EmboCube Embolization Gelatin by Biosphere Medical, S.A.

EmboCube Embolization Gelatin is a hydrophilic, medical device which consists of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. The device is available in 2 cube sizes and 3 weight configurations. Once rehydrated, the deformable cubes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

AI/ML Overview

The provided text is a 510(k) summary for the EmboCube Embolization Gelatin and does not contain information about the acceptance criteria and study proving a device meets these criteria for an AI/ML-based medical device.

This document is for a physical medical device, an embolization gelatin, and details its substantial equivalence to a predicate device. Therefore, it discusses performance attributes relevant to a physical medical implant (e.g., macroscopic appearance, digestibility, size range, density, moisture content, sterility, pyrogenicity, shelf-life, deliverability) and includes details about an animal study to evaluate its performance (immediate control of bleeding, complications, re-bleeding rate).

The request, however, asks for information typically associated with the validation of an AI/ML medical device, such as:

Acceptance criteria and reported device performance (in an AI/ML context, this would involve metrics like sensitivity, specificity, AUC).
Sample sizes for test sets, data provenance (retrospective/prospective, country of origin).
Number and qualifications of experts for ground truth establishment.
Adjudication methods.
MRMC studies and human reader improvement with AI assistance.
Standalone algorithm performance.
Types of ground truth (expert consensus, pathology, outcomes data).
Training set sample size and ground truth establishment for training.

Since the provided document is about a physical medical device and not an AI/ML device, it does not contain any of the information necessary to address the specific points in the prompt related to AI/ML device validation.

Summary

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August 6, 2019

Biosphere Medical, S.A. Rosene Amosse Senior Regulatory Affairs Specialist Parc des Nations - Paris Nord 2, 383 rue de la Belle Etoile Roissy en France, 95700 Fr

Re: K183120

Trade/Device Name: EmboCube Embolization Gelatin Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: July 5, 2019 Received: July 8, 2019

Dear Rosene Amosse:

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

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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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K183120

Device Name EmboCube Embolization Gelatin

Indications for Use (Describe)

EmboCube Embolization Gelatin is indicated for use in embolization of:

Hypervascular tumors
Blood vessels to occlude blood flow to control bleeding / hemorrhaging in the peripheral vasculature

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

August 2, 2019

GeneralProvisions	Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Registration Number:	Biosphere Medical, S.A.Parc des Nations - Paris Nord 2383, rue de la Belle Etoile95700 Roissy-en-France, France+33 (0)1 48 17 25 29+33 (0)1 49 38 02 68Alix Fonlladosa9615728
SubjectDevice	Trade Name:Common/Usual Name:Classification Name:	EmboCube Embolization GelatinEmbolization device21 CFR § 870.3300 Vascular Embolization Device
PredicateDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	Embosphere® Microspheres21 CFR § 870.3300 Vascular Embolization DeviceK181300Biosphere Medical, S.A.
ReferenceDevice	Trade Name:Classification Name:Premarket Notification:Manufacturer:	EmboCube Embolization Gelatin21 CFR § 870.3300 Vascular Embolization DeviceK181021Biosphere Medical, S.A.
Classification	Class II21 CFR § 870.3300FDA Product Code: KRDDivision of Cardiovascular Devices
Intended Use	EmboCube Embolization Gelatin is indicated for use in embolization of:Hypervascular tumors• Blood vessels to occlude blood flow to control bleeding /hemorrhaging in the peripheral vasculature

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Referencecode	Cube sizeDry (mm)	Cube sizeHydrated (mm)	Quantity of dry cubesper syringe
EC2525	2.5x2.5x2.5	2.5x2.5x2.5	25 mg
EC2550	2.5x2.5x2.5	2.5x2.5x2.5	50 mg
EC25100	2.5x2.5x2.5	2.5x2.5x2.5	100 mg
EC5025	5.0x5.0x5.0	5.0x5.0x5.0	25 mg
EC5050	5.0x5.0x5.0	5.0x5.0x5.0	50 mg
EC50100	5.0x5.0x5.0	5.0x5.0x5.0	100 mg

Once rehydrated, the deformable cubes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

EmboCube Embolization Gelatin is similar in design to the predicate device. Biosphere Embosphere Microspheres (K181300), as both provide a mechanical barrier to blood flow in the vasculature and are delivered using catheters. Both the subject device and the predicate device are available in a range of calibrated sizes (6 sizes for the subject device and 7 sizes for the predicate device). The subject and predicate devices differ in shape: EmboCube Embolization Gelatin is a cubic embolic while the predicate device, Biosphere Embosphere Microspheres (K181300) are spherical particles. The subject device is made wholly from resorbable porcine gelatin. The predicate, Biosphere Embosphere Microspheres (K181300) consists of a non-resorbable acrylic polymer impregnated with porcine gelatin.

The technological differences between the subject and predicate device have been evaluated through biocompatibility, bench and animal testing to provide evidence of substantial equivalence of the EmboCube Embolization gelatin to the predicate device, Biosphere Embosphere Microspheres (K181300).

Safetv & Performance Tests

Comparison to

Predicate

Device Description

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, vascular embolization devices are subject to the special controls specified in "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices", issued on December 29, 2004. In addition, the subject device follows the FDA Draft Guidance on Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices), issued on January 23, 2014.

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Safety &PerformanceTests(continued)	EmboCube Embolization Gelatin was evaluated for various performanceattributes to demonstrate the substantial equivalence of the device to thepredicate. Non-clinical performance testing includes:
	Macroscopic appearance (visual inspection) Pepsin digestibility Size range Density Moisture content (H20 analysis) Hydration test Effect on pH variation Sterility Pyrogenicity (Bacterial endotoxins) Shelf-life Deliverability with the recommended catheters and radiopaque contrast agents Flush test Biocompatibility
	An animal study was conducted on six test (EmboCube EmbolizationGelatin) and six control (Embosphere Microspheres, K181300) adult swinein the splenic artery over a period of 7 days. The animal study evaluated therate of immediate control of bleeding, the procedure-related complications,the clinical complications and the rate of re-bleeding over the follow-upperiod.
	The technological differences between the subject and the predicate devicedid not raise new safety or performance questions.
	Summary ofSubstantialEquivalence

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).