(270 days)
No
The device description and intended use focus on a physical embolization material and its delivery method. There is no mention of AI/ML in the device description, intended use, or performance studies. The input imaging modality (Fluoroscopy) is used for monitoring, not as input for an AI/ML algorithm.
Yes
The device is used for embolization to occlude blood flow and control bleeding/hemorrhaging, which directly treats a medical condition.
No
The device description indicates that EmboCube Embolization Gelatin is used for embolization (occluding blood flow), acting as a mechanical barrier. The "Intended Use / Indications for Use" section also confirms its role in treating hypervascular tumors and controlling bleeding/hemorrhaging, which are therapeutic interventions, not diagnostic ones. While fluoroscopy is mentioned for monitoring, the device itself is not performing a diagnostic function; it is a treatment.
No
The device description clearly states it is a physical product consisting of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The EmboCube Embolization Gelatin is a physical device intended to be injected into the body (specifically, blood vessels) to mechanically block blood flow. It is used inside the body (in vivo).
- Intended Use: The intended use is for embolization of blood vessels to control bleeding or occlude blood flow, which is a therapeutic procedure performed within the body.
- Device Description: The description clearly states it's a physical material (gelatin cubes) injected into vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the EmboCube Embolization Gelatin is a therapeutic medical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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
Product codes
KRD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Peripheral vasculature, splenic artery (in animal study)
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
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 Embolization Gelatin) and six control (Embosphere Microspheres, K181300) adult swine in the splenic artery over a period of 7 days. The animal study evaluated the rate of immediate control of bleeding, the procedure-related complications, the clinical complications and the rate of re-bleeding over the follow-up period.
Key results: The technological differences between the subject and the predicate device did not raise new safety or performance questions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
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
1
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
2
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
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Registration Number: | Biosphere Medical, S.A.
Parc des Nations - Paris Nord 2
383, rue de la Belle Etoile
95700 Roissy-en-France, France
+33 (0)1 48 17 25 29
+33 (0)1 49 38 02 68
Alix Fonlladosa
9615728 |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | EmboCube Embolization Gelatin
Embolization device
21 CFR § 870.3300 Vascular Embolization Device |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Embosphere® Microspheres
21 CFR § 870.3300 Vascular Embolization Device
K181300
Biosphere Medical, S.A. |
| Reference
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | EmboCube Embolization Gelatin
21 CFR § 870.3300 Vascular Embolization Device
K181021
Biosphere Medical, S.A. |
| Classification | Class II
21 CFR § 870.3300
FDA Product Code: KRD
Division 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 | |
4
| Reference
code | Cube size
Dry (mm) | Cube size
Hydrated (mm) | Quantity of dry cubes
per 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 |
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.
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.
5
| Safety &
Performance
Tests
(continued) | EmboCube Embolization Gelatin was evaluated for various performance
attributes to demonstrate the substantial equivalence of the device to the
predicate. 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 Embolization
Gelatin) and six control (Embosphere Microspheres, K181300) adult swine
in the splenic artery over a period of 7 days. The animal study evaluated the
rate of immediate control of bleeding, the procedure-related complications,
the clinical complications and the rate of re-bleeding over the follow-up
period. |
| | The technological differences between the subject and the predicate device
did not raise new safety or performance questions. |
| | Summary of
Substantial
Equivalence |