(153 days)
The Access25 Delivery Microcatheter is indicated to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.
The Access25 Delivery Microcatheter (Access25) is a single lumen medical device designed to aid a physician in accessing distal vasculature when used in conjunction with a guide catheter and micro guidewire. The Access25 Delivery Microcatheter is supplied with annealed stainless steel mandrels that can be used to shape the distal tip as desired.
This document pertains to the Access25™ Delivery Microcatheter by Penumbra, Inc. This is a medical device and not an AI/ML powered device, therefore some relevant sections of the query will not be applicable.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional/Visual Inspection Test | Catheter outer diameter, inner diameter, length, and coating length meet specifications. | Acceptance Criteria met |
| Simulated Use Test | Device performs as intended under simulated use conditions in a clinically relevant anatomical model. | The device performs as intended under simulated use conditions |
| Tensile Test | Peak tensile force meets ISO 10555-1 requirements after preconditioning in a simulated use model. | Acceptance Criteria met |
| Particulate Test | Particulate generation during simulated use is comparable to the predicate device. | Particulate generation was comparable to predicate device |
| Burst Pressure Test | Units can withstand sufficient pressure per ISO 10555-1 after simulated use. | Acceptance Criteria met |
| Radiopacity Test | Markerband(s) are fluoroscopically visible. | Acceptance Criteria met |
| Flow Rate Test | Contrast media can be delivered through the catheter lumen. | Acceptance Criteria met |
| Friction Test | Units meet product specification related to friction. | Friction results were comparable to the predicate |
| Corrosion Resistance Test | No visible corrosion on units when tested per ISO 10555-1. | Acceptance Criteria met |
| Torque Strength Test | Device can withstand a specified number of catheter rotations until failure. | Acceptance Criteria met |
| Elongation Test | Units meet product specification related to elongation. | Acceptance Criteria met |
| Hub/Air Test | Units have no leaks when tested per ISO 10555-1. | Acceptance Criteria met |
| Distal Tip Stiffness Test | Maximum compressive force to cause catheter tip buckling is comparable to the predicate. | Distal tip stiffness was comparable to the predicate. |
| Kink Resistance Test | Units have appropriate kink resistance. | Acceptance Criteria met |
| Liquid Leakage Test | Units can withstand sufficient pressure. | Acceptance Criteria met |
| Biocompatibility: Cytotoxicity | Non-cytotoxic (in accordance with ISO 10993-5). | Pass: Non-cytotoxic |
| Biocompatibility: Sensitization | Non-sensitizing (in accordance with ISO 10993-10). | Pass: Non-sensitizing |
| Biocompatibility: Irritation | Non-irritating (in accordance with ISO 10993-23). | Pass: Non-irritating |
| Biocompatibility: Systemic Toxicity | Non-toxic (in accordance with ISO 10993-11). | Pass: Non-toxic |
| Biocompatibility: Material-Mediated Pyrogen | Non-pyrogenic (in accordance with USP <151>). | Pass: Non-pyrogenic |
| Biocompatibility: Hemolysis (direct contact) | Non-hemolytic (in accordance with ISO 10993-4). | Pass: Non-hemolytic |
| Biocompatibility: Hemolysis (indirect contact) | Non-hemolytic (in accordance with ISO 10993-4). | Pass: Non-hemolytic |
| Biocompatibility: In-vitro Thrombogenicity | Non-thrombogenic (in accordance with ISO 10993-4). | Pass: Non-thrombogenic |
| Biocompatibility: Complement Activation | Non-activator of complement system (in accordance with ISO 10993-4). | Pass: Non-activator of complement system |
| Biocompatibility: Partial Thromboplastin Time (PTT) | Hemocompatible (in accordance with ISO 10993-4). | Pass: Hemocompatible |
| Sterilization | Sterilized using a validated EO sterilization process in accordance with ISO 11135-1. | Validated EO sterilization process per ISO 11135-1. |
| Pyrogenicity | Non-pyrogenic, meeting < 2.15 EU/device acceptance criteria per USP <151> and ANSI/AAMI ST72. | Non-pyrogenic based on material mediated rabbit pyrogen biocompatibility testing per USP <151> and LAL testing per ANSI/AAMI ST72 to meet < 2.15 EU/device acceptance criteria. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the exact sample sizes (number of devices) used for each individual test. However, it indicates that the tests were conducted on "units" multiple times ("The device was evaluated for torque strength by measuring the number of catheter rotations until failure").
The provenance of the data is from bench performance testing and biocompatibility testing. This typically implies laboratory settings rather than patient data, therefore country of origin and retrospective/prospective distinctions are not directly applicable in the same way they would be for clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a medical device, not an AI/ML algorithm requiring expert ground truth in the context of image analysis or diagnostic interpretation. The "ground truth" for this device's performance is established through adherence to recognized international standards (e.g., ISO, USP, ANSI/AAMI) and engineering specifications, which are developed and validated by experts in their respective fields (e.g., materials science, medical device design, sterilization, biocompatibility).
4. Adjudication method for the test set:
Not applicable in the context of this device. The testing described is objective performance measurement against pre-defined engineering and biological acceptance criteria, rather than subjective interpretation requiring adjudication.
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:
Not applicable. This is a physical medical device (microcatheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used:
The "ground truth" for this device's performance is based on established industry standards and regulatory requirements (e.g., ISO 10555-1, ISO 11135-1, ISO 10993 series, USP <151>, ANSI/AAMI ST72) and internal product specifications. These standards and specifications define what constitutes safe and effective performance for such a device.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As this is not an AI/ML algorithm, there is no training set or its associated ground truth establishment process. The "ground truth" in the device development context refers to the established performance requirements and standards against which the device is tested.
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December 11, 2024
Image /page/0/Picture/1 description: The image shows 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 is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Penumbra, Inc. Akshay Kulkarni Regulatory Affairs Specialist II One Penumbra Place Alameda, California 94502
Re: K242033
Trade/Device Name: Access25TM Delivery Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: July 10, 2024 Received: July 11, 2024
Dear Akshay Kulkarni:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Michael Mcknight -S
for 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) K242033
Device Name Access25TM Delivery Microcatheter
Indications for Use (Describe)
The Access25 Delivery Microcatheter is indicated to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral 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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Image /page/4/Picture/0 description: The image shows the Penumbra company logo. The word "Penumbra" is written in a red, sans-serif 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 top of the "P" to the edge of the circle.
1 510(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 Access25 Delivery Microcatheter.
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Akshay Kulkarni Regulatory Affairs Specialist II Phone: (857) 763-9024 Email: akulkarni@penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
December 09, 2024
Device Trade or Proprietary Name 1.4
Access25™ Delivery Microcatheter
1.5 Device Classification
Regulatory Class: ll Classification Panel: Cardiovascular Classification Name: Percutaneous Catheter Regulation Number: 21 CFR §870.1250 Product Code: QJP, DQY
1.6 Predicate Device - Lantern Delivery Microcatheter
| 510(k) Number | Name of Device |
|---|---|
| K152840 | Lantern™ Delivery Microcatheter |
1.7 Device Description
The Access25 Delivery Microcatheter (Access25) is a single lumen medical device designed to aid a physician in accessing distal vasculature when used in conjunction with a guide catheter and micro guidewire. The Access25 Delivery Microcatheter is supplied with annealed stainless steel mandrels that can be used to shape the distal tip as desired.
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Image /page/5/Picture/1 description: The image shows the logo for Penumbra, Inc., a global healthcare company focused on innovative therapies. The word "Penumbra" is written in a red sans-serif font. To the right of the word is a red circle with a white "P" inside, which is the company's symbol.
The Access25 Delivery Microcatheter may be available in the following shapes:
- Straight ●
- 45 degree .
- 90 degree .
- . 130 degree (J)
The Access25 Delivery Microcatheter is supplied sterile for use in a sterile clinical field.
Indications for Use 1.8
The Access25 Delivery Microcatheter is indicated to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.
Comparison of Technological Characteristics with the Predicate Device 1.9
| Lantern Delivery Microcatheter[Predicate] | Access25 Delivery Microcatheter[Subject] | |
|---|---|---|
| Classification | Class II, DQY | Class II, QJP, DQY |
| 510(k) no. | K152840 | K242033 |
| Indication | The Lantern Delivery Microcatheter isintended to assist in the delivery of diagnosticagents, such as contrast media, andtherapeutic devices, such as occlusion coils,to the peripheral and neuro vasculature. | The Access25 DeliveryMicrocatheter is indicated toassist in the delivery of diagnosticagents, such as contrast media,and therapeutic devices, such asocclusion coils, to the peripheraland neuro vasculature. |
| Dimensions | ||
| Inner Diameter | 0.025 in. min | SAME |
| Proximal OuterDiameter | 0.040 in. max | SAME |
| Distal OuterDiameter | 0.037 in. max | SAME |
| Effective Lengths | 80 cm, 110 cm, 115 cm, 130 cm,135 cm, 150 cm, 160 cm | 150 cm, 160 cm, and 170 cm |
| Materials | ||
| Materials | Commonly used medical grade plastics &metals | SAME |
| Coating | Hydrophilic (proprietary) | SAME |
| Attributes | ||
| Accessories | Peelable Introducer Sheath, ShapingMandrel, RHV | SAME |
| PackagingConfiguration | Individual catheter in tray, or hoop attached topackaging card, pouch, and box | SAME |
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Image /page/6/Picture/1 description: The image shows the word "Penumbra" in a red font, followed by a red circle with a white "P" inside. The word "Penumbra" is written in a sans-serif font. The "P" in the circle is also in a sans-serif font. The circle is slightly offset to the right of the word "Penumbra".
| Packaging Materials | Polyethylene, PET, Polyester, Tyvek | SAME |
|---|---|---|
| Sterilization | EO | SAME |
| Shelf-Life | 36 Months | 12 Months |
| Use | Single use, disposable | SAME |
1.10 Performance Data
The following performance data were provided in support of the subject device:
- . Design Verification
- . Biocompatibility
- . Shelf-Life
- Packaging Validation .
- . Sterilization
The subject device met all established requirements.
1.10.1 Summary of Bench Performance Testing
The following bench performance testing was conducted on the subject device:
| Test | Test Method Summary | Conclusion |
|---|---|---|
| Dimensional/VisualInspection Test | The catheter outer diameter, inner diameter,length, and coating length were measured. | Acceptance Criteria met |
| Simulated Use Test | Simulated use was conducted in a clinicallyrelevant anatomical model using interventionaldevices. | The device performs asintended under simulateduse conditions |
| Tensile Test | The peak tensile force was evaluated per ISO10555-1 after preconditioning in a simulateduse model. | Acceptance Criteria met |
| Particulate Test | Particulates generated during simulated use withclinically relevant interventional deviceswere evaluated. | Particulate generation wascomparable to predicatedevice |
| Burst Pressure Test | Confirms units can withstand sufficientpressure per ISO 10555-1 after simulated use. | Acceptance Criteria met |
| Radiopacity Test | Confirms markerband(s) are fluoroscopicallyvisible. | Acceptance Criteria met |
| Flow Rate Test | Confirms contrast media can be deliveredthrough the catheter lumen. | Acceptance Criteria met |
| Friction Test | Confirms units meet product specificationrelated to friction. | Friction results werecomparable to thepredicate |
| Corrosion ResistanceTest | Confirms there is no visible corrosion on unitswhen tested per ISO 10555-1. | Acceptance Criteria met |
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Image /page/7/Picture/1 description: The image shows the Penumbra company logo. The word "Penumbra" is written in a red sans-serif font. To the right of the word is a red circle with a white "P" inside of it.
| Test | Test Method Summary | Conclusion |
|---|---|---|
| Torque Strength Test | The device was evaluated for torque strength bymeasuring the number of catheter rotationsuntil failure . | Acceptance Criteria met |
| Elongation Test | Confirms units meet product specificationrelated to elongation. | Acceptance Criteria met |
| Hub/Air Test | Confirms units have no leaks when tested perISO 10555-1. | Acceptance Criteria met |
| Distal Tip Stiffness Test | The maximum compressive force to causecatheter tip buckling was measured. | Distal tip stiffness wascomparable to thepredicate. |
| Kink Resistance Test | Confirms units have appropriate kink resistance. | Acceptance Criteria met |
| Liquid Leakage Test | Confirms units can withstand sufficientpressure. | Acceptance Criteria met |
1.10.2 Summary of Biocompatibility Testing
The following biocompatibility testing was conducted for the subject device:
| Tests | Test Method Summary | Results |
|---|---|---|
| Cytotoxicity: MEM Elution | Tested in accordance with ISO 10993-5 | Pass:Non-cytotoxic |
| Sensitization: Magnusson-KligmanMethod | Tested in accordance with ISO 10993-10 | Pass:Non-sensitizing |
| Irritation: Intracutaneous Reactivity | Tested in accordance with ISO 10993-23 | Pass:Non-irritating |
| Systemic Toxicity: Acute SystemicInjection | Tested in accordance with ISO 10993-11 | Pass:Non-toxic |
| Systemic Toxicity: Material-MediatedPyrogen | Tested in accordance with USP <151> | Pass:Non-pyrogenic |
| Hemocompatibility: Hemolysis (directcontact) | Tested in accordance with ISO 10993-4 | Pass:Non-hemolytic |
| Hemocompatibility: Hemolysis (indirectcontact) | Tested in accordance with ISO 10993-4 | Pass:Non-hemolytic |
| Hemocompatibility:In-vitro Thrombogenicity | Tested in accordance with ISO 10993-4 | Pass:Non-thrombogenic |
| Hemocompatibility: ComplementActivation | Tested in accordance with ISO 10993-4 | Pass:Non-activator ofcomplement system |
| Hemocompatibility: PartialThromboplastin Time (PTT) | Tested in accordance with ISO 10993-4 | Pass:Hemocompatible |
1.10.3 Sterilization
The Access25 Delivery Microcatheter is sterilized using a validated EO sterilization process in accordance with ISO 11135-1, Sterilization of Health Care Products – Ethylene Oxide –
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Image /page/8/Picture/0 description: The image shows the logo for Penumbra, Inc., a global healthcare company focused on innovative therapies. The logo features the word "Penumbra" in a red, sans-serif font. To the right of the wordmark is a circular emblem, also in red, containing a stylized "P" shape formed by white lines.
Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
1.10.4 Pyrogenicity
The Access25 Delivery Microcatheter has been established to be non-pyrogenic based on material mediated rabbit pyrogen biocompatibility testing per USP <151> and LAL testing per ANSI/AAMI ST72 to meet < 2.15 EU/device acceptance criteria.
1.10.5 Animal and Clinical Data
No animal or clinical studies were deemed necessary to support the substantial equivalence of the subject device.
1.11 Summary of Substantial Equivalence
The subject Access25 Delivery Microcatheter is substantially equivalent to the predicate Lantern Delivery Microcatheter. The subject device has the identical intended use as the predicate device. The device testing described in the 510(k) Summary demonstrates the subject device is substantially equivalent to the predicate device in regard to intended use, operating principle, design concept, fundamental technology, and device performance.
§ 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).