BRANNON ARTERIO-VENOUS PORTSYRINGE by VASCULAR LOGICS, INC.

The piston syringe, made available in a 6cc size, of this 510(k) notification, known as the Brannon Arterio-Venous PortSyringe, A-VPS, is a combination of two legally marketed devices: (1) a piston syringe, and (2) a blood specimen collection device, BSCD. Additionally, the A-VPS is identical to the Brannon PortSyringe K960049, except the A-VPS includes a centrally disposed inner cannula within its barrel. The BSCD is integral with the plunger unit, with the BSCD communicating with the inner lumen of an attached indwelling catheter via the centrally disposed narrow conduit of the plunger and the centrally disposed inner-cannula within the barrel of the syringe. The fluid collection needle is sealed by a rubber sleeve.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Brannon Arterio-Venous PortSyringe (A-VPS):

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the primary function of the A-VPS is to aspirate fluid, keep it separate from blood being collected, and then transfer blood into vacuum specimen tubes. The acceptance criteria and performance are largely implied through comparison to predicate devices and bench testing results. Specific numerical acceptance criteria are not explicitly stated.

Acceptance Criteria (Implied/Derived)	Reported Device Performance
Functional Equivalence:
1. Ability to aspirate fluid into the syringe barrel	"One is then able to aspirate the sodium-heparin solution into the barrel of the syringe, as with the predicate piston syringes."
2. Ability to transfer whole blood to vacuum specimen tubes	"The vacuum within the specimen tube induces whole blood to flow from the inner lumen of the indwelling catheter... and into the vacuum specimen tube."
3. Separation of aspirated fluid (e.g., sodium-heparin) from blood being collected	"The bench investigation shows that a heparin fluid aspirated into the barrel of the syringe will remain separate from a fluid within the plunger-conduit."
4. Hermetic seal at piston inner-cannula interface	"The ability of the rubber piston to maintain a hermetic seal at the level of the piston inner-cannula interface was demonstrated to be effective, as evidenced by the absence of detectable mixing of the two fluids..."
5. Prevention of distal piston advancement when a vacuum tube is inserted	"The A-VPS is designed such that the piston will not advance distally when a vacuum tube is inserted into its tube holder."
6. Insignificant amount of sodium-heparin aspirated into inner cannula (initial aspiration)	"The small volume of sodium-heparin aspirated into the lumen of the inner-cannula, with the initial aspiration, is insignificant, as the total amount of sodium is 0.004mEq." and "The minute amount of sodium heparin aspirated into the inner-cannula with the initial aspiration is insignificant, as demonstrated with our bench testing."
Safety & Effectiveness (Clinical):
7. Safe use in a clinical setting	"Pneumatic phlebotomy procedures were made safer with improved efficiency and proficiency." (referring to syringe K960049, stated as substantially identical in use to A-VPS)
8. Effective use for multiple blood samples	"The patient population included intensive care unit patients requiring multiple blood samples for vacuum specimen tubes and bottles."

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

Bench Investigation: The text states, "During the bench investigation, the A-VPS was used in consecutive aspirations and there were no failures." However, a specific numerical sample size (e.g., number of devices tested, number of aspirations) for the bench test set is not provided.
Clinical Trial: The clinical trial reported was for "syringe K960049," which is described as having substantially identical use to the A-VPS. The text states:
- Sample Size: Not explicitly stated, but mentions "intensive care unit patients requiring multiple blood samples." No specific number of patients or samples is given.
- Data Provenance: Prospective, as it was an "investigation" conducted in January 1989. The country of origin is USA (University of Iowa Hospitals and Clinics, UIHC).

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

Bench Investigation: Not applicable. The "ground truth" for separation of fluids and mechanical operation in the bench test appears to be based on direct observation and measurement (e.g., "absence of detectable mixing," calculation of mEq). No explicit experts are mentioned for establishing this ground truth beyond the researchers conducting the bench study.
Clinical Trial (for predicate K960049): The text mentions a report in the "UIHC publication Pacemaker, October 1989." This suggests a peer-reviewed or internal report. While the study was conducted at a hospital, the specific number of experts (e.g., physicians, nurses, lab technicians) involved in assessing "safety and effectiveness" or establishing ground truth for the clinical outcomes is not provided. Their qualifications are implied by their affiliation with a university hospital.

4. Adjudication Method for the Test Set

Bench Investigation: No explicit adjudication method is mentioned. The assessment appears to be direct observation of "absence of detectable mixing" and functional tests (consecutive aspirations with no failures).
Clinical Trial: No explicit adjudication method is mentioned for the clinical trial. The conclusion ("cumbersome phlebotomy procedures were made safer with improved efficiency and proficiency") suggests clinical observation and assessment, but details on how safety and efficiency were adjudicated are not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The studies mentioned are a bench investigation for the A-VPS and a clinical trial for a predicate device (K960049). Neither of these describes an MRMC design where human readers' performance with and without AI assistance is compared.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. The device being described is a physical medical device (syringe), not an AI algorithm.

7. Type of Ground Truth Used

Bench Investigation: Direct observation of fluid separation and functional performance (e.g., no failures in consecutive aspirations, absence of detectable mixing, calculation of sodium-heparin amount, verification of piston immobility).
Clinical Trial (for predicate K960049): Clinical outcomes (e.g., "safer with improved efficiency and proficiency") and the ability to obtain "multiple blood samples for vacuum specimen tubes and bottles." This could be considered outcomes data or expert clinical assessment.

8. Sample Size for the Training Set

Not applicable. The device is a physical medical device, not a machine learning model or algorithm that requires a training set.

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

Not applicable. As stated above, this is a physical device and doesn't involve a machine learning training set.

Summary

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MAR - 4 1997

December 16, 1996

James K. Brannon, M.D. Contact Person VASCULAR LOGICS, INC. 5862 Bolsa Avenue, Suite 108 Huntington Beach, CA 92629 (714) 899-3022 Office (714) 899-6877 Fax Page 17

510(k) SUMMARY

Name of Device: Piston Syringe 80 FMF Common/Usual Name: Syringe Brannon Arterio-Venous PortSyringe Trade/Proprietary Name:

Sealing of the conduit with the fluid collection needle allows the piston-plunger unit and the barrel to function as a conventional syringe. The inner-cannula allows one to aspirate the sodium-heparin solution into the barrel of the syringe and around the outer surface of the inner-cannula. The amount of sodium-heparin aspirated into the lumen of the inner cannula is significantly small and does not adversely affect the laboratory results of the blood specimens, as evidence by the bench studies of this premarket notification. The fluid seal at the inner-cannula piston interface ensures that the sodium-heparin fluid aspirated into the barrel of the syringe remains separate from the lumen of the plunger-conduit. Given that the distal end of the A-VPS has a restricted opening, fluid within the barrel of the syringe will not flow out of the syringe barrel when a vacuum tube is inserted into the tube-holder portion of the A-VPS. Passive distal advancement of the pistonplunger unit, when a vacuum tube is inserted into the tube holder would require a significant amount of energy. This energy is not available through the vacuum tube, but rather, only manual manipulation of the A-VPS plunger. Functional operation simply requires that one locks the

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James K. Brannon, M.D. 510(k) Summary December 16, 1996 Page 18

female hub of an indwelling catheter to the distal luer-lock nozzle tip of the A-VPS syringe barrel. One is then able to aspirate the sodium-heparin solution into the barrel of the syringe, as with the predicate piston syringes. The small volume of sodium-heparin aspirated into the lumen of the inner-cannula, with the initial aspiration, is insignificant, as the total amount of sodium is 0.004mEq. This mEq amount is derived from a standard sodium-heparin solution with 154 mEq/L of NaCl, with a volume of the inner-cannula of ~0.031cc. Further, the user may discard the first draw of blood prior to obtaining any samples for laboratory testing. After a given amount of fluid is aspirated into the barrel of the syringe, and one observes whole blood in the distal portion of the syringe, 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 whole blood to flow from the inner lumen of the indwelling catheter, through the inner-cannula, through the plunger-conduit, and into the vacuum specimen tube, while the plunger remains in its most proximal position. The pistonplunger unit can then be slowly advanced distally to return the sodium-heparin solution to the catheter, or the syringe can be discarded without returning the sodium-heparin solution to the patient. One should aspirate only once with the A-VPS. Please review Figures 1-4.

The technological differences of the A-VPS include fluid aspiration through the distal nozzle tip of the syringe and into the syringe barrel. This fluid remains separate from whole blood induced to flow through the lumen of the inner cannula when a vacuum specimen tube is inserted into the tube-holder. This process of collecting blood differs from syringe K960049 in that with the A-VPS, a volume of fluid remains in the barrel of the syringe while blood is being transferred to a plurality of vacuum glass tubes. The predicate Becton-Dickinson piston syringe only allows influx and efflux of a fluid through the distal nozzle tip of its syringe barrel.

Regarding safety and effectiveness, a clinical trial was conducted at the University of Jowa Hospitals and Clinics, UIHC, in January of 1989. 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 unit patients requiring multiple blood samples for vacuum specimen tubes and bottles. Use of the investigational device, now syringe K960049. which required some assembly, required the use of a hypodermic needle for percutaneous blood collection. Appreciate that the new device of this summary, the Brannon Arterio-Venous PortSyringe, does not require any assembly, other than attachment to an indwelling catheter, i.e., a central line or an arterial line. Attachment to a peripheral intravenous catheter is not an intended use. It was shown in the UIHC investigation that cumbersome phlebotomy procedures were made safer with improved efficiency and proficiency. Use of the A-VPS is substantially identical to syringe K960049. Syringe K960049 requires use of a hypodermic needle, while the syringe of

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James K. Brannon, M.D. 510(k) Summary December 16, 1996 Page 19

this notification requires the use of an indwelling catheter. Both syringes, K960049 and A-VPS, The effectiveness of the A-VPS is are identical in design construct and biocompatible. demonstrated in the bench investigation of the A-VPS' ability to separate fluid within the barrel of the syringe from a fluid within its plunger-conduit. During the bench investigation, the A-VPS was used in consecutive aspirations and there were no failures. The A-VPS differs from syringe K960049 only by the addition of the inner-cannula. Specifically, the inner-cannula is manufactured with identical material as the BSCD needle.

The bench investigation shows that a heparin fluid aspirated into the barrel of the syringe will remain separate from a fluid within the plunger-conduit. The ability of the rubber piston to maintain a hermetic seal at the level of the piston inner-cannula interface was demonstrated to be effective, as evidenced by the absence of detectable mixing of the two fluids in separate fluid chambers, chamber one (1) being the syringe barrel, and chamber two (2) being the plungerconduit. The functional mechanism of this hermetic seal, at the level of the piston inner-cannula interface, is identical to the hermetic seal at the level of the piston-barrel interface, both are slidable fluid seals. Further, after fluid has been aspirated into the barrel of the A-VPS, an absolute requisite to retrieving this aspirated fluid is distal advancement of the plunger. The A-VPS is designed such that the piston will not advance distally when a vacuum tube is inserted into its tube holder. The blood that fills the vacuum specimen tube will come from the path of least resistance, i.e., the open lumen of the indwelling catheter. In this regard, the previously aspirated sodiumheparin solution will remain in the barrel of the syringe as whole blood for laboratory testing travels from the lumen of the indwelling catheter, through the inner-cannula, through the plungerconduit, and into the vacuum specimen tube. The minute amount of sodium heparin aspirated into the inner-cannula with the initial aspiration is insignificant, as demonstrated with our bench testing. Thereafter the initial blood draw, the inner-cannula would be filled with whole blood. Subsequent blood draws can proceed as outlined in this premarket notification.

In conclusion, the above summary elucidates the physical characteristics that constitute the Brannon Arterio-Venous PortSyringe. The summary further shows by comparison that the intended use, fluid aspiration and subsequent transfer of whole blood to vacuum specimen tubes, is identical to the predicate B-D piston syringe, predicate syringe K960049, and the predicate BSCD. The clinical trial conducted at the UIHC demonstrates that the Brannon Arterio-Venous PortSyringe can be used safely and effectively in a manner identical to the predicate devices of this notification. Therefore, the Brannon Arterio-Venous 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).