(29 days)
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients. (thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
The UltraVision 2 is a portable Diagnostic Ultrasound System which applies the latest technologies to produce optimal images. Various image parameter adjustments, a 15 inch high resolution display, and custom probes are configured to provide clear and stable images. It operates in B-mode and.
Here's an analysis of the provided text regarding acceptance criteria and the study proving device performance:
Unfortunately, the provided FDA 510(k) summary for the UltraVision 2 Diagnostic Ultrasound System does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for an AI/ML medical device submission.
This document is a 510(k) premarket notification for a traditional diagnostic ultrasound system, not an AI/ML-powered device. Therefore, the type of performance metrics, clinical study design, and ground truth establishment you're asking about are not present in this specific regulatory submission.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Siemens Acuson S2000 Ultrasound System). This is a common pathway for traditional medical devices, where the new device is shown to be as safe and effective as a legally marketed device without necessarily presenting novel clinical performance studies against specific acceptance criteria.
Let's break down why your requested information isn't fully available and what is described:
Based on the provided document, here's what can be inferred and what is missing or not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense for AI/ML performance. This document does not present specific quantitative performance metrics (e.g., sensitivity, specificity, AUC) with corresponding acceptance criteria because it's not a clinical performance study of an AI/ML algorithm.
- The "performance" being demonstrated is the substantial equivalence to a predicate diagnostic ultrasound system based on shared technological characteristics and safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical test set is described. The assessment is based on demonstrating that the UltraVision 2 "uses the same fundamental scientific technologies as the predicate device" and passes non-clinical safety standards.
3. 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 Applicable. There is no clinical test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set.
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 is not an AI-assisted device. No MRMC study was conducted or described. The document explicitly states: "Clinical Test: Clinical testing not required."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. Not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No specific ground truth is established for clinical performance as clinical testing was not required for this 510(k). The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. No training set for AI/ML.
What the document does say about "acceptance criteria" and "proof":
The "proof" for the device meeting regulatory requirements in this 510(k) comes from demonstrating:
- Substantial Equivalence: The primary "acceptance criterion" is that the UltraVision 2 Diagnostic Ultrasound System is substantially equivalent to the legally marketed predicate device (Siemens Acuson S2000 Ultrasound System, K081148) in terms of intended use, technological characteristics, and safety profiles.
- Evidence for Substantial Equivalence:
- Similar Intended Use: Both are diagnostic ultrasound systems. The UltraVision 2's applications (small parts: thyroid, breast, testicles, and superficial musculoskeletal diagnosis) are a subset of the predicate's broader applications but still within its scope.
- Similar Operating Principles: Both transmit ultrasonic energy, process echoes, and display images. Both use LCDs, hand-held transducers, and have similar operating modes (B-mode explicitly mentioned for UltraVision 2, with predicate having B, C, D, M).
- Similar Transducer Technology: Both use linear transducers (HL5-10EPN for UltraVision 2, 14L5 for predicate) with comparable frequency bandwidths (5-12 MHz vs. 5-14 MHz) and number of elements (128).
- Compliance with Recognized Standards:
- IEC 60601-1 (Safety Requirements for Medical Equipment)
- IEC 60601-1-2 (EMC Requirements for Medical Equipment)
- IEC 60601-2-37 (Diagnostic Ultrasound Safety Standards)
- Acoustic output testing (per FDA guidance dated Sept 9, 2008)
- ISO 10993 (Biocompatibility - Parts 1, 5, 10). The document states: "The patient contact materials of human body surface are evaluated under ISO 10993 and determined acceptable for the specified usage of the system. Both systems have the same acceptance level for biocompatibility."
- Evidence for Substantial Equivalence:
The key "differences" acknowledged (size and weight) are deemed not to raise new questions of safety or effectiveness.
In summary, for K150580, the "acceptance criteria" revolve around established safety standards and demonstration of technological similarity and equivalent performance to a predicate device, rather than specific clinical outcome metrics from a de novo study.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2015
Winprobe Corporation % Mr. Mark Job Responsible Third Party Official 1394 25th Street, NW BUFFALO MN 55313
Re: K150580
Trade/Device Name: Ultravision 2 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: March 6, 2015 Received: March 9, 2015
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
Indications for Use
510(k) Number (if known)
K150580
Device Name
UltraVision 2 Diagnostic Ultrasound System
Indications for Use (Describe)
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft issue of small patients, the in clincal examinations to
superticial museular skelets dissue of small parts in adult patients, superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by
a qualified physician a qualified physician.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017
See PRA Statement below.
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FOR FDA USE ONLY
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FORM FDA 3881 (1/14)
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Indications for Use Table (system)
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(specify) | |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (specify) | ||||||||
| Intra-operative (neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | N | |||||||
| Breast, Thyroid, Testes | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-cardiac) | ||||||||
| Musculo-skeletal (conventional) | ||||||||
| Musculo-skeletal (superficial) | N | |||||||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (specify) |
System: UltraVision 2 Diagnostic Ultrasound System
N = new indication; P= previously cleared by FDA
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Indication for Use Table (transducer)
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track 1 only) | Specific(Tracks 1 & 3) | B | M | PWD | CWD | ColorDoppler | Combined(specify) | Other(specify) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (specify) | ||||||||
| Intra-operative (neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (specify) | N | |||||||
| Breast, Thyroid, Testes | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-cardiac) | ||||||||
| Musculo-skeletal (conventional) | ||||||||
| Musculo-skeletal (superficial) | N | |||||||
| Intravascular | ||||||||
| Other (specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (specify) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (specify) |
Transducer: HL5-10EPN transducer for use with UltraVision 2
N = new indication; P= previously cleared by FDA
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Image /page/5/Picture/0 description: The image shows a coat of arms with a white background and a black border. In the center of the coat of arms is a red griffin holding a spear. Above the griffin is a banner with the word "imagine" written on it.
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is:
Submitter
WinProbe Corporation 11770 US Highway 1, suite 405E Palm Beach Gardens, Florida 33408 Telephone: (561)318-8367 Fax: (561)624-0914 Registration #
Official Correspondent:
Guy Scott WinProbe Corp. President Email: qscott@winprobe.com Telephone: (561)318-8367 11662 Lake Shore Place North Palm Beach, Florida 33408
Or
Rose Malchow WinProbe Corp. Quality Manager Email: rmalchow@winprobe.com Telephone: (561) 318-8367 11770 US Highway 1, suite 405E Palm Beach Gardens, Florida 33408
Date Prepared:
February 19, 2015
Device Name and Classification:
Common/Usual Name:
Diagnostic Ultrasound System
Proprietary Name:
UltraVision 2 Diagnostic Ultrasound System
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| Classification Names: | FR Number | Product Code |
|---|---|---|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX |
Predicate Device:
Siemens Acuson S2000 Ultrasound System, K081148.
Device Description:
The UltraVision 2 is a portable Diagnostic Ultrasound System which applies the latest technologies to produce optimal images. Various image parameter adjustments, a 15 inch high resolution display, and custom probes are configured to provide clear and stable images. It operates in B-mode and.
Intended Use:
This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients. (thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis.
The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician.
Effectiveness and Safety Contraindications:
Clinical Test: Clinical testing not required
Non-clinical Test:
Testing according to the following safety standards are conducted on the subject device:
-
- IEC 60601-1 Safety Requirements for Medical Equipment
-
- IEC 60601-1-2 EMC Requirements for Medical Equipment
-
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
-
- Acoustic output testing as per the FDA guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", dated September 9, 2008
-
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and delayed-type hypersensitivity
Comparison to the predicate device:
The UltraVision 2 diagnostic ultrasound system uses the same fundamental scientific technologies as the predicate device (Siemens Acuson S2000, K081148). Table 1 compares the UltraVision 2 to the predicate device with respect to indications for use, intended use, and principles of operation for the determination of substantial equivalence.
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Image /page/7/Picture/0 description: The image shows a coat of arms with a white background. In the center of the coat of arms is a red griffin holding a spear. Above the griffin is a white banner with the word "IMAGINE" written on it in red letters. The coat of arms has a black border.
| Manufacturer | WinProbe | Siemens |
|---|---|---|
| Trade Name | UltraVision 2 | Acuson S2000 |
| 510(k) Number | K081148 | |
| Product Code | IYO, ITX | IYN, IYO, ITX |
| Regulation Number | 892.1560892.1570 | 892.1550892.1560892.1570 |
| Regulation Name | Ultrasonic pulsed echo imaging system | Ultrasonic pulsed Doppler imaging system |
| Indications for Use | This diagnostic ultrasound system (UltraVision) and its transducers are intended for use in clinical examinations to evaluate differences in the echogenicity of soft tissue of small parts in adult patients, (thyroid, breast, and testicles) and for superficial muscular skeletal diagnosis.The system is for prescription use only by a trained sonographer under the direction of a qualified physician or directly by a qualified physician. | Indications for Use:The Modified S2000, S2000 ABVS Ultrasound System, is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system supports the transducers listed in the Ultrasound Indications for Use tables, including the 14L5BV for B-mode imaging of a patient's breast using an optional automatic scanning function. The device is not intended to be used as a replacement for screening mammography.The system also provides for the measurement of anatomical structures and analysis as provided in the original S2000 Ultrasound System, which provides information that is used by medical health care professionals for clinical diagnosis purposes. |
| Significant Differences | The main difference is the sizeDimensions: 400 mm (W) x 50 mm (H) x 250 mm (D)Weight: 4.5 kg | Dimensions: 623 mm (W) x 1300 mm (H) x 1103 mm (D)Weight: 166 kg |
Table 1. Predicate Device Comparison
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Image /page/8/Picture/0 description: The image is a coat of arms with a white background and a black border. In the center of the coat of arms is a red griffin holding a spear. Above the griffin is a banner with the word "IMAGISTER" written on it. The griffin is standing on its hind legs and facing to the left.
Intended Use:
The intended use and clinical applications of the UltraVision 2 system are narrowed, but still in the scope of the predicate device. Both systems are intended to be used with a conventional extracorporeal transducer. The type of transducer specified for use with the UltraVision 2 system is linear which is also used with the predicate system. A comparison of the transducers is provided in Table 2:
| HL5-10EPN(UltraVision 2) | 14L5(Acuson S2000) | |
|---|---|---|
| Type | Linear | Linear |
| FrequencyBandwidth | 5 - 12 MHz | 5 - 14 MHz |
| Applications | Breast Testes Thyroid Musculoskeletal | Breast Testes Thyroid Musculoskeletal Peripheral Vessel |
| Number ofElements | 128 | 128 |
| Modes of Operation | B | B, C, D, M |
| Array Footprint | 38.1 mm | 39 mm |
Table 2. Probe Comparison
Operating Principle and Design:
Both the UltraVision 2 and the predicate system transmit ultrasonic energy into patients then perform postprocessing of received echoes to generate on-screen displays of anatomic structures of the human body. Both systems are designed with an LCD display screen and hand-held transducers. Both systems support the same operating mode (B) and the same measurement functions for anatomic structures. The operation characteristics (installation and use, mode of operation) and the power supply are the same in both systems.
Non-clinical Test and Safety:
The UltraVision 2 system is in conformance with the standards described above which are the same or equivalent to those of the predicate device.
Biocompatibility:
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Image /page/9/Picture/0 description: The image is a coat of arms featuring a red winged lion holding a spear on a white background. The lion is standing on its hind legs and facing left. A banner with the word "Imagine" is draped behind the lion. The coat of arms has a simple shield shape with a black outline.
The patient contact materials of human body surface are evaluated under ISO 10993 and determined acceptable for the specified usage of the system. Both systems have the same acceptance level for biocompatibility.
Conclusion:
Clinical studies are not required to support substantial equivalence for these conventional ultrasound systems. In addition, as discussed in the above technological comparison, the technological characteristics of the Ultra\lision 2 system are substantially equivalent to the referenced predicate device that has been previously cleared for USA distribution.
Substantially Equivalent Determination:
By definition, a device is substantially equivalent to a predicate device has the same intended use and the same operational characteristics as the previously cleared predicate device, or the device has the same intended use and different operational characteristics in which substantial equivalency can be demonstrated in the device in comparison to the predicate device. In addition, the new device does not raise new questions regarding its safety and effectiveness as compared to the predicate device.
It is shown in this 510(k) submission that the difference between the UltraVision 2 and the predicate device does not raise any questions regarding its safety and effectiveness. The UltraVision 2, as designed and produced, is determined to be substantially equivalent to the predicate device.
§ 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.