(72 days)
Not Found
No
The document describes a mechanical device (coil pusher) and its intended use in embolization procedures. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes.
The device is used for interventional radiologic management of various vascular lesions, including reducing or blocking blood flow, which is a therapeutic intervention.
No
The device, TRUFILL® Vascular Occlusion System, is used to reduce or block blood flow in vessels, indicating a therapeutic or interventional purpose rather than diagnosis.
No
The device description and performance studies clearly indicate a physical device (Coil Pusher) used to manipulate other physical devices (coils) within the body. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to physically block blood flow in vessels. This is an interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical tool (Coil Pusher) used to deliver another physical device (embolic coil) into the vascular system. This is consistent with a medical device used for treatment, not diagnosis.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:
Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.
Product codes
HCG
Device Description
The TRUPUSH® Coil Pusher is used in coil embolization procedures in both the neuro and peripheral vascular systems. An embolic coil is loaded into the proximal end of a compatible microcatheter and the Coil Pusher is used to advance the device through the catheter lumen until it has exited the distal tip of the catheter.
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 / 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 in-vitro and in-vivo testing was conducted to support substantial equivalence to the predicate device, addressing the process changes, packaging changes and manufacturing site transfer.
Design Verification Testing:
- . Total Product Length
- ? Taper Length
- OD of the Proximal Joint
- . OD of the Distal Joint
- . OD of the Proximal End of the PTFE Sleeve
- . Proximal Marker Position
- Distal Placement of the PTFE Sleeve
- . PTFE Sleeve Visual Inspection
- . Distal End of PTFE Sleeve Visual Inspection
- . Overall Visual Inspection
- . Distance from the Proximal End of the PTFE Sleeve to the Corewire Taper
- t Distal Solder Joint Length
- . Distal Solder Joint Visuals
- . Turns to Failure
- . Distal Joint Strength
- . Package Integrity
- . Package Challenge
- Seal Integrity Test (Dye Penetration) .
- Packaging-Seal Strength (Pull Test) .
- . Product Migration
Design Validation Testing:
- 3-cavity torque device clip .
- Pushability .
- Retractability .
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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0-000011
Johnson-Johnson company
Page 1 of 3 CFF 10463867 Revision 02 Only the Native File to be Used
SEP 2 6 2007
510(k) Summary of Safety and Effectiveness
| Submitter's Name/Contact Person | Amarilys Machado
Manager, Regulatory Affairs
Cordis Neurovascular, Inc.
14000 NW 57th Court
Miami Lakes, Florida 33014
Ph. 786 313 6493
Fax. 786 313 6480
Amachad2@crdus.jnj.com |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name / Common Name | The trade name is :
Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher)
The common name is:
Artificial Embolization Device |
| Classification | This is a Class II Device, per 21 CFR 882.5950 (84HCG) |
| Performance Standard | The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this device. |
| Intended use | The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:
Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine. |
| Device Description | The TRUPUSH® Coil Pusher is used in coil embolization procedures in both the neuro and peripheral vascular systems. An embolic coil is loaded into the proximal end of a compatible microcatheter and the Coil Pusher is used to advance the device through the catheter lumen until it has exited the distal tip of the catheter. |
1
Cordis®
a Johnson & Johnson company
KO 71962
->/3
Page 2 of 3 CFF 10463867 Revision 02 Only the Native File to be Used
Predicate Devices The predicate devices are listed in the table below:
| Device | Company | Product Code | 510(k) Number | Predicate for:
(if multiple predicates) |
|-------------------------|-------------------------------|--------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------|
| TRUPUSH®
Coil Pusher | Cordis
Neurovascular, Inc. | K983483 | HCG | - Intended Use
- Design
- Operating
Principle - Materials
- Sterilization
- Shelf Life
- Manufacturing
Process |
0-000012
2
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 small registered trademark symbol to the right. Below "Cordis" is the text "johnson&johnson company" in a smaller, less bold font. The logo is simple and professional, reflecting the company's brand identity.
KU71962
5/3
Page 3 of 3 CFF 10463867 Revision 02 Only the Native File to be Used
Summary of Studies
The in-vitro and in-vivo testing was conducted to support substantial equivalence to the predicate device, addressing the process changes, packaging changes and manufacturing site transfer.
Design Verification Testing:
- . Total Product Length
- � Taper Length
- OD of the Proximal Joint
- . OD of the Distal Joint
- . OD of the Proximal End of the PTFE Sleeve
- . Proximal Marker Position
- Distal Placement of the PTFE Sleeve
- . PTFE Sleeve Visual Inspection
- . Distal End of PTFE Sleeve Visual Inspection
- . Overall Visual Inspection
- . Distance from the Proximal End of the PTFE Sleeve to the Corewire Taper
- t Distal Solder Joint Length
- . Distal Solder Joint Visuals
- . Turns to Failure
- . Distal Joint Strength
- . Package Integrity
- . Package Challenge
- Seal Integrity Test (Dye Penetration) .
- Packaging-Seal Strength (Pull Test) .
- . Product Migration
Design Validation Testing:
- 3-cavity torque device clip .
- Pushability .
- Retractability .
Summary of Substantial Equivalence
The proposed TRUPUSH® Coil Pusher is similar in its basic design, construction, indication for use, and performance characteristics to the predicate device the current TRUPUSH® Coil Pusher.
3
Image /page/3/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 circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cordis Neurovascular, Inc. % Amarilys Machado Regulatory Affairs Manager 14000 Northwest, 57th Court Miami Lakes, Florida 33014
SEP 26 2007
Re: K071962
Trade/Device Name: Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: August 27, 2007 Received: August 28, 2007
Dear Amarilys Machado:
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.
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.
4
Page 2 -- Amarilys Machado
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
Ftz
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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0-000009
Image /page/5/Picture/2 description: The image shows the word "Corais" in a bold, stylized font. Below the word "Corais" is the text "a Johnson-Johnson company" in a smaller, cursive font. The word "Corais" is the main focus of the image, with the company name providing context.
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: TRUPUSH® Coil Pusher
Indications For Use:
The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:
Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.
J
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Prescription Use X (Part 21 CFR 801 Subpart D)
1071962
AND/0B10(k)Number-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)