(283 days)
The IsoAid Brachytherapy Kit is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity.
The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975 or K103449 or Secure Strand) of seeds spaced at a precise distance within absorbable suture. The strand is optional, when no strand is requested the seeds and spacers are custom-loaded directly into the needle. A maximum total of 20 seeds and spacers can be loaded into a needle. The spacers (K010621 or K103449) are made from the same material as the sutures. The stranded Pd-103 (K033770) and I-125 (K011205) implants are placed inside the needle. Bone Wax (K024372 or Ethicon, Inc. Bone Wax) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.
This submission, K113210, for the IsoAid Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit, primarily focuses on demonstrating substantial equivalence to predicate devices through material and design comparisons, and biological safety testing. It does not present a study with specific performance acceptance criteria for the device's clinical effectiveness (e.g., accuracy, sensitivity, specificity) in tumor treatment.
The "Conclusions" section states: "Based on the results of the bench and animal tests performed it is concluded that these tests demonstrate that the Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit is as safe, as effective, and performs as well as or better than the predicate devices." This implies that the device is deemed to meet acceptance criteria through comparison to existing, cleared devices and adherence to established standards for safety and material integrity, rather than a clinical performance study with predefined metrics.
Here's a breakdown based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, the submission does not define specific performance acceptance criteria in terms of clinical effectiveness (e.g., tumor response rates, survival). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices in terms of:
| Acceptance Criteria (Implicit from Predicate Comparison & Standards) | Reported Device Performance |
|---|---|
| Indications for Use: Same as predicate. | "Same" as predicate (Bebig Brachytherapy Strand Device K040339). |
| Device Description: Similar components and function as predicate. See Device Description. | The IsoAid Brachytherapy Kit is a pre-sterilized kit containing a brachytherapy needle and a custom-loaded strand of seeds spaced at a precise distance within absorbable suture. The strand is optional, and seeds/spacers can be loaded directly into the needle. Maximum 20 seeds/spacers. Spacers from same material as sutures. Pd-103 and I-125 implants used. Bone Wax at tip. 18-gauge stainless steel needle. This mirrors the description of the predicate. |
| Radioactive Isotope(s): Same as predicate. | "Same" as predicate (Iodine-125 and/or Palladium-103). |
| Application Method: Same as predicate. | "Same" as predicate (Through an 18 gauge needle). |
| Secure Strand Material: Same material as predicate (SourceTech SeedLinks™ K023210). | The Secure Strand used by IsoAid is of the same material as the SourceTech SeedLinks™. |
| Secure Strand Material Composition: Same composition as predicate (MacroPore Surgi-Wrap (TS) K012025). | The Secure Strand material used by IsoAid is of the same material composition as the MacroPore Surgi-Wrap (TS). |
| Biocompatibility: Meet ISO 10993 standards for various tests (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, implantation effects, degradation products, EO residuals). | "Based on the results of the bench and animal tests performed it is concluded that these tests demonstrate that the Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit is as safe, as effective, and performs as well as or better than the predicate devices." (Implies successful completion of relevant ISO 10993 tests). |
| Material Degradation: Meet ASTM F1635-11 for in vitro degradation testing. | "Based on the results of the bench and animal tests performed it is concluded that these tests demonstrate that the Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit is as safe, as effective, and performs as well as or better than the predicate devices." (Implies successful completion of ASTM F1635-11). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical "test set" in the context of device performance on patients. The "tests" mentioned are bench and animal tests focused on material properties, biocompatibility, and degradation. No sample sizes for these specific bench or animal tests are provided in this summary, nor is data provenance in terms of country of origin or retrospective/prospective study design, as these are typically not relevant for material and biocompatibility testing as presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This type of information is relevant for studies involving human interpretation or clinical outcomes, which are not described here.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or clinical endpoint data requiring adjudication in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study would compare human reader performance with and without AI assistance for tasks like image interpretation or diagnosis. The device described is a physical medical implant, not an AI-driven diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This also pertains to AI algorithm performance.
7. The Type of Ground Truth Used
For the bench and animal tests:
- Biological Ground Truth: Established through adherence to recognized international standards (ISO 10993 series and ASTM F1635-11) for biocompatibility, material properties, and degradation. Passing these standard tests serves as the "ground truth" for the device's safety and material performance.
- Design/Functional Ground Truth: Established by direct comparison to the physical and functional characteristics of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no training set involved, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
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Image /page/0/Picture/1 description: The image shows the word "ISOAID" in large, outlined block letters. The letters are filled with a textured pattern, giving them a three-dimensional appearance. Below the word, there is a dark, curved line, possibly an underline or a design element.
AUG 1 0 2012
510 (k) SUMMARY (as required by 807.92(c))
Submitter of 510(k):
IsoAid, LLC 7824 Clark Moody Blvd., Port Richey, FL 34668 727-815-3262 Phone: 727-815-1973 Fax:
Benjamin Roedell
August 7, 2012
Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit
Brachytherapy Seed Strand in Needle
Class II (21 CFR 892.5730, Product Code KXK)
Radionuclide Brachytherapy Source
| Device | 510(k) # |
|---|---|
| Brachytherapy Strand Device | K040339 |
| SeedLinks™ | K023210 |
| MacroPore Surgi-Wrap (TS) | K012025 |
The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975 or K103449 or Secure Strand) of seeds spaced at a precise distance within absorbable suture. The strand is optional, when no strand is requested the seeds and spacers are custom-loaded directly into the needle. A maximum total of 20 seeds and spacers can be loaded into a needle. The spacers (K010621 or K103449) are made from the same material as the sutures. The stranded Pd-103 (K033770) and I-125 (K011205) implants are placed inside the needle. Bone Wax (K024372 or Ethicon, Inc. Bone Wax) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.
The IsoAid Brachytherapy Kit is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity.
Contact Person:
Date of Summary:
Trade Name:
Common Name:
Classification:
Classification Name:
Predicate Devices:
Device Description:
Intended Use:
Indications for Use:
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| Comparison to Predicate Device for Device as a Whole: | ||
|---|---|---|
| IsoAid Brachytherapy Kit | Bebig Brachytherapy Strand Device | |
| 510(k) Number | K091117 | K040339 |
| Indications for Use | Same | |
| Description | The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapyneedle and a custom-loaded strand(K013975) of seeds spaced at a precisedistance within absorbable suture. Thestrand is optional, when no strand isrequested the seeds and spacers arecustom-loaded directly into the needle.A maximum total of 20 seeds andspacers can be loaded into a needle. Thespacers (K010621) are made from thesame material as the sutures. Thestranded Pd-103 (K033770) and I-125(K011205) implants are placed inside 'the needle. Bone Wax (K024372) isused at the tip of the need to keep theimplants from falling out. The needle ismade from 18-gauge stainless steel. | The Brachytherapy Strand Device isused for the treatment of localizedtumors and is placed into a bodycavity or tissue. It consists of a pre-sterilized kit containing a prostateseeding needle and a custom-loadedstrand of seeds spaced at a precisedistance within absorbable suture. Thespacers are made from the samematerial as the sutures. Thecustomized strand can contain avariable number (1-12) of seeds and/orseeding spacers (maximum 12components per strand). The strandedPd-103 and I-125 implants are placedinside the needle. The needle is madefrom 18 gauge stainless steel. |
| RadioactiveIsotope(s) | Iodine-125 and/or Palladium-103 | Same |
| Application Method | Through an 18 gauge needle | Same |
Comparison to Predicate Device for Device as a Whole:
Comparison to Predicate Devices for Secure Strand Material:
| IsoAid Brachytherapy Kit | SourceTech SeedLinks™ | |
|---|---|---|
| 510(k) Number | K091117 | K023210 |
| Indication for Use | The IsoAid Brachytherapy Kit isindicated for tumors that are localized,unresectable, or have low to moderateradiosensitivity. | SeedLinks™ are indicated for use inbrachytherapy source spacing andlinking in brachytherapy procedures. |
| Reason forcomparison | The Secure Strand used by IsoAid is of the same material as the SourceTechSeedLinks™. |
| IsoAid Brachytherapy Kit | MacroPore Surgi-Wrap (TS) | |
|---|---|---|
| 510(k) Number | K091117 | K012025 |
| Compare statements | Indications for Use:The IsoAid Brachytherapy Kit isindicated for tumors that are localized,unresectable, or have low to moderateradiosensitivity. | Design Characteristics:MacroPore Surgi-Wrap (TS) is aresorbable implant in sheet formmanufactured from poly lactic acid(PLA). ... |
| Reason forcomparison | The Secure Strand material used by IsoAid is of the same material composition asthe MacroPore Surgi-Wrap (TS). |
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Standards Used for Bench and Animal Testing in Device Evaluation
ANSI/AAMI/ISO 10993- 10993-1: Evaluation and testing within a risk management process
ANSI/AAMI/ISO 10993- 10993-3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ANSI/AAMI/ISO 10993- 10993-5: Tests for in vitro cytotoxicity
ANSI/AAMI/ISO 10993- 10993-6: Tests for local effects after implantation
ANSI/AAMI/ISO 10993- 10993-7: Ethylene oxide sterilization residuals
ANSI/AAMI/ISO 10993- 10993-10: Tests for irritation and skin sensitization
ANSI/AAMI/ISO 10993- 10993-11: Tests for systemic toxicity
ANSI/AAMI/ISO 10993- 10993-12: Sample preparation and reference materials ANSI/AAMI/ISO 10993- 10993-13: Identification and quantification of degradation
products from polymeric medical devices
ASTM F1635-11 Standard Test Method for In Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants.
Conclusions:
Based on the results of the bench and animal tests performed it is concluded that these tests demonstrate that the Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit is as safe, as effective, and performs as well as or better than the predicate devices.
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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 stylized eagle-like symbol with three curved lines representing its wings or feathers. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion, following the curve of the symbol. The text is in all caps and appears to be in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 1 0 2012
Mr. Benjamin Roedell Quality Assurance Manger IsoAid, L.L.C. 7824 Clark Moody Boulevard PORT RICHEY FL 34668
Re: K113210
Trade/Device Name: Advantage-Strand™ /Advantage-Load™ Brachytherapy Kit Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: July 26, 2012 Received: July 27, 2012
Dear Mr. Roedell:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you declo openir darres of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 1 ou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit Device Name:
Indications for Use:
The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unreselectable, or have low to moderate radiosensitivity.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
510k K113298
1
§ 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.