Benchmark BMX96 Access System
Device Facts
| Record ID | K201271 |
|---|---|
| Device Name | Benchmark BMX96 Access System |
| Applicant | Penumbra, Inc. |
| Product Code | DQY · Cardiovascular |
| Decision Date | Jun 11, 2020 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for Use
The Benchmark BMX96 System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Device Story
Benchmark BMX96 System is a three-component percutaneous catheter system consisting of a delivery catheter, Neuron 6F Select catheter, and a dilator. Used by trained physicians in interventional procedures to access peripheral, coronary, and neuro vasculature. The dilator facilitates atraumatic skin-to-vessel entry. The delivery catheter, used with a 0.038-inch guidewire or the Neuron 6F Select catheter, provides a conduit for interventional devices. The system is single-use and ethylene oxide sterilized. Physicians operate the device under fluoroscopic guidance to navigate the vasculature. Output is the physical access path created for subsequent interventional tools, enabling minimally invasive treatment of vascular conditions.
Clinical Evidence
No clinical or animal data were provided. Substantial equivalence was established through bench testing, including dimensional/visual testing, friction, fluoroscopy, simulated use (flow model/vessel entry), particulate, hub air aspiration, tensile/elongation, burst, and corrosion resistance testing. Biocompatibility was verified per ISO 10993 and USP standards, including cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility testing.
Technological Characteristics
Three-component system: delivery catheter (single lumen, variable stiffness, stainless steel hypotube reinforcement), Neuron 6F Select catheter (braid-reinforced, variable stiffness), and dilator. Materials include polyurethane and polyether block amide. Features radiopaque marker bands and Luer hubs. EO sterilized per ISO 11135. Shelf life 36 months. Compatible with 0.038 in. guidewires.
Indications for Use
Indicated for introduction of interventional devices into peripheral, coronary, and neuro vasculature in patients requiring such procedures.
Regulatory Classification
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.
Predicate Devices
- Neuron MAX System (K111380)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 11, 2020
Penumbra, Inc. Matthew Benenati Regulatory Affairs Specialist II One Penumbra Place Alameda, California 94502
Re: K201271
Trade/Device Name: Benchmark BMX96 System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: May 11, 2020 Received: May 12, 2020
Dear Matthew Benenati:
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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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,
Xiaolin Zheng, Ph.D., M.S. 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) K201271
Device Name Benchmark BMX96 System
Indications for Use (Describe)
The Benchmark BMX96 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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "Penumbra" in a red font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the right side of the "P" to the edge of the circle. The logo is simple and modern.
### 510(k) Summary
### K201271
(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 BMX96 Access System
### 1.1 Submitter
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
Contact Person: Matthew Benenati Regulatory Specialist II Tel: (510) 995-9705 Fax: (510) 217-6414 E-mail: mbenenati@penumbrainc.com
Date of Preparation: June 9, 2020
### 1.2 Subject Device
Benchmark BMX96 System
Regulatory Class: II Classification Panel: Neurology Classification Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1250 Product Codes: QJP, DQY
### 1.3 Predicate Device
Neuron MAX System (K111380)
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
### 1.4 Device Description
The Benchmark BMX96 System is a three-component system comprised of the Benchmark BMX96 Delivery Catheter, Neuron 6F Select Catheter, and a Dilator. The
{4}------------------------------------------------
# Penu
Benchmark BMX96 Delivery Catheter can be used individually with a 0.038 in. [0.97 mm] guidewire or together with the Neuron 6F Select Catheter to access the desired anatomy.
### Benchmark BMX96 Delivery Catheter
The Benchmark BMX96 Delivery Catheter is a single lumen, variable stiffness catheter with a radiopaque marker band on the distal end and a Luer hub on the proximal end. The Benchmark BMX96 Delivery Catheter dimensions are included on the individual device label. The Benchmark BMX96 Delivery Catheter is compatible with introducer sheaths appropriately sized for the outer diameter of Benchmark BMX96.
## Neuron 6F Select Catheter
The Neuron 6F Select Catheter is a single lumen, braid-reinforced, variable stiffness catheter with a radiopaque distal end and a Luer hub on the proximal end. The Neuron 6F Select Catheter is available in four tip shapes (SIM, H1, BER, or SIM-V). The Neuron 6F Select Catheter tip shape and dimensions are included on the individual device label. The Neuron 6F Select Catheter is compatible with the Benchmark BMX96 Delivery Catheter.
### Dilator
The Dilator is a single lumen, radiopaque catheter with a tapered distal end and a Luer hub on the proximal end. The Dilator is compatible with the Benchmark BMX96 Delivery Catheter. The Dilator facilitates the percutaneous entry of the Benchmark BMX96 Delivery Catheter by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.
The Benchmark BMX96 System is a single-use, ethylene oxide (EO) sterilized system.
The Benchmark BMX96 System should be used in interventional procedures by trained physicians.
#### Indications For Use 1.5
The Benchmark BMX96 System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "Penumbra" in red font, followed by a red circle with a white "P" inside. The "P" is outlined in silver. The logo is simple and modern. The word "Penumbra" is written in a sans-serif font.
#### Comparison of Technological Characteristics with the Predicate Device 1.6
The subject device Benchmark BMX96 System has similar technological characteristics to the previously cleared predicate device. At a high level, the subject and predicate devices are based on the following same technological elements:
- . Delivery Catheter dimensions (outer diameter (OD), maximum effective length, distal flexible length)
- Delivery Catheter tip shapes .
- . Sterilization method (EO)
- . 36-month shelf life
The following technological differences exist between the subject and predicate devices:
- Stainless steel hypotube shaft reinforcement (replaced braided coil reinforcement) ●
- Catheter Inner Diameter (0.096 in.) ●
- Shorter effective length options .
- Slightly longer hydrophilic coating length ●
- Modified catheter extrusions to include additional polyurethane and polyether ● block amide materials
- . Dilator OD, length
#### 1.7 Performance Data
The following performance data were provided in support of the substantial equivalence determination.
- Design Verification ●
- Biocompatibility ●
- Shelf Life ●
- Sterilization
- Packaging
The subject device met all established requirements.
#### Design Verification Testing 1.7.1
- . Dimensional/Visual Testing
- Friction Testing
- Fluoroscopy Testing
- Simulated Use Testing (Flow Model and Vessel Entry) .
- . Particulate Testing
- Hub Air Aspiration Testing .
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image contains the word "Penumbr" in a bold, sans-serif font, colored in a dark red hue. To the right of the word is a circular logo, also in dark red, featuring a stylized letter "P" formed by a white line against the red background. The logo is simple and modern, complementing the clean typography of the wordmark.
- Tensile and Elongation Testing ●
- Burst Testing
- Corrosion Resistance ●
- Shelf life ●
- Packaging ●
- Sterilization in accordance with ISO 11135 and ISO 10993-7 ●
#### 1.7.2 Biocompatibility
The biocompatibility evaluation for Benchmark BMX96 System was conducted in accordance with ISO 10993-1, USP standards, and FDA Good Laboratory Practices (GLP) as recognized by FDA. The battery of testing included the following tests:
- In vitro Cytotoxicity (MEM Elution) ●
- Sensitization: Magnusson-Kligman Method
- Irritation: Intracutaneous Toxicity ●
- Systemic Toxicity: Acute Systemic Injection ●
- Systemic Toxicity: Material Mediated Pyrogen ●
- Hemocompatibility .
- In vitro Thrombogenicity o
- Prothrombin Time (PT) O
- Partial Thromboplastin Time (PTT) o
- Complement Activation o
- Hemolysis (indirect contact) o
- Hemolysis (direct contact) o
Biocompatibility test results demonstrate biological safety per ISO 10993 and USP requirements.
#### Performance Data - Animal, Clinical 1.7.3
No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
#### Conclusions 1.8
The subject Benchmark BMX96 System is substantially equivalent to the predicate device Neuron MAX. The subject device has identical intended use as the predicate device. The device testing described in the 510(k) Summary demonstrate the subject devices are substantially equivalent to the predicate device in regard to operating principle, design concept, fundamental technology and device performance.
