(134 days)
The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.
The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.
The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.
The provided 510(k) summary for the VPan Module to the TechnosMP Ultrasound Imaging System does not contain a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial with performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative image quality scores). It relies on a comparison to a predicate device.
The "Comparison Chart for Substantial Equivalence" serves as the primary "acceptance criteria" by showing the new device functions similarly to the predicate.
| Feature / Criterion | Predicate Device (Acuson Sequoia 512 FreeStyle Extended Imaging Software K022567) | Subject Device (Esaote Technos/TechnosMp VPan Module) |
|---|---|---|
| Scanning Method | Manual movement of probe across anatomy to be imaged | Manual movement of probe across anatomy to be imaged |
| Intended Use | Provides panoramic, wide field-of-view images for easier orientation of anatomy & pathology | Provides panoramic, wide field-of-view images for easier orientation of anatomy & pathology |
| Measurements | X, Y Linear distances | X, Y Linear distances |
| Image Manipulation | Pan / zoom / rotate | Pan / zoom / rotate |
| Transducer Types | All general imaging transducers | Convex / Linear / Phased Array |
| Image Format | Spliced B-mode | Spliced B-mode |
Reported Device Performance: The document states that the VPan Module (the subject device) "provides panoramic, wide field-of-view images for easier orientation of anatomy and pathology." The implicit performance is that it performs these functions equivalently to the predicate device. No quantitative performance metrics are provided.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a test set or data provenance for a performance study. Clinical data is not typically required for 510(k) submissions that demonstrate substantial equivalence through comparison to predicate devices, especially for devices like this that are modifications or additions to existing ultrasound systems. The focus is on technical characteristics and intended use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
Not applicable. No ground truth establishment for a test set is described as there isn't a performance study evaluating diagnostic capabilities against a reference standard.
4. Adjudication Method for the Test Set
Not applicable. No test set or independent adjudication is described.
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 an ultrasound imaging module, not an AI or CAD (Computer-Aided Detection) system. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an imaging module, not an algorithm, so standalone performance is not relevant in this context.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no performance study described that would require establishing a ground truth. The submission relies on demonstrating the new module's technical similarity and equivalent intended use to the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is an ultrasound imaging module, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned or implied.
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510(k) Addition of VPan Module to TechnosMP Ultrasound Imaging System Biosound Esaote
FEB 1 1 2003
510(k) Summary
The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).
807.92(a)(1)
Submitter Information
| Colleen Hittle Densmore, Official Correspondent | ||
|---|---|---|
| 8000 Castleway Drive | ||
| Indianapolis, IN 46250 | ||
| Phone: | (317) 849-1916 | |
| Facsimile: | (317) 577-9070 | |
| Contact Person: | Colleen Hittle Densmore | |
| Date: | January 15, 2003 | |
| 807.92(a)(2) | ||
| Trade Name: | Technos MP Ultrasound Imaging System(Addition of VPan Module) | |
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulsed doppler imaging system | 892.1550 |
| Classification Number: | 90IYN90IYO | |
| 807.92(a)(3) | ||
| Predicate Device(s) | ||
| Esaote | AU6 (Technos/TechnosMP) | K014168 |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
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510(k) Addition of VPan Module to Technos \10 Ultrasound Imaging System Biosound Esaote
807.92(a)(5)
Intended Use(s)
The VPan (View Panoramic) Module is being added to the Technos™ ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.
The Technos™ ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.
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510(k) Summary Addition of VPan Module to
Technos`ll Ultrasound Imaging System Biosound Esaote
Comparison Chart for Substantial Equivalence
| AcusonSequoia 512FreeStyle ExtendedImaging SoftwareK022567 | EsaoteTechnos/TechnosMpVPan ModuleThis Submission | |
|---|---|---|
| Scanning Method | Manual movement of probeacross anatomy to beimaged | Manual movement of probeacross anatomy to beimaged |
| Intended Use | Provides panoramic, widefield-of-view images foreasier orientation ofanatomy & pathology | Provides panoramic, widefield-of-view images foreasier orientation ofanatomy & pathology |
| Measurements | X, Y Linear distances | X, Y Linear distances |
| Image Manipulation | Pan / zoom / rotate | Pan / zoom / rotate |
| Transducer types | All general imagingtransducers | Convex / Linear / PhasedArray |
| Image Format | Spliced B-mode | Spliced B-mode |
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2003
Ms. Colleen Densmore Official Correspondent Biosound Esaote, Inc. 8000 Castleway Drive INDIANAPOLIS IN 46250 Re: K023255
Trade/Device Name: Technos MP Ultrasound Imaging System Addition of VPan Module Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYN and IYO Dated: January 15, 2003 Received: January 16, 2003
Dear Ms. Densmore:
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 vour 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
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Indications for Use
510(k) Number (if known): 1023 255-8
Device Name:
Indications for Use:
The VPan (View Panoramic) Module is being added to the TechnosMP ultrasound imaging system to provide panoramic, wide field-of-view images for easier orientation of anatomy and pathology.
The Technost 10 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vascular, fetal, pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic, other-urological and musculoskeletal applications.
Prescription Use
David A. Seayom
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.