(88 days)
No
The device description focuses on mechanical support and manual operation, with no mention of AI or ML capabilities.
Yes
The device is used to implant radioactive seeds for cancer therapy, which directly treats the condition.
No
The device aids in the treatment of prostate cancer and prostate gland voluming, but it does not diagnose a condition. It provides mechanical support and guidance for procedures, rather than identifying or assessing a disease state.
No
The device description explicitly states it is a "manually operated medical device" that provides "mechanical support" and "guides and secures a rectal probe." This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Precision Stepper and Needle Guide is a mechanical device used to support and guide a rectal ultrasound probe and needles during a medical procedure (prostate brachytherapy and voluming). It facilitates the physical placement of radioactive seeds and imaging of the prostate.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It is an accessory used during a procedure, not a test performed on a sample.
The device is clearly described as an accessory to an ultrasound system used for clinical procedures, focusing on mechanical support and guidance for imaging and treatment delivery. This aligns with the definition of a medical device used in a clinical setting, but not an IVD.
N/A
Intended Use / Indications for Use
The Precision Stepper and Needle Guide is intended for use with a rectal probe in ultrasound-guided prostate brachytherapy (radioactive seed implantation), and transperineal prostate gland voluming. The Precision Stepper and Needle Guide system is an accessory to an ultrasound system used for these medical procedures in a clinical setting.
Indications for Use:
Condition to be screened, monitored, treated or diagnosed. Prostate gland voluming and treatment of prostate cancer by transperineal brachytherapy
Physiological purpose.
The Precision Stepper provides equipment support and quidance for a rectal probe. When used with its Needle Guide, an ultrasonic imaging system, and a rectal probe, the Precision Stepper and Needle Guide System is an accessory to clinical procedures for prostate gland voluming and ultrasound-guided radioactive seed implantation.
Product codes
IWJ
Device Description
The Precision Stepper and Needle Guide is a manually operated medical device used to provide mechanical support for the application of a radionuclide source into the prostate in the course of a brachytherapy procedure in a clinical setting. The Stepper guides and secures a rectal probe which is used for imaging of the prostate. The Stepper moves the transducer in precise increments, or steps. When used in conjunction with the Stepper, the Needle Guide is used to aid the clinician in guiding needles through a template into the prostate. Under the guidance of the ultrasound probe, these needles are used to implant radioactive seeds that irradiate the prostate in cancer therapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician, clinical setting
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
The Precision Stepper and Needle Guide has been subject to extensive inspection and testing to verify that the device meets all its physical and performance specifications. Test results are maintained in the design history file and/or device history files for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5650 Manual radionuclide applicator system.
(a)
Identification. A manual radionuclide applicator system is a manually operated device intended to apply 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 I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
Image /page/0/Picture/0 description: The image shows a logo for Radiation Therapy Products, a division of Real World Design & Development Company. The logo includes a graphic of a globe on the left side. The image also includes the date JAN - 2 1998 and a number 1975786 at the top right.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
NORTHWEST RADIATION THERAPY PRODUCTS PRECISION STEPPER AND NEEDLE GUIDE
- Terence Ellard Submitter's Name/ 1. Contact Person:
- Northwest Radiation Therapy Products Company: A Division of Real World Design and Development Company 5245 Shilshole Avenue NW, Suite B Seattle, WA 98107
- (206) 789-3380 Telephone: (206) 789-3202 Facsimile:
- Northwest Radiation Therapy Products Precision Name of Device: 2. Stepper and Needle Guide
- Manual Radionuclide Applicator System Classification: 21 CFR 892.5650; Product Code IWJ Class 1 (Radiology Panel)
- The Precision Stepper and Needle Guide is a র্বা Device Description: manually operated medical device used to provide mechanical support for the application of a radionuclide source into the prostate in the course of a brachytherapy procedure in a clinical setting. The Stepper guides and secures a rectal probe which is used for imaging of the prostate. The moves the transducer in precise Stepper increments, or steps. When used in conjunction with the Stepper, the Needle Guide is used to aid the clinician in guiding needles through a
1
template into the prostate. Under the guidance of the ultrasound probe, these needles are used to implant radioactive seeds that irradiate the prostate in cancer therapy.
- The Precision Stepper and Needle Guide is 5. Intended Use: intended for use with a rectal probe in ultrasoundimplantation radioactive seed guided prostate brachytherapy), and (transperineal prostate gland voluming. The Precision Stepper and Needle Guide system is an accessory to an ultrasound system used for these medical procedures in a clinical setting.
- We believe the Precision Stepper and Needle e. Comparison of Guide to be substantially equivalent to the Technological and Seed Implant Needle Guide Characteristics: Stepper manufactured by CIVCO Medical Instruments Company under 510(k) references K875241 and Both devices provide the means of 871413. mechanical support to hold an ultrasound rectal probe and provide guidance for isotope needles into the prostate. The devices are also substantially equivalent in their materials, design, principle of operation, and technology. As a manually operated system, there is no software component or energy source to the device.
-
- Standards: No standards have been established for this device. The device is, however, manufactured in accordance with the U.S. Quality System Regulation, 21 CFR 820.
- છે. Testing: The Precision Stepper and Needle Guide has been subject to extensive inspection and testing to verify that the device meets all its physical and performance specifications. Test results are maintained in the design history file and/or device history files for this device.
In conclusion, the Precision Stepper and Needle Guide is as safe and effective as its predicate device and raises no new issues.
2
Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic element to the right and text arranged in a circular fashion to the left. The graphic element features three curved lines that resemble a stylized human form or a symbol representing health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN" at the top and likely continues with "SERVICES" at the bottom, completing the circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terence R. Ellard NW Radiation Therapy Products 5245 Shilsote Avenue, NW Suite B Seattle, WA 98107
Re: K973786 NWRTP Precision Stepper and Needle Guide Dated: October 3, 1997 Received: October 6, 1997 Regulatory Class: I 21 CFR 892.5650/Procode: 90 IWJ
JAN - 2 1998
Dear Mr. Ellard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yiu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Page 1 of 1
510(k) Number (if known): Not Known (New Submission)
Northwest Radiation Therapy Products (NWRTP) Precision Device Name: Stepper and Needle Guide
Indications for Use:
:
Condition to be screened, monitored, treated or diagnosed. Prostate gland voluming and treatment of prostate cancer by transperineal brachytherapy
Prescription use only. Yes. Caution statement is provided in the labeling for this device.
Parts of body applied to. None.
Frequency of use. Frequency as directed by physician.
Physiological purpose.
The Precision Stepper provides equipment support and quidance for a rectal probe. When used with its Needle Guide, an ultrasonic imaging system, and a rectal probe, the Precision Stepper and Needle Guide System is an accessory to clinical procedures for prostate gland voluming and ultrasound-guided radioactive seed implantation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K973786 Section 1-5 |
|---|---|
| --------------- | --------------------- |