(140 days)
Not Found
No
The device description and performance studies focus on mechanical components and fluid dynamics, with no mention of AI or ML algorithms for analysis, control, or decision-making.
Yes
The device is intended to treat a condition by removing/aspirating fluid, fresh, soft emboli and thrombi from the peripheral vasculature, which is a therapeutic action.
No
The device is intended to infuse fluids and remove/aspirate materials from the peripheral vasculature for therapeutic purposes (fluid mechanical thrombectomy), not to diagnose a condition.
No
The device description clearly outlines physical components including a catheter, syringe, and filter line, 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:
- Intended Use: The intended use is to "infuse physician specified fluids and remove/aspirate fluid, fresh, soft emboli and thrombi from the peripheral vasculature." This describes a therapeutic procedure performed directly on a patient's body (in vivo).
- Device Description: The device is a catheter system designed for infusion and aspiration within the peripheral vasculature. This is a medical device used for intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing. The aspirated material is collected for "temporary storage, inspection, analysis, transport and / or disposal," which is a consequence of the therapeutic procedure, not the primary diagnostic function of the device itself.
IVD devices are typically used to test samples like blood, urine, tissue, etc., outside of the body to provide diagnostic information. This device operates directly within the patient's circulatory system for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The V2K Rinspiration System is intended to infuse physician specified fluids and remove/aspirate fluid, fresh, soft emboli and thrombi from the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DXE, KRA
Device Description
The V2K Rinspiration System is comprised of the V2K Rinspiration Catheter and two accessory components; an Infusion Syringe and a Filter Line.
The V2K Rinspiration Catheter is a multi-lumen catheter that has infusion holes located near the distal end of the catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. Simultaneous infusion and aspiration can be performed through these lumens to perform fluid mechanical thrombectomy to remove fluid, fresh, soft emboli and thrombi from peripheral vasculature. The Rinspiration Catheter will be placed in the target vasculature of a patient over an 0.014" guide wire. The V2K Rinspiration Catheter uses a rapid exchange (a.k.a. rail) configuration for the guidewire lumen. The Rinspiration catheter distal tip will be positioned at the intended treatment site. Infusion occurs approximately 1 to 2cm proximal to the distal tip. The catheter includes a smaller radiopaque marker band at the distal tip and two larger radiopaque marker bands designating the infusion portion of the catheter. The catheter has a V-hub on the proximal end that allows access to the infusion and aspiration lumens.
Included in the same packaging as the V2K Rinspiration Catheter is a 12cc Infusion Syringe with an attached check valve. The Infusion Syringe is intended to be used for infusing physician specified fluids through the V2K Rinspiration Catheter.
The V2K Rinspiration Catheter will also be supplied with an accessory Filter Line which is intended to be used to connect the catheter to a continuous vacuum source such as an aspiration pump or hospital vacuum line. The Filter Line has two connections, one male Luer and one slip-fit connector. The male Luer is connected to the aspiration lumen of the V2K Rinspiration Catheter. The slip-fit connector is connected to the continuous vacuum source.
The Filter Line also has an in-line flow control switch and an in-line filter. The in-line flow control switch is used to open/close the connection between the continuous vacuum source and the aspiration lumen of the catheter. This allows the user a simple method to manage the aspiration flow. The in-line filter is used to collect any debris that is aspirated through the catheter and allows the user to clearly visualize what has been aspirated. This also allows for temporary storage, inspection, analysis, transport and / or disposal of the aspirated materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
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)
Bench and Lab testing was conducted in order to evaluate the differences between the proposed V2K Rinspiration System and the predicate Kerberos Rinspiration System. As V2K has access to the original design verification and validation documentation for the predicate Kerberos Rinspiration System, the data from this testing was leveraged, where possible, for comparison to the proposed V2K Rinspiration System.
The test results were reviewed and found to demonstrate that the differences between the proposed and predicate device do not significantly impact any catheter performance parameters that would affect the safety or efficacy of the proposed V2K Rinspiration Catheter.
A summary of the tests and performance specifications that were evaluated is presented in the original document. These tests were performed per V2K approved methods based on prior Kerberos test methods and catheter performance standard ISO 10555-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
January 26, 2018
V2K Medical Inc. Jake Wolenberg Quality and Regulatory Consultant 1221 Innsbruck Drive Sunnyvale, California 94089
Re: K172716
Trade/Device Name: V2K Rinspiration System, P7 Catheter - 9mm Rinse x 135cm Working Leneth, V2K Rinspiration System, P7 Catheter - 20mm Rinse x 135cm Working Length, V2K Rinspiration System, Filter Line - 108" Length Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE, KRA Dated: December 13, 2017 Received: December 18, 2017
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. 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); good
1
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.
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172716
Device Name V2K Rinspiration System
Indications for Use (Describe)
The V2K Rinspiration System is intended to infuse physician specified fluids and remove/aspirate fluid, fresh, soft emboli and thrombi from the peripheral vasculature.
Type of Use (Select one or both, as applicable)
2 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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020. See PRA Statement below.
3
Image /page/3/Picture/0 description: The image is a logo featuring a large letter 'V' split into two colors, green on the left and blue on the right. Below the 'V' is the text 'V2K Medical' in a smaller font size. The entire logo is encircled by a green ring, creating a circular emblem. The logo appears to be for a medical company.
510(k) Summary V2K Rinspiration System
A. Submitter Information
Submitter's Name: Address:
Telephone: Fax: Email: Contact Person: Date of Preparation:
B. Subject Device
Proprietary Name: 510(k) #: Common/Usual Name: Classification Name:
Product Code:
C. Predicate Device
Proprietary Name: 510(k) #'s: Common/Usual Name: Classification Name: Product Code:
V2K Medical Inc. 1221 Innsbruck Drive Sunnyvale, CA 94089 408-940-5587 408-726-2977 jwolenbergV2K(@gmail.com Jake Wolenberg January 25, 2018
V2K Rinspiration System
K172716 Embolectomy Catheter and Infusion Catheter Catheter, Embolectomy and; Catheter, Continuous Flush DXE per 21 C.F.R. 870.5150 and; KRA per 21 C.F.C 870.1210
Kerberos Proximal Solutions Rinspiration System K062275 Embolectomy Catheter Catheter, Embolectomy DXE per 21 C.F.R. 870.5150
4
Image /page/4/Picture/0 description: The image is a logo for V2K Medical. The logo consists of a green circle with a white background. Inside the circle is a large letter V, with the left half of the V being green and the right half being blue. Below the V is the text "V2K Medical" in black font.
D. Device Description:
The V2K Rinspiration System is comprised of the V2K Rinspiration Catheter and two accessory components; an Infusion Syringe and a Filter Line.
The V2K Rinspiration Catheter is a multi-lumen catheter that has infusion holes located near the distal end of the catheter to dispense an infusible fluid. The central lumen of the catheter is used for aspiration. Simultaneous infusion and aspiration can be performed through these lumens to perform fluid mechanical thrombectomy to remove fluid, fresh, soft emboli and thrombi from peripheral vasculature. The Rinspiration Catheter will be placed in the target vasculature of a patient over an 0.014" guide wire. The V2K Rinspiration Catheter uses a rapid exchange (a.k.a. rail) configuration for the guidewire lumen. The Rinspiration catheter distal tip will be positioned at the intended treatment site. Infusion occurs approximately 1 to 2cm proximal to the distal tip. The catheter includes a smaller radiopaque marker band at the distal tip and two larger radiopaque marker bands designating the infusion portion of the catheter. The catheter has a V-hub on the proximal end that allows access to the infusion and aspiration lumens.
Included in the same packaging as the V2K Rinspiration Catheter is a 12cc Infusion Syringe with an attached check valve. The Infusion Syringe is intended to be used for infusing physician specified fluids through the V2K Rinspiration Catheter.
The V2K Rinspiration Catheter will also be supplied with an accessory Filter Line which is intended to be used to connect the catheter to a continuous vacuum source such as an aspiration pump or hospital vacuum line. The Filter Line has two connections, one male Luer and one slip-fit connector. The male Luer is connected to the aspiration lumen of the V2K Rinspiration Catheter. The slip-fit connector is connected to the continuous vacuum source.
The Filter Line also has an in-line flow control switch and an in-line filter. The in-line flow control switch is used to open/close the connection between the continuous vacuum source and the aspiration lumen of the catheter. This allows the user a simple method to manage the aspiration flow. The in-line filter is used to collect any debris that is aspirated through the catheter and allows the user to clearly visualize what has been aspirated. This also allows for temporary storage, inspection, analysis, transport and / or disposal of the aspirated materials.
E. Intended Use:
The V2K Rinspiration System is intended to infuse physician specified fluid and remove/aspirate fluid, fresh, soft emboli and thrombi from the peripheral vasculature.
5
Image /page/5/Picture/0 description: The image is a logo for V2K Medical. The logo features a large letter "V" with the left side in dark green and the right side in blue. Below the "V" is the text "V2K Medical" in a smaller font. The entire logo is encircled by a thick, dark green ring, creating a circular emblem.
F. Predicate Comparison:
The subject V2K Rinspiration Catheter has the same basic catheter design, intended use, and operating principles as the predicate Kerberos Rinspiration System.
The primary update made was to replace the handheld pump (Rinspirator) that was used as part of the Kerberos Rinspiration System to simultaneously operate both an infusion syringe and an aspiration syringe. In the V2K Rinspiration System, the Rinspirator was replaced with the 12cc Infusion Syringe and the Rinspiration Filter Line. These accessories still allow for simultaneous infusion and aspiration.
The catheter hub design was also updated to help make it easier to identify how to connect the catheter to the accessory devices.
Additional updates can be found in the table below which compares the subject device models included in the 510(k) to the most similar predicate device models.
| Predicate Device | Subject Device | |
|---|---|---|
| Kerberos Proximal Solutions | ||
| Rinspiration System | V2K Rinspiration System | |
| Product Code | DXE per 21 C.F.R. 870.5150 | DXE per 21 C.F.R. 870.5150 |
| KRA per 21 C.F.C 870.1210 | ||
| Class | Class II | Same |
| Name | Embolectomy Catheter | |
| Infusion Catheter | Same | |
| Indications for Use | The Kerberos Proximal Solutions | |
| Rinspiration Catheter System is | ||
| intended to infuse physician | ||
| specified fluid and remove/aspirate | ||
| fresh, soft emboli and thrombi from | ||
| the coronary and peripheral | ||
| vasculature. | The V2K Rinspiration System is | |
| intended to infuse physician | ||
| specified fluid and remove/aspirate | ||
| fluid, fresh, soft emboli and thrombi | ||
| from the peripheral vasculature. | ||
| Catheter & | ||
| Accessory Materials | Commonly used medical grade | |
| plastics & stainless steel. | Same | |
| Lubricious Coating | Silicone Oil Solution | Same |
| Catheter Visibility | Radiopaque Tip and Infusion | |
| Markers | Same | |
| Outer Diameter | 7.0 French (= 1.5cc/sec. | |
| Flexibility and Kink | ||
| Resistance | The catheter shall not kink when passed through clinically relevant | |
| bend radii. | ||
| Strain Relief | ||
| Flexibility | The strain relief shall protect the catheter shaft when deflected with | |
| a force of 1 lbf. | ||
| Test Performed | Specification Summary | |
| Guide Sheath | ||
| Compatibility / | ||
| Coating Durability | After a clinically relevant number of insertions and removals | |
| through a 7 French guide sheath, the catheter shall be intact with no | ||
| deformation or kinks and no detectable change in resistance. | ||
| Guidewire | ||
| Compatibility | The user shall be able to advance the catheter with little resistance | |
| over a 0.014" diameter wire while infusing at a rate of 1.5cc/sec. | ||
| Radiopacity | The radiopaque markers on the distal and infusion site of catheter | |
| shall be visible under typical fluoroscopic methods. | ||
| Corrosion Test | The metallic components of the catheter shall show no signs of | |
| corrosion following worst case exposure conditions to a heated | ||
| saline solution. |
8
Image /page/8/Picture/0 description: The image is a logo for V2K Medical. The logo features a large letter "V" split into two colors, green on the left and blue on the right. Below the "V" is the text "V2K Medical" in a smaller font. The entire design is encircled by a green ring, creating a circular emblem.
H. Biocompatibility
Biocompatibility testing was performed on all direct and indirect patient contacting components of the V2K Rinspiration System. This testing was conducted to ensure that the components and raw materials used in the proposed V2K Rinspiration System, as well as the manufacturing processes and sterilization processes result in a biocompatible product. All biocompatibility tests were conducted pursuant to 21 CFR Part 58, Good Laboratory Practices, ISO 10993-1, and per the recommendations in FDA guidance document titled. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
A summary of the selected biocompatibility tests performed for the direct and indirect patient contacting components of the V2K Rinspiration System is presented for reference on the following pages. All test results passed, indicating that the V2K Rinspiration is biocompatible for its intended use.
9
Image /page/9/Picture/0 description: The image is a logo for V2K Medical. The logo features a large letter "V" with the left half in dark green and the right half in blue. Below the "V" is the text "V2K Medical" in a smaller font. The entire logo is encircled by a green ring, creating a circular emblem.
| Test | Test Method | Extraction
Methods/Conditions | Acceptance Criteria | Results |
|--------------------------------------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Cytotoxicity: ISO
MEM Elution
Method | ISO 10993-5 | Test device extracted in
MEM with 5% serum at
37+/-1°C for 24-25 hours. | Sample extracts must
yield cell lysis grade 2
or lower. | Pass,
Non-cytotoxic |
| Sensitization:
Magnusson-
Kligman Method | ISO 10993-10 | Guinea pigs exposed to test
device extracts. Challenged
sites observed for skin
sensitization 24 +/- 2 and
48 +/- 2 hours after
removal of extracts.
Extracts were prepared at
37+/-1°C for 72 +/- 2
hours. | Test Group shall yield
Grade 10% weight loss in
3 or more test animals
• Mortality of 2 or
more test animals
• Abnormal behavior
in 2 or more test
animals | Pass,
Non-Toxic |
| Test | Test Method | Extraction
Methods/Conditions | Acceptance Criteria | Results |
| Systemic Toxicity:
ISO Material
Mediated Pyrogen | ISO 10993-11 | Test device extracted in
0.9% saline solution and
injected in the marginal ear
vein. Rectal temperatures
recorded prior to injection
and every 30 min until 1-3
hours post injection.
Extracts were prepared at
37+/- 1°C for 72 +/- 2
hours. | Sample Extracts must
not cause a total rise in
body temperature of
$\geq$ 0.5°C. | Pass ,
Non-pyrogenic |
| Hemocompatibility:
ASTM Hemolysis,
indirect (human
blood) | ISO 10993-4
ASTM F756 | Extract exposed to blood
cell suspension.
Hemoglobin releases is
measured. | Sample extracts must
be nonhemolytic ( $\leq$
2% hemolytic index). | Pass ,
Non-hemolytic |
| Hemocompatibility:
ASTM Hemolysis,
direct contact
(human blood) | ISO 10993-4
ASTM F756 | Test device exposed to
blood cell suspension.
Hemoglobin releases is
measured. | Sample extracts must
be nonhemolytic ( $\leq$
2% hemolytic index). | Pass ,
Non-hemolytic |
| Hemocompatibility:
Partial
Thromboplastin
Time (PTT) | ISO 10993-4
ASTM F2382 | Test device and controls
are directly exposed to
human blood plasma with
anticoagulants at 37+/- 2°C
for 60 +/- 5 minutes.
Following exposure, the
anticoagulant is neutralized
and the time for the serum
to start clotting is recorded. | The clotting time for
the test device should
be similar to or less
than either a predicate
device, a negative
control, or the plasma
control. | Pass. Minimal
Activator |
| Hemocompatibility:
Complement
Activation Test | ISO 10993-4
ASTM F756 | Preformed in vitro using a
prepared Enzyme
Immunoassay (EIA) kit.
This kit will detect the
presence of specific
complement enzymes.
Test device extracted in
Normal Human Serum
(NHS) at 37+/- 2°C for 0.5,
1, and 1.5 hours. | The concentrations of
C3a and SC5b-9 in the
test samples are
statistically similar to
the predicate
(Exposure Control &
Ref Material) control
and statistically lower
than the positive
control for all
exposure times. | No Significant
Differences |
| In Vivo
Thrombogenicity
(Dog) | ISO 10993-4
ASTM F756 | Performed in duplicate.
Placed in one side of the
jugular vein. Vasculature
closed up and remains in
place for 4 hours. | The device must be
nonthrombogenic after
4 hours in vivo when
compared to a control
device (Merit Fountain
Infusion Catheter). | Pass .
Minimal
Thrombus
Formation |
10
Image /page/10/Picture/0 description: The image is a logo for V2K Medical. The logo consists of a large letter "V" that is split into two colors, green on the left and blue on the right. Below the "V" is the text "V2K Medical" in a smaller font. The entire logo is enclosed in a green circle.
V2K Medical Inc.
1221 Innsbruck Drive
Sunnyvale, CA 94089
Sunnyvale, CA 94089
Phone: 408-940-5587
11
Image /page/11/Picture/0 description: The image is a logo for V2K Medical. The logo features a green circle with the letters 'V' in green and blue inside the circle. Below the letters, the words 'V2K Medical' are written in black. The logo is simple and professional, and it is likely used to represent the company's brand.
I. Sterilization
The V2K Rinspiration Catheter and Rinspiration Filter Line are both sterilized using an electron beam process with a sterility assurance level of 1x106. The sterilization process was validated per the VDmax 25 method described in ANSI/AAMI/ISO 11137-1, "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices". A summary of the completed testing is presented below.
| Test Group | Catheter
Results | Filter Line
Results |
|-------------------------------------------|---------------------|------------------------|
| Sterilization Dose Map | Pass | Pass |
| Bioburden Recovery Correction Factor | Pass | Pass |
| Device Bioburden Assessment | Pass | Pass |
| Sterile Verification Dose | Pass | Pass |
| Bacteriostasis/ Fungistasis (B/F) Testing | Pass | Pass |
J. Shelf Life and Packaging
Accelerated aging testing based on ASTM F1980 was conducted to verify device, accessory, and packaging performance. A real time aging equivalent of 25 months was used for this testing and will allow for labeling of product with a 2-year shelf life.
Device and accessory performance was verified by repeating the functional tests previously discussed in Section G.
Packaging and sterile barrier integrity through transportation and aging testing was verified per the testing summarized below.
| Test | Test Method | Time
Points | Catheter
Results | Filter Line
Results |
|------------------------------------------------|-----------------------------|----------------|---------------------|------------------------|
| Packaging Visual
Inspection | ASTM F1886 /
V2K TM00294 | 25 months | Pass | Pass |
| Pouch Integrity Test -
Gross Leak Detection | ASTM F2096 | 25 months | Pass | Pass |
| Pouch Seal Strength
– Peel Strength | ASTM F88 | 25 months | Pass | Pass |
| Label Integrity | V2K TM00294 | 25 months | Pass | Pass |
12
Image /page/12/Picture/0 description: The image is a logo for V2K Medical. The logo features a large letter V, with the left half in dark green and the right half in blue. Below the V, the text "V2K Medical" is written in a smaller font. The entire logo is encircled by a green ring.
K. Conclusions
Where differences were identified between the subject V2K Rinspiration Catheter and the predicate Kerberos Rinspiration Catheter, an assessment was conducted to determine if the difference would result in new safety or efficacy concerns regarding the use of the device. As appropriate, bench and lab testing was conducted to support this assessment.
Based on the results of the conducted assessments and testing, it is concluded that V2K Rinspiration System is substantially equivalent to the predicate Kerberos Rinspiration System and that there are no new safety or efficacy concerns associated with the identified differences. This conclusion is based on both devices sharing the same intended use, basic technology characteristics, and performance characteristics, as demonstrated through welldesigned bench and lab testing.