The CT/MRI Compatible HDR Fletcher Type Applicator 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 CT/MRI Compatible HDR Henschke Type Applicator 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.

Device Description

The CT/MRI Compatible HDR Fletcher Type Applicator Set™ design is based on the conventional modified Fletcher GYN 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 set consists of precision manufactured intrauterine tandems and a pair of interlocking colpostats with Fletcher type unshielded ovoids ranging in size from 1cm to 3cm. All components are designed to allow for customization of the treated geometry. The distance between the ovoids is adjustable with a lock knob. Four different tandems are provided: one straight, one with a slight curvature of 15 degrees, one with medium curvature of 30 degrees, and one with a maximal curvature of 45 degrees.
The CT/MRI Compatible HDR Henschke Type Applicator Set™ design is based on the conventional modified Henschke GYN 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 set consists of precision manufactured intrauterine tandems and a pair of interlocking colpostats with Henschke type unshielded ovoids ranging in size from 2cm to 3cm. All components are designed to allow for customization of the treated geometry. The distance between the ovoids is adjustable with a lock knob. Four different tandems are provided: one straight, one with a slight curvature of 15 degrees, one with medium curvature of 30 degrees, and one with a maximal curvature of 45 degrees.

AI/ML Overview

The provided 510(k) summary for the "Kobold Applicator Kits" does not contain information typically found in a study proving a device meets acceptance criteria for AI/ML-based medical devices. The document concerns a physical medical device (applicators for radiation treatment) and focuses on demonstrating substantial equivalence to a predicate device rather than performance against specific analytical or clinical metrics.

Therefore, many of the requested categories for AI/ML device studies, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable or not present in this document.

However, based on the provided text, I can infer the "acceptance criteria" and how the device "meets" them within the context of a 510(k) submission for a physical device.

Acceptance Criteria and Device Performance (Inferred from 510(k) context):

The primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device (Mick® Ring Type GYN Applicator Set with K-011657). The "study" demonstrating this involves a comparison of various device characteristics.

Acceptance Criteria (Inferred)	Reported Device Performance
Intended Use: For HDR radiation treatment of cervix and uterus accepted by clinical guidelines.	Substantially equivalent to predicate. Explicitly states this for both Fletcher and Henschke type applicators. (Page 2, 4)
Technology/Design: Similar design, fundamental technology, and sterilization procedures.	Substantially equivalent. Numerous design and material similarities are listed in the table. (Page 2, 3)
Performance Characteristics: As a physical medical device, general mechanical performance and compatibility.	Substantially equivalent. "Extensive testing in accordance with known standards is documented by the manufacturer. The standard is a specification for the materials used in surgical implant applications, predicate brachytherapy devices and manufacturer's acceptance procedures are detailed in Appendix A. Mechanical testing of the finished devices is additionally described in Appendix A." (Page 4)
Safety - Biocompatibility: Safe for human contact.	Documented (for both Kobold devices). The predicate device's biocompatibility was "Not Documented" in the comparison table, but the conclusion states "Safe as Predicate Device" for biocompatibility, implying sufficient safety. (Page 3, 4)

Explanation of Non-Applicable/Missing Information for AI/ML Context:

A table of acceptance criteria and the reported device performance: Provided above, inferred from the substantial equivalence claim.
Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML algorithm requiring a test set of data. The "testing" mentioned is mechanical bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in the AI/ML sense for this physical device.
Adjudication method: Not applicable. No AI/ML performance to adjudicate.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI-assisted diagnostic or therapeutic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable. This is a physical medical device.
The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" for a physical device might refer to engineering specifications or validated material properties against known standards, which are mentioned as referenced in "Appendix A."
The sample size for the training set: Not applicable. No AI/ML model.
How the ground truth for the training set was established: Not applicable. No AI/ML model.

Summary

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K123912
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Kobold Applicator Kits

510(k) Summary

MAY 1 4 2013 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 K-TBD

Submitter's Identification: Spencer Fillmore 2410 S Sumner Lane Greenacres, WA, 99016

Correspondence:

Christina Bernstein BB Medical Surgical, Inc. 2670 Leavenworth Street San Francisco, CA 94133 Tel: 415-450-0515 Email tina@bbmedicalsurgical.com

Date of submission 07 December 2012

Device name:

Fletcher type Applicator Set Proprietary name: Kobold Fletcher Type GYN T&O Applicator Set™
Henschke type Applicator Set Proprietary name: Henschke Tvpe GYN T&O Applicator Set™

Regulation Section 892.5700 A.
B. Classification: Class II
C. Product Code: JAQ
D. Panel: Radiology

Intended Use:

The CT/MRI Compatible HDR Fletcher Type Applicator 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.

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The CT/MRI Compatible HDR Henschke Type Applicator 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.

4.

Device Description:

The CT/MRI Compatible HDR Fletcher Type Applicator Set™ design is based on the conventional modified Fletcher GYN 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 set consists of precision manufactured intrauterine tandems and a pair of interlocking colpostats with Fletcher type unshielded ovoids ranging in size from 1cm to 3cm. All components are designed to allow for customization of the treated geometry. The distance between the ovoids is adjustable with a lock knob. Four different tandems are provided: one straight, one with a slight curvature of 15 degrees, one with medium curvature of 30 degrees, and one with a maximal curvature of 45 degrees.
The CT/MRI Compatible HDR Henschke Type Applicator Set™ design is based on the conventional modified Henschke GYN 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 set consists of precision manufactured intrauterine tandems and a pair of interlocking colpostats with Henschke type unshielded ovoids ranging in size from 2cm to 3cm. All components are designed to allow for customization of the treated geometry. The distance between the ovoids is adjustable with a lock knob. Four different tandems are provided: one straight, one with a slight curvature of 15 degrees, one with medium curvature of 30 degrees, and one with a maximal curvature of 45 degrees.

5.

Substantial Equivalence Information:

Information presented supports substantial equivalence of the Kobold Fletcher and Henschke Type GYN T&O Applicator Set™ to the predicate device. Each of the two proposed devices has the same indications for use, has 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 brochure in Appendix C.

Predicate device names: Mick® Ring Type GYN Applicator Set A.
Predicate device K numbers: 011657 B.
C. Comparison with predicate:

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SUBSTANTIALEQUIVALENCETABLE	KOBOLD LLC	KOBOLD LLC	MICK RADIO-NUCLEARINSTRUMENTS, INC.®
K-Number	TBD	TBD	K-011657
Device Description	Applicator Set.Fletcher Type	Applicator Set.Henschke Type	Applicator Set, Ring Type
Indications for Use	The CT/MRICompatible HDRFletcher TypeApplicator isindicated for use inany case where highdose rate (HDR)radiation treatmentof the cervix anduterus is accepted byup-to-date clinicalguidelines.	The CT/MRICompatible HDRHenschke TypeApplicator isindicated for use inany case where highdose rate (HDR)radiation treatmentof the cervix anduterus is accepted byup-to-date clinicalguidelines.	The Mick Radio-NuclearInstruments, Inc. HDRTandem/Ring Applicator withRectal Retractor is intended foruse in Brachytherapy. Thedelivery of intra-cavitaryradiation therapy requires notonly proper visualization andlocalization of the applicatorwithin the treatment volume,but precise dosimetry and astable delivery system fromwhich treatment can beadministered. The Mick Radio-Nuclear HDR Tandem/RingApplicator with RectalRetractor meets theserequirements.
AfterloaderCompatibility	GammaMed®VariSource® withclick-fit connector.	GammaMed®.VariSource® withclick-fit connector.	GammaMed®.VariSource® withclick-fit connector.
Design Geometry	Flexible	Flexible	Flexible
Materials	Titanium. Ultem®Stainless Steel,Silicone, HighTemperature Vinyl	Titanium. Ultem®.Stainless Steel,Silicone, HighTemperature Vinyl	Titanium, Stainless Steel,Polysulphone, Silicone
Packing	Tray	Tray	Cassette
Sterility	Provided Non-Sterile	Provided Non-Sterile	Provided Non-Sterile
SterilizationMethods,SterilizationConditions.	Steam 18 min at 273°F(134°C), 44psi (3 bar)Dry 15 min; noSterrad® compatibilitydocumented	Steam 18 min at 273°F(134°C), 44psi (3 bar)Dry 15 min; noSterrad® compatibilitydocumented	Steam 20 min at 132°CDry 15 min; no Sterrad®compatibility documented
Biocompatibility	Documented	Documented	Not Documented
Anatomical Sites	Uterus, Cervix	Uterus, Cervix	Cervix
EnvironmentalCompatibility	CT/MRI Compatible	CT/MRI Compatible	CT/MRI Compatible

・ :

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Kobold Applicator Kits

Test Principle, Performance Characteristics:

FDA has not established special controls or performance standards for this device.

7. Bench Top Testing

Extensive testing in accordance with known standards is documented by the manufacturer. The standard is a specification for the materials used in surgical implant applications, predicate brachytherapy devices and manufacturer's acceptance procedures are detailed in Appendix A. Mechanical testing of the finished devices is additionally described in Appendix A.

8. Conclusions

Both versions of Kobold`s Applicator Set are similar in intended use and technological characteristics to predicate devices reviewed. Each of the two versions of the device is similar with respect to indications for use and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.

Contraindications: As per clinical guidelines and standard clinical practice.

Warnings and Precautions: The precautions are provided in the device labeling for the Kobold Fletcher Style GYN T&O Applicator Set™ and Kobold Henschke Style GYN T&O Applicator Set™. There is no warning associated with this type of device.

ੇ.

Summary

Description	Comparison with Predicate Device
Biocompatibility	Safe as Predicate Device

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K123912
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1 0

Kobold Applicator Kits

Performance Characteristics	Substantially equivalent
Intended Use	Substantially equivalent
Performance Tests	Not Required

Each version of the device 1. Kobold Fletcher Type GYN T&O Applicator Set™ and 2. Kobold Henschke Style GYN T&O Applicator Set™, based on the information submitted in this 510(k) application has been demonstrated to be substantially equivalent to the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 14, 2013

Kobold, LLC % Ms. Christina Bernstein Regulatory Director 2670 Leavenworth Street SAN FRANCISCO CA 94133

Re: K123912

Trade/Device Name: Fletcher Type GYN T&O Applicator Set™ Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: April 19, 2013 Received: May 2, 2013

Dear Ms. Bernstein:

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

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Page 2 - Ms. Christina Bernstein

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 nedical 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesTorYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Michael D. DiHara

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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Indications for Use

510(k) Number (if known): K123912

Device Name: Fletcher Type GYN T&O Applicator Set™

Indications for Use:

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Michal D. O-Ling

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health K123912 510(k)

Page 1 of 1

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.