(100 days)
No
The description focuses on a simple optical sensor detecting blood via light absorption and triggering an alarm. There is no mention of complex data processing, learning algorithms, or AI/ML terms.
No
The device monitors for blood loss and alarms if detected, but it does not treat or directly intervene in a therapeutic manner. Its primary function is detection and alert, not therapy.
No
Justification: The device monitors for potential blood loss and alarms if detected, which is an event detection and monitoring function, not a diagnostic one that identifies a disease or condition.
No
The device description explicitly states that the system consists of an "alarm unit and optical sensor incorporated into an adhesive patch," indicating the presence of 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 human body. They are used to examine specimens like blood, urine, tissue, etc., to provide information about a person's health status.
- The Redsense device monitors for blood outside the body. It detects blood leakage from the hemodialysis access site onto a sensor patch. It does not analyze a sample of blood taken from the patient.
- The intended use is to monitor for blood loss, not to diagnose a condition. While blood loss can be a symptom of a medical condition, the device's function is to alert to the presence of blood leakage, not to provide diagnostic information about the patient's health.
The Redsense device falls under the category of a medical device used for monitoring during a medical procedure (hemodialysis).
N/A
Intended Use / Indications for Use
The Redsense device is intended to monitor for potential blood loss from a hemodialysis access site in patients undergoing continuous hemodialysis treatment up to 8 hours in the clinical setting. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch.
Product codes
ODX
Device Description
Redsense is a system for monitoring the vein needle during hemodialysis. Redsense consists of an alarm unit and optical sensor incorporated into an adhesive patch. The patch with the sensor is placed over 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
Not Found
Input Imaging Modality
infrared light
Anatomical Site
hemodialysis access site; venous needle puncture site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing has been performed to verify that the Redsense device fulfills the Requirement Specifications and can be used for up to 8 hours in a clinical setting. Additional tests of the audible and visual capability of the alarm have been performed. Test results met the requirements of the standards used for testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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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510(k) Summary
Submitter: Redsense Medical AB Rörkullsvägen 4 302 41 HALMSTAD SWEDEN +46 35 106030
Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrace Fridlev. MN 55432 763-574-1976 Fax: 763-571-2437 cgbundy@live.com
Submission Date: October 26, 2010, Revised January 31, 2011
Device Name and Classification: Redsense-Alarm unit and sensor for Clinical Use (Model RA-1-RA001C), Class II, 876.5820, 876.5540, product code ODX
Submission Purpose: Expand Intended Use for up to 8 hours clinical use.
Equivalent Device Identification:
| Redsense Medical AB K071013 |
|---|
| Redsense Medical AB K092955 |
| Gambro, Inc K070643 |
Device Description: Redsense is a system for monitoring the vein needle during hemodialysis. Redsense consists of an alarm unit and optical sensor incorporated into an adhesive patch. The patch with the sensor is placed over 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: The Redsense device is intended to monitor for potential blood loss from a hemodialysis access site in patients undergoing continuous hemodialysis treatment up to 8 hours in the clinical setting. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch.
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K103242
PAGE 2 OF 3
Comparison Table:
· س
:
| Parameter | Proposed Device | Predicate device 1 | Predicate 2 | Predicate Device 3 |
|---|---|---|---|---|
| Device | Redsense Alarm | |||
| Unit, Clinical Use, | ||||
| RA-1-RA001C | Redsense Alarm | |||
| Unit | Redsense Alarm | |||
| Unit. Home use | Phoenix | |||
| HEMODIALYSIS | ||||
| DELIVERY | ||||
| SYSTEM | ||||
| For use at: | Clinic | Clinic | Home or clinic | Clinic |
| Intended | ||||
| Use | The Redsense | |||
| device is intended to | ||||
| monitor for potential | ||||
| blood loss from the | ||||
| hemodialysis access | ||||
| site in hemodialysis | ||||
| patients undergoing | ||||
| continuous | ||||
| hemodialysis | ||||
| treatment up to 8 | ||||
| hours in the clinical | ||||
| settings. The device | ||||
| includes a blood | ||||
| sensor incorporated | ||||
| into an | ||||
| adhesive sensor | ||||
| patch. The sensor | ||||
| monitors potential | ||||
| blood leakage from | ||||
| the venous needle | ||||
| puncture site via an | ||||
| infrared light and will | ||||
| alarm if blood | ||||
| leakage is detected | ||||
| via absorption onto | ||||
| the device's sensor | ||||
| patch. | The Redsense device | |||
| is intended to monitor | ||||
| for potential blood | ||||
| loss from the | ||||
| hemodialysis access | ||||
| site in hemodialysis | ||||
| patients undergoing | ||||
| continuous | ||||
| hemodialysis | ||||
| treatment up to 5 | ||||
| hours in the clinical | ||||
| setting. The device | ||||
| includes a blood | ||||
| sensor incorporated | ||||
| into an | ||||
| adhesive sensor | ||||
| patch. The sensor | ||||
| monitors potential | ||||
| blood leakage from | ||||
| the venous needle | ||||
| puncture site via an | ||||
| infrared light and will | ||||
| alarm if blood leakage | ||||
| is detected via | ||||
| absorption onto the | ||||
| device's sensor | ||||
| patch. | 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. | The Phoenix | |||
| Hemodialysis | ||||
| delivery system is | ||||
| intended to be used | ||||
| to provide high flux | ||||
| and low flux | ||||
| hemodialysis, | ||||
| hemofiltration and | ||||
| ultrafiltration on | ||||
| patients weighing 15 | ||||
| Kilograms or more. | ||||
| The Phoenix | ||||
| system is to be used | ||||
| with either high or | ||||
| low permeability | ||||
| dialyzers. | ||||
| The device is | ||||
| intended to be used | ||||
| by trained operators | ||||
| when | ||||
| prescribed by a | ||||
| physician, in a | ||||
| chronic care dialysis | ||||
| facility or acute | ||||
| care unit. | ||||
| Maximum | ||||
| Dialysis | ||||
| Time | 8 hours | 5 hours | 5 hours | 8 hours |
2