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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Redsense - Home Use device, organized by your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the types of tests performed and their general success, rather than specific numerical acceptance criteria for performance metrics like sensitivity or specificity. The focus is on demonstrating that the device meets safety and functionality requirements for home use.

Acceptance Criteria Category	Reported Device Performance (Summary)
Audible Alarm Capability	Performed according to "Class II Special Controls Guidance Document: Apnea Monitors" and met requirements. Sound level increased for home use.
Visual Alarm Capability	Tested against ISO 9703-1:1992: "Alarm signals for anesthesia and respiratory care. Part 1. Specification for visual alarm signals." Results met the requirements.
User Evaluation (Home Use)	Device could be used by patients, and Instructions for Use were sufficient. Amount of false alarms and warnings did not increase compared to clinical settings. No adverse effects observed. Device functioned successfully in the home use environment.
Compliance with Requirement Specifications and FDA Requirements	Verification testing, including additional tests for audible and visual alarms, confirmed the Redsense Home Use device fulfills these.

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

Sample Size for User Evaluation (Test Set): 8 patients
Data Provenance: Sweden (patients undergoing self-dialysis at a clinic or home dialysis in Sweden). The study was a prospective user evaluation of the device in its intended use environment.

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

The document does not explicitly state the number of experts or their specific qualifications for establishing ground truth in the user evaluation. The user evaluation focused on patient usability and false alarm rates, not on the diagnostic accuracy against an independent "gold standard" truth. It mentions that use "must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician," implying supervision, but not a panel of experts for ground truth assessment in the study itself.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The user evaluation for false alarms and warnings likely relied on observations by the patients themselves and/or the "trained and qualified person" overseeing the treatment, rather than a blinded expert panel adjudication process for each event.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed. This device is a standalone blood loss detection system, not an AI-assisted diagnostic tool that aids human interpretation.

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

Yes, the primary evaluation of the Redsense device, particularly the alarm capabilities (audible, visual, and detection of blood leakage), represents a standalone performance assessment. The user evaluation then confirmed that this standalone device functioned appropriately in the home-use context with actual patients, but the core detection and alarming are performed by the algorithm/sensor itself without human intervention in the detection process.

7. The Type of Ground Truth Used

For the audible and visual alarm tests, the "ground truth" was defined by the requirements outlined in "Class II Special Controls Guidance Document: Apnea Monitors" and ISO 9703-1:1992.
For the user evaluation, the "ground truth" related to device functionality (e.g., whether it could be used by patients, if instructions were sufficient, whether false alarms increased, or if adverse effects occurred) was established through direct observation during home or clinic dialysis and patient feedback. The "blood loss detection" aspect's ground truth would have been real or simulated blood leakage events (though specifics aren't detailed in the provided excerpt for the home use study; it only states detection if "blood loss is detected").

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for an algorithm. This device is an alarm system based on sensor detection (infrared light detecting blood), rather than a machine learning model that requires a discrete training phase.

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

As there is no explicit mention of a training set or a machine learning algorithm, information on how ground truth was established for a training set is not applicable or provided in the given text. The device's operation is based on a direct physical principle (infrared light detection of blood).

Summary

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2. 510(k) Summary

ﻟﺮﻱ ﺗ

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:

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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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.

Conclusion: Redsense Home Use device is equivalent to the Redsense device previously cleared with the addition of the home use indication. A minor difference includes an increase in the sound level. This was accomplished by minor changes regarding placement of components on the PC board inside the alarm unit. Verification and user evaluation show the Redsense Home Use device to be safe and effective for the intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized depiction of an eagle, which is a common symbol of the United States.

MAY 1 0 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6( Silver Spring, MD 20993-0002

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

Re: K092955

Trade/Device Name: Redsense - Home Use Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device Regulatory Class: II Product Code: ODX Dated: May 4, 2010 Received: May 7, 2010

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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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 1000-1050.

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/ucm115809.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 Part 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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1. Indications for Use

510(k) Number (if known): _ |< 0 92 9 5

Device Name: Redsense - Home Use

Indications for Use:

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.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)	/
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vice Evaluation (ODE)

Division Sign Off

(Division)Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K092955 510(k) Number _

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.