(29 days)
Not Found
Not Found
No
The provided text describes a medical device (detachable coil and syringe) for embolization procedures and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for embolizing intracranial aneurysms and other vascular malformations, which are therapeutic interventions.
No
Explanation: This device is indicated for embolizing aneurysms and vascular malformations, which is a treatment procedure, not a diagnostic one.
No
The device description is not available, but the intended use clearly describes a physical medical device (detachable coil and syringe) used for embolization. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in vivo (within the body) for embolizing aneurysms and vascular malformations. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: While the description is "Not Found," the intended use clearly points to a device used for a surgical procedure within the body.
- Anatomical Site: The anatomical sites listed (intracranial, neurovasculature, peripheral vasculature) are all within the human body.
Therefore, the TRUFILL DCS ORBIT™ Detachable Coil is a medical device used for therapeutic intervention within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing certain intracranial ancurysms that. because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:
very high-risk for management by traditional operative techniques l )
inoperable 2)
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulac of the neurovasculature.
The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.
The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovasculature, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Treating neurosurgical team
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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2005
Amarilys Machado Manager, Regulatory Affairs Cordis Neurovascular, Inc. 14000 N.W. 57th Court Miami Lakes, Florida 33014
Re: K053197
Trade/Device Name: Trufil! DCS Orbit Detachable Coil System Line Extension Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: November 15, 2005 Received: December 5, 2005
Dear Ms. Machado:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasel o reley press.
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 for use stated in the chelosure) to regars and ment date of the Medical Device Amendments, or to conniered provide to May 20, 1978, the enames with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic rice (11ct) that to nover, subject to the general controls provisions of the Act. The 1 ou may, diereloro, manel the Act include requirements for annual registration, listing of general controls provisions 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 If your device is classinod (tional controls. Existing major regulations affecting your device can may oc subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advisou that I Dris issually at your device complies with other requirements of the Act that i Dri has Intact and regulations administered by other Federal agencies. You must of any I cateral butter and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 607), idoomig (21 CFR Part 820); and if applicable, the electronic forth in the quanty systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Ms. Machado
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to segm mailing of substantial equivalence of your device to a legally premits tourication. The Privating of cassification 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 at not arration of (240) 276-0115. Also, please note the regulation entitled, Coliable of Compuners of a (21 CFR Part 807.97). You may obtain Wilsoraliung of reference to presensibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
chabaue Buchholz Jr
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
4-000029
Image /page/2/Picture/1 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, stylized font, with a registered trademark symbol to the right. Below the main logo, the text "a Johnson-Johnson company" is written in a smaller, more delicate font.
Page 1 of 1 CFF 20014 Only the Native File to be Used Intended Use Statement
Page 1_of_1
Indications for Use
510(k) Number (if known):
Device Name: TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe, also known as the TRUFILL DCS ORBIT™ Detachable Coil System
Indications For Use:
The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing certain intracranial ancurysms that. because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:
very high-risk for management by traditional operative techniques l )
inoperable 2)
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulac of the neurovasculature.
The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.
The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.
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 office office of Concurrence Division of General. Restor and Neurological Devices
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