOTRANS Sensor Bases.

Kits containing integral 3- and 40 cc/hr flush device are designed for use in physiologic pressure measurements where continuous flow is required to maintain catheter patency. The 40 cchr flush devices are included in Kits designed for neonatal applications in conjunction with a properly calibrated fluid delivery purnp.

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

Concurrence of CORH, Office of Device Eveluation (ODE)

Division Signision Sigg .3. // // > (Sign-Off)
(Division Sign-Off)
Division of Cardiovascular. Respiratory.
Division of Cardiovascular. Respiraces
Des Neurological Devices Sign-Off)
(Division of Cardiov Division of Cardiovasor
Division of Cardiovasous
and Neurological Devices
And Neurological Devices and New Prescription of Also unloa OR IPer 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

1/1

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).