(57 days)
The Biomerix Vascular Occlusion Device is intended for arterial and venous embolization in the peripheral vasculature.
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.
The provided text describes the Biomerix Vascular Occlusion Device but does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in a format that would allow for a precise response to all parts of your request.
Here's an analysis of what information can be extracted and what is missing:
Information Present in the Document:
- Intended Use: The device is "intended for arterial and venous embolization in the peripheral vasculature." This is a key part of what any performance study would need to address.
- Performance Data Overview: The document lists general categories of performance data collected:
- Material testing to demonstrate suitable material properties.
- Bench testing to demonstrate the device meets performance specifications for loading, deliverability, and recovery.
- Biocompatibility testing to demonstrate safety and biostability.
- Animal testing to demonstrate equivalent performance to Cook Embolization Coils in terms of "time to occlusion, migration, recanalization, and tissue response."
Missing Information (Crucial for a complete answer to your request):
- Specific Acceptance Criteria: The document mentions "performance specifications" for bench testing and "equivalent performance" for animal testing, but it does not quantify these. For example, it doesn't state:
- What is the specified loading force?
- What is the acceptable delivery time or force?
- What is the defined "time to occlusion" in animal studies (e.g., 95% occlusion within X minutes/hours)?
- What are the acceptable limits for migration or recanalization?
- What are the specific parameters for "tissue response"?
- Detailed Study Design and Results: The document summarizes that studies were done but lacks the specifics required for your numbered points.
Based on the provided text, here is the information that can be extracted, and where information is missing:
(1) A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| Material properties suitable for intended use | Material testing demonstrated suitability. |
| Meets performance specifications for loading | Bench testing demonstrated meeting specifications. |
| Meets performance specifications for deliverability | Bench testing demonstrated meeting specifications. |
| Meets performance specifications for recovery | Bench testing demonstrated meeting specifications. |
| Material is safe and biostable | Extensive biocompatibility testing demonstrated safety and biostability. |
| Equivalent performance to Cook Embolization Coils regarding time to occlusion | Animal testing demonstrated equivalence. |
| Equivalent performance to Cook Embolization Coils regarding migration | Animal testing demonstrated equivalence. |
| Equivalent performance to Cook Embolization Coils regarding recanalization | Animal testing demonstrated equivalence. |
| Equivalent performance to Cook Embolization Coils regarding tissue response | Animal testing demonstrated equivalence. |
(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 (Test Set): Not specified.
- Data Provenance: Not specified (studies are generally described as "Material testing," "Bench testing," "Biocompatibility testing," and "Animal testing" without country of origin or retrospective/prospective designation for the animal model).
(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)
- Not applicable/Not specified, as this appears to be a medical device performance (mechanical, biological, and animal model) study, not a diagnostic AI study requiring expert adjudication of images.
(4) Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified, as this appears to be a medical device performance study, not a diagnostic AI study requiring expert adjudication of images.
(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
- No. This study is focused on the physical and biological performance of a vascular occlusion device, not on AI assistance for human readers of medical images.
(6) If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
(7) The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For animal testing, the ground truth appears to be direct observation of physiological parameters (time to occlusion, migration, recanalization) and potentially histological examination for tissue response comparison against the predicate device.
- For bench testing, the ground truth would be engineering specifications and measurements.
- For biocompatibility, the ground truth would be established biological safety standards and in-vitro/in-vivo test results.
(8) The sample size for the training set
- Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
(9) How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI algorithm.
{0}------------------------------------------------
510(k) SUMMARY - Biomerix Vascular Occlusion Device
| Applicant Name: | Biomerix Corporation41 West 57th Street, 6th FloorNew York, NY 10019Phone: (212) 980-1951Fax: (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, K942189Amplatzer® Vascular Plug, K031810 |
| Device Description: | The Biomerix Vascular Occlusion Device is a cylindricaldevice made from polycarbonate-urethane. The lengthof the implant is 15 mm, and it is available in diametersof 4, 6, and 8 mm. The Biomerix Vascular OcclusionDevice is provided sterile for single use in itsuncompressed state. The device is compressed anddelivered to the target location through a commerciallyavailable peripheral introducer (5-7 F). A Loader isprovided to assist with introducing the implant into thedelivery catheter. |
| Intended Use: | The Biomerix Vascular Occlusion Device is intended forarterial and venous embolization in the peripheralvasculature. |
| Device TechnologicalCharacteristics andComparison toPredicate Device(s): | The Biomerix Vascular Occlusion Device is similar inperformance to Cook Stainless Steel coils. Both devicesdisrupt blood flow, causing thrombus formation andocclusion. Coils are composed of stainless steel andsynthetic fibers.The Biomerix Vascular Occlusion Device is similar indesign to the Amplatzer® Vascular Plug. TheAmplatzer® is also a cylindrical plug, which is available indiameter ranging from 4 to 16 mm. The Amplatzer® iscomposed 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. |
{1}------------------------------------------------
{2}------------------------------------------------
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
{3}------------------------------------------------
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
{4}------------------------------------------------
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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).