LV Liberty Vision Model 1 90Yttrium Brachytherapy Source by LV Liberty Vision Corporation

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.

Device Description

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).

AI/ML Overview

The provided document is a 510(k) summary for the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source. It describes the device, its intended use, and a comparison to a legally marketed predicate device (K163572), also the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source. This submission focuses on demonstrating substantial equivalence to an existing device rather than establishing novel performance metrics through clinical trials or standalone AI studies.

Here's an analysis based on your requested information:

1. Table of acceptance criteria and reported device performance

The document does not specify general "acceptance criteria" in the sense of performance targets for a new AI/diagnostic device. Instead, it demonstrates equivalence to a predicate device through physical and dosimetric characteristics.

Characteristic	Acceptance Criteria (Predicate Device Performance - K163572)	Reported Device Performance (LV Liberty Vision Model 1 - This Version)
Design: 90Yttrium Active Element	Max diameter: 9.6 mm, Max thickness: 0.75 mm	Max diameter: 9.4 mm, Max thickness: 0.25 mm
Encapsulation Material	Titanium	Titanium
Central Axis Dose Rate at 0.6 mm	6 mm dia source: 1.02 Gy/min-mCi8 mm dia source: 0.62 Gy/min-mCi10 mm dia source: 0.42 Gy/min-mCi	6 mm dia source: 1.08 Gy/min-mCi8 mm dia source: 0.63 Gy/min-mCi10 mm dia source: 0.40 Gy/min-mCi
Central Axis Dose Rate at 1.0 mm	6 mm dia source: 0.81 Gy/min-mCi8 mm dia source: 0.50 Gy/min-mCi10 mm dia source: 0.34 Gy/min-mCi	6 mm dia source: 0.81 Gy/min-mCi8 mm dia source: 0.50 Gy/min-mCi10 mm dia source: 0.32 Gy/min-mCi
Sterility Requirement	Not required (did not directly contact patient)	Required (may directly contact patient)
Biocompatibility Assessment	Not applicable (did not directly contact patient)	Required (outside of assembly fabricated from biocompatible titanium)
Mechanical Safety Standard	ISO 2919/ANSI N43.6 Class C53211	ISO 2919/ANSI N43.6 Class C53211
Chemical Safety Assessment	Not applicable (did not directly contact patient)	Required (outside of assembly fabricated from titanium, will not chemically react with body tissue)
Mechanical Standards Met	ISO 2919/ANSI N43.6 Classification C54213	ISO 2919/ANSI N43.6 Classification C54213

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the "acceptance criteria" (defined here as demonstrating substantial equivalence to the predicate device) is documented through nonclinical physical testing and dosimetric analysis.

Physical Testing: Prototype sources of the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source were subjected to tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919. The results "equaled or exceeded the requirements corresponding to a classification of C53211," which is the requirement for brachytherapy sources. This was deemed equivalent to the physical testing of the predicate device (K163572).
Dosimetry: The dose distribution around the new device was calculated by Monte Carlo simulation. This was stated to be "similar to the dosimetry of the predicate device."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document refers to testing of "prototype sources." It does not specify a numerical sample size but implies a sufficient number of prototypes were tested to satisfy the standards.
Data Provenance: Not explicitly stated, however, the testing standards (ANSI and ISO) are international. The company is based in Portsmouth, New Hampshire, USA. The testing would have been conducted to demonstrate compliance with US FDA requirements. The data is prospective in the sense that physical and dosimetric measurements/simulations were performed on the prototypes or models of this specific device to demonstrate its properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the study involves physical and dosimetric testing against established engineering standards (ANSI, ISO) and computational simulations (Monte Carlo), not clinical data requiring expert human interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable for physical and dosimetric testing. Adjudication methods are typically relevant for clinical studies where human expert consensus is used to establish ground truth for image or diagnostic interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a brachytherapy source, a physical medical device, not an AI or diagnostic software tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. As stated above, this is a physical medical device, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the physical testing and dosimetry, the "ground truth" is based on:

Established Engineering Standards: ANSI N43.6 and ISO 2919 provide objective pass/fail criteria and specifications for brachytherapy sources.
Physics Principles and Computational Models: Monte Carlo simulations for dosimetry are based on established physics principles to calculate dose distribution.

8. The sample size for the training set

This is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This is not applicable as there is no training set.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K193602

Device Name

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

Indications for Use (Describe)

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

K193602

Section 807.92(a)

(1) Submitter	LV Liberty Vision Corp.300 West Road, Unit 2Portsmouth, New Hampshire 03801; USA;	t: 603.319.8416
	Establishment Registration No.: 3015042204
	Contact Person: Paul T. Finger, MDChief Executive Officere: 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.

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(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.

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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.

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(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

Regulation Number and Section

§ 892.5730 Radionuclide brachytherapy source.

(a)
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.(b)
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.

TechnologicalCharacteristic	LV Liberty VisionModel 1 90Yttrium Brachytherapy Source(This Version)	LV Liberty VisionModel 1 90Yttrium Brachytherapy Source(K163572)
Design	The source consists of a solid 90Yttriumactive element, with a maximumdiameter of 9.4 mm and a maximumthickness of 0.25 mm, singlyencapsulated in metallic titanium with amaximum diameter of 10 mm and amaximum thickness of 1.0 mm.	The source consists of a solid 90Yttriumactive element, with a maximumdiameter of 9.6 mm and a maximumthickness of 0.75 mm, singlyencapsulated in metallic titanium with amaximum diameter of 10 mm and amaximum thickness of 1.0 mm.
MaterialsRadionuclideEncapsulation	90YttriumTitanium	90YttriumTitanium
PerformanceDosimetry:
Central AxisDose Rate at 0.6 mm	6 mm dia source:1.08 Gy/min-mCi8 mm dia source:0.63 Gy/min-mCi10 mm dia source:0.40 Gy/min-mCi	6 mm dia source:1.02 Gy/min-mCi8 mm dia source:0.62 Gy/min-mCi10 mm dia source:0.42 Gy/min-mCi
Dose Rate at 1.0 mm	6 mm dia source:0.81 Gy/min-mCi8 mm dia source:0.50 Gy/min-mCi10 mm dia source:0.32 Gy/min-mCi	6 mm dia source:0.81 Gy/min-mCi8 mm dia source:0.50 Gy/min-mCi10 mm dia source:0.34 Gy/min-mCi
Sterility	This source may directly contact thepatient and therefore sterility is required.	This source never directly contacts thepatient; sterility is not required.
Biocompatibility	The outside of the entire assembly isfabricated from titanium, which is abiocompatible material.	This source never directly contacts thepatient; biocompatibility assessment isnot applicable. The outside of the entireassembly is fabricated from titanium,which is a biocompatible material.
Mechanical Safety	ISO 2919/ANSI N43.6 Class C53211Applied for New Hampshire Registration	ISO 2919/ANSI N43.6 Class C53211Applied for New Hampshire Registration
Chemical Safety	The outside of the entire assembly isfabricated from titanium, which will notchemically react with body tissue.	This source assembly never directlycontacts the patient; chemical safetyassessment is not applicable. Theoutside of the entire assembly isfabricated from titanium, which will notchemically react with body tissue.

Energy Delivered	90Yttrium (half-life: 2.67 days) decays bybeta emission. The 90Yttrium beta has anend-point energy of 2280 keV and anaverage energy of 934 keV.	90Yttrium (half-life: 2.67 days) decays bybeta emission. The 90Yttrium beta has anend-point energy of 2280 keV and anaverage energy of 934 keV.
Compatibility withEnvironment andOther Devices	90Yttrium is a radioactive material andshould be strictly controlled.The source should only be used followingthe conditions and limitations specifiedby the licensing authority (NRC orAgreement State).The source should be stored in a shieldedcontainer with which it is used or thetransport container in which it isdelivered.If any source cannot be accounted for,the loss should be reported to thefederal or state licensing agency.Store at normal room temperature.When disposal is indicated, sourcesshould be disposed of in accordance withthe requirements of the institution'sradioactive material license. In general,these sources can be disposed of bymeans of a "Decay in Storage" methodapproved by the regulatory authority inaccordance with 10 CFR 35.92 orequivalent state regulations. Because ofthe short halflife, sources which havebeen stored for 60 days may be checkedfor radioactive content and, if less than 5nCi, be disposed of in normal waste.Alternatively, radioactive material shouldbe transferred to an authorized recipient,typically the source supplier.	90Yttrium is a radioactive material andshould be strictly controlled.The source should only be used followingthe conditions and limitations specifiedby the licensing authority (NRC orAgreement State).The source should be stored in a shieldedcontainer with which it is used or thetransport container in which it isdelivered.If any source cannot be accounted for,the loss should be reported to thefederal or state licensing agency.Store at normal room temperature.When disposal is indicated, sourcesshould be disposed of in accordance withthe requirements of the institution'sradioactive material license. In general,these sources can be disposed of bymeans of a "Decay in Storage" methodapproved by the regulatory authority inaccordance with 10 CFR 35.92 orequivalent state regulations. Because ofthe short halflife, sources which havebeen stored for 60 days may be checkedfor radioactive content and, if less than 5nCi, be disposed of in normal waste.Alternatively, radioactive material shouldbe transferred to an authorized recipient,typically the source supplier.
Where Used	This source should only be used within aproperly designed room following theconditions and limitations specified bythe licensing authority (NRC orAgreement State).	This source should only be used within aproperly designed room following theconditions and limitations specified bythe licensing authority (NRC orAgreement State).
Standards MetMechanical	ISO 2919/ANSI N43.6Classification C54213	ISO 2919/ANSI N43.6Classification C54213

Thermal Safety	Not Applicable	Not Applicable
Radiation Safety	This 90Yttrium source is radioactive, andappropriate precautions must be takenduring handling to minimize radiationexposure to personnel. Personnelmonitoring is required.	This 90Yttrium source is radioactive, andappropriate precautions must be takenduring handling to minimize radiationexposure to personnel. Personnelmonitoring is required.
	This source should only be used within aproperly designed room following theconditions and limitations specified bythe licensing authority (NRC orAgreement State).	This source should only be used within aproperly designed room following theconditions and limitations specified bythe licensing authority (NRC orAgreement State).
	In circumstances where emergencyoperations must be performed, theoperator should use proper applicators,maintain safe working distances andwork as rapidly as safely possible tominimize radiation exposure.	In circumstances where emergencyoperations must be performed, theoperator should use proper applicators,maintain safe working distances andwork as rapidly as safely possible tominimize radiation exposure.