(91 days)
No
The summary describes a physical coupling device and makes no mention of AI, ML, or any software-driven analytical capabilities.
Yes.
The device is used to apply a radionuclide source for radiation therapy, which is a form of medical treatment.
No
The device is described as a coupling catheter for applying a radionuclide source for radiation therapy, which is a treatment modality, not a diagnostic one.
No
The device description explicitly states it is a "coupling catheter" and describes its physical construction and materials, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a coupling for applying a radionuclide source for radiation therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a coupling catheter used in conjunction with a Remote High Dose Rate Afterloader and patient needles/devices. This aligns with radiation therapy equipment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is purely for the delivery of radiation for treatment.
N/A
Intended Use / Indications for Use
To provide an enclosed coupling between a Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy. Single Use Device.
Product codes
90-JAQ
Device Description
The AOS Universal Connecting Guide Tube coupling catheters are substantial equivalence to Varian Coupling catheter (K952913), and Omnitron International Coupling catheter (K881665). Construction and materials are the same for all referenced devices. All devices are listed as single use, provided as non sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body or to the surface of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 1 0 1997
Image /page/0/Picture/2 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '964910'. The numbers are written in a clear, legible style, with consistent spacing between them.
Section 2 Summary & Certification
November, 1996
The following is a Summary & Certification of the AOS Universal Connecting Guide Tube.
I certify that I have conducted a reasonable search of all information known or otherwise r coilable to me about the types and causes of safety and/or effectiveness problems that have been reported for a Afterloader Coupling Catheter.
Printed Name Cary Hedgr Signature
Operations Manger/Alt. RSO
Date
Title
Alpha-Omega Services, Inc., 9156 Rose St., Bellflower, CA 90706 1-800-346-7894 Fax 310-804-0610
-19-96
Brachytherapy Applicators CLASSIFICATION NAME: Afterloader Coupling Catheter COMMON/USUAL NAME: AOS Universal Connecting Guide Tube for PROPRIETARY NAME: Afterloading Systems. 21 CFR Part 892.5700, Product Code: 90-JAQ, CLASSIFICATION: Class II No Performance Standards for Brachytherapy PERFORMANCE STANDARDS: Applicators are in effect at this date. Varian Coupling Catheters (K952913) and PREDICATED DEVICE Omnitron International System (K881665). To provide an enclosed coupling between a INDICATIONS Remote High Dose Rate Afterloader and patient needles and/or other devices to apply a radionuclide source into the body or to the surface of the body for radiation therapy. Single Use Device. Do not re-clean, re-sterilize CONTRAINDICATIONS device. Any reprocessing may result in changes in the physical characteristics of the device. Do Section 2, Page 1
SUMMAR~1.DOC 11/18/96
1
not counter accepted clinical practice or institution guidelines.
The AOS Universal Connecting Guide Tube coupling catheters are substantial equivalence to Varian Coupling catheter (K952913), and Omnitron International Coupling catheter (K881665). Construction and materials are the same for all referenced devices. All devices are listed as single use, provided as non sterile.
The conclusion drawn from the above is that the AOS Universal Connecting Guide Tube is equivalent in safety and efficacy to its predicate device.
SUBSTANTIAL EQUIVALENCE
CONCLUSIONS
Section 2, Page 2 November, 1996
SUMMAR~1.DOC 11/25/96