(41 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties of a syringe, with no mention of AI or ML.
No
This device is described as a syringe used to generate pressure for the preparation and coil detachment of detachable coils, which are therapeutic devices. However, the syringe itself is an ancillary device rather than a therapeutic device that directly treats a condition.
No
The device description and intended use indicate that the TRUFILL® DCS Syringe II is used to prepare and detach coils, which is a therapeutic function, not a diagnostic one. The performance studies focus on the physical and mechanical integrity and function of the syringe, not on diagnosing any medical condition.
No
The device description clearly outlines physical components (barrel, pressure gauge, plunger assembly, extension tube) and the performance studies focus on physical properties and functionality of these hardware components. There is no mention of software as a component or its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for preparing and detaching medical coils used within the body (specifically, the TRUFILL® family of Detachable Coils). This is an interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a syringe designed to generate pressure for a medical procedure. It does not involve analyzing biological samples.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the syringe itself (gauge accuracy, pressure cycling, integrity, etc.) and its ability to perform the intended task (purging and detachment of coils). There are no studies related to analyzing biological samples or diagnosing a condition.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting biomarkers, pathogens, or any other diagnostic indicators.
In summary, the TRUFILL® DCS Syringe II is a medical device used in an interventional procedure, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.
Product codes
HCG
Device Description
The TRUFILL® DCS Syringe II consists of a 14-cc barrel with a pressure gauge, a threaded plunger assembly with a locking mechanism, and a flexible high-pressure extension tube with a male luer connector. The gauge faceplate is calibrated for use with the TRUFILL DCS ORBIT™ Detachable Coil and the TRUFILL® DCS Detachable Coil; i.e., the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe II is used to generate controllable pressure for preparation and coil detachment of the TRUFILL™ family of Detachable Coils.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following table summarizes the in-vitro laboratory performance testing that was conducted to demonstrate the safety and effectiveness of the TRUFILL® DCS Syringe.11 and to demonstrate that the device performs as it is intended.
Performance and Safety Testing:
Gauge Accuracy and Pressure Cycling
Luer Lock Connector Dimensional Verification
Chemical Compatibility Testing
Joint Pull Test
Device Integrity Test
Torque Test
Device Flush Particulate Test
Biocompatibility Testing
The following table summarizes the in-vitro testing that was conducted to validate the design of the TRUFILL® DCS Syringe II and to ensure that the device specifications conform to the user needs and intended use.
Design Validation Testing:
Syringe Packaging
Purge and Detachment of TRUFILL® DCS Detachable Coils
Purge and Detachment of TRUFILL DCS ORBIT™ Detachable Coils
Syringe Integrity
Ability to Pressurize Syringe
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
Image /page/0/Picture/0 description: The image shows the word "Cordis" in a bold, italicized font. Below the word "Cordis" is the phrase "a Johnson & Johnson company" in a smaller, less bold font. The logo appears to be a company logo.
Ko63254 1/2
Page 1 of 2 CFF 10463867 Revision 02 Only the Native File to be Used
510(k) Summary of Safety and Effectiveness
| Submitter's
Name/Contact
Person | Amarilys Machado
Regulatory Affairs Manager |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cordis Neurovascular, Inc.
14000 N.W. 57th Court
Miami Lakes, Florida 33014
786-313-6493
786-313-6480 (Fax)
amachad2@crdus.jnj.com |
| | October 26, 2006
DEC - 7 2006 |
| Trade Name /
Common Name | The trade name is:
The TRUFILL® DCS Detachable Coil System, comprised of the TRUFILL® DCS
Detachable Coil and the TRUFILL® DCS Syringe or the TRUFILL® DCS Syringe IIThe TRUFILL DCS ORBIT™ Detachable Coil System, comprised of the TRUFILL
DCS ORBIT™ Detachable Coil and the TRUFILL® DCS Syringe or the TRUFILL®
DCS Syringe II |
| | The common name for the TRUFILL® DCS and TRUFILL DCS ORBIT™ Detachable Coil
Systems is: Artificial Embolization Device. |
| Classification | These devices have been classified as Class II, per 21 CFR 882.5950 (84HCG), which have
been classified within the Division of Cardiovascular, Respiratory, and Neurological Devices. |
| Performance
Standard | There are no performance standards applicable under Section 514 of the Food, Drug and
Cosmetic Act for Artificial Embolization Devices. |
| Intended use | The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of
Detachable Coils. |
| Device
Description | The TRUFILL® DCS Syringe II consists of a 14-cc barrel with a pressure gauge, a threaded
plunger assembly with a locking mechanism, and a flexible high-pressure extension tube with
a male luer connector. The gauge faceplate is calibrated for use with the TRUFILL DCS
ORBIT™ Detachable Coil and the TRUFILL® DCS Detachable Coil; i.e., the TRUFILL®
family of Detachable Coils. The TRUFILL® DCS Syringe II is used to generate controllable
pressure for preparation and coil detachment of the TRUFILL™ family of Detachable Coils. |
1
Cordis®
2/2
Page 2 of 2 CFF 10463867 Revision 02 Only the Native File to be Used
510(k) Summary of Safety and Effectiveness
Predicate Devices The predicate device is listed in the table below:
| Device | Company | Product
Code | 510(k)
Number | Predicate for:
(if multiple
predicates) |
|-------------------------|----------------------------|-----------------|------------------|--------------------------------------------------------|
| TRUFILL® DCS
Syringe | Cordis Neurovascular, Inc. | HCG | K030963 | Intended Use Design Detachment Mechanism Sterilization |
Summary of Studies
The following table summarizes the in-vitro laboratory performance testing that was conducted to demonstrate the safety and effectiveness of the TRUFILL® DCS Syringe.11 and to demonstrate that the device performs as it is intended.
| Performance and Safety Testing |
|---|
| Gauge Accuracy and Pressure Cycling |
| Luer Lock Connector Dimensional Verification |
| Chemical Compatibility Testing |
| Joint Pull Test |
| Device Integrity Test |
| Torque Test |
| Device Flush Particulate Test |
| Biocompatibility Testing |
The following table summarizes the in-vitro testing that was conducted to validate the design of the TRUFILL® DCS Syringe II and to ensure that the device specifications conform to the user needs and intended use.
| Design Validation Testing |
|---|
| Syringe Packaging |
| Purge and Detachment of TRUFILL® DCS Detachable Coils |
| Purge and Detachment of TRUFILL DCS ORBIT™ Detachable Coils |
| Syringe Integrity |
| Ability to Pressurize Syringe |
Summary of Substantial Equivalence
The TRUFILL® DCS Syringe II is similar in its basic design, construction, indication for use, and performance characteristics to the predicate device, the TRUFILL® DCS Syringe.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, rendered in black. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", arranged in a circular fashion around the bird. The text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cordis Neurovascular, Inc. % Amarilys Machado Manager, Regulatory Affairs 14000 N.W. 57th Court Miami Lakes, Florida 33014
DEC - 7 2006
Re: K063254
Trade/Device Name: TRUFILL® DCS Syringe II Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: October 26, 2006 Received: October 27, 2006
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. Iisting 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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,
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K063i2S4
Image /page/4/Picture/1 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, serif font, with a registered trademark symbol next to it. Below the company name, in a smaller font, is the text "a Johnson & Johnson company."
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): KOG 3 2S 4
Device Name: TRUFILL® DCS Syringe II
Indications For Use:
The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.
Prescription Use x (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)
| (Division Sign-Off) | |
|---|---|
| -- | -------------------------------------- |
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K063254 |
|---|---|
| --------------- | --------- |