(191 days)
Not Found
No
The device description and performance studies focus on a simple infrared sensor detecting blood absorption, with no mention of AI/ML terms, image processing, or complex data analysis beyond a simple threshold trigger for an alarm.
No.
The device is a monitoring device that alarms when blood leakage is detected, but it does not provide any therapeutic intervention.
No
The device monitors for blood loss from a hemodialysis access site and alarms if blood leakage is detected. It does not diagnose a condition or disease.
No
The device description explicitly states that the system consists of an alarm unit and an infrared 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. The Redsense device monitors for blood leaking from the body at the hemodialysis access site. It detects blood externally on a sensor patch, rather than analyzing a sample of blood or other bodily fluid that has been removed from the patient.
- The intended use is monitoring for external blood loss. The description clearly states the device monitors for "potential blood loss from the hemodialysis access site" and detects "blood leakage from the venous needle puncture site." This is a monitoring function related to external events, not an analysis of internal biological markers.
- The mechanism is external detection. The device uses an infrared light and a sensor patch to detect blood on the patch. This is an external detection method, not an analysis of a sample in a laboratory setting.
Therefore, the Redsense device falls under the category of a medical device used for monitoring, but 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 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.
Product codes (comma separated list FDA assigned to the subject device)
ODX
Device Description
Redsense is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consists of an alarm unit and infrared sensor incorporated into an adhesive patch. The patch with the sensor is placed around the vein or arterial 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
Not Found
Anatomical Site
venous needle puncture site / hemodialysis access site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in the 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
Clincal testing was conducted at the Departments of Nephrology/Medicine at Eksjö, Halmstad, Hässleholm, Skövde, and Varberg Hospitals in Sweden. Results showed the device functioned successfully in the clinical environment.
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.
Clincal testing was conducted at the Departments of Nephrology/Medicine at Eksjö, Halmstad, Hässleholm, Skövde, and Varberg Hospitals in Sweden. Results showed the device functioned successfully in the clinical environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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PAGE 1 OF 3
Redsense Medical K071013
2. 510(k) Summary
Submitter: Redsense Medical AB Rörkullsvägen 4 Box 287 301 07 HALMSTAD SWEDEN
0CT 1 8 2007
Contact Information: Constance G. Bundy 6470 Riverview Terrace Fridley, MN 55432 Submission Date:
Device Name and Classification: Redsense, Class II, 876.5540, product code not known
Equivalent Device Identification: Neotrend (K972314) and Fresenius 2008 Touch panel control Dialysis system (K890824)
Device Description: Redsense is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consists of an alarm unit and infrared sensor incorporated into an adhesive patch. The patch with the sensor is placed around the vein or arterial 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 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.
1
Comparison Table
| Parameter | Proposed Device | Predicate device 1 | Predicate Device 2 |
|---|---|---|---|
| Device | Redsense | Neotrend Multiparameter | |
| Sensor | Vein pressure supervision, | ||
| integrated in Fresenius 2008 | |||
| Dialysis system | |||
| Intended Use | Monitor blood | ||
| leakage from | |||
| venous needle | |||
| puncture site | Continuous blood gas | ||
| monitoring system for pO2, | |||
| temperature, pCO2 and pH | Blood line separation (can be | ||
| caused by vein needle | |||
| dislodgement) | |||
| Manufacturer | Redsense Medical | Diametrics Medical Itd | Fresenius |
| Technology | Blood detection | ||
| through IR light | |||
| absorption in fiber | |||
| optics/ adhesive | |||
| absorption pad | Blood gas sensor thought | ||
| optical fiber/ fluorescence | |||
| quenching technology (fiber | |||
| optic photometric | |||
| absorption) | Pressure detection | ||
| Blood amount | |||
| for detection | approximately 2 ml | Not specified | Not specified, alarm pressure level |
| can be adjusted | |||
| Area of | |||
| detection | NA "Blood or no | ||
| blood" | pO2 20-500mmHg, | ||
| temperature 10-42 °C, pCO2 | |||
| 10-160 mmHg and pH 6.80 - | |||
| 7.80 | -60 to 520 mmHG | ||
| Tolerance | NA | pO2 +/- 3mmHg, | |
| temperature +/- 0,3 °C, | |||
| pCO2 +/- 3 mmHg and pH | |||
| +/- 0.03 | +/- 10 mmHg | ||
| Size of sensor | D= 0.25 mm | D= 0.5 mm | NA |
| Optical Fiber | |||
| type | Plastic | Plastic | NA |
| Light type | Infrared | Green and Red visible | NA |
| Components | |||
| parts | Fibre Optical blood | ||
| detector, adhesive, | |||
| absorbent | Fiber Optical blood sensor | ||
| with chemical dye | Pressure sensor | ||
| Single use | Yes | Yes | No |
| Sterile | No | Yes | NA |
| Usage time | 5h | 72 h | 5h |
| Patient | |||
| contact | Skin | Intravascular access | No |
Summary of Testing:
Verification testing has been performed to verify that the Redsense device fulfills the Requirement Specifications.
Clincal testing was conducted at the Departments of Nephrology/Medicine at Eksjö, Halmstad, Hässleholm, Skövde, and Varberg Hospitals in Sweden. Results showed the device functioned successfully in the clinical environment.
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Ko71013 PAGE 3 OF 3
Redsense Medical K071013
Conclusion: Redsense is similar in function and intended use to the vein pressure component of the Fresenius device and has sensing technology that is similar to the Neotrend device. Verification and clinical testing show the Redsense system to be safe and effective for intended use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
Redsense Medical AB c/o Ms. Constance G. Bundy Regulatory Consultant C.G. Bundy Associates, Inc. 6470 Riverview Terrace FRIDLEY MN 55432
Re: K071013
Trade/Device Name: Redsense Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: ODX Dated: October 16, 2007 Received: October 17, 2007
Dear Ms. Bundy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K071013
Device Name: Redsense
Indications For 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 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence, of CDRH, Office of Device Evaluation (ODE)
Hebert Werner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
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