(303 days)
No
The summary describes a mechanical device (coils and pusher) used for vascular occlusion under fluoroscopy. There is no mention of software, algorithms, or any technology that would suggest AI/ML is involved in the device's function or intended use. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used for the "interventional radiologic management of arteriovenous malformations, arteriovenous fistulas and other vascular lesions of the brain, spinal cord and spine," which involves treating medical conditions.
No
Explanation: The device, CES Pushable Coils, is described as being used to reduce or block blood flow in vessels, which is a therapeutic intervention, not a diagnostic one. It is used in the "interventional radiologic management" of conditions, indicating treatment rather than diagnosis.
No
The device description explicitly states that the system consists of physical components: CES Pushable Coils (made from platinum alloy and synthetic fibers) and the CES Coil Pusher. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The CES Pushable Coils are a medical device used within the body to physically block blood flow in vessels. They are used in an interventional procedure, not for analyzing samples outside the body.
- Intended Use: The intended use clearly describes a therapeutic intervention (reducing or blocking blood flow) for managing vascular lesions, not for diagnostic testing of specimens.
- Device Description: The description details the physical components of the coils and the pusher, designed for insertion and manipulation within the vascular system.
- Input Imaging Modality: Fluoroscopy is an imaging technique used to guide the placement of the device in vivo, not for analyzing samples.
Therefore, based on the provided information, the CES Pushable Coils are a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CES Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the neurovasculature for 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 CES Vascular Occlusion System consists of straight and shaped CES Pushable Coils (made from platinum alloy and synthetic fibers) and the CES Coil Pusher (with two radiopaque tip markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" I.D.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the neurovasculature, brain, spinal cord and spine.
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)
Not Found
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).
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Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '972881'. The characters are written in a dark ink, and the image is in black and white.
510(k) Summary of Oxforty and Effectiveness
General Provisions
- Common names used for this device, include:
- Platinum Fibered Coils .
- Microcoils or Minicoils .
The CES Vascular Occlusion System, consists of :
- TruFill™ Pushable Coils (or CES Pushable Coils), and .
- TruPush™ Embolic Coil Pusher (or CES Coil Pusher) .
The predicate devices are listed in the table below.
Predicate Devices
The predicate devices are listed in the table below.
| Device | Company | 510 (k) Number,
Concurrence Date | Product Code |
|------------------------------------------|-----------------------------------|-------------------------------------|--------------|
| CES Pushable Coils | Cordis Endovascular Systems, Inc. | K964367, 1/30/97 | HCG |
| Helix Shaped Coils
with Dacron Fibers | Target Therapeutics | K913312, 1/08/91 | HCG |
| Hilal Embolization
Microcoil | Cook, Inc. | K901337, 11/09/90 | HCG |
| Classification | Class III |
|---|---|
| Performance | |
| Standard | Performance standards have not been established by the FDA under Section |
| 514 of the Food, Drug and Cosmetic Act. | |
| Intended use | CES Pushable Coils may be used to reduce or block the rate of blood flow in |
| vessels of the neurovasculature for the interventional radiologic management | |
| of arteriovenous malformations, arteriovenous fistulas and other vascular | |
| lesions of the brain, spinal cord and spine. | |
| Device | |
| description | The CES Vascular Occlusion System consists of straight and shaped CES |
| Pushable Coils (made from platinum alloy and synthetic fibers) and the CES | |
| Coil Pusher (with two radiopaque tip markers). The pushable coils are | |
| designed for use under fluoroscopy with microcatheters having a minimum | |
| 0.21" I.D. |
1
0-000042 All applicable biocompatibility tests were successfully performed on the CES Biocompatibility Pushable Coils.
The CES Pushable Coils are substantially equivalent in design, materials, Summary of sterilization and indications for use to other commercially available occlusion Substantial Equivalence devices.
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Image /page/2/Picture/2 description: The image shows the date June 4, 1998. The text is in a simple, sans-serif font. The date is written in a standard format, with the month abbreviated to three letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Martine D. Schneider Sr. Regulatory Affairs Associate Cordis Endovascular 14000 N.W. 57th Court Miami Lakes, Florida 33014
Re: K972881/S1 Trade Name: CES Vascular Occlusion System Requlatory Class: III Product Code: 84HCG Dated: January 29, 1998 Received: January 30, 1998
Dear Ms. Schneider:
We have reviewed your Section 510(k) 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 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical ---Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Schneider
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to one rogalation" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". "
Sincerely yours,
Celia M. Witten. Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K972881 510 (k) Number:_______________________________________________________________________________________________________________________________________________________________
Indications for Use Statement
CES Pushable Coils may be used to obstruct or reduce the rate of blood flow in vessels of the CES Fusilable Colls may be used to Obstract of rouse and of arteriovenous malformations, newovenous fistulas and other vascular lesions of the brain, spinal cord, and spine.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ X (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
a Devices
(Division Sign-Off)
Division of General Restorative 510(k) Number