(160 days)
Not Found
No
The description focuses on the physical components and function of a catheter system for vascular access, with no mention of AI or ML technologies.
No
The device is described as an "Access System" or "Delivery Catheter" for introducing other interventional devices and facilitating navigation; it does not itself provide a therapeutic effect.
No
The device description states that the Benchmark™ Intracranial Access System is designed to aid in accessing target vasculature and to support other diagnostic or therapeutic devices, and facilitates delivery of diagnostic and/or therapeutic agents. It is an access system for interventional procedures, not a diagnostic device itself.
No
The device description explicitly states it is composed of a Delivery Catheter and a Select Catheter, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 procedural purposes, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a "Delivery Catheter (guide catheter)" and a "Select Catheter (microcatheter)" used to "facilitate navigation to the target vascular location and delivery of the necessary diagnostic and/or therapeutic agents." This further reinforces its role as an interventional tool used directly on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural and interventional.
N/A
Intended Use / Indications for Use
The Benchmark™ Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Product codes
DQY
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.
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
The performance studies included Biocompatibility Testing and Bench-top Testing. No animal study was required.
Biocompatibility tests were conducted on the materials of the Benchmark™ Intracranial Access System in accordance with EN ISO 10993 -1 guidelines for limited duration (= 0.5°C
- In Vitro Hemolysis: Non-hemolytic: Hemolytic Index = 0.70% - 1.04%; Corrected Hemolytic index = 0.00% - 0.23%
- Complement Activation: 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.
- Dog Thrombogenicity: Test Device was non-thrombogenic after 4 hours in vivo when compared to a control device.
Bench-top testing (all 100% Pass unless otherwise specified):
- Dimensional/Visual Inspection: Pass
- Simulated Use (Intracranial Access & Vessel Access Entry Performance): Pass
- Catheter Coating Integrity (N=30): 100% Pass
- Catheter Coating Integrity (N=10): 100% Pass
- Particulate Testing (Catheter Hydrophilic Coating) (N=10): 10 micrometers - 100% Pass; 25 micrometers - 100% Pass; 75 micrometers - 100% Pass; 125 micrometers - 100% Pass
- Hub/Catheter Air Aspiration (N=30): 100% Pass
- Pressure Test (N=30): 100% Pass
- Benchmark Delivery Catheter / Sheath compatibility (Friction Force) (N=30): 100% Pass
- Benchmark Delivery Catheter / Benchmark Select Catheter compatibility (Friction Force) (N=30): 100% Pass
- Catheter Shaft Tensile Strength (includes all joints) (N=30): 100% Pass
- Hub to Shaft & Hub to Hypotube Bond Strength (N=30): 100% Pass
- Elongation to Failure – Catheter (N=30): 100% Pass
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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
1
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
2
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 of
Manufacturer |
|-----------------------------------|------------------------------|-------------------------|
| K082290 / 31Oct2008 | Neuron Delivery Catheter 070 | Penumbra, Inc. |
| K083125 / 21Nov2008 | Neuron Select Catheter 070 | Penumbra, Inc. |
7
4
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 |
5
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 (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 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 |
| Rabbit Pyrogen Study | Sample Extracts must not
cause a total rise in body
temperature of $\ge$ 0.5°C | Non-pyrogenic: No
evidence of material-
mediated pyrogenicity; no
single animal had a total
body temperature rise of
$\ge$ 0.5°C | Pass |
| Hemocompatibility | | | |
| | In Vitro Hemolysis
[Extract Methode] | Sample extracts must be non-
hemolytic ( $\le$ 2% hemolytic
index) | Non-hemolytic:
Hemolytic Index = 0.70% -
1.04%
Corrected Hemolytic index
= 0.00% - 0.23% |
| 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 |
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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 | Sample
Size | Specification | Acceptance
Criteria | Results |
|----------------------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------|
| Dimensional/
Visual Inspection | | These evaluations confirm that the units used in this Design
Verification testing meet all inspection criteria for release of
finished goods (clinically acceptable) product. | | Pass |
| Simulated Use
[Intracranial
Access & Vessel
Access Entry
Performance] | | Simulated use testing of the Benchmark Delivery Catheter and
Benchmark Select Catheter was performed with accessory
devices in an anatomical model which simulated the tortuosity
of the neurovasculature. | | 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: