(64 days)
Not Found
No
The summary describes a physical medical device (catheter system) and its performance is evaluated through bench-top testing and animal studies, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The "Intended Use / Indications for Use" states that the device is "indicated for the introduction of interventional devices," and the "Device Description" states that it "accommodates larger therapeutic devices." This indicates it is a delivery or access system for therapeutic devices, not a therapeutic device itself.
No
The device is an access system for introducing interventional devices and aiding in anatomical visualization, not for diagnosing conditions.
No
The device description clearly indicates it is a physical medical device (catheter system) with a larger lumen and flexible distal tip, intended for introducing other physical devices. The performance studies also involve bench-top testing and animal studies, which are typical for hardware devices. There is no mention of software as the primary or sole component.
Based on the provided information, the Neuron MAX System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "introduction of interventional devices into the peripheral, coronary, and neuro vasculature." This describes a device used within the body for therapeutic or diagnostic procedures, not a device used to examine specimens outside the body to provide information about a patient's health.
- Device Description: The description focuses on the physical characteristics of the catheter (larger lumen, flexible tip) and its function in accommodating other devices and facilitating contrast injections. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Neuron MAX System is an interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Neuron™ MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Product codes
DQY
Device Description
The Neuron MAX System is an additional configuration to the currently available Neuron Intracranial Access System. The Neuron Max System provides a larger lumen to assist in utilizing contrast injections to further optimize anatomical visualization while maintaining a flexible distal tip. This larger lumen also accommodates larger therapeutic devices like the Penumbra System® and Penumbra Coil 400™ devices. The devices are provided sterile, non-pyrogenic, and intended for single use only.
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
Non-Clinical Data:
- Biocompatibility: Tests conducted with the Neuron MAX System were selected in accordance with ISO 10993 -1 guidelines for limited duration (
§ 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
KI11380 page 1.0+5
JUL 19 2011
510(k) Summary of Safety & Effectiveness 9
(as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra Inc. is providing the summary of Substantial Equivalence for the Neuron™ MAX System.
9.1 Sponsor/Applicant Name and Address
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA
9.2 Sponsor Contact Information
Michaela Mahl Regulatory Program Manager Phone: (510) 748-3288 FAX: (510) 217-6414 Email: michaela.mahl@penumbrainc.com
Date of Preparation of 510(k) Summary 9.3
June 24, 2011
Device Trade or Proprietary Name 9.4
Neuron™ MAX System
9.5 Device Classification
Regulatory Class: II Cardiovascular Classification Panel: Percutaneous Catheter Classification Name: 21 CFR § 870.1250 Regulation Number: Product Code: DQY
9.6 Predicate Devices
| 510(k) Number /
Clearance Date | Name of Predicate Device | Name of
Manufacturer |
|-----------------------------------|-------------------------------------------------------|-------------------------|
| K070970 / 17Aug2007 | Neuron Intracranial Access System
053, Model 5F/6F | Penumbra, Inc. |
| K082290 / 31Oct2008 | Neuron Delivery Catheter 070 | Penumbra, Inc. |
| K083125 / 21Nov2008 | Neuron Select Catheter 070 | Penumbra, Inc. |
1
Image /page/1/Picture/0 description: The image shows handwritten text that reads "K111380 page 2 of 5". The text appears to be a page number or document identifier. The handwriting is legible, and the text is centered in the image.
9.7 Device Description
The Neuron MAX System is an additional configuration to the currently available Neuron Intracranial Access System. The Neuron Max System provides a larger lumen to assist in utilizing contrast injections to further optimize anatomical visualization while maintaining a flexible distal tip. This larger lumen also accommodates larger therapeutic devices like the Penumbra System® and Penumbra Coil 400™ devices. The devices are provided sterile, non-pyrogenic, and intended for single use only.
9.8 Intended Use
The Neuron™ MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Summary of Non-Clinical Data و .و
As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of any information regarding safety and effectiveness of the device follows.
Included in this section are descriptions of the testing's, which substantiates the safe and effective performance of the Neuron MAX System as well as its substantial equivalence to the predicate devices:
- . Biocompatibility
- Design Verification (Bench-Top Testing) .
- Animal Study .
The subject Neuron MAX System met all established requirements.
Biocompatibility Testing 9.9.1
Biocompatibility tests conducted with the Neuron MAX System were selected in accordance with ISO 10993 -1 guidelines (Biological Evaluation of Medical Devices) for limited duration (> (Part 21 CFR 801 Subpart D)
AND/OR Over The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sigh-Off) Division of Cardiovaso r Devices 510(k) Number .. (