(8 days)
The Sapphire™ Detachable Coils are intended for the endovascular cmbolization 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 Tetris 3-D 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 a spherical cage of loops. The Tetris is manufactured with an inner filament made of a Nickel-Titanium. The Tetris 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.
The provided text describes the Micro Therapeutics, Inc. Sapphire Tetris 3-D Detachable Coil System.
Here's the analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Bench Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Coil Deformation | Established acceptance criteria | Meet established acceptance criteria |
| Ease of Delivery/Coil Frictional Characteristics | Established acceptance criteria | Meet established acceptance criteria |
| Reliability After Fatigue & Premature Detachment | Established acceptance criteria | Meet established acceptance criteria |
| Coil Knotting | Established acceptance criteria | Meet established acceptance criteria |
| Detachment Time | Established acceptance criteria | Meet established acceptance criteria |
| Physical Dimensions | Established acceptance criteria | Meet established acceptance criteria |
| Physician/Marketing Laboratory Evaluation (side-by-side comparison with Atlas) | Established acceptance criteria | Meet established acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The provided document describes bench testing for the device, not a human clinical study with a "test set" in the context of patient data. Therefore, information about sample size for a test set, data provenance (country of origin, retrospective/prospective), and ground truth establishment, as typically understood for clinical trials, is not applicable here. The tests were performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided as the evaluation focuses on device bench performance, not human interpretability of medical data. The "Physician/Marketing Laboratory Evaluation" suggests input from physicians, but the number and qualifications are not detailed beyond their involvement in a "side-by-side comparison with Atlas" (the predicate device).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as there is no test set of patient data requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not performed. This submission is for a medical device (embolization coil), not an AI diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance study was not performed in the context of an algorithm. The device itself (the embolization coil) is the "standalone" component being evaluated for its physical and functional performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the bench testing would be engineering specifications and performance standards. For example, the detachment time would be compared against a defined acceptable range, and physical dimensions against design specifications.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set mentioned or implied.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study that proves the Sapphire Tetris 3-D Detachable Coil System meets its acceptance criteria is a series of bench tests evaluating various physical and functional characteristics of the device. These tests were conducted according to established acceptance criteria, and the results consistently indicated that the device "Meet established acceptance criteria" across all assessed parameters, including:
- Coil Deformation
- Ease of Delivery/Coil Frictional Characteristics
- Reliability After Fatigue & Premature Detachment
- Coil Knotting
- Detachment Time
- Physical Dimensions
- Physician/Marketing Laboratory Evaluation (side-by-side comparison with the predicate device, Sapphire Atlas 3-D)
The purpose of these studies was to demonstrate substantial equivalence to the predicate device (Sapphire Atlas 3-D) by showing that the two devices share the same intended use, operating principle, basic design and material, and manufacturing/sterilization processes. The testing was focused on the device's inherent properties and performance, not on clinical outcomes or diagnostic accuracy involving human subjects.
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Micro Therapeutics, Inc.
MAR 2 5 2004
| 510(k) Summary | |
|---|---|
| Trade Name: | Sapphire Detachable Coil System (Tetris 3-D) |
| 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 | Clearance Date |
|---|---|---|---|
| K993418 | Sapphire Detachable CoilSystem | Sapphire Atlas 3-D | July 21, 2003 |
Device Description
The Sapphire Tetris 3-D 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 a spherical cage of loops. The Tetris is manufactured with an inner filament made of a Nickel-Titanium. The Tetris 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. The Sapphire "N Detachable Coils are also intended for the embolization of other neuro vascular abnormalities, such as, arteriovenous malformations and arteriovenous fistulae.
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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 |
| Coil Knotting | Meet established acceptance criteria |
| Detachment Time | Meet established acceptance criteria |
| Physical Dimensions | Meet established acceptance criteria |
| Physician/Marketing Laboratory Evaluation (side-by-sidecomparison with Atlas) | Meet established acceptance criteria |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Sapphire Tetris 3-D coils compared with the predicate device Sapphire Atlas 3-D coils.
The two devices have the same intended use,
- . Use the same operating principle,
- Incorporate the same basic design and material, .
- . Have the same Intended Use,
- Are packaged and sterilized using the samc materials and processes. .
In summary, the Sapphire Tetris 3-D 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 seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2004
Ms. Florin Truuvert Regulatory Affairs Manager Micro Therapeutics, Inc. 2 Goodyear Irvine, California 92618
Re: K040694
Trade/Device Name: Sapphire Tetris 3-D Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: March 16, 2004 Received: March 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 10 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 (sec 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 vours
Authority, 2012,
Mark N Milliman
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 Tetris 3-D Detachable Coil System Device Name:
Indications For Use:
The Sapphire™ Detachable Coils are intended for the endovascular cmbolization 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
(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 Evaluation (ODE)
Mark N. Millman
Division of General, Restorative. and Neurological Devices
Page 1 of 1
510(K) Number K040694
§ 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).