(86 days)
Not Found
No
The summary describes a radioactive brachytherapy source and its physical characteristics and testing, with no mention of AI or ML.
Yes
The device is a brachytherapy source indicated for the treatment of tumors and benign growths, which is a therapeutic purpose.
No
Explanation: The device is a brachytherapy source used for treatment (episcleral brachytherapy of tumors and benign growths), not for diagnosis.
No
The device description clearly states it is a physical radioactive source encapsulated in titanium, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "episcleral brachytherapy of tumors and benign growths." This is a therapeutic procedure performed directly on a patient's tissue (episcleral).
- Device Description: The device is a "radioactive ®Yttrium element" contained within a capsule, intended to be attached to a "manual radionuclide applicator system." This describes a source of radiation for treatment, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis
- Reagents, calibrators, or controls
This device is a therapeutic medical device used for delivering radiation directly to a tumor or growth.
N/A
Intended Use / Indications for Use
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.
Product codes
KXK
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
episcleral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Clinical Tests: Not Applicable
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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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3
Section 5 510(k) Summary
Section 807.92(a)
| (1) Submitter | LV Liberty Vision Corp.
155 Fleet Street
Portsmouth, New Hampshire 03801; USA; | t: 603.766.0451 |
|------------------|-----------------------------------------------------------------------------------------------|-------------------|
| | Establishment Registration No.: | To Be Applied For |
| | 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
- 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.
4
| Technological
Characteristic | LV Liberty Vision
Model 190Yttrium Brachytherapy
Source | Salutaris Medical Devices, Inc.
Smd Sr90-1 Radionuclide
Brachytherapy Source |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | 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. | The source consists of a solid
90Strontium/90Yttrium pellet (0.6 mm dia x
~2 mm long) singly encapsulated in
metallic stainless steel (0.8 mm dia x 3.1
mm long) and attached to a capsule
leader (0.9 mm diameter x 112 mm long). |
| Materials
Radionuclide
Encapsulation | 90Yttrium
Titanium | 90Strontium/90Yttrium
Stainless Steel |
| Performance
Dosimetry: | | |
| Central Axis
Dose Rate at 0.6 mm | 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 | 0.81 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: 0.34 Gy/min-mCi | 0.52 Gy/min-mCi |
| Sterility | This source never directly contacts the
patient; sterility is not required. | This source assembly never directly
contacts the patient; sterility is not
required. |
| Biocompatibility | 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. | This source assembly never directly
contacts the patient; biocompatibility
assessment is not applicable. The
outside of the entire assembly is
fabricated from stainless steel, 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 C53X11
Massachusetts Sealed Source
Registration
LA-1390-S-101-S |
| Chemical Safety | 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. | This source assembly never directly
contacts the patient; chemical safety
assessment is not applicable. The
outside of the entire assembly is
fabricated from stainless steel, 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. | 90Strontium/90Yttrium (half-life: 28.79
years) decays by beta emission. The
90Yttrium is in secular equilibrium with the
90Strontium. The 90Yttrium beta has an
end-point energy of 2280 keV and an
average energy of 934 keV. The
90Strontium beta has an end-point energy
of 546 keV and an average energy of 196
keV. The range of 196 keV betas is less
than 0.5 mm of tissue, and therefore has
no therapeutic effect. The therapeutic
effect is virtually exclusively from the
90Yttrium betas. |
| | | |
| Compatibility with
Environment and
Other Devices | 90Yttrium is a radioactive material and
should be strictly controlled. | 90Strontium/90Yttrium is a radioactive
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
State). | the licensing authority (NRC or Agreement
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
transport container in which it is delivered. | 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. | If any source cannot be accounted for, the
loss should be reported to the federal or
state licensing agency. |
| | Store at normal room temperature. | 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 requlatory 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. | When disposal is indicated, radioactive
material should be transferred to an
authorized recipient, typically the source
supplier. Radioactive material should
never 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 | 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
appropriate precautions must be taken
during handling to minimize radiation
exposure to personnel. Personnel
monitoring is required. | This 90Strontium/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 | 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. | op
op
ma
as
rac | |
5
6
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.