(347 days)
The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Fletcher type applicator is accepted by up-to-date clinical guidelines. The Kobold® Fletcher-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Henschke type applicator is accepted by up-to-date clinical guidelines. The Kobold® Henschke-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the vagina is accepted by up-to-date clinical guidelines. The Kobold® Vaginal Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set is indicated for use in any patient case where high dose rate (HDR) radiation treatment of the cervix, vagina, and uterus with a Miami type applicator is acceptable by up-to-date clinical guidelines. The Kobold® Miami Cylinder Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set design is based on the conventional modified Fletcher GYN applicator. Kobold manufactures versions compatible with HDR afterloaders. This applicator is mainly utilized for HDR radiation boosts to the cervix and parametrial tissues in conjunction with external beam radiation therapy. This GYN set consists of precision manufactured intrauterine tandems and a pair of interlocking vaginal colpostats with Fletcher type unshielded barrel or cylinder ovoids (all components are designed to allow for customization of the treated geometry). The distance between the two lateral ovoids is adjustable with a lock knob. Four differing tandem geometries are provided in the set: one straight, one with slight curvature, one with medium curvature, and one with maximal curvature. These allow for maximal accommodation of the uterine shape and flexure.
The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set design is based on the conventional modified Henschke GYN applicator. Kobold manufactures versions compatible with HDR afterloaders. This applicator is mainly utilized for HDR radiation boosts to the cervix and parametrial tissues in conjunction with external beam radiation therapy. This GYN set consists of precision manufactured intrauterine tandems and a pair of interlocking vaginal colpostats with Henschke type unshielded ovoids (all components are designed to allow for customization of the treated geometry). The distance between the ovoids is adjustable with a lock knob. Four differing tandem geometries are provided in the set: one straight, one with slight curvature, one with medium curvature, and one with maximal curvature. These allow for maximal accommodation of the uterine shape and flexure.
The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set design is based on conventional cylindrical HDR delivery systems with a connector interface compatible with major manufacturers' afterloaders. 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 precision manufactured vaginal cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.
The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set design is based on conventional modified Miami applicators with a connector interface compatible with major manufacturers' afterloaders. This applicator set 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. Various tandems are provided: straight. slight curvature. medium curvature, and maximal curvature. These allow for maximal accommodation of the uterine flexure.
This document is a 510(k) summary for several medical devices: Kobold® Fletcher-model Tandem and Ovoid Applicator Set, Kobold® Henschke-model Tandem and Ovoid Applicator Set, Kobold® Vaginal Cylinder Applicator Set, and Kobold® Miami Cylinder Applicator Set.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria with specific quantitative performance metrics. The stated "acceptance criteria" are effectively the characteristics of the predicate devices. The "reported device performance" is essentially that the new devices match these characteristics or exhibit similar performance where differences exist (e.g., sterilization methods, which are tested for efficacy independently).
| Acceptance Criteria (Based on Predicate Devices) | Reported Device Performance (New Devices) |
|---|---|
| Indications for Use: - For HDR radiation treatment of cervix and uterus (Fletcher/Henschke models) - For HDR radiation treatment of vagina (Vaginal Cylinder model) - For HDR radiation treatment of cervix, vagina, and uterus (Miami Cylinder model) | Substantially equivalent to predicate. |
| Afterloader Compatibility:- GammaMed®, VariSource® (predicate) | Elekta: microSelectron®, Flexitron®; Varian: GammaMed®, VariSource® (with click-fit connector). (Expanded compatibility) |
| Design Geometry: Flexible | 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 (predicate) | Steam 4 min at 270°F (132°C), 44psi (3 bar) Dry 15 min. (Different sterilization cycle parameters) |
| Biocompatibility: Documented | Documented |
| Anatomical Sites: Uterus, Cervix (Fletcher/Henschke); Vagina (Vaginal Cylinder); Cervix, Vagina, Uterus (Miami Cylinder) | Uterus, Cervix (Fletcher/Henschke); Vagina (Vaginal Cylinder); Cervix, Vagina, Uterus (Miami Cylinder) |
| Environmental Compatibility: CT/MRI Compatible (predicate) | CT Compatible / MR Unsafe (A key difference, noted in the device name and description). |
| Performance Characteristics (overall) | Substantially equivalent |
| Bench Testing: Documented in accordance with known standards | Documented by manufacturer for predicate device. (Implying the new device meets similar standards) |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not describe a clinical study or a test set of patient data with a specific sample size. The testing appears to be primarily bench testing of the devices themselves, as indicated in section 7: "Extensive testing in accordance with known standards is documented by the manufacturer for predicate device in K-123912 and K-123941." This implies the current submission relies on the established performance of the predicate devices and specific engineering tests for the new devices (e.g., material testing, sterilization efficacy). There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because no patient data study is described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. This submission does not involve a "test set" requiring expert ground truth, as it is a device substantial equivalence submission based on engineering and performance characteristics compared to predicate devices, not a clinical diagnostic or AI-driven aid.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The devices are physical medical tools (applicators for radiation treatment), not diagnostic imaging aids or AI algorithms that would involve human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
Not applicable. The devices are physical medical tools, not software algorithms.
7. The Type of Ground Truth Used:
Not applicable in the context of clinical "ground truth" (e.g., pathology, outcomes data). The "ground truth" for this submission are the established performance characteristics, safety profiles, and indications for use of the predicate medical devices, as well as engineering standards for materials and sterilization.
8. The Sample Size for the Training Set:
Not applicable. There is no AI component or "training set" mentioned in this document.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no AI component or "training set" described.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2017
Kobold, LLC % Ms. Christina Bernstein Engineer BB Medical Surgical 1736 Stockton Street, Studio 9 SAN FRANCISCO CA 94133
Re: K160610
Trade/Device Name: Kobold® Fletcher-model Tandem and Ovoid Applicator Set. Kobold® Henschke-model Tandem and Ovoid Applicator Set, Kobold® Vaginal Cylinder Applicator Set, Kobold® Miami Cylinder Applicator Set Regulation Number: 21 CFR 892.5700
Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: January 17, 2017 Received: January 18, 2017
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 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
{1}------------------------------------------------
forth in the quality systems (OS) 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 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. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use Form
The complete Indications for Use form (FDA 3881) for the devices is reproduced here.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160610
Device Name
Kobold® Fletcher-model Tandem and Ovoid Applicator Set, Kobold® Henschke-model Tandem and Ovoid Applicator Set, Kobold® Vaginal Cylinder Applicator Set, Kobold® Miami Cylinder Applicator Set
Indications for Use (Describe)
The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Fletcher type applicator is accepted by up-to-date clinical guidelines. The Kobold® Fletcher-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Henschke type applicator is accepted by up-to-date clinical guidelines. The Kobold® Henschke-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Vagmal Cylinder Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the vagina is accepted by up-to-date clinical guidelines. The Kobold® Vaginal Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set is indicated for use in any patient case where high dose rate (HDR) radiation treatment of the cervix, vagina, and uterus with a Miami type applicator is acceptable by up-to-date clinical guidelines. The Kobold® Miami Cylinder 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:
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"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.
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Sarvices (301) 443-6740
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510(k) Summary
Kobold® Fletcher-model Tandem and Ovoid Applicator Set, Kobold® Henschke-model Tandem and Ovoid Applicator Set, Kobold® Vaginal Cylinder Applicator Set, Kobold® Miami Cylinder Applicator Set
This summary of 510(k) safety and effectiveness information is furnished in accordance with requirements detailed in 21 CFR 807.92.
- The assigned submission number is K-160610
Submitter's Identification:
Deanna Hughes Kobold, LLC PO Box 1994 Veradale, WA 99037
Correspondence:
Deanna Hughes Kobold, LLC PO Box 1994 Veradale, WA 99037 Tel: 818.321.0116 Email: Deanna.Hughes@koboldmedical.com
Date of submission: January 17, 2017
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2. Device names:
Fletcher Type Applicator Set Proprietary name: Kobold® Fletcher-model Tandem and Ovoid Applicator Set
Henschke Type Applicator Set Proprietary name: Kobold® Henschke-model Tandem and Ovoid Applicator Set
Vaginal Cylinder Set Proprietary name: Kobold® Vaginal Cylinder Applicator Set
Miami Cylinder Set Proprietary name: Kobold® Miami Cylinder Applicator Set
- Regulation Section 892.5700 A.
- B. Classification: Class II
- C. Product Code: JAO
- Panel: Radiology D.
3. Intended Use:
The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Fletcher type applicator is accepted by up-todate clinical guidelines. The Kobold® Fletcher-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Henschke type applicator is accepted by up-todate clinical guidelines. The Kobold® Henschke-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the vagina is accepted by up-to-date clinical guidelines. The Kobold® Vaginal Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set is indicated for use in any patient case where high dose rate (HDR) radiation treatment of the cervix, vagina, and uterus with a Miami type applicator is acceptable by up-to-date clinical guidelines. The Kobold® Miami Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient.
{5}------------------------------------------------
4.
Device Description:
The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set design is based on the conventional modified Fletcher GYN applicator. Kobold manufactures versions compatible with HDR afterloaders. This applicator is mainly utilized for HDR radiation boosts to the cervix and parametrial tissues in conjunction with external beam radiation therapy. This GYN set consists of precision manufactured intrauterine tandems and a pair of interlocking vaginal colpostats with Fletcher type unshielded barrel or cylinder ovoids (all components are designed to allow for customization of the treated geometry). The distance between the two lateral ovoids is adjustable with a lock knob. Four differing tandem geometries are provided in the set: one straight, one with slight curvature, one with medium curvature, and one with maximal curvature. These allow for maximal accommodation of the uterine shape and flexure.
The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set design is based on the conventional modified Henschke GYN applicator. Kobold manufactures versions compatible with HDR afterloaders. This applicator is mainly utilized for HDR radiation boosts to the cervix and parametrial tissues in conjunction with external beam radiation therapy. This GYN set consists of precision manufactured intrauterine tandems and a pair of interlocking vaginal colpostats with Henschke type unshielded ovoids (all components are designed to allow for customization of the treated geometry). The distance between the ovoids is adjustable with a lock knob. Four differing tandem geometries are provided in the set: one straight, one with slight curvature, one with medium curvature, and one with maximal curvature. These allow for maximal accommodation of the uterine shape and flexure.
The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set design is based on conventional cylindrical HDR delivery systems with a connector interface compatible with major manufacturers' afterloaders. 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 precision manufactured vaginal cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.
The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set design is based on conventional modified Miami applicators with a connector interface compatible with major manufacturers' afterloaders. This applicator set 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. Various tandems are provided: straight. slight curvature. medium curvature, and maximal curvature. These allow for maximal accommodation of the uterine flexure.
{6}------------------------------------------------
న.
Substantial Equivalence Information:
Information presented supports substantial equivalence of CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid 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 general sterilization procedures.
Information presented supports substantial equivalence of CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid 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 general sterilization procedures.
Information presented supports substantial equivalence of CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder 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 general sterilization procedures
Information presented supports substantial equivalence of CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder 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 general sterilization procedures.
Please see predicate device brochures in Appendix C and previously cleared K123912 and K123941.
- A. Predicate device name: Kobold® Fletcher Type Applicator Set, Kobold® Henschke Type Applicator Set, Kobold® Vaginal Cylinder Applicator Set, Kobold Sure-Guide Miami Cylinder Set
- B. Predicate device K number: 123912, 123941
- C. Comparison with predicate:
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| SUBSTANTIALEQUIVALENCETABLE | KOBOLD LLC | KOBOLD LLC |
|---|---|---|
| K-Number | K-160610 | K-123912 |
| Device Description | Applicator Set, Fletcher model | Applicator Set, Fletcher Type |
| Indications for Use | The CT Compatible / MR UnsafeHDR Kobold® Fletcher-modelTandem and Ovoid Applicator Set isindicated for use in any case wherehigh dose rate (HDR) radiationtreatment of the cervix and uteruswith a Fletcher type applicator isaccepted by up-to-date clinicalguidelines. The Kobold® Fletcher-model Tandem and OvoidApplicator 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 casewhere high dose rate (HDR)radiation treatment of the cervixand uterus is accepted by up-to-date clinical guidelines. |
| Afterloader Compatibility* | Elekta: microSelectron®, Flexitron®Varian: GammaMed®, VariSource®with click-fit connector. | GammaMed®, VariSource® withclick-fit connector. |
| Design Geometry | Flexible | 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 4 min at 270°F (132°C), 44psi(3 bar) Dry 15 min. | Steam 18 min at 273°F (134°C),44psi (3 bar) Dry 15 min; noSterrad® compatibilitydocumented |
| Biocompatibility | Documented | Documented |
| Anatomical Sites | Uterus, Cervix | Uterus, Cervix |
| EnvironmentalCompatibility | CT Compatible / MR Unsafe | CT/MRI Compatible |
{8}------------------------------------------------
| SUBSTANTIALEQUIVALENCETABLE | KOBOLD LLC | KOBOLD LLC |
|---|---|---|
| K-Number | K-160610 | K-123912 |
| Device Description | Applicator Set, Henschke model | Applicator Set, Henschke Type |
| Indications for Use | The CT Compatible / MR UnsafeHDR Kobold® Henschke-modelTandem and Ovoid Applicator Set isindicated for use in any case wherehigh dose rate (HDR) radiationtreatment of the cervix and uteruswith a Henschke type applicator isaccepted by up-to-date clinicalguidelines. The Kobold® Henschke-model Tandem and OvoidApplicator 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 casewhere high dose rate (HDR)radiation treatment of the cervixand uterus is accepted by up-to-date clinical guidelines. |
| Afterloader Compatibility | Elekta: microSelectron®, Flexitron®Varian: GammaMed®, VariSource®with click-fit connector. | GammaMed®, VariSource® withclick-fit connector. |
| Design Geometry | Flexible | 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 4 min at 270°F (132°C), 44psi(3 bar) Dry 15 min. | Steam 18 min at 273°F (134°C),44psi (3 bar) Dry 15 min; noSterrad® compatibilitydocumented |
| Biocompatibility | Documented | Documented |
| Anatomical Sites | Uterus, Cervix | Uterus, Cervix |
| EnvironmentalCompatibility | CT Compatible / MR Unsafe | CT/MRI Compatible |
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| SUBSTANTIALEQUIVALENCETABLE | KOBOLD LLC | KOBOLD LLC |
|---|---|---|
| K-Number | K160610 | K-123941 |
| Device Description | Vaginal Cylinder Applicator Set | Cylinder Set, Vaginal |
| Indications for Use | The CT Compatible / MR UnsafeHDR Kobold® Vaginal CylinderApplicator Set is indicated for use inany case where high dose rate (HDR)radiation treatment of the vagina isaccepted by up-to-date clinicalguidelines. The Kobold® VaginalCylinder Applicator Set is intendedfor continuous use of up to 24 hoursof contact with patient. | The CT/MRI Compatible Sure-Guide Vaginal Cylinder Set isindicated for use in any patientcase where High Dose Rate(HDR) radiation treatment of thevagina is acceptable for up-to-date clinical and practiceguidelines. |
| Afterloader Compatibility | Elekta: microSelectron®, Flexitron®Varian: GammaMed®, VariSource®with click-fit connector. | GammaMed®, VariSource® withclick-fit connector. |
| 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 4 min at 270°F (132°C), 44psi(3 bar) Dry 15 min. | Steam 18 min at 273°F (134°C),44psi (3 bar) Dry 15 min; noSterrad® compatibilitydocumented |
| Biocompatibility | Documented | Documented |
| Anatomical Sites | vagina | vagina |
| EnvironmentalCompatibility | CT Compatible / MR Unsafe | CT/MRI Compatible |
{10}------------------------------------------------
| SUBSTANTIALEQUIVALENCETABLE | KOBOLD LLC | KOBOLD LLC |
|---|---|---|
| K-Number | K160610 | K-123941 |
| Device Description | Miami Cylinder Applicator Set | Cylinder Set, Miami |
| Indications for Use | The CT Compatible / MR UnsafeHDR Kobold® Miami CylinderApplicator Set is indicated for use inany patient case where high dose rate(HDR) radiation treatment of thecervix, vagina, and uterus with aMiami type applicator is acceptableby up-to-date clinical guidelines. TheKobold® Miami Cylinder ApplicatorSet is intended for continuous use ofup to 24 hours of contact with patient. | The CT/MRI Compatible MiamiHDR Set is indicated for use inany patient case where High DoseRate (HDR) radiation treatmentof the cervix, vagina and uterus isacceptable for up-to-date clinicaland practice guidelines. |
| Afterloader Compatibility | Elekta: microSelectron®, Flexitron®Varian: GammaMed®, VariSource®with click-fit connector. | GammaMed®, VariSource® withclick-fit connector. |
| 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 4 min at 270°F (132°C), 44psi(3 bar) Dry 15 min. | Steam 18 min at 273°F (134°C),44psi (3 bar) Dry 15 min; noSterrad® compatibilitydocumented |
| Biocompatibility | Documented | Documented |
| Anatomical Sites | cervix, vagina, and uterus | cervix, vagina, and uterus |
| EnvironmentalCompatibility | CT Compatible / MR Unsafe | CT/MRI Compatible |
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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 in K-123912 and K-123941. Standards specification for the materials used in surgical implant applications and predicate brachytherapy devices is in Appendix A. Finished device acceptance testing visual method sheets and performance tests are in Appendix A.
8.
Conclusions
The Kobold® Fletcher-model Tandem and Ovoid Applicator Set is similar in intended use and technological characteristics to the predicate device reviewed. The device is substantially equivalent with respect to indications for use and physical characteristics to the predicate device.
The Kobold® Henschke-model Tandem and Ovoid Applicator Set is similar in intended use and technological characteristics to the predicate device reviewed. The device is substantially equivalent with respect to indications for use and physical characteristics to the predicate device.
The Kobold® Vaginal Cylinder Applicator Set is similar in intended use and technological characteristics to the predicate device reviewed. The device is substantially equivalent with respect to indications for use and physical characteristics to the predicate device.
The Kobold® Miami Cylinder Applicator Set is similar in intended use and technological characteristics to the predicate device reviewed. The device is substantially equivalent with respect to indications for use and physical characteristics to the predicate device.
Contraindications: As per clinical guidelines and published and accepted standard clinical practice.
Warnings and Precautions: The precautions and warnings are provided in the device labeling for the Kobold® Fletcher-model Tandem and Ovoid Applicator Set, the Kobold® Henschke-model Tandem and Ovoid Applicator Set, the Kobold® Vaginal Cylinder Applicator Set, and the Kobold® Miami Cylinder 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® Fletchermodel Tandem and Ovoid Applicator Set has been demonstrated to be substantially equivalent to the predicate device. The Kobold® Henschke-model Tandem and Ovoid Applicator Set has been demonstrated to be substantially equivalent to the predicate device. The Kobold® Vaginal Cylinder Applicator Set has been demonstrated to be substantially equivalent to the predicate device. The Kobold® Miami Cylinder Applicator Set has been demonstrated to be substantially equivalent to the predicate device.
§ 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.