THERMOGARD XP THERMAL REGULATION SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Alsius Corporation. The logo is in a serif font, with the letters "A" and "l" connected. The word "Corporation" is written in smaller letters below the word "Alsius". # 072234 #### 510(k) Summary or 510(k) Statement 6 # 510(k) SUMMARY FOR ALSIUS CORPORTATION'S THERMOGARD XP AND CATHETER THERMAL REGULATION SYSTEM # Submitter's Name, Address, Telephone Number, and Contact Person ALSIUS CORPORATION 15770 Laguna Canyon Road, Suite 150 Irvine, CA 92618 Contact: Ken Collins Phone: (949)-453-0150 Fax: (949)-453-0250 Email: kcollins@alsius.com AUG 2 3 2007 # Name of Device The THERMOGARD XP and Catheter Thermal Regulation System. # Common or Usual Name Central Venous Catheter (short term) and Thermal Requlating System. # Classification Name FDA has classified the Alsius THERMOGARD XP/Alsius heat exchange catheters as Class II devices under 21 C.F.R. §§ 870.5900 - System, Hypothermia, Intravenous, Cooling. Classification Product Code: NCX. # Predicate Devices The Alsius CoolGard 3000™/Alsius THERMOGARD™ thermal regulation system. # Indications for Use The THERMOGARD XP can be used with any of the Alsius Catheters. The indications for use are specific to the catheter. Please refer to the Indications for Use statement in the catheter specific Instructions for Use. # Indications for Use (K030421, K051912, K052443) The THERMOGARD XP/Alsius Catheter Thermal Regulation System, using either the lcy™ or Fortius™ model catheter, is indicated for use: - . In cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and 15770 Laguna Canyon Road, Suite 150 Page 25 Irvine, California 92618 Tel: 949.453.0150 FAX: 949.453.0250 {1}------------------------------------------------ Company Confidential K07XXXX Thermogard XP - To induce, maintain and reverse mild hypothermia in neurosurgery patients in . surgery and recovery/intensive care. # Indications for Use (K014241, K051912) The Alsius THERMOGARD XP™ and Cool Line™ Catheter Thermal Requlation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. ### Warning - Fever Reduction The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for the four patient cohorts enrolled, are presented in the table below (CI - cerebral infarction, ICH - intracerebral hemorrhage, PTBI – primary traumatic brain injury, SAH – subarachnoid hemorrhage). | | Cool Line | | | Control | | | | |------|-----------|----|------|---------|----|------|----------| | | n | N | % | n | N | % | p-value* | | CI | 3 | 16 | 18.8 | 3 | 14 | 21.4 | 0.74 | | ICH | 8 | 33 | 24.2 | 7 | 27 | 25.9 | 1.00 | | PTBI | 10 | 44 | 22.7 | 4 | 38 | 10.5 | 0.24 | | SAH | 13 | 61 | 21.3 | 7 | 63 | 11.1 | 0.15 | | Table 1-1. Mortality by Diagnosis (ITT) | | | |------------------------------------------|--|--| | | | | *Fischer's exact test For more details on the results of this study please refer to Physician's Manual – "Normothermia for the Neuro-critically III Stroke Patient" #101416-001. #### Technical Characteristics The THERMOGARD XP and Catheter Thermal Regulation System consists of the THERMOGARD XP, a disposable Start Up Kit used to interface between the cooling bath of the THERMOGARD XP and the intravascular Catheter. The THERMOGARD XP is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller primo. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient. The technical characteristics of the Catheter are identical to the predicate device. Page 26 ALSIUS 510k Page 26 of 213 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for Alsius Corporation. The logo is in black and white and features the word "Alsius" in a stylized font. Below the word "Alsius" is the word "Corporation" in a smaller, less stylized font. The logo is simple and professional. Company Confidential - To induce, maintain and reverse mild hypothermia in neurosurgery patients in . surgery and recovery/intensive care. # Indications for Use (K014241, K051912) The Alsius THERMOGARD XP™ and Cool Line™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. # Warning - Fever Reduction The safety of this device has not been demonstrated for fever reduction in patients presenting with subarach oid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a fandomized controlled trial of 296 patients. The mortality results reported in this trial; for the four patient cohorts enrolled, are presented in the table below (CI - cerebral infarction, ICH - intracerebral hemorrhage, PTBI - primary traumatic brain injury, SAH - subarachnoid hemorrhage). | | Cool Line | | | Control | | | | |------|-----------|----|------|---------|----|------|----------| | | n | N | % | n | N | % | p-value* | | CI | 3 | 16 | 18.8 | 3 | 14 | 21.4 | 0.74 | | ICH | 8 | 33 | 24.2 | 7 | 27 | 25.9 | 1.00 | | PTBI | 10 | 44 | 22.7 | 4 | 38 | 10.5 | 0.24 | | SAH | 13 | 61 | 21.3 | 7 | 63 | 11.1 | 0.15 | | Table 1-1、Mortality by Diagnosis (ITT) | | | | | |----------------------------------------|--|--|--|--| |----------------------------------------|--|--|--|--| *Fischer's exact test For more details on the results of this study please refer to Physician's Manual - "Normothermia for the Neuro-critically III Stroke Patient" #101416-001. # Technical Characteristics The THERMOGARD XP and Catheter Thermal Regulation System consists of the THERMOGARD XP, a disposable Start Up Kit used to interface between the cooling bath of the THERMOGARD XP and the intravascular Catheter. The THERMOGARD XP is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient. The technical characteristics of the Catheter are identical to the predicatedevice with the exception of revisions to the software that controls the device. ( 15770 Laguna Canyon Road, Suite 150 Irvine, California 92618 Page 26 Tel: 949.453.0150 FAX: 949.453.0250 ALSIUS 510k Page 26 of 213 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Alsius Corporation. The logo is in black and white and features the company name in a stylized font. The word "Alsius" is in a larger font than the word "Corporation", which is located below the first word. Company Confidential All models of Alsius Intravascular catheters are available for use with the THERMOGARD XP. # Principles of Operation The THERMOGARD XP system automatically adjusts the temperature of the heater/chiller saline bath to achieve the patient target temperature that has previously been set by the attending physician. This is done via data from a temperature probe in the patient that interfaces with the temperature controller. This principle of operation is identical to the predicate device. # Summary of the Basis for Finding of Substantial Equivalence The THERMOGARD XP System is substantially equivalent to the Alsius THERMOGARD™ heat exchange system in all its specifications except that its compressor allows additional cooling power. # Conclusion In summary, descriptive information and performance data demonstrate that the Alsius THERMOGARD XP and Catheter Thermal Regulation System characteristics do not raise new questions of safety and effectiveness. Where appropriate, performance data demonstrate equivalence. The system in this revision acts as its own predicate device. The THERMOGARD XP and Catheter Thermal Regulation System is safe and effective when used in accordance with the Directions For Use and substantially equivalent to the predicate device. {4}------------------------------------------------ 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 eagle with three stripes forming its body and wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Alsius Corporation % Mr. Kenneth A. Collins Executive Vice President 15770 Laguna Canyon Road Suite 150 Irvine, California 92618 AUG 2 3 2007 Re: K072234 Trade/Device Name: Alsius THERMOGARD XP and Catheter Thermal Regulation System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: August 7, 2007 Received: August 10, 2007 Dear Mr. Collins: 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. 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. {5}------------------------------------------------ Page 2 - Mr. Kenneth A. Collins 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. ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson FOR Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Alsius THERMOGARD XP and Catheter Thermal Regulation System Indications For Use: Indications For Use: # Alsius Thermogard - Indications for Use The Alsius THERMOGARD XP and Cool Line ™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. # Warning - Fever Reduction The safety of this device has not been demonstrated for fever reduction in patients presenting with subarrachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for the four patient cohorts enrolled, are presented in the table below (CI - cerebral infarction, ICH - intracerebral hemorrhage, PTBI – primary traumatic brain injury, SAH – subarrachnoid hemorrhage). | | | Cool Line | | | | Control | | | | |------|--|-----------|----|------|--|---------|----|------|------| | | | n | N | % | | n | N | % | p* | | CI | | 3 | 16 | 18.8 | | 3 | 14 | 21.4 | 0.74 | | ICH | | 8 | 33 | 24.2 | | 7 | 27 | 25.9 | 1.00 | | PTBI | | 10 | 44 | 22.7 | | 4 | 38 | 10.5 | 0.24 | | SAH | | 13 | 61 | 21.3 | | 7 | 63 | 11.1 | 0.15 | #### ートー【"4" 【 : . . "Fischer's exact test For more details on the clinical trial results please refer to Physician's Manual -"Normothermia for the Neuro-critically III stroke patient" #101416-001. | Prescription Use _X_ | AND/OR | Over-The-Counter Use _____ | |-----------------------------|--------|----------------------------| | (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices | 510(k) Number | L072234 | |----------------|-------------| | Page 10 of 213 | Page 1 of 2 | {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Alsius THERMOGARD XP and Catheter Thermal Regulation System Indications For Use: # Fortius and Icy Catheters - Indications for Use The Alsius THERMOGARD XP/Alsius Catheter Thermal Regulation System, using either the Icy™ or Fortius™ model catheter, is indicated for use: - . in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and - to induce, maintain and reverse mild hypothermia in neurosurgery patients in . surgery and recovery/intensive care. Prescription Use X AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)