Who is the manufacturer of Indigo Aspiration System - Aspiration Catheter 7 and Separator 7?

Penumbra, Inc. filed the 510(k) submission for Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 (K193595).

What is the FDA product code for Indigo Aspiration System - Aspiration Catheter 7 and Separator 7?

QEW. It is classified under 21 CFR 870.5150 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Indigo Aspiration System - Aspiration Catheter 7 and Separator 7?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Indigo Aspiration System - Aspiration Catheter 7 and Separator 7?

Indigo Aspiration System – Aspiration Catheter 8 (K142870); Indigo Aspiration System – Advanced Separator 8 (K161523).

Who can help prepare an FDA 510(k) submission like Indigo Aspiration System - Aspiration Catheter 7 and Separator 7?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Indigo Aspiration System - Aspiration Catheter 7 and Separator 7

K193595 · Penumbra, Inc. · QEW · Aug 19, 2020 · Cardiovascular

Device Facts

Record ID	K193595
Device Name	Indigo Aspiration System - Aspiration Catheter 7 and Separator 7
Applicant	Penumbra, Inc.
Product Code	QEW · Cardiovascular
Decision Date	Aug 19, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.5150
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Indigo Aspiration System uses mechanical aspiration to remove thrombus from peripheral vasculature. System components include Aspiration Catheter, Separator, Aspiration Tubing, and Penumbra Aspiration Pump. Physician guides catheter over guidewire to occlusion site; connects to pump via tubing. Pump provides vacuum source to aspirate thrombus. If catheter lumen becomes blocked, Separator is deployed through catheter to clear thrombus from tip. Devices are visible under fluoroscopy. System enables minimally invasive thrombus removal, potentially restoring blood flow in occluded vessels. Used in clinical settings by trained interventionalists.

Clinical Evidence

Bench testing only. No clinical data presented. Verification included biocompatibility (ISO 10993), simulated use in tortuous vascular flow models, particulate testing, tensile strength, burst pressure, and coating integrity. All tests passed.

Technological Characteristics

Catheter materials: Biocompatible polymers (Grilamid, HDPE, Polyolefin, PTFE, FEP). Separator: Diamond-shaped cone. Sterilization: Ethylene Oxide (EO) per BS EN ISO 11135. Connectivity: Mechanical vacuum connection. Form factor: Catheter and wire-based separator for peripheral vascular access.

Indications for Use

Indicated for removal of fresh, soft emboli and thrombi from peripheral arterial and venous vessels. Intended for use by trained physicians in interventional techniques.

Regulatory Classification

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.

Predicate Devices

Indigo Aspiration System – Aspiration Catheter 8 (K142870)
Indigo Aspiration System – Advanced Separator 8 (K161523)

Reference Devices

Indigo Aspiration System – Modified Aspiration Tubing (K180939)
Indigo Aspiration System – Aspiration Catheter 6 (K142870)
Indigo Aspiration System – Aspiration Catheter D (K180939)
Penumbra Neuron MAX System (K111380)

Related Devices

K192981 — Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 · Penumbra, Inc. · May 28, 2020
K210083 — Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 · Penumbra, Inc. · Feb 9, 2021
K180939 — Indigo Aspiration System - Modified 110 Aspiration Tubing · Penumbra, Inc. · May 3, 2018
K192833 — Indigo Aspiration System · Penumbra, Inc. · Dec 20, 2019
K161523 — INDIGO Aspiration System · Penumbra, Inc. · Jul 1, 2016

Submission Summary (Full Text)

{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 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) ### 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}------------------------------------------------ #### 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 Place Alameda, 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 – Modified Aspiration Tubing | | | K142870 cleared on May 26, 2015 | Indigo Aspiration System – Aspiration Catheter 6 | | | Interim Non-Significant Change under K180939 [For CAT7 packaging validation only] | Indigo Aspiration System – Aspiration Catheter D | Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA | | K111380 cleared on July 19, 2011 [For SEP7 Shelf-Life] | Penumbra Neuron™ MAX System | | {4}------------------------------------------------ ### 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 Embolectomy Aspiration System (INDIGOTM Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. Not for use in the coronaries or the neurovasculature. | 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 Pump MAX. Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for the Penumbra Aspiration Systems. | 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. | SAME AS REFERENCE K180939 | {5}------------------------------------------------ | | | 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 OD Proximal ID Distal OD Distal ID Effective Length | Appropriately sized for the target vessel | | Within the range of the Predicate and Reference devices | | | Accessories | | | | | Introducer Assembly | Introducer | PTFE | FEP | Body: Grilamid ID Band: Polyolefin | | | Body | None | SAME AS PREDICATE | Body: HDPE with 40% BaSO4 (Blue) Hub: HDPE (White) | | Rotating Hemostasis Valve | Materials | Polycarbonate/Silicone/ PTFE | SAME | SAME | | | French Size | 7.5F | | 10F | | Kit Packaging Configuration | | Pouch/Tray Retainer/Tray Base/Tray Cover/Aspiration Tubing Kit/Ruler Card/Product Box | | SAME | | Packaging Materials (Kit Configuration) | | Commonly used materials for medical devices | | SAME | | Separator | | Advanced SEP8 [Predicate] | | SEP12 [Subject] | | 510(k) No. | | K161523 | | To be determined | | Materials | | | | | | | Materials | Biocompatible, commonly utilized for interventional devices | | SAME | | Dimensions | | | | | | Wire | | | | | | | OD Center Section OD Proximal Proximal Length Working Length Total Length | Appropriately sized for the paired catheter | | SAME plus additional length offerings | | 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 medical devices | 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 | | {6}------------------------------------------------ #### 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 {7}------------------------------------------------ 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 ● {8}------------------------------------------------ - 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/Visual Inspection | These evaluations confirm that the units used in this Design Verification testing meet all product specification. | Pass | | Simulated Use (Peripheral Access, Vessel Access Entry Performance, Delivery/Retrieval & Clot Removal) | Simulated use testing of the Aspiration Catheter and Separator was performed with accessory devices in an anatomical Vascular Flow model which simulated the tortuosity of the peripheral vasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Aspiration Catheter does not collapse under vacuum. | 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 | ## CAT7 Design Verification Test Results Summary {9}------------------------------------------------ | 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 informational purposes only ≥ 125 $ μ$ m particles will be recorded for informational purposes only | For Informational Purpose Only | | 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 Catheter immediately after Corrosion Testing procedure. | Pass | # SEP7 Design Verification Test Results Summary | Attribute | Specification | Results | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | Dimensional/Visual Inspection | These evaluations confirm that the units used in this Design Verification 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 after simulated 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 purposes only. $\u2265$ 125 $\u03BC$ m particles will be recorded for informational purposes only. | For Informational Purpose Only | | Separator 7 Break Force (Cone/Wire) | Minimum value per specification | Pass | {10}------------------------------------------------ # 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.