(256 days)
The UF Brachytherapy Stand is intended to be used to provide ultrasound probe alignment in planning and performing a prostate brachytherapy implant procedure.
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.
Here's an analysis of the provided text regarding the UF Brachytherapy Stand.
Important Note: The provided document is a 510(k) summary for a medical device (UF Brachytherapy Stand). 510(k)s primarily focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than detailed performance studies against specific acceptance criteria for a novel device. As such, many of the typical elements of an acceptance criteria and study report for, for example, an AI medical device, are not present in this type of document.
Therefore, the answers below will reflect the information available in the given text, highlighting what is (and isn't) present as per the nature of a 510(k) submission for a mechanical device.
Acceptance Criteria and Device Performance Study Report
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not contain a discrete table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or quantitative measurements typically associated with a new diagnostic or AI device.
For a mechanical device like the UF Brachytherapy Stand, "acceptance criteria" are generally met by demonstrating:
- Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
- Intended Use Alignment: The device meets its stated intended use.
- Material and Design Properties: The materials, dimensions, and mechanical function are appropriate and, if applicable, comparable to the predicate.
- Compliance with Standards (if applicable): Though not explicitly detailed here, mechanical devices would typically demonstrate compliance with relevant national or international performance and safety standards.
The "reported device performance" is essentially the conclusion of substantial equivalence to the predicate device, K972672, Barzell-Whitmore Maroon Bells, Inc.: Brachystepper Stepping Unit/ Needle Guide Template, Brachystand Support and Manual Adjustment Accessory. The document states:
"This device, with respect to materials, device characteristics and intended use, is substantially equivalent to the predicate device."
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the context of clinical data, images, or patient cases. This device is a mechanical stand, and its evaluation for a 510(k) typically involves engineering verification, validation, and comparison to the predicate device's design and function, not a clinical study with patient data.
- Sample Size: Not applicable in the context of a clinical test set. The "sample" would be the device itself undergoing engineering testing.
- Data Provenance: Not applicable. There is no patient data described in this 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided. The "ground truth" for a mechanical device like this would relate to its structural integrity, functionality (e.g., holding an ultrasound probe stable, facilitating stepping), and material compatibility, which are established through engineering principles, bench testing, and comparison to a predicate, not through expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable and not provided. There is no clinical "test set" requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is a mechanical stand, not an AI or imaging interpretation device. Therefore, no MRMC study or AI assistance assessment would be performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a mechanical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device, inferred from a 510(k) submission, relates to its mechanical functionality and safety. This would likely involve:
- Engineering Specifications: Ensuring the device meets its design specifications for stability, adjustability, and material strength.
- Predicate Device Comparison: Demonstrating that its mechanical properties and intended use are similar to the predicate device.
- Relevant Standards: Adherence to any applicable mechanical or medical device safety standards.
There is no mention of "expert consensus, pathology, or outcomes data" in this summary, as these are typically associated with diagnostic or therapeutic devices, not a mechanical accessory.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical stand, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set for this type of device.
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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 RoadGainesville, FL 32610-0315 |
| Contact Person: | Jodi MansfieldChief Operating Officer |
| Phone Number:Fax Number: | 352-265-0440352-265-0231 |
| Date Prepared: | October 4, 2002 |
| Device Trade Name: | UF Brachytherapy Stand |
| Device Common Name: | Transducer, Ultrasound, Diagnostic |
| Classification Name andNumber: | Transducer, Ultrasound, Diagnostic21 CFR 892.1570, 90 ITX |
| Predicate Device: | K972672, Barzell-Whitmore Maroon Bells, Inc .: BrachystepperStepping Unit/ Needle Guide Template, Brachystand Support andManual Adjustment Accessory |
| Device Description: | The UF Brachytherapy Stand is a manual, mechanical system thatincludes an ultrasound probe stabilizing stand and a stepping unit. Itis for use clamped to a table top or side-rails. |
| Intended Use: | The UF Brachytherapy Stand is intended to be used to provideultrasound probe alignment in planning and performing a prostatebrachytherapy implant procedure. |
| Conclusion: | This device, with respect to materials, device characteristics andintended use, is substantially equivalent to the predicate device. |
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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.
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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
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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.
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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)
§ 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.