The BIOPORT System is designed for needle-free access of undiluted blood from arterial catheters (typically 16 or 18 Ga.) not longer than 6.4 cm (2 - ½ "). Diluted, heparinized blood is drawn beyond the BIOPORT into the BPS Reservoir Syringe to permit needle-free withdrawal of undiluted blood from the BIOPORT using a blood sampling syringe fitted with the Blunt Cannula Adapter (BPN). After the undijuted sample is drawn, the heparinized, diluted blood in the Reservoir Syringe is reinfused into the patient to reduce fluid loss.

Device Description

The BIOPORT System is composed of a 3-way stopcock; BIOPORT (a pre-slit latex rubber septum housed in a clear, rigid, plastic housing); a 3 cc Reservoir Syringe with protective dust cover over the plunger shaft to minimize contamination of Syringe contents by dust particles; and high-pressure Extension Tubing. The BIOPORT and stopcock are bonded 12 and 14 inches, respectively, from the distal male Luer lock connector of the pressure monitoring tubing. The 3-cc Luer lock Reservoir Syringe is pre-attached to the 3-way stopcock. The stopcock, BIOPORT, and Reservoir Syringe are located on a rigid plastic support equipped with a Velcro-type fastener for mounting on a patient's arm.

A Blunt Cannula Adapter (BPN)- terminating in a female Luer lock connector at one end for attachment to the male Luer of a sampling syringe, and a hollow, blunt plastic cone at the other end for insertion into the pre-slit septum of the BIOPORT- is provided separately to effect needle-free blood access via the BIOPORT.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the BIOPORT™ Closed Blood Sampling System. As such, the information provided is a summary of the device's characteristics and its equivalence to predicate devices, rather than a detailed clinical study report with specific acceptance criteria and performance metrics in the way one might expect for a diagnostic or AI-driven device.

Therefore, many of the requested points (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance) are not applicable or cannot be determined from the provided text, as this type of submission focuses on demonstrating substantial equivalence to existing devices and adherence to recognized standards, rather than proving a specific performance level of a novel algorithm or diagnostic output.

However, I can extract the information that is present and explain why other points are not.

BIOPORT™ Closed Blood Sampling System Premarket Notification (K983372)

This submission describes a Class II medical device, the BIOPORT™ Closed Blood Sampling System, which is intended for closed, needle-free access of arterial blood from pressure monitoring catheters. The primary goal of the submission is to demonstrate substantial equivalence to predicate devices and compliance with applicable standards, rather than to present a performance study with specific acceptance criteria as you might see for a diagnostic AI.

1. A table of acceptance criteria and the reported device performance

Performance Aspect	Acceptance Criteria (Stated Requirements/Standards)	Reported Device Performance (as per submission)
Biocompatibility	Meet ISO 10993 and FDA's G95-1 Memorandum.	All components meet ISO 10993 and FDA's G95-1 Memorandum biocompatibility requirements.
Tensile Strength & Leakage Resistance	Meet or exceed requirements listed in International Standard ISO 8536-4 Infusion equipment for medical use - Part 4: Infusion sets for single use (now an FDA Consensus Standard).	Performance data demonstrate that the tensile strength and resistance to leakage under pressure of the BIOPORT System components meet or exceed the requirements listed in ISO 8536-4.
Frequency Response (Bandwidth)	Acceptable (>200 Hz) as evaluated in accordance with BP 22, American National Standard for Blood Pressure Transducers.	The bandwidth of the BIOTRANS Reusable Sensor Base with the BIOPORT sampling site was found to be acceptable (>200 Hz).
Reservoir Syringe Adequacy (Expulsion)	Adequate stop at the rear of the syringe barrel to minimize the potential for inadvertent expulsion of the plunger during anticipated hydrostatic pressures.	Tests of the Reservoir Syringes at hydrostatic pressures anticipated in the use of the device demonstrate the adequacy of the stop at the rear of the syringe barrel to minimize the potential for inadvertent expulsion of the plunger.
Needle-Free Access (Effectiveness)	(Implied: Functions as intended for needle-free blood sampling via the BIOPORT using a sampling syringe fitted with the Blunt Cannula Adapter (BPN), similar to predicate devices).	The identical BIOPORT access site and Blunt Cannula Adapter are used in the predicate Utah Medical Products' ABC and have been cleared for identical purposes.
Substantial Equivalence	Demonstrated equivalence to predicate devices (Utah Medical Products Inc.'s ABC Pressure Monitoring Kits; Baxter Healthcare Corporation's VAMP Venous/Arterial Blood Management Protection; Migada Blunt Cannula) or meets requirements of applicable, published, well-accepted standards.	Data gathered by Biosensors indicate that the performance of Biosensors BIOPORT System is equivalent to that of the predicate devices or meets the requirements of applicable, published, well-accepted standards. (FDA agrees and clears the device).

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. The document references "Performance data" and "Tests," but does not provide details on the number of units tested, the number of measurements taken, or specific sample sizes.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies appear to be internal testing conducted by Biosensors International.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. This device submission does not involve expert-established ground truth in the context of diagnostic interpretation. The "ground truth" here is adherence to engineering standards and functional performance metrics.

4. Adjudication method for the test set

Not applicable / Not provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies with subjective interpretations, which is not relevant for this device's performance assessment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical accessory (blood sampling system), not an AI-driven or diagnostic imaging system that would involve human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm. Its performance is assessed through physical and functional testing against established engineering and biocompatibility standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" is based on objective engineering and biological standards and requirements. These include:
- International Standard ISO 10993 (Biocompatibility)
- FDA G95-1 Memorandum (Biocompatibility)
- International Standard ISO 8536-4 (Tensile strength, leakage resistance)
- BP 22, American National Standard for Blood Pressure Transducers (Frequency response/bandwidth)
- Functional testing to ensure syringe plunger retention under pressure.
- Demonstration of substantial equivalence to already cleared predicate devices.

8. The sample size for the training set

Not applicable. This device does not utilize machine learning or AI, and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML algorithm, there is no corresponding ground truth to be established for it.

Summary

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K983372

Biosensors International's BIOPORT™ Closed Blood Sampling System Premarket Notification

9/21/98

510k SUMMARY

10 of 21

510k SUMMARY

FEB 5 1999 BIOPORT Closed Blood Sampling System Prepared August 21, 1998

1. Submitted by

John Shulze Sunscope International, Inc. 20250 Acacia St., Suite 115 Newport Beach, CA 92660 Tel: (949) 553-8300 Fax: (949) 553-9129

2. Contact Person

John Shulze

3. Device Identification

Trade Name Common Name Classification Name BIOPORT System Arterial Blood Access System Continuous Flush Catheter

4. Predicate Device(s)

Utah Medical Products Inc.'s ABC Pressure Monitoring Kits; Baxter Healthcare Corporation's VAMP Venous/Arterial Blood Management Protection; Migada Blunt Cannula.

5. Device Description

6. Intended Use

BIOPORT Systems are designed for closed, needle-free access of arterial blood from pressure monitoring catheters.

The BIOPORT System is designed for needle-free access of undiluted blood from arterial catheters not longer than 6.4 cm (2 - ½ "). Diluted, heparinized blood is drawn beyond the BIOPORT into the BPS Reservoir Syringe to permit needle-free withdrawal of undiluted blood from the BIOPORT using a sampling syringe fitted with the Blunt Cannula Adapter (BPN). After the undiluted sample is drawn, the diluted, heparinized blood in the Reservoir Syringe is reinfused into the patient to reduce fluid loss.

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Biosensors International's BIOPORT™ Closed Blood Sampling System Premarket Notification

9/21/98

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

The configuration of the BIOPORT System with attached Reservoir Syringe is similar to that of the predicate arm-mounted VAMP (K885281). Heparinized, diluted blood is drawn into the VAMP reservoir to dear the BIOPORT and distal volume in the VAMP. It is drawn into BIOPORT's Reservoir Syringe to clear heparinized, diluted blood from the BIOPORT and volume distal to the BIOPORT in the BIOPORT System. In both systems the heparinized, diluted blood is returned to the patient.

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

All components meet ISO 10993 and FDA's G95-1 Memorandum biocompatibility requirements.

Performance data demonstrate that the tensile strength and resistance to leakage under pressure of the BIOPORT System components (all components bonded to tubing and the tubing itself) meet or exceed the requirements listed in International Standard ISO 8536-4 Infusion equipment for medical use- Part 4: Infusion sets for single use. This document is now accepted by the FDA as a Consensus Standard.

The frequency response (bandwidth) of the BIOTRANS Reusable Sensor Base with the BIOPORT sampling site present in the fluid pathway was evaluated in accordance with BP 22, American National Standard for Blood Pressure Transducers. The bandwidth was found to be acceptable (>200 Hz).

The identical BIOPORT access site and Blunt Cannula Adapter are used in the predicate Utah Medical Products' ABC and have been cleared for identical purposes.

Tests of the Reservoir Syringes at hydrostatic pressures anticipated in the use of the device demonstrate the adequacy of the stop at the rear of the svringe barrel to minimize the potential for inadvertent expulsion of the plunger.

9. Conclusion

Data gathered by Biosensors indicate that the performance of Biosensors BIOPORT System is equivalent to that of the predicate devices or meets the requirements of applicable, published, well-accepted standards.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB

Phil Triolo, Ph.D. Principal C/O PT Consulting Sunscope International, Inc. 148 So. 1200 East 84102 Salt Lake City, UT

Re: K983372 Trade Name: BIOPORT System Requlatory Class: II Product Code: DRS December 21, 1998 Dated: Received: December 22, 1998

Dear Dr. Triolo:

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. 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 A substantially equivalent determination assumes compliance with 895. 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 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 Reqister. Please note: this response to your premarket

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Page 2 - Dr. Phil Triolo

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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions 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" (21CFR 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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510 (k) Number (if known) K 983372

Device Name Biosensors Internationals' BIOPORT Closed Blood Sampling System

Indications for Use

The BIOPORT System is designed for closed, needle-free access of arterial blood from pressure monitoring catheters.

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

	Concurrence of CDRH, Office of Device Evaluation

	(Division Sign-Off)
		Division of Cardiovascular, Respiratory,
	and Neurological Devices
510(k) Number	K983372
Prescription Use		OR	Over-the Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-

(Optional Format 1-2-96)

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).