(29 days)
No
The device description and performance studies focus on mechanical aspiration and hardware components, with no mention of AI or ML capabilities. The "additional software features" mentioned in the performance studies are not described as AI/ML.
Yes
The device is indicated for the removal of fresh, soft emboli and thrombi, and for the treatment of pulmonary embolism, which are therapeutic interventions.
No
The device is indicated for the removal of fresh, soft emboli and thrombi, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines multiple hardware components including catheters, pumps, tubing, and separators, which are physical devices used for mechanical aspiration. While there is mention of verifying "additional software features," the core device is a system of physical components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the removal of emboli and thrombi from vessels within the body. This is a therapeutic intervention performed in vivo (within a living organism).
- Device Description: The description details a system designed to physically aspirate material from blood vessels. This is a mechanical process performed directly on the patient.
- Lack of IVD Characteristics: An IVD is a device used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly designed for a therapeutic procedure performed directly on the patient's vascular system.
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
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.
Lightning Aspiration Tubing
The Lightning Aspiration Tubing is a component to the currently available INDIGO Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration. Intended users for this device are physicians who have received appropriate training in surgical procedures and/or interventional techniques. The device is provided sterile, non-pyrogenic, 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, pulmonary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians who have received appropriate training in surgical procedures and/or 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 Indigo Aspiration System - Lightning Flash Aspiration Tubing to demonstrate substantial equivalence to the predicate Indigo Aspiration System – Lightning Flash Aspiration Tubing (K222358). The same Design Verification test methods, specifications, and acceptance criteria were used for the subject device compared to the predicate. In addition, an equivalent test was conducted to verify additional software features. The following tests were performed:
- . Dimensional/Visual Inspection
- . Performance/Simulated Use Testing
- Tensile Testing
- . Indigo Aspiration System Compatibility
- Valve Sense Testing
- Vacuum Testing
The subject Indigo Aspiration System – Lightning Flash Aspiration Tubing met all established requirements.
Software verification and validation testing and documentation for the Lightning Flash Aspiration Tubing was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" (issued June 14, 2023).
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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February 2, 2024
Penumbra, Inc. Nikita Patel Regulatory Specialist II One Penumbra Place Alameda, California 94502
Re: K240030
Trade/Device Name: Indigo® Aspiration System - Lightning® Flash Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW Dated: January 3, 2024 Received: January 4, 2024
Dear Nikita Patel:
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.
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 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,
| Digitally signed by Gregory W. O'connell -S
Date: 2024.02.02 15:10:18
| -05'00' |
|---|
| Gregory W. |
| O'connell -S |
| 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
Submission Number (if known)
Device Name
Indigo® Aspiration System - Lightning® Flash
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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Page 1 of 5
1 510(k) Summary
(as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra, Inc. is providing the summary of Substantial Equivalence for the Indigo "Aspiration System - Lightning Flash.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Nikita Patel Regulatory Affairs Specialist II Phone: (408) 823-1820 FAX: (510) 217-6414 Email: npatel@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
February 02, 2024
1.4 Device Trade or Proprietary Name
Indigo® Aspiration System - Lightning® Flash
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 Device
| 510(k) Number | Name of Device |
|---|---|
| K222358 | Indigo Aspiration System – Lightning Flash Aspiration Tubing |
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Page 2 of 5
1.7 Predicate Comparison
| System Name | Indigo® Aspiration System | |
|---|---|---|
| Lightning Flash Aspiration Tubing | ||
| [Predicate] | Lightning Flash Aspiration | |
| Tubing | ||
| [Subject] | ||
| Classification | Class II, QEW | SAME |
| 510(k) no. | K222358 | K240030 |
| 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 | |
| Aspiration Tubing | Lightning Flash Aspiration Tubing | |
| [Predicate] | Lightning Flash Aspiration | |
| Tubing | ||
| [Subject] | ||
| 510(k) No. | K222358 | K240030 |
| Materials | ||
| Materials | Biocompatible, commonly utilized for | |
| interventional devices | SAME | |
| Indigo System Attributes | ||
| Packaging Materials | Commonly used materials for medical devices | SAME |
| Aspiration Source | Penumbra Aspiration Pump | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months* | SAME |
| Use | Single use, disposable | SAME |
- Shelf-life was extended from 12 months in a letter-to-file change submitted on 23 Jan 2024 for the Lightning Flash system.
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Page 3 of 5
1.8 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.
Lightning Aspiration Tubing
The Lightning Aspiration Tubing is a component to the currently available INDIGO Aspiration System. The Lightning Aspiration Tubing facilitates the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration. Intended users for this device are physicians who have received appropriate training in surgical procedures and/or interventional techniques. The device is provided sterile, non-pyrogenic, and intended for single use only.
6
Image /page/6/Picture/0 description: The image shows the text 'K240030' in a clear, bold font. The text appears to be a code or identifier, with the letter 'K' followed by a series of numbers. The numbers are '240030', and the text is horizontally oriented.
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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, 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/Performance Data
Included in this section are summary descriptions of the testing which substantiates the performance of the subject Lightning Flash.
1.10.1 Summary of Performance Testing - (Bench-Top) Testing
Bench-top performance (design verification) was performed to evaluate the subject Indigo Aspiration System - Lightning Flash Aspiration Tubing to demonstrate substantial equivalence to the predicate Indigo Aspiration System – Lightning Flash Aspiration Tubing (K222358). The same Design Verification test methods, specifications, and acceptance criteria were used for the subject device compared to the predicate. In addition, an equivalent test was conducted to verify additional software features. The following tests were performed:
- . Dimensional/Visual Inspection
- . Performance/Simulated Use Testing
- Tensile Testing
- . Indigo Aspiration System Compatibility
- Valve Sense Testing
- Vacuum Testing
The subject Indigo Aspiration System – Lightning Flash Aspiration Tubing met all established requirements.
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Page 5 of 5
1.10.2 Summary of Software Testing
Software verification and validation testing and documentation for the Lightning Flash Aspiration Tubing was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" (issued June 14, 2023).
1.10.3 Summary of Biocompatibility
There are no changes to the previously provided biocompatibility data of the Indigo System Lightning Aspiration Tubing sterile device materials cleared in K222358 (predicate device).
1.10.4 Summary of Shelf-Life
The shelf-life is 36 months based on accelerated aging data. The same test methods, specifications, and acceptance criteria were used as described in K222358.
1.10.5 Summary of Packaging
There are no changes to the packaging materials, configuration, or the packaging process for the devices cleared in K222358 (predicate device).
1.10.6 Summary of Performance Data - Animal, Clinical
No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
1.11 Summary of Substantial Equivalence
The subject Indigo Aspiration System - Lightning Flash is substantially equivalent to the predicate device, Indigo Aspiration System - Lightning Flash with regards to intended use, operating principle, design concept, fundamental technology, and device performance.