(227 days)
Not Found
No
The device description and performance studies focus on a simple optical sensor and alarm system, with no mention of AI/ML terms or methodologies.
No.
The device monitors for blood loss and alarms if detected; it does not treat or directly intervene in a therapeutic manner.
No
The device is intended to monitor for potential blood loss and detect leakage, not to diagnose a medical condition or disease.
No
The device description explicitly states it consists of an "alarm unit and optical sensor incorporated into an adhesive patch," indicating the presence of physical hardware components beyond just software.
Based on the provided information, the Redsense device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. IVDs typically involve testing blood, urine, tissue, or other biological samples outside of the body to diagnose, monitor, or screen for diseases or conditions.
- The Redsense device monitors external blood leakage. The device is placed on the skin around the hemodialysis access site and detects blood that leaks onto the adhesive patch. It does not analyze a sample taken from the patient's body.
- The intended use is for monitoring, not diagnosis. The device is intended to "monitor for potential blood loss" and "alarm if needle dislodgement or blood leakage is detected." This is a monitoring function, not a diagnostic test.
Therefore, the Redsense device falls under the category of a medical device used for monitoring, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment up to 5 hours at home or in the clinical setting. The device includes a blood sensor incorporated into an adhesive dressing. The sensor monitors potential blood leakage from the needle puncture via an infrared light and will alarm if needle dislodgement or blood leakage is detected.
All use must be administrated under physician's prescription, and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.
Product codes
ODX
Device Description
Redsense Home Use is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consists of an alarm unit and optical sensor incorporated into an adhesive patch. The patch with the sensor is placed around the vein needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
hemodialysis access site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home or clinical setting; must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.
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
Verification testing including additional tests of the audible and visual capability of the alarm has been performed to verify that the Redsense Home Use device fulfills the Requirement Specifications and additional FDA requirements. The audible testing of the alarm was conducted according to the requirements stated in "Class II Special Controls Guidance Document: Apnea Monitors''. Another additional test was performed to evaluate the visibility of the LEDs in different background light levels as stated in the standard referred to in the "Class II Special Controls Guidance Document: Apnea Monitors'', that is ISO 9703-1:1992: "Alarm signals for anesthesia and respiratory care. Part 1. Specification for visual alarm signals". The results met the requirements in the standard.
User Evaluation was conducted by eight patients. The evaluation was performed on 8 patients undergoing self dialysis at clinic or dialysis at home in Sweden. The objective of the evaluation was to evaluate if Redsense could be used by the patients and to evaluate if the Instructions for use were sufficient. The evaluation showed that the amount of false alarms and warnings did not increase compared to the device as used in the clinical settings. The evaluation showed no adverse effects. Even if the evaluations showed that the device can be handled by the patient themselves, the intended use for the product requires that all use of the device in the home "must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician". Results showed the device functioned successfully in the home use environment.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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2. 510(k) Summary
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Redsense Medical AB Submitter: Rörkullsvägen 4 Box 287 301 07 HALMSTAD SWEDEN
MAY 7 0 2010
Contact Information: Constance G. Bundy 435 Rice Creek Terrace Fridley, MN 55432 763-574-1976
Submission Date: May 18, 2010
Device Name and Classification: Redsense --Home Use, Class II, 876.5820, 876.5540, product code not known
Submission Purpose: Expand Intended Use to Home Use. The device is equivalent to the Redsense device previously cleared.
Equivalent Device Identification:
Redsense Medical AB K071013
Device Description: Redsense Home Use is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consists of an alarm unit and optical sensor incorporated into an adhesive patch. The patch with the sensor is placed around the vein needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm.
Intended Use/Indications for Use:
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment up to 5 hours at home or in the clinical setting. The device includes a blood sensor incorporated into an adhesive dressing. The sensor monitors potential blood leakage from the needle puncture via an infrared light and will alarm if needle dislodgement or blood leakage is detected.
All use must be administrated under physician's prescription, and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.
Summary of Testing:
Verification testing including additional tests of the audible and visual capability of the alarm has been performed to verify that the Redsense Home Use device fulfills the Requirement Specifications and additional FDA requirements. The audible testing of the alarm was conducted according to the requirements stated in "Class II Special Controls Guidance Document: Apnea
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