Who is the manufacturer of LV Liberty Vision Model 1 90Yttrium Brachytherapy Source?

Lv Liberty Vision Corporation filed the 510(k) submission for LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (K193602).

What is the FDA product code for LV Liberty Vision Model 1 90Yttrium Brachytherapy Source?

KXK. It is classified under 21 CFR 892.5730 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for LV Liberty Vision Model 1 90Yttrium Brachytherapy Source?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like LV Liberty Vision Model 1 90Yttrium Brachytherapy Source?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

K193602 · Lv Liberty Vision Corporation · KXK · May 29, 2020 · Radiology

Device Facts

Record ID	K193602
Device Name	LV Liberty Vision Model 1 90Yttrium Brachytherapy Source
Applicant	Lv Liberty Vision Corporation
Product Code	KXK · Radiology
Decision Date	May 29, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.5730
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system.

Device Story

The LV Liberty Vision Model 1 is a singly-encapsulated 90Yttrium brachytherapy source. It consists of a solid radioactive 90Yttrium element hermetically sealed within a titanium capsule. The device is used in a clinical setting as part of a manual radionuclide applicator system for episcleral brachytherapy. The 90Yttrium isotope decays via beta emission, delivering therapeutic radiation to tumors or benign growths. The device is operated by trained medical professionals following strict radiation safety protocols and licensing requirements. The output is the localized delivery of beta radiation to the target tissue, intended to treat growths. The device is stored in shielded containers and disposed of via decay-in-storage or transfer to authorized recipients.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical physical testing (ANSI N43.6/ISO 2919) and Monte Carlo dosimetric simulations comparing the subject device to the predicate.

Technological Characteristics

Singly-encapsulated 90Yttrium source in titanium capsule. Beta-emitter (end-point energy 2280 keV, average 934 keV). Dimensions: max 9.4mm diameter, 0.25mm thickness. Mechanical safety: ISO 2919/ANSI N43.6 Class C54213. Sterilization required. Manual application. Storage at room temperature in shielded containers.

Indications for Use

Indicated for episcleral brachytherapy of tumors and benign growths in patients requiring manual brachytherapy treatment.

Regulatory Classification

Identification

A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

Special Controls

*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

LV Liberty Vision, Inc. Model 1 90Yttrium Brachytherapy Source (K163572)

Submission Summary (Full Text)

{0}------------------------------------------------ May 29, 2020 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. LV Liberty Vision Corporation % Paul T. Finger, M.D. Chief Executive Officer 300 West Road, Unit 2 PORTSMOUTH NH 03874 Re: K193602 Trade/Device Name: LV Liberty Vision Model 1 90Yttrium Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: Class II Product Code: KXK Dated: May 8, 2020 Received: May 11, 2020 Dear Dr. Finger: 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/cfpmp/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 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 {1}------------------------------------------------ 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 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 medical devices and radiation-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, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K193602 Device Name LV Liberty Vision Model 1 90Yttrium Brachytherapy Source Indications for Use (Describe) LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system. | 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### Section 5 510(k) Summary K193602 Section 807.92(a) | (1) Submitter | LV Liberty Vision Corp. 300 West Road, Unit 2 Portsmouth, New Hampshire 03801; USA; | t: 603.319.8416 | |---------------|-----------------------------------------------------------------------------------------------|-----------------| | | Establishment Registration No.: 3015042204 | | | | Contact Person: Paul T. Finger, MD Chief Executive Officer e: pfinger@libertyvision.com | | (2) Device Name: | Classification Name: | Radionuclide Brachytherapy Source (892.5730) (90 KXK) | |-----------------------|----------------------------------------------------------| | Common or Usual Name: | Brachytherapy Source | | Proprietary Name: | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source | - (3) Legally Marketed Predicate Device: LV Liberty Vision, Inc. Model 1 90Yttrium Brachytherapy Source, cleared under 510(k) number K163572 dated 15 March 2017 - (4) Description of LV Liberty Vision Model 1 90Yttrium Brachytherapy Source: LV Liberty Vision Model 1 90Yttrium Brachytherapy Source is a singly-encapsulated 99Yttrium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive 99Yttrium element. The radioactive element is hermetically sealed in the titanium capsule and, in use, will be attached to a manual radionuclide applicator system (21 CFR 892.5650). - (5) Intended Use: LV Liberty Vision Model 1 90Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system. {4}------------------------------------------------ ### (6) Technological Characteristics: LV Liberty Vision Model 1 ®Yttrium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source that utilizes beta particles from 90Yttrium. | Technological Characteristic | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (This Version) | LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (K163572) | |--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design | The source consists of a solid 90Yttrium active element, with a maximum diameter of 9.4 mm and a maximum thickness of 0.25 mm, singly encapsulated in metallic titanium with a maximum diameter of 10 mm and a maximum thickness of 1.0 mm. | The source consists of a solid 90Yttrium active element, with a maximum diameter of 9.6 mm and a maximum thickness of 0.75 mm, singly encapsulated in metallic titanium with a maximum diameter of 10 mm and a maximum thickness of 1.0 mm. | | Materials Radionuclide Encapsulation | 90Yttrium Titanium | 90Yttrium Titanium | | Performance Dosimetry: | | | | Central Axis Dose Rate at 0.6 mm | 6 mm dia source: 1.08 Gy/min-mCi 8 mm dia source: 0.63 Gy/min-mCi 10 mm dia source: 0.40 Gy/min-mCi | 6 mm dia source: 1.02 Gy/min-mCi 8 mm dia source: 0.62 Gy/min-mCi 10 mm dia source: 0.42 Gy/min-mCi | | Dose Rate at 1.0 mm | 6 mm dia source: 0.81 Gy/min-mCi 8 mm dia source: 0.50 Gy/min-mCi 10 mm dia source: 0.32 Gy/min-mCi | 6 mm dia source: 0.81 Gy/min-mCi 8 mm dia source: 0.50 Gy/min-mCi 10 mm dia source: 0.34 Gy/min-mCi | | Sterility | This source may directly contact the patient and therefore sterility is required. | This source never directly contacts the patient; sterility is not required. | | Biocompatibility | The outside of the entire assembly is fabricated from titanium, which is a biocompatible material. | This source never directly contacts the patient; biocompatibility assessment is not applicable. The outside of the entire assembly is fabricated from titanium, which is a biocompatible material. | | Mechanical Safety | ISO 2919/ANSI N43.6 Class C53211 Applied for New Hampshire Registration | ISO 2919/ANSI N43.6 Class C53211 Applied for New Hampshire Registration | | Chemical Safety | The outside of the entire assembly is fabricated from titanium, which will not chemically react with body tissue. | This source assembly never directly contacts the patient; chemical safety assessment is not applicable. The outside of the entire assembly is fabricated from titanium, which will not chemically react with body tissue. | | | | | | Energy Delivered | 90Yttrium (half-life: 2.67 days) decays by beta emission. The 90Yttrium beta has an end-point energy of 2280 keV and an average energy of 934 keV. | 90Yttrium (half-life: 2.67 days) decays by beta emission. The 90Yttrium beta has an end-point energy of 2280 keV and an average energy of 934 keV. | | Compatibility with Environment and Other Devices | 90Yttrium is a radioactive material and should be strictly controlled. The source should only be used following the conditions and limitations specified by the licensing authority (NRC or Agreement State). The source should be stored in a shielded container with which it is used or the transport container in which it is delivered. If any source cannot be accounted for, the loss should be reported to the federal or state licensing agency. Store at normal room temperature. When disposal is indicated, sources should be disposed of in accordance with the requirements of the institution's radioactive material license. In general, these sources can be disposed of by means of a "Decay in Storage" method approved by the regulatory authority in accordance with 10 CFR 35.92 or equivalent state regulations. Because of the short halflife, sources which have been stored for 60 days may be checked for radioactive content and, if less than 5 nCi, be disposed of in normal waste. Alternatively, radioactive material should be transferred to an authorized recipient, typically the source supplier. | 90Yttrium is a radioactive material and should be strictly controlled. The source should only be used following the conditions and limitations specified by the licensing authority (NRC or Agreement State). The source should be stored in a shielded container with which it is used or the transport container in which it is delivered. If any source cannot be accounted for, the loss should be reported to the federal or state licensing agency. Store at normal room temperature. When disposal is indicated, sources should be disposed of in accordance with the requirements of the institution's radioactive material license. In general, these sources can be disposed of by means of a "Decay in Storage" method approved by the regulatory authority in accordance with 10 CFR 35.92 or equivalent state regulations. Because of the short halflife, sources which have been stored for 60 days may be checked for radioactive content and, if less than 5 nCi, be disposed of in normal waste. Alternatively, radioactive material should be transferred to an authorized recipient, typically the source supplier. | | Where Used | This source should only be used within a properly designed room following the conditions and limitations specified by the licensing authority (NRC or Agreement State). | This source should only be used within a properly designed room following the conditions and limitations specified by the licensing authority (NRC or Agreement State). | | Standards Met Mechanical | ISO 2919/ANSI N43.6 Classification C54213 | ISO 2919/ANSI N43.6 Classification C54213 | | | | | | Thermal Safety | Not Applicable | Not Applicable | | Radiation Safety | This 90Yttrium source is radioactive, and appropriate precautions must be taken during handling to minimize radiation exposure to personnel. Personnel monitoring is required. | This 90Yttrium source is radioactive, and appropriate precautions must be taken during handling to minimize radiation exposure to personnel. Personnel monitoring is required. | | | This source should only be used within a properly designed room following the conditions and limitations specified by the licensing authority (NRC or Agreement State). | This source should only be used within a properly designed room following the conditions and limitations specified by the licensing authority (NRC or Agreement State). | | | In circumstances where emergency operations must be performed, the operator should use proper applicators, maintain safe working distances and work as rapidly as safely possible to minimize radiation exposure. | In circumstances where emergency operations must be performed, the operator should use proper applicators, maintain safe working distances and work as rapidly as safely possible to minimize radiation exposure. | {5}------------------------------------------------ {6}------------------------------------------------ ### Section 807.92(b) - (7) Nonclinical Tests: ### Physical Testing The LV Liberty Vision Model 1 90yttrium Brachytherapy Source has been subjected to the tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919, as referenced in the FDA "Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources" dated 2 August 2000. Prototype sources were subjected to the tests specified in ANSI N43.6-2007 and ISO 2919-2012 and have equaled or exceeded the requirements corresponding to a classification of C53211, which is the requirement for brachytherapy sources. This is equivalent to the physical testing of the predicate device. ### Dosimetry The dose distribution around the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source was calculated by Monte Carlo simulation. This is similar to the dosimetry of the predicate device. {7}------------------------------------------------ ### (8) Clinical Tests Not Applicable - (9) Conclusions The results of the nonclinical physical testing and the dosimetric analysis, demonstrate that the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source is as safe, as effective, and performs as well as the legally marketed predicate device, LV Liberty Vision, Inc. Model 1 °Vttrium Brachytherapy Source, cleared under 510(k) number K163572 dated 15 March 2017

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

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LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

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Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

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