(28 days)
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).
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.
Here's a summary of the acceptance criteria and the study information for the TheraLoad™ Custom Loaded Needles, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on design verification and validation testing to ensure compliance with device performance specifications and safety, as well as substantial equivalence to a predicate device. The acceptance criteria are largely defined by adherence to specific international and national standards related to sterilization, packaging, and microbiological methods. The 'reported device performance' is that the device met these standards and achieved functionality, safety, and substantial equivalence.
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance |
|---|---|
| AAMI TIR 27:2001 (Sterilization of Healthcare Products Radiation - Sterilization - Substantiation of 25 kGy) | Results confirmed design inputs achieved |
| ANSI / AAMI / ISO 11137:1994 (Sterilization of Healthcare Products - Radiation Sterilization) | functionality, safety, and substantial equivalence to predicate device |
| 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) | |
| ANSI / AAMI / ISO 11737-2-1997 (Sterilization of medical devices - Microbiological methods - Part 2) | |
| ISO 11607:2003 (Packaging for terminally sterilized medical devices) | |
| ASTM F1140-00 (Standard Test Methods for internal pressurization failure resistance) | |
| ASTM F1886-98 (Standard Test Method for determining integrity of seals by visual inspection) | |
| ASTM F1929-98 (Standard Test Method for detecting seal leaks by dye penetration) | |
| ASTM F2096-02 (Standard Test Method for detecting gross leaks by internal pressurization - Bubble Test) |
2. Sample size used for the test set and the data provenance:
This document describes a design verification and validation (V&V) study for a medical device. It does not provide specific sample sizes for individual tests. The focus is on demonstrating that the device meets engineering and safety specifications through adherence to recognized standards. The data provenance is implied to be internal testing conducted by Theragenics Corporation as part of their design control process. There is no mention of specific country of origin for test data or whether it was retrospective or prospective in the clinical sense, as this is a device design validation, not typically a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The "ground truth" for this type of device (brachytherapy needles and spacers) is established by adherence to engineering specifications and international standards for sterilization, packaging, and material properties. It does not involve expert medical interpretation in the same way an AI diagnostic or prognostic device would. The "experts" involved would be engineers, microbiologists, and other technical specialists performing the V&V tests, but their number and specific qualifications are not detailed in this summary.
4. Adjudication method for the test set:
Not applicable. This is a design verification and validation study against established engineering and technical standards, not a clinical study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This device is a component for brachytherapy and its evaluation focuses on physical and biological safety, not on diagnostic performance or human-in-the-loop clinical effectiveness that would necessitate an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device itself is a physical medical product (custom-loaded needles), not a software algorithm or AI system.
7. The type of ground truth used:
The ground truth used for this device is based on engineering specifications, material science, and compliance with recognized international and national standards related to sterilization, packaging integrity, and biocompatibility. For example, for sterility, it relies on microbiological methods and a substantiated sterilization dose (25 kGy) according to AAMI TIR 27:2001 and ISO 11137:1994.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML algorithm requiring a training set.
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JAN 26 2021
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)I-Seed I-125, K021343Brachytherapy Strand Device, K040339 |
| Manufacturer: | Theragenics Corporation®5203 Bristol Industrial WayBuford, GA 30518 |
| EstablishmentRegistration Number: | 1037598 |
| Official Contact: | Betsy Cortelloni, Regulatory Affairs ManagerTheragenics Corporation5203 Bristol Industrial WayBuford, GA 30518Phone: 770-831-4294Fax: 770-831-4369cortellb@theragenics.com |
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.
{1}------------------------------------------------
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
{2}------------------------------------------------
THERAGENICS CORPORATION®
Image /page/2/Picture/1 description: The image shows a blurry, high-contrast image of what appears to be handwriting. The writing is illegible due to the image quality. The strokes are thick and uneven, suggesting it may have been written quickly or with a broad marker.
- 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
Page 44
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
{4}------------------------------------------------
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.
{5}------------------------------------------------
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 (800) 638-2041 or (301) 443-6597 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
0033
§ 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.