(265 days)
No
The summary describes a physical medical device (embolization coils and delivery system) and its performance is evaluated through bench-top, biocompatibility, and sterilization testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for embolization of various vascular abnormalities, which is a therapeutic intervention to treat these conditions.
No
Explanation: The device is a system for embolization (treatment) of intracranial aneurysms and other neurovascular abnormalities, not for diagnosis.
No
The device description explicitly states it is comprised of physical components: a platinum embolization coil, a composite delivery pusher, and a detachment handle. The performance studies also focus on the physical and mechanical properties of these hardware components.
Based on the provided information, the Penumbra LP Coil System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the embolization of various vascular abnormalities within the body (intracranial, neurovascular, peripheral vasculature). IVD devices are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is a physical coil and delivery system designed to be implanted or used within the vascular system. This is consistent with an interventional medical device, not an IVD.
- Anatomical Site: The anatomical sites listed are all within the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Penumbra LP Coil System is an implantable or interventional medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Penumbra LP Coil System is indicated for the embolization of:
- · Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- · Arterial and venous embolizations in the peripheral vasculature
Product codes
HCG, KRD
Device Description
The Penumbra LP Coil System is comprised of the Penumbra LP Coil, a platinum embolization coil attached to a composite delivery pusher with a radiopaque positioning marker and the Penumbra LP Coil Detachment Handle.
The coil/delivery pusher is packaged separately from the Penumbra LP Coil Detachment Handle. Penumbra LP Coil includes the following coil configurations:
- Ruby Coil LP ●
- Packing Coil LP ●
- PTC Coil LP ●
- Helical Coil LP ●
- Hybrid Coil LP ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovascular, peripheral vasculature (arterial and venous)
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
Bench-top Testing:
Design Verification testing was conducted to evaluate the physical and mechanical properties of the subject devices and demonstrate substantial equivalence to predicate. The following tests were performed, and all tests passed:
- Dimensional/Visual Inspection: Confirm the dimensions of the test units meet all product specifications.
- Friction Testing: Confirm that the friction within a microcatheter is acceptable.
- Fatigue Resistance Testing: Confirm that the coil implant retains its shape after being cycled into/out of the microcatheter.
- Simulated Use Testing: Simulated use testing in an anatomical model and post-detachment dimensional inspection.
- Radiopacity Testing: Confirm fluoroscopic visibility of test units.
- Torsional Resistance Testing: Confirm torsional resistance of test units.
- Corrosion Testing: Confirm that there is no visible corrosion after testing.
- Coil Stiffness Testing: Confirm that test units meet product specifications related to coil stiffness.
- Tensile Testing: Confirm tensile strength of coil implant and Detachment Pusher joints.
Biocompatibility Testing: Non-clinical testing determined the Penumbra LP Coil System to be biocompatible according to the requirements of ISO 10993-1. Some biocompatibility testing of the predicate Penumbra LP Coil System was deemed applicable considering the same materials.
The following tests were performed for the Detachment Pusher of the subject Penumbra LP Coil System:
- Cytotoxicity
- Hemocompatibility
The following tests were performed for the Introducer Sheath of the subject Penumbra LP Coil System: - Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Hemocompatibility
- Material-Mediated Pyrogenicity
Sterilization Testing: The Penumbra LP Coil System was tested to be sterile using identical acceptance criteria and testing methods as the predicate device in accordance with ISO 11135 and ISO 10993-7.
No animal or clinical studies were conducted because bench testing was determined sufficient for verification and validation purposes.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
October 25, 2023
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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Penumbra, Inc. Samyukta Rangachari Regulatory Specialist II One Penumbra Place Alameda, California 94502
Re: K230284
Trade/Device Name: Penumbra LP Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: September 26, 2023 Received: September 28, 2023
Dear Samyukta Rangachari:
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" (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).
1
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 QS 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.
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).
Sincerely,
Naira Muradyan -S
Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K230284
Device Name Penumbra LP Coil System
Indications for Use (Describe)
The Penumbra LP Coil System is indicated for the embolization of:
- · Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- · Arterial and venous embolizations in the peripheral 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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3
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1 510(k) Summary K230284
(as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Penumbra, Inc. is providing the summary of Substantial Equivalence for the subject Penumbra LP Coil System (herein after referred to as LP Coil).
Sponsor/Applicant Name and Address 1.1
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Samyukta Rangachari Regulatory Affairs Specialist Tel: (763) 742-9306 Fax: (510) 217-6414 E-mail: srangachari@penumbrainc.com
1.3 Date of Preparation of 510(k) Summary
October 25, 2023
1.4 Device Trade or Proprietary Name
Penumbra LP Coil System
Primary Device Classification 1.5
Regulatory Class: II Classification Panel: Neurology Classification Name: Neurovascular embolization device Regulation Number: 21 CFR 882.5950 Product Code: HCG
Secondary Device Classification 1.6
Regulatory Class: II Classification Panel: Cardiovascular Classification Name: Vascular embolization device Regulation Number: 21 CFR 870.3300 Product Code: KRD
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1.7 Predicate Device
| 510(k) Number | Device Name |
|---|---|
| K192955 | Penumbra LP Coil System |
1.8 Comparison of Technological Characteristics with the Predicate Device
| Attributes | Predicate Device | Subject
Device |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| General | | |
| Trade Name | Penumbra LP Coil System | Penumbra LP
Coil System |
| 510(k) Number | K192955 | K230284 |
| Classification | Class II: HCG, KRD | SAME |
| Indications for Use | The Penumbra LP Coil System is
indicated for the embolization of:
• Intracranial aneurysms
• Other neurovascular abnormalities
such as arteriovenous malformations
and arteriovenous fistulae
• Arterial and venous embolizations
in the peripheral vasculature | SAME |
| Materials | | |
| Coil | Platinum/Tungsten, Adhesive,
Titanium, Polymer | SAME |
| Introducer Sheath | Polymer | Equivalent |
| Detachment Handle | Plastic, Stainless Steel | SAME |
| Dimensions/Shape | | |
| Coil Secondary Shape | Complex, Finish | Complex, Finish,
Helical, Hybrid |
| Coil Length | 1-60 cm | 1-70 cm |
| Coil Primary Diameter | 0.0135 in. | 0.0115 in.-
0.0135 in. |
| Coil Secondary
Diameter | 1-8 mm | 1-10 mm |
| Detachment Pusher
Length | 185 cm | SAME |
| Introducer Sheath Length | 125 cm max | 126 cm max |
| Other | | |
| Sterilization | EO | SAME |
| Sterilization Assurance
Level (SAL) | ≥10-6 | SAME |
| Attributes | Predicate Device | Subject
Device |
| Use | Single Use | SAME |
| Shelf-life (coil implant &
detachment pusher) | 5 Years | 1 year |
| Shelf-life (detachment
handle) | 5 Years | SAME |
| Device Packaging
Materials and Dimensions | As specified in
K192955 | SAME |
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Image /page/5/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 logo is simple and modern.
Device Description 1.9
The Penumbra LP Coil System is comprised of the Penumbra LP Coil, a platinum embolization coil attached to a composite delivery pusher with a radiopaque positioning marker and the Penumbra LP Coil Detachment Handle.
The coil/delivery pusher is packaged separately from the Penumbra LP Coil Detachment Handle. Penumbra LP Coil includes the following coil configurations:
- Ruby Coil LP ●
- Packing Coil LP ●
- PTC Coil LP ●
- Helical Coil LP ●
- Hybrid Coil LP ●
1.10 Indications For Use
The Penumbra LP Coil System is indicated for the embolization of:
- . Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature .
1.11 Summary of Non-Clinical Data
Included in this section are summary descriptions of the testing performed on the subject Penumbra LP Coil System based on the risk analysis of changes compared to the predicate device.
1.11.1 Bench-top Testing
Design Verification testing was conducted to evaluate the physical and mechanical properties of the subject devices and demonstrate substantial equivalence to predicate. The following tests were performed, and all tests passed:
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Image /page/6/Picture/0 description: The image shows the Penumbra company logo. The logo consists of the word "Penumbra" in a red, sans-serif font, followed by a red circle with a white "P" inside. The "P" is stylized with a horizontal line extending from the top of the letter to the edge of the circle. There is a registered trademark symbol in the bottom right corner of the logo.
| Attribute | Specification | Results |
|---|---|---|
| Dimensional/Visual | ||
| Inspection | Confirm the dimensions of the test units meet all | |
| product specifications. | Pass | |
| Friction Testing | Confirm that the friction within a microcatheter is | |
| acceptable. | Pass | |
| Fatigue Resistance | ||
| Testing | Confirm that the coil implant retains its shape after | |
| being cycled into/out of the microcatheter. | Pass | |
| Simulated Use Testing | Simulated use testing in an anatomical model and | |
| post-detachment dimensional inspection. | Pass | |
| Radiopacity Testing | Confirm fluoroscopic visibility of test units. | Pass |
| Torsional Resistance | ||
| Testing | Confirm torsional resistance of test units. | Pass |
| Corrosion Testing | Confirm that there is no visible corrosion after | |
| testing. | Pass | |
| Coil Stiffness Testing | Confirm that test units meet product specifications | |
| related to coil stiffness. | Pass | |
| Tensile Testing | Confirm tensile strength of coil implant and | |
| Detachment Pusher joints. | Pass |
Table 1: Bench-Top Testing Summary
1.11.2 Biocompatibility Testing
Non-clinical testing determined the Penumbra LP Coil System to be biocompatible according to the requirements of ISO 10993-1. Some biocompatibility testing of the predicate Penumbra LP Coil System was deemed applicable considering the same materials.
The following tests were performed for the Detachment Pusher of the subject Penumbra LP Coil System:
- . Cytotoxicity
- Hemocompatibility .
The following tests were performed for the Introducer Sheath of the subject Penumbra LP Coil System:
- Cytotoxicity ●
- Sensitization ●
- Irritation ●
- Systemic Toxicity .
- Hemocompatibility ●
- Material-Mediated Pyrogenicity ●
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Image /page/7/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 line extending from the top of the "P" to the edge of the circle.
1.11.3 Sterilization Testing
The Penumbra LP Coil System was tested to be sterile using identical acceptance criteria and testing methods as the predicate device in accordance with ISO 11135 and ISO 10993-7.
1.12 Performance Data – Animal, Clinical
No animal or clinical studies were conducted because bench testing was determined sufficient for verification and validation purposes.
1.13 Summary of Substantial Equivalence
The subject Penumbra LP Coil System is substantially equivalent to the predicate device Penumbra LP Coil System. The subject device has identical intended use as the predicate device. The subject and the predicate devices differ with minor technological variations, while maintaining the same fundamental scientific technology. However, these differences do not raise different questions of safety and effectiveness.
The device testing described in the 510(k) Summary demonstrates the subject device is substantially equivalent to the predicate device with regards to operating principle, fundamental technology, and device performance.