(67 days)
The VUE 100 ultrasound system is used by or under the direction of a certified physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, and small organ applications. Small organs include Thyroid, Breast, and Testicles.
The VUE 100 is a portable ultrasound system. It is used to acquire and display real time 2D ultrasound images. Currently the system supports two mechanical sector probes, 4S2 (3MHz) and 6S4 (5MHz).
The provided text describes a 510(k) summary for the Mobilsonic VUE 100 Ultrasound Imaging System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance acceptance criteria through a dedicated study.
Therefore, many of the requested details about acceptance criteria, study methods, and performance metrics are not available in this specific regulatory submission. The 510(k) process for ultrasound systems typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed predicate device.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
Acceptance Criteria and Device Performance
Since this is a 510(k) summary focused on substantial equivalence, there are no explicit "acceptance criteria" presented in terms of quantitative performance metrics for the device itself in comparison to a benchmark. Instead, the acceptance is based on demonstrating equivalence to the predicate device, the Pie Medical 50S Tringa (K020112).
| Criterion (Implicit based on 510(k) submission) | Reported Device Performance (Mobilsonic VUE 100) |
|---|---|
| Intended Use Equivalence | Fetal, Abdominal, Pediatric, Small Organ, Peripheral Vascular applications (same as predicate for these) |
| Transducer Type Equivalence | Mechanical Sector (same as predicate) |
| Imaging Modes | 2D (predicate had 2D/M-Mode, so the VUE 100 is "less capable" in this aspect, but still considered safe and effective for its stated modes) |
| 2D Frequency MHZ (Range) | 3.0/5.0 (Predicate had 3.5/5.0/7.5) |
| Biopsy Guidance | No (same as predicate) |
| Display Type | LCD (same as predicate) |
| Monitor Size (inches) | 5.6 (Predicate had 5.4) |
| Digital Archival Capabilities | Yes (same as predicate) |
| VCR | Yes (same as predicate) |
| M&A Capabilities (Measurement & Analysis) | Fetal & Abdominal (Predicate had Cardiac, Fetal & Abdominal) |
| Electrical Safety Standards Compliance | UL 2601 (Predicate had EN60601-1, but both are recognized safety standards) |
| Ultrasound Safety Standards Compliance | Track 1 (same as predicate) |
Note: The FDA's substantial equivalence determination implies that the differences in technical characteristics (e.g., frequency range, M-Mode capability, M&A capabilities, specific electrical safety standard) do not raise new questions of safety or effectiveness.
Study Details
-
Sample size used for the test set and the data provenance:
- Not available. The document does not describe a clinical study or a test set with patient data for performance evaluation. The submission relies on technical comparison to a predicate device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not available. No ground truth establishment experts are mentioned as part of a performance study.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not available. No test set or adjudication process is described.
-
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:
- No. This device is an ultrasound imaging system, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant to this submission.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not available. This is an imaging device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not available. No performance study with ground truth data is described. The "ground truth" for this submission is the predicate device's established safety and effectiveness.
-
The sample size for the training set:
- Not applicable/Not available. As an imaging device, there isn't a "training set" in the context of an AI/ML algorithm.
-
How the ground truth for the training set was established:
- Not applicable/Not available. See point 7.
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MAY 1 7 2004
510(K) Summary VUE 100 Mobilsonic, Inc.
Section 3: 510(k) Summary
This summary of safety and effectiveness has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR807.92(a).
Submitter Information
Mobilsonic Inc. 560 Parrott Street San Jose, CA 95112 (408) 892-4309 Phone: (408) 271-0195 Fax: Bao Le Contact Person: February 18, 2004 Date:
Device Information
VUE 100 Ultrasound Imaging System Trade Name: Ultrasound Imaging System Common Name: Classification Name: Ultrasonic Pulsed Echo Imaging System (FR# 892.1560) Classification Number: 90-IYO
Predicate Device
| Company | Device Name | 510(k) Number |
|---|---|---|
| Pie Medical | 50S Tringa | K020112 |
Additional substantial equivalence information is provided in the following Comparison Chart for Substantial Equivalence.
Device Description
The VUE 100 is a portable ultrasound system. It is used to acquire and display real time 2D ultrasound images. Currently the system supports two mechanical sector probes, 4S2 (3MHz) and 6S4 (5MHz).
Intended Use(s)
The VUE 100 ultrasound system is used by or under the direction of a certified physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, and small organ applications.
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510(k) Summary VUE 100 Mobilsonic Inc.
| General Characteristics | MobilsonicVUE 100(This Submission) | Pie Medical50S Tringa(K020112) |
|---|---|---|
| Intended use | ||
| Fetal | Yes | Yes |
| Abdominal | Yes | Yes |
| Pediatric | Yes | Yes |
| Small Organ | Yes | Yes |
| Peripheral Vascular | Yes | Yes |
| Cardiac | No | Yes |
| Neonatal Cephalic | No | No |
| Adult Cephalic | No | No |
| Transesophageal | No | No |
| Transrectal | No | No |
| Transvaginal | No | No |
| Transurethral | No | No |
| Intravascular | No | No |
| Musculoskeletal | No | No |
| Transducer type | ||
| Mechanical Sector | Yes | Yes |
| Linear | No | No |
| Convex | No | No |
| 2D Freq MHZ | 3.0/5.0 | 3.5/5.0/7.5 |
| CFM/Doppler Freq MHZ | N/A | N/A |
| Biopsy Guidance | No | No |
| Display type | LCD | LCD |
| Imaging modes | 2D | 2D/M-Mode |
| Monitor size (inches) | 5.6 | 5.4 |
| Digital archival capabilities | Yes | Yes |
| VCR | Yes | Yes |
| M&A capabilities | Fetal & Abdominal | Cardiac, Fetal &Abdominal |
| Safety | ||
| Electrical safety | UL 2601 | EN60601-1 |
| Ultrasound safety | Track 1 | Track 1 |
Comparison Chart for Substantial Equivalence
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 7 2004
Mr. Bao Le Regulatory Engineer Mobilsonic, Inc. 560 Parrott Street SAN JOSE CA 95112
Re: K040652
Trade Name: VUF 100 Ultrasound Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 1YO and ITX Dated: April 22, 2004 Received: April 26, 2004
Dear Mr. Le:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have levewed your Society of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regarly the enactment date of the Medical Device Amendments, or to commerce pror to may 20, 1775, an accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general bonanifacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial cquivalence applies to the following transducers intended for use with the VUE 100 Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
4S2 Mechanical Sector Probe (3MHz) 6S4 Mechanical Sector Probe (5MHz)
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to can adam Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I reast of devilsed that i be rise complies with other requirements of the Act or any For than antines and regulations administered by other Federal agencies. You must comply with all
{3}------------------------------------------------
the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); line Act 3 requirements, merading, but notacturing practice requirements as set forth in the quality labeling (21 CFR Part 801); good manalactaning product the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the I mis device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Information, including deousing September 30, 1997 "Information for Manufacturers Seeking Appendix O, (cherosco) of the Ocher 5 Sopted Systems and Transducers." If the special report is Marketing Citatine of Diagnoste Offices (e.g., acoustic output greater than approved levels), then moonly contains anaceopacity the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and rno special roported "ADD-TO-FILE" and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device rcsults in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please IT you desire specific ad riot for your 2017 594-4591. Additionally, for questions on the promotion contact the Office of your device, please contact the Office of Compliance at (301) 594-4639. Also, and acreentialing or your are and the by reference to premarket notification" (21 CFR Part 807.97). 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely vours,
David Ingram
fp
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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Diagnostic Ultrasound Indications for Use Form
Device Name: VUE 100 Ultrasound Imaging System
Device Name: VOE 100 oultrasound imaging of the human body as follows:
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | N | |||||||||
| Abdominal | N | |||||||||
| Intraoperative | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | N | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA Additional Comments: Small organs include Thyroid, Breast, and Testicles.
(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)
Daniel A. Byron
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devic 510(k) Number
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Diagnostic Ultrasound Indications for Use Form
Device Name: 4S2 Mechanical Sector Probe (3MHz)
Intended Use: Diagnostic ultrasound imaging of the human body as follows:
| Clinical Application | A | B | M | PWD CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||
| Fetal | N | ||||||||
| Abdominal | N | ||||||||
| Intraoperative | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ | N | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | N | ||||||||
| Laparoscopic | |||||||||
| Musculo-skeletal Conventional | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA Additional Comments: Small organs include Thyroid, Breast, and Testicles.
(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)
David G. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
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Diagnostic Ultrasound Indications for Use Form
Device Name: 6S4 Mechanical Sector Probe (5MHz)
Device Name: Dognostic ultrasound imaging of the human body as follows:
| Clinical Application | A | B | M | PWD/CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||||
| Fetal | N | ||||||||
| Abdominal | N | ||||||||
| Intraoperative | |||||||||
| Intraoperative Neurological | |||||||||
| Pediatric | |||||||||
| Small Organ | N | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Cardiac | |||||||||
| Transesophageal | |||||||||
| Transrectal | |||||||||
| Transvaginal | |||||||||
| Intravascular | |||||||||
| Peripheral Vascular | N | ||||||||
| Laparoscopic | |||||||||
| Musculo-skeletal Conventional | |||||||||
| Musculo-skeletal Superficial | |||||||||
| Other (specify) |
N = new indication; P = previously cleared by FDA N = new indioution,
(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)
David br hoppn
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 5 1 0(k) Number
§ 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.