(160 days)
The Benchmark™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Benchmark™ Intracranial Access System is designed to aid the physician in accessing the target vasculature during interventional procedures. Benchmark Intracranial Access System is composed of a Delivery Catheter (guide catheter) used to support other diagnostic or therapeutic devices and a corresponding Select Catheter (microcatheter). Use of the Benchmark Intracranial Access System facilitates navigation to the target vascular location and delivery of the necessary diagnostic and/or therapeutic agents. The Benchmark Intracranial Access System devices are compatible with off-the-shelf accessories. Various lengths and distal shapes of both the Benchmark Delivery Catheter and 5F Select Catheter are provided for physician convenience.
The provided document K142321 is a 510(k) Pre-market Notification for the Penumbra, Inc. Benchmark™ Intracranial Access System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving novel clinical effectiveness through a comparative effectiveness study. As such, the information requested regarding acceptance criteria and studies would primarily relate to non-clinical performance and biocompatibility.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Please refer to the tables below, which are directly extracted and compiled from Section 7.10.1 Biocompatibility Testing and 7.10.2 Bench-top Testing of the document.
Biocompatibility Testing
| Test | Acceptance Criteria | Reported Device Performance | Pass / Fail |
|---|---|---|---|
| In Vitro Cytotoxicity | Sample extracts must yield cell lysis grade 2 or lower | Grade 0-1: None to Slight | Pass |
| Sensitization | Test Group shall yield Grade < 1 score on Magnusson and Kligman scale (provided control Grade < 1) | Grade 0: No visible change | Pass |
| Acute Intracutaneous Reactivity (Irritation) | The difference in the mean test article and mean control score must be grade 1.0 or lower | Grade <= 1.0 difference between mean test article and mean control score | Pass |
| Acute Systemic Toxicity | Sample extracts must not cause: > 10% weight loss in 3 or more test animals, Mortality of 2 or more test animals, Abnormal behavior in 2 or more test animals | No evidence of systemic toxicity from sample extracts: No weight loss, No death, All test animals appeared normal | Pass |
| Rabbit Pyrogen Study | Sample Extracts must not cause a total rise in body temperature of >= 0.5°C | Non-pyrogenic: No evidence of material-mediated pyrogenicity; no single animal had a total body temperature rise of >= 0.5°C | Pass |
| In Vitro Hemolysis [Extract Method] | Sample extracts must be non-hemolytic (<= 2% hemolytic index) | Non-hemolytic: Hemolytic Index = 0.70% - 1.04%, Corrected Hemolytic index = 0.00% - 0.23% | Pass |
| Complement Activation | The concentrations of C3a and SC5b-9 in the test samples are statistically similar to the predicate (Exposure Control & Ref Material) control and statistically lower than the positive control for all exposure times | The test sample concentrations of C3a and SC5b-9 were statistically similar or lower than the predicate control sample concentrations, and statistically lower than the positive control sample concentration | Pass |
| Dog Thrombogenicity | The device must be non-thrombogenic after 4 hours in vivo when compared to a control device | Test Device was non-thrombogenic after 4 hours in vivo when compared to a control device | Pass |
Bench-top Testing
| Attribute | Sample Size | Specification | Acceptance Criteria | Results |
|---|---|---|---|---|
| Dimensional/Visual Inspection | Not Specified | These evaluations confirm that the units used in this Design Verification testing meet all inspection criteria for release of finished goods (clinically acceptable) product. | Not Specified (implied to meet specification) | Pass |
| Simulated Use [Intracranial Access & Vessel Access Entry Performance] | Not Specified | Simulated use testing of the Benchmark Delivery Catheter and Benchmark Select Catheter was performed with accessory devices in an an anatomical model which simulated the tortuosity of the neurovasculature. | Not Specified (implied to meet specification) | Pass |
| Catheter Coating Integrity | N=30 | Coating has not delaminated, peeled, or flaked after simulated use | 100% Must meet Specification | 100% Pass |
| N=10 | Coating has not further delaminated, peeled, or flaked from coating integrity baseline | 100% Must meet Specification | 100% Pass | |
| Particulate Testing (Catheter Hydrophilic Coating) | N=10 | The maximum number of particles: <= 6000 particles >= 10 µm, <= 600 particles >= 25 µm, <= 600 particles >= 75 µm, 0 particles >= 125 µm | 100% Must meet Specification | 10 µm - 100% Pass, 25 µm - 100% Pass, 75 µm - 100% Pass, 125 µm - 100% Pass |
| Hub/Catheter Air Aspiration | N=30 | When negative pressure is pulled, no air may leak into hub | 100% Must meet Specification | 100% Pass |
| Pressure Test | N=30 | 45 psi for 30 sec MIN | 100% Must meet Specification | 100% Pass |
| Benchmark Delivery Catheter / Sheath compatibility (Friction Force) | N=30 | Maximum value per specification | 100% Must meet Specification | 100% Pass |
| Benchmark Delivery Catheter / Benchmark Select Catheter compatibility (Friction Force) | N=30 | Maximum value per specification | 100% Must meet Specification | 100% Pass |
| Catheter Shaft Tensile Strength (includes all joints) | N=30 | Minimum value per specification | 100% Must meet Specification | 100% Pass |
| Hub to Shaft & Hub to Hypotube Bond Strength | N=30 | Minimum value per specification | 100% Must meet Specification | 100% Pass |
| Elongation to Failure – Catheter | N=30 | % Elongation >= 5% | 100% Must meet Specification | 100% Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- For Biocompatibility studies, sample sizes vary by test as detailed in the Biocompatibility table above (e.g., cell culture for cytotoxicity, animal models for sensitization, irritation, systemic toxicity, pyrogen, and some hemocompatibility tests).
- For Bench-top testing, sample sizes are N=10 or N=30 for most tests, as specified in the Bench-top table above.
- No human clinical test set is described or required for this 510(k) submission.
- Data Provenance: The document does not specify the country of origin for the data. All studies are described as "non-clinical" or "bench-top testing." Biocompatibility studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. These are prospective non-clinical laboratory studies.
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 510(k) submission is for a medical device (catheter system) and relies on non-clinical (biocompatibility and bench-top engineering/performance) testing, not on interpretation of medical images or clinical outcomes that would require expert human review for ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human reviewers assess data (e.g., medical images) to establish a consensus ground truth. The presented studies are non-clinical engineering and biological tests with objective acceptance criteria.
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
No. A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and would not be relevant for this type of medical device (intracranial access system). This submission is for hardware, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an algorithm or AI device; it's a physical medical device. Performance is evaluated through standard engineering and biological tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical studies is defined by objective, pre-determined acceptance criteria based on established engineering standards and biological safety guidelines (e.g., ISO 10993). Examples include specific thresholds for cell lysis grade, weight loss, temperature rise, particle counts, tensile strength, and pressure resistance.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device. The studies described are validation tests for device performance and safety.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
Penumbra, Inc. Ms. Michaela Mahl Senior Manager, Regulatory Affairs 1351 Harbor Bay Parkway Alameda, California 94502
Re: K142321
Trade/Device Name: Benchmark Intracranial Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 15, 2014 Received: December 16, 2014
Dear Ms. Michaela 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena - SD/△
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142321
Device Name Benchmark Intracranial Access System
Indications for Use (Describe)
The Benchmark™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Research Use (Per 21 CFR 201.66 and .68) Over-The-Counter Use (21 CFR 201.66 and .68) | Research Use (Per 21 CFR 201.66 and .68) | Over-The-Counter Use (21 CFR 201.66 and .68) |
| Research Use (Per 21 CFR 201.66 and .68) | Over-The-Counter Use (21 CFR 201.66 and .68) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
(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 Benchmark™ Intracranial Access System.
7.1 Sponsor/Applicant Name and Address
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502, USA
7.2 Sponsor Contact Information
Michaela Mahl Senior Manager, Regulatory Affairs Phone: (510) 748-3288 FAX: (510) 217-6414 Email: michaela.mahl@penumbrainc.com
7.3 Date of Preparation of 510(k) Summary
January 20, 2015
7.4 Device Trade or Proprietary Name
Benchmark™ Intracranial Access System
7.5 Device Classification
| Regulatory Class: | ll |
|---|---|
| Classification Panel: Cardiovascular | |
| Classification Name: Percutaneous Catheter | |
| Regulation Number: | 21 CFR § 870.1250 |
| Product Code: | DOY |
7.6 Predicate Devices
| 510(k) Number /Clearance Date | Name of Predicate Device | Name ofManufacturer |
|---|---|---|
| K082290 / 31Oct2008 | Neuron Delivery Catheter 070 | Penumbra, Inc. |
| K083125 / 21Nov2008 | Neuron Select Catheter 070 | Penumbra, Inc. |
7
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7.7 Predicate Comparison
| System Name | Neuron Intracranial Access System | Benchmark Intracranial Access System |
|---|---|---|
| Device Name | Neuron 070 Delivery Catheter | Benchmark Delivery Catheter |
| 510(k) No. | K082290 | K142321 |
| Classification | Class II, DQY | SAME |
| Indication | The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | The Benchmark Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. |
| Catheter Materials | Commonly used medical grade plastics & stainless steel | SAME |
| Outer Dimension | 6F (0.081 in -0.083 in) | SAME |
| Inner Dimension | 0.070 in Min | SAME |
| Effective Length | 95 cm, 105 cm | 95 cm, 105 cm, 115 cm |
| Tip Shapes | Straight & Multi-Purpose | SAME |
| Packaging Materials | Commonly used medical device packaging materials | SAME |
| Sterilization | EtO | SAME |
| Shelf-Life | 36 Months | 12 Months [36 Months in-process] |
| System Name | Neuron Intracranial Access System | Benchmark Intracranial Access System |
|---|---|---|
| Device Name | Neuron Select Catheter 070 | 5F Select Catheter |
| 510(k) No. | K083125 | K142321 |
| Classification | Class II, DQY | Class II, DQY |
| Indication | The Neuron Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. | The Benchmark Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. |
| Catheter Materials | Commonly used medical grade plastics & stainless steel | SAME |
| Outer Dimension | 5F (0.069in Max) | SAME |
| Inner Dimension | 0.043 in Max | SAME |
| Effective Length | 123 cm & 131.5cm | SAME |
| Tip Shapes | Berenstein, H1 & Simmons | SAME |
| Packaging Materials | Commonly use medical device packaging materials | SAME |
| Sterilization | EtO | SAME |
| Shelf-Life | 36 Months | SAME |
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7.8 Device Description
The Benchmark™ Intracranial Access System is designed to aid the physician in accessing the target vasculature during interventional procedures. Benchmark Intracranial Access System is composed of a Delivery Catheter (guide catheter) used to support other diagnostic or therapeutic devices and a corresponding Select Catheter (microcatheter). Use of the Benchmark Intracranial Access System facilitates navigation to the target vascular location and delivery of the necessary diagnostic and/or therapeutic agents. The Benchmark Intracranial Access System devices are compatible with off-the-shelf accessories. Various lengths and distal shapes of both the Benchmark Delivery Catheter and 5F Select Catheter are provided for physician convenience.
7.9 Indications for Use
The Benchmark™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
7.10 Summary of Non-Clinical Data
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 Benchmark™ Intracranial Access System as well as its substantial equivalence to the predicate devices:
- Biocompatibility .
- Design Verification (Bench-Top Testing) .
The subject Benchmark™ Intracranial Access System met all established requirements.
7.10.1 Biocompatibility Testing
Biocompatibility tests conducted on the materials of the BenchmarkTM Intracranial Access System were selected in accordance with EN 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 Practices. In summary, non-clinical testing found the Benchmark™ Intracranial Access System to be biocompatible according to the requirements of EN ISO 10993 requirements. The following tests were performed and all tests passed successfully:
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| Test | Acceptance Criteria | Results | Pass / Fail |
|---|---|---|---|
| In Vitro Cytotoxicity | Sample extracts must yield celllysis grade 2 or lower | Grade 0-1: None to Slight | Pass |
| Sensitization | Test Group shall yield Grade <1 score on Magnusson andKligman scale (providedcontrol Grade < 1) | Grade 0: No visible change | Pass |
| Acute IntracutaneousReactivity (Irritation) | The difference in the mean testarticle and mean control scoremust be grade 1.0 or lower | Grade $\le$ 1.0 differencebetween mean test articleand mean control score | Pass |
| Systemic Toxicity | |||
| Acute Systemic Toxicity | Sample extracts must not causethe following:• > 10% weight loss in 3 ormore test animals• Mortality of 2 or more testanimals• Abnormal behavior in 2 ormore test animals | No evidence of systemictoxicity from sampleextracts• No weight loss• No death• All test animals appearednormal | |
| Rabbit Pyrogen Study | Sample Extracts must notcause a total rise in bodytemperature of $\ge$ 0.5°C | Non-pyrogenic: Noevidence of material-mediated pyrogenicity; nosingle animal had a totalbody temperature rise of$\ge$ 0.5°C | Pass |
| Hemocompatibility | |||
| In Vitro Hemolysis[Extract Methode] | Sample extracts must be non-hemolytic ( $\le$ 2% hemolyticindex) | Non-hemolytic:Hemolytic Index = 0.70% -1.04%Corrected Hemolytic index= 0.00% - 0.23% | |
| Complement Activation | The concentrations of C3a andSC5b-9 in the test samples arestatistically similar to thepredicate (Exposure Control &Ref Material) control andstatistically lower than thepositive control for allexposure times | The test sampleconcentrations of C3a andSC5b-9 were statisticallysimilar or lower than thepredicate control sampleconcentrations, andstatistically lower than thepositive control sampleconcentration | Pass |
| Dog Thrombogenicity | The device must be non-thrombogenic after 4 hours invivo when compared to acontrol device | Test Device was non-thrombogenic after 4 hoursin vivo when compared to acontrol device | Pass |
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7.10.2 Bench-top Testing
The physical and mechanical properties of the Benchmark™ Intracranial Access System were assessed using standard test methods and pre-determined acceptance criteria. The following tests were performed and all tests passed successfully:
| Attribute | SampleSize | Specification | AcceptanceCriteria | Results |
|---|---|---|---|---|
| Dimensional/Visual Inspection | These evaluations confirm that the units used in this DesignVerification testing meet all inspection criteria for release offinished goods (clinically acceptable) product. | Pass | ||
| Simulated Use[IntracranialAccess & VesselAccess EntryPerformance] | Simulated use testing of the Benchmark Delivery Catheter andBenchmark Select Catheter was performed with accessorydevices in an anatomical model which simulated the tortuosityof the neurovasculature. | Pass | ||
| Catheter CoatingIntegrity | N=30 | Coating has not delaminated,peeled, or flaked after simulateduse | 100% MustmeetSpecification | 100% Pass |
| N=10 | Coating has not furtherdelaminated, peeled, or flakedfrom coating integrity baseline | 100% MustmeetSpecification | 100% Pass | |
| ParticulateTesting (CatheterHydrophilicCoating) | N=10 | The maximum number ofparticles:<= 6000 particles ≥ 10 $μ$ m<= 600 particles ≥ 25 $μ$ m<= 600 particles ≥ 75 $μ$ m0 particles ≥ 125 $μ$ m | 100% MustmeetSpecification | 10 $μ$ m - 100% Pass25 $μ$ m - 100% Pass75 $μ$ m - 100% Pass125 $μ$ m - 100% Pass |
| Hub/Catheter AirAspiration | N=30 | When negative pressure ispulled, no air may leak into hub | 100% MustmeetSpecification | 100% Pass |
| Pressure Test | N=30 | 45 psi for 30 sec MIN | 100% MustmeetSpecification | 100% Pass |
| BenchmarkDeliveryCatheter / Sheathcompatibility(Friction Force) | N=30 | Maximum value perspecification | 100% MustmeetSpecification | 100% Pass |
| BenchmarkDeliveryCatheter /BenchmarkSelect Cathetercompatibility(Friction Force) | N=30 | Maximum value perspecification | 100% MustmeetSpecification | 100% Pass |
| Catheter ShaftTensile Strength(includes alljoints) | N=30 | Minimum value per specification | 100% MustmeetSpecification | 100% Pass |
| Attribute | SampleSize | Specification | AcceptanceCriteria | Results |
| Hub to Shaft &Hub to HypotubeBond Strength | N=30 | Minimum value per specification | 100% MustmeetSpecification | 100% Pass |
| Elongation toFailure –Catheter | N=30 | % Elongation ≥ 5% | 100% MustmeetSpecification | 100% Pass |
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The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the Benchmark™ Intracranial Access System are acceptable for the intended use and substantially equivalent to the predicate device.
7.10.3 Animal Study
No animal study was required.
7.10.4 Summary of Substantial Equivalence
The Benchmark™ Intracranial Access System is substantially equivalent to the predicate device with regard to intended use, operating principle, design concept, materials, shelflife, packaging and sterilization processes.
§ 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).