(81 days)
Not Found
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 or ML.
No.
The device is indicated for the introduction of interventional devices, acting as an access system, rather than directly treating a condition itself.
No
The device is described as an access system for introducing interventional devices, not for diagnosing conditions.
No
The device description explicitly details physical components like catheters and mentions bench, in vitro, and in vivo testing, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "introduction of interventional devices into the peripheral, coronary, and neuro vasculature." This describes a device used within the body for a therapeutic or interventional procedure, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details catheters and their dimensions, 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 other components typically associated with in vitro diagnostic testing.
In summary, the Neuron Intracranial Access System is an interventional medical device used for accessing blood vessels, not a device used for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The NeuronTM Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Neuron Intracranial Access System has a Neuron Delivery Catheter size 053 (predicate device), which is available with an inner diameter of 0.053in, and a Neuron Delivery Catheter 070 (modified device), which is available with an inner diameter of 0.070in. The Neuron Intracranial Access System also has a Neuron Select Catheter (used with predicate device), which measures 3.5F and has multiple tip configurations.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing, in vitro testing, and in vivo testing have been performed on the device materials, components, subassemblies, and final assemblies. The devices tested acceptably met the specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/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" in a stylized design.
OCT 3 1 2008
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 | K082290 |
|---|---|
| Date Summary Prepared | August 07, 2008 |
| Trade Name | Neuron™ Delivery 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 Delivery Catheter size 053 (predicate device), which is available with an inner diameter of 0.053in, and a Neuron Delivery Catheter 070 (modified device), which is available with an inner diameter of 0.070in. The Neuron Intracranial Access System also has a Neuron Select Catheter (used with predicate device), which measures 3.5F and has multiple tip configurations.
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
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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 a stylized letter "P" within the circle.
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 Delivery Catheter size 070 is substantially equivalent to the predicate device.
Testing
Bench testing, in vitro testing, and in vivo testing have been performed on the device materials, components, subassemblies, and final assemblies. The devices tested acceptably met the specifications.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 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: K082290
Trade/Device Name: Neuron™ Delivery Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: II Product Code: DQY Dated: September 25, 2008 Received: September 30, 2008
Dear 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 (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
3
Page 2 – Ms. Theresa 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 CDRI's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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,
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KOB229C
| Device Name: | NeuronTM Delivery Catheter, size 070 |
|---|---|
| Indications for Use: | The NeuronTM 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)
| Division Sign-Off | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K082250 |
Page 1 of 1Neuron Delivery Catheter size 070 CONFIDENTIAL Special 510(k) 07Aug08: Device Modification