(40 days)
No
The document describes radioactive seed implants for brachytherapy and explicitly states there is no change to the commercially available seeds. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of such technologies.
Yes
The device is described as "TheraSeed® Palladium-103 Implants" which are "indicated for tumors" and used for treatment. The term "implants" and the purpose of treating tumors clearly indicate a therapeutic function.
No
The device, TheraSeed® Palladium-103 Implants, is used for treating tumors (therapy), not for diagnosing them. It is a radioactive seed implant used in brachytherapy.
No
The device description explicitly states it is a "Pd-103 Seed Implant Kit" and refers to "TheraSeed® Palladium-103 Implants," which are physical radioactive seeds. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for treating tumors by implanting radioactive seeds. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as "Palladium-103 Seed Implants," which are physical objects implanted into the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting specific substances, or providing diagnostic information.
Therefore, the TheraSeed® Palladium-103 Implants are a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TheraSeed® Palladium-103 Implants are indicated for tumors with any of the following characteristics:
- . Localized,
- Unresectable,
- Low to moderate radiosensitivity.
The tumors may be of the following types:
- . Superficial;
- . Intrathoracic;
- . Intra-abdominal;
- 트 Lung, pancreas, prostate, head and neck;
- . Residual following external beam or excision of primary tumor;
- . Recurrent.
Product codes
KXK
Device Description
The Pd-103 Seed Implant Kits will be offered using TheraSeed® Palladium-103 Implants, which are produced and marketed commercially by Theragenics, Inc. under the 510(k) K010283. There is no change to the seeds produced by Theragenics and marketed under the name TheraSeed® Palladium-103 devices. These seeds will be packaged in various sterile and non-sterile configurations. These configurations are the same as the predicate described in K043246.
The principles of operation and fundamental scientific technology have not changed. Reference K043246 and K010283 for a detailed description.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Superficial; Intrathoracic; Intra-abdominal; Lung, pancreas, prostate, head and neck
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 Palladium-103 Seed Implant Kits was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
APR 1 9 2006
Image /page/0/Picture/3 description: The image shows the word "BARD" in a stylized, bold font. The letters are thick and have a rounded appearance. The "A" in "BARD" is designed with a unique shape, resembling a triangle with a horizontal line across the middle. The overall design of the word gives it a modern and distinctive look.
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:
Contact Person's Fax:
Date of Preparation:
| Submitter's Name: | C. R. Bard, Inc. | |
|---|---|---|
| Bard Urological Division | ||
| Address: | 13183 Harland Dr. | |
| Covington, GA 30014 | ||
| Contact Person: | Julie J. Bassett | |
| Contact Person's Telephone Number: | 678-342-4921 |
B. DEVICE NAME:
| Trade Name(s): | Palladium-103 Seed Implant Kits |
|---|---|
| Common/Usual Name: | Brachytherapy seed implants |
| Classification Names: | 90KXK - Source, Brachytherapy, Radionuclide |
| 21 CFR 892.5730 |
770-788-5517
March 9, 2006
C. PREDICATE DEVICE NAME:
Trade Name(s): TheraSeed® Palladium-103 Implants and BrachySource® Brachytherapy Seed Implants
D. DEVICE DESCRIPTION:
The Pd-103 Seed Implant Kits will be offered using TheraSeed® Palladium-103 Implants, which are produced and marketed commercially by Theragenics, Inc. under the 510(k) K010283. There is no change to the seeds produced by Theragenics and marketed under the name TheraSeed® Palladium-103 devices. These seeds will be packaged in various sterile and non-sterile configurations. These configurations are the same as the predicate described in K043246.
The principles of operation and fundamental scientific technology have not changed. Reference K043246 and K010283 for a detailed description.
TheraSeed® is a registered trademark of Theragenics Corporation®
1
E. INTENDED USE:
TheraSeed® Palladium-103 Implants are indicated for tumors with any of the following characteristics:
- . Localized,
- Unresectable,
- Low to moderate radiosensitivity.
The tumors may be of the following types:
- . Superficial;
- . Intrathoracic;
- . Intra-abdominal;
- 트 Lung, pancreas, prostate, head and neck;
- . Residual following external beam or excision of primary tumor;
- . Recurrent.
The intended use has not changed from Theragenics 510(k), K010283.
ﺎﻧﺎ TECHNOLOGICAL CHARACTERISTICS SUMMARY:
The subject device, Palladium-103 Implant Kits, has the same intended use, design and fundamental scientific technology as the predicate devices.
G. PERFORMANCE DATA SUMMARY:
The appropriate testing for the Palladium-103 Seed Implant Kits was conducted.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding it.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 9 2006
Ms. Julie J. Bassett, RAC Regulatory Affairs Specialist C.R. Bard, Inc. Bard Urological Division 8195 Industrial Blvd. COVINGTON GA 30014
Re: K060636
Trade/Device Name: Palladium-103 Seed Implant Kits Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: March 9, 2006 Received: March 10, 2006
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 (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.
Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006". The logo is circular and contains the letters "FDA" in a bold font. The text "Protecting and Promoting Public" is also visible in the image.
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease of a rison 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 (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.
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 promated 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/industry/support/index.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 Palladium-103 Seed Implant Kits Premarket Notification [510(k)]
1.3 Indications for Use Statement
510(k) Number (if known):
Device Name: Palladium-103 Seed Implant Kits_
Indications for Use:
TheraSeed® Palladium-103 Implants are indicated for tumors with any of the following characteristics:
- . Localized,
- l Unresectable,
- Low to moderate radiosensitivity. 트
The tumors may be of the following types:
- l Superficial:
- . Intrathoracic;
- 일 Intra-abdominal;
- 1 Lung, pancreas, prostate, head and neck;
- 발 Residual following external beam or excision of primary tumor;
- 지 Recurrent.
| Prescription Use | X |
|---|---|
| (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)
David A. Segrim
(Division Sign-Off) V
Division of Reproductive, Abdominal,
anır Radiological Devices K060636
(Recommended Format 11/13/2003)
TheraSeed® is a registered trademark of Theragenics Corporation®.