(65 days)
Not Found
No
The summary describes a physical medical device (detachable coils) and its mechanical and performance characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for the endovascular embolization of intracranial aneurysms and neurovascular abnormalities, which are medical conditions that affect the body. Its purpose is to treat or alleviate these conditions.
No
This device is an embolization coil, intended for the endovascular embolization of intracranial aneurysms and neurovascular abnormalities. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is manufactured from a platinum alloy wire and includes a positioning wire, a battery-operated power supply (Sapphire Detachment System), and potentially nylon fibers. These are all physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the endovascular embolization of intracranial aneurysms and other vascular abnormalities. This is a therapeutic procedure performed within the body to treat a medical condition.
- Device Description: The device is a physical coil designed to be implanted in blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a therapeutic implant used directly in the body.
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.
The intended uses of the Sapphire fiber coils are narrowed relative to the predicate device GDC, but still fall within the 510(k) cleared intended use.
Sapphire Detachable Fibered Coil - The Sapphire fibered coil is intended for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Fibered Sapphire is also intended for arterial and venous embolizations in the peripheral vasculature.
Product codes
HCG
Device Description
The Sapphire Detachable Coil (SDC) is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary helical shape. 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 (Sapphire Detachment System, SDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire. The fibered coil is manufactured with nylon fibers secured into the primary coil. The fibered coils are available in two shapes (Helix and Cyclone) and different sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovascular, arterial and venous peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- Coil Strength (Coil Deformation and Softness Testing): Meet established acceptance criteria
- Ease of Delivery: Meet established acceptance criteria
- Reliability After Fatigue & Premature Detachment: Meet established acceptance criteria
- Tensile Strength of Coil & Detachment Zone: Meet established acceptance criteria
- Tensile Strength of Delivery Wire: Meet established acceptance criteria
- Delivery Wire Flexibility: Meet established acceptance criteria
- Detachment Time: Meet established acceptance criteria
- Radiopacity: Meet established acceptance criteria
- Particulate Generation of Detachment Zone: Meet established acceptance criteria
- Aging and Shelf Life (3 year): Meet established acceptance criteria
- Fiber Pull Out: Meet established acceptance criteria
- Fiber Endurance: Meet established acceptance criteria
- Packaging validation after 3-year accelerated aging: Meet established acceptance criteria
Animal Testing (Comparison to the Predicate Device):
- Coil Per Aneurysm (Avg./S.D.): Comparable
- Detachment Time (seconds): Comparable
- Coil Detachment Reliability (detachment attempts/coil): The Sapphire demonstrated higher reliability
- Post Embolization Angiographic Assessment: Comparable
- Angiographic Assessment One-Month Follow-Up: Comparable
- Angiographic Assessment Three-Month Follow-Up: Comparable
Physician Device Evaluation (Acceptance Criteria):
- Ease of Coil Preparation: Comparable
- Ability to move coil within Catheter: Comparable
- Access: Acceptance Criteria
- Ability to Place catheter tip in desired location: Comparable
- Trackability, Friction of coil through catheter: Comparable
- Coil Visualization: Acceptance Criteria
- Fluoroscopic visibility of Coil: Comparable
- Fluoroscopic visibility of Detachment Markers: Comparable
- Coil Delivery Procedure: Acceptance Criteria
- Ability to Position Coil in Sac: Comparable
- Detachment Time: Comparable
- Ability to Pack Aneurysm Sac: Comparable
- Ability to Reposition: Comparable
- Ease of use of the SDS Detachment System: Comparable
- Coil Positional Stability/Aneurysm Occlusion: Comparable
Overall:
- Ease of Use: Comparable
- Overall performance: Comparable
- MRI Compatibility: Compatible with 1.5 Tesla
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
AUG 2 0 2003
K03 i852/P.13
Premarket Notification (510(k) for Sapphire Detachable Fibered C
| 510(k) Summary | |
|---|---|
| Trade Name: | Sapphire Detachable Fiber Coils |
| Generic Name: | Artificial Embolization Coil |
| Classification: | Class III, 21 CFR 882.5950 |
| Submitted By: | Micro Therapeutics, Inc. |
| 2 Goodyear | |
| Irvine, California 92618 | |
| Contact: | Florin Truuvert |
Predicate Device:
Micro Therapeutics, Inc.
| Number | Description | Predicate For | Clearance Date |
|---|---|---|---|
| K993418 | Fibered GDC VortX Shape | ||
| Guglielmi Detachable Coil | Sapphire Fibered Helix | ||
| and Cyclone | 1/21/2000 |
Device Description
The Sapphire Detachable Coil (SDC) is manufactured from a platinum alloy wire which is first wound into primary coil and then formed into a secondary helical shape. 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 (Sapphire Detachment System, SDS), which dissolves a small detachment element between the emboliozation coil and the positioning wire. The fibered coil is manufactured with nylon fibers secured into the primary coil. The fibered coils are available in two shapes (Helix and Cyclone) and different sizes.
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 intended uses of the Sapphire fiber coils are narrowed relative to the predicate device GDC, but still fall within the 510(k) cleared intended use.
Sapphire Detachable Fibered Coil - The Sapphire fibered coil is intended for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Fibered Sapphire is also intended for arterial and venous embolizations in the peripheral vasculature.
1
K031852/P2/3
Micro Therapeutics, Inc. Premarket Notification (510(k) for Sapphire Detachable Fibered Coil System
Verification and Test Summary Table
| Bench Testing | Sapphire Fibered Coils |
|---|---|
| Coil Strength (Coil Deformation and Softness Testing) | Meet established acceptance criteria |
| Ease of Delivery | Meet established acceptance criteria |
| Reliability After Fatigue & Premature Detachment | Meet established acceptance criteria |
| Tensile Strength of Coil & Detachment Zone | Meet established acceptance criteria |
| Tensile Strength of Delivery Wire | Meet established acceptance criteria |
| Delivery Wire Flexibility | Meet established acceptance criteria |
| Detachment Time | Meet established acceptance criteria |
| Radiopacity | Meet established acceptance criteria |
| Particulate Generation of Detachment Zone | Meet established acceptance criteria |
| Aging and Shelf Life (3 year) | Meet established acceptance criteria |
| Fiber Pull Out | Meet established acceptance criteria |
| Fiber Endurance | Meet established acceptance criteria |
| Packaging validation after 3-year accelerated aging | Meet established acceptance criteria |
| Animal Testing | Comparison to the Predicate Device |
| Coil Per Aneurysm (Avg./S.D.) | Comparable |
| Detachment Time (seconds) | Comparable |
| Coil Detachment Reliability (detachment attempts/coil) | The Sapphire demonstrated higher reliability |
| Post Embolization Angiographic Assessment | Comparable |
| Angiographic Assessment One-Month Follow-Up | Comparable |
| Angiographic Assessment Three-Month Follow-Up | Comparable |
| Physician Device Evaluation | Acceptance Criteria |
| Ease of Coil Preparation | Comparable |
| Ability to move coil within Catheter | Comparable |
| Access | Acceptance Criteria |
| Ability to Place catheter tip in desired location | Comparable |
| Trackability, Friction of coil through catheter | Comparable |
| Coil Visualization | Acceptance Criteria |
| Fluoroscopic visibility of Coil | Comparable |
| Fluoroscopic visibility of Detachment Markers | Comparable |
| Coil Delivery Procedure | Acceptance Criteria |
| Ability to Position Coil in Sac | Comparable |
| Detachment Time | Comparable |
| Ability to Pack Aneurysm Sac | Comparable |
| Ability to Reposition | Comparable |
| Ease of use of the SDS Detachment System | Comparable |
| Coil Positional Stability/Aneurysm Occlusion | Comparable |
| Overall | Acceptance Criteria |
| Ease of Use | Comparable |
| Overall performance | Comparable |
| MRI Compatibility | Compatible with 1.5 Tesla |
. •
2
K031852/P3/3
Micro Therapeutics, Inc. Premarket Notification (510(k) for Sapphire Detachable Fibered Coil System
Summary of Substantial Equivalence
The above comparison table demonstrates the technological similarity and equivalency of the Sapphire fibered coils compared with the predicate device, Target GDC fibered 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 similar materials and processes.
In summary, the Sapphire fibered coils described in this submission are, in our opinion, substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2003
Ms. Florin Truuvert Manager, Regulatory Affairs Micro Therapeutics, Inc. 2 Goodyear Irvine, California 92618
Re: K031852
Trade/Device Name: Sapphire Detachable Fibered Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: June 13, 2003 Received: June 24, 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.
4
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 N. Melson
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
5
0
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Sapphire Detachable Fibered Coil System
Indications for Use:
Sapphire Detachable Coils (Non-Fiber)
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 intended uses of the Sapphire fiber coils are narrowed relative to the predicate device GDC, but still fall within the 510(k) cleared intended use.
Sapphire Detachable Fibered Coil - The Sapphire fibered coil is intended for embolization of neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Fibered Sapphire is also intended for arterial and venous embolizations in the peripheral vasculature.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR (Per 21 CFR 801.109) | Over the Counter Use |
|---|---|---|
| ------------------ | ----------------------------------------------- | ---------------------- |
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K031852 |
|---|---|
| --------------- | --------- |