The NeuronTM Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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.

AI/ML Overview

This 510(k) summary describes a medical device, the Neuron™ Delivery Catheter, which is a Percutaneous Catheter. The document is primarily focused on demonstrating "substantial equivalence" of the new device (070 size) to a previously cleared predicate device (053 size), rather than presenting a performance study with detailed acceptance criteria and results as typically seen for novel devices or AI/software products.

Therefore, many of the requested categories related to AI/software performance studies, ground truth establishment, expert review, and MRMC studies are not applicable to this document. The information provided heavily emphasizes physical device testing and regulatory comparison.

Here's an attempt to extract relevant information and note where the requested categories are not applicable based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (from the document)
Substantial Equivalence to Predicate Device	The Neuron Delivery Catheter size 070 is substantially equivalent to the predicate device (Neuron Intracranial Access System (K070970)) regarding: - Intended Use - Method of Operation - Methods of Construction - Materials Used
Material Biocompatibility	Materials used are manufactured from medical grade materials that have historically been demonstrated to be both biocompatible and suitable for this use. They are similar or identical to the predicate devices.
Bench Testing	Performed on device materials, components, subassemblies, and final assemblies. Met the specifications.
In Vitro Testing	Performed on device materials, components, subassemblies, and final assemblies. Met the specifications.
In Vivo Testing	Performed on device materials, components, subassemblies, and final assemblies. Met the specifications.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states "Bench testing, in vitro testing, and in vivo testing have been performed on the device materials, components, subassemblies, and final assemblies." However, it does not specify the sample sizes for these tests (e.g., number of catheters tested, number of in vivo subjects/animals).
- Data Provenance: Not specified. Given it's pre-market testing for a US FDA submission, it's likely conducted in the US or collaborating labs, but this is not explicitly stated.
- Retrospective or Prospective: These would typically be prospective tests designed to evaluate the new device.
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 is a physical medical device (catheter), not an AI/software product requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for its performance would be engineering specifications and successful completion of physical and biological tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this pertains to expert consensus on interpretation, which is not relevant for this type of device submission. The success criteria for physical testing would be adjudicated by qualified engineers and technical staff following established protocols.
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 not an AI/software device. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical and biological testing, the "ground truth" would be objective engineering specifications, material standards, and established biocompatibility benchmarks. For instance, a test might verify that the catheter's inner diameter is precisely 0.070 inches, or that it withstands a certain pressure without leaking. Biocompatibility would be assessed against ISO standards, chemical analysis, and potentially animal or in vitro cell culture studies.
The sample size for the training set:
- Not Applicable. This is not an AI/software device that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. This is not an AI/software device.

Summary

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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 ParkwayAlameda, CA 94502
Contact	Theresa Brander-AllenVP of Regulatory and QualityTel: 510-748-3223Fax: 510-814-8310theresa.brandnerallen@penumbrainc.com

Predicate Devices

Neuron Intracranial Access System (K070970), manufactured by Penumbra, Inc.

Device Description

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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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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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

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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 indicatedfor the introduction of interventional devices into theperipheral, 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

Regulation Number and Section

§ 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).