The CT/MRI Compatible Sure-guide Vaginal Cylinder Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the vagina is acceptable by up-to-date clinical and practice guidelines.
The CT/MRI Compatible Sure-guide Stump Vaginal Cylinder Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the vagina is acceptable by up-to-date clinical and practice guidelines.
The CT/MRI Compatible Miami HDR Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the cervix, vagina, and uterus is acceptable by up-to-date clinical and practice guidelines.

Device Description

Vaginal

The CT/MRI compatible Sure-guide Vaginal Cylinder Set design is based on conventional cylindrical HDR delivery systems with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation as definitive treatment, adjuvant treatment, or as a treatment boost to the vaginal walls with or without external beam radiation therapy. The set consists of a precision manufactured Sure-guide cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.

Stump

The CT/MRI Compatible Sure-guide Stump Vaginal Cylinder Set design is based on conventional cylindrical HDR delivery systems with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation as definitive treatment, adjuvant treatment, or as a treatment boost to the vaginal walls with or without external beam radiation therapy. The set consists of a precision-manufactured Sure-guide Stump Cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.

Miami

The CT/MRI Compatible Sure-guide Miami HDR applicator Set is designed according to the conventional modified Miami applicator with a click fit connector interface. This applicator is particularly useful when the vaginal vault space is limited or narrow due to tumor, restricted anatomy, or fibrosis. It can also be useful to treat tumors that extend from the uterus or cervix down onto the vaginal wall. The set consists of a precision manufactured intrauterine tandems and a full set of variable diameter Miami cylinders (all components are designed to allow for customization of the treated geometry). The distance that the tandem is inserted can be customized for each case. Four differing tandems are provided: one straight, one slight curvature, one medium curvature, and one maximal curvature. These allow for maximal accommodation of the uterine flexure.

AI/ML Overview

The provided text describes K123941, the Kobold Sure-guide Vaginal Cylinder Set, Kobold Sure-guide Stump Vaginal Cylinder Set, and Kobold Sure-guide Miami Cylinder Set. This is a 510(k) submission, meaning the manufacturer is claiming substantial equivalence to a predicate device, rather than proving safety and efficacy through extensive clinical studies with acceptance criteria in the same way a novel device might.

Here's a breakdown based on the information available:

Acceptance Criteria and Reported Device Performance

The submission states that "FDA has not established special controls or performance standards for this device," and "Performance Tests: Not Required." Since this is a substantial equivalence claim, the "acceptance criteria" are primarily met by demonstrating similarity to the predicate device in aspects like intended use, design, materials, and functional characteristics.

The "reported device performance" is framed in terms of substantial equivalence to the predicate device (K-033371, Intracavity BrachyTherapy Applicators).

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Claimed Similarity to Predicate)
Intended Use	Substantially equivalent to predicate device for HDR radiation treatment of the vagina, cervix, and/or uterus.
Technological Characteristics (Design, Materials, Afterloader Compatibility, Sterilization)	Same fundamental technology, similar nature of body contact, similar in shape and design, use the same sterilization procedures. Materials are titanium, Ultem®, silicone, high-temperature vinyl (stainless steel for Miami). Afterloader compatibility with GammaMed® and VariSource® with click-fit connector.
Biocompatibility	Documented and claimed "Safe as Predicate Device."
Environmental Compatibility (CT/MRI)	CT/MRI compatible, same as predicate device.
Cleaning/Sterilization Validation	Test results included (Steam 18 min at 273°F (134°C), 44psi (3 bar) Dry 15 min).
Mechanical Testing	Documented in Appendix A (details not provided in the summary).

Study Information

The submission does not describe a traditional clinical study with defined acceptance criteria for a novel device. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, many of the requested study details are not applicable or not provided.

Sample size used for the test set and the data provenance: Not applicable. This submission relies on benchtop testing and comparison to a predicate device, not a clinical test set with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical test set is not established for this type of submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a physical applicator for brachytherapy, not an AI-powered diagnostic or treatment planning tool that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical performance evaluation. The "ground truth" here is the established safety and effectiveness of the predicate device, to which the new device is compared.
The sample size for the training set: Not applicable. There is no machine learning or AI component to this device.
How the ground truth for the training set was established: Not applicable.

Summary

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K123941

APR 3 0 2013

510(k) Summary

This summary of 510(k) safety and effectiveness information is furnished in accordance with requirements detailed in 21 CFR 807.92.

l .

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 14 December 2012

Device name: l. Vaginal Cylinders Proprietary name: Kobold Sure-guide Vaginal Cylinder Set™
Stump Cylinders Proprietary name: Kobold Sure-guide Stump Vaginal Cylinder Set™
Miami Cylinders Proprietary name: Kobold Sure-guide Miami Cylinder Set™

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

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Kobold Cylinders

Intended Use:

Vaginal

Stump

The CT/MRI Compatible Sure-guide Stump Vaginal Cylinder Set is indicated for use in any patient case where High dose Rate (HDR) radiation treatment of the vagina is acceptable by up-to-date clinical and practice guidelines.

Miami

The CT/MRI Compatible Miami HDR Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the cervix, vagina, and uterus is acceptable by up-to-date clinical and practice guidelines.

4.

Device Description:

l . Vaginal

2. Stump

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Kobold Cylinders

Sure-guide Stump Cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.

3. Miami

5.

Substantial Equivalence Information:

Information presented supports substantial equivalence of the Kobold Sure-guideTM Vaginal. Stump and Miami versions of the cvlinder set to the predicate device. Each of the proposed versions of the device 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 description in Appendix C.

A. Predicate device names: Intracavity BrachyTherapy Applicators
B. Predicate device K numbers: K-033371
Comparison with predicate: ்.

SUBSTANTIALEQUIVALENCETABLE	KOBOLD LLC	KOBOLD LLC	KOBOLD LLC	VARIAN, INC.®
K-Number	TBD	TBD	TBD	K-033371
Device Description	Cylinder Set,Vaginal	Cylinder Set,Stump Vaginal	Cylinder SetMiami	Cylinder Set,Vaginal, Stump,Cervical (Miami)
Indications for Use	The CT/MRICompatible Sure-guide VaginalCylinder Set isindicated for use inany patient casewhere High DoseRate (HDR)radiation treatmentof the vagina isacceptable by up-to-date clinical andpracticeguidelines.	The CT/MRICompatible Sure-guide StumpVaginal CylinderSet is indicated foruse in any patientcase where Highdose Rate (HDR)radiation treatmentof the vagina isacceptable by up-to-date clinical andpractice guidelines.	The CT/MRICompatibleMiami HDR Setis indicated foruse in any patientcase where HighDose Rate(HDR) radiationtreatment of thecervix, vagina,and uterus isacceptable byup-to-dateclinical andpracticeguidelines.	Vaginal ApplicatorSet is developed forintracavitybrachytherapy totreat cancer of thevagina or rectum.The maximumimplantation timefor this applicator is30 days.
AfterloaderCompatibility	GammaMed®,VariSource® withclick-fit connector.	GammaMed®,VariSource® withclick-fit connector.	GammaMed®,VariSource®with click-fitconnector.	GammaMed®,VariSource® withclick-fit connector.
Materials	Titanium, Ultem®,Silicone, HighTemperature Vinyl	Titanium, Ultem®,Silicone, HighTemperature Vinyl	Titanium,Ultem®, Silicone,HighTemperatureVinyl, StainlessSteel	PPSU, PVDF,Acetal, StainlessSteel, PEEK
Packing	Tray	Tray	Tray	Not Documented
Sterility	Provided Non-Sterile	Provided Non-Sterile	Provided Non-Sterile	Provided Non-Sterile
SterilizationMethods,SterilizationConditions,	Steam 18 min at273°F (134°C),44psi (3 bar) Dry15 min.	Steam 18 min at273°F (134°C),44psi (3 bar) Dry15 min.	Steam 18 min at273°F (134°C),44psi (3 bar) Dry15 min.	Steam Sterilizable
Biocompatibility	Documented	Documented	Documented	Not Documented
Anatomical Sites	vagina	vagina	cervix, vagina,and uterus	cervix, vagina, anduterus
EnvironmentalCompatibility	CT/MRICompatible	CT/MRICompatible	CT/MRICompatible	CT/MRI Compatible

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Kobold Cylinders

・

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6. 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 standards are specifications for the materials used in surgical implant applications, predicate brachytherapy devices and manufacturer's acceptance procedures. Mechanical testing of the finished devices is additionally described in Appendix A. Cleaning/Sterilization validation test results are also included.

8. Conclusions

All versions of Kobold's Sure-guide Cylinder Set™ are similar in intended use and technological characteristics to predicate devices reviewed. Each version 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 Sure-guide Vaginal Cylinder Set™ , Kobold Sure-guide Stump Vaginal Cylinder Set™ and Kobold Sure-guide Miami Cylinder Set™. There is no warning associated with this type of device.

9.

Summary

Description	Comparison with Predicate Device
Biocompatibility	Safe as Predicate Device
Performance Characteristics	Substantially equivalent
Intended Use	Substantially equivalent
Performance Tests	Not Required

Each version of the device, Kobold Sure-guide Vaginal Cylinder Set™ , Kobold Sureguide Stump Vaginal Cylinder Set™ and Kobold Sure-guide Miami Cylinder 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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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

April 30, 2013

Kobold, LLC % Ms. Christina Bernstein Regulatory Director 2670 Leavenworth Street San Francisco, CA 94133

Re: K123941

Trade/Device Name: Kobold Sure-guide Vaginal Cylinder Set™ Kobold Sure-guide Stump Vaginal Cylinder Set™ Kobold Sure-guide Miami Cylinder Set™ Regulation Number: 21 CFR 892.5700

Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: March 13, 2013 Received: March 18, 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 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.

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/ResourcesforYou/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. D'Hara

for

Janine M. Morris, M.S. 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): K123941

Device Name: Kobold Sure-guide Vaginal Cylinder Set™

Indications for Use:

Device Name: Kobold Sure-guide Stump Vaginal Cylinder Set™

Indications for Use:

The CT/MRI Compatible Sure-guide Stump Vaginal Cylinder Set is indicated for use in any patient case where High Dose Rate (HDR) radiation treatment of the vagina is acceptable by up-to-date clinical and practice guidelines.

Device Name: Kobold Sure-guide Miami Cylinder 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)

Michael D. O'Hara

(Division Sign C Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510(k)_______________________________________________________________________________________________________________________________________________________________________ K123941

Page I of

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.