THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06

K043596 · Theragenics Corp. · KXK · Jan 26, 2005 · Radiology

Device Facts

• Record ID: K043596
• Device Name: THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
• Applicant: Theragenics Corp.
• Product Code: KXK · Radiology
• Decision Date: Jan 26, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and spacers custom loaded according to the treatment plan. The brachytherapy source is intended to treat localized, unresectable turnors with low to moderate radiosensitivity. Tumors may be recurrent or residual following external beam or excision of primary tumor and may be superficial, intrathoracic (head, neck, lung), or intra-abdominal (pancreas, prostate).

Device Story

TheraLoad™ is a sterile, single-use prostate-seeding kit containing radioactive seeds (Pd-103 or I-125) and bioabsorbable spacers. Treating medical physicists specify patient-specific prescriptions, determining the number of seeds and spacers (1-12 components) per needle based on a treatment plan. The device is used in clinical settings for brachytherapy. By providing pre-loaded needles, the device simplifies the implantation process for the physician, ensuring accurate delivery of the prescribed radiation dose to the tumor site. This targeted delivery benefits patients by treating localized, unresectable tumors while minimizing radiation exposure to surrounding healthy tissue.

Clinical Evidence

Bench testing only. Design verification and validation were conducted in accordance with 21 CFR 820.30 to demonstrate compliance with performance specifications and safety requirements. Testing included sterilization validation, packaging integrity (ASTM F1140, F1886, F1929, F2096), and functional performance testing.

Technological Characteristics

Sterile, single-use brachytherapy kit. Components: Pd-103 or I-125 seeds, bioabsorbable spacers. Sterilization: Radiation (AAMI TIR 27, ISO 11137). Packaging: ISO 11607 compliant. Sealed source classifications: ISO/99/C53211 (Pd-103) and ISO/99/C63211 (I-125).

Indications for Use

Indicated for patients with localized, unresectable, low-to-moderate radiosensitivity tumors, including recurrent or residual tumors following external beam radiation or excision. Applicable to superficial, intrathoracic (head, neck, lung), or intra-abdominal (pancreas, prostate) 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

• TheraSeed (K010283)
• I-Seed I-125 (K021343)
• Brachytherapy Strand Device (K040339)

Submission Summary (Full Text)

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JAN 26 2021

K043596

Page 24

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

THERAGENICS CORPORATIC

| Device Name: | TheraLoad™ Custom Loaded Needles |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Model Number: | Model 200 (Pd-103), Model I25.S06 (I-125) |
| Classification Name: | Radionuclide Brachytherapy Source (KXK), 21 CFR 892.5730 |
| Device Classification: | Class II (Radiology) |
| Predicate Devices: | TheraSeed, K010283 (2001)<br>I-Seed I-125, K021343<br>Brachytherapy Strand Device, K040339 |
| Manufacturer: | Theragenics Corporation®<br>5203 Bristol Industrial Way<br>Buford, GA 30518 |
| Establishment<br>Registration Number: | 1037598 |
| Official Contact: | Betsy Cortelloni, Regulatory Affairs Manager<br>Theragenics Corporation<br>5203 Bristol Industrial Way<br>Buford, GA 30518<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |

Intended Use: TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and spacers custom loaded according to the treatment plan.

The brachytherapy source is intended to treat localized, unresectable turnors with low to moderate radiosensitivity. Tumors may be recurrent or residual following external beam or excision of primary tumor and may be superficial, intrathoracic (head, neck, lung), or intra-abdominal (pancreas, prostate).

Device Description: TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and bioabsorbable spacers custom loaded according to the treatment plan.

The variable seed spacing available with TheraLoad™ allows the treating medical physicist to specify individual patient prescriptions. The customized order can contain a variable number of seeds and/or spacers (1-12 total components). The treating medical physicist determines the total number of active seeds required for each order.

The spacer material is biocompatible and commonly used in implantable medical devices.

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#### CORPORATION® THERAGENICS

K42326
Project

Comparison of Technological Characteristics: TheraLoad™ is functionally equivalent to the predicate TheraStrand™. TheraLoad™ utilizes the same equirials, packaging, and methods (manufacturing, inspection, sterilization) TheraStrand™.

Use Type: TheraLoad™ device is custom ordered to an individual patient prescription. TheraLoad™ is provided sterile and is single use device.

Sealed Source Classification: TheraLoad™ can be configured with TheraSeed® (Pd-103) or I-Seed (I-125).

- The Sealed Source Device Registration Number for TheraSeed® is GA � 645S101S, and the ISO Sealed Sourced Classification for TheraSeed® is ISO/99/C53211
- The Sealed Source Device Registration Number for I-Seed is GA . 645S102S, and the ISO Sealed Sourced Classification for I-Seed is ISO/99/C63211

Design Verification: TheraLoad™ was developed in accordance with 21 CFR 820.30 - Design Controls. Design validation and verification testing was conducted to demonstrate compliance with device performance specifications and to establish device safety.

The following standards were used in the development of TheraLoad™ Custom Loaded Needles:

- AAMI TIR 27:2001, Sterilization of Healthcare Products Radiation . Sterilization - Substantiation of 25 kGy as a sterilization dose -- Method VD Max
- ANSI / AAMI / ISO 11137:1994, Sterilization of Healthcare Products -. Requirements for validation and routine control – Radiation Sterilization
- EN 552:1994, Sterilization of Medical Devices Validation and routine . control of sterilization by irradiation
- ANSI / AAMI / ISO 11737-1-1995, Sterilization of medical devices -. Microbiological methods - Part 1: Estimation of population of microorganisms on products
- ANSI / AAMI / ISO 11737-2-1997, Sterilization of medical devices -. Microbiological methods – Part 2: Tests of sterility performed in the validation of sterilization process
- ISO 11607:2003, Packaging for terminally sterilized medical devices .
- ASTM F1140-00, Standard Test Methods for internal pressurization . failure resistance of unrestrained packages for medical applications
- ASTM F1886-98, Standard Test Method for determining integrity of seals . for medical packaging by visual inspection

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# THERAGENICS CORPORATION®

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- ASTM F1929-98, Standard Test Method for detecting seal leaks in porous . medical packaging by dye penetration
- ASTM F2096-02 Standard Test Method for detecting gross leaks in . medical packaging by internal pressurization (Bubble Test)

Conclusion: The results of the V&V testing confirmed that design inputs were Concrusion: The results of the 1 car results demonstrated the functionality, safety actileved and the camdiative tast Custom Loaded Needles, as well as its and chocantial equivalence to the predicate TheraStrand™.

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## INDICATIONS FOR USE FORM

Kosto
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Page 1 of 1 .

510(K) number (if known): Ki43596

TheraLoad™ Custom Loaded Needles Device Name:_

### Indications for Use:

TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and spacers custom loaded according to the treatment plan.

The brachytherapy source is intended to treat localized, unresectable turnors with low to moderate radiosensitivity. Tumors may be recurrent or residual following external beam or excision of primary tumor and may be superficial, intrathoracic (head, neck, lung), or intraabdominal (pancreas, prostate).

## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFRR 801.109) OR

Over-The-Counter Use

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Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

JAN 2 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Betsy Cortelloni Regulatory Affairs Manager Theragenics Corporation Corporate Offices 5203 Bristol Industrial Way BUFORD GA 30518

Re: K043596

Trade/Device Name: TheraLoadTM Custom Loaded Needles Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: December 27, 2004 Received: December 29, 2004

Dear Ms. Cortelloni:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon 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 FORM

Page_1_of_1_

510(K) number (if known): Ki 43596

Device Name: TheraLoad™ Custom Loaded Needles

### Indications for Use:

TheraLoad™ is a sterile prostate-seeding kit containing TheraSeed® (Pd-103) or I-Seed (I-125) seeds and spacers custom loaded according to the treatment plan.

The brachytherapy source is intended to treat localized, unresectable tumors with low to moderate radiosensitivity. Tumors may be recurrent or residual following external beam or excision of primary tumor and may be superficial, intrathoracic (head, neck, lung), or intraabdominal (pancreas, prostate).

#### (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ X (Per 21 CFRR 801.109) OR

Over-The-Counter Use_

Nancyl Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K043596

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