(128 days)
Not Found
No
The summary describes a physical medical device (coils and delivery system) and its performance based on bench-top and biocompatibility testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the embolization of intracranial aneurysms, neurovascular abnormalities, and arterial and venous embolizations in the peripheral vasculature, which are direct medical treatments.
No
The Smart Coil is an embolization device used to achieve occlusion in blood vessels. Its function is therapeutic (embolization), not diagnostic. The provided information describes its physical properties, biocompatibility, and mechanical performance, which are relevant for a therapeutic device. There is no mention of it being used to detect, identify, or monitor medical conditions.
No
The device description explicitly states the system consists of three physical components: a Coil Implant, a Detachment Pusher, and a Detachment Handle. The performance studies also focus on physical and mechanical properties, biocompatibility, and sterilization, which are characteristic of hardware medical devices.
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 blood vessels within the body (intracranial, neurovascular, peripheral vasculature). This is a therapeutic procedure performed in vivo (within a living organism).
- Device Description: The device is a physical implant (coil) used to block blood flow. This is a medical device used for treatment, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Smart Coil 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 (comma separated list FDA assigned to the subject device)
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 in an identical fashion to the Penumbra Coil System. The Smart Coil System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Verification (Bench-Top Testing): The physical, mechanical and performance testing of the Smart Coil components demonstrate that the devices are substantially equivalent to the currently marketed predicate devices. All testing met specification. The results appropriately address the physical and mechanical performance expectations of the device.
Biocompatibility: Non-clinical testing found the Smart Coil and Smart Coil Detachment Handle to be biocompatible according to the requirements of EN ISO 10993. The tests performed include In vitro Cytotoxicity, Sensitization, Irritation, Implant Study, Systemic Toxicity (Acute), Material Mediated Pyrogen, Sub-Chronic Toxicity, Hemocompatibility (Thrombosis, Coagulation (PT), Coagulation (PTT), Hematology (Hemolysis), Complement Activation), and Genotoxicity (Ames Mutagenicity, Mouse Lymphoma, In vivo Mouse micronucleus). All tests showed non-toxic, non-sensitizing, non-irritant, non-pyrogenic, non-hemolytic, and non-mutagenic results where applicable.
Sterilization: The Smart Coil and Smart Coil Detachment Handle were tested to be sterile using identical acceptance criteria and testing methods as the predicate device.
Shelf Life: The Smart Coil and Smart Coil Detachment Handle were tested to have a minimum one year shelf life using identical acceptance criteria and testing methods as the predicate device.
MR Environment: The Smart Coil was tested in the MR environment to advise the MR Conditional statement in the IFU.
Conclusion: The non-clinical data supports the safety of the device and the verification and validation demonstrate that the Penumbra Smart Coil should perform as intended in the specified use conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Re:
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2015
Penumbra, Inc. % Charles DeNault Regulatory Affairs Specialist 1351 Harbor Bay Parkway Alameda, California 94502
K143218 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: January 23, 2015 Received: January 26, 2015
Dear Mr. Charles 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) K143218
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 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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3
11 510(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™.
11.1 Sponsor/Applicant Name and Address
Penumbra, Inc. 1351 Harbor Bay Parkway Alameda, CA 94502 USA
11.2 Sponsor Contact Information
Charles DeNault Regulatory Affairs Specialist Phone: (510) 748-3302 Fax: (510) 217-6414 Email: cdenault@penumbrainc.com
11.3 Date of Preparation of 510(k) Summary
March 18, 2015
11.4 Device Trade or Proprietary Name
Penumbra Smart Coil™
11.5 Primary Device Classification
| Regulatory Class: | II |
|---|---|
| Classification Panel: | Neurology |
| Classification Name: | Neurovascular embolization device |
| Regulation Number: | 21 CFR 882.5950 |
| Product Code: | HCG |
11.6 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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11.7 Predicate Devices
| 510(k) Number | Clearance Date | Name of Predicate Device | Name of
Manufacturer |
|---------------|------------------|--------------------------|-------------------------|
| K103305 | January 26, 2011 | Penumbra Coil System | Penumbra, Inc. |
| K120330 | April 02, 2012 | Penumbra Coil System | Penumbra, Inc. |
11.8 Predicate Comparison
| Penumbra Coil System | 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. Adhesive | Platinum/Tungsten, Nitinol, Polymer, Adhesives |
| Inner Coil | Stainless Steel, Polymer, Platinum/Tungsten, Nitinol | Same |
| Detachment Handle | Plastic | Same |
| Dimensions/Shape | ||
| Coil Secondary Diameter | 2-32 mm | 1-18 mm |
| Coil Length | 1-60 cm | Same |
| Coil Secondary Shape | Complex, Helical (Curve), J | Complex, Helical (Curve) |
| Pusher Length | 175 cm | 185 cm |
| Sterilization | ||
| Sterilization Method | EtO | Same |
11.9 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 in an identical fashion to the Penumbra Coil System. The Smart Coil System consists of three components: a Coil Implant attached to a Detachment Pusher and a Detachment Handle.
11.10 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
11.11 Summary of Non-Clinical Data
Included in this section is a description of the testing, which substantiates the safe and effective performance of the Smart Coil and Smart Coil Detachment Handle as well as its substantial equivalence to the predicate devices:
- Biocompatibility
- Design Verification (Bench-Top Testing) ●
- . MR Environment
- Sterilization ●
- Shelf Life
The subject Smart Coil met all predetermined requirements.
11.11.1 Biocompatibility Testing
Non-clinical testing found the Smart Coil and Smart Coil Detachment Handle to be biocompatible according to the requirements of EN ISO 10993mbra Smart Coil should perform as intended in the specified use conditions. requirements. Studies were selected in accordance with EN ISO 10993-1:2009 guidelines (Biological Evaluation of Medical Devices). All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices. The following tests were performed:
| Test | Acceptance Criteria | Results | Conclusions |
|---|---|---|---|
| In vitro Cytotoxicity | |||
| (MEM Elution) | Sample extracts must yield cell | ||
| lysis grade $\u2264$ 2 | Grade: 0 | Non-toxic | |
| Sensitization | |||
| (Magnusson-Kligman | |||
| Method) | Test Group shall yield Grade 10% in 3 or | ||
| ● | |||
| more animals | No evidence of systemic | ||
| toxicity from sample | |||
| extracts: | |||
| No deaths | |||
| ● | |||
| No toxic signs | |||
| ● | |||
| No weight loss > 10% | |||
| ● | |||
| in any animals | Non-toxic | ||
| Material Mediated | |||
| Pyrogen | Sample extracts must not cause a | ||
| total rise in body temperature of ≥ | |||
| 0.5° C | Non-pyrogenic: no animals | ||
| had a temperature rise ≥ | |||
| 0.5°C | Non- | ||
| pyrogenic | |||
| Sub-Chronic Toxicity | |||
| (Sub-Acute Toxicity) | |||
| Sub-Chronic/Sub- | |||
| Acute Toxicity: 14 | |||
| day / 14 dose IV study | |||
| (mice) | The following parameters will be | ||
| used as signs of toxicity; however | |||
| final evaluation of the test article | |||
| will involve correlation of all data | |||
| for patterns of toxicity: | |||
| Death of more than one animal | |||
| ● | |||
| in group | |||
| Mean body weight change in | |||
| group relative to control | |||
| ● | |||
| Clinical signs of toxicity in | |||
| more than one animal in group | |||
| ● | |||
| Hematology and clinical | |||
| chemistry values for animal | |||
| groups will be reviewed for | |||
| patterns of toxicity | |||
| Histopathology of tissues will | |||
| ● | |||
| be evaluated for patterns of | |||
| toxicity | Negative for systemic | ||
| toxicity: | |||
| No deaths | |||
| ● | |||
| No statistically | |||
| significant differences | |||
| between the test and | |||
| control mice body | |||
| weights | |||
| No abnormal clinical | |||
| ● | |||
| signs of toxicity | |||
| Hematology showed | |||
| ● | |||
| no findings indicative | |||
| of a pattern of toxicity | |||
| Histopathology | |||
| ● | |||
| showed no adverse | |||
| findings attributed to | |||
| the test article | Non-toxic | ||
| Hemocompatibility | |||
| Thrombosis (Dog | |||
| Thrombogenicity) | Device must be non-thrombogenic | ||
| after 4 hours in vivo when | |||
| compared to a predicate device | Test device was not | ||
| thrombogenic when | |||
| compared to the predicate. | |||
| The device exhibited | |||
| acceptable interaction with | |||
| blood | Non- | ||
| hemolytic | |||
| Coagulation (PT) | Coagulation times must be similar | ||
| to the predicate or negative control | |||
| values using analysis of variance. | Test article coagulation | ||
| times are statistically | |||
| similar to the predicate (p- | |||
| value=1.000) | |||
| Test | Acceptance Criteria | Results | Conclusions |
| Coagulation (PTT) | Coagulation times must be similar | ||
| to the predicate or negative control | |||
| values using analysis of variance. | Test article coagulation | ||
| times are statistically | |||
| similar to the predicate (p- | |||
| value=0.105) | |||
| Hematology | |||
| (Hemolysis) - Direct | |||
| Contact | Sample extracts must be | ||
| nonhemolytic (≤2% hemolytic | |||
| index) | Nonhemolytic: | ||
| Hemolytic index = 1.25% | |||
| Corrected hemolytic index | |||
| = 0.40% | |||
| Hematology | |||
| (Hemolysis) - Indirect | |||
| Contact | Sample extracts must be | ||
| nonhemolytic (≤2% hemolytic | |||
| index) | Nonhemolytic: | ||
| Hemolytic index = 0.37% | |||
| Corrected hemolytic index | |||
| = 0.00% | |||
| Complement | |||
| Activation | The concentrations of C3a and | ||
| SC5b-9 in the test samples are | |||
| statistically similar to or lower than | |||
| the predicate | Concentrations of test | ||
| article compared to | |||
| predicate: | |||
| C3a = similar at 30, 60, and | |||
| 90 minutes | |||
| SC5b-9 = lower at 30 and | |||
| 60 minutes / similar at 90 | |||
| minutes | |||
| Genotoxicity | |||
| Ames Mutagenicity | Sample extracts must be non- | ||
| mutagenic | Non-mutagenic | ||
| Mouse Lymphoma | Sample extracts must be non- | ||
| mutagenic | Non-mutagenic | Non- | |
| mutagenic | |||
| In vivo Mouse | |||
| micronucleus | Sample extracts must be non- | ||
| mutagenic | Non-mutagenic |
Biocompatibility Testing Summary – Coil Implant/Detachment Pusher
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7
Biocompatiblity Testing Summary – Detachment Handle
| Test | Acceptance Criteria | Results | Conclusion |
|---|---|---|---|
| In vitro Cytotoxicity | |||
| (MEM Elution) | Sample extracts must yield | ||
| cell lysis grade ≤ 2 | Grade: 0 | Non-toxic | |
| Sensitization | |||
| (Magnusson-Kligman | |||
| Method) | Test Group shall yield Grade |