(153 days)
Not Found
No
The summary describes a physical medical device (microcatheter) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No.
The "Intended Use / Indications for Use" states that the device is indicated to "assist in the delivery of ... therapeutic devices" but it is not itself a therapeutic device.
No
The device is indicated to assist in the delivery of diagnostic agents (like contrast media) and therapeutic devices, but it does not perform the diagnostic function itself. It is a delivery tool, not a diagnostic tool.
No
The device description clearly identifies the Access25 Delivery Microcatheter as a physical, single lumen medical device designed to be used in conjunction with other hardware (guide catheter and micro guidewire). The performance studies also focus on physical characteristics and biocompatibility, not software validation.
Based on the provided information, the Access25 Delivery Microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the delivery of diagnostic agents and therapeutic devices within the body (peripheral and neuro vasculature). This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The device is a microcatheter designed for accessing vasculature, which is a physical intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) or performing tests to diagnose a condition outside of the body.
Therefore, the Access25 Delivery Microcatheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
QJP, DQY
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Summary of Bench Performance Testing:
- Test: Dimensional/Visual Inspection Test; Test Method Summary: The catheter outer diameter, inner diameter, length, and coating length were measured.; Conclusion: Acceptance Criteria met
- Test: Simulated Use Test; Test Method Summary: Simulated use was conducted in a clinically relevant anatomical model using interventional devices.; Conclusion: The device performs as intended under simulated use conditions
- Test: Tensile Test; Test Method Summary: The peak tensile force was evaluated per ISO 10555-1 after preconditioning in a simulated use model.; Conclusion: Acceptance Criteria met
- Test: Particulate Test; Test Method Summary: Particulates generated during simulated use with clinically relevant interventional devices were evaluated.; Conclusion: Particulate generation was comparable to predicate device
- Test: Burst Pressure Test; Test Method Summary: Confirms units can withstand sufficient pressure per ISO 10555-1 after simulated use.; Conclusion: Acceptance Criteria met
- Test: Radiopacity Test; Test Method Summary: Confirms markerband(s) are fluoroscopically visible.; Conclusion: Acceptance Criteria met
- Test: Flow Rate Test; Test Method Summary: Confirms contrast media can be delivered through the catheter lumen.; Conclusion: Acceptance Criteria met
- Test: Friction Test; Test Method Summary: Confirms units meet product specification related to friction.; Conclusion: Friction results were comparable to the predicate
- Test: Corrosion Resistance Test; Test Method Summary: Confirms there is no visible corrosion on units when tested per ISO 10555-1.; Conclusion: Acceptance Criteria met
- Test: Torque Strength Test; Test Method Summary: The device was evaluated for torque strength by measuring the number of catheter rotations until failure.; Conclusion: Acceptance Criteria met
- Test: Elongation Test; Test Method Summary: Confirms units meet product specification related to elongation.; Conclusion: Acceptance Criteria met
- Test: Hub/Air Test; Test Method Summary: Confirms units have no leaks when tested per ISO 10555-1.; Conclusion: Acceptance Criteria met
- Test: Distal Tip Stiffness Test; Test Method Summary: The maximum compressive force to cause catheter tip buckling was measured.; Conclusion: Distal tip stiffness was comparable to the predicate.
- Test: Kink Resistance Test; Test Method Summary: Confirms units have appropriate kink resistance.; Conclusion: Acceptance Criteria met
- Test: Liquid Leakage Test; Test Method Summary: Confirms units can withstand sufficient pressure.; Conclusion: Acceptance Criteria met
Summary of Biocompatibility Testing:
- Tests: Cytotoxicity: MEM Elution; Test Method Summary: Tested in accordance with ISO 10993-5; Results: Pass: Non-cytotoxic
- Tests: Sensitization: Magnusson-Kligman Method; Test Method Summary: Tested in accordance with ISO 10993-10; Results: Pass: Non-sensitizing
- Tests: Irritation: Intracutaneous Reactivity; Test Method Summary: Tested in accordance with ISO 10993-23; Results: Pass: Non-irritating
- Tests: Systemic Toxicity: Acute Systemic Injection; Test Method Summary: Tested in accordance with ISO 10993-11; Results: Pass: Non-toxic
- Tests: Systemic Toxicity: Material-Mediated Pyrogen; Test Method Summary: Tested in accordance with USP ; Results: Pass: Non-pyrogenic
- Tests: Hemocompatibility: Hemolysis (direct contact); Test Method Summary: Tested in accordance with ISO 10993-4; Results: Pass: Non-hemolytic
- Tests: Hemocompatibility: Hemolysis (indirect contact); Test Method Summary: Tested in accordance with ISO 10993-4; Results: Pass: Non-hemolytic
- Tests: Hemocompatibility: In-vitro Thrombogenicity; Test Method Summary: Tested in accordance with ISO 10993-4; Results: Pass: Non-thrombogenic
- Tests: Hemocompatibility: Complement Activation; Test Method Summary: Tested in accordance with ISO 10993-4; Results: Pass: Non-activator of complement system
- Tests: Hemocompatibility: Partial Thromboplastin Time (PTT); Test Method Summary: Tested in accordance with ISO 10993-4; Results: Pass: Hemocompatible
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 – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
Pyrogenicity: The Access25 Delivery Microcatheter has been established to be non-pyrogenic based on material mediated rabbit pyrogen biocompatibility testing per USP and LAL testing per ANSI/AAMI ST72 to meet
§ 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).
0
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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Page
2
(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
3
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.
5
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 is
intended 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 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. |
| Dimensions | | |
| Inner Diameter | 0.025 in. min | SAME |
| Proximal Outer
Diameter | 0.040 in. max | SAME |
| Distal Outer
Diameter | 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, Shaping
Mandrel, RHV | SAME |
| Packaging
Configuration | Individual catheter in tray, or hoop attached to
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 | ||
| Inspection 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 clinically | |
| relevant anatomical model using interventional | ||
| devices. | The device performs as | |
| intended under simulated | ||
| use conditions | ||
| Tensile Test | The peak tensile force was evaluated per ISO | |
| 10555-1 after preconditioning in a simulated | ||
| use model. | Acceptance Criteria met | |
| Particulate Test | Particulates generated during simulated use with | |
| clinically relevant interventional devices | ||
| were evaluated. | Particulate generation was | |
| comparable to predicate | ||
| device | ||
| Burst Pressure Test | Confirms units can withstand sufficient | |
| pressure per ISO 10555-1 after simulated use. | Acceptance Criteria met | |
| Radiopacity Test | Confirms markerband(s) are fluoroscopically | |
| visible. | Acceptance Criteria met | |
| Flow Rate Test | Confirms contrast media can be delivered | |
| through the catheter lumen. | Acceptance Criteria met | |
| Friction Test | Confirms units meet product specification | |
| related to friction. | Friction results were | |
| comparable to the | ||
| predicate | ||
| Corrosion Resistance | ||
| Test | Confirms there is no visible corrosion on units | |
| 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 | |
| measuring the number of catheter rotations | ||
| until failure . | Acceptance Criteria met | |
| Elongation Test | Confirms units meet product specification | |
| related to elongation. | Acceptance Criteria met | |
| Hub/Air Test | Confirms units have no leaks when tested per | |
| ISO 10555-1. | Acceptance Criteria met | |
| Distal Tip Stiffness Test | The maximum compressive force to cause | |
| catheter tip buckling was measured. | Distal tip stiffness was | |
| comparable to the | ||
| predicate. | ||
| Kink Resistance Test | Confirms units have appropriate kink resistance. | Acceptance Criteria met |
| Liquid Leakage Test | Confirms units can withstand sufficient | |
| 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: |
| Non-cytotoxic | ||
| Sensitization: Magnusson-Kligman | ||
| Method | 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 Systemic | ||
| Injection | Tested in accordance with ISO 10993-11 | Pass: |
| Non-toxic | ||
| Systemic Toxicity: Material-Mediated | ||
| Pyrogen | Tested in accordance with USP | Pass: |
| Non-pyrogenic | ||
| Hemocompatibility: Hemolysis (direct | ||
| contact) | Tested in accordance with ISO 10993-4 | Pass: |
| Non-hemolytic | ||
| Hemocompatibility: Hemolysis (indirect | ||
| contact) | 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: Complement | ||
| Activation | Tested in accordance with ISO 10993-4 | Pass: |
| Non-activator of | ||
| complement system | ||
| Hemocompatibility: Partial | ||
| Thromboplastin 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 –
8
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 and LAL testing per ANSI/AAMI ST72 to meet