PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS

K071550 · Cp Medical · KXK · Jul 18, 2007 · Radiology

Device Facts

• Record ID: K071550
• Device Name: PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
• Applicant: Cp Medical
• Product Code: KXK · Radiology
• Decision Date: Jul 18, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.5730
• Device Class: Class 2

Intended Use

The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.

Device Story

Device consists of solid gold seed marker pre-loaded into 17 or 18 gauge brachytherapy needle; needle pre-plugged with bone wax. Used by clinicians for interstitial implantation of markers into patient tissue. Markers act as radiographic localization aids for radiation therapy planning and delivery. Packaged individually or in groups of three; sterilized via ethylene oxide.

Clinical Evidence

Bench testing only. Verification activities included sterilization validation and package validation. Product integrity was previously established for the pre-waxed needle component.

Technological Characteristics

Solid gold seed marker; 17 or 18 gauge stainless steel brachytherapy needle; bone wax plug. Sterilization via ethylene oxide. Manual interstitial placement.

Indications for Use

Indicated for interstitial placement of gold seed markers to serve as localization devices for radiation therapy.

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

• Best Radiopaque Marker (K043117)

Reference Devices

• Pre-waxed needles (K024372)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for CP Medical. The words "CP Medical" are in a sans-serif font, with the letters "CP" in a shaded box. Below the logo, the words "Portland, OR USA" are written in a smaller font.

JUL ] 8 2007

K071550

#### 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| Device Name: | Pre-Waxed Needles with Gold Fiduciary Markers |
|------------------------|-----------------------------------------------|
| Device Model Number: | FN17-xx, FN18-xx |
| Classification Name: | Implantable Radiographic Marker (NEU) |
| Device Classification: | Class II, 21 CFR 878.4300 |
| Predicate Devices: | Best Radiopaque Marker, K043117 |

CP Medical 803 NE 25th Ave. Portland, OR 97232 USA

3032563

Manufacturer:

Establishment Registration Number:

Official Contact:

Betsy Cortelloni Regulatory Affairs Manager Theragenics Corporation® 5203 Bristol Industrial Way Buford, GA 30518 Phone: [phone] Fax: [phone]

Intended Use: The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.

Device Description: The CP Medical Pre-waxed Needles with Gold Fiduciary Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of one (1) solid gold seed marker, loaded into a standard 17 or 18 gauge brachytherapy needle that has been preplugged with bone wax (CP Medical, K024372). The loaded needles are packaged individually or in groups of three. The packaged needles are sterilized via ethylene oxide.

Substantial Equivalence Comparison: The CP markers are compared to the gold "Radiopaque Marker" offered by Best Medical International, Inc. The two devices use equivalent materials and packaging.

Design Verification: The testing and verification activities performed for this product include sterilization validation and package validation. Product integrity was previously performed on the pre-waxed needles.

Conclusion: The results of verification testing confirmed that design inputs were achieved and that the CP Markers are substantial equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 1 8 2007

CP Medical, Inc. c/o Ms. Betsy Cortelloni RA/OA Manager Theragenics Corporation 5203 Bristol Industrial Way BUFORD GA 30518

Re: K071550

Trade/Device Name: Pre-waxed Needles with Gold Fiduciary Markers Regulation Number: 21 CFR §892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: June 4, 2007 Received: June 6, 2007

Dear Ms. Cortelloni:

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 (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.

Image /page/1/Picture/10 description: The image is a circular logo or emblem. The central element is the acronym "FDA" in a stylized, bold font. Above the acronym, the years "1906-2006" are displayed, indicating a centennial celebration. Below the acronym, the word "Centennial" is written in a cursive font. The entire design is surrounded by a circular border with stars and text, possibly the name of the organization or event.

Protecting and Promoting Public Health

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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.

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 21 CFR 884.xxxx 21 CFR 892.xxxxx Other

(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology); 240-276-0120 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/cdrh/industry/support/index.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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### INDICATIONS FOR USE FORM

Page 1 of _ 1 .

510(K) number (if known): K071550

Device Name: Pre-waxed Needles with Gold Fiduciary Markers

#### Indications for Use:

The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.

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#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ X (Per 21 CFRR 801.109)

OR

Over-The-Counter Use_

Helin Lewer

(Division Sign-Off Division of Reproductive, Abdominal and Radiological Devices 510(k) Number