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 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.

AI/ML Overview

This FDA 510(k) summary (K200083) indicates that the device, EMBA Hourglass® Peripheral Embolization Device (PED), is substantially equivalent to a predicate device (K171845). The submission explicitly states that "no additional testing is required" for the current device because it is considered substantially equivalent to its predicate.

Therefore, based on the provided document, there are no specific acceptance criteria or details of a study performed specifically for this device (K200083). Instead, the justification for substantial equivalence relies on the testing of the predicate device.

However, I can extract the information regarding the comparison between the subject device and the predicate device, and the general statement about performance testing.

Here's a breakdown of the requested information, where applicable:

1. A table of acceptance criteria and the reported device performance:

Since the document states that "no additional testing is required" for the subject device (K200083), there are no new acceptance criteria or reported performance unique to this submission. The substantial equivalence is based on the predicate device's performance.

Acceptance Criteria (for Predicate Device)	Reported Device Performance (for Predicate Device)
Not explicitly stated in this document (refers to predicate's testing)	Not explicitly stated for the subject device (relies on predicate's performance)
Implied Acceptance (for K200083 based on K171845)
Device functions as intended to obstruct or reduce blood flow in 6-8mm peripheral vessels.	Maintains functionality for obstructing/reducing blood flow in 6-8mm peripheral vessels.
Material and manufacturing process consistency with predicate.	Same materials and manufacturing processes as predicate.
Biocompatibility	Passed biocompatibility testing (of predicate device per ISO 10993-1).

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No new test set for K200083. The document states that "bench, animal, and clinical testing performed for the predicate device are adequate."
Data Provenance: Not applicable for K200083. The origin of data for the predicate device's testing is not mentioned in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new test set and no ground truth establishment for K200083.

4. Adjudication method for the test set:

Not applicable. No new test set for K200083.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical embolization device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical embolization device, not an algorithm.

7. The type of ground truth used:

Not applicable for K200083. The "ground truth" for the predicate device's performance would likely have involved direct observation of embolization effectiveness in animal models, and clinical outcomes if clinical studies were part of its submission.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/machine learning device.

Key takeaway from the document:

The regulatory strategy for K200083 is based on substantial equivalence to a predicate device (K171845). The primary difference noted is the Delivery System length (80cm vs. 120cm). All other design and material characteristics, as well as manufacturing processes, are stated to be identical. Due to these similarities and a risk analysis concluding no new or modified risks, the prior performance testing (bench, animal, clinical) and biocompatibility testing of the predicate device are deemed sufficient for this new submission.

Summary

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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)

Type of Use (Select one or both, as applicable)
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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

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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

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.

Regulation Number and Section

§ 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).