EMBA Hourglass Peripheral Embolization Device (PED)

K200083 · Embolic Acceleration, LLC · KRD · Feb 14, 2020 · Cardiovascular

Device Facts

• Record ID: K200083
• Device Name: EMBA Hourglass Peripheral Embolization Device (PED)
• Applicant: Embolic Acceleration, LLC
• Product Code: KRD · Cardiovascular
• Decision Date: Feb 14, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The EMBA Hourglass® Peripheral Embolization Device (PED) is a self-expanding, hourglass-shaped implantable device designed to obstruct or reduce blood flow in peripheral vasculature. It is preloaded into a catheter-based delivery system. The device is deployed under fluoroscopic guidance by a physician in a clinical setting. The device functions as a mechanical obstruction to blood flow. The primary modification from the predicate is a reduction in delivery system length from 120cm to 80cm. The device is provided sterile for single use. It benefits patients by providing a minimally invasive method for targeted vascular embolization.

Clinical Evidence

No new clinical data was provided. The manufacturer relied on bench, animal, and clinical testing performed for the predicate device, supported by an engineering assessment confirming that the modification to the delivery system length did not introduce new risks.

Technological Characteristics

Self-expanding, hourglass-shaped implantable device; catheter-based delivery system (80cm length). Materials and manufacturing processes are identical to the predicate device. Biocompatibility complies with ISO 10993-1. Sterile, single-use.

Indications for Use

Indicated for patients requiring blood flow obstruction or reduction in peripheral vasculature (6-8mm vessels). Contraindicated for vessels subject to repetitive motion (e.g., extremity or pulmonary vessels).

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• EMBA Hourglass™ Peripheral Embolization Device (K171845)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
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| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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<br>(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

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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.