(71 days)
STM 1251
Not Found
No
The device description and intended use focus on the physical characteristics and radioactive properties of the seed implants, with no mention of AI or ML technology. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as "permanent interstitial treatment of selected localized tumors" and is used to "treat residual tumors following a course of external radiation therapy and for recurrent tumors," indicating a therapeutic purpose.
No
Explanation: The device is a BrachySource® Seed Implant used for permanent interstitial treatment of selected localized tumors, indicating a therapeutic purpose rather than a diagnostic one. It contains Iodine-125 for radiation therapy.
No
The device description clearly states it is a physical implant made of titanium containing Iodine-125, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the BrachySource® Seed Implants are for the "permanent interstitial treatment of selected localized tumors." This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a radioactive implant designed to deliver radiation directly to a tumor. This is a treatment modality, not a diagnostic tool.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the BrachySource® Seed Implants are a therapeutic device used for treating cancer, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
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 completion of external radiation therapy and for recurrent tumors.
Product codes
90 KXK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head and neck, lung, pancreas, prostate, superficial, intra-abdominal and intra-thoracic locations.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The appropriate testing for the modification of the BrachySource® Seed Implant was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
1-125 Implant Seed, STM 1251
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, Radionuclide
21 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
1
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.
2
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.
3
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
4
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)