(68 days)
Not Found
No
The device description explicitly states it is a "mechanical device which is manually controlled" and there are no mentions of AI, ML, or image processing capabilities.
No
The device is described as a mechanical support and stabilization system for an ultrasonic probe, not as a device that delivers or performs any therapeutic action itself. Its function is to facilitate imaging, which is diagnostic, not therapeutic.
No
The device is described as a mechanical support and stabilization system for an ultrasonic probe, not a device that itself diagnoses conditions or processes images for diagnostic purposes. Its function is to facilitate the imaging process, not to perform the diagnosis.
No
The device description explicitly states it is a "mechanical device" and "composed of light-weight materials," indicating it is a physical hardware device, not software only.
Based on the provided information, the USHIFU Stepper 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.
- USHIFU Stepper Function: The USHIFU Stepper is a mechanical device that provides physical support and stabilization for an ultrasonic probe during imaging. It is used in conjunction with an imaging modality (ultrasound) to facilitate the acquisition of images. It does not analyze biological samples or provide diagnostic information directly from a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or any other process typically associated with IVD devices.
The USHIFU Stepper is a medical device that assists in an imaging procedure, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The USHIFU Stepper is intended to provide support and stabilization for an ultrasonic probe during prostate imaging.
Product codes
ITX
Device Description
The USHIFU Stepper is a mechanical device which is manually controlled in the horizontal and vertical directions. It is designed to allow for finite adjustments in these planes. It is composed of light-weight materials, is pre-assembled and easily attached to a surgical table.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic
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)
K843573, Super Scan/Biopsy Guide, CIVCO
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
Submitter:
USHIFU, LLC
USHIFU Stepper
Traditional 510(k)
510(k) SUMMARY
JUN 1 1 2008 | |
---|---|
Submitter Name: | USHIFU, LLC |
Submitter Address: | 1450 South Woodland Blvd. |
DeLand, FL 32720 | |
Contact Person: | Mare Ryan |
Vice President of Regulatory Affairs | |
Phone Number: | 386.785.0100 |
Fax Number: | 386.785.0101 |
Date Prepared: | April 4, 2008 |
Device Trade Name: | USHIFU Stepper |
Device Common Name: | Ultrasound Probe Stepper |
Classification Number: | 21 CFR 892.1570 |
Classification Name: | Transducer, Ultrasonic, Diagnostic |
Product Code: | ITX |
Predicate Device: | K843573, Super Scan/Biopsy Guide, CIVCO |
Statement of Intended Use: | The USHIFU Stepper is intended to provide support and stabilization for an ultrasonic probe during prostate imaging. |
Device Description: | The USHIFU Stepper is a mechanical device which is manually controlled in the horizontal and vertical directions. It is designed to allow for finite adjustments in these planes. It is composed of light-weight materials, is pre-assembled and easily attached to a surgical table. |
Comparison to the Predicate Device: | Based upon the intended use, design, and composition (materials), it can be concluded the USHIFU Stepper is substantially equivalent to the predicate device in terms of intended use, safety and effectiveness. |
:
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Mare Ryan Vice President, Regulatory Affairs USHIFU Development Company, LLC 1450 South Woodland Blvd. DELAND FL 32720
Re: K080970
Trade/Device Name: USHIFU Stepper Regulation Number: 21 CFR §892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: April 4, 2008 Received: April 4, 2008
Dear Ms. Ryan:
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 voanufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 11 your do roo is olastilia (50 such additional controls. Existing major regulations affecting your Apple rar, to they of boole of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the federal Register.
Image /page/1/Picture/10 description: The image is a circular logo with the text "FDA Centennial" and the years "1906-2006" displayed. The logo features the letters "FDA" in a stylized font, with the word "Centennial" written below. The logo is surrounded by a circular border with text and stars.
Protecting and Promoting Public Health
2
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 liasting (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 ecctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Ivgally marketed predicate device results in a classification for your device and thus, perceite 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance a one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
---|---|---|
21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
21 CFR 892:xxxx | (Radiology) | 240-276-0120 |
Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillonce at 24/0276-3474. For questions regarding the reporting of device adverse events (Medical Device Leporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may other 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) 63-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrhindustry/support/index.html i
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
3
Submitter: USHIFU, LLC
510(k) Number (if known):
Device Name:
USHIFU Stepper
Indications for Use:
The USHIFU Stepper is intended to provide support and stabilization for an ultrasonic probe during prostate imaging.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Hedin Reimer
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number