(128 days)
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
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.
The Penumbra Smart Coil is a medical device designed for the embolization of intracranial aneurysms, neurovascular abnormalities, and arterial and venous embolizations in the peripheral vasculature. The provided document focuses on demonstrating the substantial equivalence of the Penumbra Smart Coil to predicate devices through a series of non-clinical tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document presents several tables detailing acceptance criteria and results for various non-clinical tests. Due to the extensive nature of these tables, they are summarized below by category. Please refer to the original document for the full detailed tables.
| Test Category | Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Biocompatibility | ||
| In vitro Cytotoxicity | Sample extracts must yield cell lysis grade ≤ 2 | Grade: 0 (Non-toxic) |
| Sensitization | Test Group shall yield Grade < 1 score on Magnusson and Kligman scale (provided Control Grade < 1) | Grade: 0 (No Sensitization response - Non-sensitizing) |
| Irritation (Intracutaneous Reactivity) | The difference in the mean test article and mean control score must be grade 1.0 or lower | Grade 0.0 or 0.2 difference (Non-irritant) |
| Implant Study | Overall interpretation of biocompatibility exhibited by the test article based on clinical observations, and gross and microscopic analysis comparing the test article to the control, shall show the test article to be a non-irritant. | Test article is considered a non-irritant (Non-irritant) |
| Systemic Toxicity (Acute) | Sample extracts must not cause significant biological reaction greater than control (e.g., death in ≥2 animals, toxic signs, >10% weight loss in ≥3 animals). | No evidence of systemic toxicity (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 |
| Sub-Chronic Toxicity | Parameters (death, body weight change, clinical signs, hematology, histopathology) will be reviewed for patterns of toxicity. | Negative for systemic toxicity (No deaths, no significant differences in body weights, no abnormal clinical signs, no patterns of toxicity in hematology or histopathology - Non-toxic) |
| Hemocompatibility (Thrombosis) | 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; exhibited acceptable interaction with blood (Non-hemolytic) |
| Hemocompatibility (Coagulation - PT & 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=1.000 for PT, p-value=0.105 for PTT) |
| Hemocompatibility (Hemolysis) | Sample extracts must be nonhemolytic (≤2% hemolytic index). | Nonhemolytic (Hemolytic index ≤ 1.25%, Corrected hemolytic index ≤ 0.40%) |
| Hemocompatibility (Complement Activation) | The concentrations of C3a and SC5b-9 in the test samples are statistically similar to or lower than the predicate. | C3a = similar at all time points; SC5b-9 = lower at 30, 60 minutes / similar at 90 minutes. |
| Genotoxicity (Ames, Mouse Lymphoma, Mouse Micronucleus) | Sample extracts must be non-mutagenic. | Non-mutagenic |
| Bench-top Testing | ||
| Dimensional / Visual Inspection | Units meet all inspection criteria for release of finished goods (clinically acceptable product). | Pass |
| Simulated Use/Detachment Reliability | Units meet all inspection criteria for release of finished goods (clinically acceptable product). | Pass |
| Fatigue Testing | The Coil Implant shall retain its secondary shape after being cycled into/out of introducer sheath 5 times. | Pass |
| Torsion Resistance | The Coil Implant can be subjected to 8 turns minimum. | Pass |
| Corrosion Resistance | No visible corrosion after testing. | Pass |
| Friction Testing | Push/pull friction acceptable through a 0.0165 in. ID microcatheter. | Pass |
| Distal System Tensile Test | Coil Implant and Detachment Pusher joints has sufficient tensile strength. | Pass |
| Coil Dimensional Inspection (after simulated use testing) | Units withstood the simulated use testing. | Pass |
| Sterilization | Identical acceptance criteria and testing methods as the predicate device (in accordance with EN ISO 11135-1:2007). | Tested to be sterile. |
| Shelf Life | Minimum one year shelf life (using identical acceptance criteria and testing methods as the predicate device, in accordance with ASTM D4169:2009 and ASTM F2096:2004). | Tested to have a minimum one year shelf life. |
| MR Environment | Standards ASTM F2182-11, ASTM F2052-06, ASTM F2213-06, and ASTM F2119-07 (R 13) | Tested in the MR environment to advise the MR Conditional statement in the IFU. (Implies satisfactory performance for MR safety labeling) Specific performance values not in given text. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical testing (bench-top and in vitro/animal studies) for biocompatibility, physical/mechanical properties, sterilization, and shelf life.
- Sample Size: The exact sample sizes for each specific test are not explicitly stated in the summary. For example, for the systemic toxicity test, it mentions "Death in 2 or more animals" as an acceptance criterion, but not the total number of animals tested. The biocompatibility tests refer to "samples," "test articles," "animals," and "groups."
- Data Provenance: Not applicable in the context of clinical data for a device intended for human use. The studies are non-clinical (laboratory and animal studies). The document does not specify the country of origin for the non-clinical data, but it is submitted to the U.S. FDA by a U.S.-based company (Penumbra, Inc., Alameda, CA, USA). The studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices, which are US federal regulations.
- Retrospective/Prospective: These non-clinical studies are inherently prospective in their design, meaning they were planned and executed to evaluate the device's properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the provided document. The studies described are non-clinical (biocompatibility, mechanical testing, etc.) and do not involve human subjects or expert clinical evaluation to establish a "ground truth" for diagnostic or treatment efficacy. The "ground truth" for these non-clinical tests would be the measured physical, chemical, or biological responses against predefined scientific or regulatory standards. For example, in histopathology for implant studies, a pathologist would interpret slides, but their role is to report observations against scientific criteria, not establish a "ground truth" for a clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to a process where multiple clinical readers (e.g., radiologists) review cases and a discrepancy resolution method is employed, often involving a super-reader. The studies described are non-clinical and do not involve human clinical readers or case 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
This question is not applicable. The Penumbra Smart Coil is a physical neurovascular embolization device, not an AI-powered diagnostic or assistive tool for human readers. The document describes non-clinical testing of the device's material properties, mechanical performance, and biological safety, not its impact on human reader performance in interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Penumbra Smart Coil is a physical medical device, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical studies are established by:
- Scientific and regulatory standards: e.g., EN ISO 10993 for biocompatibility, ASTM standards for material testing, EN ISO 11135-1 for sterilization.
- Measured physical/chemical properties: e.g., tensile strength, corrosion presence, hemolytic index.
- Biological responses in controlled in vitro or animal models: e.g., cell lysis grade, sensitization scores, animal physiological responses, histopathological findings.
- Comparison to predicate devices: For several tests (e.g., hemocompatibility, sterilization, shelf life), performance is compared to or demonstrated using methods identical to predicate devices.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of physical medical device testing for 510(k) clearance, as this is not a machine learning or AI device. The document describes pre-market non-clinical validation studies.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8. No "training set" exists for this type of device submission.
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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
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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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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 ofManufacturer |
|---|---|---|---|
| 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 abnormalitiessuch as arteriovenous malformationsand arteriovenous fistulae• Arterial and venous embolizations inthe 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 celllysis grade $\u2264$ 2 | Grade: 0 | Non-toxic |
| Sensitization(Magnusson-KligmanMethod) | Test Group shall yield Grade < 1score on Magnusson and Kligmanscale (provided Control Grade < 1) | Grade: 0 (No Sensitizationresponse) | Non-sensitizing |
| Irritation(IntracutaneousReactivity (ISO)) | The difference in the mean testarticle and mean control score mustbe grade 1.0 or lower | Grade 0.0 difference(saline extract) and Grade0.2 difference (sesame oilextract) | Non-irritant |
| Implant Study | |||
| Test | Acceptance Criteria | Results | Conclusions |
| Implant Study | Overall interpretation ofbiocompatibility exhibited by thetest article based on the clinicalobservations, and gross andmicroscopic analysis comparingthe test article to the control, shallshow the test article to be a non-irritant. | Test article is considered anon-irritant | Non-irritant |
| Systemic Toxicity(Acute) | |||
| Systemic Injection(ISO) | Sample extracts must not causesignificant biological reactiongreater than control. That is:Death in 2 or more animals●Toxic signs (i.e. convulsions,●prostration)Weight loss > 10% in 3 or●more animals | No evidence of systemictoxicity from sampleextracts:No deaths●No toxic signs●No weight loss > 10%●in any animals | Non-toxic |
| Material MediatedPyrogen | Sample extracts must not cause atotal rise in body temperature of ≥0.5° C | Non-pyrogenic: no animalshad a temperature rise ≥0.5°C | Non-pyrogenic |
| Sub-Chronic Toxicity(Sub-Acute Toxicity) | |||
| Sub-Chronic/Sub-Acute Toxicity: 14day / 14 dose IV study(mice) | The following parameters will beused as signs of toxicity; howeverfinal evaluation of the test articlewill involve correlation of all datafor patterns of toxicity:Death of more than one animal●in groupMean body weight change ingroup relative to control●Clinical signs of toxicity inmore than one animal in group●Hematology and clinicalchemistry values for animalgroups will be reviewed forpatterns of toxicityHistopathology of tissues will●be evaluated for patterns oftoxicity | Negative for systemictoxicity:No deaths●No statisticallysignificant differencesbetween the test andcontrol mice bodyweightsNo abnormal clinical●signs of toxicityHematology showed●no findings indicativeof a pattern of toxicityHistopathology●showed no adversefindings attributed tothe test article | Non-toxic |
| Hemocompatibility | |||
| Thrombosis (DogThrombogenicity) | Device must be non-thrombogenicafter 4 hours in vivo whencompared to a predicate device | Test device was notthrombogenic whencompared to the predicate.The device exhibitedacceptable interaction withblood | Non-hemolytic |
| Coagulation (PT) | Coagulation times must be similarto the predicate or negative controlvalues using analysis of variance. | Test article coagulationtimes are statisticallysimilar to the predicate (p-value=1.000) | |
| Test | Acceptance Criteria | Results | Conclusions |
| Coagulation (PTT) | Coagulation times must be similarto the predicate or negative controlvalues using analysis of variance. | Test article coagulationtimes are statisticallysimilar to the predicate (p-value=0.105) | |
| Hematology(Hemolysis) - DirectContact | Sample extracts must benonhemolytic (≤2% hemolyticindex) | Nonhemolytic:Hemolytic index = 1.25%Corrected hemolytic index= 0.40% | |
| Hematology(Hemolysis) - IndirectContact | Sample extracts must benonhemolytic (≤2% hemolyticindex) | Nonhemolytic:Hemolytic index = 0.37%Corrected hemolytic index= 0.00% | |
| ComplementActivation | The concentrations of C3a andSC5b-9 in the test samples arestatistically similar to or lower thanthe predicate | Concentrations of testarticle compared topredicate:C3a = similar at 30, 60, and90 minutesSC5b-9 = lower at 30 and60 minutes / similar at 90minutes | |
| 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 Mousemicronucleus | Sample extracts must be non-mutagenic | Non-mutagenic |
Biocompatibility Testing Summary – Coil Implant/Detachment Pusher
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Biocompatiblity Testing Summary – Detachment Handle
| Test | Acceptance Criteria | Results | Conclusion |
|---|---|---|---|
| In vitro Cytotoxicity(MEM Elution) | Sample extracts must yieldcell lysis grade ≤ 2 | Grade: 0 | Non-toxic |
| Sensitization(Magnusson-KligmanMethod) | Test Group shall yield Grade< 1 score on Magnusson andKligman scale (providedControl Grade < 1) | Grade: 0 (NoSensitizationresponse) | Non-sensitizing |
| Irritation(IntracutaneousReactivity (ISO)) | The difference in the meantest article and mean controlscore must be grade 1.0 orlower | Grade 0.0 difference(saline extract) andGrade 0.2 difference(sesame oil extract) | Non-irritant |
11.11.2 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.
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Design Verification testing was conducted to evaluate the physical and mechanical properties of Smart Coil components. The tests performed on the Smart Coil and Smart Coil Detachment Handle components included:
| Attribute | Specification | Results |
|---|---|---|
| Dimensional / Visual Inspection | These evaluations confirm that the units used in this Design Verification testing meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass |
| Simulated Use/Detachment Reliability | These evaluations confirm that the units used in this Design Verification testing meet all inspection criteria for release of finished goods (clinically acceptable) product. | Pass |
| Fatigue Testing | The Coil Implant shall retain its secondary shape after being cycled into/out of introducer sheath 5 times | Pass |
| Torsion Resistance | The Coil Implant can be subjected to 8 turns minimum | Pass |
| Corrosion Resistance | No visible corrosion after testing | Pass |
| Friction Testing | Push/pull friction acceptable through a 0.0165 in. ID microcatheter | Pass |
| Distal System Tensile Test | Coil Implant and Detachment Pusher joints has sufficient tensile strength | Pass |
| Coil Dimensional Inspection (after simulated use testing) | These evaluations confirm that the units used in this Design Verification testing withstood the simulated use testing | Pass |
| Distal System Tensile Test | Coil Implant and Detachment Pusher joints has sufficient tensile strength | Pass |
All testing met specification. The results of the tests appropriately address the physical and mechanical performance expectations of the device. Based on these overall results, the physical and mechanical properties of the Smart Coil and Smart Coil Detachment Handle are acceptable for the intended use and substantially equivalent to the predicate devices.
11.11.3 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. Testing was accordance with EN ISO 11135-1:2007.
11.11.4 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. Testing was done in accordance to ASTM D4169:2009 and ASTM F2096:2004.
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11.11.5 MR Environment
The Smart Coil was tested in the MR environment to advise the MR Conditional statement in the IFU. Testing was done in accordance to standards ASTM F2182-11, ASTM F2052-06, ASTM F2213-06, and ASTM F2119-07 (R 13).
11.12 Summary of Substantial Equivalence
The Penumbra Smart Coil was found to have a safety and effectiveness profile that is similar to the predicate device.
11.13 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.
§ 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).