(28 days)
No
The device description focuses on mechanical aspiration and physical components. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies section also indicates no differences from the predicate device, which is unlikely if significant AI/ML capabilities were introduced.
Yes
The device is indicated for the removal of 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 fresh, soft emboli and thrombi" and "treatment of pulmonary embolism," which describes a therapeutic rather than diagnostic function. It is designed to remove thrombus, not to diagnose its presence or characteristics.
No
The device description clearly lists multiple hardware components including catheters, pumps, canisters, tubing, and separators.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The INDIGO Aspiration System is a therapeutic device designed to physically remove thrombus (blood clots) from blood vessels within the body. It is used in vivo (inside the living body) during a medical procedure.
- Intended Use: The intended use clearly states the removal of emboli and thrombi from vessels, which is a direct treatment action, not a diagnostic test performed on a sample.
- Device Description: The description details a system for mechanical aspiration within the vasculature, involving catheters, pumps, and separators used during a procedure.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens outside of the body.
Therefore, the INDIGO Aspiration System falls under the category of 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:
- 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 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
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
There are no differences in performance data between the subject and predicate devices and therefore no verification and validation studies were required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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February 9, 2021
Penumbra, Inc. Teri Nguyen Regulatory Affairs Specialist II One Penumbra Place Alameda, California 94502
Re: K210083
Trade/Device Name: Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEW Dated: January 11, 2021 Received: January 12, 2021
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
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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,
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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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® System - Aspiration Catheter 7 and Separator 7.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
Contact Person: Teri Nguyen Regulatory Affairs Specialist II Phone: (510) 995-2012 FAX: (510) 217-6414 Email: tnguyen2@penumbrainc.com
Date of Preparation: January 11, 2021
1.2 Subject Device
Indigo® Aspiration System - Aspiration Catheter 7 and Separator 7 (K210083)
Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Catheter, Embolectomy Regulation Number: 21 CFR §870.5150 Product Code: QEW
1.3 Predicate and Reference Device Information
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 (K193595) and Indigo Aspiration System (K192833)
Device Description 1.4
The INDIGO® Aspiration System is comprised of:
- INDIGO Aspiration Catheter ●
- Penumbra Aspiration Pump
- INDIGO Aspiration Pump Canister ●
- INDIGO Aspiration Tubing ●
- INDIGO Separator™ ●
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Image /page/4/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 bold, red font, followed by a circular symbol. The symbol is also red and contains a white "P" shape inside the circle, with a white line extending from the "P" to the word "Penumbra."
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 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.
Indications for Use 1.5
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.
1.6 Comparison of Technological Characteristics with the Predicate
There are no differences in the technological characteristics between the subject devices and predicate devices.
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1.7 Performance Data
There are no differences in performance data between the subject and predicate devices and therefore no verification and validation studies were required.
The Indigo System, clinical study (EXTRACT-PE) was cleared in K192833 (reference device). A review of the technological characteristics of the subject and reference devices supported leveraging the clinical outcomes of the EXTRACT-PE clinical study for the subject devices.
1.8 Conclusions
The subject Indigo System Aspiration Catheter 7 and Separator 7 are substantially equivalent to the predicate devices, Indigo System Aspiration Catheter 7 and Separator 7 (K193595). The subject devices have identical intended use and technological characteristics as the predicate devices. Also, there are no changes in terms of device performance, safety, operating principle, design concept, fundamental technology, manufacturing and packaging between the subject and predicate devices. Therefore, the subject devices are substantially equivalent.