(79 days)
No
The device description and intended use focus on mechanical aspiration and physical components. There is no mention of AI, ML, or any software-driven analysis or decision-making based on data.
Yes
The device is indicated for the removal of fresh, soft emboli and thrombi from vessels and for the treatment of pulmonary embolism, which are therapeutic interventions.
No
Explanation: The device is indicated for the removal of emboli and thrombi (treatment), not for diagnosing their presence or characteristics.
No
The device description clearly outlines multiple hardware components including catheters, a pump, tubing, and a canister, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The INDIGO Aspiration System is a medical device used for the physical removal of blood clots (emboli and thrombi) from blood vessels within the body. It is a therapeutic device that directly interacts with the patient's anatomy.
- Intended Use: The intended use clearly states the removal of emboli and thrombi from vessels and the treatment of pulmonary embolism. This is a direct intervention on the patient's circulatory system, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details a system of catheters, pumps, and tubing designed for mechanical aspiration within the vasculature. This aligns with a therapeutic device, not a diagnostic one.
Therefore, the INDIGO Aspiration System is a therapeutic medical device, 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 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 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 and 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy, CTA
Anatomical Site
vessels of the peripheral arterial and venous systems, pulmonary embolism, peripheral vasculature
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)
The Penumbra EXTRACT-PE trial was a prospective, multicenter, single arm trial to determine the safety and efficacy of the Indigo Aspiration System for mechanical thrombectomy in subjects with acute pulmonary embolism (PE). The trial enrolled 119 subjects at 22 centers in the U.S. An independent imaging core lab and a clinical events committee (CEC) reviewed safety endpoints data.
The study procedure was initiated in 119 subjects and completed in 118 subjects; one subject had the procedure aborted prior to aspiration. Conscious sedation was used in 97.5% of subjects and 78.2% had a right femoral access site. The median procedure time was 66 min; IQR [46.0, 94.0]. The median time from the first Indigo device insertion to the last Indigo device removal was 37 minutes; IQR [23.5, 60.0]. The median ICU stay was 1.0 day [1.0, 2.0].
There were 119 subjects that were enrolled and included in the Intent-To-Treat (ITT) analysis population. The Modified ITT (mITT) population was a subset of the ITT population and was the primary population for all efficacy parameters. The mITT population excluded subjects who received adjunctive treatments or thrombolytics intra-procedure through 48 hours post-procedure for the purpose of reducing clot burden in the pulmonary artery. There were 110 subjects in the mITT population. Safety endpoints are evaluated based on ITT population.
There were 110 patients who completed the study 30 day follow-up, 3 patients died, 1 withdrew from the study, and 5 were lost to follow-up.
Key results:
The primary efficacy endpoint was the reduction in RV/LV ratio from baseline to 48 hours assessed by CTA and evaluated by independent core laboratory. The lower limit of the 95% confidence interval (CI) of the change in RV/LV ratio at 48 hours was >0.20. The primary efficacy endpoint was met with absolute reduction in RV/LV ratio of 0.42±0.25 (95%CI 0.37, 0.46), representing a 26.9% reduction (p
§ 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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2019
Penumbra, Inc. Teri Nguyen Regulatory Affairs Specialist II One Penumbra Place Alameda, California 94502
Re: K192833
Trade/Device Name: Indigo Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: November 27, 2019 Received: November 29, 2019
Dear Teri Nguyen:
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
1
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 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 (OS) 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,
For
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) K192833
Device Name
Indigo Aspiration System
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Teri Nguyen Regulatory Affairs Specialist II Phone: (510) 995-2012 FAX: (510) 217-6414 Email: tnguyen2@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
December 19, 2019
1.4 Device Trade or Proprietary Name
Indigo® Aspiration System
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 Manufacture |
|---|---|---|
| Predicate Device | ||
| K142870 cleared on May 26, 2015 | Penumbra Embolectomy | |
| Aspiration System (INDIGO | ||
| Aspiration System) | Penumbra, Inc. | |
| One Penumbra Place | ||
| Alameda, CA 94502 USA | ||
| Reference Device | ||
| K180939 cleared on May 03, 2018 | INDIGO Aspiration | |
| System | Penumbra, Inc. | |
| One Penumbra Place | ||
| Alameda, CA 94502 USA | ||
| K180466 cleared on May 19, 2018 | FlowTriever Retrieval/Aspiration | |
| System | Inari Medical, Inc. | |
| 9272 Jeronimo Road | ||
| Suite 124 | ||
| Irvine, CA 92618 USA |
4
1.7 Predicate Comparison
| System Name | Predicate Device | Reference Device | Subject Device¹ | |
|---|---|---|---|---|
| 510(k) No. | K142870 | K180939 | K180466 | K192833 |
| Classification | Class II, DXE | Class II, QEW | ||
| Indication for | ||||
| Use | The Penumbra | |||
| Embolectomy Aspiration | ||||
| System (INDIGO™ | ||||
| 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. | 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 the | ||||
| Penumbra Aspiration | ||||
| Systems. | The FlowTriever | |||
| Retrieval/Aspiration System | ||||
| consists of the FlowTriever | ||||
| Catheter, Aspiration Guide | ||||
| Catheter, and Retraction | ||||
| Aspirator. The FlowTriever | ||||
| Retrieval/Aspiration System is | ||||
| indicated for: | ||||
| • The non-surgical removal of | ||||
| emboli and thrombi from blood | ||||
| vessels. | ||||
| • Injection, infusion, and/or | ||||
| aspiration of contrast media and | ||||
| other fluids into or from a blood | ||||
| vessel. | ||||
| The FlowTriever | ||||
| Retrieval/Aspiration System is | ||||
| intended for use in the peripheral | ||||
| vasculature and for the treatment | ||||
| of pulmonary embolism. | 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. |
5
| Predicate Device | Subject Device1 | |
|---|---|---|
| Packaging, | ||
| Materials & | ||
| Configurations | Commonly utilized for interventional devices | SAME |
| Aspiration Source | Penumbra Aspiration Pump | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | SAME |
| Use | Single use, disposable | SAME |
1The Indigo System Aspiration Catheters, Separators, Tubing 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 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 and 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
6
Image /page/6/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. The "P" is stylized with a horizontal line extending from the left side of the "P" to the edge of the circle.
provided with a steam shaping mandrel, rotating hemostasis valve, and introducer. The INDIGO Separator may be provided with an introducer and torque device.
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
The subject and predicate Indigo System devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged.
1.10.1 Biocompatibility
The subject and predicate Indigo System sterile devices are identical. There are no changes to the previously provided biocompatibility data of the Indigo System sterile device materials, which were reviewed and cleared under the premarket notifications listed in 1.6. No additional biocompatibility testing is required or was performed for the Indigo System sterile devices.
The subject and predicate Indigo System devices are categorized and tested as a limited exposure (0.20. The primary efficacy endpoint was met with absolute reduction in RV/LV ratio of 0.42±0.25 (95%CI 0.37, 0.46), representing a 26.9% reduction (p