(232 days)
No
The device description focuses on the mechanical design and materials of a radiation applicator, with no mention of AI or ML capabilities.
Yes
The device is used for high dose rate (HDR) radiation treatment of the cervix and uterus, which is a therapeutic intervention.
No.
The device is an applicator set used for delivering high dose rate (HDR) radiation treatment (a therapeutic procedure), not for diagnosing a condition.
No
The device description clearly outlines physical components (intrauterine rings, ring caps, tandems, ring bracket) made of materials suitable for surgical implant applications, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an applicator set used for delivering high dose rate (HDR) radiation treatment directly to the cervix and uterus. It is a physical device used in vivo (within the body) for therapeutic purposes.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information. Its sole purpose is to facilitate the delivery of radiation therapy.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
JAO
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervix, Uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The FDA has not established special controls or performance standards for this device.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
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
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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)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is furnished in accordance with requirements detailed in 21 CFR 807.92.
- 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
- 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
EQUIVALENCE
| TABLE | KOBOLD, LLC | KOBOLD, LLC |
|---|---|---|
| K-Number | K-142330 | K-123912 |
| Device Description | Applicator Set, Ring Type | Applicator Set, Henschke Type; |
| Applicator Set, Fletcher Type | ||
| Indications for 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. | The CT/MRI Compatible HDR | |
| Henschke Type Applicator and | ||
| Fletcher Type Applicator are | ||
| 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. |
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| Afterloader Compatibility | GammaMed®, VariSource® with
click-fit connector | GammaMed®, VariSource® with
click-fit connector |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Design Geometry | Defined | Flexible |
| Materials | Titanium, Ultem®, Stainless Steel,
Silicone, High Temperature Vinyl | Titanium, Ultem®, Stainless Steel,
Silicone, High Temperature Vinyl |
| Packing | Tray | Tray |
| Sterility | Provided Non-Sterile | Provided Non-Sterile |
| Sterilization Methods,
Sterilization Conditions | Steam 18 min at 273°F (134°C),
44psi (3 bar) Dry 15 min; no
Sterrad® compatibility documented | Steam 18 min at 273°F (134°C),
44psi (3 bar) Dry 15 min; no
Sterrad® compatibility documented |
| Biocompatibility | Documented | Documented |
| Anatomical Sites | Uterus, Cervix | Uterus, Cervix |
| Environmental
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™.
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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.