ANT MODEL 1

K141038 · Advanced Nuclide Technologies, LLC · KXK · Nov 12, 2014 · Radiology

Device Facts

• Record ID: K141038
• Device Name: ANT MODEL 1
• Applicant: Advanced Nuclide Technologies, LLC
• Product Code: KXK · Radiology
• Decision Date: Nov 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of ANT Model 1 Brachytherapy Source is for the treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application.

Device Story

ANT Model 1 is a singly-encapsulated brachytherapy source containing either Ytterbium-169 or Iodine-125. Device consists of a solid radioactive pellet inside a titanium capsule, sealed with a laser-welded titanium plug. Emits gamma and characteristic x-rays for localized tumor radiation therapy. Used in operating rooms by clinicians for interstitial, intracavitary, intraluminal, or intraoperative implantation. Provides targeted radiation to tumors; intended to treat localized cancer, including unresectable or residual disease. Clinicians use device to deliver therapeutic radiation doses to tumor sites, potentially improving patient outcomes by destroying malignant tissue while sparing surrounding healthy structures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and dosimetric analysis. Physical testing confirmed compliance with ANSI N43.6-2007 and ISO 2919-2012 standards (classification C53211). Dosimetry was validated via Monte Carlo simulation per AAPM and ESTRO recommendations.

Technological Characteristics

Singly-encapsulated brachytherapy source. Materials: Medical grade titanium capsule, solid Ytterbium-169 or Iodine-125 pellet. Dimensions: 0.85 mm diameter x 4.5 mm length. Energy source: Radioactive decay (gamma/x-ray emission). Standards: ANSI N43.6, ISO 2919, AAPM TG-43. Sterilization: Non-sterile, user-sterilized. Connectivity: None.

Indications for Use

Indicated for temporary or permanent interstitial, intracavitary, intraluminal, or intraoperative implantation or surface application to treat localized tumors, including unresectable tumors or residual disease after excision of primary/recurrent tumors (e.g., lung, head, neck, pancreas, prostate, breast). May be used concurrently with or following external beam therapy or chemotherapy.

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

• Implant Sciences Corp. I-Plant Model 3500 (125Iodine Brachytherapy Seed) (K994317)
• Source Production & Equipment Co., Inc. Model M-31 (K090366)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or a stylized human figure, composed of three overlapping profiles.

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

November 12, 2014

Advanced Nuclide Technologies, LLC % Sergey Baklanov, Ph.D. President 21756 Green Stable Sgare. #309 ASHBURN VA 20147

Re: K141038 Trade/Device Name: ANT Model 1 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: November 3, 2014 Received: November 6, 2014

Dear Dr. Baklanov:

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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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 D'Hara
for

Janine M. Morris 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) K141038

#### Device Name

Advanced Nuclide Technologies LLC (ANT) Model 1 Brachytherapy Source

Indications for Use (Describe)

Advanced Nuclide Technologies LLC (ANT) Model 1 Brachytherapy Sources, with individual activities up to 5 mCi (185 MBq), are indicated for temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application to treat selected localized tumors. They can be used either as primary treatment for unresectable tumors, or as treatment for residual disease after excision of primary or recurrent tumors such as for lung cancer. ANT Model 1 Brachytherapy Source may be used concurrently with or following treatment with other interventions, such as external beam therapy, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate, breast and other accessible tumors are commonly treated.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# P 510(k) Summary

# Section 807.92(a)

| (1) | Submitter | Advanced Nuclide Technologies, LLC<br>21756, Green Stable Sq., #309<br>Ashburn, VA 20147 | | t: | 267.253.2271 |
|-----|-----------|------------------------------------------------------------------------------------------|------------------------------------------------------------------|----|-------------------|
| | | Establishment Registration No.: | | | To Be Applied For |
| | | Contact Person: | Sergey Baklanov, Ph. D., President<br>e-mail: [e-mail] | | |
| | | Date Prepared: | 18 June 2014 | | |

- Device Name: (2)

| Classification Name: | Radionuclide Brachytherapy Source (892.5730) (90 KXK) |
|----------------------|-------------------------------------------------------|
|----------------------|-------------------------------------------------------|

| Common or Usual Name: | Brachythe |
|-----------------------|-----------|
|-----------------------|-----------|

Proprietary Name: ANT Model 1

- (3) Legally Marketed Predicate Devices:
Implant Sciences Corp. I-Plant Model 3500 (1251odine Brachytherapy Seed) cleared under 510(k) number K994317 dated 21 March 2000

and

Source Production & Equipment Co., Inc. Model M-31, cleared under 510(k) number K090366 dated 22 April 2009

- (4) Description of ANT Model 1 Brachytherapy Source:
ANT Model 1 is a singly-encapsulated Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive material. There are two versions of the ANT Model 1. The ANT Model 1 Type-Y contains a solid 199Ytterbium pellet. The ANT Model 1 Type-I contains a solid nonradioactive Ytterbium pellet onto which is plated radioactive 1251odine. In both cases, the capsule which contains the pellet consists of a deep-drawn titanium can which is closed on the end with a titanium plug which is laser-welded to the can.

The ANT Model 1 Brachytherapy Source emits gamma rays and characteristic x-rays from the decay of the respective radionuclides.

- (5) Intended Use
The intended use of ANT Model 1 Brachytherapy Source is for the treatment of cancer by temporary or permanent interstitial, intracavitary, intraluminal or intraoperative implantation or surface application.

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#### (6) Technological Characteristics:

The ANT Model 1 Brachytherapy Source is similar to the predicate low dose rate
brachytherapy source and utilizes photons from either 16°Ytterbium or 1251odine.

| Technological<br>Characteristic | Advanced Nuclide<br>Technologies, LLC (ANT)<br>Model 1 Brachytherapy<br>Source | Source Production &<br>Equipment Co., Inc. (SPEC)<br>M-31 169Ytterbium<br>Brachytherapy Source<br>K090366 | Implant Sciences Corp.<br>I-Plant Model 3500 (125Iodine<br>Brachytherapy Seed)<br>K994317 |
|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The source consists of a solid<br>Ytterbium rod (0.5 mm dia x<br>3.0 mm long) singly<br>encapsulated. The capsule<br>(0.85 mm dia x 4.5 mm long)<br>is titanium. The capsule is<br>seal welded. | The source consists of a solid<br>169Ytterbium rod (0.25 mm dia<br>x 1.25 mm long) singly<br>encapsulated. The capsule<br>(0.42 mm dia x 5.1 mm long)<br>is titanium. The capsule is<br>seal welded. | I-Plant Model 3500 (125Iodine<br>Brachytherapy Seed) consists<br>of a laser-welded titanium<br>capsule containing a silica<br>tube that serves as a<br>substrate for the radioactive<br>125Iodine source. The tube is<br>positioned around a silver<br>radiopaque x-ray marker that<br>identifies the source location<br>and orientation. The seeds<br>are provided non-sterile. |
| Materials<br>Radionuclide<br>Encapsulation | 169Ytterbium OR 125Iodine<br>Titanium (Medical Grade) | 169Ytterbium<br>Titanium (Medical Grade) | 125Iodine<br>Titanium (Medical Grade) |
| Performance<br>Dosimetry (TG43)<br>Dose Rate Const (λ)<br>Anisotropy (φav):<br>Radial Dose Fn: | (169Yb): 1.20 cGy h-1 U-1<br>(125I): 1.00 cGy h-1 U-1<br>(169Yb): 0.95<br>(125I): 0.93<br>Shown in Figure 1 | 1.24 cGy h-1 U-1<br>0.99<br>Shown in Figure 11 | 1.01 cGy h-1 U-1<br>0.95<br>Shown in Figure 12 |
| Sterility | Sources are non-sterile when<br>shipped. Sources are<br>sterilized by the user. | Sources are non-sterile when<br>shipped. Sources are<br>sterilized by the user. | Seeds are non-sterile when<br>shipped. Seeds are sterilized<br>by the user. |
| Biocompatibility | The outer encapsulation of the<br>ANT Model 1 Brachytherapy<br>Source is medical grade<br>titanium, which has been<br>determined to be<br>biocompatible in a large<br>number of medical devices. | The outer encapsulation of the<br>SPEC M31 169Ytterbium<br>Brachytherapy Source is<br>medical grade titanium, which<br>has been determined to be<br>biocompatible in a large<br>number of medical devices. | The outer encapsulation of the<br>I-Plant Model 3500 (125Iodine<br>Brachytherapy Seed) is<br>medical grade titanium, which<br>has been determined to be<br>biocompatible in a large<br>number of medical devices. |
| Mechanical Safety | ANSI N43.6 Class C54212 | ANSI N43.6 Class C54212 | ANSI N43.6 Class C54213 |
| Energy Delivered | For the ANT Model 1 Type-Y:<br>169Ytterbium (half-life: 32.02<br>days) which decays by<br>electron capture with the<br>emission of characteristic<br>photons and electrons. The<br>electrons are absorbed by the<br>titanium wall of the source<br>encapsulation. The principal<br>photon emissions are 50, 51, | 169Ytterbium (half-life: 32.02<br>days) which decays by<br>electron capture with the<br>emission of characteristic<br>photons and electrons. The<br>electrons are absorbed by the<br>titanium wall of the source<br>encapsulation. The principal<br>photon emissions are 50, 51,<br>57 and 59 keV x-rays and a | 125Iodine (half-life: 59.43 days)<br>which decays by electron<br>capture with the emission of<br>characteristic photons and<br>electrons. The electrons are<br>absorbed by the titanium wall<br>of the seed. The principal<br>photon emissions are 27.4<br>and 31.4 keV x-rays and a<br>35.5 keV gamma. Also |
| | 63, 94, 110, 118, 131, 177,<br>198, 261 and 308 keV<br>gammas.<br>For the ANT Model 1 Type-I:<br>125Iodine (half-life: 59.43 days)<br>which decays by electron<br>capture with the emission of<br>characteristic photons and<br>electrons. The electrons are<br>absorbed by the titanium wall<br>of the source. The principal<br>photon emissions are 27.4<br>and 31.4 keV x-rays and a<br>35.5 keV gamma. Also<br>emitted are 22.1 and 25.2 keV<br>fluorescent x-rays from the<br>silver substrate. | 198, 261 and 308 keV<br>gammas. | fluorescent x-rays from the<br>silver marker. |
| Compatibility with<br>Environment and<br>Other Devices | 169Ytterbium and 125Iodine are<br>radioactive materials and<br>should be strictly controlled. If<br>any source cannot be<br>accounted for, the loss should<br>be reported to the federal or<br>state licensing agency.<br>The source should only be<br>used following the conditions<br>and limitations specified by<br>the licensing authority (NRC<br>or Agreement State).<br>The source should be stored<br>in a shielded container, either<br>the transport container in<br>which it is delivered or other<br>suitable container.<br>Store at normal room<br>temperature.<br>When disposal is indicated,<br>radioactive material should be<br>transferred to an authorized<br>recipient, typically the source<br>supplier. Radioactive material<br>should never be disposed of in<br>normal waste. | 169Ytterbium is a radioactive<br>material and should be strictly<br>controlled.<br>The source should only be<br>used following the conditions<br>and limitations specified by<br>the licensing authority (NRC<br>or Agreement State).<br>The source should be stored<br>in a shielded container, either<br>the transport container in<br>which it is delivered or other<br>suitable container.<br>If any source cannot be<br>accounted for, the loss should<br>be reported to the federal or<br>state licensing agency.<br>Store at normal room<br>temperature.<br>When disposal is indicated,<br>radioactive material should be<br>transferred to an authorized<br>recipient, typically the source<br>supplier. Radioactive material<br>should never be disposed of in<br>normal waste. | 125Iodine is a radioactive<br>material and should be strictly<br>controlled. If any significant<br>material cannot be accounted<br>for, the loss should be<br>reported to the federal or state<br>licensing agency.<br>When disposal is indicated,<br>radioactive material should be<br>transferred to an authorized<br>radioactive waste disposal<br>agency. Radioactive material<br>should never be disposed of in<br>normal waste. |
| Where Used | ANT Model 1 Brachytherapy<br>Source is designed to be<br>opened and used in the<br>operating room. | SPEC Model M31<br>Brachytherapy Source is<br>designed to be opened and<br>used in the operating room. | I-Plant Model 3500 (125Iodine<br>Brachytherapy Seed) is<br>designed to be opened and<br>used in the operating room. |
| Standards Met<br>Mechanical<br>Dosimetry | ANSI N43.6<br>AAPM TG-43 | ANSI N43.6<br>AAPM TG-43 | ANSI N43.6<br>AAPM TG-43 |
| Electrical Safety | Not Applicable | Not Applicable | Not Applicable |
| Thermal Safety | Not Applicable | Not Applicable | Not Applicable |
| Radiation Safety | These 169Ytterbium and<br>125Iodine sources are<br>radioactive, and appropriate<br>precautions must be taken<br>during handling to minimize<br>radiation exposure to<br>personnel. Personnel<br>monitoring is required.<br><br>This sources should be<br>handled with as much<br>distance as practical between<br>sources and the operator.<br><br>Any manipulation of ANT<br>Model 1 sources should be<br>carried out behind shielding of<br>adequate thickness.<br><br>The first half value thickness<br>of lead for 169Ytterbium is 0.25<br>mm. A 6.7 mm lead sheet will<br>provide >99% reduction in<br>exposure.<br><br>The half value thickness of<br>lead for 125Iodine is 0.025 mm.<br>Thus, a 0.25 mm lead sheet<br>will provide >99% reduction in<br>exposure. | This 169Ytterbium source is<br>radioactive, and appropriate<br>precautions must be taken<br>during handling to minimize<br>radiation exposure to<br>personnel. Personnel<br>monitoring is required.<br><br>This source should be<br>handled with as much<br>distance as practical between<br>sources and the operator.<br><br>Any manipulation of SPEC<br>Model M31 sources should be<br>carried out behind shielding of<br>adequate thickness. The first<br>half value thickness of lead for<br>169Ytterbium is 0.25 mm. A 6.7<br>mm lead sheet will provide<br>>99% reduction in exposure. | I-Plant Model 3500 (125Iodine<br>Brachytherapy Seed) is<br>radioactive, and appropriate<br>precautions must be taken<br>during handling to minimize<br>radiation exposure to<br>personnel. Personnel<br>monitoring is required.<br><br>I-Plant Model 3500 (125Iodine<br>Brachytherapy Seed) should<br>be handled with forceps only<br>and with as much distance as<br>practical between seeds and<br>the operator.<br><br>Any manipulation of I-Plant<br>Model 3500 (125Iodine<br>Brachytherapy Seed) should<br>be carried out behind<br>shielding of adequate<br>thickness. The half value<br>thickness of lead for 125Iodine<br>is 0.025 mm. Thus, a 0.25 mm<br>lead sheet will provide >99%<br>reduction in exposure. |

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## Section 807.92(b)

- Nonclinical Tests (1)
### Physical Testing

The ANT Model 1 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 devices.

### Dosimetry

The dose distribution around the ANT Model 1 source was calculated by Monte Carlo simulation in accordance with the recommendations of the American Association of Physicists in Medicine and the European Society for Therapeutic Radiation Oncology. 3 This is equivalent to the dosimetry of the predicate devices.

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- (2) Clinical Tests
Not Applicable

- (3) Conclusions
The results of the nonclinical physical tests and the dosimetric analysis, demonstrate that the ANT Model 1 Brachytherapy Source is as safe, as effective, and performs as well or better than the legally marketed predicate devices:

Implant Sciences Corp. I-Plant Model 3500 (128)odine Brachytherapy Seed) cleared under 510(k) number K994317 dated 21 March 2000

and

Source Production & Equipment Co., Inc. Model M-31, cleared under 510(k) number K090366 dated 22 April 2009

¹ Currier B, Munro JJ and Medich DC, Dosimetric characterization of the GammaClip™ 169Yb low dose rate permanent implant brachytherapy source for the treatment of nonsmall cell lung cancer postwedge resection. Med Phys. 2013 Aug:40(8):080701

² Duggan DM, Johnson BL, "Dosimetry of the I-Plant Model 3500 iodine-125 brachytherapy source", Med Phys 2001 Apr;28(4):661-70

³ Perez-Calatayud J. Ballester F. Das RK, Dewerd LA, Ibbott GS, Meigooni AS, Quhib Z, Rivard MJ, Sloboda RS, Williamson JF, Dose calculation for photon-emitting brachytherapy sources with average energy higher than 50 keV: report of the AAPM and ESTRO, Med Phys. 2012 May;39(5):2904-29