BRANNON PEDI PORTSYRINGE by JAMES K. BRANNON

The piston syringe, made available in a 3cc size, of this 510(k) notification, known as the Brannon Pedi PortSyringe (BPPS), is a combination of two legally marketed devices; (1) a piston syringe and (2) a blood specimen collection device (BSCD). The BSCD is integral with the plunger unit of the piston syringe with the BSCD communicating with the fluid chamber of the piston syringe via a centrally disposed and substantially narrow conduit. The fluid collection needle is sealed by a rubber sleeve. Appreciate that the needle is not manufactured by the applicant nor a manufacturing firm identified by the Applicant, but rather purchased from an FDA recognized manufacturer/distributor. Further appreciate that the BPPS is manufactured with identical material as the predicate piston syringe.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. The text describes a 510(k) premarket notification for the Brannon Pedi PortSyringe (BPPS), which aims to demonstrate substantial equivalence to a predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate, rather than providing extensive de novo clinical trial data with predefined acceptance criteria.

However, based on the available information, I can infer and extract some details.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it aims to demonstrate equivalence to predicate devices regarding safety and effectiveness.

Acceptance Criteria	Reported Device Performance
Safety:
Biocompatibility	Meets all biocompatibility standards of the predicate piston syringe and predicate BSCD. Manufactured with identical material.
Functionality (Aspiration and Fluid Transfer)	Allows aspiration of body fluids and subsequent transfer to vacuum specimen tubes/bottles. Functionally operates as a conventional syringe.
Patient Comfort	Improved patient comfort compared to traditionally cumbersome phlebotomy procedures.
Effectiveness/Efficacy:
Same Intended Use as Predicate	Intended use (fluid aspiration and transfer to vacuum specimen tubes and bottles) is identical to the predicate piston syringe and predicate BSCD.
Efficiency of Fluid Extraction	Improved efficiency in phlebotomy procedures.
Proficiency in Use	Improved proficiency in phlebotomy procedures.
Safe Usage in Clinical Setting	Used safely and effectively in a clinical trial.

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

Sample Size: Not explicitly stated. The study involved "intensive care patients requiring multiple blood samples." The exact number of patients or samples is not provided.
Data Provenance: Prospective clinical trial conducted at the University of Iowa Hospitals and Clinics (UIHC) in January 1989. (Country of origin: USA)

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

This information is not provided. The clinical trial report focuses on the safety and effectiveness of the device in practice, rather than establishing ground truth for a diagnostic task.

4. Adjudication Method for the Test Set

This information is not provided. No adjudication method is mentioned as the study was not focused on diagnostic accuracy requiring such methods.

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.

This was not an MRMC study. This device is a medical instrument (syringe), not an AI diagnostic tool. Therefore, the concept of human readers improving with AI assistance does not apply.

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

This was not a standalone algorithm study. The device is a physical instrument for fluid collection, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is primarily observational and clinical assessment of:

Safe operation: No adverse events, proper functioning.
Effective fluid collection: Successful aspiration and transfer of fluids.
Improved clinical outcomes/experience: Enhanced efficiency, proficiency, and patient comfort.
Equivalence to predicate device function.

It's not a diagnostic "ground truth" derived from pathology or expert consensus on images.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical instrument, not an AI model that requires a training set.

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

This information is not applicable, as there is no "training set" for this type of device.

Summary

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K960047

MAY 2 4 1996

February 21, 1996

James K. Brannon, M.D. (Contact Person) 5729 Canterbury Drive Culver City, CA 90230-6547 (310) 216-0207 Office (310) 216-0207 Fax (310) 898-2834 Pager

510(k) SUMMARY AMENDED K960047

Piston Svringe 80 FMF Name of Device: Common/Usual Name: Svringe Trade/Proprietary Name: Brannon Pedi PortSyringe

Sealing of the conduit with the fluid collection needle allows the pistonplunger unit and the barrel to function as a conventional syringe. Functional operation simply requires that one compression fits a hypodermic needle of any gauge to the distal nozzle tip of the barrel. One is then able to aspirate body fluids as the predicate piston syringe. After a given amount of fluid is aspirated into the barrel of the syringe, a minimal amount will suffice, a plurality of vacuum specimen tubes can be inserted into the tube-holder. The vacuum specimen tubes are advanced over the sleeved needle while stabilizing the tube-holder. In so doing, the vacuum within the specimen tube induces the piston-plunger unit to advance distally as the aspirated fluid is transferred to the vacuum specimen tube proximally.

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James K. Brannon, M.D. Brannon Pedi PortSyringe K960047 February 21, 1996 510(k) Summary Page 2

If one desires blood for culturing, the blood aspirate is transferred to a vacuum blood culture bottle by inserting the hypodermic needle directly into the vacuum bottle as is done using a predicate piston syringe.

Regarding blood collection with simultaneous intravenous catheter insertion, the BPPS is securely fitted to the female hub of a percutaneously inserted intravenous catheter. One should briefly aspirate to assure vein patency. A plurality of vacuum specimen tubes are then inserted into the tube-holder as described in this summary.

The technological differences of the BPPS include fluid aspiration through the distal nozzle tip of the syringe barrel and subsequent transfer of the fluid aspirate through the piston-plunger unit and into a plurality of vacuum specimen tubes. The predicate piston syringe only allows influx and efflux of a fluid through the distal nozzle tip of its syringe barrel.

Regarding safety and effectiveness, a cinical trial was conducted at the University of lowa Hospitals and Clinics (UIHC) in January of 1989. The title of the investigation was "Safe, Simple & Efficient Fluid Extraction", with a report made in the UIHC publication Pacemaker, October 1989. The patient population included intensive care patients requiring multiple blood samples for vacuum specimen tubes and vacuum blood culture bottles. Use of the investigational device, which required some assembly, was as outlined in this summary. Appreciate that the new device of this summary does not require any assembly other than the attachment of a hypodermic needle. It was shown in this investigation that traditionally cumbersome phiebotomy procedures were made safer with improved efficiency, proficiency, and patient comfort.

Further appreciate that the Brannon Pedi PortSyringe meets all of the biocompatibility and performance standards (efficacy) of the predicate piston syringe and predicate BSCD, both devices are legally marketed and manufactured by Becton-Dickinson. The Brannon Pedi PortSyringe is manufactured with identical material as the predicate piston syringe and there is no deviation from this standard.

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James K. Brannon, M.D. Brannon Pedi PortSyringe K960047 February 21, 1996 510(k) Summary Page 3

In conclusion, the above summary elucidates the physical characteristics which constitute the Brannon Pedi PortSyringe. The summary further shows by comparison that the intended use, fluid aspiration and transfer of the fluid aspirate to vacuum specimen tubes and bottles, is identical to the predicate piston syringe and the predicate BSCD. The clinical trial conducted at the UIHC demonstrates that the Brannon Pedi PortSyringe can be used safely and effectively in a manner identical to the predicate piston syringe and BSCD. Therefore, the Brannon Pedi PortSyringe of this 510(k) summary is claimed to be subtantially equivalent to a predicate piston syringe.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).