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

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the BEBIG Brachytherapy Strand Device. It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than conducting a performance study with defined acceptance criteria and device performance evaluation as one might find for a diagnostic AI/ML device.

Therefore, the requested information components related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not present in this regulatory document.

However, I can extract the comparison to predicate device table which serves a similar purpose in this context: to show that the new device is comparable to existing, legally marketed devices.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This document does not present acceptance criteria in the format typically seen for a diagnostic or AI/ML device's performance study (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance" for this device is based on demonstrating substantial equivalence to predicate devices. The performance is implied by the comparison of characteristics.

Characteristic	BEBIG Brachytherapy Strand Device (Reported Performance/Description)	Predicate Device (RAPID Strand)
Premarket Notification	Subject of this 510(k) (K040339)	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.	(No specific information provided for RAPID Strand, implying similarity or that the specific material was not a differentiator in this context)
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.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a medical device for brachytherapy, and the submission is for substantial equivalence based on material and design comparison, not a clinical performance study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for a test set is not established for this type of regulatory submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication is not relevant for this type of regulatory submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device, not an AI/ML diagnostic tool, and therefore MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. Ground truth, in the context of a performance study for AI/ML or diagnostic devices, is not relevant here. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K040339

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 BrachytherapySource, 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

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Description

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 StrandDevice	RAPID Strand
PremarketNotification	Subject of this 510(k)	K030594
Sealed source	BEBIG brachytherapyI-125 source cleared byK021343 andTheraSeed® cleared byK010283	OncoSeed cleared byK914281
SeedingSpacer	Absorbable SeedingSpacer made frommedical grade Poly-(glycolide-co-L-lactide)90:10 and moulded underclass 10,000 cleanroomconditions.	Commercially availableabsorbable Seeding Spacermade from Poly(glycolide-co-L-lactide) 90:10, clearedby K013964
Seed carrier	Coated VICRYL Polyglactin 910 (Poly(glycolide-co-L-lactide) 90:10) Synthetic absorbable suture, cleared byK022269, thermally stiffened..
Sterilization	Gamma sterilization(also used for VicrylRapide Suture, cleared byK944110)	EtO sterilization
Packaging	Strands preloaded inimplantation needle.	Strands housed in plasticspacing jig.

Summary

Based on the information provided herein, we conclude that the Brachytherapy Strand Device is substantially equivalent to a legally marketed device.

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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.

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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

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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

Page 1 of 1

Regulation Number and Section

§ 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.