BRACHYTHERAPY STRAND DEVICE

K040339 · Bebig Isotopen-Und Medizintechnik GmbH · KXK · Apr 8, 2004 · Radiology

Device Facts

• Record ID: K040339
• Device Name: BRACHYTHERAPY STRAND DEVICE
• Applicant: Bebig Isotopen-Und Medizintechnik GmbH
• Product Code: KXK · Radiology
• Decision Date: Apr 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Brachytherapy Strand Device treats localized tumors via interstitial radiation. Kit contains 18-gauge stainless steel prostate seeding needle preloaded with custom-loaded strand; strand consists of 1-12 radioactive seeds (I-125 or Pd-103) spaced by absorbable poly(glycolide-co-L-lactide) spacers within coated Vicryl (polyglactin 910) suture carrier. Physician inserts needle into body cavity or tissue to place strand; suture and spacers biodegrade in situ. Device provides localized radiation therapy; intended to benefit patients by delivering targeted dose to tumor site while minimizing exposure to surrounding healthy tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

18-gauge stainless steel needle; radioactive seeds (I-125 or Pd-103); spacers and carrier made of medical grade Poly(glycolide-co-L-lactide) 90:10 (Polyglactin 910); gamma sterilization; biodegradable components.

Indications for Use

Indicated for localized, unresectable, or low-to-moderate radiosensitivity tumors. Applicable to superficial, intrathoracic, intra-abdominal, lung, pancreas, prostate, head and neck tumors, including residual or recurrent disease.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• I-125 Rapid Strand Model 7000 (K982226)
• BEBIG brachytherapy I-125 source (K021343)
• Theraseed® Palladium-103 Implant Model 200 (K010283)
• Vicry Rapide Suture (K944110)

Reference Devices

• RAPID Strand (K030594)
• OncoSeed (K914281)
• Absorbable Seeding Spacer (K013964)
• Coated VICRYL Polyglactin 910 (K022269)

Submission Summary (Full Text)

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K040339

Brachytherapy Strand Device - BEBIG 510(k) Premarket Notification

## APR = 8 2004

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## 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<br>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

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## 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<br>Device | RAPID Strand |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Premarket<br>Notification | Subject of this 510(k) | K030594 |
| Sealed source | BEBIG brachytherapy<br>I-125 source cleared by<br>K021343 and<br>TheraSeed® cleared by<br>K010283 | OncoSeed cleared by<br>K914281 |
| Seeding<br>Spacer | Absorbable Seeding<br>Spacer made from<br>medical grade Poly-<br>(glycolide-co-L-lactide)<br>90:10 and moulded under<br>class 10,000 cleanroom<br>conditions. | Commercially available<br>absorbable Seeding Spacer<br>made from Poly(glycolide-<br>co-L-lactide) 90:10, cleared<br>by K013964 |
| Seed carrier | Coated VICRYL Polyglactin 910 (Poly(glycolide-co-L-<br>lactide) 90:10) Synthetic absorbable suture, cleared by<br>K022269, thermally stiffened.. | |
| Sterilization | Gamma sterilization<br>(also used for Vicryl<br>Rapide Suture, cleared by<br>K944110) | EtO sterilization |
| Packaging | Strands preloaded in<br>implantation needle. | Strands housed in plastic<br>spacing 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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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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