(43 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 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.
Here's an analysis of the provided text regarding the Sapphire Detachable Coil System, VDS™ Tension Safe, focusing on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Bench Testing (Acceptance Criteria) | Reported Device Performance |
|---|---|
| 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 (for 6 months) |
Note: The document explicitly states "Meet established acceptance criteria" for each test, implying that specific quantitative or qualitative thresholds were defined and met. However, the exact numerical values or detailed qualitative descriptions of these criteria are not provided in the given text.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set for any of the "Bench Testing" categories. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests. The tests appear to be conducted in a laboratory or bench setting rather than using patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and therefore, not provided. The acceptance criteria and performance are based on bench testing, not on clinical evaluation or expert interpretation of medical images.
4. Adjudication Method for the Test Set
This information is not applicable and therefore, not provided. The "tests" mentioned are bench tests of mechanical and physical properties, not clinical assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through bench testing of physical and mechanical properties. There's no mention of human reader performance or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and therefore, not provided. The "device" is a physical medical implant (an embolization coil system), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests would have been the defined engineering specifications, performance standards, and material properties that the device was designed to meet. For instance:
- Coil Deformation: A specific tolerance for deformation under a defined load.
- Tensile Strength: A minimum tensile strength requirement.
- Detachment Time: A specified range for detachment time.
- Physical Dimensions: Exact dimensional specifications.
However, the document does not explicitly detail these ground truths beyond stating that the device "Meet established acceptance criteria."
8. The Sample Size for the Training Set
This information is not applicable and therefore, not provided. As mentioned, the device is a physical medical implant, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore, not provided, for the same reason as point 8.
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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 CoilSystem | 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
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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
§ 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).