(26 days)
The Smart Coil is indicated for the embolization of:
- Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arterioyenous fistulae
- · Arterial and venous embolizations in the peripheral vasculature
The Smart Coil is an endovascular embolization coil for the treatment of aneurysms or other vascular abnormalities. The Smart Coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of platinum coils to achieve occlusion. The Smart Coil consists of three components: a Coil, a Detachment Pusher (attached to Coil), and a Detachment Handle (packaged separately).
The provided text describes the Penumbra Smart Coil, a neurovascular embolization device. The 510(k) premarket notification (K160832) is primarily for a change in the detachment pusher pull wire tensile strength specification to improve manufacturability.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Internal/Specification) | Reported Device Performance (Results) |
|---|---|---|
| Tensile (Minimum break force value) | Measured per specification (Implied) | Pass |
| Simulated Use (Delivery & Detachment) | Ability to deliver and detach embolic coils in a tortuous anatomical model of the neurovasculature | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the tensile and simulated use tests. It only mentions that "Design Verification testing was repeated for all attributes affected by change to device specifications."
The data provenance is not explicitly stated in terms of country of origin. The study appears to be prospective as it involves repeated design verification testing for a specific product modification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for the tensile or simulated use tests. These tests appear to be engineering-based performance assessments.
4. Adjudication Method for the Test Set:
Not applicable, as the tests are objective engineering assessments rather than subjective evaluations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical medical device (embolization coil), not an AI diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was done:
The concept of "standalone performance" typically applies to AI algorithms. For this physical device, the "standalone" performance is represented by the direct engineering tests (Tensile and Simulated Use) without human intervention in the device's function during the test.
7. The Type of Ground Truth Used:
For the Tensile test, the "ground truth" is the engineering specification for the minimum break force.
For the Simulated Use test, the "ground truth" is the successful delivery and detachment of the embolic coils within a representative anatomical model. These are inherently tied to mechanical performance requirements.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of medical device.
In summary:
The study conducted for the Penumbra Smart Coil (K160832) was a set of design verification tests focused on the mechanical performance of the device, particularly in light of a change to the detachment pusher pull wire tensile strength specification. The acceptance criteria were met by successfully passing these engineering tests. The study did not involve human readers, AI, or traditional clinical endpoints for establishing ground truth, but rather engineering specifications and simulated performance.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 20, 2016
Penumbra, Inc. Mr. Charles Denault Regulatory Affairs Specialist III One Penumbra Place Alameda, California 94502
Re: K160832
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: March 24, 2016 Received: March 25, 2016
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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/A
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) K160832
Device Name Penumbra Smart Coil™
Indications for Use (Describe) The Smart Coil is indicated for the embolization of:
- Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arterioyenous 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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1 510(k) Summary, K160832
(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 III Phone: (510) 748-3302 Fax: (510) 217-6414 Email: cdenault@penumbrainc.com
Date of Preparation of 510(k) Summary 1.3
April 19, 2016
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 |
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1.7 Predicate Devices
| 510(k) Number | Clearance Date | Name of PredicateDevice | Name ofManufacturer |
|---|---|---|---|
| K143218 | March 18, 2015 | Penumbra Smart Coil | Penumbra, Inc. |
| K151572 | July 10, 2015 | Penumbra Smart Coil | Penumbra, Inc. |
Predicate Comparison 1.8
| Predicate: Penumbra Smart Coil | Subject: Penumbra Smart Coil | |
|---|---|---|
| 510(k) No. | K143218, K151572 | K160832 |
| Classification | Class II, HCG, KRD | Same |
| Indications for Use | Indicated for the embolization of:• Intracranial aneurysms• Other neurovascular abnormalities suchas arteriovenous malformations andarteriovenous fistulae• Arterial and venous embolizations in theperipheral vasculature | Same |
| Materials | ||
| Coil | Platinum/Tungsten, Nitinol, Polymer,Adhesives | Same |
| Detachment Pusher | Stainless Steel, Polymer,Platinum/Tungsten, Nitinol | Same |
| Detachment Handle | Plastic, Stainless Steel | Same |
| Dimensions/Shape | ||
| Coil SecondaryDiameter | 1-18 mm | Same |
| Coil Length | 1-60 cm | Same |
| Coil Secondary Shape | Complex, Helical (Curve) | Same |
| Pusher Length | 185 cm | Same |
| Other | ||
| Packagingconfigurations | Individual | Same |
| Sterilization method | Ethylene oxide (EO) | Same |
| Shelf life | 5 years | Same |
| Use | Single use, disposable | Same |
1.9 Device Description
The Smart Coil is an endovascular embolization coil for the treatment of aneurysms or other vascular abnormalities. The Smart Coil functions to selectively embolize targeted segments of the vasculature by packing a sufficient quantity of platinum coils to achieve occlusion. The
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Smart Coil consists of three components: a Coil, a Detachment Pusher (attached to Coil), and a Detachment Handle (packaged separately).
The purpose of this 510(k) pre-market notification is to change the detachment pusher pull wire tensile strength specification to a more relevant value as measured in engineering studies to improve device manufacturability.
1.10 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 .
1.11 Summary of Non-Clinical Data
Design Verification testing was repeated for all attributes affected by change to device specifications. Results of testing demonstrate that Smart Coil with modified specification is substantial equivalence to predicate Smart Coil. The following tests were performed and all tests passed successfully:
| Test | Summary | Results |
|---|---|---|
| Tensile | Minimum break force value measured per specification | Pass |
| Simulated Use | Simulated use testing of the Smart Coil in an anatomical modelwhich simulated the tortuosity of the neurovasculature. Devices weredelivered through the tortuous anatomical model to evaluate theability of the device to deliver and detach embolic coils. | Pass |
1.12 Summary of Substantial Equivalence
The Smart Coil was found to have a safety and effectiveness profile that is similar to the predicate device.
§ 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).