(97 days)
Penumbra Reperfusion Catheters and Separators: As part of the Penumbra System, the Reperfusion Catheters and Separators are 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.
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.
Penumbra Pump MAX: The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
The Penumbra System is designed to remove thrombus from the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. 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 [1.37mm] or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Penumbra Pump MAX 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 Penumbra Pump MAX, 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 Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy. The Penumbra Reperfusion Catheter, Separator, and Aspiration Tubing are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for all Penumbra System Reperfusion Catheters with Aspiration Tubing is available.
The Penumbra Pump MAX is designed to provide aspiration for the Penumbra System. The Penumbra Pump MAX operates using AC power. The Penumbra Pump MAX provides vacuum of up to 29 inHg and is available in both 110Vac and 230Vac versions. The Penumbra Pump MAX and Pump/Canister Tubing are provided non-sterile and is used outside the sterile field.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focused on the KIT configuration, as that's where new testing was performed:
1. Table of Acceptance Criteria and Reported Device Performance (KIT Configuration)
| Attribute | Specification | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| 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. | Products meet all inspection criteria. | Pass |
| Simulated Use (Intracranial Access, 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 neurovasculature. Devices were delivered through the tortuous anatomical model to evaluate the effectiveness of the devices to remove clots and that the Reperfusion Catheter does not collapse under vacuum. | Devices effectively remove clots and catheters do not collapse under vacuum. | 100% Pass |
| Catheter Coating | Coating has not delaminated, peeled, or flaked after simulated use. | Coating remains intact (not delaminated, peeled, or flaked). | 100% Pass |
| Gross Leak | Pouch seals, pouch front, and pouch back material do not leak. | No leaks in pouch seals, front, or back material. | 100% Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the "Design Verification testing" for the KIT configuration. It only mentions "units used in this Design Verification testing" for Visual Inspection, and implicitly for Simulated Use, Catheter Coating, and Gross Leak tests as they all report 100% Pass.
- Sample Size: Not explicitly stated as a number, but all tested units passed.
- Data Provenance: The tests are described as "additional testing performed for the KIT configuration packaging," suggesting these are prospective, benchtop tests conducted by Penumbra, Inc. The country of origin for the data generation would logically be the USA, given the company's location.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or clinicians being used to establish a ground truth for these non-clinical tests. The tests are focused on physical and mechanical properties and simulated use in anatomical models.
4. Adjudication Method for the Test Set
Not applicable, as these are non-clinical, objective tests and not based on expert review or consensus.
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
Not applicable. This document describes a medical device (Penumbra System and Penumbra Pump MAX) for treating acute ischemic stroke, not an AI-based diagnostic or treatment guidance system that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for these non-clinical tests is based on:
* Defined specifications and performance expectations: For Visual Inspection, Catheter Coating, and Gross Leak, the "ground truth" is adherence to predefined quality and integrity standards.
* Simulated physiological conditions and objective performance: For Simulated Use, the "ground truth" is the effective removal of clots and prevention of catheter collapse in an anatomical model that mimics neurovasculature.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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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 name in a circular arrangement around a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2016
Penumbra, Inc. Mr. Richard Kimura Regulatory Affairs Specialist One Penumbra Place Alameda, California 94502
Re: K160449
Trade/Device Name: Penumbra System and Penumbra Pump MAX Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NRY Dated: April 22, 2016 Received: April 25, 2016
Dear Mr. Richard 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 devicerelated 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.
{1}------------------------------------------------
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Carlos L. Pena -S/A
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) K160449
Device Name Penumbra System® and Penumbra Pump MAX
Indications for Use (Describe)
Penumbra Reperfusion Catheters and Separators
As part of the Penumbra System, the Reperfusion Catheters and Separators are 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.
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.
Penumbra Pump MAX The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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1 510(k) Summary
(as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra, Inc. is providing the summary of Substantial Equivalence for the Penumbra 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
April 22, 2016
1.4 Device Trade or Proprietary Name
Penumbra System® and Penumbra Pump MAX
1.5 Device Classification
Regulatory Class: II Classification Panel: Neurology Catheter, Thrombus Retriever Classification Name: Regulation Number: 21 CFR §870.1250 Product Code: NRY
1.6 Predicate Devices
| 510(k) Number/Clearance Date | Name of Predicate Device | Name ofManufacturer |
|---|---|---|
| Predicate Devices | ||
| K152541[13Jan2016] | Penumbra System ACE 64 and ACE68 Reperfusion Catheters | Penumbra, Inc. |
| K122756[02Oct2012] | Penumbra Pump MAX | Penumbra, Inc. |
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1.7 Predicate Comparison
| Predicate Device | Subject Device | |
|---|---|---|
| Trade Name | Penumbra System | Penumbra System (includingPenumbra Pump MAX) |
| Predicate 510(k)No. | Penumbra System : K152541 | |
| Reference 510(k)No. | Penumbra System: K072718, K090752,K100769, K113163, K133317,K142458, K151623Penumbra Pump MAX:K122756 andK051758 | K160449 |
| Classification | Penumbra System: Class II, NRYPenumbra Pump MAX: Class II, JCX | Class II, NRY |
| Indication for Use | Penumbra SystemThe Penumbra System is intended foruse in the revascularization of patientswith acute ischemic stroke secondary tointracranial large vessel occlusivedisease (within the internal carotid,middle cerebral – M1 and M2 segments,basilar, and vertebral arteries) within 8hours of symptom onset.Penumbra Aspiration PumpThe Penumbra Pump MAX is intendedfor general suction use in hospitals orclinics. | Reperfusion Catheters and SeparatorsAs part of the Penumbra System, theReperfusion Catheters and Separatorsare indicated for use in therevascularization of patients withacute ischemic stroke secondary tointracranial large vessel occlusivedisease (within the internal carotid,middle cerebral - M1 and M2segments, basilar, and vertebralarteries) within 8 hours of symptomonset.Penumbra Aspiration TubingAs part of the Penumbra System, thePenumbra Sterile Aspiration Tubing isindicated to connect the PenumbraReperfusion Catheters to thePenumbra Pump MAX.Penumbra Pump MAXThe Penumbra Pump MAX isindicated as a vacuum source forPenumbra Aspiration Systems. |
| Reperfusion Catheter | ||
| Materials | Biocompatible, commonly utilized forinterventional devices | SAME |
| Coating | Hydrophilic | SAME |
| Markerband | Radiopaque | SAME |
| Guidewirecompatible | Yes | SAME |
| Dimensions | ||
| - OD [Maximum] | 0.051" - 0.080" [1.295mm – 2.030mm] | SAME |
| - Working Length | $125cm - 153cm$ | SAME |
| Separator | ||
| Materials | Biocompatible, commonly utilized forinterventional devices | SAME |
| Predicate Device | Subject Device | |
| Trade Name | Penumbra System | Penumbra System (includingPenumbra Pump MAX) |
| Predicate 510(k)No. | Penumbra System : K152541 | |
| Reference 510(k)No. | Penumbra System: K072718, K090752,K100769, K113163, K133317,K142458, K151623Penumbra Pump MAX:K122756 andK051758 | K160449 |
| Classification | Penumbra System: Class II, NRYPenumbra Pump MAX: Class II, JCX | Class II, NRY |
| Dimensions | ||
| - Distal OD | 0.022" – 0.045" [0.56mm – 1.14mm] | SAME |
| - Working Length | 135cm – 155cm | SAME |
| Aspiration Tubing | ||
| Materials | Biocompatible, commonly utilized forinterventional devices | SAME |
| Dimensions | ||
| - ID | 0.071" – 0.110" [1.80mm – 2.80mm] | SAME |
| - Length | 112.0" [284.5cm] | SAME |
| Sterilization | EO | SAME |
| Shelf-Life | 36-Months | SAME |
| Aspiration Pump | ||
| IEC 60601-1Compliance | Yes | SAME |
| IEC 60601-1-2Compliance | Yes | SAME |
| Voltage | 100-115 Vac/230 Vac | SAME |
| Frequency | 50 Hz/60 Hz | SAME |
| Sterilization | Non sterile | SAME |
| Shelf Life | N/A | SAME |
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Device Description 1.8
The Penumbra System
The Penumbra System is designed to remove thrombus from the neurovasculature using continuous aspiration. The Reperfusion Catheter targets aspiration from the pump directly to the thrombus. 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 [1.37mm] or larger. The Reperfusion Catheter is introduced through a guide catheter or long femoral sheath and into the intracranial vasculature and guided over a neurovascular guidewire to the site of the primary occlusion. The Penumbra Reperfusion Catheter is used with the Penumbra Pump MAX to aspirate thrombus from an occluded vessel. As
{6}------------------------------------------------
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 Penumbra Pump MAX, 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 Separator is provided with an introducer and torque device. The devices are visible under fluoroscopy. The Penumbra Reperfusion Catheter, Separator, and Aspiration Tubing are provided sterile, non-pyrogenic, and intended for single use only. Additionally, a pre-packaged configuration (KIT packaging) for all Penumbra System Reperfusion Catheters with Aspiration Tubing is available.
The Penumbra Pump MAX
The Penumbra Pump MAX is designed to provide aspiration for the Penumbra System. The Penumbra Pump MAX operates using AC power. The Penumbra Pump MAX provides vacuum of up to 29 inHg and is available in both 110Vac and 230Vac versions. The Penumbra Pump MAX and Pump/Canister Tubing are provided non-sterile and is used outside the sterile field.
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.
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.
Penumbra Pump MAX
The Penumbra Pump MAX is indicated as a vacuum source for Penumbra Aspiration Systems.
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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 Penumbra System and Penumbra Pump MAX under the same product code (NRY), 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.
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 | AcceptanceCriteria | Results |
|---|---|---|---|
| Visual Inspection | These evaluations confirm that the units used in thisDesign Verification testing meet all inspectioncriteria for release of finished goods (clinicallyacceptable) product. | Pass | |
| Simulated Use(IntracranialAccess, VesselAccess EntryPerformance &Clot Removal) | Simulated use testing of the Catheter and Separatorwas performed with accessory devices in ananatomical model which simulated the tortuosity ofthe neurovasculature. Devices were deliveredthrough the tortuous anatomical model toevaluate the effectiveness of the devices to removeclots and that the Reperfusion Catheter does notcollapse under vacuum. | 100% Pass | |
| Catheter Coating | Coating has not delaminated, peeled, or flaked aftersimulated use. | 100% Pass | |
| Gross Leak | Pouch seals, pouch front, and pouch back materialdo 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.
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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 Penumbra System and Penumbra Pump MAX under the same product code (NRY), clarifications in the Indications for Use statements, and IFU and Operation, Maintenance, and Service Manual revisions.
1.13 Summary of Substantial Equivalence
The subject Penumbra System is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
§ 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).