Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles

K202267 · Isoray Medical, Inc. · KXK · Dec 31, 2020 · Radiology

Device Facts

• Record ID: K202267
• Device Name: Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
• Applicant: Isoray Medical, Inc.
• Product Code: KXK · Radiology
• Decision Date: Dec 31, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ MRI Markers are indicated for the treatment of malignant prostatic disease. These devices may be used as a primary treatment or in conjunction with other modalities. The MRI Markers are used to facilitate the anatomical localization of seeds after they have been implanted.

Device Story

Device consists of Cs-131 brachytherapy seeds combined with Sirius™ MRI markers and spacers; preloaded into strands or 18G needles. Seeds contain Cesium-131 isotope in titanium capsule; markers consist of PEEK capsule containing cobalt chloride/N-Acetylcysteine solution. Used in prostate brachytherapy; implanted by physician/medical physicist based on treatment plan. Markers provide visibility under MRI to facilitate post-implant anatomical localization of seeds. Device is single-use, EtO sterilized. Benefits include precise radiation delivery to tumor while sparing surrounding tissue and improved post-implant seed visualization.

Clinical Evidence

No clinical data or performance testing performed. Substantial equivalence based on the use of previously cleared components with established safety and performance profiles.

Technological Characteristics

Seeds: Titanium capsule, Cs-131 isotope. Markers: PEEK capsule, cobalt chloride/N-Acetylcysteine solution. Spacers: PLA/PGA copolymer. Dimensions: 0.8mm diameter. Sterilization: EtO per ISO 11135:2014. Single-use, prescription-only.

Indications for Use

Indicated for treatment of malignant prostatic disease in patients requiring brachytherapy. May be used as primary treatment or with other modalities. MRI markers facilitate anatomical localization of implanted seeds.

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

• Proxcelan™ (Cesium-131) Implant Devices, Multiple Configurations (K092458)

Reference Devices

• Sirius™ MRI Marker NS (K171487)

Submission Summary (Full Text)

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March 8, 2023

Image /page/0/Picture/1 description: The image contains 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.

Isoray Medical, Inc. % Grace Powers, MS, MBA, RAC Founder/Principal Consultant Powers Regulatory Consulting 2451 Cumberland Parkway SE, Suite 3740 ATLANTA GA 30080

Re: K202267

Trade/Device Name: Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: Class II Product Code: KXK

Dear Grace Powers:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 12/31/2020. Specifically, FDA is updating this SE Letter as an administrative correction to the 510(k) summary.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lora D. Weidner, OHT8: Office of Radiological Health, Ph: [phone], [e-mail].

Sincerely,

Image /page/0/Picture/9 description: The image shows a digital signature. The signature is from Lora D. Weidner -S. The date of the signature is 2023.03.08, and the time is 06:09:19 -05'00'.

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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December 31, 2020

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Isoray Medical, Inc. % Ms. Grace Powers, MS, MBA, RAC Founder/Principal Consultant Powers Regulatory Consulting 2451 Cumberland Parkway SE, Suite 3740 ATLANTA GA 30080

Re: K202267

Trade/Device Name: Cs-131 Implant Devices with Sirius™ Markers Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: Class II Product Code: KXK Dated: December 10, 2020 Received: December 11, 2020

Dear Ms. Powers:

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/cfpmn/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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael D. O'Hara 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)

#### K202267

Device Name

Cs-131 Implant Devices with SiriusTM Markers

#### Indications for Use (Describe)

The Isoray Medical, Inc. Cs-131 Implant Devices with SiriusTM MRI Markers are indicated for the treatment of malignant prostatic disease. These devices may be used as a primary treatment or in conjunction with other modalities. The MRI Markers are used to facilitate the anatomical localization of seeds after they have been implanted.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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K202267

Image /page/4/Picture/3 description: The image shows the logo for Isoray, a medical technology company. The logo features the word "isoray" in a dark blue sans-serif font. A light blue circle is positioned above the "i" in "isoray." The letters are closely spaced, and a small trademark symbol appears next to the "y".

# Section 5 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Cs-131 Implant Devices with MRI Markers Traditional 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

| Sponsor: | Isoray Medical, Inc.<br>350 Hills Street<br>Suite 106<br>Richland, WA US 99354 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC<br>Founder/Principal Consultant<br>Powers Regulatory Consulting<br>Tel: [phone] |
| Submission Date: | August 10, 2020 |
| Subject Device: | Trade Name: Cs-131 Implant Devices with SiriusTM Markers<br>Common Name: Radionuclide brachytherapy source<br>Regulation: 21 CFR §892.5730<br>Regulatory Classification: 2<br>Product Code: KXK |
| Predicate Device: | Legally marketed device to which substantial equivalence is claimed:<br>ProxcelanTM (Cesium-131) Implant Devices, Multiple Configurations (K092458) |
| Reference Device: | SiriusTM MRI Marker NS (K171487) |

#### Device Description

The Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ Markers are a combination of two commercially available devices: The Isoray Medical Cs-131 Implant Devices, and the Sirius™ MRI Markers. They come in two configurations and listed below:

- Isoray Medical, Inc. Cs-131 PL-7 Preloaded Strands with Sirius™ Markers
- Isoray Medical, Inc. Cs-131 PL-8 Preloaded Strands with Sirius™ Markers in 18G Needles ●

The Sirius™ MRI Markers combined with the Isoray Cesium-131 Implant Devices will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy.

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The Cs-131 Implant Devices are a small, cylindrical, sealed source that consists of a welded pure titanium capsule containing the low energy gamma (x-ray) emitting isotope, Cesium-131 (Cs-131), adsorbed onto an internal inorganic substrate. The external seed dimensions are 4.5 mm length and 0.8 mm diameter and the only patient-contacting material is commercially pure titanium. A schematic diagram of the internal configuration of the Isoray Medical, Inc. Cs-131 Implant Devices that are used in both the subject devices is shown in the schematic below.

Image /page/5/Figure/3 description: This image shows a cross-sectional view of a cylindrical object. The object consists of a gold x-ray marker with a diameter of 0.25 mm, an inorganic substrate with Cs-131 attached, and a titanium case with a 0.05 mm wall. The laser-welded ends have a 0.10 mm wall, and the object is 0.8 mm tall, 4.5 mm long, and 4.0 mm in the middle.

Image /page/5/Figure/4 description: The image is a title for a figure. The title reads "Figure 1: Cs-131 Brachytherapy Seed Schematic". The title is written in a bold, sans-serif font. The title is centered on the image.

The Sirius™ MRI markers consist of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride: N-Acetylcysteine solution. The Sirius™ MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy seeds containing one of the following isotopes: lodine-125, Palladium-103 or Cesium-131. The Sirius™ MRI Markers combined with the Isoray Cesium-131 Brachytherapy Seeds will be used to facilitate the anatomical location of seeds after they have been implanted. A schematic diagram of the Sirius™ MRI Markers that are used in both the subject devices is shown in the schematic below.

Figure 2: Sirius™ MRI Markers

Image /page/5/Figure/7 description: The image shows two technical drawings of a cylindrical object. The drawing on the left is a cross-sectional view, showing the object's length as 5.500 with a tolerance of +0.275/-0.275. The wall thickness is indicated as 0.750 with a tolerance of +0.035/-0.035. The drawing on the right is an end view, showing the outer diameter as 0.800 with a tolerance of +0.050/-0.050.

The spacers are used to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physicist. They are made of PLA/PGA copolymer and are absorbable. The spacer length is variable since it is a function of how many seeds are required by the patient treatment plan. The spacers are 0.8mm in diameter.

The Cs-131 Implant Devices with MRI Markers comes in two (2) configurations as listed in the table below.

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| Product Reorder Number | Product Description |
|------------------------|---------------------------------------------------------------|
| PL-7 | Cs-131 Preloaded Strands with SiriusTM Markers |
| PL-8 | Cs-131 Preloaded Strands with SiriusTM Markers in 18G Needles |

# Table 3: Isoray Medical, Inc. Cs-131 Implant Devices s with MRI Markers Additional Product Offerings

The seeds, spacers, and Sirius™ MRI markers are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physician or medical physicist. There are no product specific guidance documents or product specific standards for brachytherapy seeds. The subject devices are EtO sterilized and are a single-use device.

# Indications for Use

The Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ Markers are indicated for the treatment of malignant prostatic disease. These devices may be used as a primary treatment or in conjunction with other modalities. The MRI Markers are used to facilitate the anatomical localization of seeds after they have been implanted.

# Technological Characteristics

The Cs-131 Brachytherapy Seeds with Sirius™ Markers has similar technological characteristics as the predicate device, Cs-131 Implant Device cleared via K092458. Both devices have similar indications for use. The seeds are identical to the predicate device and the spacers are identical to the reference device. All the devices are composed of biocompatible materials. Additionally, they are both provided sterile in identical packaging for single use.

| | Subject Device:<br>Cs-131 Implant<br>Devices with<br>Sirius™ MRI Markers | Predicate Device:<br>Cs-131 Implant<br>Devices | Reference Device:<br>Sirius™ MRI<br>Markers | Comparison |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Cs-131 Implant<br>Device with Sirius™<br>MRI Markers | CS-131 PRELOADED<br>STRANDS, MODEL<br>PL-1, CS-131<br>PRELOADED<br>STRANDS IN 18<br>GAUGE NEEDLES,<br>MODEL PL-2 | Sirius™ MRI<br>Markers | N/A |
| Manufacturer | Isoray Medical, Inc. | Isoray Medical, Inc. | C4 Imaging, LLC | N/A |
| Product Code | KXK | KXK | KXK | Identical |
| Regulation<br>Number | 21 CFR 892.5730 | 21 CFR 892.5730 | 21 CFR 892.5730 | Identical |
| Device<br>Classification<br>Name | Source,<br>Brachytherapy,<br>Radionuclide | Source,<br>Brachytherapy,<br>Radionuclide | Source,<br>Brachytherapy,<br>Radionuclide | Identical |
| Device<br>Classification | Class II | Class II | Class II | Identical |
| | Subject Device:<br>Cs-131 Implant<br>Devices with<br>Sirius™ Markers | Predicate Device:<br>Cs-131 Implant<br>Devices | Reference Device:<br>Sirius™ MRI<br>Markers | Comparison |
| Indication for<br>Use | The Isoray Medical,<br>Inc. Cs-131 Implant<br>Devices with<br>Sirius™ MRI<br>Markers are<br>indicated for the<br>treatment of<br>malignant prostatic<br>disease. These<br>devices may be<br>used as a primary<br>treatment or in<br>conjunction with<br>other modalities.<br>The MRI Markers<br>are used to<br>facilitate the<br>anatomical<br>localization of<br>seeds after they<br>have been<br>implanted. | The Isoray Medical,<br>Inc. Cesium-131<br>Implant Devices are<br>indicated for the<br>treatment of<br>malignant disease<br>(e.g., head and<br>neck, brain, breast,<br>prostate, etc.), and<br>may be used in<br>surface, interstitial,<br>and intracavitary<br>applications for<br>tumors with known<br>radiosensitivity.<br>These devices may<br>be used as a<br>primary treatment<br>or in conjunction<br>with other<br>treatment<br>modalities, such as<br>external beam<br>radiation therapy,<br>chemotherapy or as<br>treatment for<br>residual disease<br>after excision of<br>primary tumors. | The Sirius™ MRI<br>Marker is a<br>component device<br>indicated as an<br>accessory for use<br>in conjunction<br>with carrier<br>sleeves and<br>radionuclide<br>brachytherapy<br>seeds containing<br>one of the<br>following<br>isotopes: lodine-<br>125, Palladium-<br>103 or Cesium-<br>131.<br>The Sirius MRI<br>Marker NS is<br>intended to<br>facilitate the<br>anatomical<br>localization of<br>seeds after they<br>have been<br>implanted in the<br>prostate of a<br>patient with<br>confirmed<br>prostatic<br>malignancy. It is<br>intended to be<br>imaged under MRI<br>within sixty (60)<br>days of<br>implantation.<br>The Sirius MRI<br>marker NS is<br>supplied non-<br>sterile and will<br>need to be | Similar-<br>The indications for<br>use are a<br>combination of the<br>indications from<br>the predicate and<br>reference device.<br>The subject device<br>indication includes<br>the indication from<br>the predicate<br>device seeds<br>limited to the<br>prostate as the<br>MRI Markers are<br>limited to use in<br>the prostate with<br>brachytherapy<br>seed carriers<br>containing the<br>Cesium-131<br>isotope. The<br>statement that the<br>MRI Markers are<br>used for<br>localization of the<br>seeds after<br>implant was also<br>included in the<br>subject device<br>indication. |
| Subject Device:<br>Cs-131 Implant<br>Devices with<br>Sirius™ Markers | Predicate Device:<br>Cs-131 Implant<br>Devices | Reference Device:<br>Sirius™ MRI<br>Markers | Comparison | |
| | | sterilized by the<br>end-use using<br>either gamma<br>radiation or<br>ethylene oxide. | | |
| Principle of<br>Operation | Brachytherapy is performed by implanting radiation sources directly into the tissue to be treated. This provides a much higher tumor dose to be delivered, while sparing normal surrounding tissue. The Sirius™ MRI Marker is a component of Isoray's Cesium-131 Implant devices that is intended to facilitate the anatomical localization of the brachytherapy seeds after they have been implanted. The operation of the Cs-131 Implant Devices with Sirius™ MRI Markers (subject device) is the same as the predicate device. | Brachytherapy is performed by implanting radiation sources directly into the tissue to be treated. This provides a much higher tumor dose to be delivered, while sparing normal surrounding tissue. | The Sirius™ MRI Marker is intended to facilitate the anatomical localization of the brachytherapy seeds after they have been implanted. | The subject, predicate have a similar principle of operation. The subject device can be used to visualize the location due to the addition of the MRI markers (reference device). |
| Condition of<br>Use | Single Use Only | Single Use Only | Single Use Only | Identical |
| Rx or OTC | Prescription Only | Prescription Only | Prescription Only | Identical |
| | Subject Device:<br>Cs-131 Implant<br>Devices with<br>Sirius™ Markers | Predicate Device:<br>Cs-131 Implant<br>Devices | Reference Device:<br>Sirius™ MRI<br>Markers | Comparison |
| Materials of<br>Construction | Seeds: Titanium<br>Spacers: PLA/PGA<br>copolymer<br>Sleeve: 5/95<br>PLA/PGA Sleeve<br>Needle: Stainless<br>Steel<br>Bone wax: Product<br>code MTJ<br>MRI Markers: PEEK | Seeds: Titanium<br>Spacers: PLA/PGA<br>copolymer<br>Sleeve: 5/95<br>PLA/PGA Sleeve<br>Needle: Stainless<br>Steel<br>Bone wax: Product<br>code MTJ | MRI Markers:<br>PEEK | The seeds, spacers,<br>sleeve, needles<br>and bone wax in<br>the subject device<br>and predicate<br>device are<br>identical. The MRI<br>marker materials<br>are identical to the<br>reference device. |
| Device<br>dimensions | Seed: 0.8mm<br>diameter, 4.5mm<br>length<br>Spacer: 0.8mm<br>diameter, 2.5mm,<br>5.5mm and 10.0<br>mm length<br>MRI Marker:<br>0.8mm diameter,<br>5.5mm length | Seed: 0.8mm<br>diameter, 4.5mm<br>length<br>Spacer: 0.8mm<br>diameter, 2.5mm,<br>5.5mm, 10.0mm<br>length | MRI Marker:<br>0.8mm diameter,<br>5.5mm length | The MRI marker<br>that is being added<br>is the same<br>diameter and<br>length as the<br>current spacer. |
| Packaging | Tray within a<br>breather bag pouch | Tray within a<br>breather bag pouch | Not applicable -<br>Sold in bulk as an<br>accessory | The subject and<br>predicate devices<br>have identical<br>packaging. |
| Device<br>Package<br>Contents | • PL-7: Cs-131<br>Preloaded<br>Strands with<br>Sirius™ Markers<br>• PL-8: Cs-131<br>Preloaded<br>Strands with<br>Sirius™ Markers<br>in 18G Needles | • PL-1: Cs-131<br>Preloaded<br>Strands<br>• PL-2: Cs-131<br>Preloaded<br>Strands in 18<br>Gauge Needles | Not applicable -<br>Sold in bulk as an<br>accessory | The contents of<br>the subject device<br>and predicate<br>device are<br>identical with the<br>exception of the<br>MRI markers<br>included in the<br>subject device. |
| Sterilization | EtO validated cycle | EtO validated cycle | Not applicable -<br>Sold non-sterile as<br>an accessory | The subject and<br>predicate devices<br>are both EtO<br>sterilized. |

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#### Performance Data

No performance data testing was performed as each of the components has been previously cleared for this intended use. No additional biocompatibility test was performed as biocompatibility evaluation was conducted for each of the components in previous regulatory clearances. The brachytherapy seeds, Sirius™ MRI markers and spacers are considered implants.

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The finished device is sterilized via a validated EtO sterilization cycle and provide a Sterility Assurance Level (SAL) of 1 x 10 °. Sterilization is performed by Isoray Medical, Inc. Validation of the device will be performed in accordance with ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide --Requirements for the development, validation and routine control of a sterilization process for medical devices. The half-cycle method was used was validation. The validation method and dose range is in accordance with ISO 11135:2014 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

#### Conclusion

The Cs-131 Implant Devices with Sirius™ Markers is substantially equivalent to the legally marketed predicate device as demonstrated by similar intended use, similar technologies and does not raise different questions of safety and effectiveness.