BRANNON PEDI PORTSYRINGE

K960047 · James K. Brannon · FMF · May 24, 1996 · General Hospital

Device Facts

• Record ID: K960047
• Device Name: BRANNON PEDI PORTSYRINGE
• Applicant: James K. Brannon
• Product Code: FMF · General Hospital
• Decision Date: May 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Indications for Use

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.

Device Story

Brannon Pedi PortSyringe (BPPS) is a 3cc piston syringe integrated with a blood specimen collection device (BSCD) in the plunger unit. Input: body fluids aspirated via hypodermic needle attached to distal nozzle. Operation: functions as conventional syringe for aspiration; for transfer, vacuum specimen tubes are inserted into the plunger-integrated tube-holder, where vacuum pressure draws fluid from the barrel through a central conduit into the tubes. Used in clinical settings (e.g., ICU) by healthcare providers. Benefits: enables safer, more efficient phlebotomy and blood culture collection by reducing manual handling of samples; allows simultaneous intravenous catheter blood collection.

Clinical Evidence

Clinical trial conducted at University of Iowa Hospitals and Clinics (January 1989) on intensive care patients requiring multiple blood samples. Study demonstrated improved safety, efficiency, proficiency, and patient comfort compared to traditional phlebotomy procedures. No specific statistical metrics (p-values, CIs) provided.

Technological Characteristics

3cc piston syringe with integrated BSCD in plunger. Materials are identical to predicate Becton-Dickinson piston syringe. Fluid path includes a centrally disposed narrow conduit in the plunger sealed by a rubber sleeve. Manual operation; no energy source. Standalone device.

Indications for Use

Indicated for intensive care patients requiring multiple blood samples for vacuum specimen tubes and vacuum blood culture bottles.

Regulatory Classification

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.

Predicate Devices

• Piston syringe (Becton-Dickinson)
• Blood specimen collection device (BSCD) (Becton-Dickinson)

Submission Summary (Full Text)

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K960047

MAY 24 1996

James K. Brannon, M.D.
(Contact Person)
5729 Canterbury Drive
Culver City, CA 90230-6547
[phone] Office
[phone] Fax
[phone] Pager

February 21, 1996

510(k) SUMMARY
AMENDED
K960047

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

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.

Sealing of the conduit with the fluid collection needle allows the piston-plunger 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 clinical trial was conducted at the University of Iowa 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 phlebotomy 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 substantially equivalent to a predicate piston syringe.