(89 days)
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No
The document describes a simple mechanical filter device and makes no mention of AI or ML.
No.
The device's intended use is as a protective device for pressure monitors and to help protect the sterility of the fluid pathway, not to treat or diagnose a medical condition.
No
The device is described as a protective device for pressure monitors and to help protect the sterility of the fluid pathway, not to diagnose medical conditions.
No
The device description clearly states it is a physical, disposable device with a filter, indicating it is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "protective devices for pressure monitors and to help protect the sterility of the fluid pathway." This describes a device used in conjunction with a medical procedure (monitoring pressure), not a device used to perform a diagnostic test on a sample taken from the body.
- Device Description: The description focuses on the physical function of the device (filtering, preventing fluid flow) within a fluid pathway, not on analyzing a biological sample for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway. This is identical to the intended use of the legally marketed predicate device.
Product codes
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Device Description
Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 m hydrophobic filter helps prevent cross-contamination by bacteria and particulate matter while preventing the flow of fluids to the machine pressure monitor at pressures less than 600 mmHg.
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
To assure that the device is safe and effective, all finished products are tested and must meet all required release specifications before distribution. The testing required for release includes, but is not limited to; sterility, pyrogenicity, physicel testing, and visual examination of both in-process and finished product. The required testing is defined by written and approved procedures that conform to the product design specifications. This testing for the Medisystems Transducer Protectors is defined in detail in the "Device Master Records."
Key Metrics
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Predicate Device(s)
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 I
510(k) Summary Required by 21 CFR §807.92
MAY 1 2 1977
I. Submitter:
Medisystems Corporation A. Name:
1201 Third Avenue, Suite 3900 B. Address: Seattle WA 98101-3016
C. Phone and Fax Numbers: Phone: 206-621-6500 Fax 206-621-6501
D. Contact Person: Mr. Fredric G. Swindler
II. Date of preparation of this Summary: February 10, 1997
III. Trade Name: Medisystems Transducer Protectors
IV. Common Name: Transducer Protectors
V. Classification Name: Hemodialysis System and Accessories
VI. The Marketed Device(s) to which Equivalence is Claimed: The Transducer Protectors which are the subject of this submission are substantially equivalent to those described in Medisystems' 510(k) number K895856.
VII. Product Description: Medisystems Transducer Protectors are designed to be used as protective devices for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 µm hydrophobic filter helps prevent cross-contamination by bacteria and particulate matter while preventing the flow of fluids to the machine pressure monitor at pressures less than 600 mmHg.
VIII. Statement of Intended Use Compared to Predicate Device: Medisystems Transducer Protectors are single use, disposable prescription devices intended for use as protective devices for pressure monitors and to help protect the sterility of the fluid pathway. This is identical to the intended use of the legally marketed predicate device.
IX. Discussion of Technological Characteristics: The technical characteristics of the device consist of a filter housing that contains a 0.2 um hydrophobic filter. Due to the pore size of the
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filter, bacteria and particulate contamination are prevented from passing from the machine pressure monitor to the blood tubing set. The combination of the pore size and hydrophobic nature of the filter also prevents the flow of fluids, bacteria, and particulate matter into the pressure monitor at pressure lower than the rated pressure of the device.
X. Safety and Effectiveness: To assure that the device is safe and effective, all finished products are tested and must meet all required release specifications before distribution. The testing required for release includes, but is not limited to; sterility, pyrogenicity, physicel testing, and visual examination of both in-process and finished product.
The required testing is defined by written and approved procedures that conform to the product design specifications. This testing for the Medisystems Transducer Protectors is defined in detail in the "Device Master Records."