(43 days)
Not Found
No
The device description focuses on the physical construction and detachment mechanism of the coil, with no mention of AI or ML capabilities. The performance studies are bench tests evaluating physical properties, not algorithmic performance.
Yes
The device is described as being used for "endovascular embolization of intracranial aneurysms", which is a medical treatment for a medical condition.
No
The device, Sapphire Detachable Coils, is described as an endovascular embolization device for intracranial aneurysms. Its purpose is to treat or manage the condition, not to diagnose it.
No
The device description clearly details physical components made of platinum alloy wire, stainless steel, and a Teflon outer jacket, along with a battery-operated power supply for detachment. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a device used for the endovascular embolization of intracranial aneurysms. This is a procedure performed inside the body (in vivo) to treat a medical condition. The device is a physical implant (coils) delivered through a catheter.
The device's function is to physically block blood flow to an aneurysm, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Sapphire Detachable Coils are intended for the endovascular embolization of 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) be inoperable.
Product codes
HCG
Device Description
The Sapphire Detachable VDS™ Tension Safe Coil is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary helical shape. The VDS Tension Safe has multiple coil segments with polymer "cap" at each segment ends, integrated into one coil system. The coil is welded to a positioning wire, which consist of ground stainless steel core wire with a stainless steel coil laser welded at the distal end and a Teflon outer jacket. The coil is detached by the battery operated power supply (SDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial aneurysms
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
Bench Testing:
- Coil Deformation: Meet established acceptance criteria
- Ease of Delivery/Coil Frictional Characteristics: Meet established acceptance criteria
- Reliability After Fatigue & Premature Detachment: Meet established acceptance criteria
- Tensile Strength of Coil & Detachment Zone: Meet established acceptance criteria
- Detachment Time: Meet established acceptance criteria
- Particulate Generation: Meet established acceptance criteria
- Physical Dimensions: Meet established acceptance criteria
- Radiopacity: Meet established acceptance criteria
- Aging and Shelf Life (6 months): Meet established acceptance criteria
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).
0
SEP 2 5 2003
Micro Therapeutics, Inc.
Special (510(k), Sapphire Detachable Coil System, VDS™ Tension Safe
510(k) Summary Sapphire Detachable VDS™ Tension Safe Coil System Trade Name: Artificial Embolization Coil Generic Name: Class III, 21 CFR 882.5950 Classification: Micro Therapeutics, Inc. Submitted By: 2 Goodyear Irvine, California 92618 Florin Truuvert Contact:
Predicate Device:
| Number | Description | Predicate For | Clearance Date |
|---|---|---|---|
| K993418 | Sapphire Detachable Coil | ||
| System | Sapphire VDS Coil | July 21, 2003 |
Device Description
The Sapphire Detachable VDS™ Tension Safe Coil is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary helical shape. The VDS Tension Safe has multiple coil segments with polymer "cap" at each segment ends, integrated into one coil system. The coil is welded to a positioning wire, which consist of ground stainless steel core wire with a stainless steel coil laser welded at the distal end and a Teflon outer jacket. The coil is detached by the battery operated power supply (SDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire.
Indication For Use
The Sapphire Detachable Coils are intended for the endovascular embolization of 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) be inoperable.
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Micro Therapeutics, Inc. Special (510(k), Sapphire Detachable Coil System, VDS™ Tension Safe
Verification and Test Summary Table
| Bench Testing | Sapphire Fibered Coils |
|---|---|
| Coil Deformation | Meet established acceptance criteria |
| Ease of Delivery/Coil Frictional Characteristics | Meet established acceptance criteria |
| Reliability After Fatigue & Premature Detachment | Meet established acceptance criteria |
| Tensile Strength of Coil & Detachment Zone | Meet established acceptance criteria |
| Detachment Time | Meet established acceptance criteria |
| Particulate Generation | Meet established acceptance criteria |
| Physical Dimensions | Meet established acceptance criteria |
| Radiopacity | Meet established acceptance criteria |
| Aging and Shelf Life (6 months) | Meet established acceptance criteria |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Sapphire VDS Tension Safe coils compared with the predicate device Sapphire VDS standard coils.
The two devices have the same intended use,
- . Use the same operating principle,
- Incorporate the same basic design, .
- . Have the same Intended Use,
- Are packaged and sterilized using the same materials and processes. .
In summary, the Sapphire VDS Tension Safe coils described in this submission are, in our opinion, substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2003
Ms. Florin Truuvert Manager, Regulatory Affairs Micro Therapeutics, Inc. 2 Goodyear Irvine, California 92618
Re: K032497
Trade/Device Name: Sapphire Detachable VDS™ Tension Safe Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: August 11, 2003 Received: August 26, 2003
Dear Ms. Truuvert:
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.
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Page 2 - Ms. Florin Truuvert
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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
4
103249
Indications for Use Statement
510(k) Number (if known): ________
Device Name:
Sapphire VDS™ Tension Safe Detachable Coil System
Indications for Use:
Sapphire Detachable Coils
The Sapphire Detachable Coils are intended for the endovascular embolization of 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) be inoperable.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use______________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
Muriam C. Provost
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(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K032477