ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA by ISOAID, L.L.C.

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.

Device Description

The IsoAid Brachytherapy Kit is a pre-sterilized kit containing brachytherapy needle and a custom-loaded strand (K013975) 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) 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) is used at the tip of the need to keep the implants from falling out. The needle is made from 18-gauge stainless steel.

AI/ML Overview

The provided document is a 510(k) Summary for the IsoAid Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit. This type of regulatory submission establishes substantial equivalence to a predicate device and typically does not include detailed studies with acceptance criteria, sample sizes for test/training sets, expert consensus, or specific performance metrics in the way a clinical trial or device validation study might.

Instead, substantial equivalence is determined by comparing the new device's technological characteristics and indications for use to a legally marketed predicate device. The information provided heavily focuses on this comparison rather than presenting a performance study with acceptance criteria.

However, based on the provided text, I can infer the "acceptance criteria" through the comparison to the predicate device, as the primary goal of this submission is to show that the new device is as safe and effective as the predicate.

Here's an attempt to structure the information based on your request, understanding that the "study" here is essentially the substantial equivalence discussion, and not a traditional performance study as you might expect for AI/software devices.

Acceptance Criteria and Device Performance Study for IsoAid Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are implicitly met if the new device demonstrates substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and safety/effectiveness. The performance evaluation is primarily a comparison.

Feature / Criterion	Acceptance Criteria (Based on Predicate Device)	Reported Device Performance (IsoAid Advantage-Strand™ / Advantage-Load™)
Indications for Use	Treatment of selected localized tumors that are localized, unresectable, or have low to moderate radiosensitivity. The device is implanted as a source of nuclear radiation for therapy. (Same as predicate: Bebig Brachytherapy Strand Device K040339)	Same as predicate: "The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, or have low to moderate radiosensitivity."
Device Description	Pre-sterilized kit with brachytherapy needle and custom-loaded strand of seeds/spacers in absorbable suture. Variable number of seeds/spacers. Pd-103 and I-125 implants. 18-gauge stainless steel needle. (Description of Bebig Brachytherapy Strand Device K040339)	Pre-sterilized kit with brachytherapy needle and custom-loaded strand of seeds spaced at a precise distance within absorbable suture (optional). Maximum 20 seeds/spacers per needle. Spacers from same material as sutures. Pd-103 (K033770) and I-125 (K011205) implants. Bone Wax at tip. 18-gauge stainless steel needle. (Similar to predicate, with minor variations like max seed count).
Radioactive Isotope(s)	Iodine-125 and/or Palladium-103 (Same as predicate)	Same: Iodine-125 and/or Palladium-103
Application Method	Through an 18 gauge needle (Same as predicate)	Same: Through an 18 gauge needle
Safety and Effectiveness	Demonstrated by substantial equivalence to the predicate device (Bebig Brachytherapy Strand Device K040339), implying similar performance characteristics, risks, and benefits in clinical use. The FDA's determination acknowledges that the new device does not raise different questions of safety and effectiveness.	The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, implying it meets the same standards of safety and effectiveness.

Note: For devices like this, "performance" is often related to manufacturing specifications, radiation characteristics (which are standardized for isotopes), and mechanical properties, not typically evaluated with metrics like sensitivity/specificity or human reader improvement. The document does not detail these specific engineering tests, but they would have been part of the underlying design controls.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical "test set" in the context of diagnostic accuracy or AI performance as you might expect. The "testing" for a device like this in a 510(k) submission primarily involves:

Bench testing to ensure manufacturing specifications, sterility, and mechanical integrity are met.
Comparison of technical specifications and intended use to a legally marketed predicate device.

Therefore, there is no mention of a "sample size for a test set" or "data provenance" from clinical cases here. The evaluation is largely based on technical specifications and regulatory comparison.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study requiring expert-established ground truth for a test set of clinical data. The "ground truth" for a medical device's performance in a 510(k) context is often established by adherence to recognized standards, established material properties, and the known safety/efficacy profile of its predicate device and active components (radioisotopes).

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance?

Not applicable. This device is a brachytherapy kit, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc)

The "ground truth" for this regulatory submission is established through:

Predicate device's safety and effectiveness: The Bebig Brachytherapy Strand Device (K040339) is a legally marketed device whose safety and efficacy have been previously established.
Material specifications and established medical use: Components like Pd-103 and I-125 brachytherapy seeds have well-understood radiation characteristics and are standard in clinical practice. The materials used (e.g., absorbable suture, stainless steel) have established biocompatibility and properties.
The submission essentially argues that because the new device is substantially equivalent in design, materials, and intended use to the predicate, its safety and effectiveness are also equivalent.

8. The Sample Size for the Training Set

Not applicable. There is no AI algorithm or "training set" for this type of device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI algorithm or "training set" for this type of device.

Summary

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691111

SEP & 5 2009

510 (k) SUMMAR Y (as required by 807.92(c))

Submitter of 510(k):

IsoAid, LLC 7824 Clark Moody Blvd., Port Richey, FL 34668 Phone: 727-815-3262 Fax: 727-815-1973

Benjamin Roedell

April 16, 2009

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

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:

Comparison to Predicate Device:

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	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 brachytherapy needle and a custom-loaded strand (K013975) 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) 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) 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 Brachytherapy Strand Device is used for the treatment of localized tumors and is placed into a body cavity or tissue. It consists of a pre-sterilized kit containing a prostate seeding needle and a custom-loaded strand of seeds spaced at a precise distance within absorbable suture. The spacers are made from the same material as the sutures. The customized strand can contain a variable number (1-12) of seeds and/or seeding spacers (maximum 12 components per strand). The stranded Pd-103 and I-125 implants are placed inside the needle. The needle is made from 18 gauge stainless steel.
RadioactiveIsotope(s)	Iodine-125 and/or Palladium-103	Same
Application Method	Through an 18 gauge needle	Same

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a bird-like symbol, possibly representing an eagle or other bird of freedom. The bird is depicted with three curved lines forming its body and wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP 1 5 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002

Mr. Benjamin Roedell Quality Assurance Manager IsoAid LLC 7824 Clark Moody Blvd. PORT RICHEY FL 34668

Re: K091117

Trade/Device Name: Advantage-Strand™ / Advantage-Load™ Brachytherany Kit Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: August 14, 2009 Received: August 17, 2009

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K091117

Advantage-Strand™ / Advantage-Load™ Brachytherapy Kit Device Name:

Indications for Use:

The IsoAid Brachytherapy Kit is indicated for tumors that are localized, unresectable, 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)

hoanm Wha

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Regulation Number and Section

§ 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.