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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.

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.

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.

The provided text describes a medical device, the IsoSeed I25.S17plus brachytherapy iodine-125 source, and its regulatory submission (K140849) for substantial equivalence to existing predicate devices. However, the document does not contain any information regarding acceptance criteria for a device's performance, nor does it describe a study to prove such performance criteria were met.

The document pertains to the device's technical specifications, indications for use, and a comparison to predicate devices to establish substantial equivalence with respect to safety and effectiveness, not a performance study with acceptance criteria.

Therefore, for the information requested I must state that none of the requested information (points 1-9) can be extracted from the provided text as it does not describe a performance study or acceptance criteria for the device.

The document details:

• Device Name: IsoSeed I25.S17plus brachytherapy iodine-125 source
• Classification: Class II, 21 CFR 892.5730 Radionuclide brachytherapy source, Product code KXK
• Predicate Devices: Nucletron SelectSeed I-125 (K002429), Eckert & Ziegler BEBIG IsoSeed I-125 (K033781), Medi-Physics OncoSeed 6711 (K914281)
• Device Description: Cylindrical sealed source, 4.5 mm long, 0.8 mm diameter, titanium capsule, radioactive Iodine-125 deposited as silver iodide on a silver bar. Half-life of 59.41 days.
• Intended Use/Indications for Use: For permanent interstitial implantation of selected localized tumors (low to moderate radiosensitivity), either as primary treatment or for residual disease. Specific activity ranges are detailed for different applications (0.189 to 1.045 mCi for permanent implants; > 1.045 mCi for temporary implants or tumors requiring higher activity).
• Nonclinical Testing: Tests according to ISO 2919 (classified C 63X11), MR compatibility tests (ASTM F2503, ASTM 2052, ASTM 2213, ASTM 2182, ASTM 2119), and Biocompatibility tests (ISO 10993-1, ISO 10993-5, ISO 10993-18). These were performed to support safety claims, not a substantial equivalence determination based on performance.
• Clinical Testing: "Not applicable"

Conclusion: The provided text is a 510(k) summary for a medical device seeking clearance through substantial equivalence. It confirms the physical characteristics, indications, and safety testing (non-clinical) to show it's similar to already approved devices. It explicitly states "Summary of Clinical Testing: Not applicable," which means no clinical performance study was conducted or presented in this document for the purpose of establishing acceptance criteria or proving device performance in that context.

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