(96 days)
No
The device description and performance studies focus on mechanical aspiration and device performance, with no mention of AI or ML.
Yes.
The device is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, which is a therapeutic purpose.
No
The device is indicated for the removal of fresh, soft emboli and thrombi, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including aspiration catheters, separators, tubing, and a physical pump (Penumbra Pump MAX).
Based on the provided text, 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 physical removal of emboli and thrombi from blood vessels within the body. It is an interventional device used during a medical procedure.
- Lack of In Vitro Testing: There is no mention of the device being used to analyze samples outside of the body or to perform any diagnostic tests on biological specimens.
The device is an interventional medical device used for therapeutic purposes (removing blockages) within the peripheral arterial and venous systems.
N/A
Intended Use / Indications for Use
INDIGO Aspiration Catheters and Separators: As part of the Penumbra Embolectomy Aspiration System (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. Not for use in the coronaries or the neurovasculature.
INDIGO Aspiration Tubing: As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for the Penumbra Aspiration Systems.
Product codes
DXE
Device Description
The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial and venous systems. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for the Aspiration Catheters with Aspiration Tubing is available.
The INDIGO Aspiration System is designed to remove thrombus from the vasculature using continuous 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 use of the INDIGO Separator may not be necessary when using an INDIGO Aspiration Catheter with an I.D. of 0.054in [1.37mm] or larger. The INDIGO Aspiration Catheter is introduced through a guide catheter or long introducer 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 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. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Pump/Canister Tubing. The INDIGO Separator is provided with an introducer and torque device. The INDIGO Aspiration Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The INDIGO Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.
The Penumbra Pump MAX is the aspiration source for the INDIGO Aspiration System. The Penumbra Pump MAX operates using AC power and is designed to be portable if needed. The Penumbra Pump MAX provides vacuum of up to 29 inHz. The pump is available in both 110Vac and 230Vac versions. The front face of the Penumbra Pump MAX has a display panel with a vacuum gauge, suction regulating valve, and power switch. The Penumbra Pump MAX connects to the canister reservoir with a tubing assembly (Penumbra Pump/Canister Tubing), which is provided as an accessory. The Penumbra Pump/Canister Tubing consists of a short tubing segment with an inline filter and connectors on each end to facilitate attachment to the pump's vacuum port. The tubing is provided pre-attached to the canister reservoir lid. The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the peripheral arterial and venous systems. Not for use in the coronaries or the neurovasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians who have received appropriate training in interventional radiology.
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)
Packaging Validation Testing:
Simulated Use (Vessel Access Entry Performance & Clot Removal) was performed. "Simulated use testing of the Catheter and Separator was performed with accessory devices in an anatomical model which simulated the tortuosity of the vasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Catheter does not collapse under vacuum." The results were 100% Pass.
Catheter Coating: "Coating has not delaminated, peeled, or flaked after simulated use." The result was 100% Pass.
Gross Leak: "Pouch seals, pouch front, and pouch back material do not leak." The result was 100% Pass.
The KIT configuration met all established requirements. The results of the tests appropriately address the physical and mechanical performance expectations of the KIT configuration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure in profile, with three faces overlapping to symbolize health, human services, and the relationship between them. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2016
Penumbra. Inc. Mr. Richard Kimura Regulatory Affairs Specialist One Penumbra Place Alameda, CA 94502
Re: K160533
Trade/Device Name: Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: April 25, 2016 Received: April 29, 2016
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 (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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) K160533
Device Name
Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System)
Indications for Use (Describe)
INDIGO Aspiration Catheters and Separators:
As part of the Penumbra Embolectomy Aspiration System (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. Not for use in the coronaries or the neurovasculature.
INDIGO Aspiration Tubing:
As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX:
The Penumbra Pump MAX is indicated as a vacuum source for the Penumbra Aspiration Systems.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary 1
(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 Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda. CA 94502 USA
1.2 Sponsor Contact Information
Richard Kimura Regulatory Affairs Specialist Phone: (510) 995-2034 FAX: (510) 217-6414 Email: rkimura@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
May 19, 2016
1.4 Device Trade or Proprietary Name
Penumbra Embolectomy Aspiration System (INDIGOTM 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 and Reference Devices
| 510(k) Number/
Clearance Date | Name of Device | Name of
Manufacturer |
|----------------------------------|------------------------------------------------------------------------|-------------------------|
| Predicate Device | | |
| K142870[26May2015] | Penumbra Embolectomy Aspiration System
(INDIGOTM Aspiration System) | Penumbra, Inc. |
| Reference Devices | | |
| K121917[19Sep2012] | Penumbra Embolectomy Aspiration System
(INDIGOTM Aspiration System) | Penumbra, Inc. |
| K122756[02Oct2012] | Penumbra Pump MAX | Penumbra, Inc. |
4
1.7 Predicate Comparison
| Predicate Device | Subject Device | |
|---|---|---|
| Trade Name | Penumbra Embolectomy Aspiration | |
| System (INDIGO™ Aspiration | ||
| System) | Penumbra Embolectomy Aspiration | |
| System (INDIGO™ Aspiration | ||
| System) (including Penumbra Pump | ||
| MAX) | ||
| Predicate 510(k) No. | INDIGO Aspiration System : K142870 | K160533 |
| Reference 510(k) No. | INDIGO Aspiration System: K121917 | |
| Penumbra Pump MAX: K122756 | ||
| Classification | INDIGO Aspiration System: Class II, | |
| DXE | ||
| Penumbra Pump MAX: Class II, JCX | Class II, DXE | |
| Indication for Use | INDIGO™ Aspiration System | |
| The 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. |
Penumbra Aspiration Pump
The Penumbra Pump MAX is intended
for general suction use in hospitals or
clinics. | INDIGO Aspiration Catheters and
Separators
As part of the Penumbra
Embolectomy Aspiration System
(INDIGOTM 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. Not for use in the coronaries
or the neurovasculature.
INDIGO Aspiration Tubing
As part of the Penumbra
Embolectomy Aspiration System
(INDIGOTM Aspiration System), the
INDIGO Sterile Aspiration Tubing is
indicated to connect the INDIGO
Aspiration Catheters to the Penumbra
Pump MAX.
Penumbra Pump MAX
The Penumbra Pump MAX is
indicated as a vacuum source for
Penumbra Aspiration Systems. |
| Aspiration Catheter | | |
| Materials | Biocompatible, commonly utilized for
interventional devices | SAME |
| Coating | Hydrophilic | SAME |
| Markerband | Radiopaque | SAME |
| Guidewire compatible | Yes | SAME |
| Dimensions | | |
| - OD [Maximum] | 0.051" - 0.080"
[1.295mm - 2.030mm] | SAME |
| - Working Length | 125cm - 153cm | SAME |
| Separator | | |
| | Predicate Device | Subject Device |
| Trade Name | Penumbra Embolectomy Aspiration
System (INDIGO™ Aspiration
System) | Penumbra Embolectomy Aspiration
System (INDIGO™ Aspiration
System) (including Penumbra Pump
MAX) |
| Predicate 510(k) No. | INDIGO Aspiration System : K142870 | K160533 |
| Reference 510(k) No. | INDIGO Aspiration System: K121917
Penumbra Pump MAX: K122756 | |
| Classification | INDIGO Aspiration System: Class II,
DXE
Penumbra Pump MAX: Class II, JCX | Class II, DXE |
| Materials | Biocompatible, commonly utilized for
interventional devices | SAME |
| Dimensions | | |
| - Distal OD | 0.022" – 0.045"
[0.56mm – 1.14mm] | SAME |
| - Working Length | 135cm – 155cm | SAME |
| Aspiration Tubing | | |
| Materials | Biocompatible, commonly utilized for
interventional devices | SAME |
| Dimensions | | |
| - ID | 0.071" – 0.110 " [1.8mm – 2.8mm] | SAME |
| - Length | 112.0" [284.5cm] | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36-Months | SAME |
| Aspiration Pump | | |
| IEC 60601-1
Compliance | Yes | SAME |
| IEC 60601-1-2
Compliance | Yes | SAME |
| Voltage | 100-115 Vac/230 Vac | SAME |
| Frequency | 50 Hz/60 Hz | SAME |
| Sterilization | Non sterile | SAME |
| Shelf Life | N/A | SAME |
5
Device Description 1.8
The Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)
The Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System) is intended for the removal of fresh, soft emboli and thrombi from vessels of the arterial and venous systems. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for the Aspiration
6
Catheters with Aspiration Tubing is available. Intended users for this device are physicians who have received appropriate training in interventional radiology.
The INDIGO Aspiration System is designed to remove thrombus from the vasculature using continuous 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 use of the INDIGO Separator may not be necessary when using an INDIGO Aspiration Catheter with an I.D. of 0.054in [1.37mm] or larger. The INDIGO Aspiration Catheter is introduced through a guide catheter or long introducer 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 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. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Pump/Canister Tubing. The INDIGO Separator is provided with an introducer and torque device. The INDIGO Aspiration Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The INDIGO Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy.
The Penumbra Pump MAX
The Penumbra Pump MAX is the aspiration source for the INDIGO Aspiration System. The Penumbra Pump MAX operates using AC power and is designed to be portable if needed. The Penumbra Pump MAX provides vacuum of up to 29 inHz. The pump is available in both 110Vac and 230Vac versions.
The front face of the Penumbra Pump MAX has a display panel with a vacuum gauge, suction regulating valve, and power switch. The Penumbra Pump MAX connects to the canister reservoir with a tubing assembly (Penumbra Pump/Canister Tubing), which is provided as an accessory. The Penumbra Pump/Canister Tubing consists of a short tubing segment with an inline filter and connectors on each end to facilitate attachment to the pump's vacuum port. The tubing is provided pre-attached to the canister reservoir lid.
7
The Penumbra Pump/Canister Tubing is provided non-sterile and is used outside the sterile field.
Indications for Use 1.9
INDIGO Aspiration Catheters and Separators
As part of the Penumbra Embolectomy Aspiration System (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. Not for use in the coronaries or the neurovasculature.
INDIGO Aspiration Tubing
As part of the Penumbra Embolectomy Aspiration System (INDIGO™ Aspiration System), the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Pump MAX.
Penumbra Pump MAX
The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
1.10 Leveraged Non-Clinical Data - Individual Packaged Devices
The subject and predicate devices are identical. There are no changes in the device design, materials, manufacturing, packaging and sterilization methods. Therefore, biocompatibility data, bench top data, sterilization data, and stability data from previous pre-market notifications listed in Section 1.6 are directly applicable and no additional testing was required or was performed to support the consolidation of the INDIGO Aspiration System and Penumbra Pump MAX under the same product code (DXE), clarifications of the Indications for Use statements, and Instructions for Use (IFU) and Operation, Maintenance, and Service Manual revisions.
1.11 Non-Clinical Data – KIT Configuration
Included in this section is a brief summary of additional testing performed for the KIT configuration packaging:
- . Packaging Validation Testing
The KIT configuration met all established requirements.
8
1.11.1 Packaging Validation
The physical and mechanical properties of the KIT configuration were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
| Attribute | Specification | Acceptance Criteria | Results |
|---|---|---|---|
| Visual Inspection | These evaluations confirm that the units used in this Design Verification testing meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass | |
| Simulated Use | |||
| (Vessel Access Entry | |||
| Performance & | |||
| Clot Removal) | Simulated use testing of the Catheter and Separator was performed with accessory devices in an anatomical model which simulated the tortuosity of the vasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Catheter does not collapse under vacuum. | 100% Pass | |
| Catheter Coating | Coating has not delaminated, peeled, or flaked after simulated use. | 100% Pass | |
| Gross Leak | Pouch seals, pouch front, and pouch back material do not leak. | 100% Pass |
The results of the tests appropriately address the physical and mechanical performance expectations of the KIT configuration. Based on these overall results, the physical and mechanical properties of the KIT configuration devices are acceptable for the intended use and substantially equivalent to the predicate device.
1.12 Leveraged Animal Study – Individual Packaged Devices and KIT Configuration
The subject and predicate devices are identical. Therefore, Animal Testing data from previous pre-market notifications listed in Section 1.6 are directly applicable and no further Animal Testing was required or was performed to support the consolidation of the INDIGO Aspiration System and Penumbra Pump MAX under the same product code (DXE), clarifications in the Indications for Use statements, and IFU and Operation, Maintenance, and Service Manual revisions.
1.13 Summary of Substantial Equivalence
The subject INDIGO Aspiration System is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelflife, packaging and sterilization processes.