(176 days)
No
The summary describes a mechanical device for embolization and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is intended to obstruct or reduce blood flow in the peripheral vasculature, which is a therapeutic intervention.
No
The device is described as an embolic coil system intended to obstruct or reduce blood flow, indicating a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components like a delivery wire, introducer sheath, and implantable coil, indicating it is a hardware-based medical device.
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 in vivo (within the body) to treat a medical condition.
- Device Description: The device is a physical implantable coil system used to block blood vessels.
- 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 in vitro (outside the body) on biological samples. This device is used in vivo to physically alter blood flow.
N/A
Intended Use / Indications for Use
The EMBOLD™ Fibered Detachable Coil system is intended to obstruct or reduce rate of blood flow in the peripheral vasculature.
This device is not intended for coronary or neurovascular use.
Product codes
KRD
Device Description
The EMBOLD™ Fibered Detachable Coil System consists of a delivery wire, removable introducer sheath, and permanent implantable fibered embolic coil. The device is compatible with 0.021 inch to 0.027 inch microcatheters. In addition, the device features a modified mechanical detachment mechanism consisting of an inner pull wire connecting the coil and delivery wire coupler arms, activated by the user through a proximal laser etched outer wire perforation. The delivery wire design allows the coil to be fully advanced, retracted, and deployed prior to final placement.
The EMBOLD™ Fibered Detachable Coil System is provided sterile, using 100% ethylene oxide (EO) gas sterilization, and is intended for hospital and single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital
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)
A full suite of biocompatibility testing, bench testing, and an acute GLP animal study were performed to support a determination of substantial equivalence between the EMBOLD™ Fibered Detachable Coil System and the predicate Interlock™ Fibered IDC™ Occlusion System (K132578). The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or effectiveness issues were raised during the device testing.
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
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2022
Boston Scientific Corporation Heidi Shearer Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311
Re: K213398
Trade/Device Name: EMBOLD Fibered Detachable Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: March 11, 2022 Received: March 14, 2022
Dear Heidi Shearer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Finn Donaldson Assistant Director (Acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213398
Device Name EMBOLD™ Fibered Detachable Coil System
Indications for Use (Describe)
The EMBOLD™ Fibered Detachable Coil system is intended to obstruct or reduce rate of blood flow in the peripheral vasculature.
This device is not intended for coronary or neurovascular use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
510(K) Summary Complying with 21 CFR 807.92
I. SUBMITTER INFORMATION
Submitter Name: Boston Scientific Corporation
Submitter Address:
One Scimed Place Maple Grove, MN 55311-1566 USA
Telephone: 763-255-0056 Fax: 763-494-2222 e-mail: Heidi.Shearer@bsci.com
Contact person name: Heidi Shearer Date Prepared: April 12, 2022
II. DEVICE INFORMATION
Proprietary Name: EMBOLD™ Fibered Detachable Coil System Tables 1 and 2 below summarize the relevant subject device information.
Table 1: EMBOLD™ Fibered Detachable Coil System UPNs
| Universal Product Numbers
(UPNs) | Coil Secondary
Wind OD (mm) | Coil Length
(cm) |
|-------------------------------------|--------------------------------|---------------------|
| M001394240020040 | 2 | 4 |
| M001394240020060 | 2 | 6 |
| M001394240030060 | 3 | 6 |
| M001394240030120 | 3 | 12 |
| M001394240040080 | 4 | 8 |
| M001394240040150 | 4 | 15 |
| M001394240050080 | 5 | 8 |
| M001394240050150 | 5 | 15 |
| M001394240060100 | 6 | 10 |
| M001394240060200 | 6 | 20 |
| M001394240080200 | 8 | 20 |
| M001394240100200 | 10 | 20 |
| M001394240100300 | 10 | 30 |
| M001394240100500 | 10 | 50 |
| M001394240120200 | 12 | 20 |
| M001394240120300 | 12 | 30 |
| M001394240120500 | 12 | 50 |
| M001394240140200 | 14 | 20 |
| M001394240140300 | 14 | 30 |
| M001394240140500 | 14 | 50 |
| M001394240180500 | 18 | 50 |
| M001394240200500 | 20 | 50 |
| M001394240220600 | 22 | 60 |
| M001394240320600 | 32 | 60 |
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Table 2: Additional Device Information
| Common or
Usual name | Regulatory
Number | Regulatory
Name | Product Code | Product Code
Name | Regulatory
Class |
|------------------------------------|-------------------------|------------------------------------|--------------|-------------------------------------------------------|---------------------|
| Vascular
embolic coil
system | 21 CFR Part
870.3300 | Vascular
Embolization
Device | KRD | Device,
Vascular, For
Promoting
Embolization | II |
III. PREDICATE DEVICE IDENTIFICATION
Name of Predicate Device
Interlock™ Fibered IDC™ Occlusion System (K132578, Cleared September 13, 2013) Predicate device referenced above has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The EMBOLD™ Fibered Detachable Coil System consists of a delivery wire, removable introducer sheath, and permanent implantable fibered embolic coil. The device is compatible with 0.021 inch to 0.027 inch microcatheters. In addition, the device features a modified mechanical detachment mechanism consisting of an inner pull wire connecting the coil and delivery wire coupler arms, activated by the user through a proximal laser etched outer wire perforation. The delivery wire design allows the coil to be fully advanced, retracted, and deployed prior to final placement.
The EMBOLD™ Fibered Detachable Coil System is provided sterile, using 100% ethylene oxide (EO) gas sterilization, and is intended for hospital and single use only.
Table 3 below provides information on the differences between the EMBOLD™ Fibered Detachable Coil System models, in relation to specific features such as coil secondary OD, length, and shape. The delivery wire and introducer sheath utilize the same design throughout the product matrix.
| Coil Secondary Wind OD (mm) | Coil Length (cm) | Coil Shape |
|---|---|---|
| 2 | 4 | Helical |
| 2 | 6 | |
| 3 | 6 | 2-Diameter (2D) |
| 3 | 12 | |
| 4 | 8 | |
| 4 | 15 | |
| 5 | 8 | |
| 5 | 15 | |
| 6 | 10 | |
| 6 | 20 | |
| 8 | 20 | |
| 10 | 20 | |
| 10 | 30 | |
| 10 | 50 | |
| 12 | 20 | |
| 12 | 30 | |
| 12 | 50 | |
| 14 | 20 | |
| 14 | 30 | |
| 14 | 50 | |
| 18 | 50 | |
| 20 | 50 |
Table 3: EMBOLD™ Fibered Detachable Coil System Device Features
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| Coil Secondary Wind OD (mm) | Coil Length (cm) | Coil Shape |
|---|---|---|
| 22 | 60 | |
| 32 | 60 |
V. INTENDED USE AND INDICATION FOR USE
Predicate and subject device intended use/indication for use is the same.
EMBOLD™ Fibered Detachable Coil System Intended Use / Indication for Use
The EMBOLD™ Fibered Detachable Coil system is intended to obstruct or reduce rate of blood flow in the peripheral vasculature.
This device is not intended for coronary or neurovascular use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The EMBOLD™ Fibered Detachable Coil System has similar technological characteristics to the predicate device as shown in the table below.
| Characteristic | Subject Device
EMBOLD™ Fibered
Detachable Coil System | Predicate Device
Interlock™ Fibered IDC ™
Occlusion System
(K132578) | Comparison |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Coil Primary
Wind OD
(inches) | 0.015 | 0.012 | SIMILAR
Minimal dimensional
differences support
additional microcatheter |
| Microcatheter
Compatibility
(inches) | 0.021 (0.53mm) to 0.027
(0.6mm) | 0.0021 (0.53mm) | compatibility. |
| Coil Lengths
(cm) | 4-60 | 4-60 | SAME |
| Secondary
Coil OD (mm) | 2-32 | 2-22 | SIMILAR
Additional OD treats
same anatomy as
predicate. |
| Coil Shapes | 2mm: Helical
3-32mm: 2D | 2-22mm: 2D | SIMILAR
Helical loops same as
2D, with no smaller
loops. |
| Delivery Wire
Length | 177cm effective length | 175cm effective length | SIMILAR
Subject device delivered
through same standard
microcatheter lengths as
predicate. |
| Coil
Detachment
Mechanism | Mechanical, user activated,
interlocking coupler arms
detach when outside of
microcatheter and when user
manually retracts inner pull
wire from coupler arms | Mechanical, user activated,
interlocking coupler arms
detach when pushed out of
microcatheter | SIMILAR
Same mechanical
detachment with coupler
arm separation, with
additional feature. |
| Introducer
Sheath | 1 length
Reinforced tapered tip
Separate lock component | 2 lengths
Tapered tip
Integrated lock | SIMILAR
Same function as
predicate with
modifications to align
with EMBOLD Fibered |
6
| Characteristic | Subject Device
EMBOLDTM Fibered
Detachable Coil System | Predicate Device
InterlockTM Fibered IDCTM
Occlusion System
(K132578) | Comparison |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MRI
Compatibility | MR Conditional | MR Conditional | SAME |
| Sterilization
Method | EO | EO | SAME |
| SAL | 10-6 | 10-6 | SAME |
| Coil Materials | Platinum /Tungsten alloy coil
Metal alloy coil coupler arm
Synthetic fibers | Platinum /Tungsten alloy coil
Metal alloy coil coupler arm
Synthetic fibers | SAME |
| Delivery Wire
Materials | Metal and polymer materials
Metal alloy delivery wire
coupler arm | Metal and polymer materials
Metal alloy delivery wire
coupler arm | SIMILAR
Basic delivery function is
the same as the
predicate with material
differences to facilitate
detachment and
microcatheter
compatibility. |
| Packaging
Materials and
Configuration | Package holds one EMBOLD
Fibered device. No RHV is
included. Sterile package
contained in shelf carton.
An eIFU exists for the
EMBOLD Fibered product.
No physical IFU included
with package. | Package holds one Interlock
Fibered IDC device. RHV is
included inside sterile
barrier. Sterile package and
paper IFU contained in shelf
carton. | SIMILAR
The RHV is no longer
provided with the device
as available through
ancillary devices or
hospital. The IFU is
available outside the
package configuration. |
VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
A full suite of biocompatibility testing, bench testing, and an acute GLP animal study were performed to support a determination of substantial equivalence between the EMBOLD™ Fibered Detachable Coil System and the predicate Interlock™ Fibered IDC™ Occlusion System (K132578). The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or effectiveness issues were raised during the device testing.
VIII. CONCLUSION
Based on the intended use, technological characteristics, and the safety and performance data provided, the EMBOLD™ Fibered Detachable Coil System is considered appropriate for the intended use and substantially equivalent to the predicate device technological and material differences do not raise new questions of safety or effectiveness, and the subject devices are substantially equivalent to the predicate Interlock™ Fibered IDC™ Occlusion System (K132578).