(105 days)
No
The device description and performance studies focus on the mechanical aspects and material properties of the coil system, with no mention of AI or ML.
Yes
The device is intended to obstruct or reduce blood flow in the peripheral vasculature, directly treating a physiological condition.
No
The device is an embolic coil system designed to obstruct or reduce blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details physical components like a delivery wire, introducer sheath, and implantable coil, indicating it is a hardware-based medical device.
No, 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 implantable coil delivered into the blood vessels.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This device is clearly designed for a therapeutic procedure within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The EMBOLD Soft Detachable Coil System and EMBOLD Packing 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 (comma separated list FDA assigned to the subject device)
KRD
Device Description
The EMBOLD Soft Detachable Coil System and EMBOLD Packing Detachable Coil System consists of a delivery wire, removable introducer sheath, and permanent implantable non-fibered embolic coil. The EMBOLD Soft coil can be delivered to challenging peripheral anatomy, and the EMBOLD Packing coil is highly conformable to enable dense packing. The device is compatible with 0.027-inch microcatheters. In addition, the device features a 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 Soft and EMBOLD Packing 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)
The EMBOLD Soft Detachable Coil system and EMBOLD Packing Detachable Coil System were subjected to testing according to the requirements of Guidance for Industry and FDA Staff-Class II Special Controls Document: Vascular and Neurovascular Embolization Devices (December 29, 2004). Bench, animal and biocompatibility testing in accordance with ISO 10993 were performed to support a determination of substantial equivalence. 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 performance issues were raised during the testing; this device is substantially equivalent to the predicate device.
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.
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.
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
§ 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).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue letters.
July 6, 2023
Boston Scientific Corporation Laure Judge Regulatory Affairs Specialist 300 Boston Scientific Way Marlborough Boston, Massachusetts 01752
Re: K230706
Trade/Device Name: EMBOLD Soft Detachable Coil System and EMBOLD Packing Detachable Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD
Dear Laura Judge:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 27, 2023. Specifically, FDA is updating this SE Letter due to a typo in the trade name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Misti Malone, OHT2: Office of Cardiovascular Devices, 301-796-2520, Misti.Malone@fda.hhs.gov.
Sincerely,
Misti L. Malone -S
Misti Malone, PhD Assistant Director 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
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Image /page/1/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.
June 27, 2023
Boston Scientific Corporation Laura Judge Regulatory Affairs Specialist 300 Boston Scientific Wav Marlborough Boston, Massachusetts 01752
Re: K230706
Trade/Device Name: EMBOLD™ Soft Detachable Coil System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: May 26, 2023 Received: May 26, 2023
Dear Laura Judge:
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
2
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 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Misti E. Malone -S
Misti Malone, PhD Assistant Director 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
3
Indications for Use
510(k) Number (if known) K230706
Device Name
EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System
Indications for Use (Describe)
The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing 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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510(k) Summary
l. SUBMITTER INFORMATION
Submitter Name: Boston Scientific Corporation
Submitter Address: 300 Boston Scientific Way Marlborough, Boston, MA 01752, USA
Telephone: 353 (86) 177 7184 Email: Laura.Judge@bsci.com
Contact person name: Laura Judge Date Prepared: March 14, 2023
= DEVICE INFORMATION
Device Name: The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System.
| 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
EMBOLD™ Fibered Detachable Coil System (K213398, Cleared April 12, 2022) Predicate device referenced above has not been subject to a design-related recall.
Reference Devices:
- IDC™ Interlocking Detachable Coil (K141378, Cleared 08 October 2014)
- Interlock™ -35 Fibered IDC Occlusion System (K133208, Cleared 14 November 2013
- Penumbra's Occlusion Device (POD®) Packing Coil (K170852, Cleared 19 July 2017).
Reference devices listed above have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System consists of a delivery wire, removable introducer sheath, and permanent implantable non-fibered embolic coil. The EMBOLD™ Soft coil can be delivered to challenging peripheral anatomy, and the EMBOLD™ Packing coil is highly conformable to enable dense packing. The device is compatible with 0.027-inch microcatheters. In addition, the device features a 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.
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The EMBOLD™ Soft and EMBOLD™ Packing Detachable Coil System is provided sterile, using 100% ethylene oxide (EO) gas sterilization, and is intended for hospital and single use only.
V. INDICATIONS FOR USE
The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing 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.
Predicate and subject devices intended uses are the same.
| Subject Device | Subject Device | Predicate Device |
|---|---|---|
| EMBOLD™ SOFT Detachable | EMBOLD™ PACKING Detachable | EMBOLD™ FIBERED Detachable Coil |
| Coil System Intended Use and | Coil Intended Use and Indications | Intended Use and Indications for Use |
| Indications for Use | for Use | |
| Intended Use/Indications for Use | ||
| The EMBOLD Soft Detachable Coil | ||
| System is indicated to obstruct or | ||
| reduce rate of blood flow in the | ||
| peripheral vasculature. This device is | ||
| not intended for coronary or | ||
| neurovascular use. | Intended Use/Indications for Use | |
| The EMBOLD Packing Detachable Coil | ||
| System is indicated to obstruct or reduce | ||
| rate of blood flow in the peripheral | ||
| vasculature. This device is not intended for | ||
| coronary or neurovascular use. | Intended Use/Indications 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 WITH THE PREDICATE DEVICE
The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System incorporate substantially equivalent device materials and design, materials and design, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device, EMBOLD™ Fibered Detachable Coil system, K213398.
Similar to the predicate Embold™ Fibered Detachable Coil System, the subject device consists of a delivery wire with an implantable platinum/tungsten coil attached at the distal end with platinum/iridium alloy coupler arms contained within an introducer sheath which also allow smooth delivery of the coil system through 0.021 inch to 0.027-inch microcatheters. EMBOLD Soft and EMBOLD Packing have the same mechanical, user-activated, detachment mechanism as the predicate device. The subject device features a non-fibered, coil implant with a stretch-resistant feature.
The following technological differences exist between the subject and predicate devices:
- Packing Coil Shape
- . Non-Fibered Coil
Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The results of bench testing provide reasonable assurance of substantial equivalence of the EMBOLD Soft Detachable Coil System and EMBOLD Packing Detachable Coil System with the predicate device (K213398).
VII. PERFORMANCE DATA
The EMBOLD™ Soft Detachable Coil system and EMBOLD™ Packing Detachable Coil System were subjected
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K230706 Page 3 of 3
to testing according to the requirements of Guidance for Industry and FDA Staff-Class II Special Controls Document: Vascular and Neurovascular Embolization Devices (December 29, 2004). Bench, animal and biocompatibility testing in accordance with ISO 10993 were performed to support a determination of substantial equivalence. 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 performance issues were raised during the testing; this device is substantially equivalent to the predicate device.
VIII. CONCLUSIONS
Based on the intended use, technological characteristics, and the safety and performance data provided, the Embold™ Soft Detachable Coil System and Embold™ Packing Detachable Coil System is considered appropriate for the intended use and substantially equivalent to the predicate device's technological and material differences do not raise new questions of safety or effectiveness, and the subject devices are as safe and effective as the predicate Embold ™ Fibered Detachable Coil System (K213398).