(30 days)
No
The summary describes a mechanical embolization device and its delivery system. There is no mention of AI/ML in the intended use, device description, or performance studies. The input imaging modality (fluoroscopy) is used for guidance, not for AI/ML analysis.
Yes
The device is described as an "Embolic Device" intended to "obstruct or reduce the rate of blood flow in the peripheral vasculature," which directly addresses a physiological condition. Therapeutic devices are used for treatment or mitigation of disease.
No
This device is an embolization device used to obstruct blood flow, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of a physical, implantable structure (Embolic Device) and a catheter-based Delivery System, which are hardware components.
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 blood flow in the peripheral vasculature. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is an implantable structure delivered via a catheter. This is a medical device used for treatment, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The EMBA Hourglass® Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.
Product codes
KRD
Device Description
The Hourglass® Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding hourglass-shaped structure (Embolic Device) preloaded in a catheter-based Delivery System. The Embolic Device is intended to be deployed to the target site in the vasculature under fluoroscopic guidance. The product is shipped sterile and labeled for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic guidance
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
A risk analysis of the device modifications was completed. An engineering assessment concluded that no new risks or modified existing risks were introduced. Therefore, the bench, animal, and clinical testing performed for the predicate device are adequate for evaluating the performance of the subject device. In addition, the subject device is manufactured using the same materials and manufacturing processes as the predicate device, so biocompatibility testing in accordance with ISO 10993-1 performed for and passed by the predicate device applies to the subject device. No additional testing is required to demonstrate biocompatibility of the subject device.
Key Metrics
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).
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February 14, 2020
Embolic Acceleration, LLC (EMBA) Veronica McDougall Quality Director 3451 Commerce Pkwy Miramar, Florida 33025
Re: K200083
Trade/Device Name: EMBA Hourglass® Peripheral Embolization Device (PED) Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: January 10, 2020 Received: January 15, 2020
Dear Veronica McDougall:
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
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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 mediation-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.
for
Misti Malone 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
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Indications for Use
510(k) Number (if known) K200083
Device Name
EMBA Hourglass® Peripheral Embolization Device (PED)
Indications for Use (Describe)
The EMBA Hourglass® Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.
| 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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EMBA Hourglass® Peripheral Embolization Device 510(k) Summary 21 CFR 807.92
In accordance with 21 CFR 807.92, a 510(k) Summary upon which substantial equivalence determination is based shall include the following:
Submitter Information
| Applicant: | Embolic Acceleration, LLC (EMBA) |
|---|---|
| 3451 Commerce Parkway | |
| Miramar, FL 33025 | |
| Phone: | 954-874-1016 |
| Contact: | Veronica McDougall, Quality Director |
| Date Prepared: | January 10, 2020 |
Subject Device Information
| Trade Name: | EMBA Hourglass® Peripheral Embolization Device |
|---|---|
| Common Name: | Vascular device for promoting embolization |
| Classification Name: | Vascular embolization device |
| Predicate Device: | EMBA Hourglass™ Peripheral Embolization Device |
| (K171845) | |
| 510(k) Number: | K200083 |
| Product Code: | KRD |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 870.3300 |
| Regulatory Panel: | Cardiovascular |
Device Description
The Hourglass® Peripheral Embolization Device (PED) consists of a covered, implantable, self-expanding hourglass-shaped structure (Embolic Device) preloaded in a catheter-based Delivery System. The Embolic Device is intended to be deployed to the
4
target site in the vasculature under fluoroscopic guidance. The product is shipped sterile and labeled for single use only.
Indications for Use
The EMBA Hourglass® Peripheral Embolization Device (PED) is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature in 6-8mm blood vessels. The device is not indicated for use in blood vessels subject to repetitive motion, such as extremity or pulmonary vessels.
Comparison of Technological Characteristics to Predicate Device
The fundamental technological characteristics of the subject device are identical to those of the predicate device with the exception of the Delivery System. The Delivery System length of the subject device is 80cm, while the Delivery System length of the predicate device is 120cm. All other design and material characteristics are identical.
Performance Testing
A risk analysis of the device modifications was completed. An engineering assessment concluded that no new risks or modified existing risks were introduced. Therefore, the bench, animal, and clinical testing performed for the predicate device are adequate for evaluating the performance of the subject device. In addition, the subject device is manufactured using the same materials and manufacturing processes as the predicate device, so biocompatibility testing in accordance with ISO 10993-1 performed for and passed by the predicate device applies to the subject device. No additional testing is required to demonstrate biocompatibility of the subject device.
Conclusions
Review of the subject device's indications for use and technological characteristics in comparison to those of the predicate device show that the subject device, the EMBA Hourglass® Peripheral Embolization Device, is substantially equivalent to the predicate device.