(90 days)
Not Found
No
The device description focuses on the mechanical and fluid dynamics of the catheter and thermal regulation system. There is no mention of AI, ML, or any software components that would suggest the use of such technologies for decision-making, control, or analysis. The performance studies are based on a traditional clinical trial comparing mortality rates, not on the performance of an AI/ML algorithm.
Yes
The device is indicated for fever reduction, maintaining normothermia, and inducing/maintaining/reversing hypothermia, which are all therapeutic interventions aimed at treating medical conditions or symptoms.
No
Explanation: The device is a thermal regulation system designed to achieve and/or maintain normothermia or induce, maintain, and reverse mild hypothermia. Its purpose is therapeutic (temperature management), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly details physical components like multi-lumen intravascular catheters with balloons, lumens for circulating saline, and infusion channels. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for fever reduction and temperature regulation (normothermia, mild hypothermia) in adult patients with specific medical conditions. This involves directly interacting with the patient's body (central venous circulation) to achieve a therapeutic effect.
- Device Description: The device description details a catheter with balloons that circulate sterile saline to exchange heat with the patient's blood. This is a physical intervention to alter the patient's body temperature.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The device's function is therapeutic, not diagnostic.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about the body's state. This device directly interacts with the body to change its state.
N/A
Intended Use / Indications for Use
The Cool Line Catheter Model CL-2295A when used with the ZOLL Thermal Regulation System is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral infaccerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The ZOLL ICY Catheter Model IC-3893A, connected to the ZOLL Thermal Regulation System, is indicated for use:
- In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:
- In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recoveryintensive care.
Product codes (comma separated list FDA assigned to the subject device)
NCX
Device Description
ZOLL IVTM Cool Line. ICY and Quattro catheters are multi lumen intravascular catheters with balloons as heat exchange units. Each of these three catheter models has two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The thermal regulation system chills/warms the saline and pumps it through the inflow lumen of the catheter. The chilled/warmed saline travels to the balloons, whose surface facilitates heat exchange between the patient's circulating blood and the saline returns to the system via the outflow lumen. The chilled/warmed saline is not infused into the patient. Two additional lumens provide infusion channels. The fifth lumen serves as a guide wire lumen which can also be used as an infusion lumen. The basic difference between these three models of catheters is size and number of balloons which provides different heat exchange capacity. The catheters are supplied sterile for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central venous circulation
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A randomized controlled trial of 296 patients was conducted to examine the safety and effectiveness of the device for fever reduction. The mortality results for the four patient cohorts enrolled are presented in a table. The study examined "Mortality by Diagnosis (ITT analysis)".
Mortality by Diagnosis (ITT analysis) for Cool Line Catheter:
CI: n=3, N=16, %=18.8
ICH: n=8, N=33, %=24.2
PTBI: n=10, N=44, %=22.7
SAH: n=13, N=61, %=21.3
Mortality by Diagnosis (ITT analysis) for Control:
CI: n=3, N=14, %=21.4, p*=0.74
ICH: n=7, N=27, %=25.9, p*=1.00
PTBI: n=4, N=38, %=10.5, p*=0.24
SAH: n=7, N=63, %=11.1, p*=0.15
*Fischer's exact test
The new coating was verified via a combination of in vitro biocompatibility testing per ISO 10993-1. In vitro Thrombogenicity testing verified performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 168 hours of hypothermia treatment. Results demonstrated that the modified device is comparable to the results of the animal model testing of the predicate device(s) included in the original submissions cleared by the FDA. The effects of coating on catheter performance in regards to intended use was verified via a battery of bench tests including Heat Exchange Efficiency test, Life Test (trouble free heat exchange for the in-dwell time), Balloon Bond and/or Catheter Burst test, Heparin Coating consistency (Toluidine Blue Staining) and Heparin Activity test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Mortality rates for different patient cohorts. P-values from Fischer's exact test comparing Cool Line and Control groups.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DEC 1 3 2015
ZOLL Circulation, Inc. Mr. Sam Nanavati Vice President, Quality and Regulatory Affairs 650 Almanor Avenue Sunnyvale, California 94085
Re: K101987
Trade/Device Name: Cool Line Catheter Model CL-2295A. ICY Catheter Model IC-3893A, Quattro Catheter Model IC-4593
Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX Dated: July 13, 2010 Received: July 14, 2010
Dear Mr. Nanavati:
This letter corrects our substantially equivalent letter of October 12, 2010.
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 and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that the Cool Line Catheter Model CL-2295A 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
1
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* | |
| 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 analysis)
*Fischer's exact test
For more details on the clinical trial results 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 these limitations are modified in any way or removed from the device's labeling. This limitation does not apply to the ICY and Quattro Catheters.
The FDA finding of substantial equivalence of your device to a legally marketed 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
2
Page 3 - Mr. Sam Nanavati
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
John W. Sheets Jr., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K101987
Device Name
Cool Line Catheter Model CL-2295A, ICY Catheter Model IC-3893A, and Quattro Catheter Model IC-4593
Indications for Use (Describe)
The Cool Line Catheter Model CL-2295A when used with the ZOLL Thermal Regulation System is indicated for use in fever reduction, as an adjunct to antipyretic therapy, in adult patients with cerebral infaccerebral 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 with subarachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized 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* | ||
| 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 analysis)
*Fischer's exact test
For more details on the clinical trial results planial - "Normothermia for the Neuro- critically III stroke patient" #101416-001.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
The ZOLL ICY Catheter Model IC-3893A, connected to the ZOLL Thermal Regulation System, is indicated for use:
- · In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- · To induce, maintain and reverse mild hypothernia in neurosurgery adult patients in surgery and recovery/intensive care.
The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:
- · In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and
- · To induce, maintain and reverse mild hypothernia in neurosurgery adult patients in surgery and recoveryintensive care.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------- | -------------------------------------------------------------------------- |
[X] Prescription Use {Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
K101987
13 510(k) Summary
OCT 1 2 2010 510(K) SUMMARY FOR MODIFICATIONS TO ZOLL IVTM COOL LINE, ICY, AND QUATTRO CATHETERS
Submitter's Name, Address, Telephone Number, and Contact Person
ZOLL Circulation, Inc. 650 Almanor Avenue Sunnyvale, CA 94085 Establishment Registration Number: 3003793491
Contact: Sam Nanavati Phone: 408-541-2140 Fax: 408-541-1030 Email: snanavati@zollcirculation.com
Name of Device
ZOLL IVTM Cool Line Catheters ZOLL IVTM ICY Catheters ZOLL IVTM Quattro Catheters
Common or Usual Name
Central Venous Catheter (short term) and Thermal Regulating System
Classification Name
21 CFR 870.5900 System, hypothermia, intravenous, cooling
Device Class
Class II
Predicate Devices
| Device Name | 510(k) # | Decision Date | Decision |
|---|---|---|---|
| Cool Line Catheter Kit Model | |||
| CL-2295A | K014241 | 08/01/2003 | Substantially equivalent - with |
| limitations (SU) | |||
| lcy Catheter Kit Model | |||
| IC-3893A | K052443 | 10/17/2005 | Substantially equivalent (SE) |
| Quattro Catheter Kit Model | |||
| IC-4593 | K070161 | 02/15/2007 | Substantially equivalent (SE) |
6
Company Confidential
Coating Change
KIO 1987
Indications for Use
The Thermogard XP can be used with any of the ZOLL IVTM Catheters. The indications for use are specific to the catheter.
Indications for Use (ICY Catheter Model IC-3893A)
The ZOLL ICY Catheter Model IC-3893A connected to the ZOLL Thermal Regulation System, is indicated for use:
- In cardiac surgery adult patients to achieve and/or maintain normothermia during . surgery and recovery/intensive care, and
- To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in . surgery and recovery/intensive care.
Indications for Use (Quattro Catheter Model IC-4593)
The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:
- In cardiac surgery adult patients to achieve and/or maintain normothermia during . surgery and recovery/intensive care, and
- To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in . surgery and recovery/intensive care.
7
Company Confidential
Coating Change
1101987
Indications for Use (Cool Line Catheter Model CL-2295A)
The Cool Line ® Catheter Model CL-2295A when used with the ZOLL Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in adult 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).
| Table 1-1. Mortality by Diagnosis (III) | ||||||
|---|---|---|---|---|---|---|
| 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 |
Toble 1.1. Mostality by Dizanosie (ITT)
*Fischer's exact test
The more details on the results of this study please refer to Physician's Manual – "Normothermia for the Neuro-critically III Stroke Patient" #101416-001.
8
Device Description
4101987
This paragraph is applicable to all three (3) different catheter models included in this document. The model specific details and comparison to predicate are included model specific tables. ZOLL IVTM Cool Line. ICY and Quattro catheters are multi lumen intravascular catheters with balloons as heat exchange units. Each of these three catheter models has two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. The inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The thermal regulation system chills/warms the saline and pumps it through the inflow lumen of the catheter. The chilled/warmed saline travels to the balloons, whose surface facilitates heat exchange between the patient's circulating blood and the saline returns to the system via the outflow lumen. The chilled/warmed saline is not infused into the patient. Two additional lumens provide infusion channels. The fifth lumen serves as a guide wire lumen which can also be used as an infusion lumen. The basic difference between these three models of catheters is size and number of balloons which provides different heat exchange capacity.
The catheters are supplied sterile for single-use only.
Principles of Operation
The principle of operation remains unchanged. The ZOLL Intravascular Temperature Management System (IVTM) 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 feedback from a temperature probe in the patient that interfaces with the temperature controller. This principle of operation is identical to currently marketed devices as well as the modified devices.
Summary of the Basis for Finding of Substantial Equivalence
The indication statement and intended use is identical to the predicate device. The principle of operation is the same as the predicate device. The technical characteristics and materials used are very similar to the predicate device.
Conclusion
This submission includes only two modifications:
- Change of antithrombotic coating and 1.
- Change of pyrogenicity claim made in the original 510(k) application. 2.
The change in coating is made because the currently cleared/approved coating (Duraflo II®) has been discontinued by the manufacturer (Edwards LifeSciences). The new coating (Applause™ from Surmodics, Inc.) contains hydrophilic properties in addition to the antithrombotic properties.
The original 510(k) applications included the statement that the catheters were "Pyrogen r no orginal o ro(n) upp. Corporation (the former sponsor) never made any labeling claim in
650 Almanor Avenue Sunnyvale, California 94085 Page 27
Tel: 408.541.2140 Fax: 408.541.1030
9
| ZOLL Circulation | Company Confidential | Coating Change | |
|---|---|---|---|
| ------------------ | -- | ---------------------- | ---------------- |
this regard. The requested change to "Non-pyrogenic" is more consistent with intravascular catheters.
No other changes are being made to the product specification, product design and/or configuration, safety features, catheter materials, kit components, indications for use or product labeling that can potentially alter the risk/safety profile of the catheters.
The new coating was verified via a combination of in vitro biocompatibility testing per ISO 10993-1.In vitro Thrombogenicity testing verified performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 168 hours of hypothermia treatment. Results demonstrated that the modified device is comparable to the results of the animal model testing of the predicate device(s) included in the original submissions cleared by the FDA.
The effects of coating on catheter performance in regards to intended use was verified via a battery of bench tests including Heat Exchange Efficiency test, Life Test (trouble free heat exchange for the in-dwell time), Balloon Bond and/or Catheter Burst test, Heparin Coating consistency (Toluidine Blue Staining) and Heparin Activity test.
In summary, descriptive information and performance data demonstrate that the modifications made to the ZOLL IVTM Catheter Models CL2295-A, IC3893-A and IC4593 characteristics do not raise new questions of safety and effectiveness. Where appropriate, performance data demonstrate equivalence. The catheter models are substantially equivalent to their predicate device(s).
પ્ર જિલ્લામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે.