(86 days)
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.
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).
The provided text describes the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source and its substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria in the format requested. The document focuses on comparing the new device's technological characteristics and performance to a legally marketed predicate device (Salutaris Medical Devices, Inc. Smd Sr90-1 Radionuclide Brachytherapy Source).
However, I can extract the information provided about the nonclinical tests and their outcomes, which serve as the basis for the device's acceptance.
Here's the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative table with pass/fail thresholds for clinical performance metrics (like sensitivity, specificity, etc.) that would typically be associated with AI/medical image analysis devices. Instead, it demonstrates equivalence to a predicate device through nonclinical (physical and dosimetry) testing and technological characteristics.
The qualitative "acceptance criteria" are implied by meeting or exceeding the standards relevant to brachytherapy sources and demonstrating comparable dosimetry and safety characteristics to the predicate.
| Characteristic / Test | Acceptance Criterion (Implicit) | Reported Device Performance (LV Liberty Vision Model 1 90Yttrium Brachytherapy Source) |
|---|---|---|
| Physical Testing | Meet or exceed requirements of ANSI N43.6 and ISO 2919 for brachytherapy sources, corresponding to a classification of C53211. | Equaled or exceeded the requirements corresponding to a classification of C53211 (as per ANSI N43.6-2007 and ISO 2919-2012). This exceeds the physical testing of the predicate device. |
| Dosimetry | Comparable dose distribution to the predicate device. | Dose distribution calculated by Monte Carlo simulation, which is stated to be equivalent to the dosimetry of the predicate device. |
| Intended Use | For episcleral brachytherapy of tumors and benign growths, within a manual brachytherapy system, with individual activity up to 20 mCi (740 MBq). | Same as the stated indication for use for the device. |
| Technological Characteristics | Similar design, materials (radionuclide, encapsulation), and safety features (sterility, biocompatibility, mechanical, chemical, radiation safety, compatibility with environment and other devices, where used, standards met) to the predicate device. | Detailed comparison provided in the tables on pages 4 and 5, demonstrating similarity or better performance where applicable (e.g., physical testing explicitly states "exceeds"). Specific dose rates are provided. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not refer to a "test set" in the context of clinical data for performance evaluation in the way AI devices are typically evaluated. The "tests" mentioned are nonclinical physical and dosimetry tests. For physical testing, "Prototype sources were subjected to the tests." The exact number of prototypes isn't specified, but it's likely a small number of physical samples for laboratory testing.
- Data Provenance: Not applicable for nonclinical physical and dosimetry testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for clinical cases or image interpretations is not relevant to the nonclinical physical and dosimetry testing performed for this brachytherapy source.
4. Adjudication method for the test set
Not applicable. No expert adjudication process for clinical ground truth is described.
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
Not applicable. This device is a brachytherapy source, not an AI software or a device that assists human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. The "performance" relates to the physical and dosimetric properties of the radioactive source itself.
7. The type of ground truth used
For physical testing, the "ground truth" would be the direct measurement of physical properties and verification against defined engineering standards (ANSI N43.6 and ISO 2919).
For dosimetry, the "ground truth" is established through Monte Carlo simulation, which is a widely accepted method for calculating dose distribution in radiophysics.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of medical device evaluation.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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.155 Fleet StreetPortsmouth, New Hampshire 03801; USA; | t: 603.766.0451 |
|---|---|---|
| Establishment Registration No.: | To Be Applied For | |
| 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
- 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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| TechnologicalCharacteristic | LV Liberty VisionModel 190Yttrium BrachytherapySource | Salutaris Medical Devices, Inc.Smd Sr90-1 RadionuclideBrachytherapy Source |
|---|---|---|
| Design | The source consists of a solid 90Yttriumactive element, with a maximum diameterof 9.6 mm and a maximum thickness of0.75 mm, singly encapsulated in metallictitanium with a maximum diameter of 10mm and a maximum thickness of 1.0 mm. | The source consists of a solid90Strontium/90Yttrium pellet (0.6 mm dia x~2 mm long) singly encapsulated inmetallic stainless steel (0.8 mm dia x 3.1mm long) and attached to a capsuleleader (0.9 mm diameter x 112 mm long). |
| MaterialsRadionuclideEncapsulation | 90YttriumTitanium | 90Strontium/90YttriumStainless Steel |
| PerformanceDosimetry: | ||
| Central AxisDose 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 | 0.81 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: 0.34 Gy/min-mCi | 0.52 Gy/min-mCi |
| Sterility | This source never directly contacts thepatient; sterility is not required. | This source assembly never directlycontacts the patient; sterility is notrequired. |
| Biocompatibility | This source never directly contacts thepatient; biocompatibility assessment is notapplicable. The outside of the entireassembly is fabricated from titanium,which is a biocompatible material. | This source assembly never directlycontacts the patient; biocompatibilityassessment is not applicable. Theoutside of the entire assembly isfabricated from stainless steel, which is abiocompatible material. |
| Mechanical Safety | ISO 2919/ANSI N43.6 Class C53211Applied for New Hampshire Registration | ISO 2919/ANSI N43.6 Class C53X11Massachusetts Sealed SourceRegistrationLA-1390-S-101-S |
| Chemical Safety | 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. | This source assembly never directlycontacts the patient; chemical safetyassessment is not applicable. Theoutside of the entire assembly isfabricated from stainless steel, which willnot chemically 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. | 90Strontium/90Yttrium (half-life: 28.79years) decays by beta emission. The90Yttrium is in secular equilibrium with the90Strontium. The 90Yttrium beta has anend-point energy of 2280 keV and anaverage energy of 934 keV. The90Strontium beta has an end-point energyof 546 keV and an average energy of 196keV. The range of 196 keV betas is lessthan 0.5 mm of tissue, and therefore hasno therapeutic effect. The therapeuticeffect is virtually exclusively from the90Yttrium betas. |
| Compatibility withEnvironment andOther Devices | 90Yttrium is a radioactive material andshould be strictly controlled. | 90Strontium/90Yttrium is a radioactivematerial 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 AgreementState). | the licensing authority (NRC or AgreementState). | |
| The source should be stored in a shielded | The source should be stored in a shielded | |
| container with which it is used or thetransport container in which it is delivered. | container with which it is used or thetransport container in which it is delivered. | |
| If any source cannot be accounted for, theloss should be reported to the federal orstate licensing agency. | If any source cannot be accounted for, theloss should be reported to the federal orstate licensing agency. | |
| Store at normal room temperature. | 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 requlatory 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. | When disposal is indicated, radioactivematerial should be transferred to anauthorized recipient, typically the sourcesupplier. Radioactive material shouldnever 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 by thelicensing authority (NRC or AgreementState). | This source should only be used within aproperly designed room following theconditions and limitations specified by thelicensing authority (NRC or AgreementState). |
| Standards MetMechanical | 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, andappropriate precautions must be takenduring handling to minimize radiationexposure to personnel. Personnelmonitoring is required. | This 90Strontium/90Yttrium source isradioactive, and appropriate precautionsmust be taken during handling to minimizeradiation exposure to personnel.Personnel monitoring is required. |
| This source should only be used within aproperly designed room following theconditions and limitations specified by thelicensing authority (NRC or AgreementState). | This source should only be used within aproperly designed room following theconditions and limitations specified by thelicensing authority (NRC or AgreementState). | |
| In circumstances where emergency | In circumstances where emergency | |
| operations must be performed, theoperator should use proper applicators,maintain safe working distances and workas rapidly as safely possible to minimizeradiation exposure. | opopmaasrac |
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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.
§ 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.