(59 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast and Testicles), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular. Applicable combined modes: B+M+PW+CW+CFM+PD. New indication: Tissue Harmonic Imaging for Cardiac.
ESAOTE's 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping, Harmonic Imaging (TEI) and Amplitude Doppler. The 7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The 7250 can drive annular array, phased, convex and linear array probes. In addition, the 7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simpson rule; specifically, it can be used to measure volumes of irregular structures since it does not require a geometrical assumption. The 7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of kev strokes. The 7250 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provide fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port. In addition, the 7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color printer, which are controlled through the keyboard.
This submission, K994369, appears to be for a 7250 Ultrasound Imaging System with the addition of a new imaging mode: Tissue Enhancement Imaging (TEI) or 2nd Harmonic Imaging Mode. The provided text is a 510(k) summary, formal FDA correspondence, and Indications for Use forms.
It is important to note that the provided document does NOT contain a study or data proving the device meets specific acceptance criteria related to its diagnostic performance (e.g., sensitivity, specificity, accuracy) for the new Tissue Enhancement Imaging mode. Instead, this document focuses on demonstrating substantial equivalence to a predicate device, primarily through technical and safety comparisons, and specifying the intended uses for the added mode.
Therefore, many of the requested sections about specific performance criteria, study design, sample sizes, and ground truth establishment cannot be extracted directly from the provided text. The submission relies on the established safety and efficacy of the predicate device and the general understanding of ultrasound technology, along with safety testing for the new mode.
Here's an attempt to answer the questions based on the available information, noting when information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided K994369 summary, there are no specific performance-based acceptance criteria (e.g., sensitivity, specificity, image quality metrics) or corresponding reported performance data for the new Tissue Enhancement Imaging mode from a diagnostic study.
The acceptance criteria implicitly referred to in this 510(k) revolve around substantial equivalence to the predicate device (Esaote 7250, K982444), particularly in terms of:
- Safety: Meeting electrical (EN60601-1) and ultrasound safety standards (Track 3 Acoustic Output Display).
- Technical Specifications: Matching or being comparable to the predicate for imaging frequencies, CFM/Doppler frequencies, biopsy guidance features, display type, digital archival capabilities, and measurement capabilities.
- Intended Use: The new mode expanding the indications for use for Cardiac applications.
While no explicit performance table is available, here's how the general comparison is presented:
| Feature/Criterion | Predicate Device (7250) | New Device (7250 with TEI) | Outcome / Equivalence |
|---|---|---|---|
| Safety - Electrical | EN60601-1 | EN60601-1 | Met (Claimed Equivalent) |
| Safety - Ultrasound | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) | Met (Claimed Equivalent) |
| Modes of Operation | 2D, M-Mode, PW, CW, CFM, Amplitude Doppler | 2D, M-Mode, PW, CW, TEI (or 2nd Harmonic), CFM, Amplitude Doppler | New TEI mode added; other modes equivalent. |
| Imaging Frequencies | 2.5, 3.5, 5.0, 7.5, 10 MHz | 2.5, 3.5, 5.0, 7.5, 10 MHz | Equivalent |
| CFM/Doppler Frequencies | 2.0, 2.5, 3.3, 5.0, 6.6 MHz | 2.0, 2.5, 3.3, 5.0, 6.6 MHz | Equivalent |
| Intended Use (Cardiac) | YES | YES (with TEI as a new mode - marked 'N' in Indications) | Expanded with new mode; other uses equivalent. |
| Biopsy Guidance | YES (General Purpose, Transrectal/Transvaginal) | YES (General Purpose, Transrectal/Transvaginal) | Equivalent |
| Probe Technology | Annular Array, Electronical Array, Bi-Scan, Doppler | Annular Array, Electronical Array, Bi-Scan, Doppler | Equivalent (for PA220E probe, specifically for Cardiac TEI) |
| Digital Archival | YES | YES | Equivalent |
| Measurements & Analysis | Cardiac, Vascular, Fetal, General Purpose | Cardiac, Vascular, Fetal, General Purpose | Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not specified in the provided document.
The document details a 510(k) submission for adding a new imaging mode (Tissue Enhancement Imaging) to an existing ultrasound system. It does not describe a clinical performance study with a "test set" in the sense of patient data used to evaluate diagnostic accuracy. The evaluation is focused on technical and safety equivalence to the predicate device.
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.
No ground truth establishment by experts is described, as no clinical performance study for diagnostic accuracy is detailed in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
No clinical performance study requiring adjudication is detailed.
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
No.
This is an ultrasound imaging device, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
This is an ultrasound imaging device, not an algorithm, and no standalone performance study is detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable.
No clinical performance study requiring a ground truth is detailed. The submission is focused on demonstrating the safety and technical comparability of the new imaging mode to the predicate device and general ultrasound standards.
8. The sample size for the training set
Not applicable.
This submission does not describe an AI or machine learning model that would require a training set.
9. How the ground truth for the training set was established
Not applicable.
This submission does not describe an AI or machine learning model that would require a training set with established ground truth.
{0}------------------------------------------------
510(k) 7250 Ultrasound Imaging System Biosound Esaote
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, Official Correspondent | ||
|---|---|---|
| 8000 Castleway Drive | ||
| Indianapolis, IN 46250 | ||
| Phone: | (317) 849-1916 | |
| Facsimile: | (317) 577-9070 | |
| Contact Person: | Colleen Hittle | |
| Date: | December 23, 1999 | |
| 807.92(a)(2) | ||
| Trade Name: | 7250 Ultrasound Imaging System (Megas)(Addition of 2nd Harmonic Imaging Mode) | |
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulsed doppler imaging systemUltrasonic pulsed echo imaging system | 892.1550892.1560 |
| Classification Number: | 90IYN90IYO | |
| 807.92(a)(3) | ||
| Predicate Device(s) | ||
| Esaote | 7250 (Megas) | K982444 |
Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.
{1}------------------------------------------------
510(k) 7250 Ultrasound Imaging System Biosound Esaote
Device Description
ESAOTE's 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler, Color Flow Mapping, Harmonic Imaging (TEI) and Amplitude Doppler. The 7250 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations.
The 7250 can drive annular array, phased, convex and linear array probes. In addition, the 7250 is equipped with a volumetric scan converter and the ability to control simultaneously two independent scan planes. This technological characteristic allows to manage Bi-Scan Probes, to obtain volumetric datasets; these datasets can then be used to display "omni-directional" 2D images (anyplane sectioning) as well as multiple parallel equidistant sections (paraplane sectioning). This Bi-Scan approach is ideal for volume computations through the Simpson rule; specifically, it can be used to measure volumes of irregular structures since it does not require a geometrical assumption.
The 7250 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of kev strokes. The 7250 offers a vast selection of calculations and measurements which can be performed quickly and easily.
The MOD.7250 is equipped with a 3.5" floppy disk drive to simplify software modifications and provide fast, cost effective system upgrades. This drive (or an optional Optical Disk Drive) can also be used for image storage. Moreover, this unit can store data directly to a Personal Computer via a LAN (Network) port.
In addition, the 7250 can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color printer, which are controlled through the keyboard.
807.92(a)(5)
Intended Use(s)
ESAOTE's Mod. 7250 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies.
{2}------------------------------------------------
510(k) Summary 7250 Ultrasound Imaging System Biosound Esaote
| 7250 (predicate) | 7250 (new mode) | |
|---|---|---|
| Electrical Safety | EN60601-1 | EN60601-1 |
| Ultrasound Safety | Track 3 (Acoustic Output Display) | Track 3 (Acoustic Output Display) |
| Intended Use | ||
| • Cardiac (Transthoracic) | YES | YES |
| • Cardiac (Transesophageal) | YES (Multiplane) | YES (Multiplane) |
| • Vascular | YES | YES |
| • Abdominal | YES | YES |
| • Fetal | YES | YES |
| • Adult Cephalic | YES | YES |
| • Neonatal Cephalic/Small organ | YES | YES |
| • Endovaginal | YES (Sagittal & Transverse Planes) | YES (Sagittal & Transverse Planes) |
| • Endorectal | YES (Sagittal & Transverse Planes | YES (Sagittal & Transverse Planes |
| Probe Technology | ||
| • Annual Array | YES | YES |
| • Electronical Array | YES | YES |
| • Bi-Scan Probes | YES | YES |
| • Doppler Probes | YES | YES |
| Modes of operation | 2D, M-Mode, PW, CW, CFM, Amplitude Doppler | 2D, M-Mode, PW, CW, TEI, CFM, Amplitude Doppler |
| Imaging Frequencies | 2.5, 3.5, 5.0, 7.5, 10 MHz | 2.5, 3.5, 5.0, 7.5, 10 MHz |
| CFM/Doppler Frequencies | 2.0, 2.5, 3.3, 5.0, 6.6 MHz | 2.0, 2.5, 3.3, 5.0, 6.6 MHz |
| Biopsy Guidance | YES | YES |
| • ABS11 & ABS13 use | General Purpose | General Purpose |
| • ABS12 use | Transrectal/transvaginal | Transrectal/transvaginal |
| • Biopsy Line Depth marker | 1 cm | 1 cm |
| • Needle guide angle | ABS11: 25-45°ABS12: fixedABS13: 30-50° | ABS11: 25-45°ABS12: fixedABS13: 30-50° |
| Display Type | SVGA | SVGA |
| Digital Archival Capabilities | YES | YES |
| VCR/Page Printer | YES | YES |
| M&A Capabilities | Cardiac, Vascular, Fetal and general purpose measurements | Cardiac, Vascular, Fetal and general purpose measurements |
·
Comparison Chart for Substantial Equivalence
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Image /page/3/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 often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2000
Colleen J. Hittle Official Correspondent Biosound Esaote, Inc. 8000 Castleway Drive Indianapolis, IN 46250
Re: K994369 7250 Ultrasound Imaging System (Addition of Tissue Enhancement Imaging) Regulatory class: II/21 CFR 892.1550 and 21 CFR 892.1560 Product Code: 90 IYN/90 IYO December 23, 1999 Dated: Received: December 27, 1999
Dear Ms. Hittle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the 7250 Ultrasound Imaging System, as described in your premarket notification:
Transducer Model Number
PA220E
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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
{4}------------------------------------------------
Page 2 - Colleen J. Hittle
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 results 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree 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 yours,
for
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal and Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Intr
Enclosure
{5}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
Mod.7250
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | See comments | ||||
| Abdominal | P | P | P | P | P | See comments | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | See Comments | |||
| Small Organ (specify) [1] | P | P | P | P | P | P | See Comments | |||
| Neonatal Cephalic | P | P | P | P | P | P | See Comments | |||
| Adult Cephalic | P | P | P | P | P | P | See Comments | |||
| Cardiac | P | P | P | P | P | See Comments | N[2] | |||
| Transesophageal | P | P | P | P | P | See Comments | ||||
| Transrectal | P | P | P | P | P | See Comments | ||||
| Transvaginal | P | P | P | P | P | See Comments | ||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | See Comments | P(3) | ||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments: [1] Small organs include Thyroid, Breast and Testicles. [2] Tissue Harmonic Imaging, [3] This unit manages Bi-scan probes for volumetric acquisitions from which any 2D tomographic image can be displayed. This unit has been previously cleared by FDA (K982444) for uses indicated as "P". Applicable combined modes: B+M+PW+CW+CFM+PD
(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)
Thiel h. Segman
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
Transducer: PA220E
| Intelluci USC. Diagnostic univasound miaging of thatMode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify) | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) [1] | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | P | P | P | P | P | P | See Comments | |||
| Cardiac | P | P | P | P | P | See Comments | N(2) | |||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaqinal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculoskeletal Superficial | ||||||||||
| Other (specify) |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N=new indication; P=previously cleared by FDA; E= added under Appendix E
Additional Comments: [2] Tissue Harmonic Imaging. This probe has been previously cleared by FDA (K982444) for uses indicated as "P". Applicable combined modes: B+M+PW+CW+CFM+PD.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED
concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 2) CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
..
§ 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.