(256 days)
Not Found
No
The device description explicitly states it is a "manual, mechanical system" and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is a stand and stepping unit used for positioning and alignment during a prostate brachytherapy implant procedure, rather than directly treating a condition or restoring a function. Its purpose is to facilitate the procedure, not to be therapeutic in itself.
No
The device description and intended use indicate it is a mechanical system to provide ultrasound probe alignment for prostate brachytherapy, not to diagnose a condition.
No
The device description explicitly states it is a "manual, mechanical system" including a "stabilizing stand and a stepping unit," which are physical hardware components.
Based on the provided information, the UF Brachytherapy Stand is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide ultrasound probe alignment for planning and performing a prostate brachytherapy implant procedure. This is a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is described as a manual, mechanical system for stabilizing and stepping an ultrasound probe. This is a physical tool used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to diagnose, monitor, or predict disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The UF Brachytherapy Stand is a surgical/procedural accessory.
N/A
Intended Use / Indications for Use
The UF Brachytherapy Stand is intended to be used to provide ultrasound probe alignment in planning and performing a prostate brachytherapy implant procedure.
Product codes
90 IYO, KXK
Device Description
The UF Brachytherapy Stand is a manual, mechanical system that includes an ultrasound probe stabilizing stand and a stepping unit. It is for use clamped to a table top or side-rails.
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
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)
K972672, Barzell-Whitmore Maroon Bells, Inc .: Brachystepper Stepping Unit/ Needle Guide Template, Brachystand Support and Manual Adjustment Accessory
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
JUN 2 4 2003
Applicant: Shands Teaching Hospital and Clinics, Inc.
UF Brachytherapy Stand Traditional 510(k) Premarket Notification
K$\phi$2343$\phi$
510(k) SUMMARY—UF Brachytherapy Stand
| Submitter Name: | Shands Teaching Hospital and Clinics, Inc.
University of Florida |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 1600 S.W. Archer Road
Gainesville, FL 32610-0315 |
| Contact Person: | Jodi Mansfield
Chief Operating Officer |
| Phone Number:
Fax Number: | 352-265-0440
352-265-0231 |
| Date Prepared: | October 4, 2002 |
| Device Trade Name: | UF Brachytherapy Stand |
| Device Common Name: | Transducer, Ultrasound, Diagnostic |
| Classification Name and
Number: | Transducer, Ultrasound, Diagnostic
21 CFR 892.1570, 90 ITX |
| Predicate Device: | K972672, Barzell-Whitmore Maroon Bells, Inc .: Brachystepper
Stepping Unit/ Needle Guide Template, Brachystand Support and
Manual Adjustment Accessory |
| Device Description: | The UF Brachytherapy Stand is a manual, mechanical system that
includes an ultrasound probe stabilizing stand and a stepping unit. It
is for use clamped to a table top or side-rails. |
| Intended Use: | The UF Brachytherapy Stand is intended to be used to provide
ultrasound probe alignment in planning and performing a prostate
brachytherapy implant procedure. |
| Conclusion: | This device, with respect to materials, device characteristics and
intended use, is substantially equivalent to the predicate device. |
000027
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which may represent the flow of information or resources within the department. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2003
Ms. Patsy J. Trisler, J.D., RAC Senior Consultant Biologics Consulting Group 5610 Wisconsin Avenue, #304 CHEVY CHASE, MD 20815
Re: K023430
Trade/Device Name: UF Brachytherapy Stand Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 IYO and KXK Dated: March 28, 2003 Received: April 1, 2003
Dear Ms. Trisler:
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 (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); 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.
2
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
3
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$$\mathsf{if}$$
known)} \end{array} \Big| \begin{array}{c} \begin{array}{c} \mathsf{(\mathsf{x}\nrightarrow\mathsf{z}\nrightarrow\mathsf{x}\nrightarrow\mathsf{y}\nrightarrow\mathsf{z}\nrightarrow\mathsf{x}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}} \\end{array} \Big| \begin{array}{c} \begin{array}{c} \mathsf{(\mathsf{x}\nrightarrow\mathsf{y}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{y}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{y}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\nrightarrow\mathsf{z}\napprox\mathsf{z}\nrightarrow\mathsf{z}\n$$
Device Name:
UF Brachytherapy Stand
Indications for Use:
The UF Brachytherapy Stand is intended to be used to provide ultrasound probe alignment in planning and performing a prostate brachytherapy implant procedure.
(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) | X |
|---|---|
| ------------------------------------------ | ---------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K023430
Section 4.0
(Optional Format 1-2-96)