(379 days)
K-11:3766, K-051423
Not Found
No
The device description and intended use focus on mechanical components (tubes, extenders) for connecting brachytherapy afterloaders and applicators. There is no mention of AI, ML, image processing, or data analysis capabilities.
No.
The device facilitates the delivery of radioactive isotopes for therapy, but it is not a therapeutic device itself as it does not directly treat the patient. It's a component of a larger brachytherapy system.
No.
The device facilitates the positioning of radioactive isotopes for treatment (brachytherapy), which is a therapeutic process, not a diagnostic one. It does not provide information about a patient's health status or disease.
No
The device description clearly describes physical components (transfer guide tubes, interstitial extenders) made of materials and subject to bench testing, 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that these devices are "transfer guide tubes" and "interstitial extenders" used to create a conduit for a radioactive source wire to travel to a tumor site within the patient. They are part of a brachytherapy system.
- Patient Contact: The description explicitly states that these products are "non-invasive products that have no direct patient contact." This further reinforces that they are not used for testing samples from the body.
- Intended Use: The intended use is to facilitate the delivery of radiation to a tumor, not to diagnose or monitor a condition through testing of bodily samples.
Therefore, the function and intended use of these devices fall outside the scope of In Vitro Diagnostics. They are part of a therapeutic system for delivering radiation.
N/A
Intended Use / Indications for Use
i) Kobold Secure Lock Transfer Guide Tube Set™
The Secure Lock transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders to HDR applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.
Secure Lock Guide Tube Sets are non-invasive products that have no direct patient contact.
ii) Kobold Interstitial Extender SetTM
The interstitial extenders have been developed to enable the connection of Varian or Kobold Transfer Tubes to Kobold Interstitial Needles. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site. All Kobold Interstitial Extenders™ are intended for single use and are disposable.
Interstitial Extenders are non-invasive products that have no direct patient contact.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
i) Kobold Secure Lock Transfer Guide Tube Set™
Each tube is numbered to ensure correct connection of the applicator channel with the corresponding afterloader channel. Only a physician who has been trained in the appropriate afterloader systems should use the Secure Lock transfer guide tubes. These transfer guide tubes are compatible with VariSource iX and VariSource 200 afterloaders.
ii) Kobold Interstitial Extender Set™
Each extender is numbered to ensure correct connection of the interstitial extenders and corresponding (1) transfer guide tube and (2) interstitial needle. Only a physician who has been trained in the appropriate afterloader systems should use the interstitial extenders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's tumor site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Only a physician who has been trained in the appropriate afterloader systems should use the Secure Lock transfer guide tubes.
Only a physician who has been trained in the appropriate afterloader systems should use the interstitial extenders.
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)
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 for finished devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K-11:3766, K-051423
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Page 1 of 7
APR 0 3 2014
510(k) Summary
This summary of 510(k) safety and effectiveness information is furnished in accordance with requirements detailed in 21 CFR 807.92.
Assigned 510(k) number K-130757:
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 Telephone (415) 450-0515 Fax (415) 474-1806 Email tina@bbmedicalsurgical.com
Date of Response: 20 March 2014
2.
Device name:
i) Extension Tubes
Proprietary name: Kobold Secure Lock Transfer Guide Tube Set™
A. Regulation Section 892.5700 B. Classification: Class II C. Product Code: JAQ D. Panel: Radiology
1
ii) Needle Extender Sets
Proprietary name: Kobold Interstitial Extender SetTM
A. Regulation Section 892.5700
B. Classification: Class II
C. Product Code: JAQ
D. Panel: Radiology
3. Intended Use:
i) Kobold Secure Lock Transfer Guide Tube Set™
The Secure Lock transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders to HDR applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.
Secure Lock Guide Tube Sets are non-invasive products that have no direct patient contact.
ii) Kobold Interstitial Extender SetTM
The interstitial extenders have been developed to enable the connection of Varian or Kobold Transfer Tubes to Kobold Interstitial Needles. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site. All Kobold Interstitial Extenders™ are intended for single use and are disposable.
Interstitial Extenders are non-invasive products that have no direct patient contact.
4. Device Description:
i) Kobold Secure Lock Transfer Guide Tube Set™
Each tube is numbered to ensure correct connection of the applicator channel with the corresponding afterloader channel. Only a physician who has been trained in the appropriate afterloader systems should use the Secure Lock transfer guide tubes. These transfer guide tubes are compatible with VariSource iX and VariSource 200 afterloaders.
2
ii) Kobold Interstitial Extender Set™
Each extender is numbered to ensure correct connection of the interstitial extenders and corresponding (1) transfer guide tube and (2) interstitial needle. Only a physician who has been trained in the appropriate afterloader systems should use the interstitial extenders.
1 13 300 11, 11, 11, 14,
ડ. Substantial Equivalence Information:
i) Kobold Secure Lock Transfer Guide Tube Set™
Information presented supports substantial equivalence of the Kobold Secure Lock Transfer Guide Tube Set™ to the predicate device. 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 cleaning and disinfecting procedures.
A. Predicate device name: Intracavity Brachytherapy Applicators
B. Predicate K-Number: K-11:3766
C. Comparison with predicate:
3
ිය පිහිටි පිහිටි පිහිටි විසින් සිට මිනිස් සිට මිනිස්තු පිහිටි මෙහි පිහිට
:
| SUBSTANTIAL
EQUIVALENCE
| TABLE | KOBOLD LLC | VARIAN®, INC. |
|---|---|---|
| K-Number | 130757 | 113766 |
| Device Description | Transfer Tube Set | Transfer Tube Set |
| Indications For Use | The Secure Lock transfer guide tubes have | |
| been developed to enable the connection | ||
| of Varian's VariSource iX and 200 | ||
| afterloaders to HDR applicators. This | ||
| connection creates a conduit for the | ||
| source wire to travel through and allows | ||
| the radioactive isotopes to be positioned | ||
| within the patient's tumor site. | ||
| Secure Lock Guide Tube Sets are non- | ||
| invasive products that have no direct | ||
| patient contact. | The VariSource Reusable | |
| Transfer Guide Tubes are | ||
| intended to connect between | ||
| the VariSource Remote HDR | ||
| Afterloader system and its | ||
| range of applicators. This | ||
| connection creates a conduit for | ||
| the source wire to travel | ||
| through and allows | ||
| radioisotopes to be positioned | ||
| within the patient's tumor site. | ||
| SecureLock Fitting | VariSource Compatible | ClickFit/ClickFit |
| Needle/Catheter/Luer | ||
| Tube Material | Fluorinated Ethylene Propylene (FEP) | Fluorinated Ethylene Propylene |
| (FEP) | ||
| Sterility | None (No Body Contact) | None (No Body Contact) |
| Environmental | ||
| Compatibility | MR Unsafe | CT/MRI Compatible |
:
・
1
:
.
.
:
・
.
·
.
:
.
.
:
4
ii) Kobold Interstitial Extenders™
Information presented supports substantial equivalence of the Kobold Interstitial Extenders™ to the predicate device. 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 is also single use.
A. Predicate device name: Needle extenders
B. Predicate K-Number: K-051423
C. Comparison with predicate:
5
. 11 11:11 10 11:00 10 11:00 14 14 14 14 14 14 14 14 14 14 14 11 11:00 11 11 11 14 14 14 14 14 14 14 11 11:00 10 11 11 11 14 14 14 11 11 11 11 11 14 14 11 11 11 11 11 11 11
:1
| SUBSTANTIAL
EQUIVALENCE
| TABLE | KOBOLD LLC | MICK RADIO-NUCLEAR®, INC. |
|---|---|---|
| K-Number | 130757 | 051423 |
| Device Description | Needle Extender Set | Needle Extender Set |
| Indications For Use | The interstitial extenders have been | |
| developed to enable the connection of | ||
| Varian or Kobold Transfer Tubes to | ||
| Kobold Interstitial Needles. This | ||
| connection creates a conduit for the | ||
| source wire to travel through and allows | ||
| the radioactive isotopes to be positioned | ||
| within the patient's tumor site. All Kobold | ||
| Interstitial Extenders™ are intended for | ||
| single use and are disposable. | ||
| Interstitial Extenders are non-invasive | ||
| products that have no direct patient | ||
| contact. | The Mick HDR Interstitial | |
| Implant Accessories (consisting | ||
| of needles, catheters, and | ||
| fixation buttons) have been | ||
| developed to function as | ||
| accessories/applicators for the | ||
| positioning of HDR Remote | ||
| AfterLoader sealed sources in | ||
| the interstitial treatment of | ||
| cancer of the oral cavity, | ||
| oropharyngeal tumors, head | ||
| and neck and soft tissue | ||
| sarcomas. | ||
| Fitting | Kobold SecureLock transfer guide tube | |
| compatible | Luer | |
| Needle Extender | ||
| Material | Nylon 11, Nylon 12 | Nylon |
| Sterility | None (No Body Contact) | None (No Body Contact) |
| Environmental | ||
| Compatibility | MR Unsafe | CT/MRI Compatible |
6.
Test Principle, Performance Characteristics:
FDA has not established special controls or performance standards for this device.
6
K130757
page 7 of 7
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 for finished devices.
8.
Conclusions:
i) Information presented supports substantial equivalence of the Kobold Secure Lock Transfer Guide Tube Set™ to the predicate device. 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 cleaning and disinfecting procedures.
ii) Information presented supports substantial equivalence of the Kobold Interstitial Extenders™ to the predicate device. 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 is also single use.
Contraindications: As per clinical guidelines and standard clinical practice.
Warnings and Precautions: The precautions are provided in the device labeling for the Kobold device. There is no warning associated with this type of device.
9. Summary:
| Description | Comparison with Predicate |
|---|---|
| Biocompatibility | Safe as predicate - no patient contact |
| Performance Characteristics | Substantially equivalent |
| Intended Use | Substantially equivalent |
| Performance Tests | Not Required |
The Kobold devices, based on the information submitted in this 510(k) application have been demonstrated to be substantially equivalent to the predicate devices.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2014
Kobold, LLC % Ms. Christine Bernstein Regulatory Director BB Medical Surgical, Inc. 2670 Leavenworth Street SAN FRANCISCO CA 94133
Re: K130757
Trade/Device Name: Kobold Secure Lock and Luer Transfer Guide Tube Sets; Kobold Luer Interstitial Extender Set
Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: February 19, 2014 Received: February 21, 2014
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 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.
8
Page 2-Ms. Bernstein
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/Resources/orYou/Industrv/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K130757
Device Name: Kobold Secure Lock Transfer Guide Tube Set™
Indications For Use:
The Secure Lock transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's turnor site.
Transfer guide tubes are non-myasive products that have no direct patient contact.
Device Name: Kobold Luer Transfer Guide Tube Set™
Indications For Use:
The Luer transfer guide tubes have been developed to enable the connection of Varian's VariSource iX and 200 afterloaders and other third party applicators that include a Luer style connection. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tunnor site.
Transfer guide tubes are non-invasive products that have no direct patient contact.
Device Name: Kobold Luer Interstitial Extender SetTM
Indications For Use:
The Luer interstitial extenders have been developed to enable the connection of Luer transfer guide tube to Kobold Interstitial Needles. This connection creates a conduit for the source wire to travel through and allows the radioactive isotopes to be positioned within the patient's tumor site.
Interstitial extenders are non-invasive products that have no direct patient contact.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
10
Concurrence of Center for Devices and Radiological Health (CDRH)
(
Michael D. O'Hara
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