(134 days)
The BENCHMARK BMX81 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
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.
This document describes the premarket notification (510(k)) for the BENCHMARK BMX81 Access System. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of an AI/ML device. Therefore, many of the requested categories related to AI/ML device performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not present in this regulatory submission.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility | |
| Cytotoxicity (MEM Elution) | Grade = 0 (Reactivity None) |
| Sensitization | NS Extract: Grade = 0, SSO Extract: Grade = 0 |
| Irritation (Intracutaneous Reactivity) | NS Extract: Difference = 0.0, SSO Extract: Difference = 1.0 (BMX81) / 0.1 (Dilator) |
| Systemic Toxicity (Acute Systemic Injection) | No evidence of systemic toxicity (no deaths, no signs of toxicity, no weight loss > 10%) |
| Systemic Toxicity (Material Mediated Pyrogen) | Non-pyrogenic (no single animal had an individual rise in body temperature ≥ 0.5 °C) |
| Hemocompatibility (In-vitro Thrombogenicity) | Thromboresistant (Assays #1, #2, #3) |
| Hemocompatibility (Prothrombin Time (PT)) | Test article coagulation times are statistically similar to predicate |
| Hemocompatibility (Partial Thromboplastin Time (PTT)) | Test article coagulation times are acceptable |
| Hemocompatibility (Complement Activation) | Test article concentrations of SC5b-9 are statistically similar to predicate at exposure time point |
| Hemocompatibility (Hemolysis, indirect contact) | Hemolytic Index = 0.00% |
| Hemocompatibility (Hemolysis, direct contact) | Hemolytic Index = 0.21% (BMX81) / 0.00% (Dilator) |
| Performance Testing | Met all established requirements |
| Visual and Dimensional Inspection | Met acceptance criteria |
| Particulate Testing | Met acceptance criteria |
| Friction Testing | Met acceptance criteria |
| Simulated Use Testing | Met acceptance criteria |
| Radiopacity Testing/Markerband Visibility | Met acceptance criteria |
| Hub Air Aspiration Testing | Met acceptance criteria |
| Burst Pressure Testing | Met acceptance criteria |
| Tensile and Elongation Testing | Met acceptance criteria |
| Corrosion Testing | Met acceptance criteria |
| Liquid Leakage Testing | Met acceptance criteria |
| Kink Resistance | Met acceptance criteria |
| Torsion Testing in Simulated Use Model | Met acceptance criteria |
| Catheter Tip Stiffness Testing | Met acceptance criteria |
| Shelf Life | Met established requirements |
| Sterilization (ISO 11135+A1 and ISO 10993-7) | Met established requirements |
| Packaging | Met established requirements |
2. Sample size used for the test set and the data provenance:
- Not applicable for an AI/ML device. This document pertains to a medical device (catheter system) for which performance is evaluated through bench testing and biocompatibility. The concept of a "test set" in the context of AI/ML performance evaluation does not directly apply. The tests described were conducted on physical samples of the device and its components. The provenance of the data is from internal testing conducted by Penumbra, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for an AI/ML device. The ground truth in this context is established by standardized laboratory testing methods and regulatory guidelines (e.g., ISO standards for biocompatibility), not by expert human interpretation of data for diagnostic purposes.
4. Adjudication method for the test set:
- Not applicable for an AI/ML device. The performance evaluation involves laboratory tests with defined quantitative or qualitative outcomes (e.g., Grade = 0 for cytotoxicity, "Pass" for non-pyrogenic), which do not typically require adjudication in the way medical image interpretation might.
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, an MRMC comparative effectiveness study was not done. This is a medical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical catheter system, not an algorithm.
7. The type of ground truth used:
- The ground truth for this medical device's performance evaluation is based on established scientific and engineering principles, international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization), and predefined acceptance criteria for physical and mechanical properties. For example, for biocompatibility, it's the absence of cytotoxicity, pyrogenicity, or certain reactivity according to the specific ISO test methods.
8. The sample size for the training set:
- Not applicable for an AI/ML device. The concept of a "training set" is relevant for machine learning models, not for traditional medical devices like a catheter system.
9. How the ground truth for the training set was established:
- Not applicable for an AI/ML device.
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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
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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
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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)
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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 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 |
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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.
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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
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- 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) | PassNon-cytotoxic |
| Sensitization: | NS Extract:Grade = 0 | NS Extract:Grade = 0 | PassNon-sensitizing |
| Tests | Results –BMX81 Delivery Catheter | Results –Dilator | Conclusions |
| Magnusson-Kligman Method(10993-10) | SSO Extract:Grade = 0 | SSO Extract:Grade = 0 | |
| Irritation:IntracutaneousReactivity | NS ExtractDifference = 0.0 | NS ExtractDifference = 0.0 | Pass |
| (10993-10, 10993-23) | SSO ExtractDifference = 1.0 | SSO ExtractDifference = 0.1 | Non-irritating |
| Systemic Toxicity:Acute SystemicInjection(10993-11) | No evidence of systemic toxicityfrom sample extracts (both NSand SSO extracts). That is:• No deaths• No signs consistent withtoxicity• No weight loss > 10% | No evidence of systemic toxicityfrom sample extracts (both NS andSSO extracts). That is:• No deaths• No signs consistent withtoxicity• No weight loss > 10% | PassNon-toxic |
| Systemic Toxicity:Material MediatedPyrogen(10993-11) | Non-pyrogenic: no single animalhad an individual rise in bodytemperature ≥ 0.5 °C | Non-pyrogenic: no single animalhad an individual rise in bodytemperature ≥ 0.5 °C | PassNon-pyrogenic |
| Hemocompatibility:In-vitroThrombogenicity(10993-4) | Assay #1:ThromboresistantAssay #2:ThromboresistantAssay #3:Thromboresistant | Assay #1:ThromboresistantAssay #2:ThromboresistantAssay #3:Thromboresistant | PassNon-thrombogenic |
| Hemocompatibility:Prothrombin Time(PT)(10993-4) | Test article coagulation times arestatistically similar to predicate | Test article coagulation times arestatistically similar to predicate | PassHemocompatible |
| Hemocompatibility:PartialThromboplastinTime (PTT)(10993-4) | Test article coagulation times areacceptable | Test article coagulation times areacceptable | PassHemocompatible |
| Hemocompatibility:ComplementActivation(10993-4) | Based on Tukey test, test articleconcentrations of SC5b-9 arestatistically similar to predicate atexposure time point | Test article concentrations ofSC5b-9 are statistically similar topredicate at exposure time point | PassHemocompatible |
| Hemocompatibility:Hemolysis, indirectcontact(10993-4) | Hemolytic Index = 0.00% | Hemolytic Index = 0.00% | PassNon-hemolytic |
| Hemocompatibility:Hemolysis, directcontact(10993-4) | Hemolytic Index = 0.21% | Hemolytic Index = 0.00% | PassNon-hemolytic |
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| 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.
§ 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).