(29 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 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.
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.
This document describes a 510(k) premarket notification for the Indigo® Aspiration System - Lightning® Flash, which is an embolectomy catheter used for removing fresh, soft emboli and thrombi.
Here's an analysis of the provided text with respect to acceptance criteria and the study:
1. Tabulation of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "The same Design Verification test methods, specifications, and acceptance criteria were used for the subject device compared to the predicate." and "The subject Indigo Aspiration System – Lightning Flash Aspiration Tubing met all established requirements." However, the exact quantitative acceptance criteria are not explicitly listed in the provided text. The performance is reported as meeting "all established requirements."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional/Visual Inspection | Met all established requirements |
| Performance/Simulated Use Testing | Met all established requirements |
| Tensile Testing | Met all established requirements |
| Indigo Aspiration System Compatibility | Met all established requirements |
| Valve Sense Testing | Met all established requirements |
| Vacuum Testing | Met all established requirements |
| Software Verification and Validation | Documentation provided as recommended by FDA guidance, implied to meet requirements. |
| Biocompatibility | No changes from predicate, previously cleared. |
| Shelf-Life (36 months) | Met based on accelerated aging data. |
| Packaging | No changes from predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no test set of human/animal data in the traditional sense, and thus no data provenance for such studies.
The testing was "bench-top" and would involve physical devices. The number of devices tested is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
As no animal or clinical study was conducted, there are no experts used to establish ground truth for a test set in the context of clinical outcomes. The "ground truth" for bench testing would be predefined engineering specifications, which are established by the device manufacturer's design and engineering teams. The qualifications of these individuals are not stated.
4. Adjudication Method for the Test Set:
Not applicable, as there was no test set involving human/animal data requiring adjudication. Bench testing typically relies on pass/fail criteria against engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was NOT done. The document explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." Therefore, there is no effect size reported for human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
This device does not appear to be an AI/software-driven diagnostic device requiring standalone algorithm performance evaluation. The "additional software features" mentioned would likely be related to control or operational aspects of the device, not image analysis or diagnostic capabilities. Therefore, a standalone performance evaluation of an algorithm in this context is not applicable/not reported.
7. Type of Ground Truth Used:
For the bench-top testing, the ground truth was engineering specifications and established requirements (e.g., dimensional tolerances, tensile strength values, vacuum levels, system compatibility).
8. Sample Size for the Training Set:
This is not applicable as the document does not describe the development or training of any AI or machine learning models. The device is a physical medical device (embolectomy catheter system).
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set mentioned or implied for this device.
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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).
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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 -SDate: 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
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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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1.7 Predicate Comparison
| System Name | Indigo® Aspiration System | |
|---|---|---|
| Lightning Flash Aspiration Tubing[Predicate] | Lightning Flash AspirationTubing[Subject] | |
| Classification | Class II, QEW | SAME |
| 510(k) no. | K222358 | K240030 |
| Indication | INDIGO Aspiration Catheters and Separators:As part of the INDIGO™ Aspiration System, theINDIGO Aspiration Catheters and Separators areindicated for the removal of fresh, soft emboli andthrombi from vessels of the peripheral arterial andvenous systems, and for the treatment ofpulmonary embolism.INDIGO Aspiration Tubing:As part of the INDIGO™ Aspiration System, theINDIGO Sterile Aspiration Tubing is indicated toconnect the INDIGO Aspiration Catheters to thePenumbra Aspiration Pump.Penumbra Aspiration Pump:The Penumbra Aspiration Pump is indicated as avacuum source for the Penumbra AspirationSystems. | SAME |
| Aspiration Tubing | Lightning Flash Aspiration Tubing[Predicate] | Lightning Flash AspirationTubing[Subject] |
| 510(k) No. | K222358 | K240030 |
| Materials | ||
| Materials | Biocompatible, commonly utilized forinterventional 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.
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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.
Image /page/6/Picture/1 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 stylized "P" inside. The "P" is formed by two parallel lines that create the shape of the letter. The logo is simple and modern, and the red and white color scheme is eye-catching.
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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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.
§ 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).