(158 days)
Not Found
No
The summary describes a radioactive brachytherapy source and its physical characteristics and testing. There is no mention of AI or ML in the intended use, device description, or performance studies. The device is used within a "manual brachytherapy system."
Yes
The device is a brachytherapy source indicated for the treatment of tumors and benign growths, which is a therapeutic purpose.
No
This device is a brachytherapy source used for treatment (delivering radiation), not for diagnosing conditions.
No
The device description clearly states it is a physical radioactive source encapsulated in titanium, intended for use within a manual brachytherapy system. This is a hardware device, not software.
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 application, delivering radiation directly to a tumor within the body.
- Device Description: The device is a "singly-encapsulated 90Yttrium Brachytherapy Source" containing a radioactive element. This is a source of radiation for treatment, not a device used to examine specimens from the human body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests.
The device described is a therapeutic medical device used for brachytherapy, a form of radiation therapy.
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 (comma separated list FDA assigned to the subject device)
KXK
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).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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) |
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3
Section 5 510(k) Summary
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