(23 days)
Not Found
No
The description focuses on the mechanical components and function of the aspiration system (catheters, separators, tubing, pump) and does not mention any computational or algorithmic processing, particularly related to AI or ML. The testing described is bench-top and physical property evaluation, not performance evaluation of an AI/ML algorithm.
Yes
The device is indicated for the "removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems," which directly addresses a medical condition (emboli and thrombi) by removing them, thus providing a therapeutic effect.
No
Explanation: The device is indicated for the removal of emboli and thrombi (treatment), not for diagnosing conditions.
No
The device description clearly outlines a system composed of physical components including catheters, separators, tubing, and a pump. The testing described focuses on the physical and mechanical properties of these hardware components. There is no mention of software as a component of the system.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the "removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a system of catheters, tubing, and a pump used to physically aspirate material from blood vessels. This is an invasive procedure.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood and tissue, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes. This device does not perform any analysis of specimens outside the body for diagnostic purposes.
The device is an interventional medical device used for a therapeutic procedure within the patient's vascular system.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DXE
Device Description
The Indigo Aspiration System ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral 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 K180105.
The Indigo System is designed to remove thrombus from the vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the Aspiration Pump directly to the thrombus. The Separator may be used to clear the lumen of the Aspiration Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using an Aspiration Catheter with an I.D. of 0.054in or larger. The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the site of the primary occlusion. The Aspiration Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Separator may be deployed from the Aspiration Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Aspiration Catheter tip. For the aspiration source, the Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the Aspiration Tubing and Canister. The Aspiration Catheter may be provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheters and Separators are visible under fluoroscopy.
The Indigo Aspiration Tubing connects the Penumbra Aspiration Pump Canister to the Indigo Aspiration Catheter within the sterile field, providing a means for introducing vacuum during procedures. The Aspiration Tubing has a flow switch that allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is available in three inner diameters: 0.071 in [1.80mm] for IST1, 0.088 in [2.24mm] for IST2, and 0.110 in [2.79mm] for IST3 and IST4. The Aspiration Tubing is designed and composed of materials which are commonly used in interventional devices.
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
Physician / 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)
Biocompatibility Testing:
Testing was performed on the modified 110 Aspiration Tubing in accordance with EN ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (≤24 hours), surface device, with skin contact. Studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP).
The modified 110 Aspiration Tubing met all acceptance criteria and successfully passed all biocompatibility tests.
Bench-top Testing:
Bench-top testing was conducted to evaluate the physical and mechanical properties of the modified 110 Aspiration Tubing. All benchtop studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures. Performance testing was based on the design specifications, risk analysis, performance standards, and guidance documents. All testing was performed using units which were 2x EO-sterilized.
The modified 110 Aspiration Tubing met all acceptance criteria and passed all tests.
Shelf Life Testing:
The modified 110 Aspiration Tubing has demonstrated device stability for 36 months based on accelerated aging. Test units were 2x EO-sterilized and underwent transportation conditioning per ASTM D4169, Distribution Cycle 3, Assurance Level 2.
Sterilization Testing:
The modified 110 Aspiration Tubing has demonstrated sterility by EO in accordance with EN ISO 11135. All test samples met the acceptance criteria for EO residual testing per EN ISO 10993-7, Comparative Resistance Testing per AAMI TIR 28, and Endotoxin (LAL) Testing per ANSI/AAMI ST72.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Biocompatibility:
- Cytotoxicity (MEM Elution): Grade 2: Mild (Pass)
- Sensitization: Grade 0: No visible change (Pass)
- Irritation (Intracutaneous Reactivity Irritation Test): Grade 0.0 difference (saline extract) and Grade 0.1 difference (sesame oil extract) (Pass)
Bench-top Testing:
- Dimensional/Visual Inspection: 100% Must meet Specification (Pass)
- Suction Connector / Canister Lid Compatibility: 100% Must meet Specification (Pass)
- Rotating Luer / RHV Compatibility: 100% Must meet Specification (Pass)
- Aspiration Tubing Lumen Ovalization under Vacuum: 100% Must meet Specification (Pass)
- Aspiration Tubing Joint Leak under Vacuum: 100% Must meet Specification (Pass)
- Flow Control Switch Function: 100% Must meet Specification (Pass)
- Penumbra Aspiration System Compatibility with Aspiration Tubing: 100% Must meet Specification (Pass)
- Penumbra Aspiration System Compatibility with Aspiration Catheter: 100% Must meet Specification (Pass)
- Suction Connector / Tubing Joint Tensile: 100% Must meet Specification (Pass)
- Rotating Male Luer / Tubing Joint Tensile: 100% Must meet Specification (Pass)
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.
Not Found
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 3, 2018
Penumbra, Inc. Mr. Richard Kimura Senior Regulatory Specialist One Penumbra Place Alameda, California 94502
Re: K180939
Trade/Device Name: Indigo Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: April 9, 2018 Received: April 10, 2018
Dear Mr. Kimura:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Mr. Richard Kimura
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180939
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 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® with modified 110 Aspiration Tubing.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Richard Kimura Senior Regulatory Affairs Specialist Phone: (510) 995-2034 FAX: (510) 217-6414 Email: rkimura@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
April 9, 2018
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: | DXE |
1.6 Predicate Device
| 510(k) Number / Clearance Date | Name of Device | Name of Manufacturer |
|---|---|---|
| Predicate Device | ||
| K180105 cleared on March 8, 2018 | Indigo Aspiration System | Penumbra, Inc. |
| One Penumbra Place | ||
| Alameda, CA 94502 USA |
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1.7 Predicate Comparison
| Predicate Device | Subject Device1 | |
|---|---|---|
| Trade Name | Indigo Aspiration System | SAME |
| 510(k) No. | K180105 | To Be Determined |
| Classification | Class II, DXE | SAME |
| 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. | SAME |
| Aspiration Tubing | | |
| | Current 110 Aspiration Tubing | Modified 110 Aspiration Tubing |
| Tubing Inner
Diameter (ID) | 0.110 in | SAME |
| Tubing Outer
Diameter (OD) | 0.188 in | SAME |
| Overall Length | 112.0 in | 100.0 in |
| Distal Length | 7.0 in | N/A (Single Piece Construction) |
| Materials | Biocompatible, commonly utilized for
interventional devices | SAME |
| Packaging
Configuration | Individually packaged | SAME |
| Sterilization | EO | SAME |
| Shelf Life | 36 months | SAME |
1 The Indigo System Aspiration Catheters, Separators, and Aspiration Pumps are unchanged and remain identical to those of the currently cleared Indigo System (K180105).
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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 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 K180105.
The Indigo System is designed to remove thrombus from the vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the Aspiration Pump directly to the thrombus. The Separator may be used to clear the lumen of the Aspiration Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using an Aspiration Catheter with an I.D. of 0.054in or larger. The Aspiration Catheter is introduced through a guide catheter or long femoral sheath and into the site of the primary occlusion. The Aspiration Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Separator may be deployed from the Aspiration Catheter to assist with thrombus removal. The Separator is advanced and retracted through the Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Aspiration Catheter tip. For the aspiration source, the Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the Aspiration Tubing and Canister. The Aspiration Catheter may be provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheters and Separators are visible under fluoroscopy.
The Indigo Aspiration Tubing
The Indigo Aspiration Tubing connects the Penumbra Aspiration Pump Canister to the Indigo Aspiration Catheter within the sterile field, providing a means for introducing vacuum during procedures. The Aspiration Tubing has a flow switch that allows the physician to start and stop the flow of aspiration. The Aspiration Tubing is available in three inner diameters: 0.071 in [1.80mm] for IST1, 0.088 in [2.24mm] for IST2, and 0.110 in [2.79mm] for IST3 and IST4. The Aspiration Tubing is designed and composed of materials which are commonly used in interventional devices.
6
Image /page/6/Picture/0 description: The image shows the Penumbra logo. The word "Penumbra" is written in a sans-serif font in a dark red color. To the right of the word is a circular logo, which is also dark red with a white "P" inside. The logo is simple and modern.
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 which substantiates the performance of the subject Indigo System with modified 110 Aspiration Tubing as well as its substantial equivalence to the predicate device:
- Biocompatibility o
- Design Verification (Bench-Top Testing) ●
- Shelf Life o
- Sterilization ●
- o Packaging
The subject Indigo System with modified 110 Aspiration Tubing met all established requirements.
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1.10.1 Biocompatibility
Biocompatibility testing was performed on the modified 110 Aspiration Tubing and the results are summarized in the table below. The studies were selected in accordance with EN ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for a limited exposure (≤24 hours), surface device, with skin contact. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP). The modified 110 Aspiration Tubing met all acceptance criteria and successfully passed all biocompatibility tests per EN ISO 10993-1 guidelines.
| Test / Standard | Acceptance Criteria | Results | Pass / Fail |
|---|---|---|---|
| Cytotoxicity (MEM Elution) / EN ISO 10993-5 | Sample extracts must yield a cell lysis grade of 2 or lower | Grade 2: Mild | Pass |
| Sensitization / EN ISO 10993-10 | Test Group shall yield Grade | ||
| 1 score on Magnusson and | |||
| Kligman scale (provided | |||
| Control Grade |