(16 days)
No
The document describes standard ultrasound imaging modes, measurement tools, and image processing techniques common to ultrasound systems. There is no mention of AI, ML, or any features that would typically indicate the use of such technologies for image analysis, interpretation, or workflow optimization beyond conventional methods.
No
The device is described as a "diagnostic ultrasound imaging or fluid flow analysis" system, and its function is to "acquire ultrasound data and to display the data" for "clinical diagnostic purposes." There is no mention of treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Additionally, the "Device Description" identifies the SA 9900 scanner as a "general purpose, mobile, software controlled, diagnostic ultrasound system" and mentions its use for "clinical diagnostic purposes."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions various hardware components like transducers, a control panel, and probes. While it is software-controlled, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the SA 9900 scanner is a diagnostic ultrasound system. It uses ultrasound waves to create images of internal structures of the human body.
- Intended Use: The intended use describes imaging and fluid flow analysis of the human body, not analysis of samples taken from the body.
- Device Description: The description focuses on the hardware and software used to generate and display ultrasound images and perform measurements based on those images. There is no mention of analyzing biological samples.
Therefore, the SA 9900 scanner is a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SA9900 intended uses as defined FDA guidance documents are:
- Fetal (including infertility monitoring of follicle development)
- Abdominal
- Intra-operative (Abdominal, Vascular)
- Intra-operative (Neurological)
- Pediatric
- Small Organ
- Neonatal Cephalic
- Adult Cephalic
- Trans-rectal
- Trans-vaginal
- Trans-esophageal (Non cardiac, Cardiac)
- Muscular-skeletal (Conventional, Superficial)
- Cardiac (Adult, Pediatric)
- Peripheral-vascular
Typical examinations performed using the system are:
- General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies.
- Study of small parts including breasts, shoulders, thyroid, and the abdominal wall.
- Pediatric scans of organs and bony structures.
- Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- Monitoring procedures for infertility studies (other than in vitro fertilization).
- First, second and third trimester pregnancy studies.
- Prostate, prostate biopsy guidance, and rectal wall studies.
- Neonatal head studies.
- Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
- Cardiac studies in adults and children.
- Biopsy guidance for tissue or fluid sampling.
- Conventional podiatry scans.
- Intra-operative application including soft tissue structures.
DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) |
|---|---|
| Ophthalmic | B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other* (Spec.) |
| Fetal Imaging & Other (Fetal (See Note 3)) | B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other* (Spec.) |
| Abdominal | B, M, PWD, CWD, Color Doppler*, Combined* (Spec.), Other* (Spec.) |
| Intra-operative (See Note 6) | N, N, N, N, N, Note 1, Notes 2, 7, 8 |
| Intra-operative (Neuro.) | N, N, N, N, N, Note 1, Note 8 |
| Laparoscopic | P, P, P, P, P, Note 1, Notes 2, 7, 8 |
| Pediatric | P, P, P, P, P, Note 1, Notes 2, 8 |
| Small Organ (See Note 5) | P, P, P, P, P, Note 1, Notes 7, 8 |
| Neonatal Cephalic | P, P, P, P, P, Note 1, Notes 7, 8 |
| Adult Cephalic | P, P, P, P, P, Note 1, Notes 7, 8 |
| Trans-rectal | P, P, P, P, P, Note 1, Notes 2, 8 |
| Trans-vaginal | P, P, P, P, P, Note 1, Notes 2, 8 |
| Trans-esoph. (non-Cardiac) | N, N, N, N, N, Note 1 (N), Notes 7, 8 (N) |
| Musculo-skel. (Convent.) | P, P, P, P, P, Note 1, Notes 2, 8 |
| Musculo-skel. (Superfic.) | P, P, P, P, P, Note 1, Notes 2, 8 |
| Cardiac Adult | P, P, P, P, P, Note 1, Notes 4, 7, 8 |
| Cardiac Pediatric | P, P, P, P, P, Note 1, Notes 4, 7, 8 |
| Trans-esophageal (Cardiac) | N, N, N, N, N, Note 1 (N), Notes 7, 8 (N) |
| Peripheral vessel | P, P, P, P, Note 1, Note 8 |
Notes:
N= new indication; P= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Color Amplitude Doppler (P) (Also includes CWD/Color Doppler, CWD/Power Doppler)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppyler (P)
Note 2: Includes imaging for guidance of biopsy (P)
Note 3: Includes infertility monitoring of follicle development (P)
Note 4: Color M-mode (P)
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patient
Note 6: Abdominal organs and peripheral vessel (P)
Note 7: Tissue Harmonic Imaging (THI) (P)
Note 8: 3D Imaging (P)
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT for MPT4-7AL /4.0-7.0 MHz/Phased Array Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) |
|---|---|
| Trans-esoph. (non-Cardiac) | N, N, N, N, N, Note 1 (N), Notes 7, 8 (N) |
| Trans-esophageal (Cardiac) | N, N, N, N, N, Note 1 (N), Notes 7, 8 (N) |
Notes:
N= new indication; P= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Color Amplitude Doppler
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppyler (P)
Note 2: Includes imaging for guidance of biopsy (P)
Note 3: Includes infertility monitoring of follicle development (P)
Note 4: Color M-mode (P)
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P)
Note 6: Abdominal organs and peripheral vessel (P)
Note 7: Tissue Harmonic Imaging (THI) (P)
Note 8: 3D Imaging
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT for CL4-8EV/4.0-8.0 MHz/Curved Linear Array Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) |
|---|---|
| Intra-operative (Abdominal, vascular) | N, N, N, N, N, Note 1, Notes 2, 7, 8 |
| Intra-operative (Neuro.) | N, N, N, N, N, Note 1, Notes 8 |
Notes:
N= new indication; P= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Color Amplitude Doppler
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Dopppler (P)
Note 2: Includes imaging for guidance of biopsy (P)
Note 3: Includes infertility monitoring of follicle development (P)
Note 4: Color M-mode (P)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P)
Note 6: Abdominal organs and peripheral vessel (P)
Note 7: Tissue Harmonic Imaging (THI) (P)
Note 8: 3D Imaging
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT for LI5-9EV/5.0-9.0 MHz/Linear Array Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) |
|---|---|
| Intra-operative (Abdominal, vascular) | N, N, N, N, N, Note I, Notes 2, 7, 8 |
| Intra-operative (Neuro.) | N, N, N, N, N, Note I, Notes 8 |
Notes:
N= new indication; P= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Color Amplitude Doppler
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Dopppler (P)
Note 2: Includes imaging for guidance of biopsy (P)
Note 3: Includes infertility monitoring of follicle development (P)
Note 4: Color M-mode (P)
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P)
Note 6: Abdominal organs and peripheral vessel (P)
Note 7: Tissue Harmonic Imaging (THI) (P)
Note 8: 3D Imaging
Product codes
90-IYO, 90-IYN, 90-ITX
Device Description
The SA 9900 scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Continuous (CW) Doppler, Pulsed (PW) Doppler, Power Doppler, and 3D imaging or as a combination of these modes. The SA 9900 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. All modes of operation have been previously cleared in 510(k) K002185. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals. The control panel has not changed from the description in the SA9900 Ultrasound System Operator's Manual, submitted in the 510(k) Special Report, Add-to-File for K002185.
Various different models of transducers are available and any four may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function.
The SA-9900 uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal. The same clinical uses were cleared for the predicate device, SA8800/HD11500 (K974269)
The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, ICA/CCA ratio, Volume flow).
Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method which has its images flow from the right to the left on the monitor. The SA9900 supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-ofinterest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Intra-operative (Abdominal, Vascular, Neurological), Pediatric, Small Organ (thyroid, breast, scrotum and penis), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (Non cardiac, Cardiac), Muscular-skeletal (Conventional, Superficial), Cardiac (Adult, Pediatric), Peripheral-vascular, Ophthalmic.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Competent health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K012867
SA9900 Ultrasound System
SEP 1 2 2001
ATTACHMENT 1(b) 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) .
Gary J. Allsebrook (510) 276-2648 Regulatory Affairs Regulatory Management Services. 16303 Panoramic Way San Leandro CA 94578-1116 Telephone: (510) 276-2648 Facsimile: (510) 276-3559
Prepared: March 6, 2001
Name of the device, including the trade or proprietary name if applicable, the common or 2) usual name, and the classification name, if known:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories Multiplane Transesophageal Ultrasound Transducer Intra-operative Ultrasound Transducer
Proprietary Name:
SonoAce 9900 Diagnostic Ultrasound System and Transducers. Multiplane Transesophageal Ultrasound Transducer (MPT4-7AL) Intra-operative Ultrasound Transducers (LI5-9EV, CL4-8EV)
| Classification Names: | FR Number | Product Code |
|---|---|---|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Ultrasonic Pulsed Doppler Imaging System | 892.1550 | 90-IYN |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
Identification of the predicate or legally marketed device: 3)
Medison believes that the SA9900 Ultrasound system are substantially equivalent to the currently marketed SA8800/HDI1500 System (K974269).
1
4) Device Description:
The SA 9900 scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, System. Its fancinous (CW) Doppler, Pulsed (PW) Doppler, Power Doppler, and 3D imaging or as a combination of these modes. The SA 9900 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. All modes of operation have been previously cleared in 510(k) K002185. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals. The control panel has not changed from the description in the SA9900 Ultrasound System Operator's Manual, submitted in the 510(k) Special Report, Add-to-File for K002185.
Various different models of transducers are available and any four may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function.
The SA-9900 uses digital beamforming technology, and supports a variety of Linear, Convex, Phased Array and Static probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal. The same clinical uses were cleared for the predicate device, SA8800/HD11500 (K974269)
The system can be used to measure distances and calculate areas, circumferences and volumes, as well as calculate the expected date of delivery by using BPD (biparietal diameter), OFD (occipitofrontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), LMP (last menstural period.), Cardiac Analysis (volume by area/length, Simpson biplane and single plane, M-mode analysis, Doppler: peak and mean gradients, pressure half time, E/A ratio and continuity equation) and Vascular Analysis (resistive index, pulsatility index, % stenosis, ICA/CCA ratio, Volume flow).
Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. M-mode uses the scroll display method which has its images flow from the right to the left on the monitor. The SA9900 supports the Cine function (capable of storing up to 256 sequential images) and real-time zoom function to the region-ofinterest. The system provides the ability to perform remote viewing of images, without compression, via a DICOM 3.0 compatible output. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
2
The SA9900 has been designed to meet the following electromechanical safety standards:
- EN 60601-1 (IEC 60601-1.) European Norm, Medical Electrical Equipment r
- UL 2601-1, Underwriters Laboratories Standards, Medical Electrical Equipment ،
- C22.2 No. 601.1, Canadian Standards Association, Medical Electrical Equipment ၊
- CEI/IEC 61157:1992. International Electrotechnical Commission, Requirements for the . declaration of the acoustic output of medical diagnostic ultrasonic equipment
- EN 60601-1-2 (IEC 60601-1-2,) European Norm, Collateral Standard: Electromagnetic = Compatibility
- Compliant with the European Medical Device Directive Certificate issued by TUV. เ
Intended Use: 5)
SA9900 intended uses as defined FDA guidance documents are:
- Fetal (including infertility monitoring of follicle development) (
- ( Abdominal
- { Intra-operative (Abdominal, Vascular)
- ( Intra-operative (Neurological)
- { Pediatric
- ( Small Organ
- { Neonatal Cephalic
- ( Adult Cephalic
- ( Trans-rectal
- く Trans-vaginal
- ( Trans-esophageal (Non cardiac, Cardiac)
- ( Muscular-skeletal (Conventional, Superficial)
- { Cardiac (Adult, Pediatric)
- ( Peripheral-vascular
Typical examinations performed using the system are:
- ( General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies.
- { Study of small parts including breasts, shoulders, thyroid, and the abdominal wall.
- ( Pediatric scans of organs and bony structures.
- ( Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
- ( Monitoring procedures for infertility studies (other than in vitro fertilization).
- { First, second and third trimester pregnancy studies.
- ( Prostate, prostate biopsy guidance, and rectal wall studies.
- { Neonatal head studies.
- ( Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
- { Cardiac studies in adults and children.
- ( Biopsy guidance for tissue or fluid sampling.
510(k) Summary of Safety and Effectiveness
3
- く Conventional podiatry scans.
- Intra-operative application including soft tissue structures. く
Technological Characteristics: 6)
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 a 2D and M-mode, Continuous wave Doppler, Spectral Doppler, Color Doppler, Power Doppler, 3D images. Transducer patient contact materials are biocompatible.
The device's acoustic output limits are:
All Applications:
| (Maximum Range) | |
|---|---|
| ISPTA | 720 mW/cm2 |
| MI | 1.9 |
The limits are the same as predicate Track 3 devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2001
Medison America, Inc. % Mr. Mark Job Program Manager TUV Product Service, Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891
Re: K012867
Trade Name: SonoAce SA-9900 Diagnostic Ultrasound System Regulatory Class: II/21CFR 892.1550 Product Code: 90 IYN Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: August 24, 2001 Received: August 27, 2001
Dear Mr. Job:
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 SonoAce SA-9900 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
MPT4-7AL/4.0-7.0 MHz/Phased Array CL4-8EV/4.0-8.0 MHz/Curved Linear Array L15-9EV/5.0-9.0 MHz/Linear 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
5
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) 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 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 regulations.
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, 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 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".
6
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David h. hyam
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
7
510(k) Premarket Notification MPT4-7AL, CL4-8EV, LI5-9EV Transducers
4.3 INDICATIONS FOR USE
DIAGNOSTIC ULTRASOUND INDICATIONS STATEMENT
510(k) No.:
SA9900 Ultrasound System System:
SA7700 Onlasound Byeten.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow Intended Use:
| Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Clinical Application | |||||||
| Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | ||||||||
| Ophthalmic | P | P | P | P | P | Note 1 | Notes 2, 7, 8 | |
| Fetal Imaging | ||||||||
| & Other | Fetal (See Note 3) | P | P | P | P | P | Note 1 | Notes 2, 7, 8 |
| Abdominal | P | P | P | P | P | Note 1 | Notes 2, 7, 8 | |
| Intra-operative (See Note 6) | N | N | N | N | N | Note 1 | Notes 2, 7, 8 | |
| Intra-operative (Neuro.) | N | N | N | N | N | Note 1 | Notes 8 | |
| Laparoscopic | P | P | P | P | P | Note 1 | Notes 2, 7, 8 | |
| Pediatric | P | P | P | P | P | Note 1 | Notes 2, 8 | |
| Small Organ (See Note 5) | P | P | P | P | P | Note 1 | Notes 7, 8 | |
| Neonatal Cephalic | P | P | P | P | P | Note 1 | Notes 7, 8 | |
| Adult Cephalic | P | P | P | P | P | Note 1 | Notes 7, 8 | |
| Trans-rectal. | P | P | P | P | P | Note 1 | Notes 2, 8 | |
| Trans-vaginal | P | P | P | P | P | Note 1 | Notes 2, 8 | |
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | N | N | N | N | N | Note 1 (N) | Notes 7, 8 (N) | |
| Musculo-skel. (Convent.) | P | P | P | P | P | Note 1 | Notes 2, 8 | |
| Musculo-skel. (Superfic.) | P | P | P | P | P | Note 1 | Notes 2, 8 | |
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | Note 1 | Notes 4,7, 8 |
| Cardiac Pediatric | P | P | P | P | P | Note 1 | Notes 4,7, 8 | |
| Trans-esophageal (Cardiac) | N | N | N | N | N | Note 1 (N) | Notes 7, 8 (N) | |
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | Note 1 | Note 8 | |
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Color Amplitude Doppler (P)
Color Doppler meludes Color Ampinade Doppier, CWD/Color Doppler, CWD/Power Doppler (P)
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppyler (P
Note 2: Includes imaging for guidance of biopsy (P)
Note 3: Includes infertility monitoring of follicle development (P)
Note 4: Color M-mode (P)
Note 4: Color Mi-inoue (r)
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patient
Note 6: Abdominal organs and peripheral vessel (P)
Note 7: Tissue Harmonic Imaging (THI) (P)
Note 8: 3D Imaging (P)
Concurrence of CDRH, Office of Device Evaluation (ODE) fescription Use (Per 21 CFR 801.109)
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012867
8
510(k) Premarket Notification MPT4-7AL, CL4-8EV, LI5-9EV Transducers
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No.: SA9900 Ultrasound System System: MPT4-7AL /4.0-7.0 MHz/Phased Array Transducer: MI X4 Title Free To Timaging or fluid flow analysis of the human body as follows: Intended Use:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging | |||||||||
| & Other | Fetal (See Note 3) | ||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal, | |||||||||
| vascular) | |||||||||
| Intra-operative (Neuro.) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | N | N | N | N | N | Note 1 (N) | Notes 7, 8 (N) | ||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal (Cardiac) | N | N | N | N | N | Note 1 (N) | Notes 7, 8 (N) | ||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Color Amplitude Doppler
Color Dopper Includes Color Ampiliaat Doppier
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Doppyler (P)
Note 2: Includes imaging for guidance of biopsy (P)
Note 3: Includes infertility monitoring of follicle development (P)
Note 4: Color M-mode (P)
Note 4: "Color M-nioue (1)
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P)
Note 6: Abdominal organs and peripheral vessel (P)
Note 7: Tissue Harmonic Imaging (THI) (P)
Note 8: 3D Imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
David G. Blynn
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K512867
9
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) No.: System: SA9900 Ultrasound System CL4-8EV/4.0-8.0 MHz/Curved Linear Array Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| (Track I only) | (Tracks I & III) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal (See Note 3) | |||||||||
| Abdominal | |||||||||
| Intra-operative (Abdominal, | |||||||||
| vascular) | N | N | N | N | N | Note 1 | Notes 2, 7, 8 | ||
| Intra-operative (Neuro.) | N | N | N | N | N | Note 1 | Notes 8 | ||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | |||||||||
| Small Organ (See Note 5) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Cardiac) | |||||||||
| Musculo-skel. (Convent.) | |||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185; E= added under Appendix E Additional Comments:
Color Doppler includes Color Amplitude Doppler
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Dopppler (P)
Note 2: Includes imaging for guidance of biopsy (P)
Note 3: Includes infertility monitoring of follicle development (P)
Note 4: Color M-mode (P)
Note 5: For example: thyroid, parathyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P)
Note 6: Abdominal organs and peripheral vessel (P)
Note 7: Tissue Harmonic Imaging (THI) (P)
Note 8: 3D Imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
David G. Simpson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012867
10
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT
510(k) Number: System: SA9900 Ultrasound System LI5-9EV/5.0-9.0 MHz/Linear Array Transducer: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation (*includes simultaneous B-mode) | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler* | Combined* | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal (See Note 3) | ||||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal, | ||||||||
| vascular) | N | N | N | N | Note I | Notes 2, 7, 8 | ||
| Intra-operative (Neuro.) | N | N | N | N | N | Note I | Notes 8 | |
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (See Note 5) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Cardiac) | ||||||||
| Musculo-skel. (Convent.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (Cardiac) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA in K002185; E= added under Appendix E
Additional Comments:
Color Doppler includes Color Amplitude Doppler
Note 1: PWD/Color Doppler, PWD/Power Doppler, CWD/Color Doppler, CWD/Power Dopppler (P)
Note 2: Includes imaging for guidance of biopsy (P)
Note 3: Includes infertility monitoring of follicle development (P)
Note 4: Color M-mode (P)
Note 5: For example: thyroid, breast, scrotum and penis in adult, pediatric and neonatal patients (P)
Note 6: Abdominal organs and peripheral vessel (P)
Note 7: Tissue Harmonic Imaging (THI) (P)
Note 8: 3D Imaging
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)
David to. Legnon