(30 days)
No
The summary describes a physical catheter system for accessing vasculature and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an access system for introducing interventional devices, not a therapeutic device itself.
No
Explanation: The device is indicated for the "introduction of interventional devices" into the vasculature, which describes a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly details physical catheters of varying sizes and materials, indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of interventional devices into the peripheral, coronary, and neuro vasculature." This describes a device used within the body for a therapeutic or interventional purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details catheters and access systems, which are tools used for accessing and navigating blood vessels. This aligns with an interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition through in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely mechanical and interventional.
N/A
Intended Use / Indications for Use
The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Product codes
DQY
Device Description
The Neuron Intracranial Access System has a Neuron Select Catheter 053 (predicate device), which is 3.5F and has multiple tip configurations, and a Neuron Select Catheter 070 (modified device) which is 5F and has multiple tip configurations. The Neuron Intracranial Access System also has a Neuron Delivery Catheter size 053, which tapers from 6F to 5F, and a Neuron Delivery Catheter 070, which is 6F.
Materials used in the Neuron Intracranial Access 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
peripheral, coronary, and neuro vasculature.
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, and in vivo testing have bcen performed on the device materials, components, subassemblies, and final assemblies. The devices tested acceptably met the specifications.
Key Metrics
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/0 description: The image shows the word "Penumbra" in a simple, sans-serif font. To the right of the word is a logo that appears to be a stylized letter "P" or a geometric design. The text and logo are presented in a dark color against a lighter background, creating a clear contrast.
510(k) Summary
NOV 2 ] 2008
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 | K083125 pg. 1of2 |
|---|---|
| Date Summary Prepared | October 21, 2008 |
| Trade Name | Neuron™ Select Catheter |
| Common Name | Percutaneous Catheter |
| Classification Name | Percutaneous Catheter |
| (21 CFR Part 870.1250; Product Code DQY) | |
| Submitted By | Penumbra, Inc. |
| 1351 Harbor Bay Parkway | |
| Alameda, CA 94502 | |
| Contact | Theresa Brander-Allen |
| VP of Regulatory and Quality | |
| Tel: 510-748-3223 | |
| Fax: 510-814-8310 | |
| theresa.brandnerallen@penumbrainc.com |
Predicate Devices
Neuron Intracranial Access System (K070970), manufactured by Penumbra, Inc.
Device Description
The Neuron Intracranial Access System has a Neuron Select Catheter 053 (predicate device), which is 3.5F and has multiple tip configurations, and a Neuron Select Catheter 070 (modified device) which is 5F and has multiple tip configurations. The Neuron Intracranial Access System also has a Neuron Delivery Catheter size 053, which tapers from 6F to 5F, and a Neuron Delivery Catheter 070, which is 6F.
Materials used in the Neuron Intracranial Access 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
The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The indication statement of
1
pg. 2 of 2 K083125
Penumbra
the Neuron Intracranial Access 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 Neuron Select Catheter size 070 is substantially equivalent to the predicate device.
Testing
Bench testing, in vitro testing, and in vivo testing have bcen performed on the device materials, components, subassemblies, and final assemblies. The devices tested acceptably met the specifications.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2008
Penumbra, Inc. c/o Ms. Theresa Brandner-Allen, M.S., B.S.M.E. Vice President of Regulatory and Quality 1351 Harbor Bay Parkway Alameda, CA 94502
Re: K083125
Trade/Device Name: Neuron™ Select Catheter Common Name: Catheter, Percutaneous Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DQY Dated: October 21, 2008 Received: October 22, 2008
Dcar Ms. Brandner-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 (sce 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
3
Page 2 - Ms. Brandner-Allen
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. 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) 276-0120. 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 Biometrics' (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,
Dana R. Lahner
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Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Neuron™ Select Catheter, size 070
Indications for Use:
The Neuron™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
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)
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Duina R. la lmes
Division Sign-Off) Division of Cardiovascular Devices
Page
of
510(k) Number_1 083125
Neuron Select Catheter size 070 Special 510(k) 210ct08: Device Modification Page 9 of 54