(124 days)
No
The description focuses on mechanical aspiration and does not mention any AI/ML components or functions.
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 designed for the mechanical removal of thrombi and emboli from blood vessels (therapeutic), not for identifying or characterizing health conditions (diagnostic).
No
The device description clearly outlines multiple hardware components including catheters, a pump, tubing, and separators, which are physical medical devices used for mechanical aspiration.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the removal of emboli and thrombi from vessels and for the treatment of pulmonary embolism. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a system designed for mechanical aspiration to remove thrombus from the vasculature. This is a physical process performed within the patient's circulatory system.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions.
The device is a medical device used for a therapeutic procedure, not a diagnostic test performed on samples outside the body.
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 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.
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.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Data/ Performance Data
Biocompatibility: Testing was conducted on the subject Lightning Bolt Aspiration Tubing. The tests performed were Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Acute Systemic Injection, Material Mediated Pyrogenicity, and Hemocompatibility (Indirect contact). The results showed the Lightning Bolt Aspiration Tubing to be biocompatible.
Design Verification (Bench-Top) Testing: Non-clinical laboratory testing was performed on the subject Lightning Bolt Aspiration Tubing device to determine substantial equivalence. The tests performed were Dimensional/Visual Inspection, Pressurization Testing, Indigo Aspiration System Compatibility/Simulated Use Testing (Thrombus Removal Testing), Valve testing, Tensile Testing, and Post Destructive Testing Dimensional Inspection. The in vitro bench-top tests demonstrated that the subject Lightning Bolt Aspiration Tubing met all acceptance criteria and performed similarly to the predicate devices. 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 devices.
Performance Data - Clinical: No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes.
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, and ISO 10079-1.
Software: 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, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005).
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).
0
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.
February 13, 2023
Penumbra, Inc. Deanna Kimlinger Senior Regulatory Specialist One Penumbra Place Alameda, California 95132
Re: K223186
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: January 13, 2023 Received: January 17, 2023
Dear Deanna Kimlinger:
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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.02.13
12-05'00'
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
2
Indications for Use
510(k) Number (if known) K223186
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 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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3
ਹ 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 Bolt Aspiration Tubing.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Deanna Kimlinger Senior Regulatory Affairs Specialist Phone: (925) 212-9088 FAX: (510) 217-6414 Email: dkimlinger@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
February 08, 2023
1.4 Device Trade or Proprietary Name
Indigo Aspiration System - Lightning Bolt Aspiration Tubing
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 and Reference Devices – Lightning Bolt Aspiration Tubing
| 510(k) Number | Name of Device | |
|---|---|---|
| Lightning Bolt Aspiration Tubing | ||
| Predicate | K210323 Indigo Aspiration System – Lightning Aspiration Tubing | |
| Catheter 7 Aspiration Catheter | ||
| Reference | K210083 Indigo Aspiration System Catheter 7, Indigo Aspiration System Separator 7, | |
| Lightning 7 | ||
| System Name | Indigo® Aspiration System | |
| Lightning Aspiration Tubing | ||
| [Predicate] | Lightning Bolt Aspiration Tubing¹ | |
| [Subject] | ||
| Classification | Class II, QEW | SAME |
| 510(k) no. | K210323 | K223186 |
| 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 AS PREDICATE K210323 |
| Aspiration Tubing | Lightning Aspiration Tubing
[Predicate] | Lightning Bolt Aspiration Tubing
[Subject] |
| 510(k) No. | K210323 | K223186 |
| Materials | | |
| Materials | Biocompatible, commonly utilized for
interventional devices | SAME |
| Dimensions | | |
| Tubing Inner Diameter (ID) | 0.125 in MIN | SAME |
| Distal Tubing Outer Diameter
(OD) | 0.220 in MIN | 0.225 ± 0.007 in |
| Paratubing Outer Diameter
(OD) | 0.223 in MIN | 0.230 + 0.009/- 0.007 in |
| Saline Tubing Outer Diameter
(OD) | N/A - Not present | 0.225 ± 0.007 in |
| Overall Length | 100 + 7 in | 120 + 7 in |
| System Name | Indigo® Aspiration System | |
| | Lightning Aspiration Tubing
[Predicate] | Lightning Bolt Aspiration Tubing1
[Subject] |
| Indigo System Attributes | | |
| Packaging Materials | Commonly used materials for
interventional devices | SAME |
| Aspiration Source | Penumbra Aspiration Pump | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | 12 Months |
| Use | Single use, disposable | SAME |
4
1.7 Predicate Comparison
5
4 The Indigo System Aspiration Catheters, Separators, and Penumbra Aspiration Pumps are unchanged and remain identical to those currently cleared in Section 1.6.
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 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.
6
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.
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
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.
1.10.1 Biocompatibility
Biocompatibility testing was conducted on the subject Lightning Bolt Aspiration Tubing. The following tests were performed:
- o Cytotoxicity
- Sensitization o
- o Irritation
- O Systemic Toxicity
7
- Acute Systemic Injection
- I Material Mediated Pyrogenicity
- Hemocompatibility o
- . Indirect contact
The results from the testing performed showed the Lightning Bolt Aspiration Tubing to be biocompatible.
1.10.2 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:
- O Dimensional/Visual Inspection
- O Pressurization Testing
- Indigo Aspiration System Compatibility/Simulated Use Testing O
- . Thrombus Removal Testing
- O Valve testing
- 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 devices. 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 devices.
1.10.3 Performance Data - Clinical
No clinical study was conducted as bench and previously performed animal testing was determined sufficient for verification and validation purposes.
1.10.4 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, and ISO 10079-1.
1.10.5 Software
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, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005).
8
1.11 Summary of Substantial Equivalence
The subject Lightning Bolt Aspiration Tubing is substantially equivalent to the predicate devices, provided in Section 1.6 with regards to intended use, operating principle, design concept, materials, sterilization processes and packaging processes.