(240 days)
INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems.
INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, nonpyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional techniques.
The INDIGO® Aspiration System is comprised of several devices:
- . INDIGO Aspiration Catheter
- Penumbra Aspiration Pump ●
- INDIGO Aspiration Pump Canister .
- INDIGO Aspiration Tubing ●
- . INDIGO Separator™
The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
The Penumbra, Inc. Indigo Aspiration System, specifically the Aspiration Catheter 7 and Separator 7, underwent various non-clinical tests to demonstrate its substantial equivalence to predicate devices. The following information summarizes the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biological safety in accordance with ISO 10993-1, USP standards, and FDA Good Laboratory Practices (GLP) for cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, and hemocompatibility (per BS EN ISO 10993-4 requirements). | Passed |
| Design Verification (Bench-top Testing) - CAT7 | ||
| Dimensional/Visual Inspection | Meet all product specifications. | Pass |
| Simulated Use (Peripheral Access, Vessel Access Entry Performance, Delivery/Retrieval & Clot Removal) | Effectiveness of devices to remove clots and Aspiration Catheter not collapsing under vacuum when simulated in an anatomical vascular flow model with accessory devices. | Pass |
| Aspiration Catheter/7F Sheath compatibility (Friction Force) | Maximum value per specification. | Pass |
| Aspiration Catheter/0.038" Guidewire compatibility (Friction Force) | Maximum value per specification. | Pass |
| Coating Integrity (Pre-Inspection/Post-Inspection) | Coating has not delaminated, peeled, or flaked prior to and after simulated use particulate testing. | Pass |
| Particulate Testing | < 10 µm will be ≤ 6000 particles; < 25 µm will be ≤ 600 particles. (> 75 µm and > 125 µm particles recorded for informational purposes only). | Pass |
| Hub Air Aspiration | No air leaks. | Pass |
| Catheter Pressure (Lumen Burst Pressure) | Minimum value per specification. | Pass |
| Hub / Shaft Tensile Strength | Minimum value per specification. | Pass |
| Catheter Shaft Tensile (all joints) | Minimum value per specification. | Pass |
| Elongation to Failure | Minimum value per specification. | Pass |
| Corrosion | No visible corrosion on Cathether immediately after Corrosion Testing procedure. | Pass |
| Design Verification (Bench-top Testing) - SEP7 | ||
| Dimensional/Visual Inspection | Meet all product specifications. | Pass |
| Separator Cone Shape | Must be Diamond shape. | Pass |
| Coating Integrity (Pre-Inspection/Post-Inspection) | Coating has not delaminated, peeled, or flaked prior to or after simulated use particulate testing. | Pass |
| Particulate Testing | The maximum number of particles: < 10 µm will be ≤ 6000 particles; < 25 µm will be ≤ 600 particles. (> 75 µm and > 125 µm particles recorded for informational purposes only). | Pass |
| Separator 7 Break Force (Cone/Wire) | Minimum value per specification. | Pass |
| Shelf Life | CAT7: 12-month shelf life (based on accelerated aging). SEP7: 36-month shelf life (leveraged from predicate device). | Met |
| Sterilization | Sterilized in accordance with BS EN ISO 11135 (Ethylene Oxide gas exposure). | Met |
| Packaging | All acceptance criteria for packaging validation. (CAT7: Packaging Validation Testing completed. SEP7: Packaging Validation Testing leveraged). | Met |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes used for each individual test within the "Design Verification (Bench-top Testing)" section. It generally states that "units used in this Design Verification testing" were evaluated. The data provenance is not explicitly stated as country of origin, but it is implied to be from Penumbra, Inc. in Alameda, CA, USA, where the device manufacturer is located. The studies are non-clinical (bench-top and laboratory testing), not human or animal studies, so the terms "retrospective" or "prospective" are not directly applicable in the same way they would be for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. The studies described are non-clinical engineering and laboratory tests (biocompatibility, mechanical performance, etc.). Ground truth in this context refers to established engineering specifications and international standards, not expert medical opinion on diagnostic images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies where multiple human readers are involved. The studies described here are objective, quantifiable engineering and laboratory tests with predetermined specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device described (Indigo Aspiration System - Aspiration Catheter 7 and Separator 7) is a physical medical device (catheter and separator for thrombus removal), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As stated above, the device is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the non-clinical tests was based on pre-determined product specifications, engineering standards, and international regulations/guidelines. For example:
- Biocompatibility: ISO 10993-1, USP standards, FDA GLP, BS EN ISO 10993-4.
- Mechanical and Physical Properties: Specific maximum/minimum values, visual criteria (e.g., "no air leaks," "no visible corrosion," "must be Diamond shape"), and adherence to accepted test methods.
- Sterilization: BS EN ISO 11135.
- Shelf Life & Packaging: Acceptance criteria established for stability and integrity.
8. The sample size for the training set:
This information is not applicable. There is no mention of an algorithm or AI model requiring a training set. The device is a physical medical instrument.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for a physical medical device.
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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 19, 2020
Penumbra, Inc. Teri Nguyen Regulatory Affairs Specialist II One Penumbra Place Alameda, California 94502
Re: K193595
Trade/Device Name: Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW Dated: July 15, 2020 Received: July 17, 2020
Dear Teri Nguyen:
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
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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 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 (QS) 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,
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193595
Device Name
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
Indications for Use (Describe)
INDIGO Aspiration Catheters and Separators
As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems.
INDIGO Aspiration Tubing
As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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1 510(k) Summary
(as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra, Inc. is providing the summary of Substantial Equivalence for the Indigo® Aspiration System - Aspiration Catheter 7 and Separator 7.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Teri Nguyen Regulatory Affairs Specialist II Phone: (510) 995-2012 FAX: (510) 217-6414 Email: tnguyen2@penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
July 15, 2020
1.4 Device Trade or Proprietary Name
Indigo® Aspiration System - Aspiration Catheter 7 and Separator 7
1.5 Device Classification
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Cardiovascular |
| Classification Name: | Catheter, Embolectomy |
| Regulation Number: | 21 CFR §870.5150 |
| Product Code: | QEW |
Predicate and Reference Devices 1.6
| 510(k) Number/Clearance Date | Name of Device | Name of Manufacture |
|---|---|---|
| Predicate Device | ||
| K142870 cleared on May 26, 2015 | Indigo Aspiration System –Aspiration Catheter 8 | Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA |
| K161523 cleared on July 1, 2016 | Indigo Aspiration System –Advanced Separator 8 | |
| Reference Device | ||
| K180939 cleared on May 3, 2018 | Indigo Aspiration System – ModifiedAspiration Tubing | |
| K142870 cleared on May 26, 2015 | Indigo Aspiration System –Aspiration Catheter 6 | |
| Interim Non-Significant Change under K180939 [For CAT7packaging validation only] | Indigo Aspiration System –Aspiration Catheter D | Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA |
| K111380 cleared on July 19, 2011 [For SEP7 Shelf-Life] | Penumbra Neuron™ MAX System |
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1.7 Predicate Comparison
| System Name | Indigo® Aspiration System | |||
|---|---|---|---|---|
| Predicate | Reference | Subject | ||
| Classification | Class II, DXE | Class II, QEW | ||
| 510(k) no. | K142870 | K161523 | K193595 | |
| Indication | The Penumbra EmbolectomyAspiration System(INDIGOTM AspirationSystem) is intended for theremoval of fresh, soft emboliand thrombi from vessels ofthe peripheral arterial andvenous systems.Not for use in the coronariesor the neurovasculature. | INDIGO AspirationCatheters and Separators:As part of the INDIGO™Aspiration System, theINDIGO AspirationCatheters and Separatorsare indicated for theremoval of fresh, softemboli and thrombi fromvessels of the peripheralarterial and venoussystems.INDIGO AspirationTubing:As part of the INDIGO™Aspiration System, theINDIGO Sterile AspirationTubing is indicated toconnect the INDIGOAspiration Catheters to thePenumbra Pump MAX.Penumbra Pump MAX:The Penumbra Pump MAXis indicated as a vacuumsource for the PenumbraAspiration Systems. | INDIGO Aspiration Catheters andSeparators:As part of the INDIGO AspirationSystem, the INDIGO AspirationCatheters and Separators areindicated for the removal of fresh,soft emboli and thrombi fromvessels of the peripheral arterialand venous systems.INDIGO Aspiration Tubing:As part of the INDIGO AspirationSystem, the INDIGO SterileAspiration Tubing is indicated toconnect the INDIGO AspirationCatheters to the PenumbraAspiration Pump.Penumbra Aspiration Pump:The Penumbra Aspiration Pump isindicated as a vacuum source forPenumbra Aspiration Systems. | SAME AS REFERENCEK180939 |
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| CAT8[Predicate] | CAT6[Reference] | CAT7[Subject] | ||
|---|---|---|---|---|
| Catheter | ||||
| 510(k) No. | K142870 | K193595 | ||
| Materials | Materials | Biocompatible, commonly utilized for interventional devices | SAME | |
| Coating | Hydrophilic | SAME | ||
| Dimensions | ||||
| Proximal ODProximal IDDistal ODDistal IDEffective Length | Appropriately sized for the target vessel | Within the range of the Predicate and Reference devices | ||
| Accessories | ||||
| IntroducerAssembly | Introducer | PTFE | FEP | Body: GrilamidID Band: Polyolefin |
| Body | None | SAME ASPREDICATE | Body: HDPE with 40%BaSO4 (Blue)Hub: HDPE (White) | |
| RotatingHemostasisValve | Materials | Polycarbonate/Silicone/PTFE | SAME | SAME |
| FrenchSize | 7.5F | 10F | ||
| Kit PackagingConfiguration | Pouch/Tray Retainer/Tray Base/TrayCover/Aspiration Tubing Kit/RulerCard/Product Box | SAME | ||
| Packaging Materials(Kit Configuration) | Commonly used materials for medicaldevices | SAME | ||
| Separator | Advanced SEP8[Predicate] | SEP12[Subject] | ||
| 510(k) No. | K161523 | To be determined | ||
| Materials | ||||
| Materials | Biocompatible, commonly utilized forinterventional devices | SAME | ||
| Dimensions | ||||
| Wire | ||||
| OD Center SectionOD ProximalProximal LengthWorking LengthTotal Length | Appropriately sized for the paired catheter | SAME plus additional lengthofferings | ||
| Cone | ||||
| Cone OD | Appropriately sized for the paired catheter | SAME | ||
| Cone Shape | Diamond | SAME | ||
| Accessories | ||||
| Torque Device | Polycarbonate/Brass/Polypropylene | SAME | ||
| Introducer Sheath | Stainless Steel with Grilamid | None | ||
| Packaging Materials | Commonly used materials for medicaldevices | SAME | ||
| Sterilization | EO | SAME | ||
| Shelf-Life | CAT7 | 36 Months | 12 Months | |
| SEP7 | 36 Months | SAME | ||
| Use | Single use, disposable | SAME | ||
| Aspiration Source | Penumbra Aspiration Pump | SAME |
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1.8 Device Description
The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The Aspiration Catheter, Separator and Aspiration Tubing are available in multiple configurations. The devices are provided sterile, nonpyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional techniques.
The INDIGO® Aspiration System is comprised of several devices:
- . INDIGO Aspiration Catheter
- Penumbra Aspiration Pump ●
- INDIGO Aspiration Pump Canister .
- INDIGO Aspiration Tubing ●
- . INDIGO Separator™
The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a
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guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
1.9 Indications for Use
INDIGO Aspiration Catheters and Separators
As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
INDIGO Aspiration Tubing
As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
1.10 Summary of Non-Clinical Data
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding substantial equivalence of the device follows.
Included in this section are summary descriptions of the testing (or rationale for not testing if not applicable) which substantiates the performance of the subject Indigo Aspiration Catheter 7 and Separator 7 as well as its substantial equivalence to the predicate device:
- Biocompatibility .
- Design Verification (Bench-Top Testing) .
- Shelf Life ●
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- Sterilization
- . Packaging
The subject Indigo Aspiration Catheter 7 and Separator 7 met all established requirements.
1.10.1 Biocompatibility
The subject Aspiration Catheter 7 and Separator 7 are categorized as a limited exposure (≤24 hours), externally communicating device with circulating blood contact in accordance with ISO 10993-1, USP standards, and FDA Good Laboratory Practices (GLP). Biocompatibility testing for cytotoxicity, sensitization, acute systemic toxicity, and material-mediated pvrogenicity was performed for the subject Aspiration Catheter 7 and Separator 7. Additionally, Hemocompatibility Testing was also performed per BS EN ISO10993-4 requirements. Biocompatibility test results demonstrate biological safety per BS EN ISO 10993 and USP requirements.
1.10.2 Design Verification (Bench-top Testing)
The physical and mechanical properties of the subject Aspiration Catheter 7 and Separator 7 devices were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
| Attribute | Specification | Results |
|---|---|---|
| Dimensional/VisualInspection | These evaluations confirm that the units used in thisDesign Verification testing meet all productspecification. | Pass |
| Simulated Use (PeripheralAccess, Vessel AccessEntry Performance,Delivery/Retrieval & ClotRemoval) | Simulated use testing of the Aspiration Catheter andSeparator was performed with accessory devices in ananatomical Vascular Flow model which simulated thetortuosity of the peripheral vasculature. Devices weredelivered through the tortuous anatomical model toevaluate the effectiveness of the devices to remove clotsand that the Aspiration Catheter does not collapse undervacuum. | Pass |
| Aspiration Catheter/ 7FSheath compatibility(Friction Force) | Maximum value per specification | Pass |
| Aspiration Catheter/0.038" Guidewirecompatibility(Friction Force) | Maximum value per specification | Pass |
| Coating Integrity (Pre-Inspection/Post-Inspection) | Coating has not delaminated, peeled, or flaked prior to andafter simulated use particulate testing. | Pass |
CAT7 Design Verification Test Results Summary
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| Attribute | Specification | Results |
|---|---|---|
| Particulate Testing | ≥ 10 $ μ$ m will be ≤ 6000 particles≥ 25 $ μ$ m will be ≤ 600 particles | Pass |
| ≥ 75 $ μ$ m particles will be recorded for informationalpurposes only≥ 125 $ μ$ m particles will be recorded for informationalpurposes only | For Informational PurposeOnly | |
| Hub Air Aspiration | No air leaks | Pass |
| Catheter Pressure (LumenBurst Pressure) | Minimum value per specification | Pass |
| Hub / Shaft Tensile Strength | Minimum value per specification | Pass |
| Catheter Shaft Tensile (all joints) | Minimum value per specification | Pass |
| Elongation to Failure | Minimum value per specification | Pass |
| Corrosion | No visible corrosion on Catheter immediately afterCorrosion Testing procedure. | Pass |
SEP7 Design Verification Test Results Summary
| Attribute | Specification | Results |
|---|---|---|
| Dimensional/VisualInspection | These evaluations confirm that the units used in this DesignVerification testing meet all product specification. | Pass |
| Separator Cone Shape | Must be Diamond shape. | Pass |
| Coating Integrity (Pre-Inspection/Post-Inspection) | Coating has not delaminated, peeled, or flaked prior to or aftersimulated use particulate testing. | Pass |
| Particulate Testing | The maximum number of particles:$\u2265$ 10 $\u03BC$ m will be $\u2264$ 6000 particles.$\u2265$ 25 $\u03BC$ m will be $\u2264$ 600 particles.$\u2265$ 75 $\u03BC$ m particles will be recorded for informational purposesonly.$\u2265$ 125 $\u03BC$ m particles will be recorded for informational purposesonly. | For InformationalPurpose Only |
| Separator 7 BreakForce (Cone/Wire) | Minimum value per specification | Pass |
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1.10.3 Shelf Life
Testing was performed on the subject Aspiration Catheter 7 to support a 12-month shelf life based on accelerated aging. Testing was leveraged from the predicate device to support a 36month shelf life for the subject Separator 7.
1.10.4 Sterilization
The subject Aspiration Catheter 7 and Separator 7 are provided sterile and intended to be singleuse. Ethylene Oxide (EO) gas exposure is used to sterilize the subject Aspiration Catheter 7 and Separator 7 in accordance with BS EN ISO 11135.
1.10.5 Packaging
Packaging Validation Testing has been completed for the subject Indigo System Aspiration Catheter 7. Packaging Validation Testing is being leveraged for the subject Separator 7. The subject devices met all acceptance criteria.
Summary of Substantial Equivalence 1.11
The subject Indigo System Aspiration Catheter 7 and Separator 7 are substantially equivalent to the predicate devices, provided in Section 1.6 with regards to intended use, operating principle, design concept, materials, sterilization processes and packaging processes.
§ 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).