REDSENSE-HOME USE

K092955 · Redsense Medical AB · ODX · May 10, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K092955
• Device Name: REDSENSE-HOME USE
• Applicant: Redsense Medical AB
• Product Code: ODX · Gastroenterology, Urology
• Decision Date: May 10, 2010
• 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 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 Story

Redsense monitors hemodialysis needle sites for dislodgement or leakage. System comprises alarm unit and optical sensor integrated into adhesive patch. Sensor uses infrared light to detect blood presence at puncture site; triggers alarm upon detection. Used in home or clinical settings; operated by patient or trained/qualified observer under physician prescription. Output is audible/visual alarm alerting user to potential blood loss. Enables rapid intervention to prevent significant blood loss during dialysis.

Clinical Evidence

User evaluation conducted with 8 patients undergoing self-dialysis at home or clinic. Evaluated usability and instructions for use. Results showed no increase in false alarms compared to clinical setting and no adverse effects. Device functioned successfully in home environment.

Technological Characteristics

System includes alarm unit and optical sensor in adhesive patch. Sensing principle: infrared light detection of blood leakage. Connectivity: standalone. Alarm: audible and visual (LEDs). Minor PC board modifications for increased sound level.

Indications for Use

Indicated for hemodialysis patients undergoing treatment up to 5 hours in home or clinical settings to monitor for blood loss from access site. Must be used under physician prescription and observed by a trained, competent person.

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 (K071013)

Submission Summary (Full Text)

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# 2. 510(k) Summary

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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:

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.

### 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 [phone] or [phone] 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:

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.

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)

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vice Evaluation (ODE)

Division Sign Off

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