(94 days)
No
The summary describes a mechanical thrombectomy system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the revascularization of patients with acute ischemic stroke, which is a therapeutic intervention aimed at restoring blood flow and treating the condition.
No
The provided text describes the Penumbra System as a device for "revascularization" and "to remove thrombus" in patients with acute ischemic stroke. This indicates a therapeutic function, not a diagnostic one. While it's used for a condition that would be diagnosed, the device itself is for treatment.
No
The device description explicitly lists physical components (catheter, separator, tubing, pump) and mentions bench, in vitro, and in vivo testing, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Penumbra System is for the "revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease." This describes a therapeutic intervention performed directly on the patient's body to restore blood flow.
- Device Description: The device description details components like catheters, separators, and aspiration tubing, which are tools used for physically removing a thrombus (blood clot) from a blood vessel. This is a mechanical procedure, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such analysis. IVDs are designed to provide diagnostic information.
In summary, the Penumbra System is a medical device used for treatment, not for diagnosis.
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 (in the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset.
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.
Product codes
NRY
Device Description
The Penumbra System consists of four 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 (K051758).
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
Intracranial large vessel occlusive disease (in the 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
Bench testing, in vitro testing, in vivo testing, and a clinical study have been performed on the device materials, components, subassemblies, and final assemblies. The devices tested met the specifications and the outcome measures of the clinical protocol.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
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72718
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
| Date Summary Prepared | September 20, 2007 | |
|---|---|---|
| Trade Name | Penumbra System™ | DEC 2 8 2007 |
| Common Name | Percutaneous Catheter | |
| Classification Name | Percutaneous Catheter | |
| (21 CFR Part 870.1250; Product Code NRY) | ||
| Submitted By | Penumbra, Inc. | |
| 2401 Merced Street, Suite 200 | ||
| San Leandro, CA 94577 | ||
| Contact | Theresa Brander-Allen | |
| VP of Regulatory and Quality | ||
| Tel: 510-618-3223 | ||
| Fax: 510-352-1766 | ||
| tballen@penumbrainc.com |
Predicate Devices
Merci Retriever models X5 and X6 (K033736) and Merci Micro Catheter (K003086) Manufactured by Concentric Medical, Inc.
Device Description
The Penumbra System consists of four 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 (K051758).
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.
Intended Use
:
、アイアン、
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
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Page @ AC
hours of symptom onset. The indication statement of the Penumbra System is substantially equivalent to the legally marketed predicate devices.
Substantial Equivalence
The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to the existing, legally marketed, predicate devices. Therefore, Penumbra believes the Penumbra System is substantially equivalent to the predicate devices.
Testing
Bench testing, in vitro testing, in vivo testing, and a clinical study have been performed on the device materials, components, subassemblies, and final assemblies. The devices tested met the specifications and the outcome measures of the clinical protocol.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEC 2 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Penumbra, Inc. % Ms. Theresa Brander-Allen V. P., Regulatory and Quality 2401 Merced Street, Suite 200 San Leandro, CA 94577
Re: K072718 Trade/Device Name: Penumbra System™ Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: NRY Dated: November 30, 2007 Received: December 3, 2007
Dear Ms. Brander-Allen:
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 such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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
Page 2 - Ms. Theresa Brander-Allen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 yours.
Mark N Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Penumbra System™
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
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)
Arlene Brown
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K020718