(64 days)
The Neuron MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
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.
The provided text describes the non-clinical testing performed for the Penumbra Neuron™ MAX System to demonstrate its safety and effectiveness and substantial equivalence to predicate devices. It does not contain information about studies conducted on diagnostic devices with acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. Therefore, I cannot provide a table of acceptance criteria and reported device performance in that sense.
However, I can summarize the acceptance criteria and the studies performed to meet those criteria based on the provided text for the Neuron™ MAX System, which is a medical device (catheter) for introducing interventional devices.
Here's a breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and the Reported Device Performance
For this type of device, "acceptance criteria" are generally that the device "Met established criteria" and "Reported device performance" is the outcome of the tests.
| Test Category | Specific Test / Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | In Vitro Cytotoxicity | No evidence of cell lysis or toxicity | No evidence of cell lysis or toxicity |
| Sensitization | Non-Sensitizing | Non-Sensitizing | |
| Acute Intracutaneous Reactivity (Irritation) | No evidence of irritation | No evidence of irritation | |
| Acute Systemic Toxicity | No evidence of systemic toxicity | No evidence of systemic toxicity | |
| Rabbit Pyrogen Study | No evidence of material-mediated pyrogenicity | No evidence of material-mediated pyrogenicity | |
| Hemo-compatibility (In Vitro Hemolysis) | Non-Hemolytic | Non-Hemolytic | |
| Hemo-compatibility (In Vitro Coagulation - PT, PTT) | Coagulation times not significantly different than corresponding control | Coagulation times are not significant different than corresponding control | |
| Hemo-compatibility (Partial Thromboplastin Time (PTT) Assay) | Non-Thrombogenic | Non-Thrombogenic | |
| Complement Activation | No greater biological response than corresponding control | No greater biological response than corresponding control | |
| Dog Thrombogenicity | Non-Thrombogenic | Non-Thrombogenic | |
| Genotoxicity (Mouse Lymphoma) | Non-Mutagenic | Non-Mutagenic | |
| Genotoxicity (Ames Mutagenicity) | Non-Mutagenic | Non-Mutagenic | |
| Genotoxicity (In Vivo Mouse Micronucleus) | Non-Clastogenic | Non-Clastogenic | |
| Bench-top Testing | Pouch Seal Strength | Met established criteria | Met established criteria |
| Dimensional / Visual Inspection | Units meet all inspection criteria for release of finished goods (clinically acceptable) | Met established criteria | |
| Simulated Use (Intracranial Access & Vessel Access Entry Performance) | Units meet all inspection criteria for release of finished goods (clinically acceptable) | Met established criteria | |
| Hub / Shaft & Mid-shaft or Shaft Tensile Strength (MAX 088 Delivery Catheter / Dilator, 6F Select Catheter) | Met established criteria | Met established criteria | |
| Hub Air Aspiration (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator) | Met established criteria | Met established criteria | |
| Burst Test (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator) | Met established criteria | Met established criteria | |
| Particulate Testing (Hydrophilic Coating) (MAX 088 Delivery Catheter) | Met established criteria | Met established criteria | |
| Friction Force (MAX 088 Delivery Catheter / 8F Sheath compatibility, etc.) | Met established criteria | Met established criteria | |
| Flow Rate (MAX 088 Delivery Catheter / 6F Select Catheter) | Met established criteria | Met established criteria | |
| Elongation to Failure (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator) | Met established criteria | Met established criteria | |
| Corrosion (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator / RHV / HVA) | Met established criteria | Met established criteria | |
| Torsion (MAX 088 Delivery Catheter / 6F Select Catheter) | Met established criteria | Met established criteria | |
| Animal Study | Vessel injury on final angiograms | No vessel injury noted | No vessel injury was noted |
| Gross or histology findings in test vessel segments | No abnormal gross or histology findings noted | No abnormal gross or histology findings were noted | |
| Significant vascular response | No significant vascular response in experimental conditions | The use of the Neuron MAX System resulted in no significant vascular response |
2. Sample size used for the test set and the data provenance
- Biocompatibility: The sample size for each specific test (e.g., number of cell cultures, animals for sensitization/toxicity tests) is not explicitly stated in the provided document. The data provenance is described as "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices," indicating a regulatory framework for the testing, likely conducted in the USA or adhering to international standards.
- Bench-top Testing: The sample size for each test is not explicitly stated. The testing was conducted internally based on "standard test methods." Data provenance is not specified beyond being "Design Verification (Bench-Top Testing)."
- Animal Study: The sample size is referred to as "a swine model," meaning the study involved pigs. The number of animals is not specified. Data provenance is not specified beyond being "an animal study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the provided document, as it describes the testing of a medical device (catheter) for physical, mechanical, and biological compatibility, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3. Performance criteria are based on objective measurements and observations in laboratory and animal settings, not on expert consensus or adjudication.
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
This information is not applicable. The device is an interventional catheter, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable, as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the Neuron™ MAX System, the "ground truth" or reference for evaluating performance was:
- Biocompatibility: Established ISO 10993-1 guidelines, ASTM methods, and USP methods, focusing on biological responses (e.g., cell lysis, irritation, systemic toxicity, hemolysis, thrombogenicity, mutagenicity). The "ground truth" is adherence to these established biological safety profiles.
- Bench-top Testing: "Standard test methods" for physical and mechanical properties. The "ground truth" is meeting pre-determined engineering and functional specifications.
- Animal Study: Direct observation during and after the procedure (e.g., angiograms for vessel injury) and histopathological examination of tissues for gross or histology findings. The "ground truth" is the pathological and angiographic findings in the swine model.
8. The sample size for the training set
This information is not applicable, as the device is not an AI algorithm requiring a training set. The descriptions pertain to R&D and verification testing, not machine learning model development.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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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 ofManufacturer |
|---|---|---|
| K070970 / 17Aug2007 | Neuron Intracranial Access System053, Model 5F/6F | Penumbra, Inc. |
| K082290 / 31Oct2008 | Neuron Delivery Catheter 070 | Penumbra, Inc. |
| K083125 / 21Nov2008 | Neuron Select Catheter 070 | Penumbra, Inc. |
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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 (<24 hours), external communicating devices, contacting circulating blood. All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory In summary, non-clinical testing found the Neuron MAX System to be Practices. biocompatible according to the requirements of ISO 10993 requirements. The following tests were performed:
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:
| Test | Method | Results |
|---|---|---|
| In Vitro Cytotoxicity | ISO Elution Test (MEMExtract) | No evidence of celllysis or toxicity |
| Sensitization | ISO Maximization Test forDelayed Hypersenitivity | Non-Sensitizing |
| Acute IntracutaneousReactivity (Irritation) | ISO Intracutaneous(Intradermal) InjectionTest | No evidence ofirritation |
| Acute SystemicToxicity | ISO Acute SystemicInjection Test | No evidence ofsystemic toxicity |
| Rabbit Pyrogen Study | USP Material-MediatedRabbit Pyrogen Test | No evidence ofmaterial-mediatedpyrogenicity |
| Hemo-compatibility | ||
| - In Vitro Hemolysis | ASTM Methode(Extraction & DirectContact) | Non-Hemolytic |
| - In Vitro Coagulation(PT, PTT) | Prothrombin Time (PT)Assay | Coagulation timesare not significantdifferent thancorrespondingcontrol |
| Partial ThromboplastinTime (PTT) Assay | Non-Thrombogenic | |
| ComplementActivation | C3a and SC5b-9 throughEnzyme Assay | No greaterbiological responsethan correspondingcontrol |
| Dog Thrombogenicity | Thrombogenicity Study inDogs - ISO | Non-Thrombogenic |
| Genotoxicity | ||
| - Mouse Lymphoma | Mouse LymphomaMutagenesis Assay - ISO | Non-Mutagenic |
| - Ames Mutagenicity | Ames Test | Non-Mutagenic |
| - In Vivo MouseMicronucleus | Micronucleus Assay - ISO | Non-Clastogenic |
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Bench-top Testing 9.9.2
The physical and mechanical properties of the Neuron MAX System were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed:
| Test / Test Subject | Attribute | Result |
|---|---|---|
| Pouch Seal | Pouch Seal Strength | Met established criteria |
| Dimensional / VisualInspection | These evaluations confirm that the unitsused in this Design Verification testing meetall inspection criteria for release of finishedgoods (clinically acceptable) product. | Met established criteria |
| Simulated Use[Intracranial Access& Vessel AccessEntry Performance] | These evaluations confirm that the unitsused in this Design Verification testing meetall inspection criteria for release of finishedgoods (clinically acceptable) product. | Met established criteria |
| MAX 088 DeliveryCatheter / Dilator | Hub /Shaft & Mid-shaft or Shaft TensileStrength | Met established criteria |
| 6F Select Catheter | Hub /Shaft & Mid-shaft TensileStrength | Met established criteria |
| MAX 088 Delivery | Hub Air Aspiration | Met established criteria |
| Catheter / 6F SelectCatheter / Dilator | Burst Test | Met established criteria |
| MAX 088 DeliveryCatheter | Particulate Testing (Hydrophilic Coating) | Met established criteria |
| MAX 088 DeliveryCatheter / 8F Sheathcompatibility | Friction Force | Met established criteria |
| MAX 088 DeliveryCatheter / 6F SelectCatheter compatibility | Friction Force | Met established criteria |
| 6F Select Catheter /0.038" Guidewirecompatibility | Friction Force | Met established criteria |
| MAX 088 DeliveryCatheter / NeuronMAX Dilatorcompatibility | Friction Force | Met established criteria |
| Neuron MAX Dilator/ 0.038" Guidewirecompatibility | Friction Force | Met established criteria |
| MAX 088 DeliveryCatheter / 6F SelectCatheter | Flow Rate | Met established criteria |
| MAX 088 DeliveryCatheter / 6F Select | Elongation to Failure | Met established criteria |
| Test / Test Subject | Attribute | Result |
| Catheter / Dilator | ||
| MAX 088 DeliveryCatheter / 6F SelectCatheter / Dilator /RHV / HVA | Corrosion | Met established criteria |
| MAX 088 DeliveryCatheter / 6F SelectCatheter | Torsion | Met established criteria |
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The results of the tests appropriately address the physical and mechanical performance expectations of the device. This is further supported by the surgical handling and performance results reported in the in vivo study. Based on these overall results, the physical and mechanical properties of the Neuron MAX System are acceptable for the intended use and substantially equivalent to the predicate devices.
9.9.3 Animal Study
An animal study was conducted to evaluate the safe use of the Neuron MAX System in a swine model. The study concluded that:
- No vessel injury was noted on the final angiograms following the vessel response . procedure.
- No abnormal gross or histology findings were noted in test vessel segments. .
- The use of the Neuron MAX System resulted in no significant vascular response . in these experimental conditions.
9.9.4 Summary of Substantial Equivalence
The Neuron MAX System is substantially equivalent to the predicate devices with regard to intended use, operating principle, design concept, materials, shelf-life, packaging and sterilization processes.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Penumbra, Inc. c/o Ms. Michaela Mahl Regulatory Program Manager 1351 Harbor Bay Parkway Alameda, CA 94502
Re: K11380 Trade/Device Name: Neuron™ MAX System Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DOY Dated: June 24, 2011 Received: June 27, 2011
JUL 1 9 2011
Dear Ms. Mahl:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Michaela Mahl
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10 Statement of Indication for Use
Indications for Use 510(k) Number (if known): KIII380
Device Name:____ Neuron™ MAX System
Indications for Use:
The Neuron MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Prescription Use >> (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 .. (
§ 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).