BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER

K043117 · Best Medical International, Inc. · KXK · Dec 9, 2004 · Radiology

Device Facts

• Record ID: K043117
• Device Name: BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER
• Applicant: Best Medical International, Inc.
• Product Code: KXK · Radiology
• Decision Date: Dec 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2

Intended Use

The Best Radiopaque Strand (Marker Strand) is made of radiopaque xxx markers (i.e, seeds) and absorbable spacers, inside an absorbable strand, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures. The Best Radiopaque Marker (Marker) is made of a radiopaque xxx solid seed, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.

Device Story

Best Radiopaque Strand and Marker are implantable devices used to improve dosimetry coverage in brachytherapy. The Strand consists of two radiopaque markers separated by absorbable spacers within an absorbable strand; the Marker is a single radiopaque seed (gold, platinum, stainless steel, titanium, or tungsten). Devices are placed in soft tissue or organ tissue prior to therapeutic procedures to provide clear identification of anatomic regions for radiation targeting. Used by clinicians in a clinical setting. Benefits include enhanced visualization of target sites for improved radiation dose delivery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: gold, platinum, stainless steel, titanium, or tungsten markers; absorbable spacers and strand. Form factor: implantable seeds and strands. Non-active, non-electronic, non-software device.

Indications for Use

Indicated for use in brachytherapy, soft tissues, or organ tissue. Contraindicated for cardiovascular or neurological procedures.

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.

Submission Summary (Full Text)

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## BEST MEDICAL INTERNATIONAL, INC.

### DEC - 9 2004

## Proprietary

K043117

#### 510(k) Summary of Safety and Effectiveness VII.

- 1. Manufacturer and Contact Information:

| Manufacturer: | Best Medical International, Inc.<br>7643 Fullerton Road<br>Springfield, VA 22153 |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Sankara Ramaswamy<br>Director, Regulatory Affairs<br>Best Medical International, Inc.<br>[phone], Ext. 107 |

- 2. Device Classification Name:
Pursuant to 21 CFR 892.5730, both the Best Radiopaque Strand and the Best Radiopaque Marker are class II devices.

| Proprietary Name: | Best Radiopaque Strand<br>Best Radiopaque Marker |
|---------------------|-----------------------------------------------------------|
| Common/Usual Name: | Best Marker Strand<br>Best Marker |
| ClassificationName: | Best Implantable Marker Strand<br>Best Implantable Strand |

- 3. Intended Use:
Please see Appendix 2 below titled, "Indications for Use Form".

- 4. Device Description and Characteristics:
The Best Radiopaque Strand (marker strand) is composed of two radiopaque markers, separated by absorbable spacers, and enclosed in an absorbable strand. It is supplied sterile.

The Best Radiopaque Marker (marker) is composed of a radiopaque nonradioactive seed (gold, platinum, stainless steel, titanium, or tungsten) which is supplied non-sterile.

The placement of the markers and marker strand in soft tissue, prior to therapeutic procedures, allows better dosimety coverage of the targeted site due to clearer identification of the anatomic regions.

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# BEST MEDICAL INTERNATIONAL, INC. Proprietary

- 5. Summary of Safety and Effectiveness:
This 510(k) Summary of Safety and Effectiveness is in accordance with the requirements of the Safe Medical Devices Act (SMDA) 1990, and is provided in Appendix 1 below.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol consists of three curved lines that resemble a human figure or a stylized representation of a person. The logo is printed in black ink on a white background.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### DEC - 9 2004

Dr. Joseph C. Whang Official Correspondent Best Medical International, Inc. 7643 Fullerton Road SPRINGFIELD VA 22153

Re: K043117

Trade/Device Name: Best Radiopaque Strand Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source

Regulatory Class: II Product Code: 90 KXK Dated: November 11, 2004 Received: November 10, 2004

Dear Dr. Whang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced work 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 reasy 20, 1110, 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 do not require approvisions of the Act. The Act. The general controls provisions of the Act include reguirements 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 (Premarket Approval), 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 this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrl/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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# BEST MEDICAL INTERNATIONAL, INC. Proprietary

### Appendix 2

Indications for Use Form

K043117

510 (k) Number: Reference xxx

(1) Device Name: Best Radiopaque Strand

Indications For Use:

The Best Radiopaque Strand (Marker Strand) is made of radiopaque xxx markers (i.e, seeds) and absorbable spacers, inside an absorbable strand, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.

(2) Devise Name: Best Radiopaque Marker

Indications For Use;

The Best Radiopaque Marker (Marker) is made of a radiopaque xxx solid seed, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.

gold, platinum, stainless steel, titanium, or tungsten a

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

David A. Norman

(Division Sian-Q 510kl Num

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