(29 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of the gelatin pledgets, with no mention of AI or ML technologies.
Yes
The device is intended for the embolization of hypervascular tumors and arteriovenous malformations, which is a therapeutic intervention to treat these conditions.
No
The device is described as an "embolic device" intended for "embolization," which is a therapeutic procedure to block blood flow, not to diagnose a condition.
No
The device description clearly states it is an "embolic device consisting of 10 radially compressed porcine derived gelatin pledgets packaged in one transparent glass vial" and includes a "delivery syringe." This describes a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "embolization of hypervascular tumors and arteriovenous malformations (AVMs)." This is a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The device is an "embolic device consisting of 10 radially compressed porcine derived gelatin pledgets." These are physical objects designed to be introduced into the bloodstream.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting. This device is clearly designed for direct intervention within the patient's vascular system.
N/A
Intended Use / Indications for Use
The Gel-Block 10x embolization pledgets is intended for use in the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
The Gel-Block 10x embolization pledgets is an embolic device consisting of 10 radially compressed porcine derived gelatin pledgets packaged in one transparent glass vial. A delivery syringe is provided for introduction of the pledgets into the delivery catheter (not included). The pledgets are available in three sizes compatible with a delivery catheter having a minimum inner diameter of ≥ 0.038", ≥ 0.027", or ≥ 0.021". When unconstrained in a blood vessel, each pledget will occlude blood flow by swelling to a specified swell size. The finished product is sterilized by electron-beam irradiation and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of substantial equivalence. The Gel-Block 10x embolization pledgets is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. Therefore the only new design verification test necessary was deliverability. Package validation tests and sterilization validation tests were completed to support the new package configuration. Biocompatibility tests were required to assess the Gel-Block 10x embolization pledgets package materials.
The following biocompatibility tests were performed as recommended by ISO 10993-1:
- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous Reactivity
- Acute Systemic Toxicity
- Hematology
The results of the deliverability, package, sterilization and biocompatibility tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Gel-Block 10x embolization pledgets is substantially equivalent to the predicate device.
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.
K113266 - Gel-Block embolization pledgets
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.
Not Found
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).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2014
Vascular Solutions, Inc. Adam Ettl Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K143038
Trade/Device Name: Gel-block 10x Embolization Pledgets Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 21, 2014 Received: October 23, 2014
Dear Adam Ettl,
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143038
Device Name Gel-Block 10x embolization pledgets
Indications for Use (Describe)
The Gel-Block 10x embolization pledgets is intended for use in the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
2 510(k) Summary
[As required by 21 CFR 807.92] Date Prepared: October 21, 2014 510(k) Number: ____K143038
Submitter's Name / Contact Person
Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Adam Ettl Sr. Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-656-4253
General Information
| Trade Name | Gel-Block 10x embolization pledgets |
|---|---|
| Common / Usual Name | Device, vascular, for promoting embolization |
| Classification Name | 870.3300, KRD - vascular embolization device; Class II |
| Predicate Device | K113266 - Gel-Block embolization pledgets (Vascular Solutions, Inc.) |
Device Description
The Gel-Block 10x embolization pledgets is an embolic device consisting of 10 radially compressed porcine derived gelatin pledgets packaged in one transparent glass vial. A delivery syringe is provided for introduction of the pledgets into the delivery catheter (not included). The pledgets are available in three sizes compatible with a delivery catheter having a minimum inner diameter of ≥ 0.038", ≥ 0.027", or ≥ 0.021". When unconstrained in a blood vessel, each pledget will occlude blood flow by swelling to a specified swell size. The finished product is sterilized by electron-beam irradiation and is intended for single use only.
Intended Use / Indications
The Gel-Block 10x embolization pledgets is intended for use in embolization of hypervascular tumors and arteriovenous malformations (AVMs).
Technological Characteristics
The porcine derived gelatin pledgets in the Gel-Block 10x embolization pledgets and the Gel-Block embolization pledgets are identical. The only differences between the subject and predicate device are the package materials and configuration. The subject device contains 10 pledgets in a glass vial with a screw cap. while the predicate device contains two delivery assemblies each containing one pledget. The subject device does not include or require the use of the delivery assemblies as the pledgets are removed from the glass vial and placed directly in the tip of the delivery syringe. The subject and predicate devices each contain one delivery syringe, either 1cc or 3cc depending on the model. The
Vascular Solutions, Inc. 6464 Sycamore Court North ◆ Minneapolis, MN ◆ 55369 Phone: 763-656-4300 ♦ Fax: 763-656-4253
4
subject device components (glass vial with screw cap, 10 pledgets, and one delivery syringe) are provided on a packing card and placed in a Tyvek pouch. The predicate device components (two individual pledgets packaged in separate delivery assemblies and one delivery syringe) are provided in a thermoformed tray with Tyvek lid that is placed in a Tyvek pouch. The subject and predicate devices are packaged in a retail box each containing five Tyvek pouches.
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of substantial equivalence. The Gel-Block 10x embolization pledgets is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. Therefore the only new design verification test necessary was deliverability. Package validation tests and sterilization validation tests were completed to support the new package configuration. Biocompatibility tests were required to assess the Gel-Block 10x embolization pledgets package materials.
The following biocompatibility tests were performed as recommended by ISO 10993-1:
- . Cytotoxicity
- Sensitization ●
- Irritation/Intracutaneous Reactivity ●
- Acute Systemic Toxicity o
- Hematology
The results of the deliverability, package, sterilization and biocompatibility tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Gel-Block 10x embolization pledgets is substantially equivalent to the predicate device.