(21 days)
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No
The device description and intended use focus on mechanical spacing of brachytherapy seeds. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as a spacer and linker for brachytherapy seeds, which are therapeutic, but the device itself does not directly deliver therapy; it supports the placement of therapeutic agents.
No
Explanation: This device is described as a spacer and linker for brachytherapy seeds, used during implant procedures to maintain accurate spacing. Its function is to facilitate the delivery of radiation, not to diagnose a condition or disease.
No
The device description clearly describes a physical component (spacer links) used to hold and space brachytherapy seeds, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for spacing and linking brachytherapy seeds during brachytherapy procedures. This is a therapeutic procedure performed on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The device description details a physical object used to hold and space radioactive seeds for implantation. It does not describe a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a tool used in a therapeutic intervention.
N/A
Intended Use / Indications for Use
SourceLink™ Brachytherapy Seeding Spacer Links are intended for spacing and linking brachytherapy seeds to be used in brachytherapy procedures.
SourceLink™ Connectors are indicated for use in seed spacing and linking in brachytherapy procedures.
Product codes (comma separated list FDA assigned to the subject device)
90 KXK
Device Description
SourceLink™ Brachytherapy Seeding Spacer Links have been designed to accurately space seeds in 0.5cm increments center-to-center during brachytherapy implant procedures. Seeds are 0.8mm in diameter and friction fit into the open female ends of the SourceLink™ Brachytherapy Seeding Spacer Links. The friction fit ensures the spacing between seeds will be accurately maintained during the implant procedure. The SourceLink ™ Brachytherapy Seeding Spacer Links are compatible by design with commonly used implant needles.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The appropriate design verification and validation activities for the modification of the SourceLink™ Brachytherapy Seeding Spacer Links was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
JUL 0 2 2004
Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with the interior of the letters being white. The letters are evenly spaced and appear to be of uniform size.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORN
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., 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 |
| Date of Preparation: | June 11, 2004 |
B. DEVICE NAME:
Trade Name(s): SourceLink™ Brachytherapy Seeding Spacer Links Common / Usual Name: Brachytherapy seeding spacer links Classification Names: (Accessory to) Source, Brachytherapy, Radionuclide
21 CFR 892.5730
్. PREDICATE DEVICE NAME:
Trade Names: SourceLink TM Brachytherapy Seeding Spacer Links
D. DEVICE DESCRIPTION:
SourceLink™ Brachytherapy Seeding Spacer Links have been designed to accurately space seeds in 0.5cm increments center-to-center during brachytherapy implant procedures. Seeds are 0.8mm in diameter and friction fit into the open female ends of the SourceLink™ Brachytherapy Seeding Spacer Links. The friction fit ensures the spacing between seeds will be accurately maintained during the implant procedure. The SourceLink ™ Brachytherapy Seeding Spacer Links are compatible by design with commonly used implant needles.
E. INTENDED USE:
SourceLink™ Brachytherapy Seeding Spacer Links are intended for spacing and linking brachytherapy seeds to be used in brachytherapy procedures.
1
Technological Characteristics Summary: F.
The subject SourceLink™ Brachytherapy Seeding Spacer Links have the same intended use, design and fundamental scientific technology as the predicate device.
G. Performance Data Summary:
The appropriate design verification and validation activities for the modification of the SourceLink™ Brachytherapy Seeding Spacer Links was conducted.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 2 2004
Mr. John C. Knorpp Sr. Regulatory Affairs Specialist Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014
Re: K041576 Trade/Device Name: SourceLinkTM Brachytherapy Seeding Spacer Links Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: June 11, 2004 Received: June 11, 2004
Dear Mr. Knorpp:
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 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 (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.
3
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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. Brydon
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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Bard Urological Division, C.R. Bard, Inc. SourceLink™ Brachytherapy Seeding Spacer Links Premarket Notification [510(k)]
Indications for Use Statement 1.3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
SourceLink™ Connectors are indicated for use in seed spacing and linking in brachytherapy procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE continue on another Page IF NEEDED)
concurrence of cdrh, office of device evaluation (ode)
V Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1/2/96)
Eamilh. Sisson
(Division Sian-Off) Division of Reproductive. and Radiological De 510(k) Number