(29 days)
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. The Sapphire™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
The Sapphire" NXT Detachable Coil is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary three-dimensional structure, which forms helical and spherical shapes. The coil is coated with parylene polymer material. The embolization coil is laser welded to the detachment element made of stainless steel. The detachment element is then laser welded to the delivery wire assembly, which consists of a stainless steel wire and a radiopaque positioning coil that is partially covered with Teflon. The positioning coil provides visual indication under fluoroscopy for positioning of the embolization coil.
In the case of fibered coils, nylon fiber bundles are secured into the primary coil at regular intervals on the coil length.
The tension safe coil is manufactured with an inner filament made of a Nickel-Titanium.
The coil is detached by the battery operated power supply (NDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire.
I am sorry, but I cannot provide a response to your request. The provided text describes a medical device, the Sapphire NXT Detachable Coil System, and its clearance process with the FDA. However, the text details bench testing results and a summary of substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria with human subjects or a detailed AI algorithm study.
The document does not contain the following information necessary to fulfill your request:
- A table of acceptance criteria and the reported device performance in a clinical setting. The provided table only lists bench testing results, which are not acceptance criteria in the context you're asking for (e.g., sensitivity, specificity, accuracy).
- Sample size used for the test set and data provenance. No information on human test sets or their origin is provided.
- Number of experts used to establish ground truth and their qualifications. Not applicable as no clinical study with ground truth establishment is described.
- Adjudication method. Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study. No such study is mentioned.
- Standalone (algorithm only) performance. The document describes a physical medical device, not an AI algorithm.
- Type of ground truth used. Not applicable.
- Sample size for the training set. Not applicable.
- How the ground truth for the training set was established. Not applicable.
Therefore, based solely on the provided text, I cannot generate the requested description of acceptance criteria and a study proving device performance in the manner you've outlined for AI/clinical study contexts. The document focuses on regulatory clearance based on substantial equivalence and bench testing for a physical medical device.
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Special (5
41649
Sapphire NXT
JUL 1 6 2004
| 510(k) Summary | |
|---|---|
| Trade Name: | Sapphire NXT Detachable Coil System |
| Generic Name: | Artificial Embolization Coil |
| Classification: | Class III, 21 CFR 882.5950 |
| Submitted By: | Micro Therapeutics, Inc.2 GoodyearIrvine, California 92618 |
| Contact: | Florin Truuvert |
Predicate Device:
| Number | Description | Predicate For | ClearanceDate |
|---|---|---|---|
| K030392 | Sapphire Detachable CoilSystem | Sapphire NXT Detachable CoilSystem | July 21, 2003 |
| K033372 | Sapphire DetachableFibered Coil System | Sapphire NXT DetachableFibered Coil System | January 9, 2004 |
| K040694 | Sapphire Tetris 3DDetachable Coil System | Sapphire NXT Tetris 3DDetachable Coil System | March 25, 2004 |
Device Description
The Sapphire" NXT Detachable Coil is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary three-dimensional structure, which forms helical and spherical shapes. The coil is coated with parylene polymer material. The embolization coil is laser welded to the detachment element made of stainless steel. The detachment element is then laser welded to the delivery wire assembly, which consists of a stainless steel wire and a radiopaque positioning coil that is partially covered with Teflon. The positioning coil provides visual indication under fluoroscopy for positioning of the embolization coil.
In the case of fibered coils, nylon fiber bundles are secured into the primary coil at regular intervals on the coil length.
The tension safe coil is manufactured with an inner filament made of a Nickel-Titanium.
The coil is detached by the battery operated power supply (NDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire.
Image /page/0/Picture/12 description: The image shows a black and white drawing of a bush. The bush is dense and has a triangular shape. The bush is sitting on a flat surface. The background is white.
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Indication For Use
The Sapphire "14 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. The Sapphire " " Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Coil Deformation | Passed |
| Ease of Delivery/Coil Frictional Characteristics | Passed |
| Reliability After Fatigue & Premature Detachment | Passed |
| Fiber Pull-Out | Passed |
| Coil Knotting | Passed |
| Tensile Testing -(Final weld of Implant to guidewire) | Passed |
| Tensile Testing ..(Weld of core-wire to positioning segment) | Passed |
| Detachment Time | Passed |
| Particulate Generation - Adjusted Particles / 1 mL | Passed |
| Coil Deployment | Comparable to standard Sapphire |
| Friction Coil-on-Coil |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Sapphire NXT coils compared with the predicate device Sapphire coils.
The two devices have the same intended use,
- . Use the same operating principle,
- Incorporate the same basic design, �
- . Use similar material,
- Are packaged and sterilized using the same materials and processes. ●
In summary, the Sapphire NXT 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 is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2004
Ms. Florin Truuvert Regulatory Affairs Manager Micro Therapeutics, Inc. 2 Goodyear Irvine, California 92618
Re: K041649
Trade/Device Name: Sapphire NXT Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: June 16, 2004 Received: June 17, 2004
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,
Mark A. Mulkeron
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
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Indications for Use
510(k) Number (if known):
Sapphire NXT Detachable Coil System Device Name:
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. The Sapphire™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
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 Evalyation (ODE)
Mark N. Millhen
(Division Sign-Off)
Division of General, Restorative, and Neurologi ... Devices
Page 1 of _1
510(k) Number: K041649
§ 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).