(67 days)
No
The device description focuses on the physical components and mechanical function of embolic coils and their delivery systems. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making components. The performance studies described are bench testing and verification/validation of physical characteristics and packaging.
Yes
The device is described as being used for the "interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions" and for "embolizing intracranial aneurysms and other vascular malformations" to "eliminate the influx of blood into the aneurysm" and disrupt blood flow, which are all therapeutic interventions aimed at treating a medical condition.
No
The device, Pushable Coils, is described as an embolic device used to block blood flow in vessels,
treating conditions like arteriovenous malformations and aneurysms. Its function is to provide
treatment by physically occluding vessels, not to diagnose conditions.
No
The device description clearly details physical components made of platinum/tungsten and synthetic fibers (coils) and a coil pusher/delivery system, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that these are implantable coils used to physically block blood flow within vessels. They are used in interventional procedures performed directly on the patient's vascular system.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient. The device's function is mechanical and performed within the body.
Therefore, the TRUFILL Pushable Coils and TRUFILL DCS ORBIT Detachable Coil System are medical devices used for therapeutic intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
The TRUFILL DCS ORBIT Detachable Coil System is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
HCG
Device Description
The intent of endovascular treatment using embolic microcoils is to pack the lumen of the aneurysm with the microcoil mass, thereby eliminating the influx of blood into the aneurysm. As blood flow is disrupted within the aneurysm, intraluminal thrombosis leads to exclusion of blood flow from the parent artery into the aneurysm. Blood flow in the parent artery is then secluded from the aneurysm and the weakened wall of the aneurysm is isolated from arterial pressures. Coil embolization may also be used to treat arteriovenous malformations and fistulas by packing coils into the lumen of the parent vessel feeding into the unwanted arteriovenous structure, resulting in cessation of blood flow. Stagnated blood within the arteriovenous malformation or fistula then thromboses, leading to involution and absorption of the aberrant vessels.
The Vascular Occlusion System consists of the TRUFILL Pushable Coils and TRUPUSH Coil Pusher. The TRUFILL Pushable Coil is loaded into the proximal end of a compatible microcatheter and advanced through the catheter to the desired vessel location. The coil is deployed using the TRUPUSH Coil Pusher which is sold separately. The TRUFILL Pushable Coils are made from platinum/tungsten and synthetic fibers, and are designed for use under fluoroscopy with the TRUPUSH Coil Pusher and microcatheters having a minimum ,021" I.D. (0.5 mm). The TRUFILL Pushable coils are available in straight and shaped configurations.
The TRUFILL DCS ORBIT Detachable Coil System consists of a delivery system (delivery tube and coil introducer) and an embolic coil. The embolic coil is the implantable segment of the device, and is comprised of a vasoocclusion coil wound from a platinum alloy wire into a primary coil and then formed into a secondary helical or complex shape. The embolic coil is detached from the delivery tube via a proprietary hydraulic release mechanism using the TRUFILL DCS Syringe II which is sold separately. The TRUFILL DCS ORBIT Detachable Coil System is designed for use under fluoroscopy with compatible infusion catheters, and is available in Standard and Fill configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
vessels of the peripheral and neurovasculature, brain, spinal cord and spine, intracranial aneurysms, arterial and venous embolization in the peripheral vasculature
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)
Bench testing demonstrated that the TRUFILL Pushable Coils and the TRUFILL DCS ORBIT Detachable Coils perform according to their description and intended use, and established the performance characteristics of the packaging modifications.
Results of verification and validation testing conducted on the TRUFILL Pushable Coils and TRUFILL DCS ORBIT Detachable Coils demonstrated that the proposed device is substantially equivalent to the predicate device and that the packaging modifications do not impact the design, safety, operation, or performance characteristics of the device.
The following tests were conducted to verify the packaging modifications for both the TRUFILL Pushable Coils and TRUFILL DCS Detachable Coils:
- Package Integrity Testing
- Dye Leak
- Visual Inspection
- Seal Strength
- Biocompatibility Testing
- Cytotoxicity Testing
- Sterilization Verification Testing
- EO/ECH Residuals Testing
- Packaging Shelf Life Verification
- Dye Leak
- Visual Inspection
- Seal Strength
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.
K030963, K032553, K053197, K080967
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.
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
510(k) SUMMARY
:
・
.
JAN 2 5 2013
A. Company Information
.
·
| Company Name: | Codman & Shurtleff, Inc. |
|---|---|
| Address: | 325 Paramount Drive |
| Raynham, MA 02767 | |
| Telephone: | 408-433-1400 |
| Fax: | 408-433-1585 |
| Contact Person: | Richard Kimura |
| Date of Submission: | November 16, 2012 |
B. Trade/Device Name: TRUFILL® Pushable Coils and TRUFILL® DCS ORBITTM Detachable Coil System
| Common Name: | Artificial Embolization Device |
|---|---|
| Classification Name: | Neurovascular Embolization Device |
| Regulation Number: | 21 CFR 882.5950 |
| Product Code: | HCG |
C. Predicate Device Information:
| Device | Company | 510(k) Number/
Concurrence Date | Product
Code | Predicate For: |
|---------------------------------|----------------------------|------------------------------------|-----------------|-----------------------------------------------------------------------|
| Vascular
Occlusion
System | Codman &
Shurtleff, Inc | K964367
January 30, 1997 | HCG | Intended Use
Design
Materials
Manufacturing
Sterilization |
| Vascular
Occlusion
System | Codman &
Shurtleff, Inc | K972881
June 4, 1998 | HCG | Intended Use
Design
Materials
Manufacturing
Sterilization |
| Vascular
Occlusion
System | Codman &
Shurtleff, Inc | K983483
March 24, 1999 | HCG | Intended Use Design
Materials
Manufacturing
Sterilization |
l
·
.
1
| Device | Company | 510(k) Number/
Concurrence Date | Product
Code | Predicate For: |
|---------------------------------------------------|----------------------------|------------------------------------|-----------------|-----------------------------------------------------------------------|
| TRUFILL DCS
ORBIT
Detachable Coil
System | Codman &
Shurtleff, Inc | K030963
June 20, 2003 | HCG | Intended Use
Design
Materials
Manufacturing
Sterilization |
| TRUFILL DCS
ORBIT
Detachable Coil
System | Codman &
Shurtleff, Inc | K032553
September 23, 2003 | HCG | Intended Use
Design
Materials
Manufacturing
Sterilization |
| TRUFILL DCS
ORBIT
Detachable Coil
System | Codman &
Shurtleff, Inc | K053197
December 15, 2005 | HCG | Intended Use
Design
Materials
Manufacturing
Sterilization |
| TRUFILL DCS
ORBIT
Detachable Coil
System | Codman &
Shurtleff, Inc | K080967
May 2, 2008 | HCG | Intended Use
Design
Materials
Manufacturing
Sterilization |
D. Device Description:
The intent of endovascular treatment using embolic microcoils is to pack the lumen of the aneurysm with the microcoil mass, thereby eliminating the influx of blood into the aneurysm. As blood flow is disrupted within the aneurysm, intraluminal thrombosis leads to exclusion of blood flow from the parent artery into the aneurysm. Blood flow in the parent artery is then secluded from the aneurysm and the weakened wall of the aneurysm is isolated from arterial pressures. Coil embolization may also be used to treat arteriovenous malformations and fistulas by packing coils into the lumen of the parent vessel feeding into the unwanted arteriovenous structure, resulting in cessation of blood
2
flow. Stagnated blood within the arteriovenous malformation or fistula then thromboses, leading to involution and absorption of the aberrant vessels.
The TRUFILL Vascular Occlusion System:
The Vascular Occlusion System consists of the TRUFILL Pushable Coils and TRUPUSH Coil Pusher. The TRUFILL Pushable Coil is loaded into the proximal end of a compatible microcatheter and advanced through the catheter to the desired vessel location. The coil is deployed using the TRUPUSH Coil Pusher which is sold separately. The TRUFILL Pushable Coils are made from platinum/tungsten and synthetic fibers, and are designed for use under fluoroscopy with the TRUPUSH Coil Pusher and microcatheters having a minimum ,021" I.D. (0.5 mm). The TRUFILL Pushable coils are available in straight and shaped configurations.
The TRUFILL DCS ORBIT Detachable Coil System:
The TRUFILL DCS ORBIT Detachable Coil System consists of a delivery system (delivery tube and coil introducer) and an embolic coil. The embolic coil is the implantable segment of the device, and is comprised of a vasoocclusion coil wound from a platinum alloy wire into a primary coil and then formed into a secondary helical or complex shape. The embolic coil is detached from the delivery tube via a proprietary hydraulic release mechanism using the TRUFILL DCS Syringe II which is sold separately. The TRUFILL DCS ORBIT Detachable Coil System is designed for use under fluoroscopy with compatible infusion catheters, and is available in Standard and Fill configurations.
E. Intended Use:
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.
The TRUFILL DCS ORBIT Detachable Coil System is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS
3
3
ORBIT Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.
F. Summary of technological characteristics of the proposed to the predicate device:
The proposed TRUFILL Pushable Coils and the TRUFILL DCS ORBIT Detachable Coils are substantially equivalent to the currently cleared TRUFILL Pushable Coils and TRUFILL DCS ORBIT Detachable Coils. No new technological characteristics are being introduced with the proposed device.
The proposed TRUFILL Pushable Coils and the TRUFILL DCS ORBIT Detachable Coils have the same intended use, same operating principle, same design, manufacturing and sterilization process. All materials are the same as the currently marketed devices with the exception of the change to the coating material on the Tyvek pouch (provided by a different vendor) and one minor change to one pouch dimension (for the TRUFILL DCS ORBIT Detachable Coil only). The following Table provides an overview of the similarities and differences for both products.
| Table 1: Similarities and Differences compared to Current Product | ||
|---|---|---|
| Characteristic | TRUFILL Pushable Coils | TRUFILL DCS ORBIT |
| Detachable Coils | ||
| Intended Use | No change | No change |
| Operating Principle | No change | No change |
| Design | No change | No change |
| Materials | No change (except coating | |
| material on Tyvek pouch) | No change (except coating | |
| material on Tyvek pouch) | ||
| Dimensions | No change | No change (except |
| packaging pouch) | ||
| Manufacturing Process & | ||
| Locations | No change | No change |
| Packaging Components | No change (except coating | |
| material on Tyvek pouch) | No change (except coating | |
| material on Tyvek pouch, | ||
| and pouch dimension) | ||
| Sterilization Process & | ||
| Location | No change | No change |
| Shelf Life | No change. | No change |
4
4
G. Summary of Nonclinical Testing:
Codman performed non-clinical testing necessary to demonstrate substantial equivalence to the predicate devices. Bench testing demonstrated that the TRUFILL Pushable Coils and the TRUFILL DCS ORBIT Detachable Coils perform according to their description and intended use, and established the performance characteristics of the packaging modifications.
Results of verification and validation testing conducted on the TRUFILL Pushable Coils and TRUFILL DCS ORBIT Detachable Coils demonstrated that the proposed device is substantially equivalent to the predicate device and that the packaging modifications do not impact the design, safety, operation, or performance characteristics of the device.
The following tests were conducted to verify the packaging modifications for both the TRUFILL Pushable Coils and TRUFILL DCS Detachable Coils:
- . Package Integrity Testing
- O Dye Leak
.
- Visual Inspection o
- Seal Strength o
- Biocompatibility Testing .
- Cytotoxicity Testing
- Sterilization Verification Testing . o EO/ECH Residuals Testing
- Packaging Shelf Life Verification .
- O Dye Leak
- Visual Inspection 0
- Seal Strength 0
Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Codman & Shurtleff, Inc., it
5
5
is concluded that the TRUFILL Pushable Coils and the TRUFILL DCS ORBIT Detachable Coils are substantially equivalent to the currently cleared TRUFILL Pushable Coils and the TRUFILL DCS ORBIT Detachable Coils and, therefore, do not raise any new questions of safety or effectiveness.
H. Summary of Clinical Testing:
Since there are no changes proposed to the intended use, design, performance characteristics, manufacturing process, sterilization, or principles of operation of the devices, clinical testing was not required to establish substantial equivalence.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Public Health Service
January 25,2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Codman & Shurtleff, Inc. c/o Richard K. Kimura Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767-0350
Re: K123560
Trade/Device Name: TRUFILL Pushable Coils TRUFILL DCS ORBIT Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG Dated: December 21, 2012 Received: December 26, 2012
Dear Mr. Kimura:
We have reviewed your Section 510(k) premarket 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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); medical device reporting of medical device
7
Page 2 - Richard K. Kimura
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
8
Indications for Use
510(k) Number (if known): K123560
Device Name: TRUFILL Pushable Coils TRUFILL DCS ORBIT Detachable Coil System
Indications For Use:
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.
The TRUFILL DCS ORBIT Detachable Coil System is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
. AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joyce M. Whang
(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K123560
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