(89 days)
No
The summary describes a mechanical vascular access system and does not mention any AI or ML components or functionalities.
No.
The device is indicated for the introduction of therapeutic or diagnostic devices, but it is not itself a therapeutic device. It acts as a conduit.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the introduction of therapeutic or diagnostic devices into the vasculature."
No
The device description explicitly states it is a "three-component system comprised of the BMX81 Delivery Catheter, Penumbra (Neuron 5F) Select Catheter, and a Dilator," which are physical hardware components.
Based on the provided information, the Element Vascular Access System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of therapeutic or diagnostic devices into the vasculature." This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens like blood or tissue.
- Device Description: The description details a system of catheters and a dilator designed to provide a conduit within the body's vascular system. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any other typical components or processes associated with in vitro diagnostics.
Therefore, the Element Vascular Access System is a medical device used for vascular access in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Element Vascular Access System is indicated for the introduction of therapeutic devices into the vasculature.
Product codes
DYB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Bench Performance Testing:
- Test: Dimensional/Visual Inspection Test, Test Method Summary: Confirms units meet all dimensional and visual product specifications., Conclusion: Acceptance Criteria met
- Test: Simulated Use Test, Test Method Summary: Confirms the functionality of units using a clinically relevant bench-top model., Conclusion: Acceptance Criteria met
- Test: Tensile Test, Test Method Summary: Confirms units meet product specification related to tensile strength., Conclusion: Acceptance Criteria met
- Test: Particulate Test, Test Method Summary: Particulates generated during simulated use were evaluated., Conclusion: Acceptance Criteria met
- Test: Liquid Leakage Pressure Test, Test Method Summary: Confirms units can withstand sufficient pressure., Conclusion: Acceptance Criteria met
- Test: Fluoroscopy Test, Test Method Summary: Confirms markerband is fluoroscopically visible., Conclusion: Acceptance Criteria met
- Test: Friction Test, Test Method Summary: Confirms units meet product specification related to friction., Conclusion: Acceptance Criteria met
- Test: Corrosion Resistance Test, Test Method Summary: Confirms there is no visible corrosion on units when tested., Conclusion: Acceptance Criteria met
- Test: Elongation Test, Test Method Summary: Confirms units meet product specification related to elongation., Conclusion: Acceptance Criteria met
- Test: Distal Tip Stiffness Test, Test Method Summary: Confirms units have appropriate distal tip stiffness., Conclusion: Acceptance Criteria met
- Test: Flexibility Kink Resistance Test, Test Method Summary: Confirms units have appropriate flexibility kink resistance., Conclusion: Acceptance Criteria met
No animal or clinical studies were deemed necessary to support the substantial equivalence of the subject device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
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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: on the left, there is a seal with a stylized image of an eagle, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size than the rest of the text.
November 20, 2024
Penumbra, Inc. Soltanzadeh Sindokht (Sisi) Sr. Regulatory Affairs Specialist One Penumbra Place Alameda, California 94502
Re: K242520
Trade/Device Name: Element Vascular Access System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 23, 2024 Received: August 23, 2024
Dear Soltanzadeh Sindokht (Sisi):
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 (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"
1
(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).
2
Sincerely,
Digitally signed by Finn E. Finn E. Donaldson -S Donaldson -S Date: 2024.11.20 11:22:46 -05'00'
Finn Donaldson Assistant Director (acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242520
Device Name Element Vascular Access System
Indications for Use (Describe)
The Element Vascular Access System is indicated for the introduction of therapeutic devices into the vasculature.
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 word "Penumbra" in red font, followed by a red circle with a white "P" inside. The word "Penumbra" is written in a simple, sans-serif font. The red circle with the white "P" is a logo for the company Penumbra, Inc. Overall, the image is clean and professional, and the red color scheme is eye-catching.
1 510(k) Summary
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Sindokht (Sisi) Soltanzadeh Sr. Regulatory Affairs Specialist Phone: (510) 995-9792 Email: ssoltanzadeh(@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
November 20, 2024
1.4 Device Trade or Proprietary Name
Element Vascular Access System
1.5 Device Classification
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Cardiovascular |
| Classification Name: | Introducer, Catheter |
| Regulation Number: | 21 CFR §870.1340 |
| Product Code: | DYB |
1.6 Predicate/Reference Devices
| 510(k) Number | Name of Device |
|---|---|
| Predicate Device | |
| K171999 | Performer Introducer |
| Reference Device | |
| K221822 | BENCHMARK BMX81 Access System |
1.7 Indications for use
Subject Device: The Element Vascular Access System is indicated for the introduction of therapeutic or diagnostic devices into the vasculature.
Predicate Device: Performer™ Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature.
Reference Device: The BENCHMARK BMX81 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
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Image /page/5/Picture/0 description: The image shows the word "Penumbra" 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. The logo is simple and modern.
1.8 Predicate Device:
The Performer™ Introducer is composed of an introducer sheath and dilator(s). This device may also be included in a set with a wire guide, serial dilators, a needle, and a syringe. The Performer™ Introducer is intended to facilitate the introduction of therapeutic or diagnostic devices into the vasculature. The sheath component of the device is manufactured in diameters ranging from 4-18 French (Fr) and lengths ranging from 5-85 centimeters (cm). The distal tip of the sheath may be straight or angled. The dilator component of the device is designed with an outside diameter consistent with the inside diameter of the sheath component.
Reference Device: 1.9
The BENCHMARK BMX81 Access System is a medical device system designed to provide a conduit for introduction of therapeutic devices to the peripheral, coronary, and neurovascular anatomy. This device is a three-component system comprised of the BMX81 Delivery Catheter, Penumbra (Neuron 5F) 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 Neuron 5F Select Catheter to access the desired anatomy. The sheath component of the device contains an inner diameter of 6 French (Fr) and lengths ranging from 55 - 115 centimeters (cm).
1.10 Comparison to Predicate and Reference Devices:
The predicate device Performer Introducer (K171999) and reference device BENCHMARK BMX81 Access System (K221822) are both similar to the subject device for use in facilitating the introduction of therapeutic or diagnostic devices into the vasculature. Both devices contain a catheter sheath and a dilator. The subject device is comparable to that of the predicate and reference device in terms of intended use, principles of operation, and basic technological characteristics. However, the subject device contains additional diameters, lengths, differing materials, and components (e.g., markerband and Tuohy valve) to the predicate device (K171999). The subject device and reference device (K221822) both have a hydrophilic coating. The substantial equivalence of the subject device modifications are supported by the performance data identified below.
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Image /page/6/Picture/0 description: The image shows the word "Penumbra" 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.
1.11 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.
1.11.1 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 | Confirms units meet all dimensional and | |
| visual product specifications. | Acceptance Criteria | |
| met | ||
| Simulated Use Test | Confirms the functionality of units using a | |
| clinically relevant bench-top model. | Acceptance Criteria | |
| met | ||
| Tensile Test | Confirms units meet product specification | |
| related to tensile strength. | Acceptance Criteria | |
| met | ||
| Particulate Test | Particulates generated during simulated use | |
| were evaluated. | Acceptance Criteria | |
| met | ||
| Liquid Leakage | ||
| Pressure Test | Confirms units can withstand sufficient | |
| pressure. | Acceptance Criteria | |
| met | ||
| Fluoroscopy Test | Confirms markerband is fluoroscopically | |
| visible. | Acceptance Criteria | |
| met | ||
| Friction Test | Confirms units meet product specification | |
| related to friction. | Acceptance Criteria | |
| met | ||
| Corrosion Resistance | ||
| Test | Confirms there is no visible corrosion on | |
| units when tested. | Acceptance Criteria | |
| met | ||
| Elongation Test | Confirms units meet product specification | |
| related to elongation. | Acceptance Criteria | |
| met | ||
| Distal Tip Stiffness | ||
| Test | Confirms units have appropriate distal tip | |
| stiffness. | Acceptance Criteria | |
| met | ||
| Flexibility Kink | ||
| Resistance Test | Confirms units have appropriate flexibility | |
| kink resistance. | Acceptance Criteria | |
| met |
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Image /page/7/Picture/0 description: The image shows the word "Penumbra" in a bold, red font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the right side of the "P" to the edge of the circle. The logo is simple and modern.
1.11.2 Animal and Clinical Data
No animal or clinical studies were deemed necessary to support the substantial equivalence of the subject device.
1.12 Summary of Substantial Equivalence
The device testing described in the 510(k) Summary demonstrates the subject device Element Vascular Access System is substantially equivalent to the predicate device Performer Introducer in regard to intended use, operating principle, design concept, fundamental technology, and device performance.