(197 days)
The Penumbra System / Penumbra System MAX are in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal caroiid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
The purpose of this 510(k) pre-market notification is to implement the following modifications to the Instructions for Use for clarity.
. Added Summary of PIVITOL Trial Clinical Data
. Moved a precaution statement to the Warnings section
Added statement that the use of a Separator may not be needed for . Reperfusion Catheters with an I.D. of 0.054in or larger.
The provided 510(k) summary (K133317) for the Penumbra System / Penumbra System MAX primarily focuses on modifications to the Instructions for Use (IFU) and demonstrates substantial equivalence to predicate devices, rather than presenting a comprehensive study proving the device meets explicit acceptance criteria in a clinical or imaging performance context typically seen for AI/ML devices.
However, based on the non-clinical data provided, we can infer the implied acceptance criteria and the study that addresses these criteria for the modifications being sought. The "device" in this context refers to the Penumbra System / Penumbra System MAX with the clarified IFU.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Catheter Tip Pressure: Aspiration pressure at the distal tip of the Reperfusion Catheters equals the pressure set at the pump. | The aspiration pressure at the distal tip of the Reperfusion Catheters was equal to the pressure set at the Pump. |
| Aspiration Flow Rate: Flow rate through the Reperfusion Catheter is consistently higher without the Separator present in the lumen (for 054, 5MAX & 5MAX ACE). | The flow rate was consistently higher without the presence of the Separator in Lumen. |
| Clot Removal (without Separator): Reperfusion Catheters (054, 5MAX & 5MAX ACE) are able to completely remove clot without the use of a Separator in a simulated environment. | All Reperfusion Catheters were able to completely remove the clot without the use of a Separator. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number of devices or trials beyond "All Sizes" for catheter tip pressure and "(054, 5MAX & 5MAX ACE)" for aspiration flow rate and clot removal. This suggests testing was performed on representative models of these specific catheter sizes.
- Data Provenance: The tests were non-clinical, using "a glass model" for clot removal. The data provenance is laboratory-based, performed by the manufacturer, Penumbra, Inc., located in Alameda, CA, USA. This is a retrospective analysis of device function, not clinical data from patients.
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)
Not applicable. This was non-clinical engineering testing. The "ground truth" was established by direct physical measurements of pressure and flow rates, and direct observation of clot removal in a simulated environment. No human expert interpretation was required for establishing these performance metrics.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this was non-clinical engineering testing, not a clinical study involving human interpretation or subjective assessment.
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 submission is for a physical medical device (thrombus removal catheter) and its updated instructions for use, not an AI/ML-driven diagnostic or assistive device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these non-clinical tests was based on physical measurements and direct observation against predetermined engineering specifications and functional outcomes (e.g., complete clot removal, pressure equality, higher flow rate).
8. The sample size for the training set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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510(k) Summary of Safety & Effectiveness 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® / Penumbra System® MAX components.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA
1.2 Sponsor Contact Information
Seth Schulman Director, Regulatory Affairs Phone: (510) 748-3223 FAX: (510) 217-6414 Email: seth.schulman@penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
May 13, 2014
Device Trade or Proprietary Name 1.4
Penumbra System® / Penumbra System® MAX
1.5 Device Classification
| Regulatory Class: | II |
|---|---|
| Review Panel: | Neurology |
| Regulation Name: | Catheter, Thrombus Removal |
| Regulation Number: | 21 CFR §870.1250 |
| Product Code: | NRY |
1.6 Predicate Devices
| 510(k) Number /Clearance Date | Name of Predicate Device | Name ofManufacturer |
|---|---|---|
| K072718 [28Dec2007] | Penumbra System [026, 032, 041] | Penumbra, Inc. |
| K090752 [21Sep2009] | Penumbra System [054] | Penumbra, Inc. |
| K100769 [21May2010] | Penumbra System Separator Flex[026, 032, 041, 054] | Penumbra, Inc. |
| K113163 [28NOV2011] | Penumbra System® MAX | Penumbra, Inc. |
1.7 Device Description
The purpose of this 510(k) pre-market notification is to implement the following modifications to the Instructions for Use for clarity.
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- . Added Summary of PIVITOL Trial Clinical Data
- . Moved a precaution statement to the Warnings section
- Added statement that the use of a Separator may not be needed for . Reperfusion Catheters with an I.D. of 0.054in or larger.
1.8 Intended Use
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
1.9 Summary of Non-Clinical Data
The following non-clinical testing was performed to support the proposed wording clarifications in the Instructions for Use.
| Test | Test Method Summary | Result |
|---|---|---|
| Catheter Tip Pressure | Aspiration (Suction)pressure was measured atthe distal tip of theReperfusion catheters (AllSizes). | The aspiration pressure atthe distal tip of theReperfusion Catheterswas equal to the pressureset at the Pump. |
| Aspiration Flow Rate | The flow rate through theReperfusion Catheter wasmeasured with andwithout Separatorspresent in the catheterlumen. (054, 5MAX &5MAX ACE) | The flow rate wasconsistently higherwithout the presence ofthe Separator in Lumen. |
| Clot Removal SimulatedUse | Clot was removed from aglass model under - 20inHg vacuum (withoutSeparator). (054, 5MAX& 5MAX ACE) | All Reperfusion Catheterswere able to completelyremove the clot withoutthe use of a Separator. |
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1.10 Summary of Substantial Equivalence
.
The Penumbra System MAX components are substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its body, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
Public Health Service
May 13, 2014
Penumbra, Inc. Mr. Seth Schulman Director, Regulatory Affairs 1352 Harbor Bay Parkway Alameda, CA 94502
Re: K133317
Trade/Device Name: Ponumbra System and Penumbra System MAX Regulation Number: 21 CFR 870.1250 Regulation Name: Thrombus Removal Catheter Regulatory Class: Class II Product Code: NRY Dated: April 7, 2014 Received: April 8, 2014
Dear Mr. Schulman:
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
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Page 2 - Mr. Seth Schulman
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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. Piena -S
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133317
Device Name
Penumbra System / Penumbra System MAX
Indications for Use (Describe)
The Penumbra System / Penumbra System MAX are in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal caroiid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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§ 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).