(17 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intra-operative (Abdominal organs and vascular), Pediatric, Small Organ (breast, thyroid, testicles.), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Convent.), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
The SonoHeart™ Hand-Carried Echocardiography System is a general purpose, highly portable, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, Color Power Doppler, and 2D PowerMap™ Directional Color Power Doppler or in a combination of modes. The SonoHeart™ Hand-Carried Echocardiography System also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes.
This is a 510(k) summary for the SonoHeart™ Hand-Carried Echocardiography System, submitted to the FDA on December 3, 1999. As such, it is a declaration of substantial equivalence to predicate devices and does not contain detailed primary study data or explicit acceptance criteria for device performance as a modern AI/ML device submission would. The document focuses on technological characteristics, intended use, and equivalence to existing devices rather than a standalone performance study.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, specific ground truth types, training set sizes, and how training ground truth was established, are not provided in this 510(k) summary. This type of information is typical for new medical device submissions involving novel algorithms or AI components, which was not the case for this device from 1999.
Here's an analysis based on the provided text, highlighting what is available:
1. Table of acceptance criteria and the reported device performance
The document does not present explicit acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics. Instead, the "acceptance criteria" are implied by compliance with established medical device standards and demonstrating substantial equivalence to predicate devices. The "reported device performance" is primarily in terms of acoustic output limits, intended uses, and modes of operation, which are compared to predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | The SonoHeart™ Hand-Carried Echocardiography System is deemed substantially equivalent to the currently marketed Toshiba PowerVision 6000 (K991710), General Electric LOGIQ 500 MD (K991611), and the previously cleared SonoSite™ 180 Hand-Carried Ultrasound System (K990806 and K981505). |
| Device Description: | - Highly portable, software-controlled, diagnostic ultrasound system. - Modes of Operation: 2D, Color Power Doppler, and 2D PowerMap™ Directional Color Power Doppler or a combination of modes. - Measurement and Analysis: Ability to measure anatomical structures and offers analysis packages for clinical diagnostic purposes. - Transducer Compatibility: Designed to accept curved or linear transducers (Frequency Range: 2.0 - 7.0 MHz). |
| Compliance with Standards: | - Complies with a comprehensive list of international and national standards including EN 60601-1:1997, IEC 61000-4-4:1995, UL 2601-1:1999, CISPR11:97, ISO 10993, 21 CFR 820, and various AIUM and NEMA standards for acoustic output. - Complies with European Active Medical Device Directive (93/42/EEC) and Japanese National Standard, JIS-T-100x series. |
| Acoustic Output Limits: | - An on-screen display feature provides information on potential thermal and cavitation bioeffect mechanisms (in compliance with AIUM/NEMA, 1998). - User education program encourages ALARA principle. - Maximum ISPTA.d: 720 mW/cm² - TIS/TIB/TIC (Range): 0.1 - 4.0 - Mechanical Index (MI) Maximum: 1.9 - ISPPAd: 0 - 700 W/cm² (Range) (Stated as "same as predicate Track 3 devices"). |
| Intended Use: | Covers a broad range of applications including Fetal - OB/GYN, Abdominal, Pediatric, General Cardiac (adult and pediatric), Small Organs, Neonatal Cephalic, Intraoperative, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (conventional), and Peripheral Vessel imaging. The specific applications for each transducer model are detailed in the subsequent pages (K994096, K99096, K994096). |
| Technological Characteristics: | Operates identically to predicate devices, using piezoelectric material for ultrasound transmission and reflection, converting signals to 2D images. Doppler shift from blood flow is displayed as Color Flow or spectrum analysis. Transducer patient contact materials are biocompatible. |
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. This document does not concern a clinical study with a test set of patient data to evaluate algorithmic performance. It is a submission for substantial equivalence based on technological similarity and compliance with 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/Not provided. As there is no "test set" of images requiring ground truth establishment, this information is not relevant to this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method is mentioned as there's no clinical performance evaluation on a 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/Not provided. This device is a diagnostic ultrasound system, not an AI-powered diagnostic aide. MRMC studies are not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware and software system, not a standalone algorithm in the modern AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. No specific "ground truth" for diagnostic accuracy or performance is described in the context of a clinical study, as the submission focuses on safety and technological equivalence.
8. The sample size for the training set
- Not applicable/Not provided. The device is a traditional ultrasound system, not an AI/ML system trained on a dataset.
9. How the ground truth for the training set was established
- Not applicable/Not provided. There is no "training set" in the context of an AI/ML algorithm for this device.
{0}------------------------------------------------
DEC 2 0 1999
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
Submitter's name, address, telephone number, contact person: 1)
Michael A. Hoffman Director - Regulatory Affairs and Quality Systems SonoSite, Inc. 19807 North Creek Parkway, Suite 200 Bothell, WA 98011-8214 (425) 951 - 1297 E-mail: michael.hoffman@sonosite.com
Date prepared: November 3, 1999
Name of the device, including the trade or proprietary name if 2) applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
SonoHeart™ Hand-Carried Echocardiography System (subject to change)
Classification Names
| FR Number | Product Code | |
|---|---|---|
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Ultrasonic Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
Identification of the predicate or legally marketed device: 3)
SonoSite, Inc. believes that SonoHeart™ Hand-Carried Echocardiography System is substantially equivalent to the currently
{1}------------------------------------------------
marketed Toshiba PowerVision 6000 (K991710), and the General Electric LOGIQ 500 MD (K991611), and the previously cleared SonoSite™ 180 Hand-Carried Ultrasound System (K990806 and K981505).
Device Description: 4)
The SonoHeart™ Hand-Carried Echocardiography System is a general purpose, highly portable, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, Color Power Doppler, and 2D PowerMap™ Directional Color Power Doppler or in a combination of modes. The SonoHeart™ Hand-Carried Echocardiography System also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes.
The SonoHeart™ Hand-Carried Echocardiography System is designed to accept curved or linear transducers of the types and frequency listed in the table below. All actions affecting the performance of the transducer are activated from the main system control panel.
| Frequency Range: | 2.0 - 7.0 MHz |
|---|---|
| Transducer Types: | Linear array |
| Curved linear array |
The SonoHeart™ Hand-Carried Echocardiography System is designed to comply with the standards listed below.
| EN 60601-1:1997 | IEC 61000-4-4:1995 |
|---|---|
| CAN/CSA C22.2, No. 601.1:1998 | IEC 61000-4-5:1999 |
| UL 2601-1:1999 | CISPR11:97 |
| EN 60601-1-2:1998 | ISO 10993 |
| CEI/IEC 61157:1992 | 21 CFR 820 |
| IEC 61000-4-2:1999 | ISO 9002 |
| IEC 61000-4-3:1997 | EN 46002 |
| Standard for Real-Time Display ofThermal and Mechanical Acoustic OutputIndices on Diagnostic UltrasoundEquipment, American Institute ofUltrasound in Medicine, 1998 | Acoustic Output Measurement andLabeling Standard for DiagnosticUltrasound Equipment, AmericanInstitute of Ultrasound in Medicine,1993 |
| Acoustic Output Measurement Standardfor Diagnostic Ultrasound Equipment,NEMA UD2-1998 | European Active Medical DeviceDirective (93/42/EEC)Japanese National Standard, JIS-T-100x series |
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5) Intended Use:
The SonoHeart™ Hand-Carried Echocardiography System intended uses as defined FDA quidance documents are:
| Fetal - OB/GYN | Small Organs (breast,thyroid, testicle) | Musculo-skeletal(conventional) |
|---|---|---|
| Abdominal | Neonatal Cephalic | Cardiac (adult andpediatric) |
| Intraoperative(abdominal organs andvascular) | Trans-Rectal | Peripheral Vessel |
| Pediatric | Trans-vaginal |
Typical examinations performed using SonoHeart™ Hand-Carried Echocardiography System are:
Abdomen: This system transmits ultrasound energy into the upper and lower quadrants of the abdomen of an adult or pediatric patient to obtain 2D or Color Power Doppler images, or PowerMap™ Directional Color Power Doppler which can be used to assess the presence and extent of disease and injury.
Study of small parts and superficial structures including breasts, shoulders. thvroid, and the abdominal wall: This system transmits ultrasound energy into the superficial soft tissue structures of body to obtain 2D, Color Power Doppler, or PowerMap™ Directional Color Power Doppler images of normal structure and pathology of the breast, thyroid abdominal wall, shoulders, wrist, ankle and knee.
Pediatric scans of organs, superficial structures, and bony structures: This system transmits ultrasound energy into the abdomen, pelvis and superficial structures of pediatric patients to obtain 2D, Color Power Doppler, or PowerMap™ Directional Color Power Doppler images of the abdominal organs, great vessels, pelvic structures and pediatric hips.
General cardiac studies in adults and pediatrics: This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, Color Power Doppler, or PowerMap™ Directional Color Power Doppler images of the heart, great vessels, and jusxtaposed anatomic and pathologic structures. This can be used to assess overall cardiac performance and size, determine the presence and size of fluid around the heart and lungs, and as an aid in certain procedures (namely pericardialcentesis, and pleuralcentesis).
GYN/Infertility: This system transmits ultrasound energy into the lower abdomen or vagina of a female patient to obtain 2D or Color Power Doppler, or PowerMap™ Directional Color Power Doppler images of the reproductive system. which can be used to assess the presence and
{3}------------------------------------------------
extent of disease in the female pelvic organs, monitor ovarian follicle size, and as an aid in CVS procedures.
Obstetrics: This system transmits ultrasound energy into the abdomen or vagina of a pregnant woman to obtain 2D images of a fetus, which can be used to estimate gestational age, number and weight, and assess the presence and extent of disease and confirm viability. Color Power Doppler or PowerMap™ Directional Color Power Doppler imaging is intended for high-risk pregnant women. High risk pregnancy indications include, but are not limited to multiple pregnancy, fetal hydrops, placental abnormalities, as well as maternal hypertension, diabetes, and lupus.
Prostate: This system transmits ultrasound energy through the prostate of an adult patient to obtain 2D or Color Power Doppler, or PowerMap™ Directional Color Power Doppler images of structures, which can be used to assess the presence and extent of disease or injury.
6) Technological Characteristics:
This device operates identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as 2D images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, Color Power Doppler, and PowerMap™ Directional Color Power Doppler) are the same as predicate devices identified in item 3. Transducer patient contact materials are biocompatible.
This device conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA, 1998) for an on-screen display feature that provides information on potential thermal and cavitation bioeffect mechanisms. A user education program provides additional information so users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle.
The device's acoustic output limits are:
720 mW/cm² (Maximum) ISPTAd TIS/TIB/TIC 0.1 - 4.0 (Range) Mechanical Index (MI) 1.9 (Maximum)
All Applications:
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| ISPPAd | 0 - 700 W/cm2 (Range) |
|---|---|
| -------- | ----------------------- |
The limits are same as predicate Track 3 devices.
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Image /page/5/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an emblem consisting of three stylized human profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 1999
SonoSite, Inc. c/o Carole Stamp TUV Product Services, Inc. 175 Old Highway 8 NW New Brighton, MN 55112
K994096 Re: Trade Name: SonoHeart™ Hand-Carried Echocardiography System Requlatory Class: II Product Code: 90 IYN and 90 IYO 21 CFR 892.1550 and 1560 Dated: December 2, 1999 December 3, 1999 Received:
Dear Ms. Stamp:
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 registration, 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 SonoHeart™ Hand-Carried Echocardiography System, as described in your premarket notification:
Transducer Model Number ICT/7-4 7-4 MHz Intercavitary Transducer L7-4 MHz Linear Array C60/5-2 5-2 MHz Curved Array C15/402 MHz MCX Convex Array
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. H 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) regulation (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 In addition, the Food and Drug Administration (FDA) may requlatory action. 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 regulations.
{6}------------------------------------------------
Page 2 - Ms. Carole Stamp
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to 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 prominently marked "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 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 requlation 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 Rod Perez at (301) 594-1212.
Sincerely yours,
David A. Stegem
CAPT. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
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System: SonoHeart™ Hand-Carried Echocardiography System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging& Other | Fetal | P | P | B+M | Note 1 | |||||
| Abdominal | P | P | B+M | Note 1 | ||||||
| Intra-operative (Abdominalorgans and vascular) | P | P | B+M | Note 1 | ||||||
| Intra-operative (Neuro.) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | P | P | B+M | Note 1 | ||||||
| Small Organ (breast,thyroid, testicles.) | P | P | B+M | Note 1 | ||||||
| Neonatal Cephalic | P | P | B+M | Note 1 | ||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | P | P | B+M | Note 2 | ||||||
| Trans-vaginal | P | P | B+M | Note 1 | ||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skel. (Convent.) | P | P | B+M | Note 1 | ||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac | Cardiac Adult | P | P | B+M | Note 1 | |||||
| Cardiac Pediatric | P | P | B+M | Note 2 | ||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.) | ||||||||||
| PeripheralVessel | Peripheral vessel | P | P | B+M | Note 1 | |||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.
Note 2: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.
Prescription Use (Per 21 CFR 801.109)
Daniel A. Seymann
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number K944016
Indications For Use
Section 4.3, page 10
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SonoHeart™ Hand-Carried Echocardiography System Svstem: Transducer: ICT/7-4 7-4 MHz Intracavitary Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | P | P | B+M | Note 1 | |||
| Abdominal | ||||||||
| Intra-operative (Abdominalorgans and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast,thyroid, testicles.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | P | B+M | Note 2 | ||||
| Trans-vaginal | P | P | B+M | Note 1 | ||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic lmaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.
Note 2: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.
Prescription Use (Per 21 CFR 801,109)
David k. Seym
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices
510(k) Number K944096
{9}------------------------------------------------
SonoHeart™ Hand-Carried Echocardiography System System: Transducer: L7-4 MHz Linear Array
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | P | P | B+M | Note 1 | |||
| Abdominal | P | P | B+M | Note 1 | ||||
| Intra-operative (Abdominalorgans and vascular) | P | P | B+M | Note 1 | ||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | B+M | Note 1 | ||||
| Small Organ (breast,thyroid, testicles.) | P | P | B+M | Note 1 | ||||
| Neonatal Cephalic | P | P | B+M | Note 1 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | B+M | Note 1 | ||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | P | P | B+M | Note 2 | ||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | P | P | B+M | Note 1 | |||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.
Note 2: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.
Prescription Use (Per 21 CFR 801.109)
Vaind a. Seymm
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K944096
{10}------------------------------------------------
SonoHeart™ Hand-Carried Echocardiography System System: Transducer: C60/5-2 5-2 MHz Curved Array
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| (Track I only) | (Tracks I & III) | |||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | B+M | Note 1 | ||||||
| Abdominal | P | P | B+M | Note 1 | ||||||
| Intra-operative (Abdominalorgans and vascular) | P | P | B+M | Note 1 | ||||||
| Intra-operative (Neuro.) | ||||||||||
| Fetal Imaging& Other | Laparoscopic | |||||||||
| Pediatric | P | P | B+M | Note 1 | ||||||
| Small Organ (breast,thyroid, testicles.) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac | Cardiac Adult | P | P | B+M | Note 1 | |||||
| Cardiac Pediatric | P | P | B+M | Note 2 | ||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.) | ||||||||||
| PeripheralVessel | Peripheral vessel | |||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler. combined B and PowerMap™ Directional Color Power Doppler, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy previously cleared through 510(k) K981505.
Note 2: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and PowerMap™ Directional Color Power Doppler, 3-D Jmaging, Harmonic Imaging, and imaging for guidance of biopsy.
Prescription Use (Per 21 CFR 801.109)
Ehrich A. Sezem
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev
510(k) Number
{11}------------------------------------------------
SonoHeart™ Hand-Carried Echocardiography System System: System: - Contract Convex Array
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General(Track I only) | Specific(Tracks I & III) | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging& Other | Fetal | N | N | B+M | Note 1 | |||
| Abdominal | N | N | B+M | Note 1 | ||||
| Intra-operative (Abdominalorgans and vascular) | N | N | B+M | Note 1 | ||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | B+M | Note 1 | ||||||
| Pediatric | N | N | B+M | Note 1 | ||||
| Small Organ (breast,thyroid, testicles.) | N | N | B+M | Note 1 | ||||
| Neonatal Cephalic | N | N | B+M | Note 1 | ||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | N | N | B+M | Note 1 | ||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | N | N | B+M | Note 2 | |||
| Cardiac Pediatric | N | N | B+M | Note 2 | ||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| PeripheralVessel | Peripheral vessel | N | N | B+M | Note 1 | |||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Additional Sommoner
Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, Note 1: Other Includes Color Power Doppler, J-D Imaging, Harmonic combined B and PowelMap - Directional Octor Power Power Power Portuge of S10(k) K981505.
imaging, and Imaging Torgan Doppler, combined B and Color Power Doppler, Note 2. Other includes Oolor Fower Doppler, 3-D Imaging, 3-D Imaging, Harmonic Imaging, and imaging for guidance of biopsy.
Prescription Use (Per 21 CFR 801.109)
David M. Symm
(Division Sign-Off)
(Division Sign-C (Division Sign-Ont)
Division of Reproductive, Abdominal, ENT, and Radiological 510(k) Number
Indications For Use
Section 4.3, page 14
§ 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.