(117 days)
No
The description focuses on mechanical aspiration and vacuum technology, with no mention of AI or ML capabilities.
Yes
The device is indicated for "the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature," which is a direct therapeutic intervention.
No
Explanation: The device is indicated for the "removal of fresh, soft emboli and thrombi" and is described as a "continuous aspiration" system to remove thrombus. This indicates a therapeutic function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including catheters, separators, tubing, and a pump, all of which are integral to the device's function.
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 Penumbra Aspiration System is designed to physically remove emboli and thrombi directly from blood vessels within the body. It is an interventional device used during a medical procedure.
- Intended Use: The intended use clearly states the removal of material from vessels in the coronary and peripheral vasculature, which is an in-vivo (within the living body) procedure.
- Device Description: The description details a system for aspiration within the body, including catheters, separators, and a pump to create vacuum for removal.
The device operates directly on the patient's vasculature, not on a specimen taken from the patient. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Penumbra Aspiration Catheters and Separators: As part of the Penumbra Aspiration System, the Penumbra Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Penumbra Aspiration Tubing: As part of the Penumbra Aspiration System, the Penumbra Sterile Aspiration Tubing is indicated to connect the 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 Penumbra Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the coronary and peripheral vasculature. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional radiology.
The Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the 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 0.054 in or larger. The Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The Aspiration Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As needed, the 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 Penumbra Pump MAX, which is connected using the Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Separator is provided with an introducer and torque device. The Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheter and Separator are visible under fluoroscopy.
The Penumbra Pump MAX is the aspiration source for the Penumbra 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 inHg. The pump is available in both 110Vac and 230Vac versions. The front face of the pump has a display panel with a vacuum gauge, vacuum regulator dial, and power switch. The pump 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
Fluoroscopy
Anatomical Site
coronary and peripheral vasculature
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)
Bench top testing was performed on the reference Penumbra System and INDIGO System devices, which are identical to the subject device. Tests included: Friction Test, Visual & Dimensional, Pouch Seal Strength, Flow Rate Test, Tensile Test, Elongation Test, Bond Strength, Hub Air Aspiration, Torsion Test, Burst Test, Simulated Use Test, Particulate Test, Flexibility Test, Packaging Test, and Corrosion Test. All established requirements and acceptance criteria were met.
Design Validation (GLP Animal Testing) was conducted on the reference Penumbra System and INDIGO System, with the following concluded results:
- No vessel injury was noted on the final angiograms following the vessel response procedure.
- No abnormal gross or histology findings were noted in test vessel segments.
- The use of the devices resulted in no significant vascular response in these experimental conditions.
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.
K072718, K090752, K100769, K113163, K151623, K160449, K121917, K142870, K160533, K122756
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2016
Penumbra, Inc. Richard Kimura Regulatory Affairs Specialist 1 Penumbra Place Alameda, California 94502
Re: K161506
Trade/Device Name: Penumbra Aspiration System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: August 23, 2016 Received: August 24, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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,
Brian D. Pullin -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) K161506
Device Name Penumbra Aspiration System
Indications for Use (Describe)
Penumbra Aspiration Catheters and Separators
As part of the Penumbra Aspiration System, the Penumbra Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Penumbra Aspiration Tubing
As part of the Penumbra Aspiration System, the Penumbra Sterile Aspiration Tubing is indicated to connect the 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Yes |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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 Penumbra 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 31, 2016
1.4 Device Trade or Proprietary Name
Penumbra Aspiration System
Device Classification 1.5
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 | | |
| K103405[22Dec2010] | Pronto V4 Extraction Catheter | Vascular Solutions, Inc. |
| Reference Devices | | |
| K072718 [28Dec2007] | Penumbra System [026, 032, 041] | Penumbra, Inc. |
| K090752 [21Sep2009] | Penumbra System [054] | Penumbra, Inc. |
| K100769 [21May2010] | Penumbra System Separator Flex [026, 032, | Penumbra, Inc. |
4
| 510(k) Number/
Clearance Date | Name of Device | Name of
Manufacturer |
|----------------------------------|----------------------------------------------------------------------|-------------------------|
| | [041, 054] | |
| K113163 [23Nov2011] | Penumbra System MAX | Penumbra, Inc. |
| K151623 [06Aug2015] | Penumbra System 110 Aspiration Tubing | Penumbra, Inc. |
| K160449 [25May2016] | Penumbra System | Penumbra, Inc. |
| K121917 [19Sep2012] | Penumbra Embolectomy Aspiration System
(INDIGO Aspiration System) | Penumbra, Inc. |
| K142870 [26May2015] | Penumbra Embolectomy Aspiration System
(INDIGO Aspiration System) | Penumbra, Inc. |
| K160533 [24May2016] | Penumbra Embolectomy Aspiration System
(INDIGO Aspiration System) | Penumbra, Inc. |
| K122756 [02Oct2012] | Penumbra Pump MAX | Penumbra, Inc. |
5
Predicate and Reference Device Comparisor 1.7
| Trade Name | Predicate Device | 510(k) No. | Classification | Indication for Use | Reference Devices | Subject Device |
|---|---|---|---|---|---|---|
| Pronto V4 Extraction | ||||||
| Catheter | K103405 | Class II, DXE | The Pronto Catheter is | |||
| indicated for the removal of | ||||||
| fresh, soft emboli and | ||||||
| thrombi from vessels in the | ||||||
| coronary and peripheral | ||||||
| vasculature. | ||||||
| INDIGO Aspiration System | K072718, K090752, K100769, | |||||
| K113163, K151623, K122756, and | ||||||
| K160449 | K121917, K142870, and K160533 | Penumbra Aspiration System | ||||
| SAME | SAME | To be determined | ||||
| Penumbra Reperfusion Catheters | ||||||
| and Separators | ||||||
| As part of the Penumbra System, the | ||||||
| Reperfusion Catheters and | ||||||
| Separators are indicated for the use | ||||||
| in the revascularization of patients | ||||||
| with acute ischemic stroke | ||||||
| secondary to intracranial large | ||||||
| vessel occlusive disease (within the | ||||||
| internal carotid, middle cerebral – | ||||||
| M1 and M2 segments, basilar, and | ||||||
| vertebral arteries) within 8 hours of | ||||||
| symptom onset. | 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. | Penumbra Aspiration Catheters | |||||
| and Separators | ||||||
| As part of the Penumbra | ||||||
| Aspiration System, the Penumbra | ||||||
| Aspiration Catheters and | ||||||
| Separators are indicated for the | ||||||
| removal of fresh, soft emboli and | ||||||
| thrombi from vessels in the | ||||||
| coronary and peripheral | ||||||
| vasculature. | ||||||
| Penumbra Aspiration Tubing | ||||||
| As part of the Penumbra System, the | ||||||
| Penumbra Sterile Aspiration Tubing | ||||||
| is indicated to connect the Penumbra | ||||||
| Reperfusion Catheters to the | ||||||
| Penumbra Pump MAX. | 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 Aspiration Tubing | |||||
| As part of the Penumbra | ||||||
| Aspiration System, the Penumbra | ||||||
| Sterile Aspiration Tubing is | ||||||
| indicated to connect the | ||||||
| Penumbra Aspiration Catheters | ||||||
| to the Penumbra Aspiration | ||||||
| Pump. | ||||||
| Penumbra Pump MAX | ||||||
| The Penumbra Pump MAX is | ||||||
| indicated as a vacuum source for | ||||||
| Penumbra Aspiration Systems. | Penumbra Pump MAX | |||||
| The Penumbra Pump MAX is | ||||||
| indicated as a vacuum source for | ||||||
| Penumbra Aspiration Systems. | Penumbra Aspiration Pump | |||||
| The Penumbra Aspiration Pump | ||||||
| is indicated as a vacuum source | ||||||
| for Penumbra Aspiration | ||||||
| Systems. |
6
| રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દ | |
|---|---|
| l | |
| 9 | |
| l | |
| X | |
| Predicate Device | Reference Devices | Subject Device | ||
|---|---|---|---|---|
| Trade Name | Pronto V4 Extraction | |||
| Catheter | Penumbra System | Penumbra Aspiration System | ||
| 510(k) No. | K103405 | K072718, K090752, K100769, | ||
| K113163, K151623, K122756, and | ||||
| K160449 | K121917, K142870, and K160533 | To be determined | ||
| Classification | Class II, DXE | SAME | SAME | SAME |
| Aspiration Catheter | ||||
| Materials | Biocompatible, commonly | |||
| utilized for interventional | ||||
| devices | SAME | SAME | SAME | |
| Coating | Hydrophilic | SAME | SAME | SAME |
| Markerband | Radiopaque | SAME | SAME | SAME |
| Guidewire | ||||
| Compatible | Yes | SAME | SAME | SAME |
| Dimensions | ||||
| OD [Maximum] | 0.0645" - 0.0865" | |||
| (1.64 – 2.20 mm) | 0.037" - 0.083" | |||
| (0.94mm – 2.1mm) | 0.037" - 0.112" | |||
| (0.94mm – 2.84mm) | SAME AS THE INDIGO | |||
| SYSTEM | ||||
| Working Length | Approximately 138 cm | 118m – 153cm | 30cm – 153cm | SAME AS THE INDIGO |
| SYSTEM | ||||
| Separator | ||||
| Materials | N/A | Biocompatible, commonly utilized | ||
| for interventional devices | Biocompatible, commonly utilized | |||
| for interventional devices | Biocompatible, commonly | |||
| utilized for interventional devices | ||||
| Dimensions | ||||
| Distal OD | N/A | 0.022" – 0.045" | ||
| (0.56mm – 1.1mm) | 0.022" – 0.068" | |||
| (0.56mm – 1.7mm) | SAME AS THE INDIGO | |||
| SYSTEM | ||||
| Working Length | N/A | 175cm – 200cm | 150cm – 200cm | SAME AS THE INDIGO |
| SYSTEM | ||||
| Aspiration Tubing | ||||
| Materials | Biocompatible, commonly | |||
| utilized for interventional | ||||
| devices | SAME | SAME | SAME | |
| Dimensions |
7
| રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દ |
|---|
| l |
| 9 |
| l |
| X |
| Predicate Device | Reference Devices | Subject Device | |
|---|---|---|---|
| Trade Name | Pronto V4 Extraction | ||
| Catheter | Penumbra System | Penumbra Aspiration System | |
| 510(k) No. | K103405 | K072718, K090752, K100769, | |
| K113163, K151623, K122756, and | |||
| K160449 | K121917, K142870, and K160533 | ||
| Classification | Class II, DXE | SAME | To be determined |
| ID | unknown | 0.071" – 0.110 " | |
| (1.8mm – 2.79mm) | 0.088" and 0.110 " | ||
| (2.2mm and 2.79mm) | |||
| Length | unknown | 112.0" (284.5cm) | 112.0" (284.5cm) |
| Sterilization | EO | SAME | SAME |
| Shelf-Life | 36 months | SAME | SAME |
| Aspiration Source | Aspiration Syringe | Aspiration Pump | Aspiration Pump |
| EC 60601-1 | |||
| Compliance | N/A | Yes | Yes |
| EC 60601-1-2 | |||
| Compliance | N/A | Yes | Yes |
| Voltage | N/A | 100-115 Vac/230 Vac | 100-115 Vac/230 Vac |
| Frequency | N/A | 50 Hz/60 Hz | 50 Hz/60 Hz |
| Sterilization | unknown | Non sterile | Non sterile |
| Shelf Life | unknown | N/A | N/A |
8
Device Description 1.8
The Penumbra Aspiration System
The Penumbra Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the coronary and peripheral vasculature. The Aspiration Catheter and Separator are available in multiple configurations. The devices are provided sterile, non-pyrogenic, and intended for single use only. Intended users for this device are physicians who have received appropriate training in interventional radiology.
The Penumbra Aspiration System is designed to remove thrombus from the coronary and peripheral vasculature using continuous aspiration. The Aspiration Catheter targets aspiration from the 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 0.054 in or larger. The Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The Aspiration Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As needed, the 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 Penumbra Pump MAX, which is connected using the Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Separator is provided with an introducer and torque device. The Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, and a peelable sheath. The Separator is provided with an introducer and torque device. The Aspiration Catheter and Separator are visible under fluoroscopy.
The Penumbra Pump MAX
The Penumbra Pump MAX is the aspiration source for the Penumbra 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 inHg. The pump is available in both 110Vac and 230Vac versions.
9
The front face of the pump has a display panel with a vacuum gauge, vacuum regulator dial, and power switch. The pump 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.
1.9 Indications for Use
Penumbra Aspiration Catheters and Separators
As part of the Penumbra Aspiration System, the Penumbra Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the coronary and peripheral vasculature.
Penumbra Aspiration Tubing
As part of the Penumbra Aspiration System, the Penumbra Sterile Aspiration Tubing is indicated to connect the 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 Leveraged Non-Clinical Data
The subject Penumbra Aspiration System devices are identical to the reference Penumbra System and INDIGO System devices. All bench top testing conducted on the reference Penumbra System and INDIGO System devices to evaluate the physical and mechanical properties of the system are therefore applicable to the subject Penumbra Aspiration System. The following bench top tests were performed and all established requirements and acceptance criteria were met:
- Friction Test . Visual & Dimensional ●
- Pouch Seal Strength .
- Flow Rate Test .
- Tensile Test Elongation Test o .
10
- Bond Strength ●
- . Hub Air Aspiration . Torsion Test
- Burst Test Simulated Use Test ● .
- . Particulate Test . Flexibility Test
- . Packaging Test
In addition, the Penumbra Aspiration System devices are manufactured using identical materials, and utilize the same manufacturing, packaging, and sterilization methods as the reference Penumbra System and INDIGO System devices. Therefore, biocompatibility 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 Penumbra Aspiration System.
Corrosion Test
●
1.11 Leveraged Animal Studies
The subject Penumbra Aspiration System is identical to the reference Penumbra System and reference INDIGO System. Design Validation (GLP Animal Testing) was conducted on the reference Penumbra System and INDIGO System, the results are which are also applicable to the subject Penumbra Aspiration System. 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 Penumbra Aspiration System.
The studies concluded that:
- No vessel injury was noted on the final angiograms following the vessel response o procedure.
- No abnormal gross or histology findings were noted in test vessel segments. .
- The use of the devices resulted in no significant vascular response in these o experimental conditions.
11
1.12 Summary of Substantial Equivalence
The subject Penumbra Aspiration System is substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelflife, packaging and sterilization processes.