(25 days)
No
The device description and performance studies focus on mechanical aspiration and bench testing, with no mention of AI or ML capabilities.
Yes
The device is indicated for the removal of fresh, soft emboli and thrombi from vessels, which is a therapeutic intervention.
No
The device is indicated for the removal of emboli and thrombi (treatment), not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including catheters, a pump, tubing, and separators. The system is designed for mechanical aspiration and is visible under fluoroscopy, indicating a physical device interacting with the patient's anatomy.
Based on the provided text, 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 description clearly states that the INDIGO Aspiration System is designed to remove thrombus (blood clots) from within the patient's blood vessels using mechanical aspiration. This is a therapeutic intervention performed in vivo (within the living body).
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information about a patient's condition. Its purpose is to physically remove blockages.
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 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.
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. 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, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
Select+ Catheter
The Select+ Catheter is an accessory within kitted configurations of the INDIGO Lightning Flash Aspiration System. The Select+ Catheter is used to aide in access to the site of occlusion and is removed prior to initiating aspiration with the aspiration catheter. The use of the Select+ Catheter to facilitate access to the site of the occlusion is an optional procedural step for INDIGO Lightning Flash Aspiration Catheters. The device is provided sterile and intended for single use only.
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
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)
Bench-top performance (design verification) was performed to evaluate the subject Select+ Catheter to demonstrate substantial equivalence to the predicate Lightning Flash Select Catheter (K222358). The same Design Verification test methods, specifications, and acceptance criteria were used for the subject device compared to the predicate.
The following tests were performed:
- Dimensional/Visual Inspection
- Performance/Simulated Use and Torsion Testing
- Radiopacity Testing
- Friction Testing
- Hub Air Aspiration
- Pressure Testing
- Tensile Testing
- Elongation Testing
- Corrosion Testing
The subject Select+ Catheter met all established requirements.
No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
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).
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June 10, 2024
Penumbra, Inc. Samyukta Rangachari Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502
Re: K241399
Trade/Device Name: Indigo® Lightning Flash Aspiration System - Select +™ Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: May 15, 2024 Received: May 16, 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"
1
(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).
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.
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.
Image /page/1/Picture/7 description: The image shows the name "Ariel G. Ash-shakoor -S" in a simple, sans-serif font. The text is arranged in two lines, with "Ariel G. Ash-" on the first line and "shakoor -S" on the second line. The text is black against a white background.
Digitally signed by Ariel G. Ash-shakoor -S Date: 2024.06.10 13:58:53 -04'00'
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices
2
OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241399
Device Name
Indigo® Lightning Flash Aspiration System - Select +TM Catheter
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 the 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. 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: June 07, 2024
2. Subject Device
Indigo" Lightning Flash Aspiration System – Select +"" Catheter
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 |
|---|---|
| Predicate | |
| K222358 | Indigo Aspiration System – Lightning Flash Select Catheter |
| Reference | |
| K111380 | Neuron Max System - Select Catheter |
Page 1 of 6
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Image /page/5/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" has a horizontal line extending from the right side of the letter to the edge of the circle.
Page 2 of 6
4. Predicate Comparison
| System Name | Indigo Lightning Flash Aspiration System | ||
|---|---|---|---|
| Select Catheter | |||
| [Predicate] | Select+ Catheter | ||
| [Subject] | |||
| Classification | Class II, QEW | SAME | |
| 510(k) no. | K222358 | K241399 | |
| 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. | SAME | |
| Dimensions and Construction | | | |
| Tip Shape | H1 Shape
Berenstein Shape | SAME | |
| OD [Max]
ID [Max]
Working Section Length | Appropriately sized for the
introduction of interventional
devices into the target vessel | SAME with increased OD on the
distal shaft and shorter working
section length appropriately
sized for introduction of Flash
Aspiration Catheter into the
target vessel | |
| System Name | Indigo Lightning Flash Aspiration System | | Page 3 of 6 |
| | Select Catheter
[Predicate] | Select+ Catheter
[Subject] | |
| Effective Length | | SAME | |
| Materials | | | |
| Materials | Biocompatible, commonly utilized
for interventional devices | SAME | |
| Indigo Aspiration System Attributes | | | |
| Aspiration Catheter | Flash Aspiration Catheter | SAME | |
| Accessories | Introducer | SAME, with Select+ Catheter | |
| | Rotating Hemostasis Valve (RHV) | | |
| | Reducer | | |
| | RHV Connector Cap
Select Catheter | | |
| Packaging Materials | Commonly used materials for
medical devices | SAME | |
| Aspiration Source | Penumbra Aspiration Pump | SAME | |
| Sterilization | Ethylene Oxide (EO) | SAME | |
| Shelf Life | 36 months | 12 months | |
| Use | Single use, disposable | SAME | |
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Image /page/6/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" has a horizontal line extending from the right side of the letter to the edge of the circle.
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Page 4 of 6
Image /page/7/Picture/1 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. A white line extends from the left side of the "P" to the edge of the circle.
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. 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, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
Select+ Catheter
The Select+ Catheter is an accessory within kitted configurations of the INDIGO Lightning Flash Aspiration System. The Select+ Catheter is used to aide in access to the site of occlusion and is removed prior to initiating aspiration with the aspiration catheter. The use of the Select+ Catheter to facilitate access to the site of the occlusion is an optional procedural step for INDIGO Lightning Flash Aspiration Catheters. Intended users for this device are physicians who have received appropriate training in interventional techniques.
8
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Page 5 of 6
The device is provided sterile and intended for single use only.
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.
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 Select+ Catheter.
7.1 Summary of Performance Testing - (Bench-Top) Testing
Bench-top performance (design verification) was performed to evaluate the subject Select+ Catheter to demonstrate substantial equivalence to the predicate Lightning Flash Select Catheter (K222358). The same Design Verification test methods, specifications, and acceptance criteria were used for the subject device compared to the predicate.
The following tests were performed:
- Dimensional/Visual Inspection
- Performance/Simulated Use and Torsion Testing
- Radiopacity Testing ●
- Friction Testing
- Hub Air Aspiration
- Pressure Testing
- Tensile Testing
- Elongation Testing
9
Image /page/9/Picture/0 description: The image shows the alphanumeric string "K241399" in a simple, sans-serif font. The characters are black against a white background, creating a clear contrast. The text appears to be a code or identifier, possibly a serial number or product key.
Image /page/9/Picture/1 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 outline. Inside the circle is a white letter "P" with a horizontal line going through it.
Page 6 of 6
- . Corrosion Testing
The subject Select+ Catheter met all established requirements.
7.2 Summary of Biocompatibility
Biocompatibility testing was leveraged for the subject Select+ Catheter (K111380).
7.3 Summary of Shelf-Life
The shelf-life is 12 months based on accelerated aging data. The same test methods, specifications, and acceptance criteria were used as described in K222358.
7.4 Summary of Packaging
There are no changes to the packaging materials, or packaging configuration compared to the devices cleared in K222358 (predicate device). Packaging testing of the predicate device was used in support of the subject device.
7.5 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 Select+ Catheter is substantially equivalent to the predicate device, Select Catheter, with regards to intended use, operating principle, design concept, fundamental technology, and device performance.