(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 described as a piston syringe for fluid aspiration and transfer to specimen tubes, indicating diagnostic or collection purposes rather than direct therapeutic treatment.
No
Explanation: The device is described as a piston syringe for fluid aspiration and transfer. Its intended use is to collect fluid samples but not to analyze them for diagnostic purposes.
No
The device description clearly states it is a combination of a piston syringe and a blood specimen collection device, both of which are hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 a sample, not performing a diagnostic test on the sample.
- Device Description: The device is described as a combination of a piston syringe and a blood specimen collection device. This is a tool for sample collection and transfer.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis or testing of the collected fluid. IVD devices are designed to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Clinical Trial Focus: The clinical trial described focuses on the efficiency, safety, proficiency, and patient comfort of the fluid extraction process, not on the diagnostic accuracy of any test performed with the collected fluid.
The device is a tool for sample collection and handling, which is a pre-analytical step in the diagnostic process, but it is not an IVD 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 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 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)
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.
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
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
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 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.
1
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.
2
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.