(15 days)
Not Found
No
The document describes a standard ultrasound system with various imaging modes and measurement capabilities. There is no mention of AI or ML in the intended use, device description, or any of the other sections.
No
The device is described as a "diagnostic ultrasound imaging" system used to "acquire and display high-resolution, real-time ultrasound data" for "clinical diagnostic purposes." Its intended use and description explicitly focus on imaging and measurement for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging". The "Device Description" also mentions it is a "diagnostic ultrasound system" and that its measurements "provide information used for clinical diagnostic purposes."
No
The device description explicitly states it is a "diagnostic ultrasound system" and mentions hardware components like transducers, a control panel, and an ECG cable assembly. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This describes a device that interacts directly with the patient's body to acquire images and data, not a device that analyzes samples taken from the body (which is the hallmark of an IVD).
- Device Description: The description details an ultrasound system that uses transducers to acquire real-time ultrasound data. This is consistent with in-vivo imaging, not in-vitro analysis.
- No mention of analyzing biological samples: The description focuses on imaging modes, measurements of anatomical structures, and data processing of ultrasound images. There is no mention of analyzing blood, urine, tissue, or any other biological sample.
In summary, the device is a diagnostic imaging system used for in-vivo examination of the human body, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended uses of the MicroMaxx™ High-Resolution Ultrasound System (C3 Series) as defined by FDA guidance documents, are:
Ophthalmic
Fetal - OB/GYN
Abdominal
Intra-operative (Abdominal organs and vascular)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (breast, thyroid, testicles.)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Musculo-skel. (Conventional)
Musculo-skel. (Superficial)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Peripheral vessel
Product codes
IYN, IYO, ITX
Device Description
The MicroMaxx™ High-Resolution Ultrasound System (C3 Series) is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes.
The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities.
The system includes the ability to measure the intima-media thickness (IMT) of the carolid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.
The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance.
The MicroMaxx™ High-Resolution Ultrasound System (C3 Series) 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 - 12.0 MHz
Transducer Types: Linear array, Curved array, Intracavitary array, Phased array, Static probes
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Prostate, Cranium, Arms, Legs.
Indicated Patient Age Range
Adult, Pediatric, Neonatal. Fetal imaging is also indicated.
Intended User / Care Setting
Not Found
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three curved lines representing the department's mission of promoting health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2006
Sonosite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K053069
Trade Name: MicroMaxx High-Resolution Ultrasound System (C3 Series) Regulation Number: 21 CFR 892.1550; 892.1560; 892.1570 Regulation Name: Ultrasonic Pulsed Doppler Imaging System; Ultrasonic Pulsed Echo Imaging System; Diagnostic Ultrasonic Transducer Regulatory Class: II Product Code: IYN; IYO; ITX Dated: October 29, 2005 Received: November 1, 2005
Dear Mr. Job:
This letter corrects our substantially equivalent letter of November 16, 2005.
We have reviewed your Section 510(k) premarket 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 SonoSite MicroMaxx High-Resolution Ultrasound System (C3 Series), as described in your premarket notification:
Image /page/0/Picture/12 description: The image shows a circular seal with the letters "FDA" in the center. Above the letters, the text "The" and "FDA" are visible. Below the letters, the word "Centennial" is written in cursive. The seal is surrounded by a dotted border.
ing and Promoting Public . Sealth
1
Transducer Model Number
D2/2 2.0 MHz Dual Element Circular Array; C60e/5-2 5.0-2.0 MHz Curved Array; HFL38/13-6 13.0-6.0 MHz Linear Array; SLA/13-6 13.0-6.0 MHz Linear Array; LAP/12-5 12.0-5.0 MHz Linear Array Laparoscopic; L38e/10-5 10.0-5.0 MHz Linear Array; TEE/8-3 8.0-3.0 MHz Trans-esophageal Echocardiography; SLT/10-5 10.0-5.0 MHz Linear Array; P10/8-4 8.0-4.0 MHz Phased Array; P17/5-1 5.0-1.0 MHz Phased Array
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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.
2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Ewa Czerska at (301) 594-1212.
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
| System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | N/A | ||||||||
| 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 | Color Doppler | Combined (Spec.) | |||
| Ophthalmic | Ophthalmic | N | N | N | N | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Fetal | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Abdominal | P | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1 | ||||||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-operative (Neuro.) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Fetal Imaging | |||||||||
| & Other | Laparoscopic | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Pediatric | |||||||||
| Small Organ (breast, | |||||||||
| thyroid, testicles, prostate) | P | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1 | ||||||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Adult Cephalic | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Trans-rectal | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Trans-vaginal | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | B+M; B+PWD; | ||
| B+CWD; B+CD | Note 1, 2 | ||||||||
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1, 2 | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | P | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1, 2 | ||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 |
Table 4.3- 1 Diagnostic Ultrasound Indications for Use Form - C3 System
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and inaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. Imaging to assist in the placement of needles and catheters in vascular or other analomical structures, and picture arching, communications and storage functionality were all previously cleared in K030949. An expanded intended use for imaging guidance for periously procedures was previously cleared in K033367. Includes Imaging of spinal cord to provide guidance for central nerve block procedures.
28
Note 2: PW Doppler Includes PW Tissue Doppler Imaging (TDI).
Prescription Use (Per 21 CFR 801.109)
ΤΟΙ).
Nange Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
co Radiological Devices
10(k) Number 12053069
Indications for Use
.
of 734 pages
:3
4
| System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | D2/2 2.0 MHz Dual Element Circular 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 | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Abdominal organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| 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 | ||||||
| Cardiac Pediatric | P | |||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) |
Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form - D2/2 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Note 1: All items marked "P" were previously cleared in 510(k) K043559.
Prescription Use (Per 21 CFR 801.109)
Janey C. Brogdon
(UNISION oductive, Abdominal. and Division of Rep Radiologic 510(k) Numb
5
| System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | C60e/5-2 5.0-2.0 MHz Curved 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 | Color | ||||
| Doppler | Combined | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-operative (Abdominal | |||||||||
| organs and vascular) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| & Other | Pediatric | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Small Organ (breast, thyroid, | |||||||||
| testicles, prostate) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | Peripheral vessel | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Vessel | Other (spec.) |
Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form - C60e/5-2 Transducer
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 Dopler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. Imaging to assist in the placement of needles and catherers in vascular or other senatomical structures was previously deared in 510(k) K030949. Includes imaging of spinal cord to central nerve block procedures.
Prescription Use (Per 21 CFR 801.109)
Nancy Gregon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053069
Indications for Use
29
of 734 pages
i
6
| System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | HFL38/13-6 13.0-6.0 MHz Linear Array Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined | ||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Abdominal | ||||||||
| organs and vascular) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Fetal Imaging | Intra-operative (Neuro.) | |||||||
| Laparoscopic | ||||||||
| & Other | Pediatric | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. (Superfic.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 |
Table 4.3- 8 Diagnostic Ultrasound Indications for Use Form - HFL38/13-6 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopter, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler can be combined with any imaging mode. Includes imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and an imaging guidance for peripheral neve block procedures. All items marked "P" were previously deared in 510(k) K04359. Includes Imaging of spinal cord to provide guidance for central nerve block procedures.
Prescription Use (Per 21 CFR 801.109)
Taneyl Boyden
(Division Sigh-Off)
Division Reproductive, Abcomman and Radionomical Dev
510(k) Number K053069
Indications for Use
of 734 pages 31
6
7
| System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | SLA/13-6 13.0-6.0 MHz Linear Array Transducer | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human | ||||||||
| body as follows: | |||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track I only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| (Abdominal organs and | |||||||||
| vascular) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-operative (Neuro.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Fetal Imaging | Laparoscopic | ||||||||
| & Other | Pediatric | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | ||||||||
| Small Organ (breast, | |||||||||
| thyroid, testicles.) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non- | |||||||||
| Card.) | |||||||||
| Musculo-skel. | |||||||||
| (Convent.) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Musculo-skel. | |||||||||
| (Superfic.) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Trans-esophageal | |||||||||
| (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (spec.) | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 |
Table 4.3- 4 Diagnostic Ultrasound Indications for Use Form -- SLA/13-6 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Nole 1: Other includes Color Power Doppler, combined B and Color Power Doppler, 3D Imaging, Tissue Hamonic Imaging, Tissue Frod 17 Chick Holledo Soler Portor Bopper of the Over Porter Dopper, Jo Innight, Tisset Timents Integrity, Color Doppler Lan be combined with any imaging mode
Prescription Use (Per 21 CFR 801.109)
Nancy brogen
(DIVISION Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices
510(k) Number R0530
Indications for Use
31 of 734 pages
8
Table 4.3- 13 Diagnostic Ultrasound Indications for Use Form – LAP/12-5 Laparoscopic Transducer
| System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | LAP/12-5 12.0-5.0 MHz Linear Array Laparoscopic 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 | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | ||||||||
| & Other | Laparoscopic | |||||||
| Pediatric | ||||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| 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.) | ||||||||
| Peripheral | ||||||||
| Vessel | 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 Dopler, combined B and Color Power Doppler, 3-D Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. All items marked "P" were previously cleared in 510(k) K043559.
Prescription Use (Per 21 CFR 801.109)
Haney C. Bragdon
. / \ uctive Abdomin adi 10(k)
9
| MicroMaxx™ High-Resolution Ultrasound System (C3 Series)
| System: | ||||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L38e/10-5 10.0-5.0 MHz Linear Array Transducer | |||||||
| Diagnostic ultrasound imaging or fluid flow analysis of the human | ||||||||
| Intended Use: | ||||||||
| body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track I only) | Specific | |||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Spec.) | Other | |||||||
| (Spec.) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative | ||||||||
| (Abdominal organs and | ||||||||
| vascular) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-operative (Neuro.) | ||||||||
| Fetal Imaging | Laparoscopic | |||||||
| & Other | Pediatric | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| Small Organ (breast, | ||||||||
| thyroid, testicles) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non- | ||||||||
| Card.) | ||||||||
| Musculo-skel. | ||||||||
| (Convent) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Musculo-skel. | ||||||||
| (Superfic.) | P | P | P | P | B+M; B+PWD; | |||
| B+CD | Note 1 | |||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac | Cardiac Pediatric | |||||||
| Trans-esophageal | ||||||||
| (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral | Peripheral vessel | P | P | P | P | B+M; B+PWD; | ||
| B+CD | Note 1 | |||||||
| Vessel | Other (spec.) |
Table 4.3- 5 Diagnostic Ultrasound Indications for Use Form - L38e/10-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, 3-0 Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode. Includes imaging to assist in the placement of needles and catherers in vascular or other analomical structures and imaging guidance for peripheral neve block procedures. Includes imaging of spinal cord to provide guidance for central nerve block procedures.
Prescription Use (Per 21 CFR 801 109)
Darcy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Indications for Use
of 734 pages 32
: : .
10
Table 4.3- 6 Diagnostic Ultrasound Indications for Use Form - TEE/8-3 Trans-Esophageal Echocardiography Transducer
| System: | MicroMaxx™ High-Resolution Ultrasound System (C3 series) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | TEE/8-3 8.0-3.0 MHz Trans-esophageal Echocardiography Transducer | |||||||||
| Intended Use: | ||||||||||
| as follows: | Diagnostic ultrasound imaging or fluid flow analysis of the human body | |||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | ||||||||||
| (Track I | ||||||||||
| only) | ||||||||||
| Ophthalmic | Specific | |||||||||
| (Tracks I & III) | ||||||||||
| Ophthalmic | B | M | PWD | CWD | Color | |||||
| Doppler | Combined | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative | ||||||||||
| (Abdominal organs and | ||||||||||
| vascular) | ||||||||||
| Intra-operative (Neuro.) | ||||||||||
| Fetal | ||||||||||
| Imaging | Laparoscopic | |||||||||
| & Other | Pediatric | |||||||||
| 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 Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal (card.) | P | P | P | P | P | B+M; B+PWD; | ||||
| B+CWD; B+CD | Note 1, 2 | |||||||||
| Other (spec.) | ||||||||||
| Peripheral | Peripheral vessel | |||||||||
| Vessel | Other (spec.) |
N= new Indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler. Color Doppler can be combined with any imaging mode.
Note 2: PW Doppler includes PW Tissue Doppler Imaging (TDI).
Prescription Use (Per 21 CFR 801.109)
Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K053069
510(k) Number
Indications for Use
33 of 734 pages
11
| System: | MicroMaxx™ High-Resolution Ultrasound System (C3 Series) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | SLT/10-5 10.0-5.0 MHz Linear Array | |||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human | |||||||||
| body as follows: | ||||||||||
| Clinical Application | Mode of Operation | |||||||||
| General | Specific | Color | Combined | Other | ||||||
| (Track I only) | (Tracks I & III) | B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) | ||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal | P | P | P | P | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Abdominal | P | P | P | P | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Intra-operative | ||||||||||
| (Abdominal organs and | P | P | P | P | B+M; B+PWD; | |||||
| B+CD | ||||||||||
| vascular) | ||||||||||
| Intra-operative (Neuro.) | B+CD | Note 1 | ||||||||
| Fetal Imaging | Laparoscopic | |||||||||
| & Other | Pediatric | P | P | P | P | B+M; B+PWD; | ||||
| B+CD | Note 1 | |||||||||
| Small Organ (breast, | ||||||||||
| thyroid, testicles.) | B+M; B+PWD; | |||||||||
| thyroid, testicles.) | P | P | P | P | B+CD | Note 1 | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non- | ||||||||||
| Card.) | ||||||||||
| Card.) | ||||||||||
| Musculo-skel. | P | P | P | P | B+M; B+PWD; | |||||
| B+CD | ||||||||||
| (Convent.) | Note 1 | |||||||||
| Musculo-skel. | P | B+CD | Note 1 | |||||||
| (Superfic.) | P | P | P | P | B+M; B+PWD; | |||||
| B+CD | Note 1 | |||||||||
| Intra-luminal | ||||||||||
| Other (spec.) | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac | Cardiac Pediatric | |||||||||
| Trans-esophageal | ||||||||||
| (card.) | ||||||||||
| Other (spec.) | ||||||||||
| B+M: B+PWD; | ||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | B+CD | Note 1 | |||
| Vessel | Other (spec.) |
Table 4.3- 18 Diagnostic Ultrasound Indications for Use Form – SLT/10-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, 3-D Imaging, Tissue Doppler Imaging and imaging for guidance of biopsy. Color Doppler includes Velocity Color Doppler can be combined with any imaging mode. All items marked "P" were previously cleared in 510(k) K043559.
Prescription Use (Per 21 CFR 801.109)
Nancy C. Stockton
Division Sign-Off
Divis ductive, Abdominal, and 510/k
Indications for Use
12
| Table 4.3-7 Diagnostic Ultrasound Indications for Use Form - P10/8-4 Phased |
|---|
| Array Transducer Intended Use Form |
| System: | MicroMaxx™ High-Resolution Ultrasound System (C3 series) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | P10/8-4 8.0-4.0 MHz Phased Array Transducer | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track I | |||||||||
| only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | N | N | N | N | N | B+M; B+PWD; B+CD | Note 1 | |
| Fetal | P | P | P | P | B+M; B+PWD | ||||
| B+CD | Note 1 | ||||||||
| Abdominal | P | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1 | ||||||||
| Intra-operative | |||||||||
| (Abdominal organs and | |||||||||
| vascular) | P | P | P | P | B+M; B+PWD | ||||
| B+CD | Note 1 | ||||||||
| Intra-operative (Neuro.) | N | N | N | N | B+M; B+PWD; | ||||
| B+CD | Note 1 | ||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD | Note 1 | |||
| Small Organ (breast, | |||||||||
| thyroid, testicles.) | P | P | P | P | B+M; B+PWD | ||||
| B+CD | Note 1 | ||||||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD | ||||
| B+CD | Note 1 | ||||||||
| Adult Cephalic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD | ||||
| B+CD | Note 1 | ||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1, 2 | ||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; | ||
| B+CWD; B+CD | Note 1, 2 | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 |
N= new Indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Doppler, combined Band Color Power Dopen Tissue Hamonic Inaging, Tissue
Doppler Imaging and imaging for guidance of biopsy. Color Doppler combined with any imaging mode. This submission includes Imaging to assist in the placement of needles in . vascular or other anatomical structures. lance K broad on
Note 2: PW Doppler includes PW Tissue Doppler Imaging (TDI).
Prescription Use (Per 21 CFR 801.109)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K05306 |
of 734 pages
Indications for Use
34
13
| System: | MicroMaxx™ High-Resolution Ultrasound System (C3 series) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Transducer: | P17/5-1 5.0-1.0 MHz Phased Array Transducer | ||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||||
| Clinical Application | Mode of Operation | ||||||||
| General | |||||||||
| (Track I | |||||||||
| only) | Specific | ||||||||
| (Tracks I & III) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Spec.) | Other | ||||||||
| (Spec.) | |||||||||
| Ophthalmic | Ophthalmic | N | N | N | N | B+M; B+PWD; B+CD | Note 1 | ||
| Fetal | P | P | P | P | B+M; B+PWD | ||||
| B+CD | Note 1 | ||||||||
| Abdominal | P | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1 | ||||||||
| Intra-operative | |||||||||
| (Abdominal organs and | |||||||||
| vascular) | P | P | P | P | B+M; B+PWD | ||||
| B+CD | Note 1 | ||||||||
| Intra-operative (Neuro.) | |||||||||
| Fetal | |||||||||
| Imaging | |||||||||
| & Other | Laparoscopic | P | P | P | P | B+M; B+PWD | Note 1 | ||
| Pediatric | P | P | P | P | B+M; B+PWD | Note 1 | |||
| Small Organ (breast, | |||||||||
| thyroid, testicles.) | P | P | P | P | B+M; B+CD | Note 1 | |||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD | ||||
| B+CD | Note 1 | ||||||||
| Adult Cephalic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skel. (Convent.) | P | P | P | P | B+M; B+PWD | ||||
| B+CD | Note 1 | ||||||||
| Musculo-skel. (Superfic.) | |||||||||
| Intra-luminal | |||||||||
| Other (spec.) | |||||||||
| Cardiac Adult | P | P | P | P | P | B+M; B+PWD; | |||
| B+CWD; B+CD | Note 1, 2 | ||||||||
| Cardiac | Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; | ||
| B+CWD; B+CD | Note 1, 2 | ||||||||
| Trans-esophageal (card.) | |||||||||
| Other (spec.) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Other (spec.) |
Table 4.3- 8 Diagnostic Ultrasound Indications for Use Form -- P17/5-1 Phased Array Transducer
N= new indication; P= previously deared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, Tissue Doppler Imaging and imaging for guidance of blopsy. Color Doppler Includes Velodiy Color Doppler. Color Doppler can be combined with any imaging mode. This submission includes imaging to assist in the placement of needles and cathelers in vascular or other analomical structures
Note 2: PW Doppler includes PW Tissue Doppler Imaging (TDI).
Prescription Use (Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off Division of Reproductive, Abd logical Devices
Indications for Use
35°C, 81734 pages
14
Image /page/14/Picture/1 description: The image shows the SonoSite logo on the left side. To the right of the logo, the text "NOV 1 6 2005" is printed. Further to the right, the text "K053069" is written in cursive.
SonoSite Inc.
1 496 841 1201
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)
SonoSite, Inc. 21919 30" Drive SE Bothell. WA 98021-3904
| Corresponding Official: | Daina L. Graham |
|---|---|
| Vice President, Regulatory Affairs and Quality Assurance | |
| E-mail: | Daina.Graham@sonosite.com |
| Telephone: | (425) 951-1275 |
| Facsimile: | (425) 951-1201 |
| Date prepared: | October 20, 2005 |
Name of the device, including the trade or proprietary name if applicable, the 2) common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
MicroMaxx ™ High-Resolution Ultrasound System (C3 Series) (subject to change)
Classification Names
| Name | 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 |
| Picture Archiving And Communications System | 892.2050 | 90-LLZ |
3) Identification of the predicate or legally marketed device:
SonoSite. Inc. believes that the System described in this Submission is substantially equivalent to a combination of the SonoSite MicroMaxx™ High-Resolution Ultrasound System (C3 Series) (K043559), and the Philips Medical Systems (formerly Advanced Technology Laboratories) HDI® 5000 Ultrasound System (K034003 and K011224).
510(K) Summary Of Safety And Effectiveness
Page 1 of 7
15
Device Description: 4)
The MicroMaxx™ High-Resolution Ultrasound System (C3 Series) is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display highresolution, real-time ultrasound data in 2D, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler, and Velocity Color Doppler or in a combination of these modes.
The System has an electrocardiography (ECG) display feature and supports a 3-lead ECG cable assembly to collect data for M-mode and Doppler measurements. The System provides measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The System has a PW and CW Doppler audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities.
The system includes the ability to measure the intima-media thickness (IMT) of the carolid artery using digital ultrasound images. The IMT measurement of the carotid artery may be used adjunctively with other medical data obtained by a physician to help assess the cardiovascular health of a patient.
The system includes Digital Imaging and Communications (DICOM) capabilities as well as general computer communication capabilities to provide the acceptance, transfer, display, storage, and digital processing of ultrasound images and loops. Security support is also provided to facilitate HIPAA compliance.
The MicroMaxx™ High-Resolution Ultrasound System (C3 Series) 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 - 12.0 MHz |
|---|---|
| Transducer Types: | Linear array |
| Curved array | |
| Intracavitary array | |
| Phased array | |
| Static probes |
The MicroMaxx™ High-Resolution Ultrasound System (C3 Series) is designed to comply with the standards listed below.
| Reference No. | Title |
|---|---|
| AAMI/ANSI/ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997) |
| AIUM | AIUM Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (1994) |
| ANSI/AAMI EC53 | ECG Cables and Electrodes except for sections 4.4 and 4.5.9 (1995) |
| EN 980 A1 | Graphical symbols for use in the labeling of medical devices (2003) |
| IEC 60601-1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988 |
| IEC 60601-1/A1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601- |
| 1:1988/A1:1991 |
FDA Recognized Consensus Standards
510(K) Summary Of Safety And Effectiveness
16
| Reference No. | Title |
|---|---|
| IEC 60601-1/A2 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601- |
| 1:1988/A2:1995 + corrigendum June 1995 | |
| IEC 60601-1-1 | Medical electrical equipment. Part 1: General requirements for safety - 1. Collateral |
| standard: Safety requirements for medical electrical systems - IEC 601-1-1:2000 | |
| IEC 60601-1-2 | Medical electrical equipment - Part 1: General requirements for safety, 2. collateral |
| standard: electromagnetic compatibility; requirements and tests - IEC 60601-1-2:200 | |
| IEC 60601-1-4 | Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral |
| standard: Programmable electrical medical systems - IEC 60601-1-4:1996 Amendment A1 | |
| IEC 60601-2-25 | Medical Electrical Equipment-Part 2. Particular Requirements for Safety-Section 25. |
| Specification for Electrocardiographs. (1999) | |
| IEC 60601-2-37 | Medical Electrical Equipment - Part 2-37; Particular requirements for the safety of ultrasonic |
| medical diagnostic and monitoring equipment (2001) | |
| NEMA UD 2-2004 | Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
| NEMA UD 3-2004 | Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on |
| Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine |
Miscellaneous Design Standards
| Reference No. | Title |
|---|---|
| ASTM D5276-98 | Standard Test Methods for Drop Test of Loaded Containers by Free Fall |
| (1998) | |
| ASTM D999-96 | Standard Methods for Vibration Testing of Shipping Containers (1996) |
| CISPR 11 | Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - |
| Electromagnetic Disturbance Characteristics - Limits and Methods of | |
| Measurement (2003) | |
| EN 60529 | Degrees of protection provided by enclosures (IP Code) (1991 |
| JIS T 0601-1 | Medical Electrical Equipment - Part 1: General Requirements for Safety |
| (Japan) (1999) | |
| JIS T 1507 | Electronic Linear Scanning Ultrasonic Diagnostic Equipment (Japan) (1989) |
| JIS-T-601-1 | Japanese Standards for Medical Electrical Equipment |
| RTCA/DO160D | Radio Technical Commission for Aeronautics, Environmental Conditions and |
| Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio | |
| Frequency Energy, Category B (1997) | |
| UL 60601-1 | Underwriters Laboratories, Medical Electrical Equipment-Part 1: General |
| Requirements for Safety (2003) | |
| UL 94 | Underwriters Laboratories, Inc., Tests for Flammability of Plastic Materials for |
| Parts in Devices and Appliances, 5th Edition | |
| EN ISO 13485 | Medical devices - Quality management systems - Requirements for |
| regulatory purposes (2003) | |
| EN ISO 14971 | Medical devices - Application of risk management to medical devices (2000) |
| (ISO 14971:2000) (Superseded standard: EN 1441) | |
| ACR-NEMA DICOM version | |
| 3.0 - 2003 | Digital Imaging and Communications in Medicine |
510(K) Summary Of Safety And Effectiveness
150
of 734 pages
17
Intended Use: 5)
The intended uses of the MicroMaxx™ High-Resolution Ultrasound System (C3 Series) as defined by FDA guidance documents, are:
| Ophthalmic | Trans-rectal |
|---|---|
| Fetal - OB/GYN | Trans-vaginal |
| Abdominal | Trans-urethral |
| Intra-operative | |
| (Abdominal organs and vascular) | Musculo-skel. (Conventional) |
| Intra-operative (Neuro.) | Musculo-skel. (Superficial) |
| Laparoscopic | Cardiac Adult |
| Pediatric | Cardiac Pediatric |
| Small Organ | |
| (breast, thyroid, testicles.) | Trans-esophageal (card.) |
| Neonatal Cephalic | Peripheral vessel |
| Adult Cephalic |
Typical examinations performed using the MicroMaxx™ High-Resolution Ultrasound System (C3 Series) are:
Abdominal Imaging Applications
This system transmits ultrasound energy into the abdomen of patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally.
Cardiac Imaging Applications
This system transmits ultrasound energy into the thorax of patients using 2D, M Mode, color Doppler (Color), Tissue Harmonic Imaging (THI), pulsed wave (PW) Doppler, and continuous wave (CW) Doppler to obtain ultrasound images. The heart, cardiac valves, great vessels, surrounding anatomical structures, overall cardiac performance, and heart size can be assessed for the presence or absence of pathology.
The patient's electrocardiogram (ECG) may be obtained and is used for accurate timing of diastolic and systolic function.
Warning: The ECG is not used to diagnose cardiac arrhythmias and is not designed for long term cardiac rhythm monitoring.
Gynecology and Infertility Imaging Applications
This system transmits ultrasound energy in the pelvis and lower abdomen using 2D, M Mode, color power Doppler (CPD), color Doppler (Color), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The uterus, adnexa, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaginally.
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Interventional and Intraoperative Imaging Applications
This system transmits ultrasound energy into the various parts of the body using 2D, color This bytion transmis and che (CPD), Tissue Harmonic Imaging (THI),and pulsed wave (PW) Doppler to obtain ultrasound images that provide guidance during interventional and intraoperative procedures. This system can be used to provide ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, spinal nerve blocks and taps, ova harvesting, amniocentesis and other obstetrical procedures, and provide assistance during abdominal, breast, neurological surgery, and vascular intraoperative procedures.
Obstetrical Imaging Applications
This system transmits ultrasound energy into the petvis of pregnant women using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), Tissue Harmonic Imaging (THI), and pulsed wave (PW) Doppler to obtain ultrasound images. The fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally or transvaginally. CPD and color Doppler (Color) 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.
Warning: To prevent injury or misdiagnosis do not use this system for Percutaneous Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not been validated to be proven effective for these two uses. CPD, or Color images can be used as an adjunctive method, not as a screening tool, for the detection of structural anomalies of the fetal heart and as an adjunctive method, not as a screening tool for the diagnosis of Intrauterine Growth Retardation (IUGR).
Pediatric and Neonatal Imaging Applications
This system transmits ultrasound energy into the pediatric patients using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), pulsed wave (PW) Doppler, and continuous wave (CW) Doppler to obtain ultrasound images. The pediatric abdominal, pelvic and cardiac anatomy, pediatric hips, neonatal head, and surrounding anatomical structures can be assessed for the presence or absence of pathology.
Prostate Imaging Applications
This system transmits ultrasound energy into the prostate of an adult male using 2D, M Mode, color power Doppler (CPD), color Doppler (Color), and pulsed wave (PW) Doppier to obtain ultrasound images. The prostate gland can be assessed for the presence or absence of pathology.
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Superficial Imaging Applications
This system transmits ultrasound energy into various parts of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, soft tissue structures, and surrounding anatomical structures can be assessed for the presence or absence of pathology. This system can be used to provide ultrasound guidance for biopsy and drainage procedures, vascular line placement, peripheral nerve blocks and spinal nerve blocks and taps.
Transcranial Imaging Applications
This system transmits ultrasound energy into the cranium using 2D, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The anatomical structures and vascular anatomy of the brain can be assessed for presence or absence of pathology. Imaging can be used temporally, trans-occipitally, or trans-orbitally.
Vascular Imaging Applications
This system transmits ultrasound energy into the various parts of the body using 2D, M Mode, color Doppler (Color), color power Doppler (CPD), and pulsed wave (PW) Doppler to obtain ultrasound images. The carotid arteries, deep veins, and arteries in the arms and legs. superficial veins in the arms and legs, great vessels in the abdomen, and various small vessels feeding organs can be assessed for the presence or absence of pathology.
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Technological Characteristics: 6)
This device operates identically 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 or M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, PW Doppler, CW Doppler, velocity color Doppler, Color Power Doppler, and duplex imaging) are the same as a combination of the 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 (AIUMINEMA UD 3-2004) 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.
| ISPTA (d) | 720 mW/cm² | Maximum |
|---|---|---|
| Tis/Tlb/Tlc | 0.0 - 4.0 | Range |
| Mechanical Index (MI) | 1.9 | Maximum |
| ISPPA (d) | 0 - 700 W/cm² | Range |
The device's acoustic output limits are:
The device's acoustic output limits for when used for ophthalmic applications are:
| ISPTA (d) | 50 mW/cm² | Maximum |
|---|---|---|
| Tls/Tlb/Tic | 0.0 - 1.0 | Range |
| Mechanical Index (MI) | 0.23 | Maximum |
The limits are the same as predicate Track 3 devices.
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