(115 days)
The AZUR PURE is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
The AZUR PURE Peripheral Coil System, Pushable 35, consists of an implantable all-polymer coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.
The provided document describes a 510(k) submission for a design modification to the AZUR PURE Peripheral Coil System, specifically the addition of an "Overcoil." This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove device performance against specific acceptance criteria.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving device performance, is not applicable or available in this summary. The submission focuses on verifying that the modified device's performance is equivalent to the predicate device through non-clinical testing.
Here's a breakdown of why this information is not provided in the document:
- Nature of 510(k) for design modification: Special 510(k)s for design modifications, like this one, aim to demonstrate that the changes do not raise new questions of safety and effectiveness. This is typically achieved by showing that the modified device performs similarly to a legally marketed predicate device through engineering tests and comparisons, rather than de novo clinical trials.
- Focus on equivalence: The document explicitly states, "The subject of this submission are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal." This is the core argument of the submission.
Analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Verification & Validation Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | Same as predicate | Met same criteria as predicate |
| Advancement Force | Same as predicate | Met same criteria as predicate |
| Tensile Strength at glue joint | Same as predicate | Met same criteria as predicate |
| Expansion Characteristics | Same as predicate | Met same criteria as predicate |
Explanation: The "acceptance criteria" for the modified device were to "Met same criteria as predicate." The actual quantitative criteria for the predicate device themselves are NOT provided in this document. The "reported device performance" is simply that the modified device met these (unspecified) criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified. This would typically be non-clinical, in-vitro testing rather than human data.
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)
- Number of experts: Not applicable. These are engineering/performance tests, not human-read clinical evaluations.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. This refers to consensus among human readers for clinical ground truth, which is not relevant here.
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
- MRMC study: No, an MRMC study was not done. This is a non-clinical device modification submission, not an AI efficacy study.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable. This device is not an algorithm, but a physical medical device. The "standalone" performance here would refer to the device's physical and mechanical capabilities. The Verification & Validation test summary (Simulated Use, Advancement Force, Tensile Strength, Expansion Characteristics) can be considered "standalone" in this context, demonstrating the device's functional performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: The "ground truth" for these engineering tests would be derived from established engineering specifications, mechanical testing standards, and the validated performance characteristics of the predicate device. For example, a tensile strength test would have a pre-defined pass/fail threshold based on the predicate.
8. The sample size for the training set
- Sample size: 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
- Ground truth establishment: Not applicable.
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AZUR PURE Peripheral Coil System, Pushable 35 Special 510(k), Design Modification - Addition of Overcoil MicroVention
510(K) SUMMARY
Trade Name: AZUR PURE Peripheral Coil System, Pushable 35 Generic Name: Vascular Embolization Device, accessory Classification: Class II, 21 CFR 870.3300 Submitted By: MicroVention, Inc OCT 2 8 2013 1311 Valencia Avenue Tustin, California 92780 U.S.A. Contact: Laraine Pangelina Predicate Device: AZUR PURE Peripheral Coil System, Pushable 35 (K122543) The AZUR PURE is intended to reduce or block the rate of blood Indications for Use: flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature. The AZUR PURE Peripheral Coil System, Pushable 35, consists of Device Description: an implantable all-polymer coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.
| Verification & ValidationTest Summary: | Test | Result |
|---|---|---|
| Simulated Use• Prep/Insert• Track/Push• Deployment• Stability• Overall Performance | Met same criteria as predicate | |
| Advancement Force | Met same criteria as predicate | |
| Tensile Strength at glue joint | Met same criteria as predicate | |
| Expansion Characteristics | Met same criteria as predicate |
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AZUR PURE Peripheral Coil System, Pushable 35 Special 510(k), Design Modification - Addition of Overcoil
| Predicate / SubjectTechnologicalComparison: | Feature | Predicate Device | Subject Device |
|---|---|---|---|
| Coil shape | Helical | Same | |
| Coil OD (mm) | 3 - 16 | Same | |
| Coil Length (cm) | 6 - 14 | Same | |
| Overcoil | None | PEEK | |
| Delivery Method | Coil housed in an introducerwith proximal hub. Pushabledelivery using guidewire. | Same | |
| Hydrogel Implant Material | Hydrophilic copolymer | Same | |
| Packaging Configuration | Placed in capped coilintroducer, placed onpackaging card, into pouch,into box, 5/box | Same |
Summary of Substantial Equivalence: The subject of this submission are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2013
MicroVention, Inc. c/o Laraine Pangelina 1311 Valencia Avenue Tustin, CA 92780
Re: K132083
Trade/Device Name: AZUR PURE Peripheral Coil System, Pushable 35 Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: September 10, 2013 Received: September 11, 2013
Dear Ms. Pangelina:
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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AZUR PURE Peripheral Coil System, Pushable 35 Special 510(k), Design Modification - Addition of Overcoil MICH THE MICH CHIP THE MICH
INDICATIONS FOR USE
K132083 510(k) Number (if known): Device Name: AZUR PURE Peripheral Coil System, Pushable 35 Indications for Use: The AZUR PURE is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.
Prescription Use _ X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (Optional Format 1-2-96).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).