(29 days)
No
The device description and performance studies focus on the mechanical aspects of the catheter and aspiration system, with no mention of AI/ML for image analysis, decision support, or any other function.
Yes
The device is indicated for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a therapeutic intervention.
No
The device is a reperfusion catheter system used for mechanical thrombectomy in stroke patients. Its function is to remove clots, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like catheters, tubing, and connections, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The ZOOM Reperfusion Catheters, Tubing, and Pump are used to physically remove blood clots from blood vessels within the brain. This is a therapeutic intervention performed directly on the patient's body, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly states "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a treatment procedure.
- Device Description: The description details a catheter designed for insertion into blood vessels and a system for applying vacuum to remove clots. This aligns with a therapeutic device, not a diagnostic one.
Therefore, the ZOOM Reperfusion system is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
Product codes
NRY
Device Description
The ZOOM Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the ZOOM Aspiration Pump, using the ZOOM Aspiration Tubing.
The ZOOM Reperfusion Catheter is offered in various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.
The ZOOM Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.
The distal section of the ZOOM Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.
The ZOOM Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.
The ZOOM Aspiration Tubing is offered in one model with the features indicated in Table 2.
The ZOOM Reperfusion Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM Reperfusion Catheter and a slip fit connector that connects to the canister on the aspiration pump. The ZOOM Aspiration tubing is made of common medical grade polymers.
In addition to the accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the ZOOM Reperfusion Catheter and Aspiration Tubing.
- Guidewires
- Support/Diagnostic Catheters
- Introducer Sheaths
- Aspiration Pump®
- Capable of achieving pressure between -20inHg to max vacuum
- Airflow rating of 0 23 LPM
- IEC 60601-1 Compliant
Imperative Care offers the ZOOM Aspiration Pump which meets the indicated criteria.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Bench testing was conducted to evaluate the similarities and differences between the subject and predicate devices. The largest and smallest diameter catheters were tested for both the subject and predicate devices.
The test results were reviewed and found to demonstrate that the differences between the subject and predicate devices do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing.
A summary of the tests and performance specifications that were evaluated is presented in Tables 4 and 5. These tests were performed per company approved protocols and test methods based primarily on catheter performance standard ISO 10555-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
September 2, 2020
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
Imperative Care Inc. Jake Wolenberg Regulatory Affairs Manager 1359 Dell Avenue Campbell, California 95008
Re: K202182
Trade/Device Name: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: July 31, 2020 Received: August 4, 2020
Dear Jake Wolenberg:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director (Acting) DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202182
Device Name
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Indications for Use (Describe)
The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
3
Special 510(k) Summary ZOOM™ Reperfusion Catheters and Aspiration Tubing
A. Submitter Information
Submitter's Name: Address:
Contact Person: Telephone: Email: Date of Preparation: Imperative Care Inc. 1359 Dell Avenue Campbell, CA 95008 Jake Wolenberg 248-496-0198 JWolenberg@imperativecare.com July 31, 2020
B. Subject Device
Proprietary Name:
Common/Usual Name: Classification Name: Product Code:
C. Predicate Device
Proprietary Name:
Common/Usual Name: Classification Name: Product Code: Manufacturer: 510(k) #:
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing Catheter, Thrombus Retriever Catheter, Percutaneous NRY per 21 C.F.R. 870.1250
MantaRay (071, 055, 045, 035) Reperfusion Catheters; Imperative Care Aspiration Tubing Set Catheter, Thrombus Retriever Catheter, Percutaneous NRY per 21 C.F.R. 870.1250 Imperative Care Inc. K183043
pg. 1 of 12
4
D. Device Description:
The ZOOM Reperfusion Catheter is a single lumen, braid and coil reinforced, variable stiffness catheter that facilitates removal of thrombus/clot from the neurovasculature when connected to a vacuum source, such as the ZOOM Aspiration Pump, using the ZOOM Aspiration Tubing.
The ZOOM Reperfusion Catheter is offered in various working lengths and nominal inner diameters (ID) and outer diameters (OD) as shown in Table 1 below.
| Product Name
(Used Throughout 510k) | Model
Number | Distal
Diameter | | Proximal
Diameter | | Nominal Usable
Catheter
Length | Hydrophilic
Coating
Length |
|----------------------------------------|-----------------|--------------------|--------|----------------------|--------|--------------------------------------|----------------------------------|
| ZOOM 71 | ICRC071137 | 0.071" | 0.083" | 0.071" | 0.083" | 137 cm | 35cm |
| ZOOM 55 | ICRC055137 | 0.055" | 0.069" | 0.067" | 0.080" | 137 cm | 35cm |
| ZOOM 45 | ICRC045144 | 0.045" | 0.060" | 0.064" | 0.080" | 144 cm | 65cm |
| ZOOM 35 | ICRC035158 | 0.035" | 0.051" | 0.047" | 0.061" | 158 cm | 90cm |
Table 1: ZOOM Reperfusion Catheter Sizes
The ZOOM Reperfusion Catheter is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers.
The distal section of the ZOOM Reperfusion Catheter has a hydrophilic coating to enhance tracking through the vasculature. The beveled distal tip allows for atraumatic tracking past vessel branches during insertion. A radiopaque marker provides the user with visual confirmation of the distal tip location under fluoroscopy.
The ZOOM Reperfusion Catheter is packaged with an accessory Rotating Hemostasis Valve (RHV). The RHV is designed to be attached to the proximal luer of the catheter and helps the user maintain hemostasis.
The ZOOM Aspiration Tubing is offered in one model with the features indicated in Table 2.
Table 2: ZOOM Aspiration Tubing Models
| Product Name
| (Used Throughout 510k) | Model Number | Tubing ID | Tubing Length |
|---|---|---|---|
| ZOOM Aspiration Tubing | TAT102B | 0.110" Minimum | 104" |
The ZOOM Reperfusion Tubing is comprised of a hollow cylindrical tube which is bonded to a standard luer fitting that connects to the ZOOM Reperfusion Catheter and a slip fit connector that connects to the canister on the aspiration pump. The ZOOM Aspiration tubing is made of common medical grade polymers.
5
In addition to the accessories discussed above, the adjunctive devices and supplies listed below are intended to be used with the ZOOM Reperfusion Catheter and Aspiration Tubing.
- . Guidewires
- Support/Diagnostic Catheters
- Introducer Sheaths ●
- Aspiration Pump® ●
- Capable of achieving pressure between -20inHg to max vacuum ●
- Airflow rating of 0 23 LPM ●
- IEC 60601-1 Compliant ●
Imperative Care offers the ZOOM Aspiration Pump which meets the indicated criteria.
E. Indications for Use:
The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.
6
Predicate Comparison: F.
The predicate device for the ZOOM Reperfusion Catheter and Aspiration Tubing in this Special 510(k) is the prior generation of ZOOM Reperfusion Catheter and Aspiration Tubing cleared under 510(k) K183043 with device name MantaRay (071, 055, 045, 035) Reperfusion Catheters; Imperative Care Aspiration Tubing Set. For ease of review the subject device is referred to as "Gen 2" and the predicate device cleared under 510(k) K183043 is referred to as "Gen 1" throughout the rest of this 510(k) Summary. Table 3 presented below provides a comparison of the similarities and differences between the Gen 1 and Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing.
The comparison between the subject and predicate devices demonstrates that Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing are substantially equivalent to the predicate Gen 1 versions of these devices and that there are no new safety or effectiveness concerns. This conclusion is based on all devices sharing the same intended use, basic technology characteristics, and performance characteristics, as demonstrated through bench and lab testing.
| Device Attribute | Gen 1 ZOOM Reperfusion Catheter
(Predicate Device) | Gen 2 ZOOM Reperfusion Catheter
(Subject Device) |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| FDA Product
Classification | Class II, NRY, 21 CFR 870.1250 | Same |
| Intended Use | Revascularization of patients with acute
ischemic stroke. | Same |
| Indications for Use | See Section E. | Same |
| Condition
Supplied | Sterile and Single Use | Same |
| Sterilization
Method | Ethylene Oxide (EO), SAL 10-6 | Same |
| Nominal Distal
Inner Diameter | 0.035" - 0.071" | Same |
| Max Distal
Outer Diameter | 0.053" - 0.085" | Same |
| Nominal Proximal
Inner Diameter | 0.047" - 0.071" | Same |
| Max Proximal
Outer Diameter | 0.062" - 0.085" | Increased by 0.001" for all sizes |
| Effective Length | 137 - 158cm | Same |
| Tip Design | Beveled edge, soft, flexible, and
atraumatic | Same |
| Tip Length | 0.5 - 1.5cm | 0.5 - 0.8cm |
| Device Attribute | Gen 1 ZOOM Reperfusion Catheter
(Predicate Device) | Gen 2 ZOOM Reperfusion Catheter
(Subject Device) |
| Coating | Hydrophilic coating | Same |
| Materials | Commonly used medical grade plastics
& metals with hydrophilic coating. | Same |
| Packaged
Accessories | Rotating Hemostasis Valve (RHV) | Same |
| Packaging
Configuration | The catheter is placed in a protective
polyethylene tube and then mounted,
along with the accessories, onto a
polyethylene packaging card.
The packaging card is inserted into a
Tyvek® pouch which is then sealed.
The sealed pouch and IFU are placed in
a carton box. | Same |
| Aspiration Pump | ZOOM Aspiration Pump | Same |
| Device Attribute | Gen 1 ZOOM Aspiration Tubing
(Predicate Device) | Gen 2 ZOOM Aspiration Tubing
(Subject Device) |
| Indications for Use | See Section E | Same |
| Condition
Supplied | Sterile and Single Use | Same |
| Sterilization
Method | Ethylene Oxide (EO), SAL 10-6 | Same |
| Tubing ID | 0.110" Minimum | Same |
| Tubing Length | 112" | 104" |
| Flow Control
Mechanism | Flow Control Switch | Flow Control Clamp |
Table 3: Subject and Predicate Device Comparison
7
8
G. Performance Data Supporting Substantial Equivalence:
Bench testing was conducted to evaluate the similarities and differences between the subject and predicate devices. The largest and smallest diameter catheters were tested for both the subject and predicate devices.
The test results were reviewed and found to demonstrate that the differences between the subject and predicate devices do not significantly impact any performance parameters that would negatively affect the safety or effectiveness of the subject Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing.
A summary of the tests and performance specifications that were evaluated is presented in Tables 4 and 5. These tests were performed per company approved protocols and test methods based primarily on catheter performance standard ISO 10555-1.
| Test Attribute | Specification |
|---|---|
| Delivery, Compatibility, | |
| and Retraction | |
| (Trackability) | The catheter shall be able to be delivered, deployed, and retracted |
| per the IFU within a simulated neurological model without | |
| incurring any damage to the catheter. | |
| Flexibility and Kink | |
| Resistance | There shall be no kinking of shaft (permanent deformation) after |
| simulated use. | |
| Compatibility with other | |
| devices (external) | The catheters shall be able to be delivered through the minimum |
| introducer sheath or guide catheter size indicated in the product | |
| labeling. | |
| Guidewire compatibility | The catheters shall be able to be delivered over the guidewire size |
| indicated in the product labeling. | |
| Interventional device | |
| compatibility (internal) | The catheters shall be able to accommodate other interventional |
| devices (e.g., support catheter, diagnostic catheter) up to the | |
| maximum size indicated in the product labeling. | |
| Luer compatibility | Devices and accessories shall be compatible with standard syringe |
| luer fittings per ISO 80369-7. | |
| Accessory compatibility | Devices shall be compatible with the accessory RHV. |
| Visual | Free of kinks, breaks, separation or particulate (greater than |
| 0.25mm^2). No exposed metal. | |
| Test Attribute | Specification |
| Dimensional | All defined catheter dimensions are within the specified tolerances. |
| Catheter Bond Strength | The catheter shall have sufficient bond strengths to remain intact throughout a procedure. |
| Flowrate - positive | |
| (forward) pressure | The catheter lumen shall allow for a minimum flowrate comparable to competitive products. |
| Flowrate – vacuum | |
| pressure | The flowrate under a vacuum shall be similar to or greater than competitive devices. |
| Freedom from Leakage | |
| – positive pressure | No liquid leakage from the hub or catheter shaft at 46psi for 30 seconds |
| Freedom from Leakage | |
| – negative pressure | No air leakage into a 20cc syringe when vacuum pulled for 15 seconds. |
| Burst Pressure | Catheter does not burst under pressures that could be seen when performing contrast injections with a standard 10cc syringe. |
| Catheter Torque | |
| Strength | No separation of any portion of the catheter when rotated at least two (2) full rotations (720 degrees). |
| Lumen Integrity | The catheter lumen shall not collapse under vacuum after multiple passes. |
| Kink Resistance | There shall be no kinking of the catheter shaft (permanent deformation) at anatomically relevant bend radii. |
| Flexibility | The flexibility of the catheter tip shall be comparable to competitive products and allow for easily tracking the device to the desired target anatomy. |
| Coating - Particulate | The amount of particulate matter that comes off the hydrophilic- coated shaft during simulated use testing shall be determined and compared to competitive products and techniques. |
Table 4: Tests and Performance Specifications for ZOOM Reperfusion Catheter
9
10
| Test Attribute | Specification |
|---|---|
| Vacuum Force at | |
| Catheter Tip | The vacuum force delivered by the aspiration tubing to the tip of |
| the catheter should be comparable to the vacuum force delivered | |
| by the predicate aspiration tubing. | |
| Connector | |
| Compatibility | The aspiration tubing connectors shall securely connect to the |
| pump canister lid and standard luer fittings. | |
| Lumen Collapse Test | The tubing lumen shall not collapse under vacuum. |
| Flow Control | |
| Functionality | The flow control mechanism shall allow users to start and stop |
| flow multiple times when the connected pump is running at | |
| maximum vacuum. | |
| Freedom From Leakage | The vacuum pressure delivered at the tip of the aspiration tubing |
| shall be consistent with the pressure generated by the pump. | |
| Tensile Strength | The bonds between the tubing and connectors shall be sufficiently |
| strong to ensure the tubing remains intact during use. |
Table 5: Tests and Performance Specifications for ZOOM Aspiration Tubing
In addition to the above tests which support that the Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing perform as intended when used with the ZOOM Aspiration Pump, general performance testing was also completed for the accessory ZOOM Aspiration Pump as documented in 510(k) K190105.
H. Biocompatibility Testing:
While there are no new patient contacting materials for the Gen 2 ZOOM Reperfusion Catheters, a subset of supporting biocompatibility testing was completed per Imperative Care's risk management and change control procedures to confirm that the Gen 2 design and manufacturing updates did not result in any significant changes to the biocompatibility of the ZOOM Reperfusion Catheters.
The changes made to the Gen 2 ZOOM Aspiration Tubing were also reviewed and it was determined that no new biocompatibility testing was necessary to implement these changes as the aspiration tubing is non-patient contacting and there were no manufacturing process updates associated with the changes that were made.
The test results for the Gen 2 ZOOM Reperfusion Catheter were compared against the test results for the Gen 1 ZOOM Reperfusion Catheter, as summarized below in Table 6 and no significant differences were noted that would negatively impact the biocompatibility of the Gen 2 ZOOM Reperfusion Catheters.
11
| Test | Test Method | Extraction
Methods/Conditions | Acceptance Criteria | Results |
|-----------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------|
| Cytotoxicity: ISO
MEM* Elution | ISO 10993-5 | Test device extracted in
MEM with 5% serum at 37 ± yield cell lysis grade 2 or
1 °C for 24 ± 2 hours | Sample extracts must
lower. | Pass, Non-
cytotoxic |
| Cytotoxicity: ISO
MTT* Assay | ISO 10993-5 | Test device extracted in
MTT* Assay Media at 37 ±
1 ℃ for 24 ± 2 hours | The percentage of cells
exhibiting lysis should be Significant
similar for all test devices. Differences | Pass, No |
| Hemocompatibility:
Hemolysis (Extract
Method) | ASTM F 756
ISO 10993-4 | Test device extracted in PBS
at 50 ± 2℃ for 72 ± 2 hours. Sample extracts must be
Extract exposed to blood cell honhemolytic (≤ 2%
suspension. % hemolysis is
measured. | hemolytic index). | Pass, Non-
hemolytic |
Table 6: Biocompatibility Test Summary
*MEM=Minimal Essential Media,
MTT Assay = (3-(4,5-Dimethylthiazol-2-yl)-2,5-Diphenyltetrazolium Bromide)
NS = Normal Saline
PBS=Phosphate Buffered Saline
I. Sterilization:
The ZOOM Reperfusion Catheter and Aspiration Tubing are both sterilized using validated EO processes with a sterility assurance level of 1x10 6. The sterilization processes were validated per the overkill method described recognized consensus standard ISO 11135, "Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices." A summary of the completed testing is presented below in Tables 7 and 8.
Table 7: Sterilization Validation Summary - ZOOM Reperfusion Catheter
| Requirement/Acceptance Criteria | Results | Summary |
|---|---|---|
| Positive BI controls must be positive in | ||
| fractional, half and full cycles. | PASS | All positive controls in each cycle read |
| positive. | ||
| Fractional cycle requirements: |
- IPCDs and EPCDs must be more difficult
to sterilize than the natural product. | PASS | 1) IPCDs and EPCDs showed more
growth than natural product. |
| 2) Product Sterility testing must show no
growth in all samples. | PASS | 2) The devices did not show any
growth when tested per the methods
in ISO 11737-2. |
| 3) Bacteriostasis/Fungistasis testing must
show that the product is not inhibitory for
growth. | PASS | 3) Bacteriostasis/Fungistasis Testing
showed product is not inhibitory to
growth when tested per the methods
in ISO 11737-2. |
12
| Requirement/Acceptance Criteria | Results | Summary |
|---|---|---|
| Half cycle requirements: |
-
IPCDs and EPCDs should show no growth
for all samples. | PASS | 1) IPCDs and EPCDs showed no
growth. |
| Full cycle requirements: -
IPCDs and EPCDs must show no growth
for all samples. -
The results for Ethylene Oxide (EO) and
Ethylene Chlorohydrin (ECH) shall meet
the requirements of ISO 10993-7. | PASS | 1) IPCDs and EPCDs showed no
growth. -
Samples passed EO residual testing. |
Table 8: Sterilization Validation Summary – ZOOM Aspiration Tubing
| Requirement/Acceptance Criteria | Results | Summary |
|---|---|---|
| Positive BI controls must be positive in | ||
| fractional, half and full cycles. | PASS | All positive controls in each cycle read |
| positive. | ||
| Fractional cycle requirements: |
- IPCDs and EPCDs must be more difficult
to sterilize than the natural product. | PASS | 1) IPCDs and EPCDs showed more
growth than natural product. |
| 2) Product Sterility testing must show no
growth in all samples. | PASS | 2) The devices did not show any
growth when tested per the methods
in ISO 11737-2. |
| 3) Bacteriostasis/Fungistasis testing must
show that the product is not inhibitory for
growth. | PASS | 3) Bacteriostasis/Fungistasis Testing
showed product is not inhibitory to
growth when tested per the methods
in ISO 11737-2. |
| Half cycle requirements: - IPCDs and EPCDs should show no
growth for all samples. | PASS | 1) IPCDs and EPCDs showed no
growth. |
| Full cycle requirements: - IPCDs and EPCDs must show no growth
for all samples. | PASS | 1) IPCDs and EPCDs showed no
growth. |
| 2) The results for Ethylene Oxide (EO) and
Ethylene Chlorohydrin (ECH) shall meet
the requirements of ISO 10993-7. | PASS | 2) Samples passed EO residual testing. |
13
Shelf Life and Packaging: J.
Accelerated aging testing based on ASTM F1980 was conducted to verify device, accessory, and packaging performance. A minimum shelf life was established based on this testing and is indicated by the expiration date provided on the product labeling.
Device and accessory performance was verified by repeating the functional tests previously presented in Section G of this 510(k) summary.
Packaging and sterile barrier integrity through transportation has been verified for the packaging configurations used for the ZOOM Reperfusion Catheter and ZOOM Aspiration Tubing. Aging testing has also been performed that supports the sterile barrier integrity following aging. A summary of the completed packaging tests is presented below in Tables 9 and 10.
Table 9: Packaging Validation Summary - ZOOM Reperfusion Catheter
| Test | Test Method | T0 Results
(Pass/Fail) | Shelf Life Results
(Pass/Fail) |
|------------------------------------------------|-------------------------------------------|---------------------------|-----------------------------------|
| Packaging Visual
Inspection | ASTM F1886
Imperative Care
Internal | Pass | Pass |
| Pouch Integrity Test -
Gross Leak Detection | ASTM F2096 | Pass | Pass |
| Pouch Seal Strength
– Peel Strength | ASTM F88 | Pass | Pass |
| Label Integrity | Imperative Care
Internal | Pass | Pass |
Table 10: Packaging Validation Summary - ZOOM Aspiration Tubing
| Test | Test Method | T0 Results
(Pass/Fail) | Shelf Life Results
(Pass/Fail) |
|------------------------------------------------|-----------------------------|---------------------------|-----------------------------------|
| Packaging Visual
Inspection | ASTM F1886
TWBM Internal | Pass | Pass |
| Pouch Integrity Test -
Gross Leak Detection | ASTM F2096 | Pass | Pass |
| Pouch Seal Strength
– Peel Strength | ASTM F88 | Pass | Pass |
| Label Integrity | TWBM Internal | Pass | Pass |
14
K. Conclusions:
Where differences were identified between the subject Gen 2 ZOOM Reperfusion Catheter and Aspiration Tubing and the predicate Gen 1 ZOOM Reperfusion Catheter and Aspiration Tubing, a risk assessment was completed to determine if the difference would result in new safety or effectiveness concerns regarding the use of the device. As appropriate, bench and lab testing were conducted to support this assessment.
Based on the results of the completed risk assessments and associated testing, it is concluded that the subject Gen 2 ZOOM Reperfusion Catheter and Aspiration Catheter is substantially equivalent to the predicate Gen 1 ZOOM Reperfusion Catheter and Aspiration Tubing and that there are no new safety or effectiveness concerns associated with the identified differences. This conclusion is supported by the subject and predicate devices sharing the same intended use, basic technology characteristics, and equivalent performance characteristics, as confirmed through well-designed bench and lab testing.