(405 days)
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No
The summary describes blood tubing sets, which are passive medical devices used for fluid transport, and there is no mention of AI or ML in the provided text.
No
The device is a blood tubing set, which connects blood access devices to a treatment device (e.g., hemodialyzer); it is not the treatment device itself.
No
Explanation: The device description states its purpose is to connect blood access devices to flow-through treatment devices during extracorporeal procedures, which is a functional role in treatment delivery rather than diagnosis. There is no mention of the device analyzing data or identifying conditions.
No
The device description clearly states it is "blood tubing sets," which are physical hardware components used in extracorporeal procedures. 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/Indications for Use: The description clearly states the blood tubing sets are for connecting blood access devices to flow-through treatment devices (like hemodialyzers) during extracorporeal procedures. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description reinforces this by stating their use in extracorporeal procedures to connect devices.
- Lack of Diagnostic Elements: There is no mention of analyzing blood or other biological samples to provide information about a patient's health status, disease, or condition. IVDs are designed for this purpose.
- No Mention of IVD-Specific Information: The provided text lacks any of the typical information associated with IVDs, such as performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.), or details about sample handling or analysis.
Therefore, this device falls under the category of a medical device used for treatment support, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The blood tubing sets are intended for use with a blood access device and a medically approved flowthrough treatment device.
Product codes
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Device Description
Medisystems blood tubing sets are used during extracorporeal procedures by providing a means to connect blood access devices to flow-through treatment device(s) (e.g. a hemodialyzer).
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Section B
510(k) Summary Required by 21 CFR $807.92
I. Submitter:
| A. Name: | McKenna & Cuneo, L.L.P. |
|---|---|
| on behalf of Medisystems Corporation |
-
B. Address: 1575 Eye St. NW Washington, DC 20005
C. Phone and Fax Numbers: Phone: 202-789-7500 Fax 202-789-7756 -
D. Contact Person: Ms. Suzan Onel
II. Date of preparation of this Summary: July 25, 1995
III. Trade Name: Arterial - Venous Blood Tubing Set
IV. Common Name: Tubing set
V. Classification Name: Set, Tubing, Blood, with and without Antiregurgation Valve
VI. The Marketed Device(s) to which Equivalence is Claimed: The blood tubing sets which are the subject of this submission are substantially equivalent to Medisystems blood tubing sets in commercial distribution pursuant to a prior premarket notification that was cleared on September 8, 1981.
VII. Product Description: Medisystems blood tubing sets are used during extracorporeal procedures by providing a means to connect blood access devices to flow-through treatment device(s) (e.g. a hemodialyzer).
VIII. Statement of Intended Use Compared to Legally Marketed Device: The intended use of the Medisystems blood tubing set is identical to that of the legally marketed predicate device: The blood tubing sets are intended for use with a blood access device and a medically approved flowthrough treatment device.
IX. Discussion of Technological Characteristics: Because the intent of this 510(k) is to seek FDA acknowledgment for a change in the labeling of currently marketed devices, the technological
1
characteristics of the device are unchanged. The specific proposed labeling changes consist of the following:
A. The directions for use have been expanded to provide the user with an increased amount of information concerning the use of the device.
B. Additional warnings and precautions are proposed to better inform the user of current information regarding hemodialysis procedures and to comply with the labeling requirements of ANSI/AAMI RD-17, Hemodialyzer Blood Tubing.
X. Safety and Effectiveness: The proposed changes to the blood tubing sets consist of modifications to the case insert label. The proposed labeling changes do not affect the product's design, composition, manufacturing, or performance characteristics. The labeling revisions are proposed to provide the user with an increased amount of information concerning the use of the device. Although none of the label changes raise new issues regarding safety and effectiveness, additional warnings and precautions are proposed to better inform the user of recent trends in dialysis procedures involving high efficiency or high flux dialysis and to be consistent with recognized standards.