(183 days)
No
The document describes a computer-controlled medical device for brachytherapy but does not mention any AI or ML capabilities. The focus is on the mechanical and software control of the radioactive source and the various applicators.
Yes
The device is described as "intended to apply brachytherapy treatment" and "provide high dose rate brachytherapy treatment by sending a radioactive source into an anatomical site, through an applicator, to deliver a physician prescribed dose," which directly indicates its purpose is to treat medical conditions.
No
Explanation: The SagiNova® system is intended to apply brachytherapy treatment by delivering a physician-prescribed dose using a radioactive source. It is described as a "treatment unit," indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states that the SagiNova HDR afterloading systems are "computer controlled medical devices" that include a "treatment unit," "applicators," and "accessories," in addition to the software. The testing section also details extensive hardware testing. This indicates it is a system with both hardware and software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SagiNova® system is for applying brachytherapy treatment to specific body sites with a remote-controlled radioactive source. This is a therapeutic procedure performed on the patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a system that delivers radiation to a target area within or on the patient. It involves a radioactive source, applicators inserted into the body, and a control system to manage the radiation delivery. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The SagiNova® system's function is to treat a condition using radiation, which is a therapeutic intervention.
N/A
Intended Use / Indications for Use
SagiNova® is a family of Eckert & Ziegler BEBIG HDR afterloading systems that are intended to apply brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intra-operative or skin surface) with a remote controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The SagiNova "HDR afterloading systems are computer controlled medical devices that provide high dose rate brachytherapy treatment by sending a radioactive source into an anatomical site, through an applicator, to deliver a physician prescribed dose.
The SagiNova HDR afterloading system includes the following models:
| Model | Key Features |
|---|---|
| SagiNova® | Safe shielding suitable for a Co-60 or Ir-192 Source Contains 25 channels |
| SagiNova® S | Safe shielding suitable for a Co-60 or Ir-192 Source Contains 5 channels |
| SagiNova® Ir | Safe shielding suitable for a Ir 192 Source Contains 25 channels |
| SagiNova® Ir-S | Safe shielding suitable for a Ir 192 Source Contains 5 channels |
These afterloading systems include the same treatment unit, applicators, and accessories. They differ in the type of radioactive source that can be accommodated within the shielded safe of the treatment unit and the number of allowed treatment channels.
- The SagiNova and SagiNova Sare capable of accommodating a Co-60 or Ir-192 radioactive . source due to the tungsten and lead safe that is incorporated within the treatment unit. These sources (Co-60 and Ir-192) are nearly identical in construction and clinical performance but differ in half life (Co-60 = 1953.2 days, Ir-192=73.4 days) and maximum activity (Co-60 = 2.2 Ci, Ir-192=13Ci).
- 0 The SagiNova Ir and SagiNova Ir-S can only accommodate an Ir-192, 13 Ci radioactive source within the lead safe that is incorporated in the treatment unit.
The number of treatment channels does not interfere with the performance of the device or the size of the implant that can be treated, but strictly limits the number of channels that can be connected at one time. This difference was designed to provide the user with a system that meets their specific clinical requirements. For standard HDR brachytherapy, e.g. GYN treatment, the 5 channel systems (SagiNova S and SagiNova Ir-S) are sufficient. While clinics that routinely perform more complex HDR brachytherapy implants, e.g. interstitial treatment, the 25 channel systems (SagiNova "Ir) are required.
The applicators and accessories are interchangeable between all SagiNova "models and are based on clinically accepted designs required for HDR remote afterloading brachytherapy treatment. The range of applicators includes:
- Intracavitary GYN applicators for the treatment of the vagina, cervix and endometrium including o tandem and ovoid, ring applicators and vaginal cylinders.
- Interstitial applicators for the treatment of breast, prostate, and soft tissue including templates, needles and flexible catheters.
- 0 Intraluminal applicators for the treatment of esophagus, lung, nasopharynx including molds, catheters and bougie tubes
- o Intraoperative applicators for the treatment of tumor beds include needles, catheters, and molds
- 0 Surface applicators for the treatment of skin surface and mucosa including flexible molds. The applicators are available for different imaging modalities including CT/MR and X-ray imaging. The applicators are securely connected to the SagiNova with specially designed transfer tubes or connectors. The transfer tube designs are based on the type of applicator to be connected to the treatment unit, e.g. "Easy Click" transfer tubes for plastic needles and catheters, Transfer Tubes for GYN applicators and metal needles and connectors for universal applicators.
The different components of the SagiNova HDR remote afterloading system work together to provide safe and effective HDR brachytherapy treatment to physician prescribed treatment areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT/MR and X-ray imaging
Anatomical Site
interstitial, intracavitary, intraluminal, and intra-operative or skin surface. Specific examples include vagina, cervix, endometrium, breast, prostate, soft tissue, esophagus, lung, nasopharynx, tumor beds, skin surface, and mucosa.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals trained in radiation oncology
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)
Non-clinical testing of SagiNova® HDR Afterloading System was performed in accordance with the Eckert & Ziegler BEBIG quality system and included comprehensive testing of the system hardware and software, radioactive sources, applicators and accessories. The test results confirmed that the product requirements, identified control measures from the risk management process and requirements from the appropriate standards were met.
Testing was performed from defined test cases with clear acceptance criteria both internally and through external test laboratories. Hardware testing included design, usability, and functionality of the systems and sub-systems, as well as requirements defined in the standards; IEC 60601-2-17, IEC 60601-1, IEC 60601-2, IEC 60601-1-6, IEC 60601-8. Software testing of the treatment control unit included design and functionality testing in accordance with the product specifications, risk control measures and usability requirements. The radioactive sources were extensively tested in accordance with ISO 2919 and through prototype testing of the Co-60 source with the SagiNova "S afterloading system and the Ir-192 source with the SagiNova , SagiNova Ir, and SagiNova Ir-S. The results of this testing confirmed the source integrity and all weld connections for both sources, including 100,000 source transfers with the Co-60 source in both models and 25,000 source transfers with the Ir 192 source in all models. The applicator design and functionality testing was performed in accordance with the applicator specifications and risk control measures with additional testing performed for; biocompatibility of the applicator materials (ISO 10993-5, ISO 10993-6, ISO 10993-9, ISO 10993-13, ISO 10993-7), MR Testing of the applicators (ASTM 2052-6, F2213-06e1 , F2119-07, F2182-11a, ASTM F2503-13) and sterilization testing for EtO (ISO 11135) and steam sterilization (ISO 17665-1) methods.
The successful results of the SagiNova" HDR remote afterloading system non-clinical testing has confirmed that the product meets the defined functional requirements, the applicable recognized standards and clinical expectations. These results were the same if not better than performed for the predicate devices and confirms that the device is safe and effective for clinical use.
Clinical testing was not required to demonstrate substantial equivalence.
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
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a caduceus, with three human profiles facing right, connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2015
Eckert & Ziegler BEBIG Gmbh % Ms. Lu Anne Johnson President, Capamed Inc. 1917 29 3/4 Ave RICE LAKE WI 54868
Re: K142986
Trade/Device Name: SagiNova Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: February 16, 2015 Received: February 24, 2015
Dear Ms. Johnson:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael O'Hara
for
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142986
Device Name
SagiNova®
Indications for Use (Describe)
SagiNova® is a family of Eckert & Ziegler BEBIG HDR afterloading systems that are intended to apply brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intra-operative or skin surface) with a remote controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology.
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
Image /page/3/Picture/0 description: The image shows the logo for Eckert & Ziegler. The logo consists of a red symbol to the left of the company name. The symbol is a red oval between two red rectangles. The text "Eckert & Ziegler" is written in a simple, sans-serif font.
Eckert & Ziegler BEBIG GmbH
Robert-Rössle-Str. 10 13125 Berlin Germany Phone: (+49)30-941084772 (+49)30-941084770 Fax:
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92
න්
| Date: | April 2, 2015 |
|---|---|
| Submitter of 510(k): | |
| Company name: | Eckert & Ziegler BEBIG GmbH |
| Establishment Registration number: | 9617477 |
| Address: | Robert Rössle Str. 10 |
| 13125 Berlin | |
| Germany | |
| Phone: | (+49)30941084145 |
| Fax: | (+49)30941084112 |
| Correspondent: | Heiko Jacobs |
| Head of Quality Management and Assurance | |
| Device Name: | |
| Trade/Proprietary Name: | SagiNova® |
| Common/Usual Name: | High Dose Rate Remote Afterloading Brachytherapy System |
| Classification | Class II |
| Classification Name: | Remote controlled radio-nuclide applicator system |
| (21 CFR 892.5700 Product Code: JAQ) |
Legally Marketed Devices
Our devices is based on the legally marketed devices cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Varian | Gammamed plus IX Brachytherapy Afterloader, | |
| Gammamed plus 3/24 IX Brachytherapy Afterloader | K120993 | |
| Nucletron | MicroSelectron HDR version 2 | K953946 |
4
Reference Device
Scientific methodology was supported by the reference device cited in the table below
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron | Selectron HDR | K852842 |
Device Description:
The SagiNova "HDR afterloading systems are computer controlled medical devices that provide high dose rate brachytherapy treatment by sending a radioactive source into an anatomical site, through an applicator, to deliver a physician prescribed dose.
The SagiNova HDR afterloading system includes the following models:
| Model | Key Features |
|---|---|
| SagiNova® | Safe shielding suitable for a Co-60 or Ir-192 Source |
| Contains 25 channels | |
| SagiNova® S | Safe shielding suitable for a Co-60 or Ir-192 Source |
| Contains 5 channels | |
| SagiNova® Ir | Safe shielding suitable for a Ir 192 Source |
| Contains 25 channels | |
| SagiNova® Ir-S | Safe shielding suitable for a Ir 192 Source |
| Contains 5 channels |
These afterloading systems include the same treatment unit, applicators, and accessories. They differ in the type of radioactive source that can be accommodated within the shielded safe of the treatment unit and the number of allowed treatment channels.
- The SagiNova and SagiNova Sare capable of accommodating a Co-60 or Ir-192 radioactive . source due to the tungsten and lead safe that is incorporated within the treatment unit. These sources (Co-60 and Ir-192) are nearly identical in construction and clinical performance but differ in half life (Co-60 = 1953.2 days, Ir-192=73.4 days) and maximum activity (Co-60 = 2.2 Ci, Ir-192=13Ci).
- 0 The SagiNova Ir and SagiNova Ir-S can only accommodate an Ir-192, 13 Ci radioactive source within the lead safe that is incorporated in the treatment unit.
The number of treatment channels does not interfere with the performance of the device or the size of the implant that can be treated, but strictly limits the number of channels that can be connected at one time. This difference was designed to provide the user with a system that meets their specific clinical requirements. For standard HDR brachytherapy, e.g. GYN treatment, the 5 channel systems (SagiNova S and SagiNova Ir-S) are sufficient. While clinics that routinely perform more complex HDR brachytherapy implants, e.g. interstitial treatment, the 25 channel systems (SagiNova "Ir) are required.
The applicators and accessories are interchangeable between all SagiNova "models and are based on clinically accepted designs required for HDR remote afterloading brachytherapy treatment. The range of applicators includes:
- Intracavitary GYN applicators for the treatment of the vagina, cervix and endometrium including o tandem and ovoid, ring applicators and vaginal cylinders.
- . Interstitial applicators for the treatment of breast, prostate, and soft tissue including templates, needles and flexible catheters.
5
- 0 Intraluminal applicators for the treatment of esophagus, lung, nasopharynx including molds, catheters and bougie tubes
- o Intraoperative applicators for the treatment of tumor beds include needles, catheters, and molds
0 Surface applicators for the treatment of skin surface and mucosa including flexible molds. The applicators are available for different imaging modalities including CT/MR and X-ray imaging. The applicators are securely connected to the SagiNova with specially designed transfer tubes or connectors. The transfer tube designs are based on the type of applicator to be connected to the treatment unit, e.g. "Easy Click" transfer tubes for plastic needles and catheters, Transfer Tubes for GYN applicators and metal needles and connectors for universal applicators.
The different components of the SagiNova HDR remote afterloading system work together to provide safe and effective HDR brachytherapy treatment to physician prescribed treatment areas.
Intended use:
SagiNova is a family of Eckert & Ziegler BEBIG HDR afterloading systems that are intended to provide brachytherapy treatment to specific body sites (interstitial, intracavitary, intraluminal, and intraoperative or skin surface) with a remote controlled radioactive source. The systems are intended to be used by medical professionals trained in radiation oncology.
Summary of the Technical Characteristics
SagiNova® HDR Afterloading Systems and the predicate devices have technical characteristics for providing high dose rate brachytherapy which includes: a remote controlled computerized treatment unit, radioactive source, applicators and accessories. These components are exclusively used together to provide a prescribed high dose rate brachytherapy treatment. The systems utilize a small, high activity radioactive source which is dispatched from the machine into the treatment site via a closed system of transfer tubes and applicators. The main difference between the SagiNova® HDR Afterloading Systems the predicate devices is the ability of the SagiNova® and SagiNova S® to accommodate a Co-60 or Ir-192 radioactive source. The use of Co-60 for HDR remote afterloading brachytherapy was demonstrated with the reference device, Selectron HDR. The reference device was an accepted method of HDR remote afterloading brachytherapy treatment before the miniaturized Ir-192 HDR source, attached to a flexible wire, was in clinical use. Due to the size of the original Selectron HDR Co-60 source (2.5 mm pellets) this device could not be used for interstitial treatment, however it was in clinical use for intracavitary and intraluminal HDR brachytherapy treatment. The Co-60 radioactive source, for use with the SagiNova and SagiNova S remote afterloading systems, provides a clinically established HDR brachytherapy treatment method with a re-designed source (miniaturized HDR source attached to a flexible wire) comparable to the predicate device.
For substantial equivalence, the predicate device K120993 was used for the SagiNova® system and K953946 was used for the SagiNova® applicators and accessories. SagiNova® HDR Afterloading Systems and the predicate devices are based on established HDR brachytherapy techniques and are identical in design and functionality. These similarities in design and technology are the basis and reason for substantial equivalence of SagiNova® HDR Afterloading Systems to the legally marketed predicate devices.
6
Summary of Non- clinical testing
Non-clinical testing of SagiNova® HDR Afterloading System was performed in accordance with the Eckert & Ziegler BEBIG quality system and included comprehensive testing of the system hardware and software, radioactive sources, applicators and accessories. The test results confirmed that the product requirements, identified control measures from the risk management process and requirements from the appropriate standards were met.
Testing was performed from defined test cases with clear acceptance criteria both internally and through external test laboratories. Hardware testing included design, usability, and functionality of the systems and sub-systems, as well as requirements defined in the standards; IEC 60601-2-17, IEC 60601-1, IEC 60601-2, IEC 60601-1-6, IEC 60601-8. Software testing of the treatment control unit included design and functionality testing in accordance with the product specifications, risk control measures and usability requirements. The radioactive sources were extensively tested in accordance with ISO 2919 and through prototype testing of the Co-60 source with the SagiNova "S afterloading system and the Ir-192 source with the SagiNova , SagiNova Ir, and SagiNova Ir-S. The results of this testing confirmed the source integrity and all weld connections for both sources, including 100,000 source transfers with the Co-60 source in both models and 25,000 source transfers with the Ir 192 source in all models. The applicator design and functionality testing was performed in accordance with the applicator specifications and risk control measures with additional testing performed for; biocompatibility of the applicator materials (ISO 10993-5, ISO 10993-6, ISO 10993-9, ISO 10993-13, ISO 10993-7), MR Testing of the applicators (ASTM 2052-6, F2213-06e1 , F2119-07, F2182-11a, ASTM F2503-13) and sterilization testing for EtO (ISO 11135) and steam sterilization (ISO 17665-1) methods.
The successful results of the SagiNova" HDR remote afterloading system non-clinical testing has confirmed that the product meets the defined functional requirements, the applicable recognized standards and clinical expectations. These results were the same if not better than performed for the predicate devices and confirms that the device is safe and effective for clinical use.
Summary of Clinical testing
Clinical testing was not required to demonstrate substantial equivalence.
Conclusion
The SagiNova® HDR Afterloading Systems have passed all defined criteria and are determined to be safe and effective for clinical use. The systems have performed as well or better than the predicate devices and are therefore considered substantially equivalent to the cleared predicate devices.
UCG
Heiko Jacobs Head of Quality Management and Assurance Eckert & Ziegler BEBIG GmbH Berlin Germany
Image /page/6/Picture/10 description: The image shows a blue stamp with the letters "HJA" on the top line. The second line of the stamp reads "1 b, April 2015". Below the stamp is the word "Date".