(142 days)
No
The summary describes a combination brachytherapy device and MRI markers for anatomical localization. There is no mention of AI or ML being used for image analysis, treatment planning, or any other function. The localization is facilitated by the physical markers visible in MRI.
Yes
The device is indicated for the "treatment of malignant prostatic disease" using implanted radioactive sources, which directly addresses a medical condition.
No
The device is a therapeutic device (brachytherapy seeds) used for the treatment of malignant prostatic disease, not for diagnosis. The MRI markers facilitate post-implantation localization, which is a monitoring function, not a diagnostic one.
No
The device description clearly details physical components including radioactive seeds, MRI markers, and spacers, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of malignant prostatic disease using brachytherapy (implanting radioactive seeds). This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device consists of radioactive seeds, MRI markers, and spacers, all of which are implanted into the patient's body. This is an in vivo (within the body) application.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit this definition.
The MRI markers are used for localization of the implanted seeds after they have been placed in the body, which is a form of post-treatment imaging and not a diagnostic test of a specimen.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KXK
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.
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.
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.
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 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. The subject devices are EtO sterilized and are a single-use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
The MRI Markers are used to facilitate the anatomical localization of seeds after they have been implanted.
Anatomical Site
prostatic disease (prostate gland)
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)
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.
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.
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
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: (240) 402-6424, Lora.Weidner@fda.hhs.gov.
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
1
December 31, 2020
Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a square and the name written out to the right of it. The full name is "U.S. Food & Drug Administration".
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
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
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.
350 Hills Street
Suite 106
Richland, WA US 99354 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC
Founder/Principal Consultant
Powers Regulatory Consulting
Tel: 404-931-8730 |
| Submission Date: | August 10, 2020 |
| Subject Device: | Trade Name: Cs-131 Implant Devices with SiriusTM Markers
Common Name: Radionuclide brachytherapy source
Regulation: 21 CFR §892.5730
Regulatory Classification: 2
Product Code: KXK |
| Predicate Device: | Legally marketed device to which substantial equivalence is claimed:
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.
5
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.
6
| 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:
Cs-131 Implant
Devices with
Sirius™ MRI Markers | Predicate Device:
Cs-131 Implant
Devices | Reference Device:
Sirius™ MRI
Markers | Comparison |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Cs-131 Implant
Device with Sirius™
MRI Markers | CS-131 PRELOADED
STRANDS, MODEL
PL-1, CS-131
PRELOADED
STRANDS IN 18
GAUGE NEEDLES,
MODEL PL-2 | Sirius™ MRI
Markers | N/A |
| Manufacturer | Isoray Medical, Inc. | Isoray Medical, Inc. | C4 Imaging, LLC | N/A |
| Product Code | KXK | KXK | KXK | Identical |
| Regulation
Number | 21 CFR 892.5730 | 21 CFR 892.5730 | 21 CFR 892.5730 | Identical |
| Device
Classification
Name | Source,
Brachytherapy,
Radionuclide | Source,
Brachytherapy,
Radionuclide | Source,
Brachytherapy,
Radionuclide | Identical |
| Device
Classification | Class II | Class II | Class II | Identical |
| | Subject Device:
Cs-131 Implant
Devices with
Sirius™ Markers | Predicate Device:
Cs-131 Implant
Devices | Reference Device:
Sirius™ MRI
Markers | Comparison |
| Indication 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. | The Isoray Medical,
Inc. Cesium-131
Implant Devices are
indicated for the
treatment of
malignant disease
(e.g., head and
neck, brain, breast,
prostate, etc.), and
may be used in
surface, interstitial,
and intracavitary
applications for
tumors with known
radiosensitivity.
These devices may
be used as a
primary treatment
or in conjunction
with other
treatment
modalities, such as
external beam
radiation therapy,
chemotherapy or as
treatment for
residual disease
after excision of
primary tumors. | The Sirius™ MRI
Marker is a
component device
indicated as an
accessory for use
in conjunction
with carrier
sleeves and
radionuclide
brachytherapy
seeds containing
one of the
following
isotopes: lodine-
125, Palladium-
103 or Cesium-
131.
The Sirius MRI
Marker NS is
intended to
facilitate the
anatomical
localization of
seeds after they
have been
implanted in the
prostate of a
patient with
confirmed
prostatic
malignancy. It is
intended to be
imaged under MRI
within sixty (60)
days of
implantation.
The Sirius MRI
marker NS is
supplied non-
sterile and will
need to be | Similar-
The indications for
use are a
combination of the
indications from
the predicate and
reference device.
The subject device
indication includes
the indication from
the predicate
device seeds
limited to the
prostate as the
MRI Markers are
limited to use in
the prostate with
brachytherapy
seed carriers
containing the
Cesium-131
isotope. The
statement that the
MRI Markers are
used for
localization of the
seeds after
implant was also
included in the
subject device
indication. |
| Subject Device:
Cs-131 Implant
Devices with
Sirius™ Markers | Predicate Device:
Cs-131 Implant
Devices | Reference Device:
Sirius™ MRI
Markers | Comparison | |
| | | sterilized by the
end-use using
either gamma
radiation or
ethylene oxide. | | |
| Principle of
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
Use | Single Use Only | Single Use Only | Single Use Only | Identical |
| Rx or OTC | Prescription Only | Prescription Only | Prescription Only | Identical |
| | Subject Device:
Cs-131 Implant
Devices with
Sirius™ Markers | Predicate Device:
Cs-131 Implant
Devices | Reference Device:
Sirius™ MRI
Markers | Comparison |
| Materials of
Construction | Seeds: Titanium
Spacers: PLA/PGA
copolymer
Sleeve: 5/95
PLA/PGA Sleeve
Needle: Stainless
Steel
Bone wax: Product
code MTJ
MRI Markers: PEEK | Seeds: Titanium
Spacers: PLA/PGA
copolymer
Sleeve: 5/95
PLA/PGA Sleeve
Needle: Stainless
Steel
Bone wax: Product
code MTJ | MRI Markers:
PEEK | The seeds, spacers,
sleeve, needles
and bone wax in
the subject device
and predicate
device are
identical. The MRI
marker materials
are identical to the
reference device. |
| Device
dimensions | Seed: 0.8mm
diameter, 4.5mm
length
Spacer: 0.8mm
diameter, 2.5mm,
5.5mm and 10.0
mm length
MRI Marker:
0.8mm diameter,
5.5mm length | Seed: 0.8mm
diameter, 4.5mm
length
Spacer: 0.8mm
diameter, 2.5mm,
5.5mm, 10.0mm
length | MRI Marker:
0.8mm diameter,
5.5mm length | The MRI marker
that is being added
is the same
diameter and
length as the
current spacer. |
| Packaging | Tray within a
breather bag pouch | Tray within a
breather bag pouch | Not applicable -
Sold in bulk as an
accessory | The subject and
predicate devices
have identical
packaging. |
| Device
Package
Contents | • PL-7: Cs-131
Preloaded
Strands with
Sirius™ Markers
• PL-8: Cs-131
Preloaded
Strands with
Sirius™ Markers
in 18G Needles | • PL-1: Cs-131
Preloaded
Strands
• PL-2: Cs-131
Preloaded
Strands in 18
Gauge Needles | Not applicable -
Sold in bulk as an
accessory | The contents of
the subject device
and predicate
device are
identical with the
exception of the
MRI markers
included in the
subject device. |
| Sterilization | EtO validated cycle | EtO validated cycle | Not applicable -
Sold non-sterile as
an accessory | The subject and
predicate devices
are both EtO
sterilized. |
7
8
9
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.
10
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.