(28 days)
Not Found
No
The 510(k) summary describes a radioactive seed implant for brachytherapy and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for the "permanent interstitial treatment of selected localized tumors," which is a therapeutic purpose.
No
Explanation: The device is a Brachytherapy Seed Implant used for treating tumors with radiation, not for diagnosing them.
No
The device description clearly states it consists of a welded titanium capsule containing Iodine-125 absorbed onto a wire, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The provided information clearly describes a radioactive seed implant used for internal radiation therapy to treat tumors within the body. It is implanted directly into the tissue.
- Lack of Specimen Examination: The device does not involve the examination of specimens taken from the body.
Therefore, based on the provided information, the BrachySource® Seed Implants are a therapeutic device, not an in vitro diagnostic device.
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 a course of external radiation therapy and for recurrent tumors.
Product codes (comma separated list FDA assigned to the subject device)
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 tifanium 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, and early stage 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 bench testing to determine substantial equivalence was completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
DEC 2 3 2009
Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, outlined font. The letters are thick and have a textured appearance, possibly due to the image being a scan or a low-resolution graphic. The word is horizontally oriented and appears to be the primary focus of the image.
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 Medical Division | |
| Address: | 8195 Industrial Blvd. Covington, GA 30014 |
| Contact Person: | Julie Bassett |
|---|---|
| Contact Person's Telephone Number: | 770-784-6375 |
| Contact Person's Fax: | 770-385-4706 |
B. DEVICE NAME:
| Device Name: | Brachytherapy seed implants |
|---|---|
| Trade Name(s): | BrachySource ® Brachytherapy Seed Implants |
| Common/Usual Name: | Brachytherapy seed implants |
| Classification Names: | 90KXK - Source, Brachytherapy, Radionuclide |
| CFR Reference: | 21 CFR 892.5730 – Radionuclide Brachytherapy |
| Source Class II |
C. PREDICATE DEVICE NAME:
| Trade Names: | BrachySource® Brachytherapy Seed Implants |
|---|---|
| K043246 |
D. DEVICE DESCRIPTION:
480-06
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 tifanium wall of the BrachySource Seed Implant absorbs the electrons.
1
E. 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 used in superficial, intra-abdominal, and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual ournors following completion of a course of external radiation therapy and for recurrent tumors.
TECHNOLOGICAL-CHARACTERISTICS-SUMMARY:-
The subject BrachySource® Brachytherapy Seed Implants have the same intended use, general design and fundamental scientific technology as the predicate device.
G. PERFORMANCE DATA SUMMARY:
The appropriate bench testing to determine substantial equivalence was completed.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEC 2 3 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
Ms. Julie Bassett Regulatory Affairs Specialist C. R. Bard, Inc. Bard Medical Division 8195 Industrial Blvd. COVINGTON GA 30014
Re: K093663
Trade/Device Name: BrachySource® Brachytherapy Seed Implants Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: November 23, 2009 Received: November 25, 2009
Dear Ms. Bassett:
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 (PMA), it may be subject to 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); medical device reporting of medical
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Page 2 -
Enclosure
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ramona M. Mavis
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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C.R. Bard, Inc., Bard Medical Division BrachySource® Brachytherapy Seed Implants Premarket Notification [510(k)]
1.4 Indications for Use Statement
510(k) Number (if known): K093663
Device Name:
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 a course of external radiation therapy and for recurrent tumors.
X 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 IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Houn M. Wher
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(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number