(22 days)
No
The device description and performance studies focus on mechanical aspiration and physical properties, 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 direct treatment for a medical condition.
No
The device is indicated for the removal of emboli and thrombi, which is a therapeutic function, not a diagnostic one. While it is visible under fluoroscopy (an imaging modality), this is for guiding the therapeutic procedure, not for diagnosing a condition.
No
The device description clearly outlines multiple hardware components including catheters, a pump, tubing, and a canister. The performance studies also focus on the physical and mechanical properties of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury.
- Device Function: The INDIGO Aspiration System is designed to physically remove thrombus (blood clots) from within blood vessels. It is a therapeutic device used for intervention within the body, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states the removal of emboli and thrombi from vessels and treatment of pulmonary embolism, which are interventional procedures.
- Device Description: The description details a mechanical system for aspiration within the vasculature, not for laboratory analysis of specimens.
Therefore, the INDIGO Aspiration System falls under the category of a therapeutic medical device used for interventional procedures, 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 (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 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. 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.
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, and for the treatment of pulmonary embolism
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
The following nonclinical performance testing has been conducted, using the established test methods used in the cleared predicate device, to support the substantial equivalence of the Lightning Aspiration Tubing to its predicate device. In all instances, the Lightning Aspiration Tubing met all specifications and testing requirements under the previously established test methods.
- Bench-top performance (design verification) was performed to evaluate the physical and mechanical properties of the subject Indigo Aspiration System - Lightning Aspiration Tubing to demonstrate substantial equivalence to the predicate Indigo Aspiration System - Lightning Aspiration Tubing. Additional testing performed was the same to that performed on the predicate device, including the test methods, specifications and acceptance criteria. The subject Indigo Aspiration System - Lightning Aspiration Tubing met all established requirements.
- Electrical Safety and Suction Equipment Testing completed on the predicate Indigo Aspiration System - Lightning Aspiration Tubing has been leveraged for the subject Indigo Aspiration System - Lightning Aspiration Tubing due to the identical design outputs and substantial equivalence between both devices. Additional testing per IEC 60601-1, IEC 60601-1-2 & -6 has been completed to support all risks associated with the subject Indigo Aspiration System - Lightning Aspiration Tubing and have been fully mitigated. The subject Indigo Aspiration System - Lightning Aspiration Tubing successfully met all applicable requirements under the previously established test methods as evaluated in the predicate Indigo Aspiration System - Lightning Aspiration Tubing.
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).
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February 26, 2021
Penumbra, Inc. Micaela Victoria Regulatory Specialist III One Penumbra Place Alameda, California 94501
Re: K210323
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 2, 2021 Received: February 4, 2021
Dear Micaela 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
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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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Indications for Use
510(k) Number (if known) K210323
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 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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K210323
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.
2. Sponsor/Applicant Name and Address
Penumbra. Inc. One Penumbra Place Alameda, CA 94502 USA
Contact Name: Micaela Victoria Regulatory Affairs Specialist III Phone: (510) 995-2082 FAX: (510) 217-6414 Email: mvictoria@penumbrainc.com
Date of Preparation: February 25, 2021
3. Subject Device
Indigo® Aspiration System - Lightning™ Aspiration Tubing
Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Catheter, Embolectomy Regulation Number: 21 CFR §870.5150 Product Code: QEW
4. Predicate and Reference Device Information
Primary Predicate:
K193244 - Indigo Aspiration System - Lightning Aspiration Tubing
Reference Devices:
K200771 - Indigo Aspiration System - Lightning Aspiration Tubing
K202821 - Indigo Aspiration System - Indigo Aspiration Catheter 12, Separator 12, and
Lightning 12
K180939 (Biocompatibility only) - Indigo Aspiration System
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Image /page/4/Picture/0 description: The image shows the Penumbra 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 right side of the "P" to the edge of the circle.
5. 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 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. 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.
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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. Comparison of Technological Characteristics with the Predicate Device
The Indigo Aspiration System - Lightning Aspiration Tubing has similar technological characteristics as its predicate Indigo Aspiration System - Lightning Aspiration Tubing (K193244). Both facilitate the transfer of vacuum between the INDIGO Aspiration Catheter and the Penumbra Aspiration Pump while providing aspiration. Like the predicate device, vacuum is controlled using a flow switch located near the distal end of the Lightning Aspiration Tubing, which operates a solenoid valve on the base unit to obstruct flow and stop vacuum. The subject Lightning Aspiration Tubing has the same intended use, packaging materials, sterilization method, and aspiration source as the predicate Indigo Aspiration System - Lightning Aspiration Tubing.
The Indigo Aspiration System - Lightning Aspiration Tubing is packaged with the Indigo Aspiration Catheter 8 or Aspiration Catheter 12, and catheter accessories.
The subject Indigo Aspiration System - Lightning Aspiration Tubing utilizes a new Male Luer which is made of the same materials used in the predicate device. New materials in the subject Indigo Aspiration System - Lightning Aspiration Tubing have been incorporated to non-patient contacting components. Materials present in patient-contacting components of the Indigo Aspiration System - Lightning Aspiration Tubing are the same as those in the predicate device. Dimensional changes were made to different components of the subject device; however, these changes do not impact the overall dimensions, which remain identical to the predicate device. Hardware updates were made to improve manufacturability. Software updates were made to accommodate changes to hardware; however, the fundamental software function remains unchanged.
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Image /page/6/Picture/0 description: The image shows the Penumbra logo. The word "Penumbra" is written in red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The "P" is connected to the word "Penumbra" by a thin white line.
8. Performance Data
The following nonclinical performance testing has been conducted, using the established test methods used in the cleared predicate device, to support the substantial equivalence of the Lightning Aspiration Tubing to its predicate device. In all instances, the Lightning Aspiration Tubing met all specifications and testing requirements under the previously established test methods.
- Bench-top performance (design verification) was performed to evaluate the physical and . mechanical properties of the subject Indigo Aspiration System - Lightning Aspiration Tubing to demonstrate substantial equivalence to the predicate Indigo Aspiration System - Lightning Aspiration Tubing. Additional testing performed was the same to that performed on the predicate device, including the test methods, specifications and acceptance criteria. The subject Indigo Aspiration System - Lightning Aspiration Tubing met all established requirements.
- Electrical Safety and Suction Equipment Testing completed on the predicate Indigo Aspiration System - Lightning Aspiration Tubing has been leveraged for the subject Indigo Aspiration System - Lightning Aspiration Tubing due to the identical design outputs and substantial equivalence between both devices. Additional testing per IEC 60601-1, IEC 60601-1-2 & -6 has been completed to support all risks associated with the subject Indigo Aspiration System - Lightning Aspiration Tubing and have been fully mitigated. The subject Indigo Aspiration System - Lightning Aspiration Tubing successfully met all applicable requirements under the previously established test methods as evaluated in the predicate Indigo Aspiration System - Lightning Aspiration Tubing.
The subject device utilizes equivalent materials and identical packaging to the predicate device. Therefore, the biocompatibility, sterilization, and packaging characteristics of the predicate device were maintained.
9. Summary of Substantial Equivalence
The subject device has the identical intended use as the predicate device. The subject and predicate devices differ slightly in regards to minor technological variations, while maintaining the same fundamental scientific technology. However, these differences do not raise different questions of safety and effectiveness. The device testing described in the 510(k) Summary demonstrate the subject device is substantially equivalent to the predicate device in regard to intended use, fundamental technology and device performance.
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10. Conclusion
The subject device has been evaluated in nonclinical testing in accordance with FDA's recognized standards and pre-established acceptance criteria. Testing demonstrates the device performs as intended. Therefore, the subject Indigo Aspiration System - Lightning Aspiration Tubing is substantially equivalent to the predicate device, Indigo Aspiration System – Lightning Aspiration Tubing (K193244).