(262 days)
No
The 510(k) summary describes a physical medical device (catheter system) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is an access system intended to facilitate the introduction and delivery of other interventional (therapeutic) devices, not to provide therapy itself.
No
This device is designed to aid in the introduction and delivery of interventional devices, facilitating access and navigation within the vasculature. It does not perform any diagnostic function.
No
The device description explicitly states it is composed of a Delivery Catheter and a Select Catheter, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Benchmark Intracranial Access System is used for the introduction of interventional devices into the vasculature. This is a device used within the body for a procedural purpose, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or any other activities typically associated with IVD devices.
This device is an interventional medical device used to facilitate procedures within the vascular system.
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
QJP, DQY
Device Description
The Benchmark Intracranial Access System is designed to aid the physician in accessing the target vasculature during interventional procedures. The Benchmark Intracranial Access System is composed of a Delivery Catheter used for introduction of interventional devices and a corresponding Select Catheter. Use of the Benchmark Intracranial Access System facilitates navigation to the target vascular location and delivery of interventional devices. The Benchmark Intracranial Access System devices are compatible with off-theshelf accessories. Various lengths and distal shapes of both the Benchmark Delivery Catheter and 5F Select Catheter are provided for physician convenience.
The Benchmark Intracranial Access System will be available in two packaging configurations:
- The Benchmark Delivery Catheter is individually packaged.
- The Benchmark Delivery Catheter is pre-packaged with a 5F Select Catheter . (K083125).
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
physicians who have received appropriate training in interventional techniques.
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
Bench-top Performance.
The subject device met all established requirements.
The following bench-top performance tests were performed on the subject device and all have met the acceptance criteria:
- . Particulate Testing and Coating Integrity Testing.
- . Simulated Use Testing.
Biocompatibility
The subject Benchmark Intracranial Access System is categorized as a limited exposure (
§ 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
May 27, 2022
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Penumbra, Inc. Buu Buu Ly Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502
Re: K212838
Trade/Device Name: Benchmark Intracranial Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: April 27, 2022 Received: April 29, 2022
Dear Buu Buu Ly:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212838
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) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 subject Benchmark™ Intracranial Access System
Submitter 1.1
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
Contact person: Buu Buu Ly Regulatory Specialist III Tel: (510) 995-2332 Fax: (510) 217-6414 E-mail: bly@penumbrainc.com
Date of preparation: May 26, 2022
1.2 Subject Device
Benchmark Intracranial Access System
Regulatory Class: II Classification Panel: Neurology Classification Name: Catheter, Percutaneous, Neurovasculature Regulation Number: 21 CFR 870.1250 Product Code: QJP, DQY
Predicate Device 1.3
Benchmark Intracranial Access System (K142321)
No reference devices were used in this submission.
1.4 Device Description
The Benchmark Intracranial Access System is designed to aid the physician in accessing the target vasculature during interventional procedures. The Benchmark Intracranial
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Access System is composed of a Delivery Catheter used for introduction of interventional devices and a corresponding Select Catheter. Use of the Benchmark Intracranial Access System facilitates navigation to the target vascular location and delivery of interventional devices. The Benchmark Intracranial Access System devices are compatible with off-theshelf accessories. Various lengths and distal shapes of both the Benchmark Delivery Catheter and 5F Select Catheter are provided for physician convenience.
Intended users for the Benchmark Intracranial Access System are physicians who have received appropriate training in interventional techniques. The devices are provided sterile, non-pyrogenic, and are intended for single use only.
The Benchmark Intracranial Access System will be available in two packaging configurations:
- The Benchmark Delivery Catheter is individually packaged. ●
- The Benchmark Delivery Catheter is pre-packaged with a 5F Select Catheter . (K083125).
Indications For Use 1.5
The Benchmark Intracranial Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
1.6 Comparison of Technological Characteristics with the Predicate Device
The subject and predicate devices have identical technological characteristics.
The only difference between the subject and predicate devices are additional instructions added to the instructions for use (IFU) for the subject device related to radial access use.
1.7 Performance Data
The following performance data were provided in support of the substantial equivalence determination:
- Bench-top Performance.
The subject device met all established requirements.
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1.7.1 Bench-top Performance
The following bench-top performance tests were performed on the subject device and all have met the acceptance criteria:
- . Particulate Testing and Coating Integrity Testing.
- . Simulated Use Testing.
1.7.2 Biocompatibility
The subject Benchmark Intracranial Access System is categorized as a limited exposure (