(170 days)
Not Found
No
The device description focuses on physical components (coils and pusher) and their materials, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used to reduce or block blood flow in vessels to manage various vascular lesions, which constitutes a therapeutic intervention.
No
The device is used to reduce or block blood flow in vessels, functioning as a therapeutic intervention rather than a diagnostic tool to identify or characterize medical conditions.
No
The device description explicitly states that the system consists of physical components: platinum alloy and synthetic fiber coils, and a coil pusher. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that this device is a "Vascular Occlusion System" consisting of coils and a pusher. Its intended use is to "reduce or block the rate of blood flow in vessels" and is used for "interventional radiologic management" of vascular lesions. This involves physically interacting with the patient's vascular system inside the body.
Therefore, this device is an implantable medical device used for therapeutic intervention, not an IVD used for diagnostic testing on samples.
N/A
Intended Use / Indications for Use
The Vascular Occlusion System may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.
Product codes (comma separated list FDA assigned to the subject device)
MCG
Device Description
The Vascular Occlusion System consists of straight and shaped TRUFILL Pushable Coils (made from platinum allow and synthetic fibers) and the TRUPUSH Coil Pusher (with 1 or 2 radiopaque markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" inner diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the peripheral and neurovasculature, brain, spinal cord, and spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
interventional radiologic management
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K901337, K901721, K964367, K972881
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).
0
3/24/99
K983483
0-000029
Appendix A - Summary of Safety and Effectiveness, Continued
General Provisions
- The common names used for this device include: .
- Platinum Fibered Coils .
- Microcoils or Minicoils .
- The Vascular Occlusion System consists of the following components: .
- TRUFILL Pushable Coils .
- TRUPUSH Coil Pusher .
Predicate Devices
The predicate devices are listed in the table below:
Devices
| Device | Manufacturer | 510(k) Number,
Concurrence Date | Product Code |
|------------------------------------------|--------------------------------------|-------------------------------------|--------------|
| Hilal Embolization
Microcoil | Cook, Inc. | K901337, 11/9/90 | HCG |
| Helix Shaped Coils
with Dacron Fibers | Target Therapeutics | K901721, 1/8/91 | HCG |
| Vascular Occlusion
System | Cordis Endovascular
Systems, Inc. | K964367, 1/30/97
K972881, 6/4/98 | HCG |
Classification Class II
Performance The FDA under Section 514 of the Food, Drug and Cosmetic Act has not Standard established performance standards.
Intended Use The Vascular Occlusion System may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.
- Device The Vascular Occlusion System consists of straight and shaped TRUFILL Description Pushable Coils (made from platinum allow and synthetic fibers) and the TRUPUSH Coil Pusher (with 1 or 2 radiopaque markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" inner diameter.
1
Appendix A - Summary of Safety and Effectiveness, Continued
| Biocompatibility | All applicable biocompatibility testing was successfully performed for the Vascular Occlusion System. |
|---|---|
| Summary of | |
| Substantial | |
| Equivalence | The Vascular Occlusion System is substantially equivalent in design, materials, sterilization, and indications for use as other commercially available occlusion devices.1 |
1 A statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the Federal Food, Drug and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seq. (1977).
2
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them that resemble waves or ribbons.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 1999
Ms. Martine D. Martino Sr. Regulatory Affairs Associate Cordis Endovascular Systems, Inc. 14000 N.W. 57th Court Miami Lakes, FL 33014
K983483 Re: Vascular Occlusion System Regulatory Class: III (Three) Product Code: 84 MCG Dated: December 21, 1998 December 24, 1998 Received:
Dear Ms. Martino:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further requlatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Martine D. Martino
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Collelon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix C - Indications for Use Statement, Continued
Indications for Use Statement
The Cordis Endovascular Systems, Inc. Vascular Occlusion System may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use i (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Beet R. Demperle
Division Sign-Off
(Division Sign-Off Division of Cardiovascul and Neurological Devi K983483 510(k) Number