(240 days)
Not Found
No
The device description focuses on mechanical components and their function in brachytherapy. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The summary also explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is indicated for use in brachytherapy, which is a form of radiation therapy used to treat cancer. This involves delivering radiation directly to the tumor, which is a therapeutic intervention.
No
The device is used for interstitial Brachytherapy treatments, which is a therapeutic procedure involving the delivery of radiation, not for diagnosing conditions.
No
The device description explicitly details physical components made of silicone and metal (needles, guide tubes, collars, etc.) used in a physical medical procedure (brachytherapy). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is used for interstitial Brachytherapy treatments. This is a therapeutic procedure where radioactive sources are placed directly into or near the tumor.
- Intended Use: The intended use is for Brachytherapy of the cervix or prostate, which is a treatment, not a diagnostic test performed on a specimen.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device is used to physically deliver radiation sources.
Therefore, this device falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AOS Interstitial Templates, Needles, and Accessories are indicated for use in adults where Brachytherapy of the cervix or prostate is an accepted clinical practice.
Product codes
JAQ
Device Description
AOS Interstitial Templates, Needles, and Accessories are designed for interstitial Brachytherapy treatments of the cervix and prostate. The Templates are designed to be sutured to the perineal area in order to fix the geometry of the Template Need into the cervix or prostate.
AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (Center-to center). AOS Templates are supplied in two configurations to accommodate a prostate or GYN treatment.
The Template is sutured in place and Template Needles are inserted into the Template. The number and type of Template Needles is dependent on the model of Afterloader.
Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole with a quide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide groove. The Vaginal Guide is pushed to the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS Collar is then used to push the Vaginal Guide until it can be slipped over and on to the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaqinal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required.
Where an Afterloader is used, the Template Needles are connected to the 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, P/N SGJ0007, 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 other end slips over the plain end of the Template Needle 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
cervix or prostate
Indicated Patient Age Range
adults
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)
Nonclinical testing were not performed as device is identical to the predicate device.
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
July 10, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
Alpha-Omega Services, Inc. % Bob Robnett Director Regulatory Affairs & Quality Assurance 9156 Rose Street BELLFLOWER, CA 90706
Re: K233628
Trade/Device Name: AOS Interstitial Templates, Needles, and Accessories Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: November 10, 2023 Received: November 13, 2023
Dear Bob 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
1
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Locon Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
AOS Interstitial Templates, Needles, and Accessories (Various)
Indications for Use (Describe)
AOS Interstitial Templates, Needles, and Accessories are indicated for use in adults where Brachytherapy of the cervix or prostate is an accepted clinical practice.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
| 510(k) #: K233628 | 510(k) Summary | Prepared on: 2024-06-13 |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Alpha-Omega Services, Inc. | |
| Applicant Address | 9156 Rose Street Bellflower CA 90706 United States | |
| Applicant Contact Telephone | 562-804-0604 | |
| Applicant Contact | Mr. Bob Robnett | |
| Applicant Contact Email | brobnett@alphaomegaserv.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | AOS Interstitial Templates, Needles, and Accessories | |
| Common Name | Remote controlled radionuclide applicator system | |
| Classification Name | System, Applicator, Radionuclide, Remote-Controlled | |
| Regulation Number | 892.5700 | |
| Product Code | JAQ | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K062823 | AOS Interstitial Templates, Needles & Accessories | JAQ |
| Device Description Summary | 21 CFR 807.92(a)(4) |
4
AOS Interstitial Templates, Needles, and Accessories are designed for interstitial Brachytherapy treatments of the cervix and prostate. The Templates are designed to be sutured to the perineal area in order to fix the geometry of the Template Need into the cervix or prostate.
AOS Templates are made of silicone, with holes in a circular pattern, typically spaced 1 cm (Center-to center). AOS Templates are supplied in two configurations to accommodate a prostate or GYN treatment.
The Template is sutured in place and Template Needles are inserted into the Template. The number and type of Template Needles is dependent on the model of Afterloader.
Additional accessories are required in vaginal cases. The AOS GYN Templates have a large hole with a quide strip. The matching AOS Vaginal Guide Tube is inserted in this hole, lining up the guide groove. The Vaginal Guide is pushed to the desired depth and the large O-Ring is slipped over the Vaginal Guide. The AOS Collar is then used to push the Vaginal Guide until it can be slipped over and on to the Template. The O-Ring's elasticity tightens down and provides sufficient tension to hold the Vaqinal Guide in place. Each Vaginal Guide has six (6) Needle grooves for the insertion of additional Template Needles as required.
Where an Afterloader is used, the Template Needles are connected to the 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, P/N SGJ0007, 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 other end slips over the plain end of the Template Needle and is tightened down to hold and connect the Template Needle.
Intended Use/Indications for Use
AOS Interstitial Templates, Needles, and Accessories are indicated for use in adults where Brachytherapy of the cervix or prostate is an accepted clinical practice.
Indications for Use Comparison
Wording of the Indications for Use was reworded for clarifications for Use have not changed.
Technological Comparison
ged
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
5
The predicate device was marketed as sterilization is now completed by the end user. All other technological characteristics are the same as the predicate device.
NOTE: The following devices originally included in the predicate 510(k) K062823 have been discontinued due to market demands: CNT0003-001, Needle Cap CNT0004-001, Needle Cap NFD0001-000, FlexiGuide Needle NFV0001-000, FlexiGuide Needle NFV0002-000, FlexiGuide Needle NFV0003-000, FlexiGuide Needle NFW0001-000, FlexiGuide Needle NTD0001-000, Template Needle NTD0002-000, Template Needle NTD0003-000, Template Needle NTD0004-000, Template Needle NTD0005-000, Template Needle NTD0006-000, Template Needle OTD0001-000, O-Ring (Was previously sold separately) SNF0001-000, Stylet SNF0002-000, Stylet SNF0003-000, Stylet SNT0001-000, Stylet SNT0002-000, Stylet SNT0003-000, Stylet TGD0002-000, GYN-2 Template TNS0001-000, Needle Tip TRD0001-000, Rectal Template
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Nonclinical testing were not performed as device is identical to the predicate device.
TRD0002-000, Rectal Template
Nonclinical testing were not performed as device is identical to the predicate device.
Nonclinical testing were not performed as device is identical to the predicate device.