(50 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related concepts. The description focuses on standard ultrasound imaging modes and functionalities.
No
The device is described as a general-purpose ultrasound system for evaluation and imaging, not for treating or rehabilitating a condition, which are characteristics of a therapeutic device.
Yes
The device is described as a general purpose ultrasound system intended for use by a qualified physician for "evaluation by ultrasound imaging or fluid flow analysis of the human body" and can be used to "assess overall cardiac performance and size, determine the presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves. Also the system can be used to access the presence and extent of some injuries and diseases." These functions directly align with diagnostic purposes.
No
The device description explicitly states "SonoSite ultrasound systems are highly portable, software-controlled ultrasound systems used to acquire and display high resolution, real-time ultrasound data". This indicates the device includes hardware components (the ultrasound system itself) in addition to software control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- This Device's Function: The provided description clearly states that the SonoSite Series Ultrasound Systems are used for "evaluation by ultrasound imaging or fluid flow analysis of the human body." This involves transmitting ultrasound energy into the body and receiving the reflected waves to create images or analyze flow within the body.
The device operates in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The SonoSite Series Ultrasound Systems are a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal/OB; Abdominal; Intra-operative (abdominal organs and vascular); Laparoscopic; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Neonatal Cephalic; Adult Cephalic; Trans-rectal, Trans-vaginal; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esophageal (cardiac); Peripheral Vessel.
Cardiac Imaging Applications
This system allows the clinician to perform focused cardiac studies. This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, PowerMap, DCPD, M-mode (where available), Tissue Harmonic Imaging, or PW and CW Doppler images of the heart, great vessels, and anatomic or pathologic structure. This system can be used to assess overall cardiac performance and size, determine the presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves. Also the system can be used to access the presence and extent of some injuries and diseases. The ECG (where available) is used for accurate timing of diastolic and systolic function. The ECG trace is not used to diagnose cardiac rhythms and is not designed for long term cardiac rhythm monitoring.
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
SonoSite ultrasound systems are highly portable, software-controlled ultrasound systems used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings. The SonoSite 180™ Hand Carried Ultrasound System (K014116) provided clearance for a fully described cardiac indication including the imaging of surrounding structures, notably the Lung. The NanoMaxx Series Ultrasound System (K092058), and the Maxx Series (M turbo, S Series) Ultrasound System (K071134, K082098), which are collectively referred to as the SonoSite Ultrasound System, have all been previously cleared and are currently in interstate commerce.
This 510(k) premarket notification includes no changes, including no new system functions or technology changes, to the ultrasound systems, transducers, or accessories that were the subjects of the above-referenced submissions. This 510(k) premarket notification only extends the previously cleared indications to specifically identify the "Presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis and visualize bloodflow through cardiac valves". Additionally, the indications for use under K014116 specifically included the cardiac intended use; "The system can be used to assess the presence and extent of some injuries and diseases".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Ophthalmic, Fetal, Abdominal, Intra-operative (abdominal organs, vascular, neuro), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicles, prostate), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esophageal (non-cardiac, cardiac), Musculo-skeletal (Conventional, Superficial), Intravascular (cardiac), Intra-cardiac, Cardiac Adult, Cardiac Pediatric, Peripheral vessel, Heart, Lungs, Spinal Cord
Indicated Patient Age Range
Adult and pediatric patients (Cardiac Imaging Applications)
Intended User / Care Setting
Qualified physician
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)
SonoSite performs testing in order to verify compliance with the standards. Testing reports have been provided in previous submissions per guidance. As this submission is in support of expanding marketing claims only, there have been no changes to technology, software or hardware. As such no additional testing was performed in support of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K071134, K082098, K092058, K014116
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
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)
Manufacturer's Name & Address:
K10175'7
SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904
AUG 1 2 2010
Corresponding Official:
Mary K. Moore Vice President of Regulatory Affairs 21919 3010 Drive SE Bothell, WA 98021-3904
E-mail: mary moore@sonosite.com Telephone: (425) 951-1275 Facsimile: (425) 951-1201
Initial Distributor (if manufacturer is overseas):
Not Applicable
- Name of the device, including the trade or proprietary name if applicable, the 2) common or usual name, and the classification name, if known:
Device Names:
NanoMaxx™ Series Ultrasound System (subject to change) Maxx Series Ultrasound System (M Turbo , S Series™) (subject to change)
SonoSite® Ultrasound System (subject to change)
Common Name:
Diagnostic ultrasound system with accessories
Page 92 of 1041
It
... ...
1
Classification:
| Regulatory Class: | II |
|---|---|
| Review Category: | Tier 2 |
| Classification Panel: | Radiology |
| 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 |
3) Identification of the predicate or legally marketed device:
SonoSite, Inc., believes that the SonoSite Ultrasound Systems described in this Submission, and previously cleared on 510(k)'s K071134, K082098 and K092058 are substantially equivalent to the SonoSite 180 Hand Carried Ultrasound System (K014116).
4) Device Description:
SonoSite ultrasound systems are highly portable, software-controlled ultrasound systems used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings. The SonoSite 180™ Hand Carried Ultrasound System (K014116) provided clearance for a fully described cardiac indication including the imaging of surrounding structures, notably the Lung. The NanoMaxx Series Ultrasound System (K092058), and the Maxx Series (M turbo, S Series) Ultrasound System (K071134, K082098), which are collectively referred to as the SonoSite Ultrasound System, have all been previously cleared and are currently in interstate commerce.
This 510(k) premarket notification includes no changes, including no new system functions or technology changes, to the ultrasound systems, transducers, or accessories that were the subjects of the above-referenced submissions. This 510(k) premarket notification only extends the previously cleared indications to specifically identify the "Presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis and visualize bloodflow through cardiac valves". Additionally, the indications for use under K014116 specifically included the cardiac intended use; "The system can be used to assess the presence and extent of some injuries and diseases".
Page 93 of 1041
2
This clinical application and intended use is consistent with current clinical practice and FDA guidelines. Ultrasound is commonly used to visualize existing landmarks in the anatomy, and the use of diagnostic ultrasound for the evaluation of fluid flow in the cardiac system, including lung is well established. Specific clinical application to the discrimination of Lung anatomy, including other types of anatomical detail, adds no significant risk to the general indication for use.
By this Submission, then, the clinical application of imaging guidance for the presence or absence of pathology of the cardiac system including the lung is being added in order to support marketing claims only. This update required no new technology, no new software, and no new instructions for use.
Previously cleared indications for use for each of the referenced SonoSite Ultrasound Systems and to the following transducers:
| System | Transducer | Transducer
Type | Frequency
Range |
|-----------------------------------------------|------------|--------------------|--------------------|
| NanoMaxx High-Resolution Ultrasound
System | P21n | Linear Array | 5.0 - 1.0 MHz |
| | L25n | Linear Array | 13.0 - 6.0 MHz |
| Maxx Series Ultrasound System | P21x | Linear Array | 5.0 - 1.0 MHz |
| | L25x | Linear Array | 13.0 - 6.0 MHz |
Each of the SonoSite Series Ultrasound Systems were designed, developed and tested per the applicable standards detailed below. Safety and effectiveness are established by developing product per industry recognized standards. SonoSite development records demonstrate compliance and are maintained in the Device History Record, in compliance with 21 CFR 820.
SonoSite performs testing in order to verify compliance with the standards. Testing reports have been provided in previous submissions per guidance. As this submission is in support of expanding marketing claims only, there have been no changes to technology, software or hardware. As such no additional testing was performed in support of this submission.
| Reference No. | Title |
|---|---|
| AAMI/ANSI/ISO 10993-1 | ISO 10993-1:2003(E),, Biological evaluation of medical devices -- Part 1: Evaluation |
| and testing | |
| AAMI/ANSI/ISO 10993-12 | ISO 10993-12:2007, Biological evaluation of medical devices -- Part 12: Sample |
| preparation and reference materials | |
| AAMI/ANSI/ISO 10993-10 | ISO 10993-10:2002, Biological evaluation of medical devices - Part 10: Tests for |
| irritation and delayed-type hypersensitivity | |
| AAMI/ANSI/ISO 10993-11 | ISO 10993-11:2006, Biological evaluation of medical devices -- Part 11: Tests for |
Applicable Standards
Page 94 of 1041
3
| systemic toxicity. | |
|---|---|
| IEC 60601-1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601- |
| 1:1988 | |
| 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 Standards
| Reference No. | Title |
|---|---|
| ISO 9001:2008 | Quality management systems - Requirements International Organization for |
| Standardization (2008) | |
| Title 21 CFR Part 820 | Quality System Regulation - Medical Devices: Current Good Manufacturing Practice |
| (CGMP); Final Rule | |
| EN ISO 13485:2003 | Medical devices - Quality management systems - Requirements for regulatory |
| purposes (2003) | |
| EN ISO 14971:2000 | Medical devices - Application of risk management to medical devices (2000) |
| (ISO 14971:2000) | |
| RTCA D160E | Radio Technical Commission for Aeronautics: Environmental Conditions and Test |
| Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy |
5) Intended Use:
The intended uses of the SonoSite Series Ultrasound Systems remain the same as the information supplied in the predicate 510(k)'s K071134, K082098 and K092058, except for the following addition.
Cardiac Imaging Applications
This system allows the clinician to perform focused cardiac studies. This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, PowerMap, DCPD, M-mode (where available), Tissue Harmonic Imaging, or PW and CW Doppler images of the heart, great vessels, and anatomic or pathologic structure. This system can be used to assess overall cardiac performance and size, determine the presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves. Also the system can be used to access the presence and extent of some injuries and diseases. The ECG (where available) is used for accurate timing of diastolic and systolic function. The ECG trace is not used to diagnose cardiac rhythms and is not designed for long term cardiac rhythm monitoring.
4
6) Technological Characteristics:
The Technological Characteristics of the SonoSite Series Ultrasound Systems remain the same as those supplied and cleared in the predicate 510(k)'s K071134, K082098 and K092058.
7) Conclusion
Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. The product development process conforms with 21 CFR 820, and ISO 13485:2003 quality systems. The device conforms to applicable electromedical device safety standards with compliance verified through independent evaluation and ongoing factory audits. Medical diagnostic ultrasound has an established history of safety and effectiveness. It is the opinion of SonoSite, Inc. that the SonoSite Series Ultrasound System is substantially equivalent with regard to safety and effectiveness to other devices already cleared for marketing.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 1 2 2010
SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K101757
Trade/Device Name: NonoMaxx: SonoSite NanoMaxx Series Ultrasound System, M Turbo: SonoSite Maxx Series Ultrasound System, S Series: SonoSite Maxx
Series Ultrasound System
Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYO, ITX, and IYN Dated: July 28, 2010
Dear Ms. Stenberg:
Received: July 29, 2010
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 NonoMaxx: SonoSite NanoMaxx Series Ultrasound System, M Turbo: SonoSite Maxx Series Ultrasound System, S Series: SonoSite Maxx Series Ultrasound System, as described in your premarket notification:
Transducer Model Number
L25n/13-6 P21n/5-1 Phased Array P21x/5-1 MHz L25x/13-6 MHz
6
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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Paul Hardy at (301) 796-6542.
Sincerely vours.
Marked D. O'Keeffe
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
7
510(k) Submission for SonoSite Ultrasound Systems
May 20, 2010
Indications for Use
510(k) Number (if known): TBD
AUG122200
Device Names:
- NanoMaxx: SonoSite NanoMaxx Series Ultrasound System .
- M Turbo: SonoSite Maxx Series Ultrasound System .
- . S Series: SonoSite Maxx Series Ultrasound System
Indications for Use:
The SonoSite Series Ultrasound Systems are a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal/OB; Abdominal; Intra-operative (abdominal organs and vascular); Laparoscopic; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Neonatal Cephalic; Adult Cephalic; Trans-recta;, Trans-vaginal; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esophageal (cardiac); Peripheral Vessel.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mull O'Keeffe
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) . .
Page 1 of 1
Page 54 of 1041
8
510(k) Submission for SonoSite Ultrasound Systems
Table 1.3-1 Diagnostic Ultrasound Indications for Use Form – SonoSite NanoMaxx Series Ultrasound System
| System: | SonoSite NanoMaxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| 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 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined | ||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | P | P | B+CD, B+CPD | Note 1 | |||
| Abdominal | P | P | B+CD, B+CPD | Note 1 | ||||
| Intra-operative (Abdominal Organs, | ||||||||
| Vascular) | P | P | B+CD, B+CPD | Note 1 | ||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | B+CD, B+CPD | Note 1 | ||||
| Small Organ (Breast, Thyroid, | ||||||||
| Testicles, Prostate) | P | P | B+CD, B+CPD | Note 1 | ||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal (Conventional) | P | P | B+CD, B+CPD | Note 1 | ||||
| Musculo-skeletal (Superficial) | P | P | B+CD, B+CPD | Note 1 | ||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult. | P | P | B+CD, B+CPD | Note 1 | |||
| Cardiac Pediatric | P | P | B+CD, B+CPD | Note 1 | ||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | B+CD, B+CPD | Note 1 | |||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
N = new indeston; P = previously classed by FDA; E = atded unter this appendic
° Examples of operation may indude; A-mode, Anplitude Dopler, 3-D Inaging, Harmonic Imaging, Ti
Additional Comments:
Note 1: Other Includes Color Power Doppler, combined B and Color Power Doppler, Tissue Harmonic Imaging, SonoHD, SonoMB Compound Imaging, Tissue Dopler Imaging. Color Dopler Includes Color Velocity Doppler can be combined with any imaging mode. Includes Imaging to assist in the placement of needles and cathers in vascular or other anatomical structures and imaging guidance for perioheral nerve block procedures. Indudes imaging of spinal cord to provide guidance for central nerve block procedures.
All Items marked "P" were previously cleared in 510{k) K092058
Prescription Use (Per 21 CFR 801.109)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) Number
Page 55 of 1041
9
Table 1.3-2 Diagnostic Ultrasound Indications for Use Form – L25n/13-6 Transducer
| System:
Transducer:
| Intended Use: | SonoSite NanoMaxx™ Series Ultrasound System | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| L25n/13-6 13.0-6.0 MHz Linear Array | ||||||||||||||
| Diagnostic ultrasound imaging or fluid flow analysis of the human body as | ||||||||||||||
| follows | ||||||||||||||
| Clinical Application | Mode of Operation | |||||||||||||
| General | ||||||||||||||
| (Track 1 Only) | Specific | |||||||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||||||||
| Doppler | Combined (Specify) | Other | ||||||||||||
| (Specify) | ||||||||||||||
| Ophthalmic | Ophthalmic | |||||||||||||
| Fetal Imaging & | Fetal | |||||||||||||
| Other | Abdominal | P | P | P | B+CD, B+CPD | Note 1 | ||||||||
| Intra-operative (Abdominal | ||||||||||||||
| Organs, Vascular) | P | P | P | B+CD, B+CPD | Note 1 | |||||||||
| Intra-operative (Neuro) | ||||||||||||||
| Laparoscopic | ||||||||||||||
| Pediatric | P | P | P | B+CD, B+CPD | Note 1 | |||||||||
| Small Organ (Breast, Thyroid, | ||||||||||||||
| Testicles, Prostate) | P | P | P | B+CD, B+CPD | Note 1 | |||||||||
| Neonatal Cephalic | ||||||||||||||
| Adult Cephalic | ||||||||||||||
| Trans-rectal | ||||||||||||||
| Trans-vaginal | ||||||||||||||
| Trans-urethral | ||||||||||||||
| Trans-esoph. (non-Card.) | ||||||||||||||
| Musculo-skeletal (Conventional) | P | P | P | B+CD, B+CPD | Note 1 | |||||||||
| Musculo-skeletal (Superficial) | P | P | P | B+CD, B+CPD | Note 1 | |||||||||
| Intravascular | ||||||||||||||
| Other (Specify) | ||||||||||||||
| Cardiac | Cardiac Adult | P | P | P | B+CD, B+CPD | Note 1 | ||||||||
| Cardiac Pediatric | ||||||||||||||
| Intravascular (Cardiac) | ||||||||||||||
| Trans-esoph. (Cardiac) | ||||||||||||||
| Intra-cardiac | ||||||||||||||
| Other | ||||||||||||||
| Peripheral | Peripheral vessel | P | P | P | B+CD, B+CPD | Note 1 | ||||||||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this spendic
- Examples of ober modes of operation nay include : A-mode, Anplibale Dopler, 3-D Inaging, Ham
Additional Comments:
Note 1: Other Includes Color Power Dopler, combined B and Color Power Dopler, SonoMB Compound Imaging, Color Dopler includes Color Velocity Doppler. Color Dopplar can be combined with any imaging to assist in the placement of needles and catheters in vascular or other anatomical structures and an expanded intended use for peripheral neve block procedures. All items marked "P" were previously cleared in 510(k) K092058
Prescription Use (Per 21 CFR 801.109),
Prescription 003 (Ref.21 CFR 1306).
MLD/OK
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number
Page 56 of 1041
10
510(k) Submission for SonoSite Ultrasound Systems
Table 1.3-3 Diagnostic Ultrasound Indications for Use Form – P21n/5-1 Phased Array Transducer
| System: | SonoSite NanoMaxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | ||||||||
| Intended Use: | P21n/5-1 5.0-1.0 MHz Phased Array Transducer | |||||||
| Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | ||||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color Doppler | Combined (Specify) | Other* | |
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | Fetal | P | P | B+CD, B+CPD | Note 1 | |||
| Other | Abdominal | P | P | B+CD, B+CPD | Note 1 | |||
| Intra-operative (Abdominal | ||||||||
| Organs, Vascular) | P | P | B+CD, B+CPD | Note 1 | ||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | B+CD, B+CPD | Note 1 | ||||
| Small Organ (Breast, Thyroid, | ||||||||
| Testicles, Prostate) | P | P | B+CD, B+CPD | Note 1 | ||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P | P | B+CD, B+CPD | Note 1 | |||
| Cardiac Pediatric | P | P | B+CD, B+CPD | Note 1 | ||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other | ||||||||
| Peripheral | Peripheral vessel | P | P | B+CD, B+CPD | Note 1 | |||
| Vessel | Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
N = new indicalion; P = periously class = p = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Additional Comments:
Note 1: Other Includes Color Power Doppler, combined B and Color Power Dopler, Tissue Harmonic Inaging, SonoHD, SonoMB Compound Imaging, Tissue Dopler Imaging. Color Doppler Includes Color Velocity Doppler can be combined with any imaging mode. Includes Imaging to assist in the placement of needles and cathers in vascular or other analomical structures and imaging guidance for perioneral nerve block procedures. Includes imaging of spinal cord to provide guidance for central nerve block procedures.
All items marked "P" were previously cleared in 510(k) K071134 and K082098
Prescription Use (Per 21 CFR 801.109)
Mishael D. Hohn
Division Sign-Off Office of In Vitro Diagnostic Device Omeo of in vide Blaghosa
Evaluation and Safety () {
510(k) Number ರ್ಗ 510(k) Number
. Page 57 of 1041
11
Table 1,3-4 Diagnostic Ultrasound Indications for Use Form – SonoSite Maxx™ Series Ultrasound System
| System: | SonoSite Maxx™ Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| 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 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined (Specify) | Other | ||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | B+M; B+PWD; B+CD | ||
| Fetal Imaging & | ||||||||
| Other | 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, 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 | ||
| Laparoscopic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | |
| Small Organ (Breast, Thyroid, | ||||||||
| Testicles, Prostate) | 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 | 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-skeletal | ||||||||
| (Conventional) | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Musculo-skeletal (Superficial) | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | |
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | |
| Intra-cardiac | B+M; B+PWD; B+CD | |||||||
| Other | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (Specify) |
N = new Indication; P = previously cleared by FDA; E = added under this appendix
N = new lndication: P = previously class = ( = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Additional Comments:
Note 1: Other includes Color Power Dopler, combined B and Color Power Doppler, SonoHD trraging, SonoMB Compound Imaging, Color Doppler indudes Color Velodiy Doppier . Odor Dopier can be combined with any imaging to assist in the placement of needles and cabester in vascular or other analomical structures and an expanded intended use for imaging guidance for peripheral nerve block procodures.
All items marked "P" were previously cleared in 510(k) K071134 and K082098
Prescription Use (Per 21 CFR 801.109)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) Number
Page 58 of 1041
12
Table 1.3-5 Diagnostic Ultrasound Indications for Use Form – P21x/5-1MHz Transducer
| System: | SonoSite Maxx™ Series Ultrasound System | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Transducer: | P21x/ 5.0 - 1.0 MHz Linear Array | ||||||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | ||||||||||
| Clinical Application | Mode of Operation | ||||||||||
| General | |||||||||||
| (Track 1 Only) | Specific | ||||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||||
| Doppler | Combined (Specify) | Other* | |||||||||
| (Specify) | |||||||||||
| Ophthalmic | Ophthalmic | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |||
| Fetal Imaging & | Fetal | P | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |||
| Other | Abdominal | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | |||
| Intra-operative (Abdominal | |||||||||||
| Organs, Vascular) | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |||||
| Intra-operative (Neuro) | |||||||||||
| Laparoscopic | |||||||||||
| Pediatric | P | P | P | P | B+M; B+PWD | Note 1 | |||||
| Small Organ (Breast, Thyroid, | |||||||||||
| Testicles, Prostate) | 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-skeletal | |||||||||||
| (Conventional) | P | P | P | P | B+CD, B+CPD | Note 1 | |||||
| Musculo-skeletal (Superficial) | |||||||||||
| Intravascular | |||||||||||
| Other (Specify) | |||||||||||
| Cardiac | Cardiac Adult | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 | |||
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | |||||
| Intravascular (Cardiac) | |||||||||||
| Trans-esoph. (Cardiac) | |||||||||||
| Intra-cardiac | |||||||||||
| Other | |||||||||||
| Peripheral | Peripheral vessel | P | P | P | P | B+CD, B+CPD | Note 1 | ||||
| Vessel | Other (Specify) |
N= new indication; P = previously cleared by FDA; E = added under this appendix
N = new indicalion; P = previously classed by FDA; E = added under bis appendix
- Examples of other notes of opention may include Dopler, 3-D Inaging, Harmonic imaging, Tis
Additional Comments:
Not 1: Other includes Color Power Dopler, Smolf Imaging, SonolfB imaging, SonalB Compund maging, Color Dopper
includes Color Velociy Dopler can be cambinel with any imaging g
All Items marked "P" were previously cleared in 510(k) K071134 and K082098
Prescription Use (Per 21 CFR 801.109)
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number
Page 59 of 1041
- Division Sign-Off
。
13
Table 1.3-6 Diagnostic Ultrasound Indications for Use Form – L25x/13-6 MHz Transducer
| System: | SonoSite Maxx TM Series Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L25x/ 13.0 – 6.0 MHz Linear Array | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows | |||||||
| Clinical Application | Mode of Operation | |||||||
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD CWD | Color | ||||
| Doppler | Combined (Specify) | Other* | ||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | P | P | P | B+M; B+CD | Note 1 | ||
| Fetal Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | P | P | P | B+M; B+CD | Note 1 | |||
| Intra-operative (Abdominal | ||||||||
| Organs, Vascular) | P | P | P | B+M; B+CD | Note 1 | |||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | B+M; B+CD | Note 1 | |||
| Small Organ (Breast, Thyroid, | ||||||||
| Testicles, Prostate) | P | P | P | B+M; B+CD | Note 1 | |||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | P | P | P | B+M; B+CD | Note 1 | |||
| Musculo-skeletal (Superficial) | P | P | P | B+M; B+CD | Note 1 | |||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | P | P | P | B+M, B+CD, B+CPD | Note 1 | ||
| Other (Specify) |
N= new Indication; P = previously cleared by FDA; E = added under this appendix
N = now locklass). P = previously cleaned by FDA; E = actor under this appends
^ Examples of other modes of operation may industr. Ample; Ample; 3-D Inaging, Hamonic braging,
Additional Comments:
Note 1: Other Includes Color Power Dopler, contined B and Color Power Doppler, Tissue Harmonic Imaging, SonoHD, SonoHD, SonoHD, SonoHD, SonoHD, SonoHD, SonoHD, SonoHD, SonoHD Tissue Doplar Imaging. Color Doppler interests of the Populer, itsee Names , San II, San Millian, San Millian Singlian including model, Including mode, Includes includes inc assist in the placement of needles in vascular or other and micel structures and insigning guidance for priseiners newell material procedures. Includes imaging of spinal cord to provide guidance for central nerve block procedures.
All Items marked "P" were previously cleared in 510(k) K043559 and K053069
Prescription Use (Per 21 CFR 801.109)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safe 510(k) Number -_
Page 60 of 1041