(30 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 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.
This 510(k) summary describes a medical device, the Neuron™ Select Catheter, and its substantial equivalence to a predicate device, rather than providing data from a study directly comparing the device against acceptance criteria in the style you've requested for AI/software-based devices.
Therefore, many of the specific questions you've asked (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable or not provided by this type of regulatory submission for a physical medical device.
However, I can extract information related to the general "acceptance criteria" and "study" mentioned for this device:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical medical device, acceptance criteria are generally established through testing against design specifications, manufacturing standards, and regulatory requirements rather than performance metrics like sensitivity/specificity.
| Acceptance Criterion (Generalized from "Testing" section) | Reported Device Performance (Generalized) |
|---|---|
| Adherence to device specifications (e.g., dimensions, material properties, functionality of components) | "The devices tested acceptably met the specifications." |
| Biocompatibility | "demonstrated to be both biocompatible" |
| Suitability for intended use | "suitable for this use." |
| Substantial equivalence to predicate device (Neuron Intracranial Access System (K070970)) in terms of: - Intended use - Method of operation - Methods of construction - Materials used | "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." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. This document refers to "Bench testing, in vitro testing, and in vivo testing" which would involve testing a certain number of devices or components, but the exact sample sizes are not detailed in this summary.
- Data Provenance: Not specified, but generally, such testing is conducted within controlled laboratory environments (bench, in vitro) and/or animal models (in vivo) as part of the device development and validation process.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. For physical devices, "ground truth" often refers to engineering specifications, material properties, and functional performance benchmarks rather than expert consensus on diagnostic images. Experts involved would typically be engineers, material scientists, and medical professionals contributing to design validation, but not in the context of establishing "ground truth" for a test set as you would for an AI algorithm.
4. Adjudication method
- Not Applicable. Adjudication methods are typically relevant for human interpretation of data, especially in the context of AI performance evaluation where there might be disagreements among human experts. This is not mentioned or relevant for the testing of this physical catheter.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- No. This type of study is typically performed for diagnostic imaging devices or AI algorithms that assist human readers. This document describes a physical catheter, not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Engineering specifications, material testing results, and functional performance benchmarks. For example, tests would confirm catheter dimensions, tensile strength, pushability, trackability, torque response, lubricity, burst pressure, and biocompatibility against predefined acceptable ranges.
8. The sample size for the training set
- Not Applicable. This is a physical medical device. Training sets are relevant for AI/machine learning algorithms.
9. How the ground truth for the training set was established
- Not Applicable. As above, this is a physical medical device.
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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 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
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
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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
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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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510(k) Number_1 083125
Neuron Select Catheter size 070 Special 510(k) 210ct08: Device Modification Page 9 of 54
§ 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).