(71 days)
BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual tumors following a course of external radiation therapy and for recurrent tumors.
BrachySource® Seed Implants consist of a welded titanium capsule containing lodine-125 absorbed onto a nickel/copper coated, gold cored aluminum wire. The implants are nominally 4.5mm long by 0.8mm in diameter. lodine-125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and a 35.5 keV gamma. The titanium wall of the BrachySource® Seed Implant absorbs the electrons.
The provided text is a 510(k) summary for the BrachySource® Brachytherapy Seed Implants. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance studies in the way a clinical trial for a new drug or a novel medical device would.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct comparison of the device's performance against such criteria. The core of the 510(k) submission is to demonstrate "substantial equivalence" to a predicate device, which implies that the new device is as safe and effective as the existing one.
Instead of a table, the document makes the following statement regarding performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "The subject BrachySource® Seed Implants have the same intended use, design and fundamental scientific technology as the predicate device.""The appropriate testing for the modification of the BrachySource® Seed Implant was conducted." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information about a "test set" in the context of typical device performance evaluation (e.g., a set of patient data or samples used to validate performance metrics like sensitivity/specificity). The testing mentioned is for a "modification" of the device, which is typically engineering or laboratory testing to ensure the modification does not alter the fundamental characteristics or safety.
Therefore, this section cannot be filled out from the provided text.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of submission. The 510(k) is about device design and manufacturing, not diagnostic performance requiring expert interpretation of results.
4. Adjudication Method
This information is not applicable to this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. Brachytherapy seeds are medical devices for treatment, not diagnostic tools that involve human readers interpreting images.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. This device is a physical brachytherapy seed implant, not an algorithm.
7. Type of Ground Truth Used
This information is not explicitly stated as "ground truth" in the diagnostic sense. The "ground truth" for this device would be its physical and radiological properties (e.g., half-life, energy emission, dimensions, material composition) and its clinical effectiveness in treating tumors. The document implies that these fundamental properties are consistent with the predicate device. For "indications for use," the ground truth would be established by medical consensus and historical clinical outcomes for brachytherapy.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical product, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
Summary and Caveats:
The provided text is a 510(k) summary for a brachytherapy seed implant. A 510(k) submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device. This process typically involves:
- Comparison of Intended Use: Showing the new device has the same intended use as the predicate.
- Comparison of Technological Characteristics: Demonstrating that differences in technological characteristics do not raise new questions of safety or effectiveness.
- Performance Data: This usually refers to bench testing, engineering tests, biocompatibility, sterilization validation, software validation (if applicable), and sometimes limited human factors testing, all aimed at confirming the device meets design specifications and is as safe and effective as the predicate. It generally does not involve large-scale clinical trials or diagnostic performance studies with specific sensitivity/specificity acceptance criteria unless a significant functional change or a new indication is being sought.
Therefore, the detailed metrics requested in your prompt (sample sizes for test/training sets, expert consensus, adjudication, MRMC studies, standalone algorithm performance) are typically associated with the development and validation of diagnostic AI tools or novel, high-risk medical devices, not usually with a 510(k) for a brachytherapy seed implant. The "acceptance criteria" here are fundamentally about meeting the requirements for substantial equivalence.
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BARD
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
A. SUBMITTER INFORMATION:
| Submitter's Name: | C. R. Bard, Inc. |
|---|---|
| Bard Urological Division | |
| Address: | 8195 Industrial Blvd. |
| Covington, GA 30014 | |
| Contact Person: | John C. Knorpp |
| Contact Person's Telephone Number: | 770-784-6451 |
| Contact Person's Fax: | 770-784-6419 |
B. DEVICE NAME:
| Trade Name(s): | BrachySource® Brachytherapy Seed Implants(BrachySource® Seed Implants) |
|---|---|
| Common/Usual Name: | Brachytherapy seed implants |
| Classification Names: | 90KXK - Source, Brachytherapy, Radionuclide21 CFR 892.5730 |
November 22, 2004
C. PREDICATE DEVICE NAME:
Date of Preparation:
1-125 Implant Seed, STM 1251 Trade Name(s):
D. DEVICE DESCRIPTION:
BrachySource® Seed Implants consist of a welded titanium capsule containing lodine-125 absorbed onto a nickel/copper coated, gold cored aluminum wire. The implants are nominally 4.5mm long by 0.8mm in diameter.
lodine-125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and a 35.5 keV gamma. The titanium wall of the BrachySource® Seed Implant absorbs the electrons.
INTENDED USE: E.
BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants may be
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in superficial, intra-abdominal and intra-thoracic locations. used ased - in - ospornals are indicated to treat residual tumors following Brachyoureee of external radiation therapy and for recurrent tumors.
Technological Characteristics Summary: F.
The subject BrachySource® Seed Implants have the same intended use, design and fundamental scientific technology as the predicate device.
Performance Data Summary: G.
The appropriate testing for the modification of the BrachySource® Seed Implant was conducted.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains an image of a bird in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.
FEB - 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John C. Knorpp Sr. Regulatory Affairs Specialist Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014
Re: K043246 Trade/Device Name: BrachySource® Brachytherapy Seed Implant Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: November 22, 2004 Received: November 23, 2004
Dear Mr. Knorpp:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced worre 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 the enerosate) to e enactment date of the Medical Device Amendments, or to devices that have been May 20, 1770, the characterith the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmou in acoveral of a premarket approval application (PMA). You may, therefore, market the do not require approvisions 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 If you de rio is classince to such additional controls. Existing major regulations affecting your Applo rary, to may of babyer 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 I rease of advisou 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 I casur starees and rogening, 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 (QS) (2) 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) I this letter wilf anow you to begin makesing of substantial equivalence of your device to a legally premarket nothleation: "The PDF mailies sification 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 If you desire specific advice for your as root 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 Also, please note the regulation on your responsibilities under the Act from the 807.77). Tou may ooually ourers, International and Consumer Assistance at its toll-free number (800) DVNSion of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.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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C.R. Bard, Inc., Bard Urological Division BrachySource® Brachytherapy Seed Implants Premarket Notification [510(k)]
Indications for Use Statement 1.3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ___ BrachySource® Brachytherapy Seed Implant
Indications for Use:
BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected BrachySource® Seed implants are indication in proceess, and early stage prostate. localized lumors such as. - nead and Though Tang, Particial, intra-abdominal and intracthoriaci BrachySource® Seed Implants are indicated to treat residual tumors following locations. locations. " Drachyood. Google of external radiation therapy and for recurrent turnors.
× Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE continue on another page if needed)
concurrence of cdrh, office of device evaluation (ode)
David R. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
(Recommended Format 11/13/2003)
§ 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.