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.

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).

AI/ML Overview

The provided text is a 510(k) summary for the Kobold Ring and Tandem Applicator Set, which is a medical device used in high dose rate (HDR) radiation treatment. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting acceptance criteria and a study proving the device meets those criteria from an AI/algorithm performance perspective.

Therefore, many of the requested items related to AI system evaluation (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance) are not applicable to this type of device clearance document.

However, I can extract information regarding the device's characteristics and the basis for its clearance, framed in terms of substantial equivalence.

Here's the breakdown of the information that can be extracted or deduced from the document:

1. A table of (implied) acceptance criteria and the reported device performance from the provided text:

Since this is a substantial equivalence submission for a physical medical device, the "acceptance criteria" are not standard performance metrics for an AI algorithm. Instead, they are characteristics that demonstrate the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" is the comparison made to establish this equivalence.

Acceptance Criteria (Implied from Substantial Equivalence Comparison)	Reported Device Performance (Kobold Ring and Tandem Applicator Set)	Predicate Device Performance (Kobold Fletcher/Henschke Type Applicator Set - K123912)
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. 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.
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
Performance Characteristics	Substantially equivalent (as stated in summary)	(Implied to be acceptable as a legally marketed device)
Safety	Safe as Predicate Device (Biocompatibility)	(Implied to be acceptable as a legally marketed device)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. This document describes a physical medical device, not an AI algorithm evaluated on a dataset. The "testing" involved bench testing, not evaluation on patient data.
Data Provenance: Not applicable for the reasons above.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood for AI evaluation is not relevant to this type of device clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this physical device, the "ground truth" for demonstrating substantial equivalence relied on comparing its design, materials, intended use, and performance characteristics (through bench testing and documentation) to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established

Not applicable. This is not an AI algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" presented is a 510(k) Premarket Notification which aims to demonstrate substantial equivalence to a predicate device already on the market (Kobold Fletcher Type Applicator Set; Kobold Henschke Type Applicator Set, K123912).

The core of the "proof" relies on:

Comparison Table: A detailed comparison of the new device (K142330) with the predicate device (K123912) across various characteristics, including indications for use, afterloader compatibility, design geometry, materials, packing, sterility, sterilization methods, biocompatibility, anatomical sites, and environmental compatibility.
Bench Testing: The document states, "Extensive testing in accordance with known standards is documented by the manufacturer for predicate device K123912" and that the predicate device's acceptance procedures are provided. This implies that the new device either underwent similar bench testing or leverages the established safety and performance of the predicate through design similarity and material equivalence. The key statement is, "The FDA has not established special controls or performance standards for this device," suggesting that meeting the requirements for substantial equivalence to a device with a known safety profile is sufficient.
Conclusion: The submission concludes that the Kobold Ring and Tandem Applicator Set is "similar in intended use and technological characteristics to predicate device reviewed" and "similar with respect to indications for use and physical characteristics to predicate device in terms of section 510(k) substantial equivalency."

In essence, the device is deemed to meet "acceptance criteria" because it is shown to be as safe and effective as a device already legally marketed, based on direct comparison of features and relevant non-clinical (bench) testing.

Summary

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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.

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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 (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 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 Kobold Ring and Tandem Applicator Set is intended for continuous use of up to 24 hours of contact with patient.

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4. Device Description

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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:

SUBSTANTIALEQUIVALENCETABLE	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 UnsafeHDR Kobold Ring and TandemApplicator Set is indicated for usein any case where high dose rate(HDR) radiation treatment of thecervix and uterus is accepted byup-to-date clinical guidelines.The Kobold Ring and TandemApplicator Set is intended forcontinuous use of up to 24 hours ofcontact with patient.	The CT/MRI Compatible HDRHenschke Type Applicator andFletcher Type Applicator areindicated for use in any case wherehigh dose rate (HDR) radiationtreatment of the cervix and uterusis accepted by up-to-date clinicalguidelines.

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Afterloader Compatibility	GammaMed®, VariSource® withclick-fit connector	GammaMed®, VariSource® withclick-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; noSterrad® compatibility documented	Steam 18 min at 273°F (134°C),44psi (3 bar) Dry 15 min; noSterrad® compatibility documented
Biocompatibility	Documented	Documented
Anatomical Sites	Uterus, Cervix	Uterus, Cervix
EnvironmentalCompatibility	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.

Regulation Number and Section

§ 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.