(143 days)
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No
The device description and performance studies focus on the mechanical function of a syringe and blood collection device, with no mention of AI or ML.
No
The device is used for fluid aspiration and transfer for diagnostic purposes (specimen collection), not for treating a disease or condition.
No
The device is described as a piston syringe for fluid aspiration and transfer, primarily for collecting fluid samples in vacuum specimen tubes. Its function is to facilitate the collection of samples, not to analyze them or provide diagnostic information.
No
The device description clearly details a physical medical device consisting of a piston syringe and a blood specimen collection device, made of materials identical to predicate physical devices. There is no mention of software components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD). Here's why:
- Intended Use: The intended use is "fluid aspiration and transfer of the fluid aspirate to vacuum specimen tubes and bottles." This describes a process of collecting and transferring biological fluid, not performing a diagnostic test on the fluid itself.
- Device Description: The device is a combination of a piston syringe and a blood specimen collection device. Its function is to facilitate the collection and transfer of fluid into specimen tubes. It does not contain reagents or components designed to analyze the fluid for diagnostic purposes.
- Lack of Diagnostic Function: The description focuses on the mechanical process of aspiration and transfer. There is no mention of any component or process that would analyze the collected fluid to provide diagnostic information about a patient's health.
- Performance Studies: The performance study described focuses on the safety and efficiency of the fluid extraction process, not on the accuracy or reliability of any diagnostic results obtained from the collected fluid.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease. This device's function is limited to the collection and transfer of the specimen, which is a pre-analytical step, not the diagnostic analysis itself.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The piston syringe, made available in a 5cc size, of this 510(k) notification. known as the Brannon PortSyringe (BPS), 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 BPS is manufactured with identical material as the predicate piston syringe.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Regarding safety and effectiveness, a clinical 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 phlebotomy procedures were made safer with improved efficiency, proficiency, and patient comfort.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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 K960049
Name of Device: Piston Syringe 80 FMF Common/Usual Name: Svringe Trade/Proprietary Name: Brannon PortSyringe
The piston syringe, made available in a 5cc size, of this 510(k) notification. known as the Brannon PortSyringe (BPS), 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 BPS is manufactured with identical material as the predicate piston syringe.
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.
February 21. 1996
1
James K. Brannon, M.D. Brannon PortSyringe K960049 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 BPS 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 BPS 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 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 phlebotomy procedures were made safer with improved efficiency, proficiency, and patient comfort.
Further appreciate that the Brannon PortSyringe meets all of the biocompatibility and performance standards (efficacy) of the predicate piston syringe and predicate BSCD. The Brannon PortSyringe is manufactured with identical material as the predicate piston syringe (B-D disposable piston syringe) and there is no deviation from this standard. Further, the Brannon PortSyringe was used during consecutive aspirations and fluid transfers to vacuum specimen tubes at the bench and there were no failures. The Brannon PortSyringe works safely and effectively as outlined in the Premarket Notification 510(k).
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James K. Brannon, M.D. Brannon PortSyringe K960049 February 21, 1996 510(k) Summary Page 3
In conclusion, the above summary elucidates the physical characteristics which constitute the Brannon PortSyringe. The summary further shows by comparison that the indicated 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 PortSyringe can be used safely and effectively in a manner identical to the predicate piston syringe and BSCD. Therefore, the Brannon PortSyringe of this 510(k) summary is claimed to be subtantially equivalent to a predicate piston syringe.