(29 days)
Not Found
No
The description focuses on the physical characteristics of the coils and the detachment system, and the testing performed relates to mechanical properties, MR compatibility, and biocompatibility. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described as "intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities," indicating its therapeutic purpose.
No
The device is an embolization coil used for the treatment of vascular abnormalities, not for diagnosis.
No
The device description clearly details physical components made of platinum-tungsten alloy and stainless steel, and the testing described focuses on the physical properties and performance of these materials and the assembled device. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities through endovascular embolization. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a physical implant (coils) and a delivery system used to place the implant within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on samples taken from a patient. This device is used inside the body for treatment.
N/A
Intended Use / Indications for Use
Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Target Coils are indicated for endovascular embolization of: · Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- · Arterial and venous embolizations in the peripheral vasculature
Target Detachable Coils are indicated for the endovascular embolization of:
- . Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature .
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
Boston Scientific Corporation's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Boston Scientific's InZone™ Detachment System (sold separately).
Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.
Boston Scientific's InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
On September 15, 2010 Boston Scientific submitted a Special 510(k) for modification of the grade of stainless-steel for two components of the finished device: 1) the stainless-steel wire sub-assembly and 2) the etched link component.
The stainless-steel wire sub-assembly is a component of the delivery wire to which the main coil is attached. During assembly, the wire is placed coaxially through the lumen of a coil-hypotube assembly. The etched link component joins the delivery wire to the main coil.
The modification was made to minimize magnetic resonance imaging (MRI) artifact during follow-up MRI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, neurovascular, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Verification testing of the modified Target Detachable Coil consisted of the following:
-
Functional testing to assess:
Main Junction Tensile Strength
Delivery Wire Tensile Strength
Coil Detachment Time -
MR Compatibility testing to assess:
Magnetically induced displacement (ASTM F2052)
Magnetically induced torque (ASTM 2213)
Magnetically induced heating effect (in 1.5 T and 3 T MR systems - ASTM F2182)
MR induced image artifact (ASTM F2119)
As a result of MR compatibility testing, the Directions for Use (DFU) for the Target Detachable Coil has been revised to include a more comprehensive MR Conditional statement describing the conditions under which the device was tested
-
Pre-clinical testing to provide post-implant MR artifact data and to assess and compare the modified Target Detachable Coil to control coils in coiled aneurysm models.
-
Confirmatory biocompatibility testing as follows:
MEM Elution Cytotoxicity
Hemolysis, Direct Contact
USP Physico-Chemical -
Assessment of the new grade stainless-steel by Boston Scientific's Coporate Toxicology group.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K002181, K021494, K031049, K042539, K050700, K093142
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 1 5 2010
510(k) Summary Of Safety And Effectiveness Summary Date October 7, 2010 Submitter Name and Boston Scientific Corporation Address 47900 Bayside Parkway Fremont, CA. 94538 Contact Person: Jim Leathley Regulatory Affairs Project Manager Phone: 510 440 7836 Fax: 510 440 7752 Email: leathlej@bsci.com Trade Name: Target® Detachable Coils Common Name: Occlusion Coil, Vascular Occlusion Coil, Neurovascular Occlusion Coil Classification Name: Target Detachable Coils are Class II devices (special controls) classed as neurovascular embolization devices under 21 CFR 882.5950 (HCG) and vascular embolization devices under 21 CFR 870.3300 (KRD). The special control for the devices is FDA's guidance document, Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices (issued 29 Dec 2004).
,
Page 1 of 4
1
Legally Marketed
| Predicate Devices: | |
|---|---|
| -------------------- | -- |
| Reference (Clearance Date) | Device |
|---|---|
| K002181 (11 Aug 2000) | GDC 10-UltraSoft® Coils |
| (introduction of UltraSoft coils) | |
| K021494 (6 June 2002) | GDC Power Supply and Detachable |
| Coil Connecting Cables | |
| K031049 (3 June 2003) | Clearance of ISAT indication for all |
| GDC devices | |
| K042539 (19 Oct 2004) | GDC 360 Detachable Coils |
| (introduction of 360 shape coils) | |
| K050700 (15 April 2005) | Matrix2® Detachable Coils |
| K093142 (4 Feb 2010) | Target Detachable Coil and InZone® |
| Detachment System |
Device Description:
Boston Scientific Corporation's Target Detachable Coils are comprised of four coil types: Target Coil 360 STANDARD, Target Coil 360 SOFT, Target Coil 360 ULTRA and Target Coil HELICAL ULTRA. All Target Coils are stretch resistant coils. Target Coils incorporate a length of multi-strand material through the center of the coil designed to help resist stretching. Target Coils are designed for use with Boston Scientific's InZone™ Detachment System (sold separately).
Each Target Coil type consists of a platinum-tungsten alloy coil attached to a stainless steel delivery wire. For Target Coil 360 STANDARD, Target Coil 360 SOFT and Target Coil 360 ULTRA coils the distal end of the main coil is formed such that there is a smaller distal loop at the end of the main coil to facilitate placement of the coil. The diameter of the distal loop is 75% that of the rest of the main coil loops.
Boston Scientific's InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
On September 15, 2010 Boston Scientific submitted a Special 510(k) for modification of the grade of stainless-steel for two components of the finished device: 1) the stainless-steel wire sub-assembly and 2) the etched link component.
2
510(k) Summary Of Safety And Effectiveness (cont.)
.
·
に
ﻳ
・
| Device Description:
(cont.) | The stainless-steel wire sub-assembly is a component of the
delivery wire to which the main coil is attached. During
assembly, the wire is placed coaxially through the lumen of a
coil-hypotube assembly. The etched link component joins the
delivery wire to the main coil.
The modification was made to minimize magnetic resonance
imaging (MRI) artifact during follow-up MRI. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Verification Testing: | Verification testing of the modified Target Detachable Coil
consisted of the following:
- Functional testing to assess:
Main Junction Tensile Strength
Delivery Wire Tensile Strength
Coil Detachment Time
- MR Compatibility testing to assess:
Magnetically induced displacement (ASTM F2052)
Magnetically induced torque (ASTM 2213)
Magnetically induced heating effect (in 1.5 T and 3 T MR
systems - ASTM F2182)
MR induced image artifact (ASTM F2119)
As a result of MR compatibility testing, the Directions for
Use (DFU) for the Target Detachable Coil has been revised
to include a more comprehensive MR Conditional statement
describing the conditions under which the device was tested
-
Pre-clinical testing to provide post-implant MR artifact data
and to assess and compare the modified Target Detachable Coil
to control coils in coiled aneurysm models. -
Confirmatory biocompatibility testing as follows:
MEM Elution Cytotoxicity
Hemolysis, Direct Contact
USP Physico-Chemical
- Assessment of the new grade stainless-steel by Boston
Scientific's Coporate Toxicology group. |
3
510(k) Summary Of Safety And Effectiveness (cont.)
Accessories:
Target Detachable Coils are packaged within a flushing dispenser coil assembly. The dispenser coil is an accessory item with an attached flushport used to hydrate the coil prior to use.
Indications for Use / Intended Use:
Target Detachable Coils are intended for use in the treatment of intracranial aneurysms and other neuro and peripheral vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Target Coils are indicated for endovascular embolization of: · Intracranial aneurysms
- · Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- · Arterial and venous embolizations in the peripheral vasculature
Comparison to Predicate Device:
Target Detachable Coils
Boston Scientific Corporation's modified Target Detachable Coils have the same intended use/indications for use as the predicate Target Detachable Coils.
Although the coils incorporate modifications to materials and instructions for use, the modifications do not alter the fundamental scientific technology of the predicate devices.
Risk assessment of the modifications in the form of design and use failure modes and effects analysis (design and use FMEAs) has been conducted in accordance with EN ISO 14971 +A1:2003. Boston Scientific has determined the modifications to the predicate devices raise no new questions of safety or effectiveness.
Verification testing has demonstrated the modified Target Detachable Coils are substantially equivalent to the predicate Target Detachable Coils.
Because the subject modifications do not alter the intended use or indications for use of the predicate devices, or the fundamental scientific technology of the predicate devices; and because risk assessment of the modifications and successful verification testing raise no new questions of safety and effectivenss, Boston Scientific has determined the modified Target Detachable Coils to be substantially equivalent to the predicate devices.
Conclusion:
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Neurovascular c/o Mr. Jim Leathley Regulatory Affairs Project Manager 47900 Bayside Parkway Fremont, CA 94538-6515
Re: K102672
OCT 1 5 2010
Trade/Device Name: Target Detachable Coils Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: Class II Product Code: HCG, KRD Dated: September 15, 2010 Received: September 16, 2010
Dear Mr. Leathley
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2 - Mr. Jim Leathley
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Celin m.k
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
QCT 1 5 2010
510(k) Number (if known): K102672
Device Name: Target Detachable Coils
Indications For Use:
Target Detachable Coils are indicated for the endovascular embolization of:
- . Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature .
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 LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q. Hoang
Page 1 of 1 - 1
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102672
510(k) Number