(51 days)
Not Found
No
The device description and performance summary focus on the physical components and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is indicated for arterial and venous embolizations, which are medical procedures designed to treat conditions in the peripheral vasculature, thus serving a therapeutic purpose.
No
The device is a Concerto™ Detachable Coil System, which is used for embolizations in the peripheral vasculature. Its function is to deliver platinum coils for therapeutic purposes (embolization), not for diagnosing conditions.
No
The device description clearly outlines physical components: an implantable coil, an implant delivery pusher, and an instant detacher. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "arterial and venous embolizations in the peripheral vasculature." This describes a therapeutic procedure performed within the patient's body to block blood vessels.
- Device Description: The device is a "platinum coil secured to a composite delivery wire" and is implanted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not involve the analysis of biological samples.
The Concerto™ Detachable Coil System is a therapeutic medical device used for embolization procedures.
N/A
Intended Use / Indications for Use
The Concerto™ Detachable Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
Product codes
KRD
Device Description
The Concerto™ Detachable Coil System consists of a platinum coil secured to a composite delivery wire and is compatible with a 2-marker band micro catheter and a mechanical detachment system. The Concerto™ coil configurations include bare platinum coils.
The Concerto™ Detachable Coil System consists of three components:
1- Implantable Coil,
2- Implant Delivery Pusher,
3- Instant Detacher (called the LRS (Linear Release System) actuator in K060747). The Instant Detacher is packaged and sold separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
The ConcertoTM Detachable Coil System is substantially equivalent to the Axium™ Detachable Coil System since the same methods and materials in construction, packaging and sterilization are used therefore no performance data were generated in support of this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
090046 212
FEB 2 7 2009 Micro Therapeutics d.b.a.ev3 Neurovascular Applicant: 9775 Toledo Way Irvine, CA 92618 USA Phone: +1-949-837-3700 Fax: +1-949-837-2044 Dec 17, 2008 Date: Contact Person: Neelu Medhekar Director, Global Regulatory Affairs Proprietary Device Name: ConcertoTM Detachable Coil System Vascular Embolization Device Common Device Name: (21CFR 870.3300, Product Code KRD) Class II Classification: Micro Therapeutics, Inc. Axium™ Detachable Coil System Predicate Devices: cleared under K081465 on Aug 19, 2008; Micro Therapeutics, Inc. FX Detachable Coil System cleared under K060747 on April 24, 2007 - marketed as the ev3 Axium™ Detachable Coil System ev3 Neurovascular a division of ev3 Inc. Manufacturer: 9775 Toledo Way Irvine, CA 92618 USA
Note: Micro Theraputics Inc., does business as ev38 Neurovascular, which is a division of ev3 Inc. To simplify the product identification for the purposes of this submission, references will only be made to ev30 Inc.
8.1. Substantially Equivalent To:
The Concerto™ Detachable Coil System is substantially equivalent to the ev3 Axium™ Detachable Coil System, in terms of intended use, design, specifications, and materials. The Concerto TM Detachable Coil System uses
1
the same design, methods and materials in construction, packaging and sterilization as its predicate. The modification to the indications use statement has not altered the fundamental scientific technology of the Concerto "M Detachable Coil System.
Description of the Device Subject to Premarket Notification: 8.2.
The Concerto™ Detachable Coil System consists of a platinum coil secured to a composite delivery wire and is compatible with a 2-marker band micro catheter and a mechanical detachment system. The Concerto™ coil configurations include bare platinum coils.
The Concerto™ Detachable Coil System consists of three components:
1- Implantable Coil,
2- Implant Delivery Pusher,
3- Instant Detacher (called the LRS (Linear Release System) actuator in K060747). The Instant Detacher is packaged and sold separately.
This submission localizes the indications for use statement for the Concerto™ Detachable Coil System for use in the peripheral vasculature. This indication is discussed further in Section 12.
8.3. Indications for Use:
The Concerto™ Detachable Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
8.4. Performance Data:
The ConcertoTM Detachable Coil System is substantially equivalent to the Axium™ Detachable Coil System since the same methods and materials in construction, packaging and sterilization are used therefore no performance data were generated in support of this submission.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ev3 Neurovascular c/o Ms. Neelu Medhekar Director, Global Regulatory Affairs 9775 Toledo Way Irvine, CA 92618
Re: K090046
Concerto™ Detachable Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: February 4, 2009 Received: February 10, 2009
Dear Ms. Medhekar:
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.
3
Page 2 - Ms. Neelu Medhekar
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 Biometrics' (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,
Bram D. Zuckoman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ev3@ Inc. 05 January 2009
Statement of Indications for Use 7.
Indications for Use
510(k) Number (if known): _K690046
Device Name: Concerto™ Detachable Coil System
Indications for Use:
The Concerto™ Detachable Coil System is indicated for arterial and venous embolizations in the peripheral vasculature.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
comell
(Division Sign-Off) Division of Cardiovascular Devices K090046 510(k) Number
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