(30 days)
No
The summary describes a mechanical embolization coil system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for the embolization of intracranial aneurysms, neurovascular abnormalities, and arterial/venous embolizations, which are treatments for medical conditions.
No
This device is designed for embolization procedures, which are therapeutic interventions to block blood flow, not to diagnose a condition.
No
The device description clearly outlines physical components like coils, pushers, sheaths, and handles, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the embolization of various vascular abnormalities within the body (intracranial, neurovascular, peripheral vasculature). This is a therapeutic intervention performed in vivo (within a living organism).
- Device Description: The device is a physical implant (coil) delivered endovascularly. It is designed to physically block blood flow.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is used in vivo for treatment.
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 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 ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovascular, arterial, venous, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians who have received appropriate training in interventional radiology.
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)
Design Verification (Bench-Top Testing and Sterilization Testing).
Bench-Top Testing:
Dimensional/Visual Inspection - Confirm the dimensions of the units meet all product specifications. Results: Pass.
Friction Testing - Push/pull friction acceptable through a 0.0165 in. ID microcatheter. Results: Pass.
Fatigue Resistance - The Coil Implant retains its secondary shape after being cycled into/out of the 0.0165" ID microcatheter 5 times. Results: 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. Results: Pass.
Distal System Tensile Test - Minimum per specification. Results: Pass.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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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
1
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
2
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 Predicate
Device | Name of
Manufacturer |
|------------------|----------------|-----------------------------|-------------------------|
| 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 Smart | ||
| Coil | 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 the | ||
| embolization of: | |||
| • Intracranial | |||
| aneurysms | |||
| • Other | |||
| neurovascular | |||
| abnormalities | |||
| such as | |||
| arteriovenous | |||
| malformations | |||
| and arteriovenous | |||
| fistulae | |||
| • Arterial and | |||
| venous | |||
| embolizations in | |||
| the peripheral | |||
| vasculature | SAME | SAME | |
| Coil Materials/Construction | |||
| Coil | 92% Platinum/8% | ||
| Tungsten, 90% | |||
| Platinum/10% | |||
| Iridium, Stainless | 92% Platinum/8% | ||
| Tungsten, | |||
| Adhesive, | |||
| Titanium, Polymer | SAME as | ||
| Reference |
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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 Secondary | |||
| Shape | Complex, Helical | Complex, Helical, | |
| Finish | Complex, Finish | ||
| Coil Length | 1-60 cm | SAME | SAME |
| Coil Primary | |||
| Diameter | 0.0105-0.0130 in. | 0.020 in. | 0.0135 in. |
| Coil Secondary | |||
| Diameter | 1-18 mm | 2-40 mm | 1-8 mm |
| Other | |||
| Sterilization | EO | SAME | SAME |
| Sterilization | |||
| assurance level | |||
| (SAL) | $\geq$ 10-6 | SAME | SAME |
| Use | Single Use | SAME | SAME |
| Shelf-life (coil | |||
| implant & | |||
| detachment pusher) | 5 Years | 8 Years | SAME as |
| Predicate | |||
| Shelf-life | |||
| (detachment handle) | 5 Years | 3 Years | SAME as |
| Predicate | |||
| Device Packaging | |||
| Materials and | |||
| Dimensions | As specified in | ||
| K143218 | As described in | ||
| K173614 | SAME as | ||
| Predicate |
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/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 |
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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.