(182 days)
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils consists of an implantable 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. Both the delivery catheter and guidewire are not included in the system.
Here's an analysis of the provided text regarding the HydroCoil Embolic System (HES) to extract the requested information about acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific acceptance criteria and performance metrics for a novel device. Therefore, much of the requested information (especially quantitative performance data, sample sizes for test/training sets, expert details, and MRMC studies) is not present in this type of regulatory submission. The answers below will reflect the information available.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
Based on the 510(k) summary, the acceptance criteria are implicitly tied to demonstrating "substantial equivalence" to predicate devices rather than meeting specific quantitative performance targets. The "reported device performance" is a general statement about equivalence.
| Acceptance Criteria Category | Acceptance Criteria (Implicit from 510(k)) | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Device is substantially equivalent in operating principle, method of application, design, materials, packaging, and sterilization to predicate devices. | "The HydroCoil® Embolic System (HES)... is substantially equivalent in operating principle, method of application, indications for use, design, materials, packaging and sterilization to the predicate devices." |
| Performance (Safety & Effectiveness) | Device is equivalent in performance to the predicate devices, ensuring similar safety and effectiveness. | "Performance testing has demonstrated that the HydroCoil® Embolic System (HES)... is equivalent in performance to the predicate devices." |
| Indications for Use Consistency | Indications for Use are consistent with those of the predicate devices. | The stated Indications for Use are similar to common uses for embolization coils, implying consistency with predicates. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the 510(k) summary. The document mentions "Performance testing" but does not detail the number of samples or cases used.
- Data Provenance: Not specified. This type of submission relies heavily on non-clinical (bench and in-vitro) testing to establish substantial equivalence for embolization coils, rather than extensive clinical data. If any clinical data was used, its origin (country, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not specified. The 510(k) summary does not describe a process involving expert ground truth establishment for a test set, as it's not a diagnostic AI device or a study involving human interpretation of images.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. This information is not relevant for a device of this type or the nature of testing described in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. An MRMC study is typically performed for diagnostic imaging devices where human readers interpret medical images. This device is an embolization system, not a diagnostic tool requiring such a study.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as no MRMC study or AI assistance for human readers is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical medical device (embolization coil), not a software algorithm. Therefore, "standalone performance" in the context of AI algorithms does not apply. The performance testing refers to the physical and functional properties of the coil.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the conventional sense of diagnostic performance. For physical devices like embolization coils, "ground truth" would relate to successful deployment, mechanical stability, embolic efficacy in an in-vitro or animal model, and biocompatibility. The regulatory submission relies on performance testing (e.g., mechanical properties, fluid dynamics in simulated vessels, biocompatibility tests) against pre-defined engineering and safety specifications, and comparison to predicate device characteristics. Pathology or outcomes data aren't the primary ground truth for the device itself in this context, although they would be for the clinical effectiveness of the embolization procedure.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. This device is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As this is not an AI algorithm, there is no "training set" or "ground truth" establishment in that context.
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Section 2 - 510(k) Summary
(1) Company Information
MicroVention, Inc. 75 Columbia Aliso Viejo, CA 92656 Telephone: (949) 461-3314 Fax: (949) 349-1360 www.microvention.com
(2) Contact Information
Vincent Cutarelli Telephone: (949) 951-0505 Fax: (949) 349-1360 E-mail: vinc@microvention.com
(3) Device Name
| Classification Name: | Device, Embolization, Arterial |
|---|---|
| Trade/Proprietary Name: | HydroCoil ® Embolic System (HES) |
| AZUR TM Peripheral HydroCoil ® Endovascular Embolization Coil System - Pushable 18 and 35 | |
| Common/Usual Name: | Embolization Coil |
| Classification | Class II |
(4) Device Description
.
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils consists of an implantable 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. Both the delivery catheter and guidewire are not included in the system.
JAN
1 2000
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(5) Indications for Use
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.
(6) Name of Predicate or Legally Marketed Device
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is substantially equivalent to the Cordis Vascular Occlusion System that was determined to be substantially equivalent on March 24, 1999 (reference K983483), the MicroVention MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) with a Modified Detachment System that was determined to be substantially equivalent on June 28, 2005 (reference K050954) and the MicroVention MicroPlex® Coil System (MCS) and HydroCoil® Embolic System (HES) with the HES-HC-R (18) and HVO-HC-R (18) Coils that was determined to be substantially equivalent on October 22, 2003 (reference K032590)..
(7) Technological Characteristics and Substantial Equivalence
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is substantially equivalent in operating principle, method of application, indications for use, design, materials, packaging and sterilization to the predicate devices.
(8) Performance Data Summary
Performance testing has demonstrated that the HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is equivalent in performance to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
JAN 11 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MicroVention Inc. c/o Mr. Vincent Cutarelli Vice President, Regulatory Affairs and Quality Assurance 75 Columbia, Suite A Aliso Viejo, CA 92656
Re: K071939
HydroCoil® Embolization System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) Coils Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 30, 2007 Received: November 2, 2007
Dear Mr. Cutarelli:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Vincent Cutarelli
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Duna R. Vuchner
( ) 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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Indications For Use
510(k) Number: __K071939
Device Name: HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils
Indications for Use: The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.
Concurrence of CDRH, Office of Device Evaluation (ODE):
Duana R. Lechner
(Division Sign-Off)
Division of Cardiac
(1978) Sign-Oli)
Division of Cardiovascular Devices
510(k) Number_k © 7 193 9
Prescription Use: __X (Per 21 CFR 801.109)
§ 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).