Lesion-Loc Iodine I-125 Seed/Needle

K142668 · Intramedical Imaging, LLC · KXK · Nov 21, 2014 · Radiology

Device Facts

• Record ID: K142668
• Device Name: Lesion-Loc Iodine I-125 Seed/Needle
• Applicant: Intramedical Imaging, LLC
• Product Code: KXK · Radiology
• Decision Date: Nov 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2

Intended Use

The Lesion-Loc I-125 Seed/Needle is intended for clinical use in the marking of lesions with the seed in close proximity to or within the lesion site. The lesion (as seen in a mammogram or ultrasound image) is then located using an appropriate hand held gamma radiation detector.

Device Story

Device consists of I-125 radioactive seed loaded into 18-gauge needle; used for temporary localization of breast or other tissue lesions. Physician inserts needle to place seed near/in lesion identified by mammogram or ultrasound. Seed emits photons; clinician uses handheld gamma radiation detector (Gammaprobe) to locate seed and lesion site. Facilitates surgical excision or biopsy by providing precise lesion coordinates. Device is single-use, sterile, and removed shortly after procedure. Benefits include improved accuracy in lesion targeting during surgical intervention.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, technological characteristics, and the established safety/biocompatibility profile of the OEM-supplied I-125 seed (Theragenics AgX100).

Technological Characteristics

Titanium capsule (0.05 mm wall) containing silver rod with silver iodide active material. Seed dimensions: 4.5 mm length, 0.8 mm diameter. Standard 18-gauge needle (up to 15 cm). Energy source: I-125 radionuclide (half-life ~60 days). Performance testing per ISO 2919. Sterilized product.

Indications for Use

Indicated for localization of lesions in breast or other tissue identified via mammogram or ultrasound. For use under direct supervision of a qualified physician. Not for permanent implantation; must be removed within a few days. Used in conjunction with Gammaprobe.

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® Localization Needle with I-125 Source (K122704)

Reference Devices

• Theragenics Corporation AgX100 (K103319)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2014

IntraMedical Imaging, LLC % Farhad Daghighian, Ph.D. President 12569 Crenshaw Blvd. HAWTHORNE CA 90250

Re: K142668

Trade/Device Name: Lesion-Loc I-125 Seed/Needle Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: September 30, 2014 Received: October 1, 2014

Dear Dr. Daghighian:

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 either 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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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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Michael D. O'Hara
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: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K142668

Device Name Lesion-Loc I 125 Seed/Needle

## Indications for Use (Describe)

Lesion-Loc I-125 Seed/Needle is indication of lesions (as shown by mamnogram or ultrasound) in the breast or other tissue under the direct supervision of a qualified physician. The device is "single-use sterile device". Lesion-Loc I-125 Seed/needle is not intended for permanant implantation and should be removed in a few days after implantation. It us to be used in conjunction with the Gammaprobe® (IntraMedical Imaging) for localization of lesions (as shown by a mammogram or ultrasound images) in the breast and other tissues.

Type of Use (Select one or both, as applicable)

x Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

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

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# Appendix A: 510(k) Summary of Safety and Effectiveness

| Statement | Information supporting claims of substantial equivalence, as defined under<br>the Federal Food, Drug and Cosmetic Act, respecting safety and<br>effectiveness is summarized below. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | For the convenience of the Reviewer, this summary is formatted in<br>accordance with the Agency's final rule “…510(k) Summaries and 510(k)<br>Statements…” (21 CFR §807) and can be used to provide a substantial<br>equivalence summary to anyone requesting it from the Agency. |
| Device Name: Lesion-Loc I-125 Seed/Needle | |
| Device Model<br>Number: | LL 125-XX (XX indicates length of needle – 05, 07, 10 &15 cm) |
| Device<br>Classification<br>Name: | Source, Brachytherapy, Radionuclide (KXK) 21 CFR 892.5730 |
| Device<br>Classification: | Class II (Radiology) |
| Predicate<br>Device: | Best® Localization Needle with I-125 Source (K122704) |
| | Manufacturer: IntraMedical Imaging<br>12569 Crenshaw Blvd.<br>Hawthorne, CA 90250 |
| Establishment<br>Registration<br>Number: | 2031874 |
| Official<br>Contact: | Farhad Daghighian<br>President and Chief Scientist Farhad Daghighian, Ph.D.<br>Tel: [phone], Mobile: [phone]<br>Email: [e-mail] |
| Intended Use: | The Lesion-Loc I-125 Seed/Needle is intended for clinical use in the<br>marking of lesions with the seed in close proximity to or within the lesion<br>site. The lesion (as seen in a mammogram or ultrasound image) is then<br>located using an appropriate hand held gamma radiation detector. |

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- Lesion-Loc I-125 Seed/Needle contains a source 4.5 mm long and 0.8 mm in Device Description: diameter. The source consists of a welded titanium capsule with a 0.05 mm thick wall and a silver rod, which is about 4 mm length with the active material as silver iodide on the surface, welded inside the titanium capsule. The seed is contained in a needle. The needles used are standard 18 gauges available commercially in lengths up to 15 cm. The I-125 seed is loaded inside the needle. The radioactive seeds are introduced into the lesion area as directed by a radiologist per Written Directive and prescription. The devices are packaged in a pouch with label and provided sterile.
- Technological The Lesion-Loc I-125 Seed/Needle uses the Theragenics Corporation AgX100 characteristics (having a 510k number K103319) seed that typically has less radioactive strength than those used for brachytherapy. I-125 has a half-life of about 60 days and decays by electron capture with the emission of characteristic photons and electrons. The titanium walls of the seed absorb the electrons but the photons continue through the walls. An appropriate hand held gamma radiation detector probe is used to locate the seed and therefore also the lesion (as seen in a mammogram or ultrasound image).
- Performance The Lesion-Loc I-125 Seed/Needle is based on Theragenics Corporation AgX100 seed (having a 510k number K103319) design and commercially data available needle implant technology. Theragenics Corporation (Buford, GA, USA) contract manufactures the seed/needle device and provides the sterilized product to IntraMedical Imaging only after meeting all the performance qualification. A number of performance tests are done by Theragenics on the seed as per ISO 2919. IntraMedical Imaging distributes the Seed/Needle device for localization only as prescribed by a physician at a licensed hospital or other medical institution.
- Conclusion The technological characteristics and intended use of the Lesion-Loc I-125 Seed/Needle is substantially equivalent as the predicate device: Best® Localization Needle with I-125 Source.

Please note that the predicate Best Medical is identical in shape and size and the indication for use is also localization. Further conclusion is that also the OEM Theragenics Corporation Model AgX100 has been certified as safe, biocompatible and has been in clinical use for radiation therapy use without complaints.