(71 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 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 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 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 Lightning Bolt Aspiration Tubing (INDIGO Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating transfer of vacuum between the Penumbra Aspiration Pump and the INDIGO Aspiration Catheter while providing intermittent, continuous, or modulated aspiration. Modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the INDIGO Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous (IV) bag at ambient pressure.
The provided text is a 510(k) summary for the Penumbra Indigo® Aspiration System - Lightning Bolt Aspiration Tubing (K242075). It describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device (K223186).
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the subject device meets specific clinical performance acceptance criteria in a standalone study against a predefined clinical benchmark. The studies described are primarily bench-top (non-clinical) tests to verify that the subject device performs similarly to the predicate device and functions as intended.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical tests performed, stating that the subject device met all acceptance criteria. However, it does not provide a table detailing specific quantitative acceptance criteria or corresponding device performance values for most tests. Instead, it offers general statements of compliance or similarity to the predicate device.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional/Visual Inspection | (Not explicitly stated, but implied to match design specifications and be free of defects) | Met all acceptance criteria |
| Pressurization Testing | (Not explicitly stated, but implied to withstand pressure without failure) | Met all acceptance criteria |
| Indigo Aspiration System Compatibility/Simulated Use Testing | (Not explicitly stated, but implied to function correctly with the aspiration system) | Met all acceptance criteria, performed similarly to predicate |
| Thrombus Removal Testing | (Not explicitly stated, but implied to be effective in removing thrombus) | Met all acceptance criteria, performed similarly to predicate |
| Valve Testing | (Not explicitly stated, but implied to ensure proper valve function) | Met all acceptance criteria |
| Tensile Testing | (Not explicitly stated, but implied to meet strength requirements) | Met all acceptance criteria |
| Post Destructive Testing Dimensional Inspection | (Not explicitly stated, but implied to assess structural integrity after destructive tests) | Met all acceptance criteria |
| Biocompatibility | Previously provided biocompatibility data of the predicate device (K223186) | No changes, maintained previous biocompatibility profile |
| Shelf-Life | Stability for 12 months | Met 12 months shelf-life based on accelerated aging data |
| Electrical Safety/EMC Testing | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, AIM 7351731, ISO 10079-1, and ISO 10079-4 | Complies with specified standards |
| Software Verification/Validation | Aligned with FDA's "Content of Premarket Submissions for Device Software Functions" guidance | Testing and documentation provided as recommended |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly provide the sample sizes (number of units or test iterations) for each specific bench-top test. It generally references "testing performed on the subject Lightning Bolt Aspiration Tubing device."
The data provenance is non-clinical bench testing, conducted by the manufacturer, Penumbra, Inc. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate equivalence. There is no information about country of origin of the data beyond implicitly being from testing conducted by the US-based manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For the non-clinical bench-top tests described, the concept of "ground truth" as established by medical experts (e.g., radiologists) is not applicable. These tests evaluate engineering and material performance against predefined specifications, often based on industry standards or internal design requirements. The "ground truth" for these tests would be the physical properties and performance of the device as measured in the lab.
4. Adjudication Method for the Test Set
Since the tests are non-clinical bench tests evaluating engineering performance, an adjudication method (like 2+1, 3+1 for clinical endpoints) is not relevant. Test results are typically objective measurements against a Pass/Fail criterion.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an 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 information on the effect size of human readers improving with or without AI assistance, as this is not an AI device.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone study was not done. This device is physical medical tubing, not an AI algorithm.
7. Type of Ground Truth Used
For the bench testing, the "ground truth" is based on:
- Engineering specifications and design requirements for mechanical, dimensional, and material properties.
- Industry standards (e.g., ISO for sterility, various IEC standards for electrical safety).
- Performance of the predicate device as a benchmark for comparison (e.g., "performed similarly to the predicate device").
8. Sample Size for the Training Set
Not Applicable. This is a physical medical device (tubing), not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
September 25, 2024
Penumbra, Inc. Nikita Patel Regulatory Affairs Specialist II One Penumbra Place Alameda, California 94502
Re: K242075
Trade/Device Name: Indigo® Aspiration System - Lightning Bolt Aspiration Tubing Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: August 1, 2024 Received: August 2, 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 QS 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 Rue"). 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 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).
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Sincerely,
Gregory W. O'connell -S
Digitally signed by Gregory W. O'connell -S Date: 2024.09.25 16:19:28 -04'00'
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
510(k) Number (if known) K242075
Device Name
Indigo® Aspiration System - Lightning Bolt Aspiration Tubing
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/4/Picture/1 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. A thin white line extends from the right side of the word "Penumbra" to the left side of the "P" in the circle.
510(k) Summary
1 Submitter
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
Contact Person Nikita Patel Regulatory Affairs Specialist II Phone: (408) 823-1820 Email: npatel@penumbrainc.com
Date of Preparation:
August 01, 2024
2 Subject Device
Indigo" Aspiration System – Lightning" Bolt Aspiration Tubing
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Cardiovascular |
| Classification Name: | Catheter, Embolectomy |
| Regulation Number: | 21 CFR §870.5150 |
| Product Code: | QEW |
3 Predicate and Reference Devices – Lightning Bolt Aspiration Tubing
| 510(k) Number | Name of Device |
|---|---|
| Predicate | |
| K223186 | Indigo Aspiration System - Lightning Bolt Aspiration Tubing |
| Reference | |
| K192833 | Indigo Aspiration System |
| K210083 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 |
| K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
4 Predicate Comparison
| System Name | Indigo® Aspiration System | |
|---|---|---|
| Lightning Bolt Aspiration Tubing[Predicate] | Lightning Bolt Aspiration Tubing1[Subject] | |
| Classification | Class II, QEW | SAME |
| 510(k) no. | K223186 | K242075 |
| System Name | Indigo® Aspiration System | |
| Lightning Bolt Aspiration Tubing[Predicate] | Lightning Bolt Aspiration Tubing1[Subject] | |
| Indication | INDIGO Aspiration Catheters andSeparators:As part of the INDIGO AspirationSystem, the INDIGO AspirationCatheters and Separators are indicatedfor the removal of fresh, soft emboli andthrombi from vessels of the peripheralarterial and venous systems, and for thetreatment of pulmonary embolism.INDIGO Aspiration Tubing:As part of the INDIGO AspirationSystem, the INDIGO Sterile AspirationTubing is indicated to connect theINDIGO Aspiration Catheters to thePenumbra Aspiration Pump.Penumbra Aspiration Pump:The Penumbra Aspiration Pump isindicated as a vacuum source for thePenumbra Aspiration Systems. | SAME |
| Aspiration Tubing | Lightning Bolt Aspiration Tubing[Predicate] | Lightning Bolt Aspiration Tubing[Subject] |
| 510(k) No. | K223186 | K242075 |
| Materials | ||
| Materials | Biocompatible, commonly utilized forinterventional devices | SAME |
| Dimensions | ||
| Tubing Inner Diameter (ID) | Appropriately sized for AspirationCatheters | SAME plus larger diameters |
| Distal Tubing Outer Diameter(OD) | ||
| Paratubing Outer Diameter(OD) | ||
| Saline Tubing Outer Diameter(OD) | ||
| Overall Length | 120 + 7 in | 114 + 7 in |
| System Name | Indigo® Aspiration System | |
| Lightning Bolt Aspiration Tubing[Predicate] | Lightning Bolt Aspiration Tubing1[Subject] | |
| Indigo System Attributes | ||
| Packaging Materials | Commonly used materials forinterventional devices | SAME |
| Aspiration Source | Penumbra Aspiration Pump | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | 12 Months |
| Use | Single use, disposable | SAME |
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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. A thin gray line connects the end of the word "Penumbra" to the left side of the red circle.
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Image /page/6/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 left, connecting to the "a" in "Penumbra". The logo is simple and modern, with a focus on the company name and a distinctive symbol.
4 The Indigo System Aspiration Catheters, Separators, and Penumbra Aspiration Pumps are unchanged and remain identical to those currently cleared in Section 3.
5 Device Description
The INDIGO® Aspiration System is comprised of 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 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 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.
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Image /page/7/Picture/0 description: The image shows the logo for Penumbra, Inc., a global healthcare company focused on innovative therapies. The logo features the word "Penumbra" in a red sans-serif font, followed by a stylized "P" enclosed in a red circle. A thin gray line connects the end of the word "Penumbra" to the "P" symbol, visually linking the name with the company's brand identity.
Lightning Bolt Aspiration Tubing
The Lightning Bolt Aspiration Tubing (INDIGO Aspiration Tubing) is designed to serve as a conduit to assist in thrombus removal, facilitating transfer of vacuum between the Penumbra Aspiration Pump and the INDIGO Aspiration Catheter while providing intermittent, continuous, or modulated aspiration. Modulated aspiration is provided when the Lightning Bolt Aspiration Tubing alternates between connecting the INDIGO Aspiration Catheter to the Penumbra Aspiration Pump and a sterile saline intravenous (IV) bag at ambient pressure.
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
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding substantial equivalence of the devices follows. Included in this section are summary descriptions of the testing which substantiates the performance of the subject Lightning Bolt Aspiration Tubing.
7.1 Design Verification (Bench-Top) Testing
Non-clinical laboratory testing was performed on the subject Lightning Bolt Aspiration Tubing device to determine substantial equivalence. The following tests were performed:
- Dimensional/Visual Inspection O
- O Pressurization Testing
- Indigo Aspiration System Compatibility/Simulated Use Testing O
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Image /page/8/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 stylized silver "P" inside. The "P" is connected to the word "Penumbra" by a thin silver line.
- . Thrombus Removal Testing
- Valve Testing o
- Tensile Testing o
- Post Destructive Testing Dimensional Inspection O
The in vitro bench-top tests demonstrated that the subject Lightning Bolt Aspiration Tubing met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the Lightning Bolt Aspiration Tubing device functions as intended and has a safety and effectiveness profile that is similar to the predicate device.
7.2 Biocompatibility
There are no changes to the previously provided biocompatibility data of the Indigo System Lightning Bolt Aspiration Tubing sterile device materials cleared in K223186 (predicate device).
7.3 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 K223186 (predicate device).
Summary of Performance Data – Animal, Clinical 7.4
No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
7.5 Electrical Safety/EMC Testing
Electrical Safety and EMC testing were conducted on the subject Lightning Bolt Aspiration Tubing. The subject device complies with the requirements of IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, AIM 7351731, ISO 10079-1, and ISO 10079-4.
Software 7.6
Software verification and validation testing and documentation for the subject Lightning Bolt 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).
8 Summary of Substantial Equivalence
The subject Lightning Bolt Aspiration Tubing is substantially equivalent to the predicate device, provided in Section 3 with regards to intended use, operating principle, design concept, fundamental technology, device performance, materials, sterilization processes and packaging processes.
§ 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).