(30 days)
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
The LP Coil consists of a Coil Implant attached to a Detachment Pusher, both contained within a Sheath. The Detachment Pusher comprises a shaft with a radiopaque positioning marker, a Distal Detachment Tip (DDT), and a pull wire. A Detachment Handle (packaged separately) is used to detach the Coil Implant from the Detachment Pusher. The LP Coil is designed for endovascular embolization in the neuro and peripheral vasculature. Intended users for this device are physicians who have received appropriate training in interventional radiology. The LP Coil is a line extension to the Penumbra Smart Coil System (hereinafter referred to as Smart Coil) that uses the existing Sheath, Detachment Pusher, and Detachment Handle from the Smart Coil. This line extension includes two configurations:
- Ruby LP .
- Finish LP ●
This document describes the Penumbra LP Coil System, a neurovascular embolization device. The information provided outlines the device's indications for use, its classification, and a comparison to predicate and reference devices, as well as a summary of non-clinical data.
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Specification | Reported Device Performance |
|---|---|---|
| Dimensional/Visual Inspection | Confirm the dimensions of the units meet all product specifications. | Pass |
| Friction Testing | Push/pull friction acceptable through a 0.0165 in. ID microcatheter. | Pass |
| Fatigue Resistance | The Coil Implant retains its secondary shape after being cycled into/out of the 0.0165" ID microcatheter 5 times. | Pass |
| Simulated Use Flow Model Testing | Simulated use testing with accessory devices in an anatomical model which simulated the tortuosity of the neurovasculature. Devices were delivered through the model to evaluate the effectiveness of the devices to embolize targeted vasculature. | Pass |
| Distal System Tensile Test | Minimum per specification. | Pass |
| Sterilization Testing | Sterile, meeting identical acceptance criteria and testing methods as the predicate device, in accordance with ISO 11135 and ISO 10993-7. | Passed |
2. Sample Size and Data Provenance for Test Set:
The provided text does not specify the exact sample sizes used for each individual bench-top test (Dimensional/Visual Inspection, Friction Testing, Fatigue Resistance, Simulated Use Flow Model Testing, Distal System Tensile Test, and Sterilization Testing). It generally states "all tests passed," implying that the tested samples met the criteria.
The data provenance is from non-clinical data (bench-top testing and sterilization testing) performed by Penumbra, Inc. in Alameda, CA, USA. The studies are prospective in nature, as they involve actively testing the device against predefined specifications.
3. Number of Experts and Qualifications for Ground Truth:
This document describes a premarket notification for a medical device (510(k)) based on substantial equivalence, primarily supported by non-clinical bench-top and sterilization testing. The concept of "ground truth established by experts" in the context of clinical interpretation, such as by radiologists, is not directly applicable here.
For non-clinical tests, the "ground truth" is defined by the engineering specifications and industry standards (e.g., ISO 11135, ISO 10993-7), which are set by qualified engineers and scientists during the design and development process. The testing itself is conducted by trained technicians or engineers to verify adherence to these established specifications. The document doesn't specify the number of individuals involved in setting these specifications.
4. Adjudication Method for the Test Set:
For the non-clinical tests described, a formal adjudication method like "2+1" or "3+1" is typically not used, as these are more common in clinical studies involving interpretation of data by multiple human observers.
Instead, the results are likely determined by direct measurement against objective criteria and specifications. A "Pass" or "Fail" outcome is generally determined by whether the device performance falls within the predefined acceptable range for each attribute. Any discrepancies during testing would likely be handled through standard quality control and engineering review processes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
The document discusses a non-clinical substantial equivalence determination for a physical medical device (coils) and does not involve AI or human interpretation of images requiring an MRMC study. The comparison is between the subject device and predicate devices based on design, materials, and non-clinical performance characteristics.
6. Standalone Performance Study:
Since this is a physical medical device and not an algorithm/AI system, the term "standalone performance" in the context of an algorithm's performance without human-in-the-loop is not applicable. The "standalone performance" of the device is demonstrated by the bench-top and sterilization testing results, which show the device's intrinsic mechanical and material properties meet specifications.
7. Type of Ground Truth Used:
The ground truth used for this study is:
- Engineering Specifications and Design Requirements: For dimensional/visual inspection, friction testing, fatigue resistance, distal system tensile test, and overall simulated use performance. These specifications define the expected physical and mechanical properties.
- International Standards: For sterilization testing (ISO 11135 for sterilization, ISO 10993-7 for ethylene oxide residuals). These standards define acceptable levels and methods for sterilization.
8. Sample Size for the Training Set:
Not applicable. This document describes non-clinical testing for a physical medical device. It does not involve machine learning or AI, and therefore there is no "training set" in the computational sense. The "training" in the context of manufacturing would involve calibrating machinery, training personnel, and establishing processes, which are part of good manufacturing practices, but not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an algorithm, there is no ground truth established for it. The "ground truth" for the device's design and manufacturing is established through engineering design processes, risk analysis, and adherence to relevant industry standards and regulations.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
November 20, 2019
Penumbra, Inc. Anush Puvvada Regulatory Specialist III One Penumbra Place Alameda, California 94502
Re: K192955
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: October 18, 2019 Received: October 21, 2019
Dear Anush Puvvada:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Xiaolin Zheng, Ph.D. Director (Acting) 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) K192955
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)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the word "Penumbra" in a red font. To the right of the word is a red circle with a white "P" inside. The "P" is stylized with a white line extending from the top of the "P" to the left, connecting to the end of the word "Penumbra."
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 subject Penumbra LP Coil System (herein after referred to as LP Coil).
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
Sponsor Contact Information 1.2
Anush Puvvada Regulatory Specialist III Tel: (510) 440-5568 Fax: (510) 217-6414 E-mail: ypuvvada@penumbrainc.com
1.3 Date of Preparation of 510(k) Summarv
October 18, 2019
Device Trade or Proprietary Name 1.4
Penumbra LP Coil System
Primary Device Classification 1.5
II Regulatory Class: Classification Panel: Neurology Classification Name: Neurovascular embolization device Regulation Number: 21 CFR 882.5950 Product Code: HCG
1.6 Secondary Device Classification
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 and Reference Devices
| 510(k)Number | Clearance Date | Name of PredicateDevice | Name ofManufacturer |
|---|---|---|---|
| Predicate Device | |||
| K143218 | March 18, 2015 | ||
| K151572 | July 10, 2015 | Penumbra Smart Coil | Penumbra, Inc. |
| K160832 | April 20, 2016 | ||
| Reference Device | |||
| K173614 | April 17, 2018 | Penumbra Coil 400 | Penumbra, Inc. |
Predicate and Reference Device Comparison 1.8
| Attributes | Predicate Device | Reference Device | Subject Devices |
|---|---|---|---|
| General | |||
| Trade name | Penumbra SmartCoil | Penumbra Coil 400 | LP Coil |
| 510(k)(s) | K143218, K151572,K160832 | K173614 | K192955 |
| Classification | Class II: HCG,KRD | SAME | SAME |
| Indications for Use | Indicated for theembolization of:• Intracranialaneurysms• Otherneurovascularabnormalitiessuch asarteriovenousmalformationsand arteriovenousfistulae• Arterial andvenousembolizations inthe peripheralvasculature | SAME | SAME |
| Coil Materials/Construction | |||
| Coil | 92% Platinum/8%Tungsten, 90%Platinum/10%Iridium, Stainless | 92% Platinum/8%Tungsten,Adhesive,Titanium, Polymer | SAME asReference |
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Image /page/5/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 bold, red font. To the right of the name is a circular graphic, also in red, with a stylized "P" inside, created by a white line that forms the letter and extends beyond the circle's edge.
| Attributes | Predicate Device | Reference Device | Subject Devices |
|---|---|---|---|
| Steel, Adhesive, | |||
| Titanium, Polymer | |||
| Coil Dimensions/Shape | |||
| Coil SecondaryShape | Complex, Helical | Complex, Helical,Finish | Complex, Finish |
| Coil Length | 1-60 cm | SAME | SAME |
| Coil PrimaryDiameter | 0.0105-0.0130 in. | 0.020 in. | 0.0135 in. |
| Coil SecondaryDiameter | 1-18 mm | 2-40 mm | 1-8 mm |
| Other | |||
| Sterilization | EO | SAME | SAME |
| Sterilizationassurance level(SAL) | $\geq$ 10-6 | SAME | SAME |
| Use | Single Use | SAME | SAME |
| Shelf-life (coilimplant &detachment pusher) | 5 Years | 8 Years | SAME asPredicate |
| Shelf-life(detachment handle) | 5 Years | 3 Years | SAME asPredicate |
| Device PackagingMaterials andDimensions | As specified inK143218 | As described inK173614 | SAME asPredicate |
Device Description 1.9
The LP Coil consists of a Coil Implant attached to a Detachment Pusher, both contained within a Sheath. The Detachment Pusher comprises a shaft with a radiopaque positioning marker, a Distal Detachment Tip (DDT), and a pull wire. A Detachment Handle (packaged separately) is used to detach the Coil Implant from the Detachment Pusher. The LP Coil is designed for endovascular embolization in the neuro and peripheral vasculature. Intended users for this device are physicians who have received appropriate training in interventional radiology. The LP Coil is a line extension to the Penumbra Smart Coil System (hereinafter referred to as Smart Coil) that uses the existing Sheath, Detachment Pusher, and Detachment Handle from the Smart Coil. This line extension includes two configurations:
- Ruby LP .
- Finish LP ●
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Image /page/6/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 bold, red font. To the right of the name is a circular graphic, also in red, with a stylized "P" inside, connected to the wordmark by a thin line.
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
Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a summary of information regarding Substantial Equivalence of the device is as follows.
Included in this section are descriptions of the design control testing performed on the subject LP Coil based on a risk analysis of any technological changes compared to the predicate device. Design Verification (Bench-Top Testing and Sterilization Testing) was performed on the subject device as part of the design control activities. The subject device met all established requirements. No new biocompatibility testing was performed due to the same materials of construction between the subject and predicate devices.
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:
| Attribute | Specification | Results |
|---|---|---|
| Dimensional/VisualInspection | Confirm the dimensions of the units meet all productspecifications. | Pass |
| Friction Testing | Push/pull friction acceptable through a 0.0165 in. IDmicrocatheter | Pass |
| Fatigue Resistance | The Coil Implant retains its secondary shape afterbeing cycled into/out of the 0.0165" IDmicrocatheter 5 times | Pass |
| Simulated Use FlowModel Testing | Simulated use testing with accessory devices in ananatomical model which simulated the tortuosity ofthe neurovasculature. Devices were deliveredthrough the model to evaluate the effectiveness ofthe devices to embolize targeted vasculature. | Pass |
| Distal System TensileTest | Minimum per specification | Pass |
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1.11.2 Sterilization Testing
The LP Coil System was tested to be sterile using identical acceptance criteria and testing methods as the predicate device. Testing was accordance with ISO 11135 and ISO 10993-7.
1.12 Summary of Substantial Equivalence
The subject LP Coil is substantially equivalent to the predicate device Smart Coil. The subject device has identical intended use as the predicate device. The subject and the predicate devices differ slightly in regard to 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 demonstrate the subject devices are substantially equivalent to the predicate device in regard to operating principle, fundamental technology and device performance.
§ 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).