(166 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 Detachable Coil (SDC) is manufactured from a platinum alloy attached to a positioning wire. The coil is detached by the Sapphire Detachment System (SDS) power supply, which dissolves a small detachment element between the emboliozation coil and the positioning wire. This occurs after desired placement of the coil in the anatomy. The Sapphire coils are manufactured from platinum/iridium alloy wire that is first wound into the primary coil, and then formed into a secondary (spherical or helical) shape. The Sapphire Detachment Coils are manufactured in different shapes and sizes. These coils are available in spherically shaped configurations, as well as, helically shaped configurations of various diameters and lengths.
The Sapphire Detachable Coil System underwent various tests to demonstrate its performance and substantial equivalence to the predicate device. The Acceptance Criteria and reported performance are summarized below, though specific numerical acceptance criteria were not provided in the document for all tests. The document states that "All performance characteristics met the acceptance criteria" and "All testing demonstrated compliance with the appropriate standard and/or met the acceptance criteria," indicating successful completion of the tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Coil Strength (force required to deform coil shape) | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Ease of Delivery (friction during advancement/retraction) | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Detachment Time | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Reliability after Fatigue (10 cycles) | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Coil, Detachment Zone & Coil Weld Tensile Strength | Met unspecified acceptance criteria | Measured, evaluated, and met acceptance criteria |
| Delivery Wire Flexibility | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Radiopacity | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Particulate Generation | Met unspecified acceptance criteria | Measured, evaluated, and met acceptance criteria |
| Material Compatibility | ||
| MRI Compatibility | Met unspecified acceptance criteria | Evaluated and met acceptance criteria |
| Packaging & Sterility | ||
| Packaging | Met unspecified acceptance criteria | Tested, evaluated, and met acceptance criteria |
| Sterile Integrity & Sterility Validation | Met unspecified acceptance criteria | Tested, evaluated, and met acceptance criteria |
| Detachment System Performance (SDS) | ||
| Conductance of Current | Met product specifications | Tested, evaluated, and met acceptance criteria |
| Compliance with Product Specifications | Met product specifications | Tested, evaluated, and met acceptance criteria |
| Detachment Reliability (in-vitro and in-vivo) | Met unspecified acceptance criteria | Tested, evaluated, and met acceptance criteria |
| Electrical Safety | Compliant with appropriate standard | Tested, evaluated, and demonstrated compliance |
| Radiated Emission | Compliant with appropriate standard | Tested, evaluated, and demonstrated compliance |
| Radio Disturbance | Compliant with appropriate standard | Tested, evaluated, and demonstrated compliance |
| Electro-Static Discharge Immunity | Compliant with appropriate standard | Tested, evaluated, and demonstrated compliance |
| SDS Firmware (expression of modes and states) | Conforms to Design Specifications | Tested, evaluated, and demonstrated compliance |
2. Sample Size for Test Set and Data Provenance
The document describes "animal studies" for the Sapphire Detachable Coil series. However, the specific sample size (number of animals) used for these studies is not provided. The data provenance is described as prospective animal studies. The country of origin of the data is not specified.
3. Number of Experts and Qualifications for Ground Truth
The provided text does not include information on the number of experts used to establish ground truth or their qualifications. The animal studies would rely on observations and measurements from the researchers and veterinarians involved.
4. Adjudication Method
The provided text does not include information on any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this device is a medical implant and not an imaging or diagnostic AI device that would typically involve human readers. The studies focused on the physical and functional performance of the coil and its detachment system.
6. Standalone (Algorithm Only) Performance Study
While the Sapphire Detachment System (SDS) includes firmware, the "standalone" performance described is not in the context of an AI algorithm producing a standalone diagnostic output. Instead, it refers to the functional performance of the SDS, including electrical safety, emission, disturbance, ESD immunity, and firmware compliance with design specifications. The performance of the coil itself is also assessed in a standalone context in the sense that its physical properties are measured independently.
7. Type of Ground Truth Used
The ground truth used in the studies includes:
- Physical Measurements and Standards: For tests like coil strength, tensile strength, flexibility, radiopacity, particulate generation, and electrical properties, ground truth is established by objective measurements against predefined engineering specifications and relevant industry standards.
- In-vitro Performance Assessment: For aspects like ease of delivery, detachment time (in-vitro), and detachment reliability (in-vitro), the ground truth is based on the devices' performance in controlled laboratory settings and simulations.
- Animal Outcomes/Observations: For the animal studies, the ground truth relates to observed physiological responses and device function within a living system, such as fluoroscopic visibility, ability to position and pack the aneurysm sac, coil reposition-ability, ease of use of the detachment system, coil detachment reliability, and coil stability.
8. Sample Size for the Training Set
The concept of a "training set" is typically applicable to machine learning algorithms. Since the Sapphire Detachable Coil System is a physical medical device and not an AI algorithm in the context of its development as described, there is no mention of a training set in the provided information.
9. How the Ground Truth for the Training Set Was Established
As there is no training set discussed, information on how its ground truth was established is not applicable/provided.
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K030392/P1/2
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510(k) Summary
JUL 21 2003
| Trade Name | Sapphire 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 | Target Therapeutics' Detachable Platinum Coil (GuglielmiDetachable Coil, GDC) |
| DeviceDescription | The Sapphire Detachable Coil (SDC) is manufactured from aplatinum alloy attached to a positioning wire. The coil is detachedby the Sapphire Detachment System (SDS) power supply, whichdissolves a small detachment element between the emboliozationcoil and the positioning wire. This occurs after desired placement ofthe coil in the anatomy. The Sapphire coils are manufactured fromplatinum/iridium alloy wire that is first wound into the primary coil,and then formed into a secondary (spherical or helical) shape.The Sapphire Detachment Coils are manufactured in differentshapes and sizes. These coils are available in spherically shapedconfigurations, as well as, helically shaped configurations ofvarious diameters and lengths. |
| Indication ForUse | The Sapphire™ Detachable Coils are intended for the endovascularembolization of intracranial aneurysms that - because of theirmorphology, their location, or the patient's general medicalcondition - are considered by the treating neurosurgical team to bea) very high risk for management by traditional operativetechniques, or b) be inoperable. The Sapphire™ Detachable Coilsare also intended for the embolization of other neuro vascularabnormalities, such as, arteriovenous malformations andarteriovenous fistulae. |
| Testing | The Sapphire Detachable Coil (SDC) series have been tested andevaluated in performance characteristics including: Coil strength,e.g., the force required to deform the coil shape; the ease of deliveryas measured by friction when advancing and retracting the coilthrough various catheters positioned in a simulated tortuosity, andthe detachment time. In addition, reliability after fatigue (10cycles), coil, detachment zone & coil weld tensile strength, deliverywire flexibility, radiopacity and particulate generation weremeasured and evaluated. The materials of the Sapphire DetachableCoil series were evaluated with respect to compatibility withMagnetic Resonance Imaging. All performance characteristics metthe acceptance criteria. All the above tests were performed andevaluated after 1-year simulated aging and met the acceptancecriteria. |
| The Sapphire Detachable Coil (SDC) series have been tested andevaluated with respect to packaging, sterile integrity and sterilityvalidation. The Sapphire Detachable Coil series has been validatedin animal studies addressing a wide range of performanceparameters, including: the ability to move coil within amicrocatheter, fluoroscopic visibility of coil ability to position coilin aneurysm, coil reposition-ability, ability to pack the aneurysmsac, ease of use of the detachment system, coil detachment time,detachment reliability & coils stability.The Sapphire Detachment System (SDS) has been tested andevaluated for conductance of current, compliance with its productspecifications, detachment reliability, in-vitro and in-vivo, and hasmet all acceptance criteria. The Sapphire Detachment System hasbeen tested and evaluated for electrical safety, radiated emission,radio disturbance and Electro-Static Discharge immunity. Thefirmware as part of the Sapphire Detachment System was tested andevaluated with respect to the expression of its modes and states asdescribed in its Design Specifications. All testing demonstratedcompliance with the appropriate standard and/or met the acceptancecriteria. | |
| Summary ofSubstantialEquivalence | The Sapphire Detachable Coil System is substantially equivalent tothe predicate device, Target Therapeutics' Detachable PlatinumCoil (Guglielmi Detachable Coil, GDC) in- Use the same operational principle- Incorporate the same basic design- Have the same intended use- Are packaged and sterilized using similar materials, and processesIn summary, the Sapphire Detachable Coil system described in thissubmission is, in our opinion, substantially equivalent to thepredicate device. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2003
Ms. Florin Truuvert Regulatorv Affairs Manager Microtherapeutics, Inc. 2 Goodyear Irvine, California 92618
Re: K030392
Trade/Device Name: Sapphire Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: May 7, 2003 Received: May 8, 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 (OS) 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 vour 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. 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 premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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
fe 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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K030392
Indications for Use Statement
510(k) Number (if known): _________
Device Name:
Sapphire Detachable Coil System
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 TM Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use OR Over the Counter Use (Per 21 CFR 801.109)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030392
GUS
§ 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).