(251 days)
AOS Prostate Template, Rectal Template, GYN Template (Preamendment), AOS Template Needle (Preamendment), AOS Template Tip (Preamendment)
Not Found
No
The device description focuses on mechanical components and their function in delivering radiation sources. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is used to apply radioactive sources for radiation therapy (brachytherapy), which is a form of medical treatment.
No
The device is used to provide an enclosed pathway for the application of radioactive sources for radiation therapy (brachytherapy), which is a treatment, not a diagnostic procedure.
No
The device description clearly details physical components made of silicone and metal (needles, guides, collars, etc.) used for delivering radioactive sources, indicating it is a hardware device, not software-only.
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 and enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachytherapy)." This describes a device used in vivo (within the body) for therapeutic purposes (radiation therapy).
- Device Description: The description details a physical device (templates, needles, accessories) used to guide the placement of radioactive sources within the body. It does not describe a device used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a medical device used for therapeutic intervention, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The purpose of AOS Interstitial Templates, Needles and Accessories is to provide and enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachytherapy).
Product codes (comma separated list FDA assigned to the subject device)
JAQ, KXK
Device Description
Alpha-Omega Services (AOS) Templates, Template Needles and Accessories provide a fixed array of needles, via the template. AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (center-to center). AOS templates are supplies in various sizes to accommodate treatment sites as prostate, rectum, or vagina.
The Template is sutured in place and Template Needles are inserted into the holes of the Template. The number and type of Template needles is dependant on the model of Afterloader or if the manual LDR method is used, which consists of strands or ribbons of discrete sources.
Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole, with a guide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide strip with the guide grove. The Vaginal Guide is pushed do the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS collar is then used to push the O-Ring along the Vaginal Guide until it can be slipped over and on to the grooved ring on the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaginal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required.
Template Needles may have a plain end or some sort of attachment device, such as a female luer adaptor if an Afterloader is to be used. If the Manual LDR method is used, typically a Template Needles with or without a collar is chosen. Where an Afterloader is used, the Template Needles are connected to the HDR Afterloader via an appropriate connector. If the Template Needle has a female Luer Adaptor on the proximal end, connection to the AOS Universal Connecting Guide Tube (K964910) provides an unobstructed pathway for the source wire or cable from the Afterloader to the appropriate distance as determined by the Afterloader. Some Afterloaders provide a transfer tube, which is connected, to the Afterloader while the other end slips over the plain end of the Template Needles and is tightened down to hold and connect the Template Needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body or surface of the body, prostate, rectum, vagina
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): 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.
AOS Prostate Template, Rectal Template, GYN Template (Preamendment), AOS Template Needle (Preamendment), AOS Template Tip (Preamendment)
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
Kdo28223
510(k) Summary AOS Interstitial Templates, Needles & Accessories
Alpha-Omega Services, Inc. 9156 Rose Street Bellflower, CA 90706 Tel: (800) 346-7894 Fax: (562) 804-0604 Bob A. Robnett July 2006
MAY 2 9 2007
DEVICE NAME
AOS Interstitial Templates, Needles & Accessories
PROPRIETARY NAME
AOS Interstitial Templates, Needles & Accessories
COMMON/USUAL NAME
Interstitial Template
CLASSIFICATION
System, Applicator, Radionuclide, Remote-Controlled 21 CFR 892.5700, Product Code: JAQ, Class II
PREDICATED DEVICES
AOS Prostate Template, Rectal Template, GYN Template (Preamendment, See Appendix A) AOS Template Needle (Preamendment, See Appendix A) AOS Template Tip (Preamendment, See Appendix A)
DESCRIPTION
Alpha-Omega Services (AOS) Templates, Template Needles and Accessories provide a fixed array of needles, via the template. AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (center-to center). AOS templates are supplies in various sizes to accommodate treatment sites as prostate, rectum, or vagina.
The Template is sutured in place and Template Needles are inserted into the holes of the Template. The number and type of Template needles is dependant on the model of Afterloader or if the manual LDR method is used, which consists of strands or ribbons of discrete sources.
Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole, with a guide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide strip with the guide grove. The Vaginal
1
Guide is pushed do the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS collar is then used to push the O-Ring along the Vaginal Guide until it can be slipped over and on to the grooved ring on the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaginal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required.
Template Needles may have a plain end or some sort of attachment device, such as a female luer adaptor if an Afterloader is to be used. If the Manual LDR method is used, typically a Template Needles with or without a collar is chosen. Where an Afterloader is used, the Template Needles are connected to the HDR Afterloader via an appropriate connector. If the Template Needle has a female Luer Adaptor on the proximal end, connection to the AOS Universal Connecting Guide Tube (K964910) provides an unobstructed pathway for the source wire or cable from the Afterloader to the appropriate distance as determined by the Afterloader. Some Afterloaders provide a transfer tube, which is connected, to the Afterloader while the other end slips over the plain end of the Template Needles and is tightened down to hold and connect the Template Needle.
INTENDED USE
The purpose of AOS Interstitial Templates, Needles, and Accessories is to provide an enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachtherapy).
CONTRAINDICTIONS
Single Use Device
PERFORMANCE STANDARDS
No performance Standards for Brachytherapy Applicators are in effect at this date.
SUBSTANTIAL EQUIVALENCE
AOS Interstitial Templates, Needles & Accessories are substantial equivalence to the AOS Implant Tube (Preamendment), AOS Implant Needle (Preamendmont), and AOS Retaining Button (Preamendment). A comparison summary of technological characteristics is listed below. See Sections 7 Device Description for detailed information.
| NEW DEVICE: | AOS Interstitial Templates |
|---|---|
| PREDICATE: | AOS Prostate Template, Rectal Template, |
| GYN Template | |
| DESIGN: | Both the new and predicate device share the |
| same design | |
| MATERIAL: | Both the new and predicate device are |
| constructed of the same materials |
2
| SINGLE USE: | Both the new and predicate device are Single Use Only. |
|---|---|
| STERILE: | New device is sterile. Predicate is non-sterile |
| NEW DEVICE: | AOS Interstitial Needles |
| PREDICATE: | AOS Template Needles |
| DESIGN: | Both the new and predicate device share the same design |
| MATERIAL: | Both the new and predicate device are constructed of the same materials |
| SINGLE USE: | Both the new and predicate device are Single Use Only. |
| STERILE: | New device is sterile. Predicate is non-sterile |
| NEW DEVICE: | AOS Interstitial Accessories |
| PREDICATE: | AOS Needle Tips |
| DESIGN: | Both the new and predicate device share the same design |
| MATERIAL: | Both the new and predicate device are constructed of the same materials |
| SINGLE USE: | Both the new and predicate device are Single Use Only. |
| STERILE: | New device is sterile. Predicate is non-sterile |
Conclusions
The Conclusion drawn from the above is that the AOS Interstitial Templates, Needles & Accessories are equivalent in safety and efficacy to their predicate devices.
3
Image /page/3/Picture/0 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a symbol consisting of three curved lines that resemble a stylized human figure. The logo is black and white and appears to be a scan of a document.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Bob A. Robnett Director Regulatory Affairs & Quality Alpha-Omega Services, Inc. 9156 Rose Street, P.O. Box 789 BELLFLOWER CA 90706
MAY 2 9 2007
Re: K062823
Trade/Device Name: AOS Interstitial Templates, Needles & Accessories Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: JAQ and KXK Dated: May 1, 2007 Received: May 3, 2007
Dear Mr. Robnett:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image shows a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906-2006" are displayed. Below the letters, the word "Centennial" is written in a cursive font. Three stars are located below the word "Centennial". The logo is surrounded by a dotted border.
Protecting and Promoting Public Health
4
Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Rast of activities that I Drivings and that your device complies with other requirements of the Act that I Dri has made a son regulations administered by other Federal agencies. You must of any I carates and registents, including, but not limited to: registration and listing (21 Comply with an the Hot CFR Part 801); good manufacturing practice requirements as set CITY at 807), ademig (21 CENT PET CENT Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you'ls begin inding of substantial equivalence of your device to a legally premarket noticated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advise for you one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (21GI IC I at 607.97). "Tod may obtains of Scharactonal and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
on at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known): K061823
Device Name: AOS Interstitial Templates, Needles & Accessories
Indications For Use: The purpose of AOS Interstitial Templates, Needles and Accessories is to provide and enclosed pathway for application of radioactive source(s) into the body or surface of the body for radiation therapy (brachytherapy).
Prescription Use: Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The Counter Use: NO (21 CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office or Device Evaluation
Huberto Leves Led