Kobold Ring and Tandem Applicator Set

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing to the right, arranged in a way that suggests unity and forward movement. The profiles are rendered in a dark color, creating a strong contrast against the background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 9, 2015 Kobold, LLC % Ms. Kathy Arpin Regulatory Specialist 23403 E. Mission Avenue, Suite 220E LIBERTY LAKE WA 99019 Re: K142330 Trade/Device Name: Kobold Ring and Tandem Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: II Product Code: JAO Dated: March 27, 2015 Received: April 1, 2015 Dear Ms. Arpin: 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. {1}------------------------------------------------ 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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D'Hara for Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K142330 Device Name Kobold Ring and Tandem Applicator Set #### Indications for Use (Describe) The CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines. The Kobold Ring and Tandem Applicator Set is intended for continuous use of up to 24 hours of contact with patient. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary This summary of 510(k) safety and effectiveness information is furnished in accordance with requirements detailed in 21 CFR 807.92. 1. The assigned 510(k) number is K142330 Submitter's Identification: Kobold, LLC 23403 E. Mission Ave., Suite 220E Liberty Lake, WA 99019 Correspondence: Kathy Arpin Kobold, LLC 23403 E. Mission Ave., Suite 220E Liberty Lake, WA 99019 Tel: 509-703-5090 Email: kathy.arpin@koboldmedical.com Date of submission: August 14, 2014 2. Device name Kobold Ring Type Applicator Set Proprietary name: Kobold Ring and Tandem Applicator Set™ - Regulation Section: 892.5700 A. - B. Classification: Class II - ﻥ Product Code: JAQ - Panel: Radiology D. #### 3. Intended Use The CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines. The Kobold Ring and Tandem Applicator Set is intended for continuous use of up to 24 hours of contact with patient. {4}------------------------------------------------ #### 4. #### Device Description The CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set™ design is based on the modified conventional Ring/Tandem applicator with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation boost to the cervix and parametrical tissues in conjunction with external beam radiation therapy. The applicator consists of precision manufactured intrauterine rings, ring caps, and tandems, interlocking via a ring bracket. All components are designed for a defined geometry. The rings are provided in three different angles (30 degrees, 45 degrees, and 60 degrees) with three different tandem lengths (20 mm, and 60 mm from the ring axis) provided for each ring angle. Two ring caps are provided (5.0 mm and 7.0 mm). ## న్. ## Substantial Equivalence Information Information presented supports substantial equivalence of the CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set™ to the predicate device. The proposed device has similar indications for use, similar nature of body contact, is similar in shape and design, has the same fundamental technology and uses the same sterilization procedures. Please see predicate device brochures in Appendix C. - Predicate device name: Kobold Fletcher Type Applicator Set; Kobold Henschke A. Type Applicator Set - Predicate device K number: 123912 B. - ட் Comparison with predicate: | SUBSTANTIAL<br>EQUIVALENCE<br>TABLE | KOBOLD, LLC | KOBOLD, LLC | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K-Number | K-142330 | K-123912 | | Device Description | Applicator Set, Ring Type | Applicator Set, Henschke Type;<br>Applicator Set, Fletcher Type | | Indications for Use | The CT Compatible / MR Unsafe<br>HDR Kobold Ring and Tandem<br>Applicator Set is indicated for use<br>in any case where high dose rate<br>(HDR) radiation treatment of the<br>cervix and uterus is accepted by<br>up-to-date clinical guidelines.<br>The Kobold Ring and Tandem<br>Applicator Set is intended for<br>continuous use of up to 24 hours of<br>contact with patient. | The CT/MRI Compatible HDR<br>Henschke Type Applicator and<br>Fletcher Type Applicator are<br>indicated for use in any case where<br>high dose rate (HDR) radiation<br>treatment of the cervix and uterus<br>is accepted by up-to-date clinical<br>guidelines. | {5}------------------------------------------------ | Afterloader Compatibility | GammaMed®, VariSource® with<br>click-fit connector | GammaMed®, VariSource® with<br>click-fit connector | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Design Geometry | Defined | Flexible | | Materials | Titanium, Ultem®, Stainless Steel,<br>Silicone, High Temperature Vinyl | Titanium, Ultem®, Stainless Steel,<br>Silicone, High Temperature Vinyl | | Packing | Tray | Tray | | Sterility | Provided Non-Sterile | Provided Non-Sterile | | Sterilization Methods,<br>Sterilization Conditions | Steam 18 min at 273°F (134°C),<br>44psi (3 bar) Dry 15 min; no<br>Sterrad® compatibility documented | Steam 18 min at 273°F (134°C),<br>44psi (3 bar) Dry 15 min; no<br>Sterrad® compatibility documented | | Biocompatibility | Documented | Documented | | Anatomical Sites | Uterus, Cervix | Uterus, Cervix | | Environmental<br>Compatibility | CT Compatible/MR Unsafe | CT/MRI Compatible | ## 6. Test Principle, Performance Characteristics The FDA has not established special controls or performance standards for this device. # 7. Bench Testing Extensive testing in accordance with known standards is documented by the manufacturer for predicate device K123912. The standard is a specification for the materials used in surgical implant applications and predicate brachytherapy devices and for manufacturer's acceptance procedures for predicate device as provided in Appendix A. ## 8. #### Conclusions The Kobold Ring Type Applicator Set is similar in intended use and technological characteristics to predicate device reviewed. The device is similar with respect to indications for use and physical characteristics to predicate device in terms of section 510(k) substantial equivalency. Contraindications: As per clinical guidelines and standard clinical practice. Warnings and Precautions: The precautions and warnings are provided in the device labeling for the Kobold Ring and Tandem Applicator Set™. {6}------------------------------------------------ ## 9. Summary | Description | Comparison with Predicate Device | |-----------------------------|----------------------------------| | Biocompatibility | Safe as Predicate Device | | Performance Characteristics | Substantially equivalent | | Intended Use | Substantially equivalent | | Performance Tests | Not Required | Based on the information submitted in this 510(k) application, the Kobold Ring and Tandem Applicator Set™ has been demonstrated to be substantially equivalent to the predicate device.