(90 days)
Not Found
No
The device description and intended use describe a mechanical coil system and syringe for embolization. There is no mention of software, algorithms, or any components that would suggest the use of AI or ML. The performance studies focus on equivalence to a predicate device through in-vitro, animal, and clinical testing, not on the performance of an AI/ML algorithm.
Yes
The device is intended for embolizing certain intracranial aneurysms and vascular malformations, which involves addressing and treating a medical condition.
No
The device is described as an embolization system intended for treating certain intracranial aneurysms and vascular malformations by occluding them, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components including coils, delivery systems, and syringes, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The TRUFILL® DCS Detachable Coil System is a medical device intended for embolization, which is a procedure to block blood vessels. It is used to treat conditions like intracranial aneurysms and vascular malformations by physically placing a coil within the blood vessel. This is an in vivo procedure (performed within the living body), not an in vitro test (performed outside the body).
- No Mention of Samples or Testing: The description focuses on the physical components of the coil system and its use in a surgical/interventional procedure. There is no mention of analyzing biological samples or performing diagnostic tests.
Therefore, the TRUFILL® DCS Detachable Coil System is a therapeutic medical device used for embolization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TRUFILL® DCS Detachable Coil System is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:
a) very high risk for management by traditional operative techniques, or,
b) inoperable,
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The TRUFILL® DCS Detachable Coil System is also intended for arterial and venous embolizations in the peripheral vasculature.
The TRUFILL® DCS Detachable Syringe is indicated for use with the TRUFILL® DCS Detachable Coil.
Product codes
HCG, KRD
Device Description
The TRUFILL® DCS Detachable Coil System is comprised of the TRUFILL® DCS Detachable Coil and TRUFILL® DCS Syringe.
- The TRUFILL® DCS Detachable Coil consists of a delivery system (delivery tube and coil introducer) and an embolic coil. The delivery tube is comprised of a hub, a strain relief, a stiff proximal section, and a floppy distal section. The coil introducer is a tube designed to protect the detachable embolic coil in the packaging dispenser and provide support for introducing the embolic coil into the microcatheter. The embolic coil is the implantable segment of the device. It is comprised of a vasocclusion coil wound from a platinum alloy wire (92% Platinum / 8% Tungsten) into a primary coil and then formed into a secondary helical or complex shape.
- The TRUFILL®DCS Syringe consists of a 25-cc barrel with a pressure gauge, a threaded plunger assembly with a locking wing mechanism, and a flexible high-pressure extension tube with a male luer connector.
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)
Non-Clinical Performance Data:
The following in-vitro and animal testing was presented to support substantial equivalence to the predicate device.
Comparative Testing:
- Embolic coil radiopacity
- Markerband radiopacity
- Embolic coil softness
- Force exerted on the wall of a simulated aneurysm
- Force required to push the device through a microcatheter
- Migration in a simulated worst case fistula model
- Distal tip softness
- Distal tip angular displacement
- Animal studies
Biocompatibility: All appropriate biocompatibility tests were successfully performed on the materials used to manufacture the TRUFILL® DCS Detachable Coil System.
Clinical Data: Results of clinical testing demonstrated comparable safety and effectiveness to the predicate device.
Conclusion: Results of in-vitro, animal, and clinical testing demonstrated that the TRUFILL® DCS Detachable Coil System is substantially equivalent to the predicate device, Target's GDC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K951256, K960705, K962503, K971395, K991139, K993415, K993417, K993418, K001083, K002181
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
7 2002 MAR
Summary of Safety and Effectiveness
510(k) Summary of Safety and Effectiveness
| Trade name | The trade name of this device is: TRUFILL® DCS Detachable Coil and TRUFILL® DCS
Syringe, also known as the TRUFILL® Detachable Coil System (DCS). |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | The common name of this device is: Artificial Embolization Device. |
| Applicant's
Name | Cordis Neurovascular, Inc.
14000 NW 57 Court
Miami, Florida 33014 |
| Contact Person | Alina Caraballo
Regulatory Affairs Manager
(305) 512-6518
(305) 512-6480 fax |
| Summary Date | December 5, 2001 |
| | Continued on next page |
1
510(k) Summary of Safety and Effectiveness, Continued
The TRUFILL® DCS Detachable Coil System is intended for embolizing certain intracranial TRUFILL® DCS aneurysms that - because of their morphology, their location, or the patient's general medical Detachable Coil condition - are considered by the treating neurosurgical team to be: Intended Use very high risk for management by traditional operative techniques, or, a) b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL® DCS Detachable Coil System is also intended for arterial and venous embolizations in the peripheral vasculature. 2017年07月25日 11:54:00 AM R 11:50 PM R 11:00 AM 10:00 PM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 10:00 AM 1 The TRUFILL® DCS Detachable Syringe is indicated for use with the TRUFILL® DCS TRUFILL® DCS Syringe Intended Detachable Coil. Use The table below compares the TRUFILL® DCS Detachable Coil System with the currently
Comparative Characteristics
marketed device Target's Guglielmi Detachable Coil (GDC).
| Characteristics | Cordis Neurovascular, Inc.
TRUFILL® DCS Detachable Coil
and TRUFILL® DCS Syringe | Target's Guglielmi Detachable Coil
GDC |
|------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Anatomical Sites | Peripheral and Neurovasculature | Peripheral and Neurovasculature |
| Intended Use | Aneurysms, AVMs, AVFs, Long-Term
Use | Aneurysms, AVMs, AVFs, Long-Term
Use |
| Method of Coil Attachment | Mechanical Elastomeric Press Fit | Gold/Tin Solder Joint |
| Method of Coil Detachment | Hydraulically expandable gripper
material | Electrolytically dissolvable solder joint |
| Detachment Feedback | Pressure Gauge with detachment
indicator | Voltmeter and ammeter with LED
detachment indicator |
| Coil Shape Configurations | Helical and Complex | Helical |
| Coil Wire Outer Diameter (in) | 0.0015-0.004 | 0.00175-0.004 |
| Primary Coil Diameter (in) | 0.010-0.016 | 0.0095-0.015 |
| Secondary Coil Diameter (mm) | 2 - 20 | 2-20 |
| Coil Length (cm) | 2 - 30 | 2 - 30 |
| Coil Material | Platinum/Tungsten | Platinum/Tungsten |
| Delivery System Usable Length (cm) | 155-210 | 175 - 195 |
| Delivery System Body Design | Microcatheter design | Guidewire design |
| Radiopaque Marker Bands | Platinum/Tungsten coils, Window design | Platinum/Tungsten coil with Gold/Tin
solder attachment joints. T design |
Continued on next page
2
510(k) Summary of Safety and Effectiveness, Continued
| Device | Company | 510 (k) Number/
Concurrence Date | Product
Code | Predicate for: |
|------------------------------|------------------------------|-------------------------------------|-----------------|----------------------|
| Guglielmi Detachable
Coil | Boston Scientific,
Target | K951256 | HCG | Embolic coil |
| | | K960705 | | Delivery system |
| | | K962503 | | Detachment mechanism |
| | | K971395 | | Sterilization |
| | | K991139 | | |
| | | K993415 | | |
| | | K993417 | | |
| | | K993418 | | |
| | | K001083 | | |
| | | K002181 | | |
The predicate device is listed in the table below. Predicate Devices
Device Description
The TRUFILL® DCS Detachable Coil System is comprised of the TRUFILL® DCS Detachable Coil and TRUFILL® DCS Syringe.
- The TRUFILL® DCS Detachable Coil consists of a delivery system (delivery tube and . coil introducer) and an embolic coil. The delivery tube is comprised of a hub, a strain relief, a stiff proximal section, and a floppy distal section. The coil introducer is a tube designed to protect the detachable embolic coil in the packaging dispenser and provide support for introducing the embolic coil into the microcatheter. The embolic coil is the implantable segment of the device. It is comprised of a vasocclusion coil wound from a platinum alloy wire (92% Platinum / 8% Tungsten) into a primary coil and then formed into a secondary helical or complex shape.
- The TRUFILL®DCS Syringe consists of a 25-cc barrel with a pressure gauge, a threaded . plunger assembly with a locking wing mechanism, and a flexible high-pressure extension tube with a male luer connector.
Continued on next page
3
014041
510(k) Summary of Safety and Effectiveness, Continued
Non-Clinical Performance Data
AMA
,
The following in-vitro and animal testing was presented to support substantial equivalence to the predicate device.
| Comparative Testing |
|---|
| Embolic coil radiopacity |
| Markerband radiopacity |
| Embolic coil softness |
| Force exerted on the wall of a simulated aneurysm |
| Force required to push the device through a microcatheter |
| Migration in a simulated worst case fistula model |
| Distal tip softness |
| Distal tip angular displacement |
| Animal studies |
All appropriate biocompatibility tests were successfully performed on the materials used to Biocompatibility manufacture the TRUFILL® DCS Detachable Coil System.
Clinical Data Results of clinical testing demonstrated comparable safety and effectiveness to the predicate device.
2017年 - 2012 - 10:50 - 10:50 - 10:50 - 10:50 - 10:50 - 10:50 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00 - 10:00
Conclusion
Results of in-vitro, animal, and clinical testing demonstrated that the TRUFILL® DCS Detachable Coil System is substantially equivalent to the predicate device, Target's GDC.
】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 【 】 】 【 】 】 【 】 】 】 【 】 】 】 【 】 】 】 【 】 【 】 】 【 】 】 【 】 【 】 】 【 】 】 【 】 【 】 】 【 】 】 【 】 【 】 】 【 】 【 】 】 【 】 】 【 】
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and a serpent winding around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2002 MAR
Ms. Alina Caraballo Manager, Regulatory Affairs Cordis Neurovascular, Inc. 14000 NW 57th Court Miami Lakes, Florida 33014
Re: K014041
Trade/Device Name: TRUFILL® DCS Detachable Coil System Regulation Number: 882.5950 and 870.3300 Regulation Name: Artificial embolization device, Arterial embolization device Regulatory Class: III Product Code: HCG and KRD Dated: December 5, 2001 Received: December 7, 2001
Dear Ms. Caraballo:
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.
5
Page 2 - Ms. Alina Caraballo
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 prematicated predicated on "The 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general mistmances, International 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/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K O1 YOU (
Device Name: TRUFILL® DCS Detachable Coil System comprised of the TRUFILL® DCS Detachable Coil and TRUFILL® DCS Syringe
Indications for Use Statement
The TRUFILL® DCS Detachable Coil System is intended for embolizing certain intracranial aneurysms that because of their morphology, their 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, or, a)
inoperable, b)
and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.
The TRUFILL® DCS Detachable Coil System is also intended for arterial and venous embolizations in the peripheral vasculature.
The TRUFILL® DCS Detachable Syringe is indicated for use with the TRUFILL® DCS Detachable Coil.
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K014041
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use