Access25™ Delivery Microcatheter

K242033 · Penumbra, Inc. · QJP · Dec 11, 2024 · Cardiovascular

Device Facts

• Record ID: K242033
• Device Name: Access25™ Delivery Microcatheter
• Applicant: Penumbra, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: Dec 11, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Single-lumen microcatheter; aids physician in accessing distal vasculature; used with guide catheter and micro guidewire. Supplied with annealed stainless steel mandrels for distal tip shaping. Available in straight, 45, 90, and 130-degree (J) shapes. Used in sterile clinical field by physicians. Facilitates delivery of contrast media or therapeutic devices (e.g., occlusion coils) to peripheral and neuro vasculature. Benefits patient by enabling precise navigation and delivery of diagnostic/therapeutic agents in complex vascular anatomy.

Clinical Evidence

Bench testing only. No clinical or animal studies performed. Testing included dimensional/visual inspection, simulated use, tensile strength, particulate evaluation, burst pressure, radiopacity, flow rate, friction, corrosion resistance, torque strength, elongation, hub/air leakage, distal tip stiffness, kink resistance, and liquid leakage. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility). All tests met acceptance criteria.

Technological Characteristics

Single-lumen catheter; medical grade plastics and metals; hydrophilic coating. Dimensions: 0.025 in. ID, 0.040 in. proximal OD, 0.037 in. distal OD. Lengths: 150, 160, 170 cm. Sterilization: Ethylene Oxide (ISO 11135-1). Accessories: Peelable introducer sheath, shaping mandrel, RHV. No software or electronic components.

Indications for Use

Indicated for patients requiring delivery of diagnostic agents (e.g., contrast media) or therapeutic devices (e.g., occlusion coils) to the peripheral 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

• Lantern Delivery Microcatheter (K152840)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | <div> <span> <input type="checkbox"/> </span> <span> </span> </div> <div> <span> <input type="checkbox"/> </span> <span> </span> </div> |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|

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: [phone] Email: [e-mail]

#### 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<br>[Predicate] | Access25 Delivery Microcatheter<br>[Subject] |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II, DQY | Class II, QJP, DQY |
| 510(k) no. | K152840 | K242033 |
| Indication | The Lantern Delivery Microcatheter is<br>intended to assist in the delivery of diagnostic<br>agents, such as contrast media, and<br>therapeutic devices, such as occlusion coils,<br>to the peripheral and neuro vasculature. | The Access25 Delivery<br>Microcatheter is indicated to<br>assist in the delivery of diagnostic<br>agents, such as contrast media,<br>and therapeutic devices, such as<br>occlusion coils, to the peripheral<br>and neuro vasculature. |
| Dimensions | | |
| Inner Diameter | 0.025 in. min | SAME |
| Proximal Outer<br>Diameter | 0.040 in. max | SAME |
| Distal Outer<br>Diameter | 0.037 in. max | SAME |
| Effective Lengths | 80 cm, 110 cm, 115 cm, 130 cm,<br>135 cm, 150 cm, 160 cm | 150 cm, 160 cm, and 170 cm |
| Materials | | |
| Materials | Commonly used medical grade plastics &<br>metals | SAME |
| Coating | Hydrophilic (proprietary) | SAME |
| Attributes | | |
| Accessories | Peelable Introducer Sheath, Shaping<br>Mandrel, RHV | SAME |
| Packaging<br>Configuration | Individual catheter in tray, or hoop attached to<br>packaging 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/Visual<br>Inspection Test | The catheter outer diameter, inner diameter,<br>length, and coating length were measured. | Acceptance Criteria met |
| Simulated Use Test | Simulated use was conducted in a clinically<br>relevant anatomical model using interventional<br>devices. | The device performs as<br>intended under simulated<br>use conditions |
| Tensile Test | The peak tensile force was evaluated per ISO<br>10555-1 after preconditioning in a simulated<br>use model. | Acceptance Criteria met |
| Particulate Test | Particulates generated during simulated use with<br>clinically relevant interventional devices<br>were evaluated. | Particulate generation was<br>comparable to predicate<br>device |
| Burst Pressure Test | Confirms units can withstand sufficient<br>pressure per ISO 10555-1 after simulated use. | Acceptance Criteria met |
| Radiopacity Test | Confirms markerband(s) are fluoroscopically<br>visible. | Acceptance Criteria met |
| Flow Rate Test | Confirms contrast media can be delivered<br>through the catheter lumen. | Acceptance Criteria met |
| Friction Test | Confirms units meet product specification<br>related to friction. | Friction results were<br>comparable to the<br>predicate |
| Corrosion Resistance<br>Test | Confirms there is no visible corrosion on units<br>when 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 by<br>measuring the number of catheter rotations<br>until failure . | Acceptance Criteria met |
| Elongation Test | Confirms units meet product specification<br>related to elongation. | Acceptance Criteria met |
| Hub/Air Test | Confirms units have no leaks when tested per<br>ISO 10555-1. | Acceptance Criteria met |
| Distal Tip Stiffness Test | The maximum compressive force to cause<br>catheter tip buckling was measured. | Distal tip stiffness was<br>comparable to the<br>predicate. |
| Kink Resistance Test | Confirms units have appropriate kink resistance. | Acceptance Criteria met |
| Liquid Leakage Test | Confirms units can withstand sufficient<br>pressure. | 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:<br>Non-cytotoxic |
| Sensitization: Magnusson-Kligman<br>Method | Tested in accordance with ISO 10993-10 | Pass:<br>Non-sensitizing |
| Irritation: Intracutaneous Reactivity | Tested in accordance with ISO 10993-23 | Pass:<br>Non-irritating |
| Systemic Toxicity: Acute Systemic<br>Injection | Tested in accordance with ISO 10993-11 | Pass:<br>Non-toxic |
| Systemic Toxicity: Material-Mediated<br>Pyrogen | Tested in accordance with USP <151> | Pass:<br>Non-pyrogenic |
| Hemocompatibility: Hemolysis (direct<br>contact) | Tested in accordance with ISO 10993-4 | Pass:<br>Non-hemolytic |
| Hemocompatibility: Hemolysis (indirect<br>contact) | Tested in accordance with ISO 10993-4 | Pass:<br>Non-hemolytic |
| Hemocompatibility:<br>In-vitro Thrombogenicity | Tested in accordance with ISO 10993-4 | Pass:<br>Non-thrombogenic |
| Hemocompatibility: Complement<br>Activation | Tested in accordance with ISO 10993-4 | Pass:<br>Non-activator of<br>complement system |
| Hemocompatibility: Partial<br>Thromboplastin Time (PTT) | Tested in accordance with ISO 10993-4 | Pass:<br>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.