(240 days)
No
The device description and performance studies focus on mechanical aspiration and physical properties, with no mention of AI or ML.
Yes
The device is indicated for the removal of fresh, soft emboli and thrombi from vessels, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is indicated for the removal of fresh, soft emboli and thrombi from vessels, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines multiple hardware components including catheters, a pump, tubing, and a canister. The performance studies also focus on the physical and mechanical properties of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The INDIGO Aspiration System is a medical device used within the body (in vivo) to physically remove blood clots (emboli and thrombi) from blood vessels. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states the removal of emboli and thrombi from vessels, which is an interventional procedure, not a diagnostic test.
- Device Description: The description details a system designed for mechanical aspiration within the vasculature.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the INDIGO Aspiration System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
QEW
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the peripheral and venous systems (peripheral arterial and venous systems)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians who have received appropriate training in interventional techniques.
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)
Summary of Non-Clinical Data:
- Biocompatibility .
- Design Verification (Bench-Top Testing) .
- Shelf Life ●
- Sterilization
- . Packaging
The subject Indigo Aspiration Catheter 7 and Separator 7 met all established requirements.
Biocompatibility: 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.
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:
CAT7 Design Verification Test Results Summary:
- Dimensional/Visual Inspection: These evaluations confirm that the units used in this Design Verification testing meet all product specification. Results: 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. Results: Pass
- Aspiration Catheter/ 7F Sheath compatibility (Friction Force): Maximum value per specification. Results: Pass
- Aspiration Catheter/ 0.038" Guidewire compatibility (Friction Force): Maximum value per specification. Results: Pass
- Coating Integrity (Pre-Inspection/Post-Inspection): Coating has not delaminated, peeled, or flaked prior to and after simulated use particulate testing. Results: Pass
- Particulate Testing: (>= 10 micrometers will be = 25 micrometers will be = 75 micrometers particles will be recorded for informational purposes only. >= 125 micrometers particles will be recorded for informational purposes only. Results: Pass (For Informational Purpose Only for 75 and 125 micrometers)
- Hub Air Aspiration: No air leaks. Results: Pass
- Catheter Pressure (Lumen Burst Pressure): Minimum value per specification. Results: Pass
- Hub / Shaft Tensile Strength: Minimum value per specification. Results: Pass
- Catheter Shaft Tensile (all joints): Minimum value per specification. Results: Pass
- Elongation to Failure: Minimum value per specification. Results: Pass
- Corrosion: No visible corrosion on Catheter immediately after Corrosion Testing procedure. Results: Pass
SEP7 Design Verification Test Results Summary:
- Dimensional/Visual Inspection: These evaluations confirm that the units used in this Design Verification testing meet all product specification. Results: Pass
- Separator Cone Shape: Must be Diamond shape. Results: Pass
- Coating Integrity (Pre-Inspection/Post-Inspection): Coating has not delaminated, peeled, or flaked prior to or after simulated use particulate testing. Results: Pass
- Particulate Testing: The maximum number of particles: >= 10 micrometers will be = 25 micrometers will be = 75 micrometers particles will be recorded for informational purposes only. >= 125 micrometers particles will be recorded for informational purposes only. Results: (For Informational Purpose Only for 75 and 125 micrometers)
- Separator 7 Break Force (Cone/Wire): Minimum value per specification. Results: Pass
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 36-month shelf life for the subject Separator 7.
Sterilization: The subject Aspiration Catheter 7 and Separator 7 are provided sterile and intended to be single-use. Ethylene Oxide (EO) gas exposure is used to sterilize the subject Aspiration Catheter 7 and Separator 7 in accordance with BS EN ISO 11135.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K180939, K142870, Interim Non-Significant Change under K180939, K111380
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 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)
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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 |
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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.