LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source

K163572 · Lv Liberty Vision Corp. · KXK · Mar 15, 2017 · Radiology

Device Facts

• Record ID: K163572
• Device Name: LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
• Applicant: Lv Liberty Vision Corp.
• Product Code: KXK · Radiology
• Decision Date: Mar 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source is for the treatment of tumors and benign growths by temporary episcleral irradiation.

Device Story

LV Liberty Vision Model 1 is a singly-encapsulated Yttrium-90 brachytherapy source; consists of solid radioactive Yttrium element hermetically sealed in titanium capsule. Device attaches to manual radionuclide applicator system for temporary episcleral irradiation of tumors and benign growths. Used in clinical settings by trained personnel following licensing authority conditions. Emits beta particles for therapeutic effect. Healthcare providers use device to deliver localized radiation; output affects clinical decision-making by providing targeted treatment for ocular/surface growths. Benefits patient through localized tumor/growth control.

Clinical Evidence

No clinical data. Evidence based on bench testing (ISO 2919/ANSI N43.6 mechanical safety) and Monte Carlo dosimetric simulations.

Technological Characteristics

Solid Yttrium-90 active element; titanium encapsulation. Max source diameter 9.6mm, thickness 0.75mm. Beta emission (end-point 2280 keV, average 934 keV). Mechanical safety meets ISO 2919/ANSI N43.6 Class C53211. Manual operation; no electrical/thermal components. Sterility not required as device does not directly contact patient.

Indications for Use

Indicated for episcleral brachytherapy of tumors and benign growths. Intended for use within a manual brachytherapy system.

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

• Salutaris Medical Devices, Inc. Smd Sr90-1 Radionuclide Brachytherapy Source (K142701)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 15, 2017

LV Liberty Vision Corp. % Paul T. Finger, M.D. Chief Executive Officer 155 Fleet Street PORTSMOUTH NH 03801

Re: K163572

Trade/Device Name: LV Liberty Vision Model 1 90 ttrium Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: December 11, 2016 Received: December 19, 2016

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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Paul T. Finger, M.D.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

K163572

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) |

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## Section 5 510(k) Summary

Section 807.92(a)

| (1) Submitter | LV Liberty Vision Corp.<br>155 Fleet Street<br>Portsmouth, New Hampshire 03801; USA; | t: 603.766.0451 |
|------------------|-----------------------------------------------------------------------------------------------|-------------------|
| | Establishment Registration No.: | To Be Applied For |
| | Contact Person: Paul T. Finger, MD<br>Chief Executive Officer<br>e: [e-mail] | |
| (2) Device Name: | | |

### Classification Name: Radionuclide Brachytherapy Source (892.5730) (90 KXK) Common or Usual Name: Brachytherapy Source

- LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source Proprietary Name:
- (3) Legally Marketed Predicate Device:

Salutaris Medical Devices, Inc. Smd Sr90-1 Radionuclide Brachytherapy Source, cleared under 510(k) number K142701 dated 24 April 2015

- (4) Description of LV Liberty Vision Model 1 90Yttrium Brachytherapy Source:
LV Liberty Vision Model 1 ®Yttrium Brachytherapy Source is a singly-encapsulated ®º (ttrium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive ®Yttrium 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
The intended use of the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source is for the treatment of tumors and benign growths by temporary episcleral irradiation.

- (6) Technological Characteristics:
LV Liberty Vision Model 1 90 ttrium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source that utilizes beta particles from 90Yttrium.

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| Technological<br>Characteristic | LV Liberty Vision<br>Model 190Yttrium Brachytherapy<br>Source | Salutaris Medical Devices, Inc.<br>Smd Sr90-1 Radionuclide<br>Brachytherapy Source |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The source consists of a solid 90Yttrium<br>active element, with a maximum diameter<br>of 9.6 mm and a maximum thickness of<br>0.75 mm, singly encapsulated in metallic<br>titanium with a maximum diameter of 10<br>mm and a maximum thickness of 1.0 mm. | The source consists of a solid<br>90Strontium/90Yttrium pellet (0.6 mm dia x<br>~2 mm long) singly encapsulated in<br>metallic stainless steel (0.8 mm dia x 3.1<br>mm long) and attached to a capsule<br>leader (0.9 mm diameter x 112 mm long). |
| Materials<br>Radionuclide<br>Encapsulation | 90Yttrium<br>Titanium | 90Strontium/90Yttrium<br>Stainless Steel |
| Performance<br>Dosimetry: | | |
| Central Axis<br>Dose Rate at 0.6 mm | 6 mm dia source: 1.02 Gy/min-mCi<br>8 mm dia source: 0.62 Gy/min-mCi<br>10 mm dia source: 0.42 Gy/min-mCi | 0.81 Gy/min-mCi |
| Dose Rate at 1.0 mm | 6 mm dia source: 0.81 Gy/min-mCi<br>8 mm dia source: 0.50 Gy/min-mCi<br>10 mm dia source: 0.34 Gy/min-mCi | 0.52 Gy/min-mCi |
| Sterility | This source never directly contacts the<br>patient; sterility is not required. | This source assembly never directly<br>contacts the patient; sterility is not<br>required. |
| Biocompatibility | This source never directly contacts the<br>patient; biocompatibility assessment is not<br>applicable. The outside of the entire<br>assembly is fabricated from titanium,<br>which is a biocompatible material. | This source assembly never directly<br>contacts the patient; biocompatibility<br>assessment is not applicable. The<br>outside of the entire assembly is<br>fabricated from stainless steel, which is a<br>biocompatible material. |
| Mechanical Safety | ISO 2919/ANSI N43.6 Class C53211<br>Applied for New Hampshire Registration | ISO 2919/ANSI N43.6 Class C53X11<br>Massachusetts Sealed Source<br>Registration<br>LA-1390-S-101-S |
| Chemical Safety | This source assembly never directly<br>contacts the patient; chemical safety<br>assessment is not applicable. The<br>outside of the entire assembly is<br>fabricated from titanium, which will not<br>chemically react with body tissue. | This source assembly never directly<br>contacts the patient; chemical safety<br>assessment is not applicable. The<br>outside of the entire assembly is<br>fabricated from stainless steel, which will<br>not chemically react with body tissue. |
| Energy Delivered | 90Yttrium (half-life: 2.67 days) decays by<br>beta emission. The 90Yttrium beta has an<br>end-point energy of 2280 keV and an<br>average energy of 934 keV. | 90Strontium/90Yttrium (half-life: 28.79<br>years) decays by beta emission. The<br>90Yttrium is in secular equilibrium with the<br>90Strontium. The 90Yttrium beta has an<br>end-point energy of 2280 keV and an<br>average energy of 934 keV. The<br>90Strontium beta has an end-point energy<br>of 546 keV and an average energy of 196<br>keV. The range of 196 keV betas is less<br>than 0.5 mm of tissue, and therefore has<br>no therapeutic effect. The therapeutic<br>effect is virtually exclusively from the<br>90Yttrium betas. |
| | | |
| Compatibility with<br>Environment and<br>Other Devices | 90Yttrium is a radioactive material and<br>should be strictly controlled. | 90Strontium/90Yttrium is a radioactive<br>material and should be strictly controlled. |
| | The source should only be used following | The source should only be used following |
| | the conditions and limitations specified by | the conditions and limitations specified by |
| | the licensing authority (NRC or Agreement<br>State). | the licensing authority (NRC or Agreement<br>State). |
| | The source should be stored in a shielded | The source should be stored in a shielded |
| | container with which it is used or the<br>transport container in which it is delivered. | container with which it is used or the<br>transport container in which it is delivered. |
| | If any source cannot be accounted for, the<br>loss should be reported to the federal or<br>state licensing agency. | If any source cannot be accounted for, the<br>loss should be reported to the federal or<br>state licensing agency. |
| | Store at normal room temperature. | Store at normal room temperature. |
| | When disposal is indicated, sources<br>should be disposed of in accordance with<br>the requirements of the institution's<br>radioactive material license. In general,<br>these sources can be disposed of by<br>means of a "Decay in Storage" method<br>approved by the requlatory authority in<br>accordance with 10 CFR 35.92 or<br>equivalent state regulations. Because of<br>the short halflife, sources which have<br>been stored for 60 days may be checked<br>for radioactive content and, if less than 5<br>nCi, be disposed of in normal waste. | When disposal is indicated, radioactive<br>material should be transferred to an<br>authorized recipient, typically the source<br>supplier. Radioactive material should<br>never be disposed of in normal waste. |
| | | |
| | Alternatively, radioactive material should<br>be transferred to an authorized recipient,<br>typically the source supplier. | |
| Where Used | This source should only be used within a<br>properly designed room following the<br>conditions and limitations specified by the<br>licensing authority (NRC or Agreement<br>State). | This source should only be used within a<br>properly designed room following the<br>conditions and limitations specified by the<br>licensing authority (NRC or Agreement<br>State). |
| Standards Met<br>Mechanical | ISO 2919/ANSI N43.6 | ISO 2919/ANSI N43.6 |
| Electrical Safety | Not Applicable | Not Applicable |
| Thermal Safety | Not Applicable | Not Applicable |
| Radiation Safety | This 90Yttrium source is radioactive, and<br>appropriate precautions must be taken<br>during handling to minimize radiation<br>exposure to personnel. Personnel<br>monitoring is required. | This 90Strontium/90Yttrium source is<br>radioactive, and appropriate precautions<br>must be taken during handling to minimize<br>radiation exposure to personnel.<br>Personnel monitoring is required. |
| | This source should only be used within a<br>properly designed room following the<br>conditions and limitations specified by the<br>licensing authority (NRC or Agreement<br>State). | This source should only be used within a<br>properly designed room following the<br>conditions and limitations specified by the<br>licensing authority (NRC or Agreement<br>State). |
| | In circumstances where emergency | In circumstances where emergency |
| operations must be performed, the<br>operator should use proper applicators,<br>maintain safe working distances and work<br>as rapidly as safely possible to minimize<br>radiation exposure. | op<br>op<br>ma<br>as<br>rac | |

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ions must be performed, the or should use proper applicators, ain safe working distances and work idly as safely possible to minimize on exposure.

### Section 807.92(b)

- (7) Nonclinical Tests
### Physical Testing

The LV Liberty Vision Model 1 90 Yttrium 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 exceeds to the physical testing of the predicate device.

#### Dosimetry

The dose distribution around the LV Liberty Vision Model 1 90 fttrium Brachytherapy Source was calculated by Monte Carlo simulation. This is equivalent to the dosimetry of the predicate device.

- (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 ** Yttrium Brachytherapy Source is as safe, as effective, and performs as well or better than the legally marketed predicate device, Salutaris Medical Devices, Inc. Smd Sr90-1 Radionuclide Brachytherapy Source, cleared under 510(k) number K142701 dated 24 April 2015.