(185 days)
Penumbra System™, Neuron™ Intracranial Access System
Not Found
No
The document describes a mechanical system for thrombus removal and does not mention any AI or ML components or functionalities.
Yes
The device is intended 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 is described as a device to remove thrombus for revascularization in patients with acute ischemic stroke, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states that the Penumbra System consists of physical components: the Penumbra Reperfusion Catheter, Penumbra Separator, and Aspiration Tubing, used with a Penumbra Aspiration Pump. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Penumbra System™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the revascularization of patients with acute ischemic stroke by removing thrombus. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device components (catheter, separator, aspiration tubing, pump) are designed for physical interaction within the blood vessels to remove blockages.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The Penumbra System does not perform this function.
The Penumbra System is a medical device used for a therapeutic procedure, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
NRY
Device Description
The Penumbra System™ consists of three devices that work as a system to remove thrombus including the Penumbra Reperfusion Catheter, Penumbra Separator and Aspiration Tubing. The Penumbra System is used with the Penumbra Aspiration Pump.
Materials used in the Penumbra System devices are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate devices, and have historically been demonstrated to be both biocompatible and suitable for this use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
I esting, in vitro testing, and in vivo testing have been performed on the device materials, Denen resting, in Thi b teenig af tinal assemblies. The devices tested acceptably met the specifications.
Key Metrics
Not Found
Predicate Device(s)
Penumbra System™ and Neuron™ Intracranial Access System
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
SEP 2 1 2009
Penumbra
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c)
510(k) Number
March 19, 2009
Date Summary Prepared
Trade Name 054
Common Name
Classification Name
Submitted By
Contact
Percutaneous Catheter
Percutaneous Catheter (21 CFR Part 870, 1250; Product Code NRY)
Penumbra Reperfusion Catheter 054 and Penumbra
Separator
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502
Louise Musante Regulatory Specialist Tel: 510-748-3247 louise.musante@penumbrainc.com
(Alternate Contact)
Theresa Brandner-Allen VP of Regulatory Tel: 510-748-3223 Fax: 510-814-8310 theresa.brandnerallen@penumbrainc.com
Predicate Devices
Penumbra System™ and Neuron™ Intracranial Access System, manufactured by Penumbra, Inc.
Device Description
Dovice Doceription
The Penumbra System™ consists of three devices that work as a system to remove thrombus including the Penumbra Reperfusion Catheter, Penumbra Separator and Aspiration Tubing. The Penumbra System is used with the Penumbra Aspiration Pump.
Materials used in the Penumbra System devices are manufactured from medical grade materials that are commonly used in the industry, are similar or identical to the predicate devices, and have historically been demonstrated to be both biocompatible and suitable for this use.
1
Image /page/1/Picture/0 description: The image contains the word "Penumbra" in a simple, sans-serif font. To the right of the word is a circular logo. The logo appears to contain the letter "P" inside of the circle.
Intended Use
The Penumbra System is intended for use in the revascularization of patients with acute ischemic 1116 I chumora Dyoren is moial large vessel occlusive disease (in the internal carotid, middle stroke secondary to miractural large ar, and vertebral arteries) within 8 hours of symptom onset.
Substantial Equivalence
Substantial Equivations
The intended use, methods of operation, methods of construction, and materials used are either identical or substantially equivalent to the existing, legally marketed, predicate devices. IChical of Substantially equires that the Penumbra Reperfusion Catheter 054 and Penumbra Separator 054 are substantially equivalent to the predicate devices.
Testing
I esting, in vitro testing, and in vivo testing have been performed on the device materials, Denen resting, in Thi b teenig af tinal assemblies. The devices tested acceptably met the specifications.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, representing the three levels of government: federal, state, and local. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
SEP 2 1 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Penumbra, Inc. c/o Seth Schulman Director, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, CA 94502
Re: K090752
· Trade/Device Name: Penumbra Reperfusion Catheter 054, Penumbra Separator 054 Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: II
Product Code: NRY
Dated: September 1, 2009
Received: September 2, 2009
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.
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 device-related 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Emile Thormer Jr.
Malvina B. Eydelman, M.L Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K090752
Device Name:
Indications for Use:
Penumbra Reperfusion Catheter 054, Penumbra Separator 054
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.
Prescription Use _ X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kristen Bowsher
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K090752 510(k) Number_