REDSENSE-ALARM UNIT AND SENSOR

K103242 · Redsense Medical AB · ODX · Feb 10, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103242
• Device Name: REDSENSE-ALARM UNIT AND SENSOR
• Applicant: Redsense Medical AB
• Product Code: ODX · Gastroenterology, Urology
• Decision Date: Feb 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

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.

Device Story

Redsense system monitors hemodialysis venous needle site for blood loss; consists of alarm unit and optical sensor in adhesive patch. Sensor placed over needle puncture site; uses infrared light to detect blood leakage via absorption onto patch. If leakage detected, device triggers audible/visual alarm. Used in clinical settings; operated by trained staff. Output alerts clinicians to needle dislodgement or leakage; enables rapid intervention to prevent patient blood loss.

Clinical Evidence

Bench testing only. Verification testing performed to confirm device fulfills requirement specifications for 8-hour clinical use. Testing included verification of audible and visual alarm capabilities. Results met all requirements.

Technological Characteristics

System comprises an alarm unit and an optical sensor integrated into an adhesive patch. Sensing principle: infrared light absorption to detect blood leakage. Connectivity: standalone alarm unit. Power: not specified. Sterilization: not specified.

Indications for Use

Indicated for hemodialysis patients undergoing continuous hemodialysis treatment in clinical settings for up to 8 hours to monitor for potential blood loss from the venous needle puncture site.

Regulatory Classification

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.

Predicate Devices

• Redsense Medical AB (K071013)
• Redsense Medical AB (K092955)
• Phoenix HEMODIALYSIS DELIVERY SYSTEM (K070643)

Submission Summary (Full Text)

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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 [phone]

Contact Information: Constance G. Bundy C. G. Bundy Associates, Inc. 435 Rice Creek Terrace Fridlev. MN 55432 763-574-1976 Fax: [phone] [e-mail]

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
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## Comparison Table:

· س

:

| Parameter | Proposed Device | Predicate device 1 | Predicate 2 | Predicate Device 3 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Redsense Alarm<br>Unit, Clinical Use,<br>RA-1-RA001C | Redsense Alarm<br>Unit | Redsense Alarm<br>Unit. Home use | Phoenix<br>HEMODIALYSIS<br>DELIVERY<br>SYSTEM |
| For use at: | Clinic | Clinic | Home or clinic | Clinic |
| Intended<br>Use | The Redsense<br>device is intended to<br>monitor for potential<br>blood loss from the<br>hemodialysis access<br>site in hemodialysis<br>patients undergoing<br>continuous<br>hemodialysis<br>treatment up to 8<br>hours in the clinical<br>settings. The device<br>includes a blood<br>sensor incorporated<br>into an<br>adhesive sensor<br>patch. The sensor<br>monitors potential<br>blood leakage from<br>the venous needle<br>puncture site via an<br>infrared light and will<br>alarm if blood<br>leakage is detected<br>via absorption onto<br>the device's sensor<br>patch. | The Redsense device<br>is intended to monitor<br>for potential blood<br>loss from the<br>hemodialysis access<br>site in hemodialysis<br>patients undergoing<br>continuous<br>hemodialysis<br>treatment up to 5<br>hours in the clinical<br>setting. The device<br>includes a blood<br>sensor incorporated<br>into an<br>adhesive sensor<br>patch. The sensor<br>monitors potential<br>blood leakage from<br>the venous needle<br>puncture site via an<br>infrared light and will<br>alarm if blood leakage<br>is detected via<br>absorption onto the<br>device's sensor<br>patch. | The Redsense<br>device is intended to<br>monitor for potential<br>blood loss from the<br>hemodialysis access<br>site in hemodialysis<br>patients undergoing<br>hemodialysis<br>treatment up to 5<br>hours at home or in<br>the clinical setting.<br>The device includes a<br>blood sensor<br>incorporated into an<br>adhesive dressing.<br>The sensor monitors<br>potential blood<br>leakage from the<br>needle puncture via<br>an infrared light and<br>will alarm if needle<br>dislodgement or blood<br>leakage is detected.<br>All use must be<br>administrated under<br>physician's<br>prescription, and must<br>be observed by a<br>trained and qualified<br>person considered to<br>be competent in the<br>use of this device by<br>the prescribing<br>physician. | The Phoenix<br>Hemodialysis<br>delivery system is<br>intended to be used<br>to provide high flux<br>and low flux<br>hemodialysis,<br>hemofiltration and<br>ultrafiltration on<br>patients weighing 15<br>Kilograms or more.<br>The Phoenix<br>system is to be used<br>with either high or<br>low permeability<br>dialyzers.<br>The device is<br>intended to be used<br>by trained operators<br>when<br>prescribed by a<br>physician, in a<br>chronic care dialysis<br>facility or acute<br>care unit. |
| Maximum<br>Dialysis<br>Time | 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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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 [phone] or [phone] 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:

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.

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

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