(90 days)
Not Found
No
The device description and intended use focus solely on the physical characteristics and radioactive properties of a brachytherapy source. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a radioactive brachytherapy source indicated for permanent or temporary implantation to treat selected localized tumors, which is a therapeutic use.
No
This device is a radioactive brachytherapy source used for interstitial treatment of tumors, which is a therapeutic rather than a diagnostic application.
No
The device description clearly states it is a radioactive brachytherapy source, which is a physical object containing radioactive material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a radioactive brachytherapy source (IsoSeed I25.S17plus) that is implanted directly into the body to treat tumors. This is an in vivo treatment, not an in vitro diagnostic test performed on a sample outside the body.
The device's function is to deliver radiation therapy internally, which is a therapeutic intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
IsoSeed I25.S17plus with apparent activities from 0.189 to 1.045 mCi are indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable turnors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intraabdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas, and prostate (early stages) are commonly treated.
IsoSeed I25.S17plus with total apparent activities greater than 1.045 mCi are indicated for interstitial treatment of tumors which have the following characteristics: unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation as temporary implants. IsoSeed 125.S17plus are indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with IsoSeed I25.S17plus.
Product codes
KXK
Device Description
IsoSeed I25.S17plus is a radioactive brachytherapy source intended for permanent as well as temporary implantation. IsoSeed 125.S17plus is a cylindrical sealed source containing radioactive Iodine-125. The source is 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium according to ASTM F67. The radioactive iodine 1-125 is deposited as silver iodide (Agl) on the surface of a silver bar. The silver bar also serves as an X-ray marker.
lodine-125 has a half-life of 59.41 days. It decays with 100% to Te-125 as a result of electron capture by the radiation of X-rays and y-radiation in the energy range up to 35 keV. The most commonly used activities used for implants are up to 1.045 mCi. Other source strengths for temporary applications are available up to 25 mCi.
IsoSeed I25.S17plus is delivered non-sterile and must be steam sterilized by the user. The device is intended for single use, unless it is used as temporary implant without direct tissue contact.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, superficial, intraabdominal, intrathoracic, head, neck, lung, pancreas
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
Not applicable
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 02 2014
Eckert & Ziegler
K140849
Page 1 of 3
Summary of Safety and Effectiveness Information
·
Submitter and Owner
Company name Establishment Registration number Address
Correspondent
Phone Fax Summary prepared:
Eckert & Ziegler BEBIG GmbH 9617477 Robert Rössle Str. 10 13125 Berlin, Germany Sven Langer Regulatory Affairs Phone: +49 30 941084-734 Fax: +49 30 941084-770 May 6, 2014
Device Name
Trade / Proprietary name Common / Usual name Classification Regulation, Panel, Productcode lsoSeed I25.S17plus brachytherapy iodine-125 source Class II 21 CFR 892.5730 Radionuclide brachytherapy source Radiology, Product code KXK
Predicate Devices
Device Nucletron SelectSeed I-125 Eckert & Ziegler BEBIG IsoSeed I-125 Medi-Physics OncoSeed 6711
Device Description
IsoSeed I25.S17plus is a radioactive brachytherapy source intended for permanent as well as temporary implantation. IsoSeed 125.S17plus is a cylindrical sealed source containing radioactive lodine-125. The source is 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium according to ASTM F67. The radioactive iodine 1-125 is deposited as silver iodide (Agl) on the surface of a silver bar. The silver bar also serves as an X-ray marker.
Premarket #
lodine-125 has a half-life of 59.41 days. It decays with 100% to Te-125 as a result of electron capture by the radiation of X-rays and y-radiation in the energy range up to 35 keV. The most commonly used activities used for implants are up to 1.045 mCi. Other source strengths for temporary applications are available up to 25 mCi.
IsoSeed I25.S17plus is delivered non-sterile and must be steam sterilized by the user. The device is intended for single use, unless it is used as temporary implant without direct tissue contact.
1
Intended Use
Indications for Use
IsoSeed I25.S17plus with apparent activities from 0.189 to 1.045 mCi are indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable turnors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intraabdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas, and prostate (early stages) are commonly treated.
IsoSeed I25.S17plus with total apparent activities greater than 1.045 mCi are indicated for interstitial treatment of tumors which have the following characteristics: unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation as temporary implants. IsoSeed 125.S17plus are indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with IsoSeed I25.S17plus.
The indications statement of IsoSeed 125.S17plus is the same as for the predicate device OncoSeed 6711. Only the activity range for implants in the indications for use differs slightly due to the specification of homogenous activity classes used by Eckert & Ziegler BEBIG GmbH. This difference is therapeutically irrelevant.
Summary and comparison of technological characteristics
lsoSeed I25.S17plus has the same design as the selectSeed. Like the predicate device it is a cylindrical sealed source which is 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium according to ASTM F67. Radioactive iodine I-125 is deposited as silver iodide (Agl) on the surface of a silver bar contained in the capsule.
The indications of IsoSeed I25.S17plus are the same as for OncoSeed 6711. The activity range from 0.2 to 25 mCi is similar to the standard activity range of OncoSeed 6711 which is 0.2 to 21 mCi (up to 40 mCi available by special request) and is appropriate for the intended use of IsoSeed 125.S17plus. IsoSeed 125.S17plus is packaged non-sterile in a radiation protection capsule. The packaging is similar to IsoSeed I-125.
Summary of Nonclinical Testing
Tests according to ISO 2919 have been carried out. IsoSeed I25.S17plus has been classified under C 63X11. Furthermore IsoSeed I25.S17plus has passed tests for MR compatibility according to ASTM F2503, ASTM 2052, ASTM 2213, ASTM 2182, and ASTM 2119, Biocompatibility has been confirmed according to ISO 10993-1 and has been tested according to ISO 10993-5 and ISO 10993-18. These nonclinical tests have been performed to support safety claims. They are not relied on for a determination of substantial equivalence with the predicate devices.
2
K140849
Page 3 of 3
- Eckert & Ziegler
Summary of Clinical Testing
Not applicable
Conclusion of Substantial Equivalence
IsoSeed I25.S17plus has the same design as the selectSeed. The indications of IsoSeed I25.S17plus are the same as for OncoSeed 6711. The packaging is similar to IsoSeed I-125. Upon reviewing the safety and effectiveness information provided in this submission and comparing the intended use, indications for use, and their technological characteristics it can be concluded that IsoSeed I25.S17plus is substantially equivalent to its predicate devices.
Eckert & Ziegler BEBIG GmbH
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing its wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2014
Eckert & Ziegler BEBIG GmbH % Mr. Sven Langer Regulatory Affairs Robert Rossle Str.10. 13125 Berlin GERMANY
Re: K140849
Trade/Device Name: IsoSeed (Model 125.S17plus) Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: March 31, 2014 Received: April 3, 2014
Dear Mr. Langer:
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 (2) 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.
4
Page 2-Mr. Langer
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 D. O'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
5
14165
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name
IsoSecd 125.S17plus
Indications for Use (Describe)
IsoSed 125.S17plus with apparent activities from 0.189 to 1.045 mCi are indicated for permanent interstitul implantation of selected localized umors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prosslate cancer or unresectable turners) or for treatment of residion of the primary turner. Seeds in this apparent setivity runge may be used to treat superficial, intratheracic tumors. Tumors of the head, neck. lung, pancress, and prostate (early stages) are commonly treated.
IsoSed I2S.S17plus with total apparent activities greater than 1.045 mC' are indicated for intersitial treatment of tumors which have the following characterisins: unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation applications as temporary implants. IsoSed I25.517plus are indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy. In addition, recurrent tumors may be implanced with IsoSeed 125.S I 7plus.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
FORM FDA 3881 (9/13)
P.L. 101-476, 104 Stat. 1141, Sec. 602 (a)(1)(A)(i)(I) & (b.)