The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment. The device includes a blood sensor incorporated into a sensor patch. The sensor monitors potential blood leakage from the venous needle blood access via a light signal and will alarm if blood leakage is detected by the device's sensor.

Device Description

Redsense Medical provides a system for monitoring the blood access during haemodialysis consisting of an alarm unit and a sensor connected to a specifically developed patch. The Redsense Patch uses integrated optic fibers to detect blood leakage from wounds. The optic fiber is connected to the sensor and alarm unit. If blood leakage occurs during haemodialysis, the patch surrounding the vein needle registers the event and changes a light signal to the alarm unit. This immediately activates a light and an alarm signal. Thus if a vein needle comes out of place extensive blood leakage is prevented.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Redsense Alarm System

The Redsense Alarm System (K130554) is a device intended to monitor for potential blood loss from the hemodialysis access site during hemodialysis treatment. The device includes a blood sensor incorporated into a sensor patch that detects blood leakage via a light signal and alarms if detected.

1. Acceptance Criteria and Reported Device Performance

The core functional acceptance criteria for the Redsense Alarm System are primarily based on sound output level and compliance with relevant electrical and EMC standards. The device's ability to detect blood is validated through non-clinical testing.

Acceptance Criteria	Reported Device Performance Report
Audible Alarm: ≥ 65 dB(A) at 1 meter	Sound test report = 72 dB(A) at 1m
EMC requirements	Fulfills IEC 60601-1-2:2001 and IEC 61000-6-1 (for Medical devices + home use)
Electrical safety	Verified (not explicitly quantified in the provided text, but stated as fulfilled)
Biocompatibility of materials	Verified (not explicitly quantified in the provided text, but stated as fulfilled)
Performance (blood detection)	Validated in nonclinical test

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

The provided document does not describe a specific test set with human subjects for the K130554 device's performance evaluation. The device's performance for blood detection was validated in "nonclinical test." The clinical evidence for the intended use and safety for the subject device (K130554) relies on previous clinical data from a predicate device (K071013).

Regarding the "user evaluation" mentioned:

Sample Size: Not specified.
Data Provenance: Not specified, but based on "user feedback," it is likely retrospective or observational use of the predicate device (K071013) that informed design changes for K130554, and potentially some limited prospective evaluation for the K130554 to confirm users "can handle the device and understand its use."

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

This information is not provided as the primary performance validation for blood detection was non-clinical. For the "user evaluation," no details are given about experts or their role in establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided as there is no detailed description of a clinical test set for K130554's performance.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

There was no MRMC comparative effectiveness study described for the Redsense Alarm System (K130554) or its predicate devices. The device is an alarm system, not an interpretive diagnostic tool that involves human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device's core function is an automated alarm for blood leakage. The "ability to detect blood is validated in nonclinical test." This suggests a form of standalone performance evaluation for the sensor and alarm mechanism without direct human intervention as part of the detection process. However, the details of this non-clinical test are not provided.

7. Type of Ground Truth Used

For blood detection (non-clinical test): The "ground truth" would have been established by controlled simulations of blood leakage under laboratory conditions, using known quantities and types of blood or blood-like substances to trigger the device's sensor.
For the clinical evidence (derived from K071013): This would have involved actual patient outcomes and observations of blood loss instances in a clinical setting.

8. Sample Size for the Training Set

This information is not provided. The Redsense Alarm System appears to be based on a deterministic optical principle rather than a machine learning model that typically requires a "training set." The development of its algorithm would be based on engineering specifications and empirical testing.

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

As noted above, the concept of a "training set" in the context of machine learning does not readily apply to the described device. The "ground truth" for the device's development and validation would have been established through:

Engineering specifications and physics: Understanding the optical properties of blood and how light interacts with it.
Empirical testing and calibration: Testing the sensor's response to various concentrations and types of blood in a controlled environment to calibrate its sensitivity and alarm thresholds. This would involve creating controlled blood leakage scenarios and confirming the device's triggering mechanism.

Summary

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NOV 222 2013

2. 510(k) Summary

Submitter: Redsense Medical AB · Gyllenhammars väg 26 302 92 HALMSTAD SWEDEN

Contact Information: Mr.PatrikByhmer Patrik.byhmer@redesensemedical.com

Submission Date: February 28, 2013

Device Name/trade name and Classification: Redsense alarm system, Class II, 21 CFR 876.5820 and product code ODX

Equivalent Device Identification:

Comments of the control of the control of the first of the first of the contribution of the comments of the comments of the comments of the comments of the comments of the coRedsense Medical alarm unit K103242
Redsense Medical home use K092955

Device Description: Redsense Medical provides a system for monitoring the blood access during haemodialysis consisting of an alarm unit and a sensor connected to a specifically developed patch. The Redsense Patch uses integrated optic fibers to detect blood leakage from wounds. The optic fiber is connected to the sensor and alarm unit. If blood leakage occurs during haemodialysis, the patch surrounding the vein needle registers the event and changes a light signal to the alarm unit. This immediately activates a light and an alarm signal. Thus if a vein needle comes out of place extensive blood leakage is prevented.

Intended Use:

Issue 19Nov2013

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Comparison Table

	Redsense alarm system	Redsense alarm unit	Redsense home use
Used	Home/self+ clinic	Clinic	Home/self
Usage time	NA ( not battery operated)	8h	5h
510(k) number	New (K130554)	K103242	K092955
Intended use	The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment. The device includes a blood sensor incorporated into a sensor patch. The sensor monitors potential blood leakage from the venous needle blood access via a light signal and will alarm if blood leakage is detected by the device's sensor.	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 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.
Manufacturer	Audible AlarmRedsense MedicalComplying with IEC60 601-2-16 51,107;	Redsense MedicalComplying with IEC60 601-2-16 51,107;	Redsense MedicalComplying with IEC60 601-2-16 51,107;

Issue 19Nov2013

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	Requirements=65dB(A) at 1 mSound test report = 72dB(A) at 1m	Requirements=65dB(A) at 1 mSound test report = 72dB(A) at 1m	Requirements=65dB(A) at 1 mSound test report = 72dB(A) at 1m
Operation power	Power supply	Internal rechargeablebattery	Internal rechargeablebattery
EMC requirements	Fulfills IEC 60601-1-2:2001 and IEC 61000-6-1 (for Medicaldevices + home use)	Fulfills IEC 60601-1-2:2001 and IEC 61000-6-1 (for Medical devices+ home use)	Fulfills IEC 60601-1-2:2001 and IEC 61000-6-1 (for Medicaldevices + home use)
Type of Clinical trialobtained	No new clinical data.Same as K071013used.	No new clinical data.Same as K071013 used.	No new clinical data.Same as K071013used.
Electrical contact	Standard US electricaloutlet (power supply)	Standard US electricaloutlet (charger)	Standard US electricaloutlet (charger)
Sensor used	New Redsense sensor	Redsense Sensor	Redsense Sensor

Discussion with respect to predicate devices

The Redsense alarm system is not battery operated, has two material changes (skin contact material), the sensor is slightly re-designed and can be used both at the clinic and at home. There is one predicate device K071013 manufactured by Redsense Medical as well not part of the table above but is also very similar in the technique and material. The predicate devices above rely on the clinical user evaluation data for the K071013 as well as some of the materials and so does the new device.

The new sensor operates on the same optical principle but is designed differently to be automate the production. This will reduce operator introduced risks as well as provide a better more stable production process. Instead of a bend of a thinner optical fiber we use a thicker which has been processed with a tip that will cause the same physical phenomena as with a bend of the fiber.

The redesign of the patch is that we use two materials that are flexible thus casier to place over a fistula that bulges. Also we use a larger absorbent patch so that the placement of the sensor becomes more forgiving.

All devices refer to the same clinical evidence presented in K071013. The changes we have made for the subject device are driven mainly by user feed-back. The clinical evaluations we have made is to confirm that the users can handle the device and understand it use. The ability to detect blood is validated in nonclinical test.

The major reason for change in the software is due to the change in power management. The predicate device was driven from a rechargeable battery. The subject device is not battery driven but instead supplied continuously from the power socket. For example the alarm algorithm for detecting blood is the same as is the failure handling in the software (i.e. low power, faulty signals etc).

Summary of Testing:

Verification testing has been performed to verify that the Redsense Alarm system device fulfills the Requirement Specifications. The electrical safety and EMC are fulfilled as well as the biocompatibility of the material and the performance.

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Conclusion: Redsense Alarm system is similar in function and intended use to the Redsense Medical K071013, Redsense Alarm unit K103242 and home use device K092955. Verification and user evaluation show the Redsense systems to be safe and effective for the intended use.

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Issue 19Nov2013

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is positioned to encircle the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-00002

November 22, 2013

Redsense Medical AB Patrik Byhmer CEO Gyllenhammars väg 26 Halmstad 30292 Sweden

Re: K130554

Trade/Device Name: Redsense Alarm System Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: ODX Dated: October 14, 2013 Received: October 17, 2013

Dear Patrik Byhmer,

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. Iisting 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.

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Page 2 - Patrik Byhmer

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 (reporting of medical device-related 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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P., Lerner -S

for

Benjamin R. Fisher. Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

610(k) Number (If known) K 130554

Device Name

Redsense Alam System

Indications for Use (Describe)

The Redserse device is intended to potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodlalysis treatment. The device indudes a blood sensor incorporated into a sensor monitors potential blood leakege from the versous needle blood access via a light signal and will alam if blood leakage is detected by the device's sensor.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

SEAST PROPERTY CONTRACT FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Canter for Devices and Radiological Health (CDRH) (Signature)

Herbert P. Lemer - 5
2013.11.22 17:04:50:-05'00'

FORM FDA 3881 (8/13)

Page 1 of 2

75C Publishing Serion (101) 410-4700

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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.