(140 days)
The V2K Rinspiration System is intended to infuse physician specified fluids and remove/aspirate fluid, fresh, soft emboli and thrombi from the peripheral vasculature.
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.
The provided document is a 510(k) Summary for the V2K Rinspiration System, outlining its substantial equivalence to a predicate device. It details various performance tests conducted for this medical device, which is an embolectomy/infusion catheter.
However, the questions posed (related to acceptance criteria and study data for an AI/ML powered medical device) are not applicable to the content of this document. This submission does not describe an AI/ML powered device, nor does it contain information about clinical studies with human readers, ground truth establishment by experts, or training/test sets for an algorithm. It focuses on the physical and biological performance characteristics of a catheter system.
Therefore, I cannot extract the requested information from the provided text as it pertains to a different type of medical device and regulatory submission.
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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
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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
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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)
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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
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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.
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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 SolutionsRinspiration System | V2K Rinspiration System | |
| Product Code | DXE per 21 C.F.R. 870.5150 | DXE per 21 C.F.R. 870.5150KRA per 21 C.F.C 870.1210 |
| Class | Class II | Same |
| Name | Embolectomy CatheterInfusion Catheter | Same |
| Indications for Use | The Kerberos Proximal SolutionsRinspiration Catheter System isintended to infuse physicianspecified fluid and remove/aspiratefresh, soft emboli and thrombi fromthe coronary and peripheralvasculature. | The V2K Rinspiration System isintended to infuse physicianspecified fluid and remove/aspiratefluid, fresh, soft emboli and thrombifrom the peripheral vasculature. |
| Catheter &Accessory Materials | Commonly used medical gradeplastics & stainless steel. | Same |
| Lubricious Coating | Silicone Oil Solution | Same |
| Catheter Visibility | Radiopaque Tip and InfusionMarkers | Same |
| Outer Diameter | 7.0 French (<0.093") | Same |
| Aspiration LumenID | ID ≥ 0.050" | ID ≥ 0.048" |
| Infusion HoleSpacing | 9mm | 9mm & 20mm |
| Effective Length | 135cm | Same |
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Image /page/6/Picture/0 description: The image is a logo for V2K Medical. The logo consists of a green circle with a large letter "V" inside. The left half of the "V" is dark green, while the right half is blue. Below the "V" is the text "V2K Medical" in black font.
| Predicate Device | Subject Device | |
|---|---|---|
| Kerberos Proximal SolutionsRinspiration System | V2K Rinspiration System | |
| GuidewireCompatibility | 0.014” | Same |
| Maximum InfusionPressure | 3.1 psi | Same |
| Catheter Accessories | 3cc Infusion syringeInfusion Supply LineRinspirator Handle5cc aspiration syringeIn-Line FilterAspiration bag | 12cc Infusion Syringe with CheckValveFilter Line |
| Sterile Barrier | Tyvek with polymer backing | Same |
| Sterilization | EtO, SAL 10-6 | E-Beam, SAL 10-6 |
| Condition Supplied | Sterile, Single Use, Disposable | Same |
G. Performance Data Supporting Substantial Equivalence:
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 on the following pages. These tests were performed per V2K approved methods based on prior Kerberos test methods and catheter performance standard ISO 10555-1.
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Image /page/7/Picture/0 description: The image is a logo for V2K Medical. The logo consists of a green circle with a large letter V inside. The left half of the V is dark green, and the right half is blue. Below the V, the text "V2K Medical" is written in black.
V2K Medical Inc.
1221 Innsbruck Drive
Sunnyvale, CA 94089
Sunnyvale, CA 94089
Phone: 408-940-5587
| Test Performed | Specification Summary |
|---|---|
| Visual Inspection | The product and packaging shall be free of significant defects orassembly issues. |
| DimensionalVerification | All product dimensions critical to device performance shall meet theproduct specifications with the required tolerances. |
| Catheter BondStrength | All bonds/joints made throughout the catheter and accessories shallbe strong enough to prevent separation during normal use. |
| Fatigue Testing -Infusion | The catheter and accessories shall be able to function and maintainintegrity following infusion of a worst-case fluid volume through theinfusion lumen. |
| Fatigue Testing -Filter Line | The Filter Line shall function and maintain integrity followingcontinuous aspiration for a clinically relevant time. |
| Fatigue Testing -Flow Control Switch | The flow control switch shall be able to function and maintainintegrity following a clinically relevant number of on/off cycles andfollowing continuous aspiration for a clinically relevant time. |
| Freedom fromLeakage | The catheter and accessories shall remain free of leaks or damagefollowing exposure to clinically relevant positive pressure andvacuum. |
| Simulated Use | The catheter shall be able to be delivered through a simulated usemodel and successfully used to infuse fluids, aspirate and beretracted per the IFU without incurring any damage. |
| Infusion Flow Rate& Height | The user shall be able to inject physician specified fluids at a rate of1.5cc/sec without generating excessive pressure/fluid velocity at thedistal tip of the catheter. |
| Aspiration FlowRate | When connected to an aspiration pump, the user should be able toaspirate at an average flow rate >= 1.5cc/sec. |
| Flexibility and KinkResistance | The catheter shall not kink when passed through clinically relevantbend radii. |
| Strain ReliefFlexibility | The strain relief shall protect the catheter shaft when deflected witha force of 1 lbf. |
| Test Performed | Specification Summary |
| Guide SheathCompatibility /Coating Durability | After a clinically relevant number of insertions and removalsthrough a 7 French guide sheath, the catheter shall be intact with nodeformation or kinks and no detectable change in resistance. |
| GuidewireCompatibility | The user shall be able to advance the catheter with little resistanceover 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 cathetershall be visible under typical fluoroscopic methods. |
| Corrosion Test | The metallic components of the catheter shall show no signs ofcorrosion following worst case exposure conditions to a heatedsaline solution. |
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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.
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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 | ExtractionMethods/Conditions | Acceptance Criteria | Results |
|---|---|---|---|---|
| Cytotoxicity: ISOMEM ElutionMethod | ISO 10993-5 | Test device extracted inMEM with 5% serum at37+/-1°C for 24-25 hours. | Sample extracts mustyield cell lysis grade 2or lower. | Pass,Non-cytotoxic |
| Sensitization:Magnusson-Kligman Method | ISO 10993-10 | Guinea pigs exposed to testdevice extracts. Challengedsites observed for skinsensitization 24 +/- 2 and48 +/- 2 hours afterremoval of extracts.Extracts were prepared at37+/-1°C for 72 +/- 2hours. | Test Group shall yieldGrade < 1 score onMagnusson andKligman scale(provided controlGrade < 1). | Pass,Non-Sensitizing |
| Irritation: ISOIntracutaneousToxicity | ISO 10993-10 | Rabbits are injected withextracts of test device.Injection sitesexamined/scored at 24 +/-2, 48 +/- 2 and 72 +/- 2hours after injections.Extracts were prepared at37+/-1°C for 72 +/- 2hours. | The difference in themean test article andmean control scoremust be grade 1.0 orlower. | Pass,Non-Irritant |
| Systemic Toxicity | ||||
| Systemic Toxicity:ISO SystemicInjection | ISO 10993-11 | Mice are injected withextracts of test device.Animals are observed forsigns of toxicityimmediately afterinjection, 4+/- 0.75, 24 +/-2, 48 +/- 2 and 72 +/- 2hours after injections.Body weights aremeasured prior to injectionand on all 3 days.Extracts were prepared at37+/-1°C for 72 +/- 2hours. | Sample extracts mustnot cause thefollowing:• > 10% weight loss in3 or more test animals• Mortality of 2 ormore test animals• Abnormal behaviorin 2 or more testanimals | Pass,Non-Toxic |
| Test | Test Method | ExtractionMethods/Conditions | Acceptance Criteria | Results |
| Systemic Toxicity:ISO MaterialMediated Pyrogen | ISO 10993-11 | Test device extracted in0.9% saline solution andinjected in the marginal earvein. Rectal temperaturesrecorded prior to injectionand every 30 min until 1-3hours post injection.Extracts were prepared at37+/- 1°C for 72 +/- 2hours. | Sample Extracts mustnot cause a total rise inbody temperature of$\geq$ 0.5°C. | Pass ,Non-pyrogenic |
| Hemocompatibility:ASTM Hemolysis,indirect (humanblood) | ISO 10993-4ASTM F756 | Extract exposed to bloodcell suspension.Hemoglobin releases ismeasured. | Sample extracts mustbe nonhemolytic ( $\leq$2% hemolytic index). | Pass ,Non-hemolytic |
| Hemocompatibility:ASTM Hemolysis,direct contact(human blood) | ISO 10993-4ASTM F756 | Test device exposed toblood cell suspension.Hemoglobin releases ismeasured. | Sample extracts mustbe nonhemolytic ( $\leq$2% hemolytic index). | Pass ,Non-hemolytic |
| Hemocompatibility:PartialThromboplastinTime (PTT) | ISO 10993-4ASTM F2382 | Test device and controlsare directly exposed tohuman blood plasma withanticoagulants at 37+/- 2°Cfor 60 +/- 5 minutes.Following exposure, theanticoagulant is neutralizedand the time for the serumto start clotting is recorded. | The clotting time forthe test device shouldbe similar to or lessthan either a predicatedevice, a negativecontrol, or the plasmacontrol. | Pass. MinimalActivator |
| Hemocompatibility:ComplementActivation Test | ISO 10993-4ASTM F756 | Preformed in vitro using aprepared EnzymeImmunoassay (EIA) kit.This kit will detect thepresence of specificcomplement enzymes.Test device extracted inNormal Human Serum(NHS) at 37+/- 2°C for 0.5,1, and 1.5 hours. | The concentrations ofC3a and SC5b-9 in thetest samples arestatistically similar tothe predicate(Exposure Control &Ref Material) controland statistically lowerthan the positivecontrol for allexposure times. | No SignificantDifferences |
| In VivoThrombogenicity(Dog) | ISO 10993-4ASTM F756 | Performed in duplicate.Placed in one side of thejugular vein. Vasculatureclosed up and remains inplace for 4 hours. | The device must benonthrombogenic after4 hours in vivo whencompared to a controldevice (Merit FountainInfusion Catheter). | Pass .MinimalThrombusFormation |
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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
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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 | CatheterResults | Filter LineResults |
|---|---|---|
| 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 | TimePoints | CatheterResults | Filter LineResults |
|---|---|---|---|---|
| Packaging VisualInspection | 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 |
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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.
§ 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).