(29 days)
No
The description focuses on mechanical aspiration and physical components, with no mention of AI or ML.
Yes
The device is indicated for the removal of emboli and thrombi, which directly treats a medical condition.
No
This device is designed for the mechanical removal of thrombi and emboli from vessels, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including catheters, a pump, tubing, and separators, indicating it is a system with physical devices, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the removal of emboli and thrombi from blood vessels and for the treatment of pulmonary embolism. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a mechanical aspiration system designed to physically remove material from the vasculature. It involves catheters, a pump, and tubing used within the patient's circulatory system.
- Lack of Diagnostic Purpose: The device is not used to analyze samples (like blood, tissue, or other bodily fluids) in vitro (outside the body) to provide diagnostic information about a patient's condition.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is used to treat a condition by removing blockages from blood vessels.
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 the 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. TraX may be used with its prepackaged Aspiration Catheter to facilitate access to 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, Select Catheter, introducer, and TraX. TraX compatibility is limited to its prepackaged Aspiration Catheter. 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 arterial and venous systems, and for the treatment of 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)
Bench-Top Testing: Particulate Testing, Dimensional/Visual Inspection, Friction Testing, Performance/Simulated Use Testing, Markerband Visibility, Tensile Testing, Pressure Testing, Elongation Testing, Torsion Testing, Hub Air Aspiration, Corrosion Testing.
Biocompatibility: Evaluated in accordance with ISO 10993-1 and the FDA Guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", for limited exposure (
§ 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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 3, 2024
Penumbra, Inc. Samyukta Rangachari Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502
Re: K242319
Trade/Device Name: Indigo® Aspiration System - Aspiration Catheter 6X Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: August 2, 2024 Received: August 5, 2024
Dear Samyukta Rangachari:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
| Ariel G. Ash- | Digitally signed by Ariel G.
Ash-shakoor -S |
|---------------|------------------------------------------------|
| shakoor -S | Date: 2024.09.03 14:20:05
-04'00' |
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Indigo® Aspiration System - Aspiration Catheter 6X
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the word "Penumbra" in red font, followed by a red circle with a white "P" inside. The word "Penumbra" is written in a sans-serif font and is the main focus of the image. The red circle with the white "P" is located to the right of the word "Penumbra" and serves as a logo for the company.
K242319 Page 1 of 7
510(k) Summary
1. Submitter
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
Contact Person: Samyukta Rangachari Regulatory Affairs Specialist III Phone: (763) 742-9306 Email: srangachari@penumbrainc.com
Date of Preparation: August 29, 2024
2. Subject Device
Indigo® Aspiration System – Aspiration Catheter 6X
Regulatory Class: ll Classification Panel: Cardiovascular Classification Name: Catheter, Embolectomy Regulation Number: 21 CFR §870.5150 Product Code: QEW
3. Predicate/Reference Devices
| 510(k) Number | Name of Device | System Name | INDIGO Aspiration System | Penumbra System | INDIGO Aspiration System |
|---|---|---|---|---|---|
| Predicate | Device Name | Indigo Aspiration Catheter 5 | |||
| [Predicate] | Reperfusion Catheter RED 72 [Reference] | Indigo Aspiration Catheter | |||
| 6X [Subject] | |||||
| K192833 | Indigo Aspiration System – Aspiration Catheter 5 | 510(k) No. | K192833 | K211654 | K242319 |
| Reference | Classification | Class II, QEW | Class II, NRY | SAME as Predicate | |
| K211654 | Penumbra System (Reperfusion Catheter RED 72) | 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, 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 the
Penumbra Aspiration Systems. | Penumbra Reperfusion Catheters and
Separators:
As part of the Penumbra System, the
Reperfusion Catheters and Separators are
indicated for use in the revascularization of
patients with acute ischemic stroke secondary
to intracranial large vessel occlusive disease
(within the internal carotid, middle cerebral –
M1 and M2 segments, basilar, and vertebral
arteries) within 8 hours of symptom onset.
Patients who are ineligible for intravenous
tissue plasminogen activator (IV t-PA) or who
fail IV t-PA therapy are candidates for
treatment.
Penumbra 3D Revascularization Device:
As part of the Penumbra System, the Penumbra
3D Revascularization Device is indicated for use
in the revascularization of patients with acute
ischemic stroke secondary to intracranial large
vessel occlusive disease (within the internal
carotid, middle cerebral – M1 and M2
segments) within 8 hours of symptom onset. | SAME as Predicate |
| K191946 | Penumbra System – MAX Delivery Device | | | | |
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Image /page/5/Picture/0 description: The image contains the word "Penumbra" in a bold, red font. To the right of the word is a circular logo, also in red, with a white "P" inside. The logo has a white line extending from the left side of the "P" to the edge of the circle, creating a visual effect of light or shadow. The logo is a registered trademark.
4. Predicate Comparison
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Image /page/6/Picture/0 description: The image shows the Penumbra company logo. The word "Penumbra" is written in a red serif font. To the right of the word is a red circle with a white "P" inside of it.
| Page 3 of 7 | |||
|---|---|---|---|
| System Name | INDIGO Aspiration System | Penumbra System | INDIGO Aspiration System |
| Device Name | Indigo Aspiration Catheter 5 | ||
| [Predicate] | Reperfusion Catheter RED 72 [Reference] | Indigo Aspiration Catheter | |
| 6X [Subject] | |||
| Patients who are ineligible for intravenous | |||
| tissue plasminogen activator (IV t-PA) or who | |||
| fail IV t-PA therapy are candidates for | |||
| treatment. |
Penumbra Aspiration Tubing:
As part of the Penumbra System, the Penumbra
Sterile Aspiration Tubing is indicated to connect
the Penumbra Reperfusion Catheters to the
Penumbra Aspiration Pump.
Penumbra Aspiration Pump:
The Penumbra Aspiration Pump is indicated as a
vacuum source for Penumbra Aspiration
Systems. | |
| Catheter | Aspiration Catheter 5 | Reperfusion Catheter RED 72 | Aspiration Catheter 6X |
| Materials | Biocompatible, commonly utilized for
interventional devices | Biocompatible, commonly utilized for
interventional devices | SAME |
| Coating | Hydrophilic (proprietary) | Hydrophilic (proprietary) | SAME as Reference |
| Proximal and
Distal OD | | | |
| Proximal and
Distal ID
Effective
Lengths | Appropriately sized for the target
vessel | SAME, with larger diameters and additional
effective length offerings | SAME as Reference |
| System Name | INDIGO Aspiration System | Penumbra System | INDIGO Aspiration System |
| Device Name | Indigo Aspiration Catheter 5 [Predicate] | Reperfusion Catheter RED 72 [Reference] | Indigo Aspiration Catheter 6X [Subject] |
| Accessories | Introducer, Shaping Mandrel, RHV | Introducer, Shaping Mandrel, RHV, SENDit Technology (Optional) | Introducer, Shaping Mandrel, RHV, TraX (Optional) |
| Aspiration Tubing | Modified 110 Aspiration Tubing (K180939) | Modified 110 Aspiration Tubing | SAME |
| Packaging Materials | Commonly used materials for medical devices | Commonly used materials for medical devices | SAME |
| Aspiration Source | Aspiration Pump | Aspiration Pump | SAME |
| Sterilization | EO | EO | SAME |
| Shelf-Life | 36 months | 12 months | SAME as Reference |
| Use | Single use, disposable | Single use, disposable | SAME |
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Image /page/7/Picture/0 description: The image shows the word "Penumbra" 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 horizontal line extending from the right side of the "P" to the edge of the circle. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image shows the word "Penumbra" in red font, followed by 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. The logo is simple and modern.
5. Device Description
The INDIGO® Aspiration System is comprised of the 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. TraX may be used with its prepackaged Aspiration Catheter to facilitate access to 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, Select Catheter, introducer, and TraX. TraX compatibility is limited to its prepackaged Aspiration Catheter. The INDIGO Separator may be provided with an introducer and torque device.
6. 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.
9
Image /page/9/Picture/0 description: The image shows the Penumbra company logo. The logo consists of the word "Penumbra" in a red, sans-serif font, followed by a red circle with a white "P" inside. A white line extends from the right side of the "a" in "Penumbra" to the right side of the circle, visually connecting the text and the symbol.
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.
7. Summary of Non-Clinical Data/Performance Data
Included in this section are summary descriptions of the testing which substantiates the performance of the subject Aspiration Catheter 6X.
7.1 Summary of Performance Testing - (Bench-Top) Testing
The following bench-top performance (design verification) tests were used in support of the subject device to determine substantial equivalence:
- . Particulate Testing
- Dimensional/Visual Inspection ●
- Friction Testing ●
- Performance/Simulated Use Testing
- Markerband Visibility
- Tensile Testing ●
- Pressure Testing
- Elongation Testing
- Torsion Testing ●
- Hub Air Aspiration
- Corrosion Testing
7.2 Summary of Biocompatibility
Biocompatibility was evaluated for the subject device in accordance with ISO 10993-1 and the FDA Guidance for Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", for limited exposure (≤24 hours), externally communicating devices with circulating blood contact. The subject device met all requirements.
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Image /page/10/Picture/0 description: The image shows the Penumbra company logo. The logo consists of the word "Penumbra" in red font, followed by a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the top of the "P" to the edge of the circle.
7.3 Summary of Shelf-Life
The shelf-life of the subject device is established for 12 months based on accelerated aging data.
7.4 Summary of Performance Data – Animal, Clinical
No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
8. Summary of Substantial Equivalence
The subject Aspiration Catheter 6X is substantially equivalent to the predicate device, Aspiration Catheter 5, with regards to intended use, operating principle, design concept, fundamental technology, and device performance.