(57 days)
No
The document describes a physical medical device (brachytherapy strand) and its intended use, without mentioning any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
This device is intended for the treatment of tumors using radioactive sources, which is a therapeutic intervention.
No
The device description and intended use clearly state that it is used for the "treatment of tumors" by placing "radioactive sources" or "seeds" within or near the tumor. This indicates a therapeutic, not diagnostic, function.
No
The device description clearly outlines physical components such as radioactive sources, needles, sutures, and spacers, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of tumors by placing radioactive sources within or near the tumor. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a brachytherapy strand used for delivering radiation directly to a tumor. This is a treatment modality.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) or providing information for diagnosis. The device's function is to deliver radiation for therapeutic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The BEBIG I-125 sources are intended for use in the treatment of turnors, with radioactive sources within or in close proximity to the turnor. The Brachytherapy Strand Device is indicated for tumors with any of the following characteristics: - o Localized - Unresectable O - Low to Moderate Radiosensitivity The tumors may be of the following type: - Superficial O - Intrathoracic o - Intra-abdominal O - Lung, Pancreas, Prostate, Head and Neck O - Residual following external beam radiation or excision of primary tumor 0 - ೧ Recurrent
Product codes
90 KXK
Device Description
The Brachytherapy Strand Device is used for the treatment of localized tumors and is placed into a body cavity or tissue. It consists of a pre-sterilized kit containing a prostate seeding needle and a custom-loaded strand of seeds spaced at a precise distance within absorbable suture. The spacers are made from the same material as the sutures. The customized strand can contain a variable number (1-12) of seeds and/or seeding spacers (maximum 12 components per strand). The stranded Pd-103 and I-125 implants are placed inside the needle. The needle is made from 18 gauge stainless steel
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Localized, 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982226, K021343, K010283, K944110
Reference Device(s)
K030594, K914281, K013964, K022269, K944110
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
Brachytherapy Strand Device - BEBIG 510(k) Premarket Notification
APR = 8 2004
page 1 of 2
510(k) Summary of Safety and Effectiveness
The Brachytherapy Strand Device
The following 510(k) Summary of Safety and Effectiveness is provided according to the requirements of 21 CFR 807.92.
Date
February 06, 2004
Company Name
BEBIG Isotopen- and Medizintechnik GmbH Robert Rössle Str. 10 13125 Berlin, Germany phone: ++49 30 94 10 84-0 ++49 30 94 10 84-112 fax:
Official Contact
Sven Langer Regulatory Affairs
Device Name
| Proprietary Name: | Brachytherapy Strand Device |
|---|---|
| Common Name: | Brachytherapy seed strand |
| Classification : | Class II, 21 CFR 892.5730, Radionuclide Brachytherapy |
| Source, KXK |
Predicate Devices used for Substantial Eguivalence
| Device | Premarket # |
|---|---|
| I-125 Rapid Strand Model 7000 | K982226 |
| BEBIG brachytherapy I-125 source | K021343 |
| Theraseed® Palladium-103 Implant Model 200 | K010283 |
| Vicry Rapide Suture | K944110 |
Intended Use
The BEBIG I-125 sources are intended for use in the treatment of turnors, with radioactive sources within or in close proximity to the turnor.
Indications for use
The Brachytherapy Strand Device is indicated for tumors with any of the following characteristics:
- o Localized
- Unresectable O
- Low to Moderate Radiosensitivity ರ
The tumors may be of the following type:
- Superficial O
- Intrathoracic o
- Intra-abdominal O
- Lung, Pancreas, Prostate, Head and Neck O
- Residual following external beam radiation or excision of primary tumor 0
- ೧ Recurrent
1
Description
The Brachytherapy Strand Device is used for the treatment of localized tumors and is placed into a body cavity or tissue. It consists of a pre-sterilized kit containing a prostate seeding needle and a custom-loaded strand of seeds spaced at a precise distance within absorbable suture. The spacers are made from the same material as the sutures. The customized strand can contain a variable number (1-12) of seeds and/or seeding spacers (maximum 12 components per strand). The stranded Pd-103 and I-125 implants are placed inside the needle. The needle is made from 18 gauge stainless steel
Comparison to predicate device
Both devices are composed of seeds incorporated within suture material, with spacers separating the seeds. The suture material and spacers are completely biodegradable within the body.
| | Characteristics Brachytherapy Strand
Device | RAPID Strand |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Premarket
Notification | Subject of this 510(k) | K030594 |
| Sealed source | BEBIG brachytherapy
I-125 source cleared by
K021343 and
TheraSeed® cleared by
K010283 | OncoSeed cleared by
K914281 |
| Seeding
Spacer | Absorbable Seeding
Spacer made from
medical grade Poly-
(glycolide-co-L-lactide)
90:10 and moulded under
class 10,000 cleanroom
conditions. | Commercially available
absorbable Seeding Spacer
made from Poly(glycolide-
co-L-lactide) 90:10, cleared
by K013964 |
| Seed carrier | Coated VICRYL Polyglactin 910 (Poly(glycolide-co-L-
lactide) 90:10) Synthetic absorbable suture, cleared by
K022269, thermally stiffened.. | |
| Sterilization | Gamma sterilization
(also used for Vicryl
Rapide Suture, cleared by
K944110) | EtO sterilization |
| Packaging | Strands preloaded in
implantation needle. | Strands housed in plastic
spacing jig. |
Summary
Based on the information provided herein, we conclude that the Brachytherapy Strand Device is substantially equivalent to a legally marketed device.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, possibly symbolizing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2004
Mr. Sven Langer Regulatory Affairs BEBIG, Isotopen-und Medizintechnik GmbH Robert-Rossle-Straße 10 D-13125, Berlin GERMANY
Re: K040339 Trade/Device Name: Brachytherapy Strand Device Regulation Number: 21 CFR 892.5730 Regulation Number: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: February 6, 2004 Received: February 11, 2004
Dear Mr. Langer:
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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
510(k) Number (if known):
Device Name: Brachytherapy Strand Device
Indications for Use:
The Brachytherapy Strand Device is indicated for tumors with any of the following characteristics:
- Localized 0
- Unresectable 0
- Low to Moderate Radiosensitivity O
The tumors may be of the following type:
- Superficial O
- Intrathoracic O
- Intra-abdominal 0
- O Lung, Pancreas, Prostate, Head and Neck
- Residual following external beam radiation or excision of primary tumor O
- Recurrent 0
Prescription Use × (Part 21 CFR 801 Subpart D) AND / OR
Over-The -Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040339
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