Who is the manufacturer of BENCHMARK BMX81 Access System?

Penumbra, Inc. filed the 510(k) submission for BENCHMARK BMX81 Access System (K221822).

What is the FDA product code for BENCHMARK BMX81 Access System?

QJP. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for BENCHMARK BMX81 Access System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BENCHMARK BMX81 Access System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BENCHMARK BMX81 Access System

K221822 · Penumbra, Inc. · QJP · Nov 4, 2022 · Cardiovascular

Device Facts

Record ID	K221822
Device Name	BENCHMARK BMX81 Access System
Applicant	Penumbra, Inc.
Product Code	QJP · Cardiovascular
Decision Date	Nov 4, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

The BENCHMARK BMX81 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

Device Story

Three-component system: BMX81 Delivery Catheter, Penumbra Select Catheter, and Dilator; used for percutaneous access to peripheral, coronary, and neuro vasculature. Delivery catheter features single lumen, variable stiffness, radiopaque markerband, and hydrophilic coating. Select catheter is braid-reinforced, variable stiffness 5F. Dilator provides atraumatic transition from skin to vessel. Used by trained physicians in interventional procedures. System facilitates introduction of interventional devices; provides access to desired anatomy. Single-use; EO sterilized.

Clinical Evidence

Bench testing only. No animal or clinical studies conducted. Performance data included visual/dimensional inspection, particulate, friction, simulated use, radiopacity, hub air aspiration, burst pressure, tensile/elongation, corrosion, leakage, kink resistance, torsion, and tip stiffness. Biocompatibility testing per ISO 10993-1 and USP standards confirmed non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic, and hemocompatible.

Technological Characteristics

Single lumen, variable stiffness delivery catheter; braid-reinforced 5F select catheter; tapered dilator. Hydrophilic coating on distal shaft. Radiopaque markerbands. EO sterilization per ISO 11135+A1. Biocompatibility per ISO 10993-1. Compatible with 0.038 in guidewires.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

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

Benchmark Intracranial Access System (K212838)

Reference Devices

Benchmark BMX96 System (K201271)
Neuron 5F Select Catheter (K083125)

Related Devices

K213390 — Benchmark BMX96 Access System · Penumbra, Inc. · Aug 18, 2022
K201271 — Benchmark BMX96 Access System · Penumbra, Inc. · Jun 11, 2020
K240746 — Neurovascular Access System Family · Q'Apel Medical, Inc. · Nov 20, 2024
K212838 — Benchmark Intracranial Access System · Penumbra, Inc. · May 27, 2022
K200910 — BOSS Balloon Guide Catheter · Marblehead Medical · May 2, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ November 4, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. Penumbra, Inc. Sindokht Soltanzadeh Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502 Re: K221822 Trade/Device Name: BENCHMARK BMX81 Access System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: October 7, 2022 Received: October 11, 2022 Dear Sindokht Soltanzadeh: 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 medical devices and radiation-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 -S 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) K221822 Device Name BENCHMARK BMX81 Access System Indications for Use (Describe) The BENCHMARK BMX81 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) ### 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 logo for Penumbra, Inc., a healthcare company. The word "Penumbra" is written in a bold, red font. To the right of the word is a red circle with a white "P" inside of it. A thin, gray line connects the word "Penumbra" to the "P" in the circle. ### 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 BMX81 Access System. #### 1.1 Submitter Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA Contact Person: Sindokht (Sisi) Soltanzadeh Regulatory Affairs Specialist III Tel: (510) 995-9799 Fax: (510) 217-6414 E-mail: ssoltanzadeh@penumbrainc.com Date of Preparation: November 2, 2022 #### Subject Device 1.2 BENCHMARK BMX81 Access System Regulatory Class: II Classification Panel: Neurology Classification Name: Catheter, Percutaneous, Neurovasculature Regulation Number: 21 CFR 870.1250 Product Code: QJP, DQY #### 1.3 Predicate/Reference Devices | 510(k) Number | Name of Device | |-------------------------|--------------------------------------| | Predicate Device | | | K212838 | Benchmark Intracranial Access System | | Reference Device | | | K201271 | Benchmark BMX96 System | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Penumbra" in red font. To the right of the word is a red circle with a white "P" inside. A thin gray line connects the end of the word "Penumbra" to the "P" inside the circle. ### Device Description 1.4 The BENCHMARK BMX81 Access System is a three-component system comprised of the BMX81 Delivery Catheter, Penumbra Select Catheter, and a Dilator. The BMX81 Delivery Catheter can be used individually with a 0.038 in [0.97 mm] guidewire or together with the Penumbra Select Catheter to access the desired anatomy. # BMX81 Delivery Catheter: The BMX81 Delivery Catheter is a single lumen, variable stiffness catheter with a radiopaque markerband on the distal end and a Luer hub on the proximal end. The BMX81 Delivery Catheter dimensions are included on the individual device label. The BMX81 Delivery Catheter is compatible with introducer sheaths appropriately sized for the outer diameter of BMX81 Delivery Catheter. The BMX81 Delivery Catheter has a hydrophilic coating on the distal segment of the catheter shaft. The hydrophilic coating length is 18 cm. ## Penumbra Select Catheter: The Penumbra Select Catheter is a single lumen, braid-reinforced, variable stiffness 5F catheter with a radiopaque distal end and a Luer hub on the proximal end. The Penumbra Select Catheter is available in tip shapes (SIM, H1, or BER). The Penumbra Select Catheter tip shape and dimensions are included on the individual device label. The Penumbra Select Catheter is compatible with the BMX81 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 BMX81 Delivery Catheter. The Dilator facilitates the percutaneous entry of the BMX81 Delivery Catheter by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel. The BENCHMARK BMX81 Access System is a single-use, ethylene oxide (EO) sterilized system. The BENCHMARK BMX81 Access System should only be used by physicians who have received appropriate training in interventional techniques. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Penumbr" in a red font. To the right of the word is a red circle with a white "P" inside. The "P" is connected to the word "Penumbr" by a thin white line. The logo is simple and modern. ### Indications For Use 1.5 The BENCHMARK BMX81 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. ### Comparison of Technological Characteristics with the Predicate/Reference 1.6 Devices The subject device BENCHMARK BMX81 Access System has similar technological characteristics to the previously cleared predicate and reference devices. At a high level, the subject and predicate and reference devices are based on the following same technological elements: - . Principles of Operation - Delivery Catheter materials ● - Delivery Catheter tip shapes ● - . Dilator materials and inner diameter (ID) - Neuron 5F Select Catheter (K083125)* ● - Accessories . - Sterilization method (EO) ● *Note: The Penumbra Select Catheter included in the subject BENCHMARK BMX81 Access System is identical to the Neuron 5F Select Catheter (K083125) and identical to the Select Catheter included in the predicate Benchmark Intracranial Access System (K212838). The following technological differences exist between the subject and predicate and reference devices: - . Delivery Catheter dimensions (inner diameter (ID), outer diameter (OD), Effective Lengths, Distal Flexible length) - Hydrophilic coating ● - Dilator OD and effective length ● - Packaging pouch material - Shelf-life . #### Performance Data 1.7 The following performance data were provided in support of the substantial equivalence determination: - . Design Verification {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Penumbra" in a bold, red font. To the right of the word is a red circle with a white "P" inside. A thin white line connects the end of the word "Penumbra" to the "P" in the circle. The logo is simple and modern. - Biocompatibility ● - Shelf Life ● - Sterilization ● - Packaging . The subject device met all established requirements. ### 1.7.1 Performance Testing - Design Verification - Visual and Dimensional Inspection o - Particulate Testing O - Friction Testing o - Simulated Use Testing O - Radiopacity Testing/Markerband Visibility O - Hub Air Aspiration Testing O - Burst Pressure Testing O - Tensile and Elongation Testing o - Corrosion Testing O - Liquid Leakage Testing O - Kink Resistance о - Torsion Testing in Simulated Use Model O - Catheter Tip Stiffness Testing O - Shelf Life ● - Packaging ● - Sterilization in accordance with ISO 11135+A1 and ISO 10993-7 ● ### 1.7.2 Biocompatibility The biocompatibility evaluation for BENCHMARK BMX81 Access 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: | Tests | Results - BMX81 Delivery Catheter | Results - Dilator | Conclusions | |----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Cytotoxicity: MEM Elution (10993-5) | Grade = 0 (Reactivity None) | Grade = 0 (Reactivity None) | Pass Non-cytotoxic | | Sensitization: | NS Extract: Grade = 0 | NS Extract: Grade = 0 | Pass Non-sensitizing | | Tests | Results – BMX81 Delivery Catheter | Results – Dilator | Conclusions | | Magnusson- Kligman Method (10993-10) | SSO Extract: Grade = 0 | SSO Extract: Grade = 0 | | | Irritation: Intracutaneous Reactivity | NS Extract Difference = 0.0 | NS Extract Difference = 0.0 | Pass | | (10993-10, 10993- 23) | SSO Extract Difference = 1.0 | SSO Extract Difference = 0.1 | Non-irritating | | Systemic Toxicity: Acute Systemic Injection (10993-11) | No evidence of systemic toxicity from sample extracts (both NS and SSO extracts). That is: • No deaths • No signs consistent with toxicity • No weight loss > 10% | No evidence of systemic toxicity from sample extracts (both NS and SSO extracts). That is: • No deaths • No signs consistent with toxicity • No weight loss > 10% | Pass Non-toxic | | Systemic Toxicity: Material Mediated Pyrogen (10993-11) | Non-pyrogenic: no single animal had an individual rise in body temperature ≥ 0.5 °C | Non-pyrogenic: no single animal had an individual rise in body temperature ≥ 0.5 °C | Pass Non-pyrogenic | | Hemocompatibility: In-vitro Thrombogenicity (10993-4) | Assay #1: Thromboresistant Assay #2: Thromboresistant Assay #3: Thromboresistant | Assay #1: Thromboresistant Assay #2: Thromboresistant Assay #3: Thromboresistant | Pass Non- thrombogenic | | Hemocompatibility: Prothrombin Time (PT) (10993-4) | Test article coagulation times are statistically similar to predicate | Test article coagulation times are statistically similar to predicate | Pass Hemocompatible | | Hemocompatibility: Partial Thromboplastin Time (PTT) (10993-4) | Test article coagulation times are acceptable | Test article coagulation times are acceptable | Pass Hemocompatible | | Hemocompatibility: Complement Activation (10993-4) | Based on Tukey test, test article concentrations of SC5b-9 are statistically similar to predicate at exposure time point | Test article concentrations of SC5b-9 are statistically similar to predicate at exposure time point | Pass Hemocompatible | | Hemocompatibility: Hemolysis, indirect contact (10993-4) | Hemolytic Index = 0.00% | Hemolytic Index = 0.00% | Pass Non-hemolytic | | Hemocompatibility: Hemolysis, direct contact (10993-4) | Hemolytic Index = 0.21% | Hemolytic Index = 0.00% | Pass Non-hemolytic | {7}------------------------------------------------ Image /page/7/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. A thin gray line connects the end of the word "Penumbra" to the "P" inside the circle. {8}------------------------------------------------ Image /page/8/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 of it. A thin gray line connects the word "Penumbra" to the circle. The logo is simple and modern. | Tests | Results – BMX81 Delivery Catheter | Results – Dilator | Conclusions | |-----------|--------------------------------------|----------------------|-------------| | (10993-4) | | | | Biocompatibility test results demonstrate biological safety per ISO 10993-1 and USP requirements. ### Performance Data – Animal, Clinical 1.7.3 No animal or clinical studies were conducted because bench testing was determined sufficient for verification and validation purposes. #### 1.8 Conclusions The subject BENCHMARK BMX81 Access System is substantially equivalent to the predicate device Benchmark Intracranial Access System. The subject device has the same indications for use as the predicate device. The device testing described in the 510(k) Summary demonstrates that the subject device is substantially equivalent to the predicate device in regard to intended use, operating principle, design concept, fundamental technology and device performance. The differences between the subject device and the predicate device do not raise new questions of safety and effectiveness.