(139 days)
No
The summary describes a mechanical heat exchange catheter system and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for use in modulating body temperature (normothermia, mild hypothermia, fever reduction) in patients with specific medical conditions, directly providing a therapeutic effect by achieving or maintaining a desired physiological state.
No
The device is designed to regulate body temperature (induce hypothermia, maintain normothermia, or reduce fever) by circulating warmed or chilled saline in a closed loop for heat exchange with the blood. This is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical catheter with lumens, a balloon, and connections to external hardware (CoolGard 3000/Thermogard XP Console and Start-Up Kit) for circulating saline and heat exchange. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Solex 7 Intravascular Heat Exchange Catheter is an intravascular device. It is placed inside the patient's central venous system to directly warm or cool the circulating blood for therapeutic purposes (temperature management).
- Lack of Diagnostic Testing: The description focuses entirely on the mechanical and thermal function of the catheter for heat exchange. There is no mention of analyzing biological samples or providing diagnostic information about a patient's condition.
The device is a therapeutic device used for temperature management within the patient's body, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Solex 7™ Intravascular Heat Exchange Catheter connected to the CoolGard 3000®/Thermal Regulation System is indicated for use:
· In cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care. (Maximum use period = 4 days)
· To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care. (Maximum use period = 4 days)
· In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infarcerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period = 7 days)
Product codes
NCX
Device Description
The Solex 7 Intravascular Heat Exchange Catheter (Solex 7 Catheter) is a sterile, single use 9.3F flexible catheter designed for placement in the Superior Vena Cava from an insertion site in the Jugular and Subclavian Veins. The Solex 7 Catheter is connected to a single use, disposable CoolGard 3000 or Thermogard XP® Start-Up Kit (SUK) and the CoolGard 30000 or Thermogard XP® Console, all of which comprise the ZOLL Intravascular Heat Exchange The Start-Up Kit (SUK) and the CoolGard 3000 or Thermogard XP Console are System. supplied separately. The ZOLL Heat Exchange System is also designed for use with an off-theshelf temperature probe. The Solex 7 Catheter is comprised of a polyurethane shaft and a serpentine shaped PET balloon at the distal end. The blood contact surfaces of the catheter incorporate a hydrophilic heparin coating.
The catheter has five lumens, two of which when connected to the Start-Up Kit, are used to circulate sterile saline in a closed loop circuit for heat exchange with the blood in the central venous system. Warmed or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the serpentine balloon that interfaces with the patient's blood to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the warmed or chilled saline circulates. The warmed or chilled saline is not infused into the patient.
Additional lumens of the Solex 7 Catheter consist of a 0.032" guidewire compatible lumen that can also be used as a primary infusion lumen, and two additional infusion lumens within the catheter shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Superior Vena Cava, Jugular and Subclavian Veins
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)
Nonclinical testing was performed including Bench Performance, Packaging Validation (SUK only), Biocompatibility, and Usability Testing.
1. 7-Day Indwell Testing (Bench Performance)
- Study Type: Bench Performance Testing for 7-day indwell time.
- Sample Size: Not explicitly stated, but "Catheter samples" are mentioned in results.
- Key Results:
- Visual Inspection: Catheter samples met acceptance criterion for smooth appearance with no pits.
- Catheter Indwell Life (7 days): Catheter samples met acceptance criterion for normal function for seven days without leakage.
- Dimensional Measurement: Catheter samples met acceptance criteria for dimensional requirements per product specification.
- Toluidine Blue Staining: Catheter samples met acceptance criteria for consistent blue purple color and stained portion covered all depth markers.
- Particulate Testing: Solex 7 samples and Cool Line samples demonstrated particulate levels below USP .
- Tensile Testing: Catheter joints met acceptance criteria for tensile strength requirements of EN ISO 10555-1:2013.
- Burst/Leak Testing: Catheter samples met acceptance criteria to withstand a minimum of 100 psi static pressure at 37°C without embolic failure.
- Flow Resistance Testing: Catheter samples met acceptance criterion for a back pressure of less than 7 psi at a flow rate of 2000 ml/hr.
- Flow Rate Testing: Catheter samples met acceptance criteria for flow rate requirements of EN ISO 10555-1:2013.
- Heat Exchange Testing: Catheter samples met acceptance criterion for a heat exchange power of 125 Watts minimum.
- Flexural Fatigue/Tip Flex Testing: Catheter samples met acceptance criteria to withstand 100 cycles of tip flexure.
- Infusion Lumen Aspiration Rate Testing: Catheter samples met acceptance criterion of a blood sampling rate of 10cc in 15 seconds or less.
- Torsional Integrity Testing: Catheter samples met acceptance criterion to withstand one complete twist without failure.
- In Vitro Thrombogenicity Testing: Coated catheter samples showed statistically significant decreases (p 0.050 when the test article was compared to the predicate and negative control at 30, 60, and 90 minute time points, indicating statistical similarity.
- SC5b-9: P value was >0.050 when the test article was compared to the predicate at 30, 60, and 90 minute time points, indicating statistical similarity. P value was >0.050 when the test article was compared to the negative control at 30 and 60 minute time points, indicating statistical similarity. P value was
§ 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2016
ZOLL Circulation, Inc. Mr. Sam Nanavati Vice President, Quality & Regulatory Affairs 2000 Ringwood Avenue San Jose, California 95131
Re: K153226
Trade/Device Name: Solex 7™ Intravascular Heat Exchange Catheter and Start-Up Kit Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: NCX Dated: February 23, 2016 Received: February 25, 2016
Dear Mr. Sam Nanavati:
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 this device 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 (IFU) statement:
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. A randomized controlled trial of endovascular cooling in patients with fever associated with subarachnoid hemorrhage
1
and primary traumatic brain injury showed increased mortality as compared to patients receiving standard of care.
Please note that the above labeling limitations are 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.
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 (reporting of medical devicerelated 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 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
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.
2
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,
William H. Maisel - S
William H. Maisel, MD, MPH Director (Acting) Office of Device Evaluation Deputy Center Director for Science Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K153226
Device Name
Solex 7TM Intravascular Heat Exchange Catheter and Start-Up Kit
Indications for Use (Describe)
The Solex 7™ Intravascular Heat Exchange Catheter connected to the CoolGard 3000®/Thermal Regulation System is indicated for use:
· In cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care. (Maximum use period = 4 days)
· To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care. (Maximum use period = 4 days)
· In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infarcerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period = 7 days)
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. A randomized controlled trial of endovascular cooling in patients with fever associated with subarachnoid hemorrhage and primary traumatic brain injury showed increased mortality as compared to patients receiving standard of care.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
PREMARKET NOTIFICATION 510(K) SUMMARY K153226
| Date Prepared: | March 9, 2016 |
|---|---|
| Submitter: | ZOLL Circulation, Inc. |
| Address: | 2000 Ringwood Avenue |
| San Jose, CA 95131 | |
| Phone: | 408-419-2950 |
| Fax: | 408-541-1030 |
| Contact Person: | Sam Nanavati, VP, Quality and Regulatory Affairs |
| Trade Name/Proprietary | |
| Name: | Solex 7™ Intravascular Heat Exchange Catheter and |
| Start-Up Kit | |
| Common Name: | Central Venous Catheter (short term) and Thermal Regulating |
| System | |
| Classification/Name: | Class II; System, Hypothermia, Intravenous, Cooling |
| Regulation: | 21 CFR 870.5900, Thermal Regulating System |
| Product Code: | NCX |
| Legally marketed devices to | |
| which substantial | |
| equivalence is claimed: | Solex Intravascular Heat Exchange Catheter Kit, 510(k) K141139 |
| Cool Line Intravascular Heat Exchange Catheter Kit, 510(k) | |
| K101987 and K150046 | |
| Start-Up Kit Model CG-500D and Model CG-500D EX, 510(k) | |
| K014241 and K150046 |
I. Device Description:
The Solex 7 Intravascular Heat Exchange Catheter (Solex 7 Catheter) is a sterile, single use 9.3F flexible catheter designed for placement in the Superior Vena Cava from an insertion site in the Jugular and Subclavian Veins. The Solex 7 Catheter is connected to a single use, disposable CoolGard 3000 or Thermogard XP® Start-Up Kit (SUK) and the CoolGard 30000 or Thermogard XP® Console, all of which comprise the ZOLL Intravascular Heat Exchange The Start-Up Kit (SUK) and the CoolGard 3000 or Thermogard XP Console are System. supplied separately. The ZOLL Heat Exchange System is also designed for use with an off-theshelf temperature probe. The Solex 7 Catheter is comprised of a polyurethane shaft and a serpentine shaped PET balloon at the distal end. The blood contact surfaces of the catheter incorporate a hydrophilic heparin coating.
The catheter has five lumens, two of which when connected to the Start-Up Kit, are used to circulate sterile saline in a closed loop circuit for heat exchange with the blood in the central venous system. Warmed or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the serpentine balloon that interfaces with the patient's blood to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the warmed or chilled saline circulates. The warmed or chilled saline is not infused into the patient.
5
Additional lumens of the Solex 7 Catheter consist of a 0.032" guidewire compatible lumen that can also be used as a primary infusion lumen, and two additional infusion lumens within the catheter shaft.
II. Indications for Use:
The intended use/indications for use of the modified Solex Catheter (Solex 7 Catheter) is as follows:
The Solex 7™ Intravascular Heat Exchange Catheter connected to the CoolGard 3000 /Thermogard XP® Thermal Regulation System is indicated for use:
- In cardiac surgery patients to achieve and or maintain normothermia during surgery and . recovery/intensive care. (Maximum use period = 4 days)
- To induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care. (Maximum use period = 4 days)
- 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. (Maximum use period = 7 days)
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. A randomized controlled trial of endovascular cooling in patients with subarachnoid hemorrhage and primary traumatic brain injury showed increased mortality as compared to patients receiving standard of care.
III. Summary of Technological Characteristics of the Proposed Device Compared to the Predicate Device:
The Solex 7 Catheter
The modified Solex Catheter (Solex 7 Catheter) is substantially equivalent to the 510(k) cleared Solex Catheter (K141139) and the ZOLL Cool Line Catheter (K101987) with regard to intended use / indications for use, technological characteristics, and principles of operation. With the exception of the Custom Luers, the modified Solex Catheter (Solex 7 Catheter) is identical to the cleared Solex Catheter with respect to design and materials. Table 1 provides a comparison of the similarities and differences between the modified Solex Catheter (Solex 7 Catheter), the cleared Solex Catheter, and the cleared ZOLL Cool Line Catheter (comparisons are relative to the subject device).
6
| Table 1. Comparison of Solex 7 Catheter with Custom Luers to Predicates | ||
|---|---|---|
| ------------------------------------------------------------------------- | -- | -- |
| ZOLL Intravascular Heat Exchange Catheters | ||||
|---|---|---|---|---|
| Feature | SUBJECT DEVICE | |||
| Solex 7 Intravascular | ||||
| Heat Exchange Catheter | PRIMARY PREDICATE | |||
| DEVICE | ||||
| Cool Line Intravascular | ||||
| Heat Exchange Catheter | REFERENCE | |||
| PREDICATE | ||||
| DEVICE | ||||
| Solex Intravascular | ||||
| Heat Exchange | ||||
| Catheter | REFERENCE | |||
| PREDICATE DEVICE | ||||
| Quattro Intravascular | ||||
| Heat Exchange | ||||
| Catheter | ||||
| 510(k) | ||||
| Number | K153226 | K101987 and K150046 | K141139 | K150046 |
| Class | II | Same | Same | Same |
| Classification/ | ||||
| Regulation | ||||
| Name | System, Hypothermia, | |||
| Intravenous. | ||||
| Cooling/Thermal | ||||
| Regulating System | Same | Same | Same | |
| Regulation | ||||
| Number | 21 CFR 870.5900 | Same | Same | Same |
| Product Code | NCX | Same | Same | Same |
| Heparin | ||||
| Coating | SurModics Applause | |||
| Heparin Coating | Same | Same | Same | |
| Luer Designs | Inflow and Outflow Luers: | |||
| ZOLL Custom Luers* | ||||
| Infusion Luers: Standard | ||||
| Luers | ||||
| Vent Caps: ZOLL Custom | ||||
| Vent Caps | Same | Inflow and Outflow | ||
| Luers: Standard Luers | ||||
| Infusion Luers: Same | ||||
| Vent Caps: Standard | ||||
| Vent Caps | Same as Subject Device | |||
| Catheter | ||||
| working | ||||
| length (tip to | ||||
| manifold) | 26cm | 22 cm | Same as Subject | |
| Device | 48 cm | |||
| Shaft | ||||
| diameter | 9.3 Fr | Same | Same | Same |
| Number of | ||||
| lumens | 5 lumens: | |||
| 2 infusion | Same | Same | Same | |
| Feature | ZOLL Intravascular Heat Exchange Catheters | |||
| SUBJECT DEVICE | ||||
| Solex 7 Intravascular | ||||
| Heat Exchange Catheter | PRIMARY PREDICATE | |||
| DEVICE | ||||
| Cool Line Intravascular | ||||
| Heat Exchange Catheter | REFERENCE | |||
| PREDICATE | ||||
| DEVICE | ||||
| Solex Intravascular | ||||
| Heat Exchange | ||||
| Catheter | REFERENCE | |||
| PREDICATE DEVICE | ||||
| Quattro Intravascular | ||||
| Heat Exchange | ||||
| Catheter | ||||
| Guidewire | ||||
| Compatibility | 1 guidewire (also infusion) | |||
| 1 inflow | ||||
| 1 outflow | ||||
| 0.032" | Same | Same | Same | |
| Flow Rate (by | ||||
| lumen) | Distal - 1900 mL/hr | |||
| Medial - 1300 mL/hr | ||||
| Proximal - 1300 mL/hr | Distal - 2100 mL/hr | |||
| Medial - 1200 mL/hr | ||||
| Proximal - 1400 mL/hr | Distal - Same as | |||
| Subject Device | ||||
| Medial - Same as | ||||
| Subject Device | ||||
| Proximal - Same as | ||||
| Subject Device | Distal - 1300 mL/hr | |||
| Medial - 800 mL/hr | ||||
| Proximal - 1100 mL/hr | ||||
| Heat | ||||
| exchange | ||||
| balloons | 1 (serpentine) | 2 (straight/coaxial) | Same as Subject | |
| Device | 4 (straight/coaxial) | |||
| Inflated | ||||
| Balloon OD | ||||
| (Cross- | ||||
| sectional Area) | Balloon OD: N/A | |||
| Cross-sectional Area: | ||||
| 54mm2 | Balloon OD: 5mm | |||
| Cross-sectional area: N/A | Same as Subject | |||
| Device | Balloon OD: 8mm | |||
| Cross-sectional area: | ||||
| N/A | ||||
| Cross | ||||
| Sectional | ||||
| Area (approx. | ||||
| inflated outer | ||||
| diameter) | 54mm2 (12.2 mm OD) | 20mm2 (5 mm) | Same as Subject | |
| Device | 50mm2 (8 mm) | |||
| Insertion Site | Jugular and | |||
| Subclavian Veins | Femoral, Jugular, Subclavian | |||
| Veins | Jugular Vein | Femoral | ||
| Max. Use | ||||
| Period | 7 days | 7 days | 2 days | 4 days |
| ZOLL Intravascular Heat Exchange Catheters | ||||
| Feature | SUBJECT DEVICE | |||
| Solex 7 Intravascular | ||||
| Heat Exchange Catheter | PRIMARY PREDICATE | |||
| DEVICE | ||||
| Cool Line Intravascular | ||||
| Heat Exchange Catheter | REFERENCE | |||
| PREDICATE | ||||
| DEVICE | ||||
| Solex Intravascular | ||||
| Heat Exchange | ||||
| Catheter | REFERENCE | |||
| PREDICATE DEVICE | ||||
| Quattro Intravascular | ||||
| Heat Exchange | ||||
| Catheter | ||||
| Materials | Shaft: Polyurethane | |||
| Heat Exchange Balloon: | ||||
| PET | Shaft: Same | |||
| 2 Heat Exchange Balloons: | ||||
| Polyurethane | Shaft: Same | |||
| Heat Exchange | ||||
| Balloon: | ||||
| Same as Subject | ||||
| Device | Shaft: Same | |||
| Heat Exchange | ||||
| Balloons: Same as | ||||
| Subject Device | ||||
| Sterilization | ||||
| method and | ||||
| SAL | EO, SAL 10-6 | Same | Same | Same |
7
8
*The ZOLL Custom Luers on the ZOLL Cool Line, ICY, and Quattro Catheters were cleared via K150046 on October 30, 2015
9
The Modified Start-Up Kit with Custom Luers
The modified Start-Up Kit (SUK) with Custom Luers is substantially equivalent to the 510(k) cleared SUK (K014241) with regard to intended use, technological characteristics, and principles of operation. Table 2 provides a comparison of the similarities and differences between the modified SUK and the predicate SUK.
| Characteristic | SUBJECT DEVICE
ZOLL Start-up Kit with ZOLL Custom
Luers | PREDICATE DEVICE
ZOLL Start-up Kit with ZOLL Standard
Luers |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| | (modified)
K150046 | |
| 510(k) Number | TBD | K014241 |
| Intended Use | To control patient core temperature using
heat exchange fluid in conjunction with the
CoolGard 3000 or Thermogard XP system
and ZOLL Heat Exchange Catheters | Same |
| Class | II | Same |
| Classification/
Regulation Name | System, Hypothermia, Intravenous,
Cooling/Thermal Regulating System | Same |
| Regulation
Number | 21 CFR 870.5900 | Same |
| Product Code | NCX | Same |
| Patient Contact | Indirect patient contact | Same |
| Luer Function | Join the SUK to the Inflow/Outflow Lumens
of the catheters, and allow saline to circulate
through the catheter/SUK fluid path | Same |
| Supplied 20 ml
Sterile Deflation
(Slip-Fit) Syringe | Syringe, compatible with new Custom Luer
locks, provided with SUK for removal of
saline from catheter heat exchange balloon
prior to catheter removal | Syringe not provided with SUK |
| Sterilization | Provided sterile (Gamma sterilization) | Same |
Table 2. Comparison of Modified Start-up Kit with Custom Luers to Predicate
IV. Summary of the Nonclinical Tests Performed:
Nonclinical testing was performed to ensure that the modified Solex Catheter (Solex 7 Catheter) and modified SUK meet their design performance specifications and that the product is substantially equivalent to the predicate devices (Catheters: K141139, K101987; SUK: K014241). Nonclinical testing performed includes: Bench Performance. Packaging Validation (SUK only), Biocompatibility, and Usability Testing. The nonclinical test results demonstrate that the modified devices continue to meet product design specifications.
1. 7-Day Indwell Testing
Bench Performance testing of the modified Solex Catheter (Solex 7 Catheter) was performed to support the proposed modification to the 7 day indwell time.
Where applicable, testing was performed in accordance with the following standards:
- . ISO 10555-1:2013 - Sterile, single-use intravascular catheters Part 1. General requirements
10
- ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and . certain other medical equipment Part 1: General requirements
- ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and ● certain other medical equipment Part 2: Lock fittings
The modified Solex Catheter (Solex 7 Catheter) was functionally tested after being subjected to 7 days of simulated use conditions to verify that the catheter continues to perform as intended. Testing completed is shown in Table 3.
| Test Name | Test Method Summary | Results |
|---|---|---|
| Visual Inspection | Visual inspection to ensure catheter | |
| is smooth without major pits. | Catheter samples met the | |
| acceptance criterion for smooth | ||
| appearance with no pits. | ||
| Catheter Indwell Life (7 days) | Verification that the catheter does | |
| not leak saline from the heat | ||
| exchange path during simulated use | ||
| for seven days. | Catheter samples met the | |
| acceptance criterion for normal | ||
| function for seven days without | ||
| leakage. | ||
| Dimensional Measurement | Measurement of catheter | |
| dimensional aspects | Catheter samples met the | |
| acceptance criteria for dimensional | ||
| requirements per the product | ||
| specification. | ||
| Toluidine Blue Staining | Dye staining of catheter and visual | |
| inspection to ensure consistent | ||
| coverage of blue purple color and | ||
| that stained portion covers all depth | ||
| markers. | Catheter samples met the | |
| acceptance criteria for consistent | ||
| blue purple color and stained | ||
| portion covered all depth markers. | ||
| Particulate Testing | Determination of catheter coating | |
| integrity following simulated | ||
| indwell and flow rate conditions. | Solex 7 samples and Cool Line | |
| samples tested demonstrated levels | ||
| of particulate below that required in | ||
| USP . | ||
| Tensile Testing | Strength testing of various catheter | |
| joints. Must conform to EN ISO | ||
| 10555-1:2013. | Catheter joints met the acceptance | |
| criteria for tensile strength | ||
| requirements of EN ISO 10555- | ||
| 1:2013. | ||
| Burst/Leak Testing | Determination of catheter burst/leak | |
| resistance. Must conform to EN | ||
| ISO 10555-1:2013. | Catheter samples met the | |
| acceptance criteria to withstand a | ||
| minimum of 100 psi static pressure | ||
| at 37°C without embolic failure. | ||
| Flow Resistance Testing | Measurement of catheter back | |
| pressure. | Catheter samples met the | |
| acceptance criterion for a back | ||
| pressure of less than 7 psi at a flow | ||
| rate of 2000 ml/hr. | ||
| Flow Rate Testing | Measurement of catheter infusion | |
| lumen flow rates. Must conform to | ||
| EN ISO 10555-1:2013. | Catheter samples met the | |
| acceptance criteria for flow rate | ||
| requirements of EN ISO 10555- | ||
| 1:2013 | ||
| Heat Exchange Testing | Determination of heat exchange | |
| capability of catheter. | Catheter samples met the | |
| acceptance criterion for a heat | ||
| exchange power of 125 Watts | ||
| minimum. | ||
| Flexural Fatigue/Tip Flex Testing | Determination of catheter tip | |
| strength and flexure. | Catheter samples met the | |
| acceptance criteria to withstand 100 | ||
| Test Name | Test Method Summary | Results |
| Infusion Lumen Aspiration Rate Testing | Determination of catheter blood sampling rate | cycles of tip flexure. |
| Catheter samples met the | ||
| acceptance criterion of a blood | ||
| sampling rate of 10cc in 15 seconds | ||
| or less. | ||
| Torsional Integrity Testing | Determination of catheter (tip to | |
| manifold) ability to withstand | ||
| twisting. | Catheter samples met the | |
| acceptance criterion to withstand | ||
| one complete twist without failure | ||
| In Vitro Thrombogenicity Testing | Measurement of thrombogenic | |
| behavior of catheter following 7 | ||
| day simulated use by radioactive | ||
| platelet quantification and visual | ||
| inspection. | Coated catheter samples showed | |
| statistically significant decreases ( $p$ | ||
| 0.050 | ||
| when the test article was compared | ||
| to the predicate at the 30, 60, and | ||
| 90 minute time points; the test | ||
| article and predicate are statistically | ||
| similar at these time points. |
The P value was >0.050 when the
test article was compared to the
negative control at the 30, 60, and
90 minute time points; the test
article and predicate are statistically
similar at these time points.
SC5b-9: The P value was >0.050
when the test article was compared
to the predicate at the 30, 60, and
90 minute time points; the test
article and predicate are statistically
similar at these time points.
The P value was >0.050 when the
test article was compared to the |
| Test Category | Test Method Summary | Results |
| | | minute time points; the test article
and negative control are statistically
similar at these time points. The P
value was ≤0.050 when the test
article was compared to the
negative control at the 90 minute
time point; the test article is
statistically lower than the negative
control at this time point |
Table 6. Luer Standards Performance Testing
Based on the test results obtained, it can be concluded that all of the standard and custom catheter Luers, custom SUK Luers, and custom catheter vented caps are qualified for use in the assemblies used to manufacture the modified SUK and Solex Catheter with Custom Luers.
d. Biocompatibility
The only material change for the Solex Catheter and SUK has been to the Custom Luers. To verify the biocompatibility of the new materials of the Custom Luers for the Solex Catheter, ZOLL conducted biocompatibility testing on the proximal (modified) portion of the catheter only. Similarly, to verify the biocompatibility of the modified SUK, ZOLL conducted biocompatibility testing on the SUK Custom Luers only. Biocompatibility testing was conducted in accordance with GLP regulations.
Because the Custom Luer components located on the SUK and on the proximal end of the catheter have indirect blood contact and prolonged exposure. ZOLL conducted testing based on the classification of an externally communicating device, blood path indirect for prolonged exposure (>24hrs and ≤30 days). Based on this classification, the following categories of biocompatibility tests were performed: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity and Hemocompatibility.
The biocompatibility test results are shown in Table 7.
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Table 7. Biocompatibility Testing
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The results of the testing demonstrate that the modified SUK and the modified Solex Catheter with Custom Luers are biocompatible for their intended use and the modifications made to the subject devices do not adversely affect the established biocompatibility of the predicate devices.
e. Usability/Human Factors
Pursuant to FDA's guidance document entitled, "Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design" Human Factors testing was conducted as follows:
1. Summary of Formative Testing
Human factors formative testing was performed to determine if users trained according to the IFU can properly perform the following:
- Identify infusion lumens, (proximal, medial, and distal) ●
- Properly connect the IN and OUT Luers to the Start-Up Kit (SUK) ●
- Identify the saline IN and OUT Luers
- . Identify any lumen that is appropriate for pharmacological infusate.
- . Disconnect the Saline IN and OUT track (SUK Luers) including evacuating the saline from the catheter using a syringe.
User tasks were based on identifying and (or) making proper connections as documented in the Formative Human Factors Protocol for ZOLL Custom Luers. The test session ran over the course of two days.
Four scenarios were presented, and participants were evaluated based on 14 predefined success metrics. All participants correctly executed each scenario, with no failures. All participants who received representative level of training and had access to the IFU successfully completed all of the tasks. This indicates that the device design, training content and the IFU adequately mitigate the risk of misconnections. No device design, training or IFU modifications were indicated based on this formative test.
2. Summary of Summative Testing
Human factors summative testing was performed to evaluate if users trained according to the ZOLL Custom Luer Training Program and IFU can properly perform the following:
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- Match the new catheter and new Start-Up Kit (SUK) with Custom Luers
- Place 20 cc syringe on saline hook on Thermogard XP (TGXP) console ●
- Connect the IN and OUT Luers on the catheter to its counterpart on the SUK .
- Select an infusion lumen for an IV infusion
- . Use 20 cc syringe for aspiration of saline after a catheter is used as a CVC after temperature management therapy ends
- Aspirate saline prior to catheter removal ●
A total of five scenarios were presented, and each participant had to correctly answer questions 9-13 to achieve a passing score. All other questions (1-8, 14-15) required a minimum of an 80% passing score. The acceptance criteria were met with 100% of the users passing the critical tests (9-13). All of the non-critical items (1-8 and 14-15) were passed with at least 12 participants passing (80%).
All participants who received training and followed the IFU successfully met the acceptance criteria. This testing confirms that the custom Luer design, training, and IFU facilitate appropriate catheter and SUK connections. No device design, training or IFU modifications were indicated based on the summative evaluation.
V. Summary of Clinical Tests Performed:
Clinical evaluations were not necessary to evaluate the modifications incorporated in the Solex Catheter and SUK to demonstrate substantial equivalence to the predicate devices.
VI. Substantial Equivalence:
Based on the results of the Bench Performance, Packaging Validation (SUK only), Biocompatibility, and Usability testing, the modified Solex Catheter (Solex 7 Catheter) and modified SUK are substantially equivalent to the currently cleared Solex Catheter (K141139), Cool Line Catheter (K101987), and SUK (K014241) with respect to intended use/indication for use, technological characteristics, and principles of operation and that the modifications do not affect the performance or function of the devices. The minor differences in the design between the modified and cleared devices, do not raise any new types of safety or effectiveness questions as confirmed by design verification testing. Therefore, the modified Solex Catheter (Solex 7 Catheter) and modified SUK are substantially equivalent to the previously cleared predicate devices.
VII. Conclusions:
ZOLL concludes that based on the results of the Bench Performance. Packaging Validation (SUK only). Biocompatibility, and Usability testing, that the modified Solex Catheter (Solex 7 Catheter) and modified SUK are substantially equivalent to the predicate devices.