(61 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the coil and delivery system, with no mention of AI or ML algorithms for image analysis, decision support, or any other function.
Yes
The device is intended to obstruct or reduce the rate of blood flow in the peripheral vasculature, which implies a therapeutic intervention to treat a medical condition.
No
Explanation: The device is indicated to obstruct or reduce blood flow, which is a therapeutic intervention, not a diagnostic use.
No
The device description clearly states it is manufactured from platinum and comes attached to a pusher, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obstruct or reduce rate of blood flow in the peripheral vasculature." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical implant (platinum coil) delivered into blood vessels.
- Input Imaging Modality: Fluoroscopy is used for guidance during the procedure, not for analyzing biological samples.
- Anatomical Site: The device is used within the peripheral vasculature of the patient.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The IDC System is indicted to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
Product codes
74KRD,KRD
Device Description
The Boston Scientific IDC System is manufactured from platinum and comes attached to an Interlocking Coil Pusher. It is designed to be delivered under fluoroscopy using a .018" compatible microcatheter with two radiopaque tip makers. The interlocking design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in precise, controlled delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
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
Functional and integrity bench testing and Biocompatibility testing to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evalution and Testing" were performed, and the data supported the substantial equivalence of the IDC System to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K911779, K914786, K891688, K901721
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(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 § 870.1(e).
0
APR 1 3 2004
Image /page/0/Picture/1 description: The image contains the text 'K040342'. The text appears to be handwritten with thick, dark strokes. The characters are a mix of uppercase letters and numbers, with the 'K' being the only letter and the rest being numerical digits.
Interlocking Detacha 510(k) PreMarket Notification-Traditional February 5, 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to § 513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "… adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation has chosen to submit a summary of information respecting safety and effectiveness. According to 6 513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "
The summary regarding the adverse health effects of the proposed IDC System is as follows:
| Common Name | Arterial Embolization Device |
|---|---|
| Trade Name | Interlocking Detachable Coil System (IDC) |
| Device Classification Name | Arterial Embolization Device |
| Product Code - 74KRD | |
| Regulation Number - 870.3300 | |
| Device Classification | Class III |
| Device Panel | Cardiovascular |
| Performance Standards | No formal performance standards have been established by the Food and Drug Administration for this device. |
Predicate Devices
The predicate devices are listed in the table below.
| Table 3 | ||
|---|---|---|
| Device | Company | 510(k) Number/ |
| Concurrence Date | ||
| Coil Pusher | K911779 | |
| Boston Scientific Target | K914786 | |
| Coil Pusher - 16 | K891688 | |
| Boston Scientific Target | ||
| GDC Coil | ||
| Boston Scientific Target | ||
| Occlusion Coils | K914786 | |
| Boston Scientific Target | K901721 | |
| K911779 | ||
| K891688 |
All of the devices mentioned above have been determined substantially equivalent by FDA
Device Description The Boston Scientific IDC System is manufactured from platinum and comes attached to an Interlocking Coil Pusher. It is designed to be delivered under fluoroscopy using a .018" compatible microcatheter with two radiopaque tip makers. The interlocking design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in precise, controlled delivery.
1
Safety and Performance:
Functional and integrity bench testing and Biocompatibility testing to the FDA guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evalution and Testing" were performed, and the data supported the substantial equivalence of the IDC System to the predicate devices.
Conclusion:
Based on the Indictions for Use, technical characteristics testing the IDC System has been show to be substantially equivalent to the predicate device.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2004
Boston Scientific Corporation c/o Mr. Arthur Friedman Vice President, Regulatory Affiars One Boston Scientific Place Natick, MA 01760
K040342 Re:
Interlocking Detachable Coil System (IDC System) Regulation Number: 21 CFR 870.3300 Regulation Name: Embolization Arterial Device Regulatory Class: III (three) Product Code: KRD Dated: February 5, 2004 Received: February 12, 2004
Dear Mr. Friedman:
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.
3
Page 2 - Mr. Arthur Friedman
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. 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) 594-4648. 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,
Duna R. bohner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Interlocking Detachabe Coil 510(k) Premarket Notification - Traditional February 5, 2004
Indications for Use
510(k) Number (if known):
Interlocking Detachable Coil System (IDC System) Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The IDC System is indicted to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.
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)
Dung R. b. line
Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K040342
Confidential Boston Scientific Corporation