(55 days)
No
The device description focuses on mechanical aspiration and physical components, with no mention of AI or ML capabilities.
Yes
The device is indicated for "the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism," which describes a therapeutic action to treat a medical condition.
No
The device is indicated for the removal of emboli and thrombi (a therapeutic function), not for diagnosing their presence or characteristics.
No
The device description clearly outlines multiple hardware components including catheters, a pump, tubing, and a canister, which are integral to the system's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a system designed to mechanically aspirate thrombus from the vasculature. This is a physical procedure, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to remove material from the body, not to diagnose a condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 arterial and venous systems, and for the treatment of pulmonary embolism.
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 (comma separated list FDA assigned to the subject device)
QEW
Device Description
The INDIGO® Aspiration System is comprised of:
- 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 and 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
Fluoroscopy
Anatomical Site
vessels of the peripheral arterial and venous systems, pulmonary embolism
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The Indigo System, clinical study (EXTRACT-PE) was cleared in K192833 (reference device). The EXTRACT-PE trial demonstrated that the Indigo Aspiration System showed substantially equivalent safety and effectiveness outcomes for acute PE. The primary efficacy and safety endpoints were met. No additional clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes. A review of the technological characteristics of the subject and reference device supported leveraging the clinical outcomes of the EXTRACT-PE Clinical study for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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November 18, 2020
Penumbra, Inc. Michaela Mahl Senior Manager of Regulatory Affairs One Penumbra Place Alameda, California 94502
Re: K202821
Trade/Device Name: Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: September 22, 2020 Received: September 24, 2020
Dear Michaela Mahl:
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 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
1
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) K202821
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 arterial and venous systems, and for the treatment of pulmonary embolism.
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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Image /page/3/Picture/0 description: The image contains the word "Penumbra" in a red, sans-serif font. To the right of the word is a circular logo, also in red, with a white stylized "P" inside. The logo has a white horizontal line extending from the "P" to the edge of the circle. The overall design is clean and modern.
K202821
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® 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
Michaela Mahl Senior Manager of Regulatory Affairs Phone: (510) 748-3288 FAX: (510) 217-6414 Email: mmahl@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
November 18, 2020
Device Trade or Proprietary Name 1.4
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 |
Predicate and Reference Devices 1.6
| 510(k) Number | Name of Device | Name of
Manufacture |
|------------------|-----------------------------------------------------------------------|------------------------|
| Predicate Device | | |
| K192981 | Indigo Aspiration System – Aspiration Catheter 12
and Separator 12 | Penumbra, Inc. |
| Reference Device | | |
| K192833 | Indigo Aspiration System | Penumbra, Inc. |
| K180466 | FlowTriever Retrieval/Aspiration System | Inari Medical, Inc. |
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Image /page/4/Picture/0 description: The image shows the word "Penumbra" in a red sans-serif font, followed by a red circle with a white "P" inside. The "P" is formed by a horizontal line that extends beyond the circle. The logo is simple and modern, and the red color gives it a sense of energy and excitement. The registered trademark symbol is located at the bottom right of the red circle.
Predicate Comparison 1.7
| System Name | Indigo® Aspiration System | ||
|---|---|---|---|
| Predicate Device | Reference Device | Subject Device | |
| Classification | Class II, QEW | SAME | |
| 510(k) no. | K192981 | K192833 | K202821 |
| Indication | 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. | 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, | |||
| and for the treatment of pulmonary | |||
| embolism. | |||
| 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 | ||
| Device | |||
| K192833 | |||
| System | |||
| Components | Reperfusion Catheter, Separator, | ||
| Aspiration Tubing, Aspiration Source | SAME | SAME | |
| Materials, | |||
| Packaging & | |||
| Configurations | Commonly utilized for interventional | ||
| devices | SAME | SAME | |
| Aspiration | |||
| Source | Penumbra Aspiration Pump | SAME | SAME |
| Sterilization | EO | SAME | SAME |
| Shelf-Life | 36 Months | 36 Months | SAME |
Device Description 1.8
The INDIGO® Aspiration System is comprised of:
- INDIGO Aspiration Catheter .
- Penumbra Aspiration Pump .
- INDIGO Aspiration Pump Canister ●
- INDIGO Aspiration Tubing ●
- INDIGO Separator™ .
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Image /page/5/Picture/0 description: The image shows the Penumbra company logo. The word "Penumbra" is written in a red sans-serif font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a line extending from the top of the "P" to the edge of the circle.
K202821
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 and 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.
Indications for Use 1.9
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, and for the treatment of pulmonary embolism.
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
The subject and predicate Indigo System devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged.
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1.10.1 Summary of Biocompatibility
There are no changes to the previously provided biocompatibility data of the Indigo System - Aspiration Catheter 12 and Separator 12 sterile device materials cleared in K192981 (predicate device).
1.10.2 Summary of Performance Testing - Bench-Top
There are no changes to the previously provided bench-top data of the devices cleared in K192981 (predicate and reference device).
1.11 Summary of Performance Data - Clinical
The Indigo System, clinical study (EXTRACT-PE) was cleared in K192833 (reference device). The EXTRACT-PE trial demonstrated that the Indigo Aspiration System showed substantially equivalent safety and effectiveness outcomes for acute PE. The primary efficacy and safety endpoints were met. No additional clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes. A review of the technological characteristics of the subject and reference device supported leveraging the clinical outcomes of the EXTRACT-PE Clinical study for the subject device.
1.12 Summary of Shelf-Life
There are no changes to the previously provided shelf-life data of the devices cleared in K192981 (predicate device).
1.13 Summary of Packaging
There are no changes to the packaging material listing or the packaging process for the devices cleared in K192981 (predicate device).
1.14 Summary of Substantial Equivalence
The subject device is substantially equivalent to the predicate and reference devices with regard to indications, intended use, design, performance, materials, sterilization, and packaging.