ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT

K113210 · Isoaid, LLC · KXK · Aug 10, 2012 · Radiology

Device Facts

• Record ID: K113210
• Device Name: ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
• Applicant: Isoaid, LLC
• Product Code: KXK · Radiology
• Decision Date: Aug 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Pre-sterilized brachytherapy kit containing 18-gauge stainless steel needle and custom-loaded radioactive seeds (Pd-103 or I-125). Seeds and spacers are either loaded directly into needle or within absorbable suture strand. Bone wax used at needle tip to retain implants. Used by clinicians for implantation into body cavities or tissue to treat localized tumors via nuclear radiation. Output is the localized delivery of radiation therapy to the tumor site; intended to benefit patients by providing targeted treatment for unresectable or radiosensitive malignancies.

Clinical Evidence

Bench and animal testing only. Testing included biocompatibility (ISO 10993 series: cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation effects), ethylene oxide sterilization residuals, and in vitro degradation testing (ASTM F1635-11). No clinical data provided.

Technological Characteristics

18-gauge stainless steel needle; radioactive seeds (Pd-103, I-125); absorbable suture strand; bone wax tip sealant. Materials comply with ISO 10993 biocompatibility standards. Sterilization via ethylene oxide. No software or electronic components.

Indications for Use

Indicated for patients with localized, unresectable, or low to moderate radiosensitivity tumors.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Brachytherapy Strand Device (K040339)
• SeedLinks™ (K023210)
• MacroPore Surgi-Wrap (TS) (K012025)

Submission Summary (Full Text)

{0}------------------------------------------------

K113210

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: [phone] 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:

{1}------------------------------------------------

| 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-<br>sterilized kit containing brachytherapy<br>needle and a custom-loaded strand<br>(K013975) of seeds spaced at a precise<br>distance within absorbable suture. The<br>strand is optional, when no strand is<br>requested the seeds and spacers are<br>custom-loaded directly into the needle.<br>A maximum total of 20 seeds and<br>spacers can be loaded into a needle. The<br>spacers (K010621) are made from the<br>same material as the sutures. The<br>stranded Pd-103 (K033770) and I-125<br>(K011205) implants are placed inside '<br>the needle. Bone Wax (K024372) is<br>used at the tip of the need to keep the<br>implants from falling out. The needle is<br>made from 18-gauge stainless steel. | The Brachytherapy Strand Device is<br>used for the treatment of localized<br>tumors and is placed into a body<br>cavity or tissue. It consists of a pre-<br>sterilized kit containing a prostate<br>seeding needle and a custom-loaded<br>strand of seeds spaced at a precise<br>distance within absorbable suture. The<br>spacers are made from the same<br>material as the sutures. The<br>customized strand can contain a<br>variable number (1-12) of seeds and/or<br>seeding spacers (maximum 12<br>components per strand). The stranded<br>Pd-103 and I-125 implants are placed<br>inside the needle. The needle is made<br>from 18 gauge stainless steel. |
| Radioactive<br>Isotope(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 is<br>indicated for tumors that are localized,<br>unresectable, or have low to moderate<br>radiosensitivity. | SeedLinks™ are indicated for use in<br>brachytherapy source spacing and<br>linking in brachytherapy procedures. |
| Reason for<br>comparison | The Secure Strand used by IsoAid is of the same material as the SourceTech<br>SeedLinks™. | |

| | IsoAid Brachytherapy Kit | MacroPore Surgi-Wrap (TS) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K091117 | K012025 |
| Compare statements | <b>Indications for Use:</b><br>The IsoAid Brachytherapy Kit is<br>indicated for tumors that are localized,<br>unresectable, or have low to moderate<br>radiosensitivity. | <b>Design Characteristics:</b><br>MacroPore Surgi-Wrap (TS) is a<br>resorbable implant in sheet form<br>manufactured from poly lactic acid<br>(PLA). ... |
| Reason for<br>comparison | The Secure Strand material used by IsoAid is of the same material composition as<br>the MacroPore Surgi-Wrap (TS). | |

{2}------------------------------------------------

### 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.

{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 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

{4}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

## 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