(72 days)
No
The device description and performance studies focus on the physical properties and mechanical function of the gelatin foam embolization device. There is no mention of AI or ML in the text.
Yes
The device is described as an embolization device used to occlude blood flow to control bleeding/hemorrhaging, which is a therapeutic intervention.
No
Explanation: The device is an embolic agent used to occlude blood flow, which is a therapeutic intervention, not a diagnostic one. While it can be monitored with imaging (fluoroscopy) during the procedure, the device itself does not provide diagnostic information.
No
The device description clearly states it is a physical, resorbable gelatin foam device preloaded into a cartridge, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The Torpedo Gelatin Foam is a device used in vivo (inside the body) to physically block blood vessels. It is used for embolization, which is a therapeutic procedure to stop bleeding or reduce blood flow to tumors.
- Lack of Specimen Analysis: The device does not analyze any biological specimens (blood, tissue, etc.) outside of the body. Its function is purely mechanical and performed within the patient's vasculature.
Therefore, based on the provided information, the Torpedo Gelatin Foam is a therapeutic medical device used for embolization, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Torpedo Gelatin Foam 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 (comma separated list FDA assigned to the subject device)
KRD
Device Description
Torpedo Gelatin Foam is a hydrophilic medical device which consists of resorbable dry gelatin foam that is compressed into a cylindrical shape and preloaded into a cartridge with a standard female and male luer fittings. The device is available in two sizes (0.9 mm and 1.7 mm) and two lengths configurations (10 mm and 20 mm).
Once rehydrated, the deformable torpedoes 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
Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy.
Anatomical Site
peripheral vasculature
renal arteries
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
An animal study was conducted on seven test (Torpedo Gelatin Foam, K183578) and eight control (EmboCube Embolization Gelatin, K183120) adult female sheep in the renal arteries over a period of 4 weeks. Comparison of safety and performances between both devices was assessed by comparing the vascular occlusion, local tissue effects, and in vivo degradation. Angiography and histopathology confirmed that the Torpedo provided an embolic effect in renal arteries for at least four weeks; normal flow of the renal arterial vasculature was never recovered in any animal at any time point. There was no significant difference for artery patency between any articles at any time point. All test animals had a necrotized renal tissue, indicative of successful embolization. The animals were clinically normal throughout the study duration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 21, 2019
Biosphere Medical, S.A. Alix Fonlladosa Regulatory Affairs Manager Parc des Nations - Paris Nord 2, 383, rue de la Belle Etoile Roissy-en-France, 95700 Fr
Re: K192480
Trade/Device Name: Torpedo Gelatin Foam Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: August 30, 2019 Received: September 10, 2019
Dear Alix Fonlladosa:
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
1
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 (OS) 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,
Misti Malone, PhD 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) K192480
Device Name Torpedo Gelatin Foam
Indications for Use (Describe)
Torpedo Gelatin Foam 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 K192480
November 18, 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: | Torpedo Gelatin Foam
Embolization device
21 CFR § 870.3300 Vascular Embolization Device | |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | EmboCube Embolization Gelatin
21 CFR § 870.3300 Vascular Embolization Device
K183120
Biosphere Medical, S.A. | |
| Reference
Device #1 | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Torpedo Gelatin Foam
21 CFR § 870.3300 Vascular Embolization Device
K183578
Biosphere Medical, S.A. | |
| Classification | Class II
21 CFR § 870.3300
FDA Product Code: KRD
Division of Cardiovascular Devices | | |
| Intended Use | Torpedo Gelatin Foam 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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Torpedo Gelatin Foam is a hydrophilic medical device which consists of resorbable dry gelatin foam that is compressed into a cylindrical shape and preloaded into a cartridge with a standard female and male luer fittings. The device is available in two sizes (0.9 mm and 1.7 mm) and two lengths configurations (10 mm and 20 mm).
| Device |
|---|
| Description |
| Reference
code | Compressed /
Dehydrated
Torpedo Diameter | Uncompressed /
Hydrated Torpedo
Section | Torpedo
Length |
|-------------------|------------------------------------------------|-----------------------------------------------|-------------------|
| TOR2510 | 0.9 mm | 2.5 mm x 2.5 mm | 10 mm |
| TOR2520 | 0.9 mm | 2.5 mm x 2.5 mm | 20 mm |
| TOR5010 | 1.7 mm | 5.0 mm x 5.0 mm | 10 mm |
| TOR5020 | 1.7 mm | 5.0 mm x 5.0 mm | 20 mm |
Once rehydrated, the deformable torpedoes 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.
Torpedo Gelatin Foam is similar in design to the predicate device, EmboCube Embolization Gelatin (K183120), as both of them provide a mechanical barrier to blood flow in the vasculature and are delivered using catheters. The changes to the device are as follows: a) A variant of the gelatin cube device has been added to the range, b) A new packaging has been added, c) A blunt stylet has been included.
- Comparison The subject device is available in two sizes, as the predicate device. The subject and predicate devices differ in shape. The predicate EmboCube to Predicate Embolization Gelatin (K183120) has a cubic shape, whether dry or hydrated, At the dry state, the subject Torpedo Gelatin Foam is compressed into a cylindrical shape. In the uncompressed / hydrated state, the subject Torpedo Gelatin Foam is a solid rectangle of the same section as the predicate (2,5 mm or 5.0 mm), only the length differs. Both the subject device and the predicate device, EmboCube Embolization Gelatin (K183120) are made wholly from the identical resorbable porcine gelatin.
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The bench testing was leveraged from the cleared Torpedo Gelatin Foam (K183578), because no changes to material, general design or processing were made.
The previous animal testing listed in the 510(k) of the predicate device EmboCube Embolization Gelatin (K183120) was leveraged to support the new Indications for Use of the subject device Torpedo Gelatin Foam.
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.
Safetv & Substantial equivalence between the reference device and the predicate Performance device was supported by the animal testing listed in the 510(k) of the reference device Torpedo Gelatin Foam (K183578). An animal study was conducted on Tests seven test (Torpedo Gelatin Foam, K183578) and eight control (EmboCube Embolization Gelatin, K183120) adult female sheep in the renal arteries over a period of 4 weeks. Comparison of safety and performances between both devices was assessed by comparing the vascular occlusion, local tissue effects, and in vivo degradation. Angiography and histopathology confirmed that the Torpedo provided an embolic effect in renal arteries for at least four weeks; normal flow of the renal arterial vasculature was never recovered in any animal at any time point. There was no significant difference for artery patency between any articles at any time point. All test animals had a necrotized renal tissue, indicative of successful embolization. The animals were clinically normal throughout the study duration.
Device design of the subject device was leveraged from the reference device Torpedo Gelatin Foam (K183578). Both products have exactly the same materials, design and processing. There are no differences that could raise new questions of safety and effectiveness for the use of the subject device, Torpedo Gelatin Foam, in bleeding / hemorrhaging application.