(29 days)
The IMT.LAB software is a Windows 2000/XP software application package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote Pie ultrasound systems.
The IMT.LAB software is a Windows 2000/XP software package to be used on a personal computer for the automatic measurement of the intima media thickness of the carotid artery from video images obtained from Esaote Pie ultrasound systems.
This submission focuses on establishing substantial equivalence for the IMT.LAB software, a picture archiving and communication system (PACS) intended for automatic measurement of intima media thickness (IMT) of the carotid artery from ultrasound images. The provided document does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices (SonoMetric Health's SonoCalc and Philips Medical Systems' QLAB) based on technological characteristics and intended use.
Therefore, I cannot populate a table of acceptance criteria and reported device performance from this document. The document also does not describe a standalone study with a test set, expert ground truth, adjudication methods, or MRMC comparative effectiveness study results.
Here's what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance:
- Not provided in the document. The submission focuses on substantial equivalence based on intended use and technological characteristics compared to predicate devices, not on quantitative performance metrics or specific acceptance criteria for IMT accuracy.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document does not describe a performance study with a test set.
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 provided. As there's no described performance study, there's no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided.
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 provided. The document does not describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not explicitly described as a standalone performance study with metrics. The device's "automatic measurement" function implies a standalone algorithmic capability, but no dedicated study demonstrating its performance in isolation is detailed in this submission. The comparison to predicate devices for "automatic distance measurement of the intima media thickness of an artery" is the closest information provided, but it's not a performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided.
8. The sample size for the training set:
- Not provided.
9. How the ground truth for the training set was established:
- Not provided.
Summary of available information related to performance/validation (indirectly):
The submission argues for substantial equivalence primarily by comparing the IMT.LAB software's intended use and technological characteristics to two predicate devices: SonoMetric Health's SonoCalc (K030223) and Philips Medical Systems' QLAB (K021966).
- Key shared characteristics (implying similar performance expectations):
- Intended Use: Automatic measurement of intima media thickness of the carotid artery from ultrasound video images.
- Image Source: Ultrasound images.
- Operating environment: Standalone application on a personal computer with Microsoft Windows.
- Functionality: Automatic distance measurement of the intima media thickness of an artery.
This type of 510(k) submission, particularly for software that performs automated measurements and is compared to existing devices offering similar functionality, often relies on the predicate devices having already established safety and effectiveness. The current submission's focus is on demonstrating that the new device does not introduce new questions of safety or effectiveness compared to the predicates. Specific performance metrics (accuracy, precision, etc.) and studies to prove them are not detailed in this summary.
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510(k) Summary IMT.LAB Pie Medical
JAN - 5 2005
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
Carri Graham, Official Correspondent
7992 Castleway Drive
Indianapolis, IN 46250
| Phone: | (317) 849-1916, extension 103 |
|---|---|
| Facsimile: | (317) 577-9070 |
| Contact Person: | Carri Graham |
|---|---|
| Date: | December 1, 2004 |
807.92(a)(2)
| Trade Name: | IMT.LAB software |
|---|---|
| Common Name: | Picture archiving and communications system |
| Classification Name(s): | System, Image Processing, Radiological |
| Classification Number: | 90 LLZ |
807.92(a)(3)
Predicate Device(s)
| SonoMetric Health | SonoCalc | K030223 |
|---|---|---|
| Phillips | QLAB | K021966 |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
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510(k) Summary IMT.LAB Pie Medical 807.92(a)(6)
Technological Characteristics
ESAOTE believes that IMT.LAB is substantially equivalent to the SonoMetric Health's SonoCalc product (K030223) and to the Philips Medical Systems' QLAB product (K021966)
| Characteristic | ESAOTEIMT.LABVia this Submission | SonoMetric HealthSonoCalc(K030223) | Philips MedicalSystemsQLAB (K021966) |
|---|---|---|---|
| Intended use | The IMT.LABsoftware is aWindows 2000/XPsoftware package tobe used on apersonal computerfor the automaticmeasurement of theintima mediathickness of thecarotid artery fromvideo imagesobtained fromEsaote Pieultrasound systems. | The SonoCalcsoftware is aWindows-basedapplication programused on a personalcomputer for theautomaticmeasurement of theintima mediathickness of thecarotid artery fromimages obtainedfrom ultrasoundsystems | The Q LABQuantificationsoftware is aWindows2000/Windows XPsoftware applicationpackage. It isdesigned to viewand quantify imagedata acquired onPhilips MedicalSystems ultrasoundproducts. |
| Image source | Ultrasound images | Ultrasound images | Ultrasound images |
| Operatingenvironment,system andhardware | Stand aloneapplication programfor use on apersonal computerwith MicrosoftWindows | Stand aloneapplication programfor use on apersonal computerwith MicrosoftWindows | Stand aloneapplication programfor use on a personalcomputer withMicrosoft Windows |
| Image format | DICOM, JPEG andWindows BMP | JPEG and WindowsBMP | AVI and WindowsBMP |
| Image storage andreport generation | Yes | Yes | Yes |
| Automatic distancemeasurement of theintima mediathickness of anartery | Yes | Yes | Yes |
| Classification | 90LLZ892.2050 | 90LLZ892.2050 | 90LLZ892.2050 |
| Image Compression | JPEGLoss-less | JPEGLossy | None |
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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 features a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 2005
Pie Medical % Ms. Carri Graham Consultant The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250
Re: K043360
Trade/Device Name: IMT.LAB Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ
Dated: December 1, 2004 Received: December 7, 2004
Dear Ms. Graham:
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 your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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) This icler witi anow you to organ mating of substantial equivalence of your device to a legally premaired predicated. " The PDF mailing sification 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 If you desire specifice of Compliance at 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" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 807.77). Tou may obtain curers, 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/cdrb/dsmadsmamain.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): ____________________________________________________________________________________________________________________________________________________
Device Name: IMT.LAB Software
Indications for Use:
The IMT.LAB software is a Windows 2000/XP software application I he IMT.LAD Software is a Wall omputer for the automatic measurement package to be used on a perse of the carotid artery from video images obtained from Esaote Pie ultrasound systems.
X Prescription Use (Part 21 CFR 801 Subpart D) AAD/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. degman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices V 04 93 510(k) Number __
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).