(133 days)
The Neuron™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Neuron Intracranial Access System has a Neuron Delivery Catheter (outer catheter), which is available with a diameter of 6F proximal and 5F distal, and a Neuron Select Catheter (inner catheter), which measures 3.5F and has multiple tip configurations. The Neuron Delivery Cather may be used with a guidewire or with the Neuron Select Catheters. 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.
This 510(k) summary describes a medical device, the Neuron™ Intracranial Access System, which is a catheter. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a formal clinical study.
Therefore, many of the requested categories for AI/clinical study performance data are not applicable to this document, as it pertains to a traditional medical device (catheter) and not an AI/ML-driven diagnostic or therapeutic system.
Here's a breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was measured) | Reported Device Performance (How did it perform) |
|---|---|
| Intended Use Equivalence: The Neuron Intracranial Access System's intended use is substantially equivalent to legally marketed predicate devices. | "The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The indication statement of the Neuron Intracranial Access System is substantially equivalent to the legally marketed predicate devices." |
| Method of Operation Equivalence: The method of operation of the Neuron Intracranial Access System is identical or substantially equivalent to predicate devices. | "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." |
| Methods of Construction Equivalence: The methods of construction of the Neuron Intracranial Access System are identical or substantially equivalent to predicate devices. | "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." |
| Materials Used Equivalence: The materials used in the Neuron Intracranial Access System are identical or substantially equivalent to predicate devices and are biocompatible and suitable for use. | "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." "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." |
| Bench, In Vitro, and In Vivo Testing: Adherence to specifications through 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." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for any of the bench, in vitro, or in vivo testing.
- The document does not specify data provenance (e.g., country of origin, retrospective/prospective). This type of detail is generally not included in a 510(k) summary for a catheter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This information is not relevant to a 510(k) submission for a non-AI medical device like a catheter. Ground truth as typically understood in AI/ML is not a concept applied in this context. The "ground truth" here is the physical performance against specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for subjective assessments, often in clinical trials or expert review panels for AI/ML outputs. This isn't relevant for a catheter's bench, in vitro, and in vivo performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical medical device (catheter), not an AI/ML system, so MRMC studies or human reader improvement with AI are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (catheter), not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" would be objective physical and material properties, mechanical performance specifications, and biological responses (e.g., biocompatibility) as measured in bench, in vitro, and in vivo tests. It is not an expert consensus on an image or pathology.
8. The sample size for the training set
- Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this device.
{0}------------------------------------------------
K070970 p 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Penumbra, Inc., a company that specializes in stroke intervention. The logo features the company name in a simple, sans-serif font, with a curved line above the name. The words "stroke intervention" are written in a smaller font below the company name. The logo is simple and modern, and it effectively communicates the company's focus on stroke intervention.
AUG 17 2007
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 | April 4, 2007 |
|---|---|
| Trade Name | Neuron™ Intracranial Access System |
| Common Name | Percutaneous Catheter |
| Classification Name | Percutaneous Catheter(21 CFR Part 870.1250; Product Code DQY) |
| Submitted By | Penumbra, Inc.2401 Merced Street, Suite 200San Leandro, CA 94577 |
| Contact | Theresa Brander-AllenVP of Regulatory and QualityTel: 510-618-3223Fax: 510-352-1766tballen@penumbrainc.com |
Predicate Devices
-
Penumbra Balloon Guide Catheter (K053491), manufactured by Penumbra, Inc.
-
Guider Softip Guiding Catheter XF 5F (K010853), manufactured by Boston Scientific Corporation
Device Description
The Neuron Intracranial Access System has a Neuron Delivery Catheter (outer catheter), which is available with a diameter of 6F proximal and 5F distal, and a Neuron Select Catheter (inner catheter), which measures 3.5F and has multiple tip configurations. The Neuron Delivery Cather may be used with a guidewire or with the Neuron Select Catheters.
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.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image contains the text "K070970" and "picefz". The text appears to be handwritten and is slightly faded. The text is arranged horizontally, with "K070970" on the left and "picefz" on the right.
Image /page/1/Picture/1 description: The image shows the logo for Penumbra, a stroke intervention company. The logo features the word "Penumbra" in a bold, sans-serif font, with the words "stroke intervention" in a smaller font below it. Above the word "Penumbra" is a curved line. The logo is simple and modern, and it effectively communicates the company's focus on stroke intervention.
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 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 Intracranial Access System is substantially equivalent to the predicate devices.
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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2007
Penumbra, Inc. c\o Ms. Theresa Brandner-Allen VP of Regulatory and Quality 2401 Merced St, Suite 200 San Leandro, CA 94577
Re: K070970
Trade/Device Name: Neuron™ Intracranial Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: August 10, 2007 Received: August 13, 2007
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 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. Brandner-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) 276-0120. 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) 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.
QML
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Penumbra, a stroke intervention company. The logo features the word "Penumbra" in a bold, sans-serif font, with the words "stroke intervention" in a smaller font underneath. Above the word "Penumbra" is a curved line. The logo is simple and modern, and it effectively communicates the company's focus on stroke intervention.
Indications for Use
| 510(k) Number (if known): | K 070970 |
|---|---|
| --------------------------- | ---------- |
Device Name:
Neuron™ Intracranial Access System
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)
QQ Mall
sion Silah-Off ision of Cardiovascular Devices
Page of
K070970 510(k) Number
Neuron™ Intracranial Access System Traditional 510(k) 04Aprr07
CONFIDENTIAL
§ 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).