LC Bead LUMI

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 11, 2015 Biocompatibles UK Ltd. % Robert Lally Senior Vice President Regulatory Affairs BTG International Inc. Five Tower Bridge, Suite 800 300 Barr Harbor Drive West Conshohocken, Pennsylvania 19428 Re: K152157 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: October 29, 2015 Received: November 4, 2015 Dear Robert Lally: 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, # Kenneth J. Cavanaugh -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) K152157 Device Name LC Bead LUMI Indications for Use (Describe) LC Bead LUMI are 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below the circle is the text "BTG" in a bold, sans-serif font. #### 5 510(k) Summary 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: Robert Lally Phone: 1 610 278 1660 Fax: 1 610 278 1605 Email: robert.lally@btgplc.com Date Prepared: April 17, 2015 #### 5.2 Device Name of Device: LC Bead LUMI™ 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 Device LC Bead™ Microspheres K083091 LC Bead Microspheres / Bead Block Compressible Microspheres Manufacturer: Biocompatibles UK Ltd. CFR 870.3300 Product code: KRD Image /page/3/Picture/12 description: The image shows a graphic design with overlapping curved shapes in different shades of blue and purple. The shapes create a sense of depth and movement, with the darker blues in the foreground and lighter purples in the background. The overall effect is abstract and modern, with a clean and simple aesthetic. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for BTG. The logo consists of a blue circle with four white lines curving across the top right portion of the circle. Below the circle, the letters "BTG" are written in a bold, sans-serif font. This predicate has not been subject to a design-related recall. No reference devices were used in this submission. #### Device Decription 5.4 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 tumors 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 Xray imageability by rendering the microspheres radiopaque. LC Bead LUMI™ has been designed as a radiopaque version of the 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 visualised 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for BTG. The logo consists of a blue circle with four white curved lines inside, resembling a globe with lines of longitude. Below the circle, the letters "BTG" are written in a bold, sans-serif font. LC Bead LUMI™ is available in the following three size ranges: | Stated Size Range | |-------------------| | 70-150 μm | | 100-300 μm | | 300-500 μm | One associated accessory is provided with LC Bead LUMI™: - Vented vial access device, 20mm aids bead removal from vial ● #### Indications for Use 5.5 LC Bead LUMI™ is indicated to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs). The indication for use statement for LC Bead LUMI™ is identical to the predicate device LC Bead™. #### Comparison of Technological Characteristics with the Predicate Device 5.6 The intended use of LC Bead LUMI™ and the predicate device are the same and unchanged. Biocompatibles UK Ltd intends to market LC Bead LUMI™ in only three size ranges (see Table 2) which fall within the same size ranges commercially available for the predicate device. For each size range the size specification to the predicate device is unchanged. | LC Bead (Predicate) | LC Bead LUMI™ | |--------------------------------------|-----------------| | (21CFR870.3300 and<br>21CFR882.5950) | (21CFR870.3300) | | 70-150μm | 70-150μm | | 100-300μm | 100-300μm | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for BTG. The logo consists of a blue circle with several white lines emanating from the left side, resembling a stylized globe or planet. Below the circle, the letters "BTG" are written in a bold, sans-serif font. The letters are black. | LC Bead (Predicate)<br>(21CFR870.3300 and<br>21CFR882.5950) | LC Bead LUMITM<br>(21CFR870.3300) | |-------------------------------------------------------------|-----------------------------------| | 300-500μm | 300-500μm | | 500-700μm | - | | 700-900μm | - | | 900-1200μm | - | Table 2 Size ranges of LC Bead LUMI™ and LC Bead™ The substantial equivalence claim of LC Bead LUMI™ embolization device with Biocompatibles UK Ltd own pre-existing marketed device LC Bead™ is based on the equivalence with the following elements: - . Device material - Intended use - . Size specification - . Target population - . Mode of action - . Application location - Route of application . - Biological characteristics / bench and animal performance . As per the predicate device, LC Bead LUMI™ consist of a macromer derived from a sulphonate modified polyvinyl alcohol (PVA) macromer. Additionally LC Bead LUMI™ 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 device radiopaque. The inclusion of this radiopaque moiety and related process modifications (such as coupling of the radiopaque moiety as well as omission of a blue dye used for the predicate) is the key differentiator between LC Bead LUMI™ and LC Bead™. In addition to the inclusion of the radiopaque moiety there are some additional changes to the endotoxin and solvent limits. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for BTG. The logo consists of a blue circle with four white lines running across the top right quadrant. Below the circle is the text "BTG" in a bold, sans-serif font. #### 5.7 -Performance Data Bench testing data, verification and validation studies, in vitro and in-vivo biocompatibility 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 device. 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 manufacturer has provided a detailed comparison of the product LC Bead LUMI™ to demonstrate substantial equivalence of this product to the predicate LC Bead™ in terms of indication for use, target population, mode of action, route and location of administration as well as product characteristics such as chemistry and bead size. Given the key difference between the predicate and the subject device is the ability to visualize LC Bead LUMI™, by imaging techniques, Biocompatibles UK Ltd has generated a set of in vitro and in-vivo biocompatibility data as well as further bench and non-clinical data to support that the subject device has equivalent safety and performance to the predicate device. The results of the LC Bead LUMI™ non-clinical data support the conclusion that the addition of the radiopaque moiety does not raise different questions of safety of the subject device. Changes in the manufacturing process based on the introduction of the radiopaque moiety do not raise new questions of safety and effectiveness of the subject device. In conclusion, the bench testing data, verification and validation data show that performance is substantially equivalent to the predicate device.