(68 days)
The USHIFU Stepper is intended to provide support and stabilization for an ultrasonic probe during prostate imaging.
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.
Here's an analysis of the provided information, addressing your questions about acceptance criteria and the study:
The provided document is a 510(k) summary for a medical device called the "USHIFU Stepper." Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on intended use, design, and materials, rather than presenting performance data from a specific study against acceptance criteria.
Therefore, I cannot populate the table or answer most of your questions based on the provided text.
Here's what I can infer and what is missing:
Acceptance Criteria and Study Information (Not Present in Document)
| Acceptance Criteria Category | Acceptance Criteria Value | Reported Device Performance | Comments / Missing Information |
|---|---|---|---|
| Performance Metrics | Not specified | Not reported | The document does not define any quantitative or qualitative performance metrics (e.g., stability, precision, ease of use beyond simple operation). |
| Clinical Endpoints | Not specified | Not reported | No clinical endpoints are mentioned, as the device is a mechanical support, not one with diagnostic or therapeutic output. |
| Safety Endpoints | Not specified | Not reported | General safety is implied by substantial equivalence, but specific safety criteria or test results are not provided. |
| Usability/Usability Test | Not specified | Not reported | No usability criteria or testing is detailed. |
Study Details (Information Not Present in Document)
1. Sample sized used for the test set and the data provenance:
Not available. The document does not describe any specific test set or clinical study.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not available. No study or ground truth establishment is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not available. No study or adjudication method is described.
4. 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/Not available.
- The device is a mechanical support for an ultrasonic probe, not an AI device.
- Therefore, an MRMC study comparing human readers with/without AI assistance would not be relevant to this device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable/Not available.
- The device is a mechanical support, not an algorithm.
- No standalone performance testing of an algorithm is described.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not available. No study or ground truth establishment is described.
7. The sample size for the training set:
Not available. The device is a mechanical device, not an AI model, so the concept of a "training set" is not applicable in this context.
8. How the ground truth for the training set was established:
Not applicable/Not available. The device is a mechanical device, not an AI model, so the concept of establishing ground truth for a training set is not applicable.
Summary of the USHIFU Stepper 510(k)
The K080870 submission for the USHIFU Stepper is a Traditional 510(k), which aims to demonstrate substantial equivalence to a previously legally marketed device (the predicate device: K843573, Super Scan/Biopsy Guide, CIVCO).
The core argument for substantial equivalence is based on:
- Intended Use: Both devices are for supporting and stabilizing an ultrasonic probe during prostate imaging.
- Design: Both are mechanical devices allowing for adjustments. The USHIFU Stepper is described as manually controlled in horizontal and vertical directions, allowing for finite adjustments.
- Composition/Materials: Both are composed of light-weight materials, pre-assembled, and easily attached to a surgical table (implied for the predicate as well, given the equivalence claim).
The FDA's review concluded that the device is substantially equivalent, allowing it to be marketed. This type of submission generally does not require new clinical studies or detailed performance testing against acceptance criteria if substantial equivalence can be demonstrated through comparison to a predicate device with similar technological characteristics and intended use. The 510(k) process often relies on existing data or widely accepted engineering principles to demonstrate safety and effectiveness for devices that are similar to those already on the market.
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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. |
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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
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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
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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
N/A