(29 days)
No
The device description and performance studies focus on the physical properties and radioactive decay of the seed implant and bioabsorbable caps, with no mention of AI or ML for image analysis, treatment planning, or any other function.
Yes.
The device is used for the "permanent interstitial treatment of selected localized tumors," which is a therapeutic purpose.
No
This device is described as an implant used for the permanent interstitial treatment of tumors using radiation (brachytherapy), not for diagnosing conditions.
No
The device description clearly details a physical implantable device consisting of a titanium capsule, radioactive material (Iodine-125), and bioabsorbable caps. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the BrachySource® Seed Implants are implanted directly into the body for the permanent interstitial treatment of tumors. This is an in vivo (within the living body) treatment, not an in vitro test performed on a sample outside the body.
- Mechanism of Action: The device works by emitting radiation from Iodine-125 to treat tumors within the body. This is a therapeutic mechanism, not a diagnostic one.
Therefore, the BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps fall under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.
Product codes
KXK
Device Description
BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps consist of a seed implant with bioabsorbable caps fitted onto each end of the seed. The seed implant is a welded titanium capsule containing lodine-125 adsorbed onto a nickel/copper coated, gold cored aluminum wire. The bioabsorbable caps are composed of 70% L-lactide and 30% D L-lactide copolymer.
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 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons. The bioabsorbable caps break down over 18-24 months and do not impact the emissions from the lodine-125 seed.
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 modified device, BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps, have been tested via nonclinical functional performance testing. Nonclinical functional performance tests included testing to verify the assembly and integrity of the bioabsorbable caps with the seed and the interface of the seed with bioabsorbable caps within brachytherapy implant needles.
The bioabsorbable caps are the same material as the SourceLink® Brachytherapy Seeding Spacer Links (K041576). The SourceCap Bioabsorbable Caps and SourceLink® Links have the same patient contact and duration. The requirements per ISO 10993-1:2009, Biologicol evoluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing" have been met for this material.
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.
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K140856
Page 1 of 2
510(k) Summary
Special 510(k) | BrachySource Seed Implar SourceCap Bioabsorbable Caps
Bard Medical Division C.R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps 510{k) premarket notification.
Sponsor:
BARD Medical Division C. R. BARD, Inc. 8195 Industrial Blvd. Covington, GA 30014 Establishment Registration Number: 1018233
Contact:
Michele Davis, RAC Regulatory Affairs Project Manager Bard Medical Division 770-784-6274 Tel: Fax: 770-385-4706
Date:
April 2, 2014
Subject Device:
Trade Name: BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps Common or Classification Name: Radionuclide Brachytherapy Source Regulation: 21 CFR 892.5730 Classification: II Product Code: KXK
Legally marketed device to which substantial equivalence is claimed:
. BrachySource® Brachytherapy Seed Implants, K093663
Device Description
BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps consist of a seed implant with bioabsorbable caps fitted onto each end of the seed. The seed implant is a welded titanium capsule containing lodine-125 adsorbed onto a nickel/copper coated, gold cored aluminum wire. The bioabsorbable caps are composed of 70% L-lactide and 30% D L-lactide copolymer.
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 35.5 keV gamma. The titanium wall of the BrachySource Seed Implants absorbs the electrons. The bioabsorbable caps break down over 18-24 months and do not impact the emissions from the lodine-125 seed.
1
K140856
page 2 of 2
Special 510(k) | BrachySource Seed Implants with SourceCap Bioabsorbable Caps
Intended Use
BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed lmplants with SourceCap™ Bioabsorbable Caps are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.
Technological Characteristics
BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps has the same intended use and fundamental scientific technology as the predicate device, BrachySource® Brachytherapy Seed Implants. The difference between the subject and predicate device is the addition of bioabsorbable caps on the ends of the seed to increase the surface area of the seed and aid to resist movement of the seed within the tissue. The modification to the BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps is deemed equivalent to the current device, BrachySource® Brachytherapy Seed Implants (K093663).
Performance Data
The modified device, BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps, have been tested via nonclinical functional performance testing. Nonclinical functional performance tests included testing to verify the assembly and integrity of the bioabsorbable caps with the seed and the interface of the seed with bioabsorbable caps within brachytherapy implant needles.
The bioabsorbable caps are the same material as the SourceLink® Brachytherapy Seeding Spacer Links (K041576). The SourceCap Bioabsorbable Caps and SourceLink® Links have the same patient contact and duration. The requirements per ISO 10993-1:2009, Biologicol evoluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing" have been met for this material.
Substantial Equivalence
The BrachySource Seed Implants with SourceCap Bioabsorbable Caps has the same indications for use and fundamental scientific technological characteristics as the predicate device. Based on this, the design and the summary of design control activities provided in this submission, the proposed BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps has been shown to be substantially equivalent to the cleared BrachySource® Brachytherapy Seed Implants, K093663.
Conclusion:
The modified device, BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps, is substantially equivalent to the predicate device, BrachySource® Brachytherapy Seed Implants.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
Mav 2, 2014
C. R. Bard. Inc. % Ms. Michele Davis Regulatory Affairs Project Manager 8195 Industrial Blvd. COVINGTON GA 30014
Re: K140856
Trade/Device Name: BrachySource" Seed Implants with SourceCap™ Bioabsorbable Caps Regulation Number: 21 CFR 892.5730
Regulation Name: Radionuctide brachytherapy source
Regulatory Class: II Product Code: KXK Dated: April 2. 2014 Received: April 3. 2014
Dear Ms. Davis:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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 (reporting of medical 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.
3
Page 2-Ms. Davis
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug AdmInistration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140856
Device Name
BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps
Indications for Use (Describe)
BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants with SourceCap™ Bioabsorbable Caps are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent lumors.
Type of Use (Select one or both, as applicable)
Prescription Use {Part 21 CFR 801 Subpart D}
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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