(107 days)
Not Found
No
The device description focuses on mechanical components and their function as accessories for brachytherapy, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an "accessory to commercially available high dose rate remote afterloading systems for prostate brachytherapy," and its function is to position needles for treatment rather than directly delivering therapy itself.
No
This device is described as an accessory to high dose rate remote afterloading systems for prostate brachytherapy, used for holding needles in place during treatment. It facilitates therapy, rather than diagnosing a condition.
No
The device description explicitly details physical components (template, plastic needles, needle obturators) and their materials and functions, indicating it is a hardware device with accessories, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The HDR Prostate Template and Accessories are used during a medical procedure (prostate brachytherapy) to guide and hold needles for delivering radiation. They are accessories to a remote afterloading system.
- Lack of Specimen Analysis: The device itself does not analyze any biological specimens. Its function is purely mechanical and procedural.
The device is a surgical accessory used in a therapeutic procedure, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
The Photon Technologies HDR Prostate Template and Accessories are intended to be used as accessories to commercially available high dose rate remote afterloader systems for prostate brachytherapy. The template allows the precision alignment, placement, and position retention of the HDR needles. The HDR needles and associated obturators provide a treatment path to the prescribed area for the radiation source while preventing the source from coming into contact with bodily fluids.
The HDR ProstateTemplate and Accessories are indicated for use as an accessory to commercially available high dose rate remote afterloading systems for prostate brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The Photon Technologies HDR Prostate Template and Accessories are designed to work as accessories to commercially available high dose rate remote afterloader systems and consists of a template, plastic needles and needle obturators.
The template is designed to mount on various ultrasound stepping devices and the grid of needle sized holes is compatible with the standard ultrasound image grid. The template is also designed with a simple locking mechanism for holding the needles in place and suture holes for suturing the template to the patient.
The needle is a plastic tube that is closed to a sharp point at one end and equipped with a metal connector for attaching the needle to the remote afterloader transfer tube on the open end.
The needle obturator is a spring temper metal rod that is inserted into the needle before use to straighten and stiffen it before implantation and to prevent damage between treatments or the possible entry of bodily fluids or other foreign matter.
The HDR Prostate Template and Accessories are single use accessories that are provided unsterile and whose components are compatible with steam autoclave sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
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.
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
K09/230
510(k) Summary
Submitter: Photon Technologies Corporation 1572 Highway 85 N., Ste. # 308 Fayetteville, GA 30214 Phone: 770-716-9958 770-716-9958 Fax: Contact: Jeffrey Edwards Summary prepared: April 20, 2009
AUG 1 2 2009
Device Name
Trade/Proprietary name: HDR Prostate Template and Accessories Common or Usual name: Applicator for Remote Controlled Afterloading Brachytherapy Classification name: System, Applicator, Radionuclide, Remote-controlled 21 CFR 892.5700, Class II, Product Code JAQ
Predicate Device: Nucletron Corporation, Prostate Stepper Template Set, K003270
Description
The Photon Technologies HDR Prostate Template and Accessories are designed to work as accessories to commercially available high dose rate remote afterloader systems and consists of a template, plastic needles and needle obturators.
The template is designed to mount on various ultrasound stepping devices and the grid of needle sized holes is compatible with the standard ultrasound image grid. The template is also designed with a simple locking mechanism for holding the needles in place and suture holes for suturing the template to the patient.
The needle is a plastic tube that is closed to a sharp point at one end and equipped with a metal connector for attaching the needle to the remote afterloader transfer tube on the open end.
The needle obturator is a spring temper metal rod that is inserted into the needle before use to straighten and stiffen it before implantation and to prevent damage between treatments or the possible entry of bodily fluids or other foreign matter.
The HDR Prostate Template and Accessories are single use accessories that are provided unsterile and whose components are compatible with steam autoclave sterilization.
Intended Use
The Photon Technologies HDR Prostate Template and Accessories are intended to be used as accessories to commercially available high dose rate remote afterloader systems for prostate brachytherapy. The template allows the precision alignment, placement, and position retention of the HDR needles. The HDR needles and
1
associated obturators provide a treatment path to the prescribed area for the radiation source while preventing the source from coming into contact with bodily fluids.
Summary of Technological Characteristics
This new device is substantially equivalent to the predicate device in design, construction, and function. A comparison summary of technological characteristics between the new device and the predicate device is listed in section 4.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by a staff with a snake winding around it, symbolizing medicine and health. The seal is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Roon1 - WO66-G609 Silver Spring, MD 20993-0002
Mr. Jeffrey A. Edwards President Photon Technologies Corporation 1572 Hwy. 85 N. Ste 308 FAYETTEVILLE GA 30214
AUG 1 2 2009
Re: K091230
Trade/Device Name: HDR Prostate Template and Accessories Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: July 14, 2009 Received: July 14, 2009
Dear Mr. Edwards:
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. Drue, 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 (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
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Lammy M. Monk
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K691230
Device Name: HDR Prostate Template and Accessories
Indications For Use:
The HDR ProstateTemplate and Accessories are indicated for use as an accessory to commercially available high dose rate remote afterloading systems for prostate brachytherapy.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Logu Mnhy
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
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