(114 days)
Not Found
No
The device description focuses on the physical properties and imaging capabilities of the embolic beads, with no mention of AI or ML for image analysis, decision support, or any other function.
Yes
The device is intended for the embolization of hypervascular tumors and arteriovenous malformations (AVMs), which means it directly treats a medical condition.
No
Explanation: The device, LC Bead LUMI, is described as an embolic product used for the embolization of hypervascular tumors and AVMs. Its purpose is to physically block blood vessels, not to diagnose conditions or process diagnostic images. While it is imageable by X-ray for monitoring its delivery and location, this visualization is for procedural guidance and post-procedure confirmation of the therapeutic intervention, not for diagnosing a condition initially.
No
The device description clearly states that LC Bead LUMI is a physical product consisting of non-resorbable microspheres supplied in a saline buffer solution. It is a tissue-contacting, implantable device. This is a hardware 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 for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). This is a therapeutic procedure performed in vivo (within the body) to block blood vessels.
- Device Description: The device is described as an "imageable spherical embolic product" that is delivered via microcatheters to physically block target vessels. It is a "single use, tissue contacting, implantable device." These characteristics are consistent with a medical device used for treatment, not for diagnostic testing of samples in vitro (outside the body).
- Mechanism of Action: The device works by physically blocking blood flow, not by analyzing biological samples to provide diagnostic information.
- Imaging Modality: While it uses X-ray based imaging for visualization during the procedure, this is for guiding the delivery and confirming placement of the device in vivo, not for analyzing images of biological samples for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
LC Bead LUMI is intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
LC Bead LUMI™ is an imageable spherical embolic product that can be visualised by X-ray based imaging (e.g. fluoroscopy and CT). The beads are non-resorbable microspheres with calibrated size ranges. LC Bead LUMI™ are intended to be used for the embolization of hypervascular tumours and arteriovenous malformations (AVM).
LC Bead LUMI™ are supplied in a saline buffer solution within a sealed glass vial. A vial access device is also provided within the secondary packaging. LC Bead LUMI™ is provided sterile (moist heat sterilization).
LC Bead LUMI™ consist of a macromer derived from a sulphonate modified polyvinyl alcohol (PVA) macromer which contains a radiopaque moiety that is covalently bound within the hydrogel structure. The incorporation of this radiopaque moiety into the co-polymer imparts X-ray imageability by rendering the microspheres radiopaque.
LC Bead LUMI™ has been designed as a radiopaque version of LC Bead™. Currently embolization with LC Bead™ lacks post-procedural imaging feedback on exact bead location. The embolization process with LC Bead™ is monitored by detecting changes in antegrade flow of soluble iodinated contrast in which the beads are diluted. The embolization is continued until a desired embolization endpoint is reached. This process is completed without specific feedback on the bead location. In order to address this limitation, the manufacturer has developed an imageable spherical embolic bead that can be visualized by X-ray based imaging.
At the time of use, LC Bead LUMI™ is mixed with non-ionic contrast agent in order to monitor the delivery of the product during the embolization procedure. LC Bead LUMI™ is delivered via typical microcatheters to physically block the target vessel. Once the product has been delivered the iodine moiety allows for visualization of the microspheres. LC Bead LUMI™ is a single use, tissue contacting, implantable device available only for prescription use.
LC Bead LUMI™ is available in the following four size ranges:
Stated Size Range
40-90 μm
70-150 μm
100-300 μm
300-500 μm
One associated accessory is provided with LC Bead LUMI™:
. 20 mm ViaLok Vented Vial Access Device – aids bead removal from vial
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray based imaging (e.g. fluoroscopy and CT)
Anatomical Site
Vascular system, specifically for hypervascular tumors and arteriovenous malformations (AVMs).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Bench testing data, verification studies and in-vivo safety and performance studies involving LC Bead LUMI™ show that the subject device has equivalent safety and performance to the predicate devices.
The performance data were provided in support of the substantial equivalence determination. Both biocompatibility and animal testing were conducted in accordance with "FDA Guidance - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices, December 29, 2004".
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2016
Biocompatibles UK Limited Dr. Simon Leppard Director of Regulatory Affairs Chapman House, Farnham Business Park, Weydon Lane Farnham, Surrey GU9 8QL GB United Kingdom
Re: K162373
Trade/Device Name: LC Bead LUMI Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: November 16, 2016 Received: November 17, 2016
Dear Simon Leppard:
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,
Brian D. Pullin -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) K162373
Device Name LC Bead LUMI
Indications for Use (Describe)
LC Bead LUMI is intended to be used for 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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510(k) Summary 5.
LC Bead LUMI™ (BTG 13-002) (per 21 CFR 807.92)
5.1 Submitter
Biocompatibles UK Ltd. Chapman House Farnham Business Park Weydon Lane, Farnham, Surrey United Kingdom Phone: +44 (0) 1252 732732 Fax: +44 (0) 1252 732777
Contact Person: Simon Leppard Phone: +44 (0) 1276 902054 Fax: +44 (0)1276 537 162/163 Email: simon.leppard@btqplc.com Date Prepared: December 14, 2016
5.2 Device
Name of Device: LC Bead LUMI™ Radiopaque Embolic Bead Common or Usual Name: Vascular Embolization Device Classification Name: Vascular Embolization Device (21 CFR 870.3300) Regulatory Class: II Product Code: KRD
5.3 Predicate Devices
Primary Predicate Device: LC Bead LUMI™ microspheres Manufacturer: Biocompatibles UK Ltd. K152157 LC Bead LUMI Product code: KRD CFR section 870.3300 This predicate has not been subject to a design-related recall.
Embozene® Microspheres CeloNova Biosciences, Inc. K132675
4
Product Code: KRD CFR Section: 870.3300
5.4 Device Description
LC Bead LUMI™ is an imageable spherical embolic product that can be visualised by X-ray based imaging (e.g. fluoroscopy and CT). The beads are non-resorbable microspheres with calibrated size ranges. LC Bead LUMI™ are intended to be used for the embolization of hypervascular tumours and arteriovenous malformations (AVM).
LC Bead LUMI™ are supplied in a saline buffer solution within a sealed glass vial. A vial access device is also provided within the secondary packaging. LC Bead LUMI™ is provided sterile (moist heat sterilization).
LC Bead LUMI™ consist of a macromer derived from a sulphonate modified polyvinyl alcohol (PVA) macromer which contains a radiopaque moiety that is covalently bound within the hydrogel structure. The incorporation of this radiopaque moiety into the co-polymer imparts X-ray imageability by rendering the microspheres radiopaque.
LC Bead LUMI™ has been designed as a radiopaque version of LC Bead™. Currently embolization with LC Bead™ lacks post-procedural imaging feedback on exact bead location. The embolization process with LC Bead™ is monitored by detecting changes in antegrade flow of soluble iodinated contrast in which the beads are diluted. The embolization is continued until a desired embolization endpoint is reached. This process is completed without specific feedback on the bead location. In order to address this limitation, the manufacturer has developed an imageable spherical embolic bead that can be visualized by X-ray based imaging.
At the time of use, LC Bead LUMI™ is mixed with non-ionic contrast agent in order to monitor the delivery of the product during the embolization procedure. LC Bead LUMI™ is delivered via typical microcatheters to physically block the target vessel. Once the product has been delivered the iodine moiety allows for visualization of the microspheres. LC Bead LUMI™ is a single use, tissue contacting, implantable device available only for prescription use.
LC Bead LUMI™ is available in the following four size ranges:
| Stated Size Range |
|---|
| 40-90 μm |
| 70-150 μm |
| 100-300 μm |
| 300-500 μm |
Table 1 Size ranges of LC Bead LUMITM
5
One associated accessory is provided with LC Bead LUMI™:
- . 20 mm ViaLok Vented Vial Access Device – aids bead removal from vial
5.5 Indications for Use
LC Bead LUMI™ are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
5.6 Comparison of Technological Characteristics with the Predicate Devices
The intended use of LC Bead LUMI™ remains unchanged compared to the primary predicate device LC Bead LUMI™ (cleared by FDA in December 2015, K152157). The subject device (LC Bead LUMI™) and the primary predicate LC Bead LUMI™ have the same design, specifications, scientific technology, and packaging. The key difference to the primary predicate device is the addition of a smaller bead size (40 - 90μm) which is in the same range as the commercially available second predicate device Embozene® Microspheres, CeloNova (see Table 2).
| LC Bead LUMI™
(Subject device)
(21CFR870.3300) | LC Bead LUMI™ (Predicate)*
(21CFR870.3300) | Embozene® Microspheres
CeloNova
(Predicate)
(21CFR870.3300) |
|------------------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------|
| 40-90 μm | - | 40 ± 10μm
75 ± 15μm
100 ± 25μm |
| 70-150μm | 70-150μm | 100 ± 25μm |
| 100-300μm | 100-300μm | 250 ± 50μm |
| 300-500μm | 300-500μm | 400 ± 50μm
530 ± 50μm
(larger sizes available) |
Table 2 Size ranges of LC Bead LUMI™ and predicates; *cleared (K152157)
The substantial equivalence claim of the subject device LC Bead LUMI™ (incl. the smallest size range 40 – 90μm) with Biocompatibles UK Ltd own pre-existing marketed device LC Bead LUMI™ and the CeloNova BioSciences Embozene Microspheres is based on the equivalence with the following elements:
- Device material .
- Intended use ●
- Size specification ●
- Target population
- Mode of action ●
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K162373
- . Application location
- Route of application .
- . Biological characteristics / bench and animal performance
The key difference of the subject device LC Bead LUMI™ to the primary predicate device LC Bead LUMI™ (K152157) is the addition of the bead size 40 – 90μm.
5.7 Performance Data
Bench testing data, verification studies and in-vivo safety and performance studies involving LC Bead LUMI™ show that the subject device has equivalent safety and performance to the predicate devices.
The performance data were provided in support of the substantial equivalence determination. Both biocompatibility and animal testing were conducted in accordance with "FDA Guidance - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices, December 29, 2004".
5.8 Conclusions
The subject device of this 510k submission, LC Bead LUMI™, is substantially equivalent to the predicate devices LC Bead LUMI™ (K152157) and Embozene® Microspheres, (K132675) in terms of indication for use, target population, mode of action, route and location of administration, and is identical to the primary predicate in its product characteristics of chemistry and device material. The key difference between the primary predicate device and the subject device is the addition of the 40 – 90μm bead size. The subject device is substantially equivalent to the predicate Embozene® CeloNova with respect to the smallest bead size (40 – 90μm). In vitro bench testing and non-clinical testing in animals support that the subject device has equivalent safety and performance to the predicate devices.