(109 days)
No
The device description focuses on mechanical aspiration and physical components, with no mention of AI or ML.
Yes
The device is indicated for the removal of fresh, soft emboli and thrombi from vessels, which is a therapeutic intervention aimed at treating medical conditions.
No
The device description and intended use clearly state that the INDIGO Aspiration System is used for the removal of fresh, soft emboli and thrombi, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including catheters, separators, tubing, and a pump, which are integral to the system's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the INDIGO Aspiration System is used for the removal of emboli and thrombi directly from blood vessels within the patient's body. This is an interventional procedure performed in vivo (within a living organism), not a diagnostic test performed in vitro (in a lab setting).
- Intended Use: The intended use is for the removal of material, not for the diagnosis of a condition based on analyzing a sample.
The device is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
INDIGO Aspiration Catheters and Separators
As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems.
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 (comma separated list FDA assigned to the subject device)
QEW
Device Description
The Indigo Aspiration System ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems using the Indigo Aspiration Catheter, Indigo Separator, Indigo Aspiration Tubing, and Penumbra Aspiration Pump. The Indigo System was most recently cleared under K180939.
The INDIGO® Aspiration System is comprised of the several devices:
- · INDIGO Aspiration Catheter
- Penumbra Aspiration Pump
- INDIGO Pump/Canister Tubing
- 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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral arterial and venous systems.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended users for this device are 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)
Summary of Non-Clinical Data:
- Biocompatibility (Leveraged)
- Design Verification (Bench-Top Testing)
- Shelf Life
- Sterilization
- Packaging
- Software
- Electrical/EMC
Biocompatibility (Leveraged): Studies selected in accordance with ISO 10993-1 guidelines for a limited exposure (
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
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March 13, 2020
Penumbra, Inc. Ms. Micaela Victoria Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502
Re: K193244
Trade/Device Name: Indigo Aspiration System - Lightning Aspiration Tubing Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: February 11, 2020 Received: February 12, 2020
Dear Ms. Victoria:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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) K193244
Device Name
Indigo Aspiration System - Lightning 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 and venous systems.
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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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 Aspiration Tubing.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Micaela Victoria Regulatory Affairs Specialist III Phone: (510) 995-2082 FAX: (510) 217-6414 Email: mvictoria@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
January 14, 2020
1.4 Device Trade or Proprietary Name
Indigo® Aspiration System – Lightning 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
| 510(k) Number/Clearance Date | Name of Device | Name of Manufacturer | System Name | INDIGO® Aspiration System | ||
|---|---|---|---|---|---|---|
| Predicate Device | Device Name | 110 Aspiration Tubing (modified) | ||||
| [Predicate Device] | 110 Aspiration Tubing | |||||
| [Reference Device] | Lightning Aspiration | |||||
| Tubing | ||||||
| Subject Device | ||||||
| K180939 cleared on May 3, 2018 | 110 Aspiration Tubing | |||||
| (Modified) – INDIGO | ||||||
| Aspiration System | Penumbra, Inc. | |||||
| One Penumbra Place | ||||||
| Alameda, CA 94502 USA | 510(k) Number | K180939 | K142870 | TBD | ||
| Reference Device | Classification | DXE | SAME | QEW | ||
| K142870 cleared on May 26, 2015 | 110 Aspiration Tubing – | |||||
| INDIGO Aspiration | ||||||
| System | Penumbra, Inc. | |||||
| One Penumbra Place | ||||||
| Alameda, CA 94502 USA | Indication 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. | ||||||
| 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 Penumbra Embolectomy | |||||
| Aspiration System is | ||||||
| intended for the removal of | ||||||
| fresh, soft emboli and | ||||||
| thrombi from vessels of the | ||||||
| peripheral arterial and | ||||||
| venous systems. | ||||||
| Not for use in the coronaries | ||||||
| or the neurovasculature. | SAME as Predicate | |||||
| Device | ||||||
| Materials | Biocompatible, commonly utilized for | |||||
| interventional devices | SAME | SAME | ||||
| Dimensions | ||||||
| Tubing inner diameter | ||||||
| (ID) | 0.110 in | SAME as Predicate Device | 0.131 in |
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1.7 Predicate Comparison
5
| Tubing outer diameter
| (OD) | 0.188 in | SAME as Predicate Device | 0.237 in |
|---|---|---|---|
| Overall Length | 100.0 in | 112.0 in | SAME as Predicate |
| Device | |||
| Distal length | N/A (Single piece construction) | 7.9 in | 8 in |
| Packaging | |||
| Configurations | Individual and Kit | SAME as Predicate Device | Kit only |
| Packaging Materials | Commonly utilized for interventional devices | SAME | SAME |
| Aspiration Source | Penumbra Aspiration Pump | SAME | SAME |
| Sterilization | EO | SAME | SAME |
| Shelf Life | 36 months | SAME as Predicate Device | 12 months |
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1.8 Device Description
The Indigo Aspiration System ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems using the Indigo Aspiration Catheter, Indigo Separator, Indigo Aspiration Tubing, and Penumbra Aspiration Pump. The Indigo System was most recently cleared under K180939.
The INDIGO® Aspiration System is comprised of the several devices:
- · INDIGO Aspiration Catheter
- Penumbra Aspiration Pump
- INDIGO Pump/Canister Tubing
- 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, 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
7
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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.
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.
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
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 device follows.
Included in this section are summary descriptions of the testing (or rationale for not testing if not applicable) which substantiates the performance of the subject Indigo Aspiration System - Lightning Aspiration Tubing as well as its substantial equivalence to the predicate device:
- Biocompatibility (Leveraged) ●
- Design Verification (Bench-Top Testing) .
- Shelf Life .
- Sterilization
- Packaging ●
- Software .
- Electrical/EMC ●
The subject Lightning Aspiration Tubing met all established requirements.
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1.10.1 Biocompatibility (Leveraged)
Biocompatibility was leveraged for the subject Lightning Aspiration Tubing. The studies were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (