BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS

K140856 · C.R. Bard, Inc. · KXK · May 2, 2014 · Radiology

Device Facts

• Record ID: K140856
• Device Name: BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS
• Applicant: C.R. Bard, Inc.
• Product Code: KXK · Radiology
• Decision Date: May 2, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

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 Implants with SourceCap™ Bioabsorbable Caps are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.

Device Story

BrachySource Seed Implants with SourceCap Bioabsorbable Caps are permanent interstitial brachytherapy sources. Device consists of welded titanium capsule containing Iodine-125 adsorbed onto gold-cored aluminum wire, fitted with bioabsorbable copolymer caps (70% L-lactide/30% DL-lactide) at each end. Caps increase surface area to resist seed migration within tissue; degrade over 18-24 months. Iodine-125 emits characteristic photons and Auger electrons for localized radiation therapy. Used by clinicians in clinical settings for tumor treatment. Output is localized radiation dose to target tissue. Benefits include precise radiation delivery to localized tumors while minimizing movement via cap-enhanced tissue anchoring.

Clinical Evidence

No clinical data. Evidence consists of nonclinical functional performance testing verifying assembly integrity and interface with implant needles, plus biocompatibility assessment per ISO 10993-1 and FDA G95-1 for the bioabsorbable cap material.

Technological Characteristics

Titanium capsule containing Iodine-125 on gold-cored aluminum wire; bioabsorbable caps (70% L-lactide/30% DL-lactide). Energy source: Iodine-125 (59.6-day half-life, 27.4/31 keV x-rays, 35.5 keV gamma). Biocompatibility per ISO 10993-1:2009.

Indications for Use

Indicated for permanent interstitial treatment of localized tumors (head, neck, lung, pancreas, early-stage prostate) in superficial, intra-abdominal, or intra-thoracic locations; also for residual tumors post-external radiation or recurrent tumors.

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

• BrachySource® Brachytherapy Seed Implants (K093663)

Reference Devices

• SourceLink® Brachytherapy Seeding Spacer Links (K041576)

Submission Summary (Full Text)

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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: [phone]

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.

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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.

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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