(29 days)
No
The document describes a mechanical aspiration system for removing blood clots and does not mention any AI or ML components.
Yes
The device is indicated for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," which is a treatment for a medical condition.
No
The Penumbra System components are indicated for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease" and described as "intended for the removal of thrombus from the neuro vasculature using continuous aspiration." This indicates a therapeutic, not diagnostic, purpose.
No
The device description clearly outlines multiple hardware components including catheters, separators, tubing, and a pump, all of which are integral to the system's function.
Based on the provided information, 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 Penumbra System, including the Reperfusion Catheters, Separators, 3D Revascularization Device, Aspiration Tubing, and Aspiration Pump, is designed for the mechanical removal of thrombus (blood clots) from blood vessels in the brain. This is a therapeutic intervention performed directly on the patient's vasculature.
- Intended Use: The intended use clearly states "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease." This describes a treatment procedure, not a diagnostic test performed on a sample.
- Device Description: The description details the physical components and how they are used to aspirate and remove thrombus from within the blood vessels.
- Lack of Sample Analysis: There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
The Penumbra System is a medical device used for a therapeutic procedure, not for in vitro diagnostic testing.
N/A
# Intended Use / Indications for Use
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA ) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
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 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)
NRY
# Device Description
The Penumbra System is intended for the removal of thrombus from the neuro vasculature using continuous aspiration. Intended users for this device are physicians who have received appropriate training in interventional neuroradiology and the treatment of acute ischemic stroke.
The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an I.D. of 0.054in or largerfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under fluoroscopy.
The Penumbra Aspiration Tubing connects the Penumbra Aspiration Pump Canister to the Penumbra Reperfusion 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 PST1, 0.088 in [2.24mm] for PST2, and 0.110 in [2.79mm] for PST3 and PST4. The Aspiration Tubing is designed and composed of materials which are commonly used in interventional devices. The Modified 110 Aspiration Tubing (PST4) is the subject device for this submission ([K182522](https://510k.innolitics.com/search/K182522)).
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries)
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
physicians who have received appropriate training in interventional neuroradiology and the treatment of acute ischemic stroke.
# 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)
Non-Clinical Data Summary:
- Biocompatibility: Performed on the modified 110 Aspiration Tubing in accordance with EN ISO 10993-1 guidelines for limited exposure (
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
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October 12, 2018
Penumbra, Inc. Micaela Victoria Regulatory Affairs Specialist II One Penumbra Place Alameda, California 94502
Re: K182522
Trade/Device Name: Penumbra System (Modified 110 Aspiration Tubing) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: September 11, 2018 Received: September 13, 2018
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
Xiaolin Zheng -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182522
Device Name Penumbra System (Modified 110 Aspiration Tubing)
Indications for Use (Describe)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA ) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
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 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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510(k) Summary - K182522 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 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
Micaela Victoria Regulatory Affairs Specialist II Phone: (510) 995-2082 FAX: (510) 217-6414 Email: mvictoria@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
October 09, 2018
1.4 Device Trade or Proprietary Name
Penumbra System® (Modified 110 Aspiration Tubing)
1.5 Device Classification
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Neurology |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR §870.1250 |
| Product Code: | NRY |
1.6 Predicate and Reference Devices
| 510(k) Number / Clearance Date | Name of Device | Name of Manufacturer |
|---|---|---|
| Predicate Device | ||
| K151623 cleared on August 6, 2015 | Penumbra System – 110 Aspiration Tubing | Penumbra, Inc. |
| One Penumbra Place | ||
| Alameda, CA 94502 USA | ||
| Additional Predicate Devices | ||
| K162901 cleared on April 20, 2017 | Penumbra System - 3D Revascularization Device | Penumbra, Inc. |
| One Penumbra Place | ||
| Alameda, CA 94502 USA | ||
| K173761 cleared on August 17, 2018 | Penumbra System – Reperfusion Catheter JET 7 |
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Image /page/4/Picture/0 description: The image shows the Penumbra company 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 logo is simple and modern.
| Reference Device | ||
|---|---|---|
| K180939 cleared on May, 3, 2018 | Indigo Aspiration System – Advanced 110 | |
| Aspiration Tubing | Penumbra, Inc. | |
| One Penumbra Place | ||
| Alameda, CA 94502 USA |
1.7 Predicate Comparison
| Predicate Device | Subject Device1 | ||
|---|---|---|---|
| Trade Name | Penumbra System | SAME | |
| 510(k) No. | K151623 [Primary Predicate] | K182522 | |
| Classification | Class II, NRY | SAME | |
| Indication for Use | The Penumbra System / Penumbra System | ||
| MAX are intended for 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. | |||
| The Penumbra System is intended for 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. The | |||
| Reperfusion Catheters ACE 64 and ACE 68 | Penumbra Reperfusion Catheters and | ||
| Separators | |||
| As part of the Penumbra System, the | |||
| Reperfusion Catheters and Separators are | |||
| indicated for 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. | |||
| Patients who are ineligible for | |||
| intravenous tissue plasminogen activator | |||
| (IV t-PA) or who fail IV t-PA therapy are | |||
| candidates for treatment. | |||
| are intended for use in revascularization | |||
| within the Internal Carotid Artery (ICA) | |||
| within 8 hours of symptom onset. | Penumbra 3D Revascularization Device | ||
| As part of the Penumbra System, the | |||
| Penumbra 3D Revascularization Device | |||
| is indicated for 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) within 8 hours of | |||
| symptom onset. Patients who are | |||
| ineligible for intravenous tissue | |||
| plasminogen activator (IV t-PA) or who | |||
| fail IV t-PA therapy are candidates for | |||
| treatment. | |||
| Penumbra Aspiration Tubing | |||
| As part of the Penumbra System, the | |||
| Penumbra Sterile Aspiration Tubing is | |||
| indicated to connect the Penumbra | |||
| Predicate Device | Subject Device1 | ||
| Trade Name | Penumbra System | SAME | |
| 510(k) No. | K151623 [Primary Predicate] | K182522 | |
| Classification | Class II, NRY | SAME | |
| Reperfusion Catheters to the Penumbra | |||
| Aspiration Pump. | |||
| Penumbra Aspiration Pump | |||
| The Penumbra Aspiration Pump is | |||
| indicated as a vacuum source for | |||
| Penumbra Aspiration Systems. | |||
| 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 | |||
| Tubing Material | Polyurethane & Nylon | SAME | |
| Rotating Male | |||
| Luer | Polycarbonate with EPDM OR Silicone O- | ||
| Ring | SAME | ||
| Tubing/Luer Joint | |||
| Adhesive | Cyclohexanone | SAME | |
| Female Luer | Polycarbonate | N/A | |
| Suction Connector | |||
| Material | Polyvinylchloride (PVC) | SAME | |
| Tubing/Suction | |||
| Connector Joint | |||
| Adhesive | Loctite | Cyclohexanone | |
| Flow Control | |||
| Switch Body | |||
| Material | Polycarbonate | SAME | |
| Flow Control | |||
| Switch Slider | |||
| Material | Acetal | Acetal | |
| Flow Control | |||
| Switch Slider | |||
| Material Pin | Acetal | Nylon | |
| Collar | ABS | N/A | |
| Valve | Silicone | N/A | |
| "ON" Logo | Polyolefin | Heat Stamp Foil | |
| "OFF" Logo | Polyolefin | Heat Stamp Foil | |
| Predicate Device | Subject Device1 | ||
| Trade Name | Penumbra System | SAME | |
| 510(k) No. | K151623 [Primary Predicate] | K182522 | |
| Classification | Class II, NRY | SAME | |
| Packaging | |||
| Materials | Pouch | Polyester/Polyethylene/Tyvek® | Nylon/ADH/HDPE/Tyvek® |
| Display | |||
| Box | SBS Paperboard | SAME | |
| Label Stock | Label stock | SAME | |
| Sterilization | EO | SAME | |
| Shelf Life | 36 months | SAME |
l The Penumbra System Reperfusion Catheters, Separators, and Aspiration Pumps are unchanged and remain identical to those of the currently cleared Penumbra System (K162901, K173761, and K180008,).
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Image /page/6/Picture/0 description: The image shows the logo for Penumbra, Inc., a healthcare company. 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 of it. The logo is simple and modern, and the red color is eye-catching.
Device Description 1.8 -
The Penumbra System is intended for the removal of thrombus from the neuro vasculature using continuous aspiration. Intended users for this device are physicians who have received appropriate training in interventional neuroradiology and the treatment of acute ischemic stroke.
The Penumbra System is designed to remove thrombus from the vasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. The 3D Revascularization Device is used with Reperfusion Catheters to facilitate aspiration and removal of the thrombus when needed. The Separator may be used to clear the lumen of the Reperfusion Catheter should it become blocked with thrombus. The use of the Separator may not be necessary when using a Reperfusion Catheter with an I.D. of 0.054in or largerfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the primary occlusion. The Penumbra Reperfusion Catheter is used with the Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, a Penumbra Separator may be deployed from the Reperfusion Catheter to assist with thrombus removal. The Penumbra Separator is advanced and retracted through the Penumbra Reperfusion Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the Reperfusion Catheter tip. For the aspiration source, the Penumbra Reperfusion Catheter is used in conjunction with the Aspiration Pump, which is connected using the Penumbra Aspiration Tubing and the Penumbra Pump/Canister Tubing. The Penumbra Reperfusion Catheter is provided with a steam shaping mandrel and rotating hemostasis valve, and a peelable sheath. The Penumbra 3D Revascularization Device is provided with an introducer sheath. The Penumbra Separator is provided with an introducer and torque device. The Penumbra Reperfusion Catheters, 3D Revascularization Device and Separators are visible under
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Image /page/7/Picture/0 description: The image shows the Penumbra company logo. The logo consists of the word "Penumbra" in a red, sans-serif font, followed by a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the left side of the letter to the edge of the circle.
fluoroscopy.
The Penumbra Aspiration Tubing connects the Penumbra Aspiration Pump Canister to the Penumbra Reperfusion 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 PST1, 0.088 in [2.24mm] for PST2, and 0.110 in [2.79mm] for PST3 and PST4. The Aspiration Tubing is designed and composed of materials which are commonly used in interventional devices. The Modified 110 Aspiration Tubing (PST4) is the subject device for this submission (K182522).
1.9 Indications for Use
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for 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. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Penumbra 3D Revascularization Device
As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for 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) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
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 Aspiration Pump.
Penumbra Aspiration Pump
The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.
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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 Penumbra System with modified 110 Aspiration Tubing as well as its substantial equivalence to the predicate device:
- Biocompatibility .
- Design Verification (Bench-Top Testing) ●
- Shelf Life ●
- Sterilization ●
- Packaging ●
The subject Penumbra System with modified 110 Aspiration Tubing met all established requirements.
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