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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Redsense Alarm Unit for Clinical Use, Model RA-1-RA001C. The submission's purpose is to expand the intended use of the device for up to 8 hours of clinical use, compared to the previously cleared 5 hours.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity, specificity, or false alarm rates) or numerical performance metrics for the device. Instead, the "Summary of Testing" broadly states that "Test results met the requirements of the standards used for testing."

Acceptance Criteria (Inferred)	Reported Device Performance
Device fulfills requirement specifications for up to 8 hours clinical use.	"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."
Audible and visual alarm capabilities meet requirements.	"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."
Device is safe and effective for its intended use (up to 8 hours clinical use, potential blood loss detection).	"Verification testing showed the Redsense device to be safe and effective for its intended use." (This is a conclusion drawn from the testing, not a direct performance metric). The FDA's substantial equivalence determination implies that current performance is at least equivalent to the predicate device for this expanded use.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply refers to "Verification testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the test set.

4. Adjudication Method for the Test Set:

No information is provided about any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, the document does not mention an MRMC comparative effectiveness study, nor does it discuss the effect size of human readers improving with AI vs. without AI assistance. The Redsense device is described as a standalone alarm system, not an AI-assisted diagnostic tool for humans.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, the device described is a standalone alarm unit. The description of its function ("will alarm if blood leakage is detected via absorption onto the device's sensor patch") indicates it operates independently to detect blood loss and trigger an alarm without requiring human interpretation of its internal detection mechanism. The verification testing would have assessed this standalone performance.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for the verification testing. Given the nature of the device (detecting blood leakage), it's highly probable that the ground truth would involve simulated or actual blood leakage events under controlled conditions, with the "true positive" of blood presence verified through direct observation or precise measurement. It is unlikely to be pathology, expert consensus in the diagnostic sense, or outcomes data for this type of device function.

8. The Sample Size for the Training Set:

The document does not refer to a "training set" or "training data." This is consistent with the device being a hardware-based sensor and alarm system, rather than a machine learning or AI algorithm that typically requires a training phase. The "verification testing" described is for demonstrating the device's functional performance against specifications.

9. How the Ground Truth for the Training Set Was Established:

As no training set is mentioned, there is no information on how its ground truth would have been established.

Summary

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K103242 PAGE 1 OF 3

FEB 1 0 2011

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 AlarmUnit, Clinical Use,RA-1-RA001C	Redsense AlarmUnit	Redsense AlarmUnit. Home use	PhoenixHEMODIALYSISDELIVERYSYSTEM
For use at:	Clinic	Clinic	Home or clinic	Clinic
IntendedUse	The Redsensedevice is intended tomonitor for potentialblood loss from thehemodialysis accesssite in hemodialysispatients undergoingcontinuoushemodialysistreatment up to 8hours in the clinicalsettings. The deviceincludes a bloodsensor incorporatedinto anadhesive sensorpatch. The sensormonitors potentialblood leakage fromthe venous needlepuncture site via aninfrared light and willalarm if bloodleakage is detectedvia absorption ontothe device's sensorpatch.	The Redsense deviceis intended to monitorfor potential bloodloss from thehemodialysis accesssite in hemodialysispatients undergoingcontinuoushemodialysistreatment up to 5hours in the clinicalsetting. The deviceincludes a bloodsensor incorporatedinto anadhesive sensorpatch. The sensormonitors potentialblood leakage fromthe venous needlepuncture site via aninfrared light and willalarm if blood leakageis detected viaabsorption onto thedevice's sensorpatch.	The Redsensedevice is intended tomonitor for potentialblood loss from thehemodialysis accesssite in hemodialysispatients undergoinghemodialysistreatment up to 5hours at home or inthe clinical setting.The device includes ablood sensorincorporated into anadhesive dressing.The sensor monitorspotential bloodleakage from theneedle puncture viaan infrared light andwill alarm if needledislodgement or bloodleakage is detected.All use must beadministrated underphysician'sprescription, and mustbe observed by atrained and qualifiedperson considered tobe competent in theuse of this device bythe prescribingphysician.	The PhoenixHemodialysisdelivery system isintended to be usedto provide high fluxand low fluxhemodialysis,hemofiltration andultrafiltration onpatients weighing 15Kilograms or more.The Phoenixsystem is to be usedwith either high orlow permeabilitydialyzers.The device isintended to be usedby trained operatorswhenprescribed by aphysician, in achronic care dialysisfacility or acutecare unit.
MaximumDialysisTime	8 hours	5 hours	5 hours	8 hours

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<103242

Summary of Testing: 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.

Conclusion:

Redsense device is identical to the Redsense device previously cleared with the addition of the 8 hour clinical use indication. Verification testing showed the Redsense device to be safe and effective for its 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 features a stylized image of an eagle or bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

FEB 1 0 2011

Redsense Medical AB c/o Constance G. Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrance FRIDLEY MN 55432

Re: K103242

Trade/Device Name: Redsense Alarm Unit for Clinical Use, Model RA-1-RA001C Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: ODX Dated: February 3, 2011 Received: February 8, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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,

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); medical device reporting of medical device-related

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Page 2

adverse events) (21 CFR 803); 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 0,000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115800.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Pạrt 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 the (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Huker Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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Indications for Use

510(k) Number (if known): K103242

Device Name: Redsense Alarm Unit for Clinical Use, Model RA-1-RA001C

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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)

Hales Leun

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K103242

Page 1 o

Regulation Number and Section

§ 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.