(78 days)
The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the IcyTM 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.
The Alsius CoolGard® 3000 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.
The CoolGard and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 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 provided document is a 510(k) Summary and an FDA 510(k) clearance letter for the Alsius CoolGard 3000 and Catheter Thermal Regulation System. This submission is for modifications to the software of an existing device, and the device acts as its own predicate.
As such, acceptance criteria and device performance in the traditional sense of a new medical device showing clinical efficacy or diagnostic accuracy are not explicitly outlined as a pass/fail threshold. Instead, the study aims to demonstrate that the software modifications do not raise new questions of safety or effectiveness and that the updated system is substantially equivalent to its existing predicate (itself).
The document details a randomized controlled trial that was previously conducted, which is relevant to a specific warning for the device, rather than being the primary study proving the current software modification meets acceptance criteria.
Let's break down the information based on your request, focusing on what is available and noting where details are not provided due to the nature of this 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) is for a software modification to an existing device, the "acceptance criteria" are not reported as specific performance metrics against a threshold for new clinical efficacy. Instead, the acceptance criteria are implicitly that the software modifications do not negatively impact the device's safety or effectiveness as established by its previous clearances. The reported device performance relates to a clinical trial mentioned in a warning on its labeling.
| Acceptance Criteria (Implicit for Software Modification) | Reported Device Performance (from cited clinical trial relevant to a warning) |
|---|---|
| No new questions of safety or effectiveness | Trial results for mortality by diagnosis are provided. The "device performance" in this context is the observed mortality rates in different cohorts with and without the device (Cool Line) for fever reduction, to inform a warning about specific uses. The p-values indicate no statistically significant difference in mortality across the groups for the specified conditions (CI, ICH, PTBI, SAH) in this particular study. This study is not proving efficacy for the current software modification, but providing data for a device warning. |
| Substantial equivalence to predicate device (itself) | "descriptive information and performance data demonstrate that the Alsius CoolGard and Catheter Thermal Regulation System characteristics do not raise new questions of safety and effectiveness. Where appropriate, performance data demonstrate equivalence." - The specific technical performance data supporting this claim for the software modification are summarized but not detailed in this 510(k) summary. |
2. Sample Size Used for the Test Set and Data Provenance
The primary "test set" discussed in relation to clinical outcomes is from a randomized controlled trial of 296 patients. This study's data informs a warning related to fever reduction with the Cool Line Catheter.
- Sample Size (for the referenced clinical trial): 296 patients
- Cool Line group: (16 CI + 33 ICH + 44 PTBI + 61 SAH) = 154 patients
- Control group: (14 CI + 27 ICH + 38 PTBI + 63 SAH) = 142 patients
- Data Provenance: The document does not specify the country of origin. It is a retrospective analysis of previously collected data, forming the basis of a clinical trial used to establish a warning rather than being a prospective trial for the current software modification. The trial itself would have been prospective to collect the data, but the analysis presented here is of already completed data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The clinical trial generated patient outcomes (mortality), which served as the "ground truth" for evaluating the safety concern, rather than requiring expert consensus on a subjective measure.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given that the outcome measured was mortality, which is an objective endpoint, a formal adjudication method for interpretation might not have been
explicitly required in the same way it would be for subjective diagnostic evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the performance of human readers, sometimes with and without AI assistance, especially in diagnostic imaging. The device in question is a thermal regulation system, not an imaging or diagnostic AI device. The study cited is a randomized controlled trial assessing mortality outcomes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
No, a standalone algorithm-only study was not done in the context of diagnostic performance. The device is a physical thermal regulation system with software control. The "algorithm" here refers to the software controlling the device's function. The 510(k) submission for the software modification indicates that software revisions were made and "supportive evidence is provided to establish that there are no new questions of safety or efficacy." The details of this "supportive evidence" are not fully elaborated in the summary but would likely involve verification and validation testing of the software changes to ensure it performs as intended and does not introduce hazards (e.g., in a standalone testing environment for the software, but not in the sense of a standalone clinical performance study).
7. The Type of Ground Truth Used (for the described clinical trial)
The ground truth for the clinical trial was outcomes data, specifically mortality. Mortality is an objective and directly observable outcome.
8. The Sample Size for the Training Set
The document is for a 510(k) submission for a software modification to an existing medical device. It does not describe a machine learning algorithm or an AI model that would require a "training set" in the conventional sense. The "software revisions" mentioned would have been developed and tested, but the term "training set" doesn't apply here.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no "training set" in the context of this 510(k) submission. The software modifications would have undergone software validation and verification according to established engineering and regulatory practices, rather than being "trained" on data.
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K0600308
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Company Confidential
CoolGard 3000 Thermal Regulation System
.
510(k) Summary or 510(k) Statement 5
510(k) SUMMARY FOR ALSIUS CORPORTATION'S COOLGARD 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 |
Name of Device
The Alsius CoolGard And Catheter Thermal Regulation System.
Common or Usual Name
Central Venous Catheter (short term) and Thermal Regulating System.
Classification Name
FDA has classified the Alsius CoolGard 3000/Alsius heat exchange catheters as Class Il devices under 21 C.F.R. §§ 870.5900 - System, Hypothermia, Intravenous, Cooling. Classification Product Code: NCX.
Predicate Devices
The product acts as its own predicate. This is a modification to the software of the device.
Indications for Use
The following Indications for Use have clearance within the USA. The COOLGARD™ 3000 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 COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the IcyTM 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
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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 CoolGard® 3000 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 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 CoolGard and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 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 predicate device with the exception of revisions to the software that controls the device.
The following models of Intravascular catheters are available for use with the CoolGard and Catheter Thermal Regulation System:
-
- ICY® Catheter Kit Model IC-3585A(CO)
| 15770 Laguna Canyon Road, Suite 150 | Page 18 |
|---|---|
| Irvine, California 92618 |
Tel: 949.453.0150 FAX: 949,453.0250
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-
- ICY® Catheter Kit Model IC-3893A(CO)
-
- Fortius® Catheter Kit Model FR-5093B(CO)
-
- Cool Line® Catheter Kit Model CL 2085B(CO)
-
- Cool Line® Catheter Kit Model CL 2295A(CO)
Principles of Operation
The CoolGard™ 3000 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 System in this premarket notification acts as its own predicate. There are no changes to the indications for use of the device. Revisions have been made to the software of the device for which supportive evidence is provided to establish that there are no new questions of safety or efficacy.
The System is substantially equivalent to the predicate device, the system itself.
Conclusion
In summary, descriptive information and performance data demonstrate that the Alsius CoolGard 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 CoolGard 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
APR 2 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alsius Corporation c/o Kenneth A. Collins, M.D. Executive Vice President 15770 Laguna Canyon Road, Suite 150 Irvine, California 92618
Re: K060308
Trade/Device Name: Alsius CoolGard 3000 and Catheter Thermal Regulation System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: February 2, 2006 Received: February 9, 2006
Dear Dr. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that the Cool Line Catheter will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling as a box warning immediately following the indications for use statement: 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).
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Page 2 - Kenneth A. Collins, M.D.
| 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 |
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 ill stroke patient" #101416-001.
Please note that the above labeling limitation is required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before this limitation is modified in any way or removed from the device's labeling. This limitation does not apply to the Icy & Fortius Catheters.
The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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); 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.
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Page 3 - Kenneth A. Collins. M.D.
If you desire specific information about the application of other labeling requirements to your device (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: (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
V.C.M.
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060308
Alsius CoolGard 3000 and Catheter Thermal Regulation System Device Name:
Indications For Use:
Indications For Use:
Cool Line Cathers - Indications for Use:
The Alsius CoolGard® 3000 and Cool Line ™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in nationts 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 (C1 - cerebral infarction, ICH - intracerebral hemormage, PTBI - primary traumatic brain injury, SAH - subarrachnoid hemorrhage).
| Mortality by Diagnosis (ITT analysis) | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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 |
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 Deyise Evalua
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Indications for Use
510(k) Number (if known): K060308
Alsius CoolGard 3000 and Catheter Thermal Regulation System Device Name:
Indications For Use:
Fortius and Icy Catheters - Indications for Use:
The COOLGARD™ 3000/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.
AND/OR -Over-The-Counter Use Prescription Use _X (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)
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).