(29 days)
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.
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).
The provided text describes the acceptance criteria and the study for the Penumbra System (Modified 110 Aspiration Tubing), regulated under K182522.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Subject | Attribute | Acceptance Criteria | Reported Device Performance | Pass / Fail |
|---|---|---|---|---|
| Biocompatibility | ||||
| Cytotoxicity (MEM Elution) | Cell lysis grade | Sample extracts must yield a cell lysis grade of 2 or lower | Grade 2: Mild | Pass |
| Sensitization | Test Group score on Magnusson and Kligman scale (provided Control Grade < 1) | Test Group shall yield Grade < 1 score | Grade 0: No visible change | Pass |
| Irritation (Intracutaneous) | Difference in the mean test article and mean control score | The difference in the mean test article and mean control score must be grade 1.0 or lower | Grade 0.0 difference (saline extract) and Grade 0.1 difference (sesame oil extract) | Pass |
| Bench-top Testing | ||||
| Dimensional/Visual Inspection | Conformance to dimensional and visual specifications | 100% Must meet Specification | Pass | Pass |
| Suction Connector/Canister Lid Compatibility | Secure attachment of Suction Connector to Pump Canister lid | 100% Must meet Specification | Pass | Pass |
| Rotating Luer/RHV Compatibility | Secure connection of Rotating Luer to RHV port | 100% Must meet Specification | Pass | Pass |
| Aspiration Tubing Lumen Ovalization under Vacuum | Maintenance of functionality and open lumen at vacuum pressure | 100% Must meet Specification | Pass | Pass |
| Aspiration Tubing Joint Leak under Vacuum | Maintenance of functionality with no leaks at vacuum pressure | 100% Must meet Specification | Pass | Pass |
| Flow Control Switch Function | Complete and immediate fluid flow cessation after specified ON/OFF cycles | 100% Must meet Specification | Pass | Pass |
| Penumbra Aspiration System Compatibility with Aspiration Catheter and Separator | Clot removal under minimum vacuum pressure | 100% Must meet Specification | Pass | Pass |
| Penumbra Aspiration System Compatibility with Aspiration Catheter | Clot removal under minimum vacuum pressure | 100% Must meet Specification | Pass | Pass |
| Suction Connector/Tubing Joint Tensile | Break force per product specification. | 100% Must meet Specification | Pass | Pass |
| Rotating Male Luer/Tubing Joint Tensile | Break force per product specification. | 100% Must meet Specification | Pass | Pass |
| Shelf Life | Device stability for 36 months | Demonstrated device stability for 36 months based on accelerated aging | The modified 110 Aspiration Tubing has demonstrated device stability for 36 months based on accelerated aging. | Pass |
| Sterilization | Sterility by EO, EO residual testing, Comparative Resistance Testing, Endotoxin (LAL) Testing | Met 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. | The modified 110 Aspiration Tubing has demonstrated sterility by EO in accordance with EN ISO 11135. All test samples met the specified acceptance criteria. | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state specific sample sizes for each test within the "Bench-top Testing" summary. However, it indicates that "All bench-top studies were conducted using good scientific practices and statistical sampling methods as required by the Penumbra Design Control procedures." The data provenance is not specified, but the context implies it is generated internally by Penumbra, Inc. (Alameda, CA, USA) as part of their design verification process. The studies are non-clinical (bench-top and laboratory tests).
For Biocompatibility, the studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices (GLP).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The studies described are non-clinical, involving laboratory and bench-top testing, and thus do not involve human expert interpretation for establishing ground truth in the way a medical imaging study might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The studies described are non-clinical, involving objective measurements and established laboratory procedures, which do not typically involve human adjudication for ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader, multi-case comparative effectiveness study was not done. The submission focuses on the modified aspiration tubing and its physical and mechanical properties, not on diagnostic performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. The device is a physical medical device (aspiration tubing), not a software or AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical studies:
- Biocompatibility: Ground truth was established by adherence to recognized standards (EN ISO 10993-1, EN ISO 10993-5, EN ISO 10993-10) and specific acceptance criteria determined by these standards and GLP.
- Bench-top Testing: Ground truth was based on pre-defined design specifications, risk analysis, and performance standards.
- Shelf Life & Sterilization: Ground truth was established by adherence to recognized standards (ASTM D4169, EN ISO 11135, EN ISO 10993-7, AAMI TIR 28, ANSI/AAMI ST72) and specific acceptance criteria.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for a machine learning model, no ground truth needed to be established for it.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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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
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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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Image /page/3/Picture/0 description: The image shows the word "Penumbra" in a red, sans-serif font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the right side of the "P" to the edge of the circle. The logo is simple and modern.
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 PlaceAlameda, CA 94502 USA |
| Additional Predicate Devices | ||
| K162901 cleared on April 20, 2017 | Penumbra System - 3D Revascularization Device | Penumbra, Inc.One Penumbra PlaceAlameda, CA 94502 USA |
| K173761 cleared on August 17, 2018 | Penumbra System – Reperfusion Catheter JET 7 |
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| Reference Device | ||
|---|---|---|
| K180939 cleared on May, 3, 2018 | Indigo Aspiration System – Advanced 110Aspiration Tubing | Penumbra, Inc.One Penumbra PlaceAlameda, 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 SystemMAX are intended for use in therevascularization of patients with acuteischemic stroke secondary to intracranial largevessel occlusive disease (within the internalcarotid, middle cerebral - M1 and M2segments, basilar, and vertebral arteries)within 8 hours of symptom onset.The Penumbra System is intended for use inthe revascularization of patients with acuteischemic stroke secondary to intracranial largevessel occlusive disease (within the internalcarotid, middle cerebral - M1 and M2segments, basilar, and vertebral arteries)within 8 hours of symptom onset. TheReperfusion Catheters ACE 64 and ACE 68 | Penumbra Reperfusion Catheters andSeparatorsAs part of the Penumbra System, theReperfusion Catheters and Separators areindicated for use in the revascularizationof patients with acute ischemic strokesecondary to intracranial large vesselocclusive disease (within the internalcarotid, middle cerebral - M1 and M2segments, basilar, and vertebral arteries)within 8 hours of symptom onset.Patients who are ineligible forintravenous tissue plasminogen activator(IV t-PA) or who fail IV t-PA therapy arecandidates for treatment. | |
| are intended for use in revascularizationwithin the Internal Carotid Artery (ICA)within 8 hours of symptom onset. | Penumbra 3D Revascularization DeviceAs part of the Penumbra System, thePenumbra 3D Revascularization Deviceis indicated for use in therevascularization of patients with acuteischemic stroke secondary to intracraniallarge vessel occlusive disease (within theinternal carotid, middle cerebral – M1and M2 segments) within 8 hours ofsymptom onset. Patients who areineligible for intravenous tissueplasminogen activator (IV t-PA) or whofail IV t-PA therapy are candidates fortreatment.Penumbra Aspiration TubingAs part of the Penumbra System, thePenumbra Sterile Aspiration Tubing isindicated 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 PenumbraAspiration Pump. | |||
| Penumbra Aspiration Pump | |||
| The Penumbra Aspiration Pump isindicated as a vacuum source forPenumbra Aspiration Systems. | |||
| Aspiration Tubing | |||
| Current 110 Aspiration Tubing | Modified 110 Aspiration Tubing | ||
| Tubing InnerDiameter (ID) | 0.110 in | SAME | |
| Tubing OuterDiameter (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 MaleLuer | Polycarbonate with EPDM OR Silicone O-Ring | SAME | |
| Tubing/Luer JointAdhesive | Cyclohexanone | SAME | |
| Female Luer | Polycarbonate | N/A | |
| Suction ConnectorMaterial | Polyvinylchloride (PVC) | SAME | |
| Tubing/SuctionConnector JointAdhesive | Loctite | Cyclohexanone | |
| Flow ControlSwitch BodyMaterial | Polycarbonate | SAME | |
| Flow ControlSwitch SliderMaterial | Acetal | Acetal | |
| Flow ControlSwitch SliderMaterial 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 | |
| PackagingMaterials | Pouch | Polyester/Polyethylene/Tyvek® | Nylon/ADH/HDPE/Tyvek® |
| DisplayBox | 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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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 acell lysis grade of 2 or lower | Grade 2: Mild | Pass |
| Sensitization / EN ISO10993-10 | Test Group shall yield Grade <1 score on Magnusson andKligman scale (providedControl Grade < 1) | Grade 0: No visible change | Pass |
| Irritation (IntracutaneousReactivity Irritation Test) /EN ISO 10993-10 | The difference in the mean testarticle and mean control scoremust be grade 1.0 or lower | Grade 0.0 difference (salineextract) and Grade 0.1difference (sesame oil extract) | Pass |
Summary of Biocompatibility Testing for Modified 110 Aspiration Tubing
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The Aspiration Tubing is classified as skin contact only and no contact (direct or indirect) with patient blood; there is no blood going back to the patient. All components of the Aspiration Tubing Assembly are categorized as limited exposure (≤24 hours), surface device, with skin contact. Please see table below for patient contact information for each component of the Aspiration Tubing.
The subject and predicate Penumbra System Reperfusion Catheters, Separators, and 3D Revascularization Device are identical. There are no changes to the materials and processes of the Penumbra System Reperfusion Catheters, Separators, 3D Revascularization Device, the biocompatibility data of which were reviewed and cleared under previous premarket notifications. Therefore, no additional biocompatibility testing is required or was performed for the Penumbra System Reperfusion Catheters, Separators and 3D Revascularization Device.
The Penumbra Aspiration Pumps (Pump MAX and Engine Pump) are non-sterile reusable capital equipment and their associated canisters are non-sterile, single use only. The pumps and canisters do not contact the patient, nor are they introduced into the sterile field. As such, biocompatibility testing is not required and was not performed for the Aspiration Pumps and canisters.
1.10.2 Design Verification (Bench-top Testing)
With the exception of the modified flow switch assembly and the single piece of continuous tubing, the modified 110 Aspiration Tubing will have the same specifications as the current 110 Aspiration Tubing. Bench-top testing was conducted to evaluate the physical and mechanical properties of the modified 110 Aspiration Tubing. All bench-top 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.
A summary of bench top testing performed on the modified 110 Aspiration Tubing is provided in the table below. The modified 110 Aspiration Tubing met all acceptance criteria and passed all tests.
Summary of Bench-Top Testing for Modified 110 Aspiration Tubing
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| Test/Test Subject | Attribute | Acceptance Criteria | Result |
|---|---|---|---|
| Dimensional/Visual Inspection | These evaluations confirm that the testunits used in Design Verificationtesting meet all dimensional and visualspecifications. | 100% Must meet Specification | Pass |
| SuctionConnector /Canister LidCompatibility | Suction Connector of AspirationTubing Assembly securely attaches toPump Canister lid via press fit. | 100% Must meet Specification | Pass |
| Rotating Luer/RHVCompatibility | Rotating Luer of Aspiration TubingAssembly securely connects to RHVport. | 100% Must meet Specification | Pass |
| AspirationTubing LumenOvalizationunder Vacuum | Aspiration Tubing Assembly maintainsfunctionality and maintains an openlumen at vacuum pressure per productspecification. | 100% Must meet Specification | Pass |
| AspirationTubing JointLeak underVacuum | Aspiration Tubing Assembly maintainsfunctionality with no leaks at vacuumpressure per product specification. | 100% Must meet Specification | Pass |
| Flow ControlSwitch Function | Flow Control Switch completely andimmediately stops fluid flow after aspecified number of ON/OFF cycles. | 100% Must meet Specification | Pass |
| PenumbraAspirationSystemCompatibilitywith AspirationCatheter andSeparator | The Aspiration Tubing Assembly iscompatible with Penumbra AspirationSystem (Clot can be removed underminimum vacuum pressure per productspecification). | 100% Must meet Specification | Pass |
| PenumbraAspirationSystemCompatibilitywith AspirationCatheter | The Aspiration Tubing Assembly iscompatible with Penumbra AspirationSystem (Clot can be removed underminimum vacuum pressure per productspecification). | 100% Must meet Specification | Pass |
| SuctionConnector /Tubing JointTensile | Break force per product specification. | 100% Must meet Specification | Pass |
| Rotating MaleLuer / TubingJoint Tensile | Break force per product specification. | 100% Must meet Specification | Pass |
1.10.3 Shelf Life
The modified 110 Aspiration Tubing has demonstrated device stability for 36 months based on accelerated aging and may be labelled with a 36 month shelf life. Test units were 2x
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EO-sterilized and underwent transportation conditioning per ASTM D4169, Distribution Cycle 3, Assurance Level 2.
The subject and predicate Penumbra System Reperfusion Catheters Separators, and 3D Revascularization Device are identical. Therefore, there are no changes to the previously determined stability of the Reperfusion Catheters, Separators, and 3D Revascularization Device, the data for which were reviewed and cleared under previous Penumbra System premarket notifications. No additional shelf life testing is required or was performed for the Penumbra System Reperfusion Catheters Separators, and 3D Revascularization Device.
The subject and predicate Penumbra Aspiration Pumps (Pump MAX and Engine Pump) and their associated canisters are identical. Furthermore, the Aspiration Pumps are nonsterile reusable capital equipment. Therefore, shelf life testing is not applicable to the Aspiration Pumps. Both the Pump MAX and Engine Pump have established a 500 hour minimum operating life based on completed testing, the data for which were reviewed and cleared under previous Penumbra System premarket notifications.
1.10.4 Sterilization
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.
The subject and predicate Penumbra System Reperfusion Catheters, Separators, and 3D Revascularization Device are identical. There are no changes to the previously provided sterilization data of these devices, which were reviewed and cleared under previous Penumbra System premarket notifications. No additional sterilization testing is required or was performed for these devices.
Sterilization testing is not applicable to the Penumbra Aspiration Pumps (Pump MAX/Canister Tubing and Engine Pump/Canister). Both are supplied non-sterile and are not intended to be sterilized.
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1.11 Summary of Substantial Equivalence
The subject Penumbra System with modified 110 Aspiration Tubing is substantially equivalent to the predicate and references devices, provided in Section 1.6, with regard to indications, intended use, design, performance, materials, sterilization, and packaging.
§ 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).