(217 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, non-pyrogenic, 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 provided text describes the submission of a 510(k) premarket notification for the "Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12." This specific document is a summary of non-clinical data and does not contain information about a study based on the performance of an AI/ML powered medical device.
Therefore, I cannot answer questions 1 through 9. The information provided in the document focuses on the physical and material properties of a medical device (a catheter and separator for aspiration), its biocompatibility, shelf life, sterilization, and packaging, rather than the performance of an AI/ML algorithm.
The "Acceptance Criteria" table in this document refers to engineering specifications (e.g., maximum friction force, minimum burst pressure, particle limits) for the physical device, not performance metrics for an AI/ML model.
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May 28, 2020
Penumbra, Inc Teri Nguyen Regulatory Affairs Specialist II One Penumbra Place Alameda, California 94502
Re: K192981
Trade/Device Name: Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW Dated: May 15, 2020 Received: May 18, 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,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Interventional 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) K192981
Device Name
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
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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510(k) Summary 1
(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 12 and Separator 12.
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
1.3 Date of Preparation of 510(k) Summary
May 22, 2020
1.4 Device Trade or Proprietary Name
Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12
1.5 Device Classification
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Cardiovascular |
| Classification Name: | Catheter, Embolectomy |
| Regulation Number: | 21 CFR §870.5150 |
| Product Code: | QEW |
1.6 Predicate and Reference Devices
| 510(k) Number | Name of Device | Name of Manufacture |
|---|---|---|
| Predicate Device | ||
| K142870 | Indigo Aspiration System – Aspiration Catheter 8 andSeparator 8 | Penumbra, Inc. |
| Reference Device | ||
| K161523 | Indigo Aspiration System – Advanced Separator 8 | Penumbra, Inc. |
| K180939 | Indigo Aspiration System - Modified Aspiration Tubing | |
| K180466 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. |
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Predicate Comparison 1.7
| System Name | Indigo® Aspiration System | |||
|---|---|---|---|---|
| Predicate | Reference | Subject | ||
| Classification | Class II, DXE | QEW | ||
| 510(k) no. | K142870 | K161523 | K180939 | K192981 |
| Indication | The Penumbra EmbolectomyAspiration System (INDIGOTMAspiration System) is intendedfor the removal of fresh, softemboli and thrombi fromvessels of the peripheral arterialand venous systems.Not for use in the coronaries orthe neurovasculature. | INDIGO AspirationCatheters and Separators:As part of the INDIGOTMAspiration System, theINDIGO AspirationCatheters and Separators areindicated for theremoval of fresh, soft emboliand thrombi from vessels ofthe peripheral arterial andvenous systems.INDIGO Aspiration Tubing:As part of the INDIGOTMAspiration System, theINDIGO Sterile AspirationTubing is indicated toconnect the INDIGOAspiration Catheters to thePenumbra Pump MAX.Penumbra Pump MAX:The Penumbra Pump MAX isindicated as a vacuum sourcefor the Penumbra AspirationSystems. | 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 from vesselsof the peripheral arterial and venoussystems.INDIGO Aspiration Tubing:As part of the INDIGO AspirationSystem, the INDIGO SterileAspiration Tubing is indicated toconnect the INDIGO AspirationCatheters to the Penumbra AspirationPump.Penumbra Aspiration Pump:The Penumbra Aspiration Pump isindicated as a vacuum source forPenumbra Aspiration Systems. | SAME AS REFERENCEK180939 |
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| Catheter | CAT8[Predicate] | CAT12[Subject] | ||
|---|---|---|---|---|
| 510(k) No. | K142870 | K192981 | ||
| Materials | ||||
| Materials | Biocompatible, commonly utilized forinterventional devices | SAME plus additional materialcompositions | ||
| Coating | Hydrophilic | SAME | ||
| Dimensions | ||||
| Proximal OD | ||||
| Proximal ID | SAME plus larger diameters | |||
| Distal OD | Appropriately sized for the target vessel | |||
| Distal ID | ||||
| Effective Length | ||||
| Accessories | ||||
| Introducer | PTFE | Sheath: GrilamidID Band: Polyolefin | ||
| Rotating | Materials | Polycarbonate/Silicone/PTFE | SAME | |
| HemostasisValve | French Size | 7.5F | 10F | |
| Kit PackagingConfiguration | Pouch/Tray Retainer/Tray Base/TrayCover/Aspiration Tubing Kit/RulerCard/Product Box | SAME | ||
| Packaging Materials (KitConfiguration) | Commonly used materials for medicaldevices | SAME | ||
| Separator | Advanced SEP8[Reference] | SEP12[Subject] | ||
| 510(k) No. | K161523 | K192981 | ||
| Materials | ||||
| Materials | Biocompatible, commonly utilized forinterventional devices | SAME plus additional materialcompositions | ||
| Dimensions | ||||
| Wire | ||||
| OD Center Section | ||||
| OD Proximal | SAME | |||
| Proximal Length | Appropriately sized for the target vessel | |||
| Working Length | ||||
| Total Length | ||||
| Cone | ||||
| Cone OD | 0.072 in (1.82 mm) | 0.110 in (2.79 mm) | ||
| Cone Shape | Diamond | SAME | ||
| Accessories | ||||
| Torque Device | Polycarbonate/Brass/Polypropylene | SAME | ||
| Introducer Sheath | Stainless Steel with Grilamid | N/A |
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| Packaging Materials | Commonly used materials for medicaldevices | SAME |
|---|---|---|
| Aspiration Source | Penumbra Aspiration Pump | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | 12 Months |
| Use | Single use, disposable | SAME |
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, non-pyrogenic, 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
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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 12 and Separator 12 as well as its substantial equivalence to the predicate device:
- Biocompatibility .
- Design Verification (Bench-Top Testing) ●
- . Shelf Life
- Sterilization ●
- Packaging
The subject Indigo Aspiration Catheter 12 and Separator 12 met all established requirements.
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1.10.1 Biocompatibility
Biocompatibility was conducted on the subject Indigo Aspiration Catheter 12 and Separator 12. The studies were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (< 24 hours), externally communicating device with circulating blood contact. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP). The following tests were successfully performed:
| Tests |
|---|
| In-vitro Cytotoxicity:MEM Elution(10993-5) |
| Sensitization:Magnusson-Kligman Method(10993-10) |
| Irritation:Intracutaneous Toxicity(10993-10) |
| Systemic Toxicity:Acute Systemic Injection(10993-11) |
| Systemic Toxicity:Material Mediated Pyrogen(10993-11, USP) |
| Hemocompatibility:In-vitro Thrombogenicity(10993-4) |
| Hemocompatibility:Prothrombin Time (PT)(10993-4) |
| Hemocompatibility:Partial Thromboplastin Time (PTT)(10993-4) |
| Hemocompatibility:Complement Activation(10993-4) |
| Hemocompatibility:(indirect contact)(10993-4) |
| Hemocompatibility:(direct contact)(10993-4) |
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In summary, non-clinical testing substantiates that the Indigo Aspiration Catheter 12 and Separator 12 are non-cytotoxic, non-sensitizing, non-toxic, non-toxic, non-pyrogenic, non-hemolytic, and non-thrombogenic.
1.10.2 Design Verification (Bench-top Testing)
The physical and mechanical properties of the subject Aspiration Catheter 12 and Separator 12 devices were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed:
| 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/ 12FSheath 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 |
| Particulate Testing | ≥ 10 µm will be ≤ 6000 particles≥ 25 µm will be ≤ 600 particles | Pass |
| Particulate Testing | ≥ 75 µm particles will be recorded for informationalpurposes only≥ 125 µm particles will be recorded for informationalpurposes only | Data was recorded forinformational purposesonly. |
| Hub Air Aspiration | No air leaks | Pass |
| Catheter Pressure (LumenBurst Pressure) | Minimum value per specification | Pass |
| Hub / Shaft TensileStrength | Minimum value per specification | Pass |
| Catheter Shaft Tensile (alljoints) | Minimum value per specification | Pass |
CAT12 Design Verification Test Results Summary
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| Attribute | Specification | Results |
|---|---|---|
| Elongation to Failure | Minimum value per specification | Pass |
| Corrosion | No visible corrosion on Catheter immediately afterCorrosion Testing procedure. | Pass |
SEP12 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 (Teardrop) 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:≥ 10 $\mu$ m will be ≤ 6000 particles.≥ 25 $\mu$ m will be ≤ 600 particles.≥ 75 $\mu$ m particles will be recorded for informational purposesonly.≥ 125 $\mu$ m particles will be recorded for informational purposesonly. | Data was recorded forinformational purposesonly. |
| Separator 12 BreakForce (Cone/Wire) | Minimum value per specification | Pass |
1.10.3 Performance Data – Clinical
No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes. A review was conducted considering published clinical study articles that featured the predicate device and other devices with similar dimensions used for direct aspiration. The literature review was used to support the determination of substantial equivalence by leveraging clinical outcomes from devices that are considered technologically equivalent.
1.10.4 Shelf Life
Testing was performed on the subject Aspiration Catheter 12 and Separator 12 to support a 12-month shelf life based on accelerated aging.
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1.10.5 Sterilization
The subject Aspiration Catheter 12 and Separator 12 are provided sterile and intended to be single-use. Ethylene Oxide (EO) gas exposure is used to sterilize the subject Aspiration Catheter 12 and Separator 12 in accordance with BS EN ISO 11135.
1.10.6 Packaging
Packaging Validation Testing has been completed for the subject Indigo System Aspiration Catheter 12 and Separator 12. The subject devices met all acceptance criteria.
1.11 Summary of Substantial Equivalence
The subject Indigo System Aspiration Catheter 12 and Separator 12 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).