REDSENSE

K071013 · Redsense Medical AB · ODX · Oct 18, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071013
• Device Name: REDSENSE
• Applicant: Redsense Medical AB
• Product Code: ODX · Gastroenterology, Urology
• Decision Date: Oct 18, 2007
• 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 continuous hemodialysis treatment up to 5 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 access sites for accidental dislodgement or leakage. System comprises alarm unit and infrared sensor integrated into adhesive patch. Sensor placed over needle puncture site; detects blood via IR light absorption if leakage occurs onto patch. Upon detection, device triggers alarm. Used in clinical settings during hemodialysis treatments up to 5 hours. Provides real-time monitoring to alert clinicians of blood loss; enables rapid intervention to prevent patient blood loss.

Clinical Evidence

Clinical testing conducted at multiple hospitals in Sweden (Eksjö, Halmstad, Hässleholm, Skövde, and Varberg). Study demonstrated the device functioned successfully in the clinical environment for its intended use.

Technological Characteristics

System includes fiber optical blood detector, adhesive, and absorbent pad. Sensing principle: infrared light absorption. Form factor: adhesive patch with 0.25 mm diameter sensor. Connectivity: standalone alarm unit. Single-use sensor patch.

Indications for Use

Indicated for hemodialysis patients undergoing continuous hemodialysis treatment (up to 5 hours) in clinical settings 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

• Neotrend (K972314)
• Fresenius 2008 Touch panel control Dialysis system (K890824)

Submission Summary (Full Text)

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Redsense Medical K071013

## 2. 510(k) Summary

Submitter: Redsense Medical AB Rörkullsvägen 4 Box 287 301 07 HALMSTAD SWEDEN

0CT 1 8 2007

Contact Information: Constance G. Bundy 6470 Riverview Terrace Fridley, MN 55432 Submission Date:

Device Name and Classification: Redsense, Class II, 876.5540, product code not known

Equivalent Device Identification: Neotrend (K972314) and Fresenius 2008 Touch panel control Dialysis system (K890824)

Device Description: Redsense is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consists of an alarm unit and infrared sensor incorporated into an adhesive patch. The patch with the sensor is placed around the vein or arterial 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 the hemodialysis access site in hemodialysis patients undergoing continuous hemodialysis treatment up to 5 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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### Comparison Table

| Parameter | Proposed Device | Predicate device 1 | Predicate Device 2 |
|-------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Device | Redsense | Neotrend Multiparameter<br>Sensor | Vein pressure supervision,<br>integrated in Fresenius 2008<br>Dialysis system |
| Intended Use | Monitor blood<br>leakage from<br>venous needle<br>puncture site | Continuous blood gas<br>monitoring system for pO2,<br>temperature, pCO2 and pH | Blood line separation (can be<br>caused by vein needle<br>dislodgement) |
| Manufacturer | Redsense Medical | Diametrics Medical Itd | Fresenius |
| Technology | Blood detection<br>through IR light<br>absorption in fiber<br>optics/ adhesive<br>absorption pad | Blood gas sensor thought<br>optical fiber/ fluorescence<br>quenching technology (fiber<br>optic photometric<br>absorption) | Pressure detection |
| Blood amount<br>for detection | approximately 2 ml | Not specified | Not specified, alarm pressure level<br>can be adjusted |
| Area of<br>detection | NA "Blood or no<br>blood" | pO2 20-500mmHg,<br>temperature 10-42 °C, pCO2<br>10-160 mmHg and pH 6.80 -<br>7.80 | -60 to 520 mmHG |
| Tolerance | NA | pO2 +/- 3mmHg,<br>temperature +/- 0,3 °C,<br>pCO2 +/- 3 mmHg and pH<br>+/- 0.03 | +/- 10 mmHg |
| Size of sensor | D= 0.25 mm | D= 0.5 mm | NA |
| Optical Fiber<br>type | Plastic | Plastic | NA |
| Light type | Infrared | Green and Red visible | NA |
| Components<br>parts | Fibre Optical blood<br>detector, adhesive,<br>absorbent | Fiber Optical blood sensor<br>with chemical dye | Pressure sensor |
| Single use | Yes | Yes | No |
| Sterile | No | Yes | NA |
| Usage time | 5h | 72 h | 5h |
| Patient<br>contact | Skin | Intravascular access | No |

#### Summary of Testing:

Verification testing has been performed to verify that the Redsense device fulfills the Requirement Specifications.

Clincal testing was conducted at the Departments of Nephrology/Medicine at Eksjö, Halmstad, Hässleholm, Skövde, and Varberg Hospitals in Sweden. Results showed the device functioned successfully in the clinical environment.

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Ko71013 PAGE 3 OF 3

Redsense Medical K071013

Conclusion: Redsense is similar in function and intended use to the vein pressure component of the Fresenius device and has sensing technology that is similar to the Neotrend device. Verification and clinical testing show the Redsense system to be safe and effective for 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2007

Redsense Medical AB c/o Ms. Constance G. Bundy Regulatory Consultant C.G. Bundy Associates, Inc. 6470 Riverview Terrace FRIDLEY MN 55432

Re: K071013

Trade/Device Name: Redsense Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: ODX Dated: October 16, 2007 Received: October 17, 2007

#### 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.

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

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K071013

Device Name: Redsense

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 5 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Hebert Werner

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

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