(57 days)
Not Found
No
The device description and performance studies focus on material properties, mechanical performance, and biological response, with no mention of AI or ML.
Yes
The device is intended for arterial and venous embolization, which is a therapeutic intervention to block blood vessels.
No
The device description and intended use clearly state that it is for "arterial and venous embolization," which is a treatment procedure, not a diagnostic one. It is a physical device intended to block blood vessels.
No
The device description clearly states it is a physical, cylindrical implant made from polycarbonate-urethane, intended for insertion into the body. It is a hardware device, not software.
Based on the provided information, the Biomerix Vascular Occlusion Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Biomerix Vascular Occlusion Device is a physical implant intended for arterial and venous embolization in the peripheral vasculature. This is a therapeutic procedure performed within the body, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic measurements.
Therefore, the Biomerix Vascular Occlusion Device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Biomerix Vascular Occlusion Device is intended for arterial and venous embolization in the peripheral vasculature.
Product codes
KRD
Device Description
The Biomerix Vascular Occlusion Device is a cylindrical device made from polycarbonate-urethane. The length of the implant is 15 mm, and it is available in diameters of 4, 6, and 8 mm. The Biomerix Vascular Occlusion Device is provided sterile for single use in its uncompressed state. The device is compressed and delivered to the target location through a commercially available peripheral introducer (5-7 F). A Loader is provided to assist with introducing the implant into the delivery catheter.
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
Material testing was performed to demonstrate that the material properties are suitable for the intended use.
Bench testing was performed to demonstrate that the devices as manufactured meet the performance specifications for loading, deliverability, and recovery.
Extensive biocompatibility testing was performed to demonstrate that the material is safe and biostable.
Animal testing demonstrates that the device performs equivalently to Cook Embolization Coils in terms of time to occlusion, migration, recanalization, and tissue response.
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).
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510(k) SUMMARY - Biomerix Vascular Occlusion Device
| Applicant Name: | Biomerix Corporation
41 West 57th Street, 6th Floor
New York, NY 10019
Phone: (212) 980-1951
Fax: (212) 752-3633 |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Craig Friedman, M.D.
VP, Medical Research and Development |
| Date Prepared: | December 7, 2004 |
| Device Trade Name: | Biomerix Vascular Occlusion Device and Loader |
| Device Common Name: | Arterial embolization device |
| Classification Name: | Device, embolization, arterial |
| Predicate Devices: | Cook Embolization Coils, K942189
Amplatzer® Vascular Plug, K031810 |
| Device Description: | The Biomerix Vascular Occlusion Device is a cylindrical
device made from polycarbonate-urethane. The length
of the implant is 15 mm, and it is available in diameters
of 4, 6, and 8 mm. The Biomerix Vascular Occlusion
Device is provided sterile for single use in its
uncompressed state. The device is compressed and
delivered to the target location through a commercially
available peripheral introducer (5-7 F). A Loader is
provided to assist with introducing the implant into the
delivery catheter. |
| Intended Use: | The Biomerix Vascular Occlusion Device is intended for
arterial and venous embolization in the peripheral
vasculature. |
| Device Technological
Characteristics and
Comparison to
Predicate Device(s): | The Biomerix Vascular Occlusion Device is similar in
performance to Cook Stainless Steel coils. Both devices
disrupt blood flow, causing thrombus formation and
occlusion. Coils are composed of stainless steel and
synthetic fibers.
The Biomerix Vascular Occlusion Device is similar in
design to the Amplatzer® Vascular Plug. The
Amplatzer® is also a cylindrical plug, which is available in
diameter ranging from 4 to 16 mm. The Amplatzer® is
composed of Nitinol, platinum, and stainless steel. |
| Performance Data: | Material testing was performed to demonstrate that the material properties are suitable for the intended use. |
| | Bench testing was performed to demonstrate that the devices as manufactured meet the performance specifications for loading, deliverability, and recovery. |
| | Extensive biocompatibility testing was performed to demonstrate that the material is safe and biostable. |
| | Animal testing demonstrates that the device performs equivalently to Cook Embolization Coils in terms of time to occlusion, migration, recanalization, and tissue response. |
| Conclusion: | Based on the material, bench, and animal testing, and the proposed device labeling, the Biomerix Vascular Occlusion Device and Loader is substantially equivalent to the identified predicate devices in terms of intended use, safety, and effectiveness. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three parallel lines forming its body and wings.
FEB - 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christina Kichula. RAC Manager. Regulatory Affairs Biomerix Corporation c/o PPD Medical Device 1700 Rockville Pike. Suite 400 Rockville. MD 20852
K043371 Re:
Trade/Device Name: Biomerix Vascular Occlusion Device Regulation Number: 21 CFR 870.3300 Regulation Name: Arterial Embolization Device Regulatory Class: Class II (two) Product Code: KRD Dated: December 7. 2004 Received: December 8. 2004
Dear Ms. Kichula:
We have reviewed vour 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. Ilsting of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.
If vour 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 he 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): good manufacturing practice requirements as set
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Page 2 - Ms. Christina Kichula, RAC
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quanty systems (Q5) regulation (Sections 531-542 of the Actily 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Action Section S product radiation control provisions (Scetions 35 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your antial equivale of your device to a legally premarket notification. THE PDA midning of backannal of .
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 If you desire specific advice for your de rice on other not and the regulation entitled, and the regulation entitled, contact the Office of Comphanes at (301) 37 cart 807.97). You may obtain "Misoranding by reletence to premantee no all reasons bill the set from the Division of Small other geteral information on your responsibility of the manber (800) 638-2041 or
Manufacturers, International and Consumer Assistance of al (demostern attral Manufacturers, International and Consults: 12015.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna E. Lochner
- 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 (if known): _ K043371
Device Name:__Biomerix Vascular Occlusion Device
Indications For Use:
The Biomerix Vascular Occlusion Device is intended for arterial and venous embolization in the peripheral vasculature.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Divina P. Lechuer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number k04337
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