(29 days)
Not Found
No
The document describes a mechanical coil system for embolization and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for embolization of intracranial aneurysms and other vascular abnormalities, which are medical conditions, and its function involves achieving occlusion within the vasculature to treat these conditions.
No
The device is described as an embolization coil system used to occlude blood vessels, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the system consists of physical components: a Coil Implant, a Detachment Pusher, and a Detachment Handle. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The Penumbra Smart Coil System is a medical device used for embolization within the body's vasculature. It is implanted to block blood flow to specific areas.
The description clearly indicates it's an implantable device used for a therapeutic procedure (embolization), not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Penumbra Smart 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 Smart Coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of bare platinum coils to achieve occlusion. The Smart Coil System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.
The purpose of this 510(k) pre-market notification is to implement the following modifications to the Instructions for Use (IFU):
- . Revise precaution
- . Update legal address of manufacturer
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, peripheral 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A literature review was conducted to substantiate the safe and effective performance of the Smart Coil and Smart Coil Detachment Handle, as well as its substantial equivalence to the predicate device. Current literature was reviewed in relationship to device precautions. Review concluded that revised labeling is appropriate. Additionally, revised labeling was found to have a safety and effectiveness profile that is similar to the predicate device.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with three curved lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2015
Penumbra, Inc. Mr. Charles DeNault Regulatory Affairs Specialist One Penumbra Place Alameda, California 94502
Re: K151572
Trade/Device Name: Penumbra Smart Coil™ Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: June 10, 2015 Received: June 11, 2015
Dear Mr. DeNault:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S 同公
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151572
Device Name Penumbra Smart Coil
Indications for Use (Describe)
The Penumbra Smart 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 CER 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ |
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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 Penumbra Smart Coil™
1.1 Sponsor/Applicant Name and Address
Penumbra, Inc. One Penumbra Place Alameda, CA 94502 USA
1.2 Sponsor Contact Information
Charles DeNault Regulatory Affairs Specialist Phone: (510) 748-3302 Fax: (510) 217-6414 Email: cdenault@penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
July 6, 2015
Device Trade or Proprietary Name 1.4
Penumbra Smart Coil™
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 |
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 |
1.7 Predicate Devices
| 510(k) Number | Clearance Date | Name of Predicate Device | Name of Manufacturer |
|---|---|---|---|
| K143218 | March 18, 2015 | Penumbra Smart Coil System | Penumbra, Inc. |
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Predicate Comparison 1.8
| Penumbra Smart Coil | Penumbra Smart Coil | |
|---|---|---|
| Classification | Class II, HCG, KRD | 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 | |
| Materials | ||
| Coil Implant | Platinum/Tungsten, Nitinol, Polymer, | |
| Adhesives | Same | |
| Inner Coil | Stainless Steel, Polymer, | |
| Platinum/Tungsten, Nitinol | Same | |
| Detachment Handle | Plastic | Same |
| Dimensions/Shape | ||
| Coil Secondary Diameter | 1-18 mm | Same |
| Coil Length | 1-60 cm | Same |
| Coil Secondary Shape | Complex, Helical (Curve) | Same |
| Pusher Length | 185 cm | Same |
| Sterilization | ||
| Sterilization Method | EtO | Same |
Device Description 1.9
The Smart Coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of bare platinum coils to achieve occlusion. The Smart Coil System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.
The purpose of this 510(k) pre-market notification is to implement the following modifications to the Instructions for Use (IFU):
- . Revise precaution
- . Update legal address of manufacturer
1.10 Indications for Use
The Penumbra Smart Coil System is indicated for the embolization of:
- . Intracranial aneurysms
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- . 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
A literature review was conducted to substantiate the safe and effective performance of the Smart Coil and Smart Coil Detachment Handle, as well as its substantial equivalence to the predicate device. Current literature was reviewed in relationship to device precautions. Review concluded that revised labeling is appropriate. Additionally, revised labeling was found to have a safety and effectiveness profile that is similar to the predicate device.
1.12 Summary of Substantial Equivalence
The Penumbra Smart Coil was found to have a safety and effectiveness profile that is similar to the predicate device.
1.13 Conclusion
The non-clinical data supports the safety of the device and the Penumbra Smart Coil should perform as intended in the specified use conditions.