(197 days)
Not Found
No
The 510(k) summary describes modifications to the Instructions for Use and performance testing related to catheter function, not AI/ML capabilities. There are no mentions of AI, ML, image processing, or data sets for training/testing AI models.
Yes
The device is described as being 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 intended use of the Penumbra System / Penumbra System MAX is for "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease," indicating a therapeutic purpose rather than diagnosis. The device description also focuses on modifications to instructions for use and performance testing related to clot removal, not diagnostic capabilities.
No
The device description explicitly states that the purpose of the 510(k) is to modify the Instructions for Use for the Penumbra System / Penumbra System MAX, which are physical devices used in revascularization procedures. The performance studies also involve testing physical components like catheters and separators.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the revascularization of patients with acute ischemic stroke. This is a therapeutic procedure performed in vivo (within the body) to restore blood flow.
- Device Description: The description talks about modifications to the Instructions for Use for a system used in a medical procedure. It mentions catheters and a pump, which are typical components of a system used for interventional procedures.
- Performance Studies: The performance studies described involve testing catheter tip pressure, aspiration flow rate, and simulated clot removal. These are tests related to the physical function and performance of a medical device used in a procedure, not tests performed on biological samples in vitro.
- Anatomical Site: The anatomical site is within the intracranial arteries, indicating an internal procedure.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device clearly does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
NRY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial (internal carotid, middle cerebral - M1 and M2 segments), basilar, and vertebral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following non-clinical testing was performed to support the proposed wording clarifications in the Instructions for Use.
Test: Catheter Tip Pressure, Test Method Summary: Aspiration (Suction) pressure was measured at the distal tip of the Reperfusion catheters (All Sizes). Result: The aspiration pressure at the distal tip of the Reperfusion Catheters was equal to the pressure set at the Pump.
Test: Aspiration Flow Rate, Test Method Summary: The flow rate through the Reperfusion Catheter was measured with and without Separators present in the catheter lumen. (054, 5MAX & 5MAX ACE), Result: The flow rate was consistently higher without the presence of the Separator in Lumen.
Test: Clot Removal Simulated Use, Test Method Summary: Clot was removed from a glass model under - 20 inHg vacuum (without Separator). (054, 5MAX & 5MAX ACE), Result: All Reperfusion Catheters were able to completely remove the clot without the use of a Separator.
Key Metrics
Not Found
Predicate Device(s)
K072718, K090752, K100769, K113163
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 of
Manufacturer |
|-----------------------------------|--------------------------------------------------------|-------------------------|
| 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.
1
- . 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 at | ||
| the distal tip of the | ||
| Reperfusion catheters (All | ||
| Sizes). | The aspiration pressure at | |
| the distal tip of the | ||
| Reperfusion Catheters | ||
| was equal to the pressure | ||
| set at the Pump. | ||
| Aspiration Flow Rate | The flow rate through the | |
| Reperfusion Catheter was | ||
| measured with and | ||
| without Separators | ||
| present in the catheter | ||
| lumen. (054, 5MAX & | ||
| 5MAX ACE) | The flow rate was | |
| consistently higher | ||
| without the presence of | ||
| the Separator in Lumen. | ||
| Clot Removal Simulated | ||
| Use | Clot was removed from a | |
| glass model under - 20 | ||
| inHg vacuum (without | ||
| Separator). (054, 5MAX | ||
| & 5MAX ACE) | All Reperfusion Catheters | |
| were able to completely | ||
| remove the clot without | ||
| the use of a Separator. |
2
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.
3
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
4
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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