(136 days)
Not Found
No
The summary describes a physical medical device (microspheres) and its intended use and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as being used for the "embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH)", which are therapeutic interventions.
No
The device is described as Embozene Color-Advanced Microspheres, intended for embolization of certain medical conditions by occluding blood vessels. It is used to treat conditions by stopping bleeding or blocking arteries to cause tumor necrosis, not to diagnose them.
No
The device description clearly states that the device is composed of physical microspheres suspended in liquid and supplied in syringes, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Embozene Microspheres Function: Embozene Microspheres are implanted into the body to physically block blood vessels. They are a therapeutic device used for embolization procedures.
- Intended Use: The intended use clearly states embolization of arteriovenous malformations and hypervascular tumors, which are procedures performed directly on the patient's circulatory system.
- Device Description: The description details a physical object (microspheres) injected into the bloodstream, not a test performed on a sample outside the body.
Therefore, based on the provided information, Embozene Color-Advanced Microspheres are a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Embozene Color-Advanced Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). The device is not intended for neurovascular use.
Product codes
KRD, NOY, NAJ
Device Description
Embozene Color-Advanced Microspheres (hereafter may be referenced as Embozene Microspheres or Embozene) are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer shell (Polyzene-F). The microspheres are suspended in liquid and then injected into the bloodstream to permanently occlude blood vessels. They are used to stop bleeding when the underlying lesion is not likely to heal or block arteries supplying a tumor to cause tumor necrosis and/or shrinkage.
Embozene Color-Advanced Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml of microspheres in approximately 7 ml of transport solution. The Embozene Microspheres are available in 40-1300 µm sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arteriovenous malformations, hypervascular tumors (uterine fibroids, hepatoma), prostatic 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
Non-clinical Testing: Embozene underwent non-clinical testing to demonstrate the design and performance met the established design criteria and is substantial equivalent to the predicate device. The subject device successfully completed mechanical testing to ensure the device with the new syringe met all related specifications.
Sterilization: Embozene Microspheres are steam sterilized to ensure a minimum sterility assurance level of 10 in accordance with ISO 17665-1, ISO 11138-1, ISO 11737-1 and ISO 11737-2.
Biocompatibility: Biocompatibility testing of Embozene Microspheres in accordance with ISO 10993-1 demonstrated that the patient-contacting components are biocompatible.
Packaging Integrity and Shelf Life: Packaging integrity and shelf-life testing for Embozene Microspheres was performed in accordance with ISO 11607-1 and ISO 11607-2.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2025
Varian Medical Systems, Inc. Lynn Allman Senior Director, Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304
Re: K242608
Trade/Device Name: Embozene Color-Advanced Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: II Product Code: KRD, NOY, NAJ Dated: December 19, 2024 Received: December 20, 2024
Dear Lynn Allman:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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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,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Embozene Color-Advanced Microspheres
Indications for Use (Describe)
Embozene Color-Advanced Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). The device is not intended for neurovascular use.
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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Image /page/4/Picture/3 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is black and white.
Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038
Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com
PREMARKET NOTIFICATION
510(k) Summary Embozene Color-Advanced Microspheres The following information is provided as required by 21 CFR 807.92
l. Submitter's Information:
| Name and Address: | Varian Medical Systems Inc.
3100 Hansen Way
Palo Alto, CA 94304-1038 |
|-------------------|----------------------------------------------------------------------------------|
| Manufacturer: | Varian Medical Systems, Inc.
9825 Spectrum Drive, Building 2 Austin, TX 78717 |
| Contact Name: | Lynn Allman, Senior Director Regulatory Affairs |
| E-mail: | submissions.support@varian.com |
| Date Prepared: | August 31, 2024 |
Device Information: ll.
| Proprietary Name: | Embozene Color-Advanced Microspheres |
|---|---|
| Common/ Usual Name: | Microspheres for embolization |
| Classification Name: | Device, Vascular, for Promoting Embolization |
| Agents, Embolic, for Treatment of Benign Prostatic Hyperplasia | |
| Classification Panel: | Cardiovascular |
| Gastroenterology/Urology Gastroenterology/Urology | |
| Regulation Number: | 21 CFR Part 870.3300 (KRD, NAJ) |
| 21 CFR Part 876.5550 (NOY) | |
| Product Codes: | KRD, NOY, NAJ |
lll. Predicate Device:
Embozene Color-Advanced Microspheres (K180102)
IV. Subject Device Description:
Embozene Color-Advanced Microspheres (hereafter may be referenced as Embozene Microspheres or Embozene) are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer shell (Polyzene-F). The microspheres are suspended in liquid and then injected into the bloodstream to permanently occlude blood vessels. They are used to stop bleeding when the underlying lesion is not likely to heal or block arteries supplying a tumor to cause tumor necrosis and/or shrinkage.
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Image /page/5/Picture/2 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is simple and modern, and it conveys the message that Varian is a part of the Siemens Healthineers family.
Embozene Color-Advanced Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml of microspheres in approximately 7 ml of transport solution. The Embozene Microspheres are available in 40-1300 µm sizes.
V. Intended Use/ Indications of Use Statement:
Embozene Color-Advanced Microspheres
Embozene Color-Advanced Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). The device is not intended for neurovascular use.
VI. Substantial Equivalence Discussion:
Embozene Color-Advanced Microspheres are substantially equivalent to the legally marketed Embozene Color-Advanced Microspheres, cleared by FDA (K180102). Both devices have the same indications for use and the same technological characteristics. Both devices are spherical, non-resorbable polymer microspheres which are delivered through a microcatheter to embolize a target vessel. While there are no technological differences, the subject device incorporates an updated syringe due to end of life of the previously used syringe. The potential impacts of this change, including mechanical performance, biocompatibility, sterility, packaging and shelf-life, have been evaluated and demonstrated that the subject device meets all device specifications of the predicate device.
VII. Performance Data:
The following performance data were provided in support of the substantial equivalence determination.
1. Non-clinical Testing:
Embozene underwent non-clinical testing to demonstrate the design and performance met the established design criteria and is substantial equivalent to the predicate device. The subject device successfully completed mechanical testing to ensure the device with the new syringe met all related specifications.
2. Sterilization:
Embozene Microspheres are steam sterilized to ensure a minimum sterility assurance level of 10 in accordance with ISO 17665-1, ISO 11138-1, ISO 11737-1 and ISO 11737-2.
Biocompatibility: 3.
Biocompatibility testing of Embozene Microspheres in accordance with ISO 10993-1 demonstrated that the patient-contacting components are biocompatible.
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Image /page/6/Picture/2 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font.
Packaging Integrity and Shelf Life: 4.
Packaging integrity and shelf-life testing for Embozene Microspheres was performed in accordance with ISO 11607-1 and ISO 11607-2.
VIII. Conclusion:
The performance data for Embozene Color-Advanced Microspheres support the safety of the devices and the verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. Varian considers Embozene Color-Advanced Microspheres to be as safe, effective as the predicate device and therefore, substantially equivalent to the predicate device.