(20 days)
The SonoSite Edge Ultrasound System is 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/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.
The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.
Here's an analysis of the provided 510(k) summary regarding the SonoSite Edge™ Ultrasound System, structured to address your specific points:
Acceptance Criteria and Device Performance Study
The SonoSite Edge™ Ultrasound System is a general-purpose diagnostic ultrasound system. The provided document does not describe acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, acceptance is implicitly tied to demonstrating substantial equivalence to a previously cleared predicate device, the SonoSite Maxx Series Ultrasound System (K071134 / K082098), and compliance with various safety and performance standards.
The "study" proving the device meets its acceptance criteria is primarily a non-clinical safety and performance evaluation, as specified in the document, rather than a clinical effectiveness study with defined performance numbers.
Here's the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance and Evidence |
|---|---|
| Substantial Equivalence to Predicate Device (SonoSite Maxx Series Ultrasound System K071134 / K082098) | Demonstrated via comparison of technological characteristics and intended use. The SonoSite Edge and Maxx Series Ultrasound Systems "employ the same fundamental scientific technology." The intended uses for the SonoSite Edge System and its various transducers (C8x/8-5 MHz, C11x/8-5 MHz, D2x/2 MHz, C60x/5-2 MHz, HFL38x/13-6 MHz, HFL50x/15-6 MHz, ICTx/8-5 MHz, L25x/13-6 MHz, L38xi/10-5 MHz, L38x/10-5 MHz, P10x/8-4 MHz, P21x/5-1 MHz, SLAx/13-6 MHz, TEEx/8-3 MHz) are largely shown to be "P" (previously cleared by FDA) under the predicate device K071134 and K082098, with a few "N" (new indications) for certain transducer/application/mode combinations (e.g., L38xi/10-5 MHz for Abdominal, Intra-operative, Pediatric, Small Organ, Musculo-skeletal Conventional & Superficial, and Peripheral vessel applications). The FDA's 510(k) clearance letter explicitly states: "We have determined the device is substantially equivalent... to legally marketed predicate devices." |
| Compliance with Electrical, Thermal, Mechanical, and EMC Safety Standards | Evaluated, and the device "has been found to conform to all applicable mandatory medical device safety standards." (Specific standards referenced for the Maxx series, which is the predicate, include AAMI/ANSI/ISO 10993-1, 10993-5, 10993-12 for biocompatibility, and unspecified voluntary standards detailed in tables 1.1-1 and 1.1-2, though these tables are not provided in the excerpt). |
| Compliance with Cleaning/Disinfection Requirements | Evaluated. |
| Biocompatibility of Patient Contact Materials | Evaluated. "All patient contact materials are biocompatible." |
| Acoustic Output Compliance | Evaluated. |
| Quality Assurance (System & Software Verification, Hardware Verification, Clinical Validation, Human Factors Validation) | "Assurance of quality was established by employing the following elements of product development: System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. Reports for these product development elements are referenced in Attachment 6." However, "The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence." This means "Clinical Validation" in this context refers to demonstrating that the device performs as intended for its stated uses, implicitly equivalent to the predicate, rather than an independent clinical trial to establish new clinical efficacy or performance metrics. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/Not provided. The submission explicitly states: "The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence." Therefore, there was no separate clinical "test set" in the context of generating new clinical performance data (like sensitivity/specificity) for this 510(k) submission. The evaluation was primarily non-clinical and a comparison to a predicate device's existing clearance.
- Data Provenance: Not applicable. As no new clinical studies were conducted for this submission, there is no new data provenance (country of origin, retrospective/prospective). The basis is primarily the regulatory clearance of the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. Since no new clinical studies were performed requiring new ground truth establishment, this information is not provided. The clinical indications listed as "P" (previously cleared) rely on the ground truth established for the predicate device.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was performed for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance
- No. This is a submission for a general diagnostic ultrasound system, not an AI-enabled device. Therefore, no MRMC study or assessment of AI assistance was conducted or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This is a diagnostic ultrasound system, not an algorithm.
7. The Type of Ground Truth Used
- For the "P" (previously cleared) indications, the ground truth was established through the original clinical validations and regulatory clearances of the predicate device (SonoSite Maxx Series, K071134 and K082098). The specific type of ground truth (e.g., pathology, outcomes data) for the predicate device is not detailed in this particular summary.
- For the "N" (new) indications, specifically for the L38xi/10-5 MHz transducer, these are new combinations of application and mode on a new transducer for which the previous system (Edge) also had "N" indications for "B+M; B+PWD; B+CD" combined modes. The basis for these "new" indications still relies on the fundamental scientific technology being equivalent to the predicate, and safety/performance evaluations rather than novel clinical ground truth data.
8. The Sample Size for the Training Set
- Not applicable. This submission is for a diagnostic imaging device, not an AI/machine learning algorithm that requires a "training set." The system's development involved "System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation," but these are engineering and validation processes, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" in the machine learning sense, this question is not relevant.
{0}------------------------------------------------
510(K) Summary
NOV 1 5 2011
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.
1) Submitter's name, address, telephone number, contact person:
SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904
| Corresponding Official: | Scott E. PaulsonSr. Regulatory Affairs Specialist |
|---|---|
| E-mail: | Scott.Paulson@sonosite.com |
| Telephone: | (425) 951-6926 |
| Facsimile: | (425) 491-8356 |
| Date prepared: | October 4, 2011 |
2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name
Diagnostic Ultrasound System with Accessories
Proprietary Name
SonoSite Edge™ Ultrasound System (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 | LLZ |
3) Identification of the predicate or legally marketed device:
SonoSite Maxx Series Ultrasound System K071134 / K082098
4) Device Description:
The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readily lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.
{1}------------------------------------------------
5) Intended Use:
The intended uses of the SonoSite Edge Ultrasound System as defined by FDA guidance documents, are:
| Ophthalmic | Adult Cephalic |
|---|---|
| Fetal - OB/GYN | Trans-rectal |
| Abdominal | Trans-vaginal |
| Intra-operative | Musculo-skel. (Conventional) |
| (Abdominal organs and vascular) | |
| Intra-operative (Neuro.) | Musculo-skel. (Superficial) |
| Laparoscopic | Cardiac Adult |
| Pediatric | Cardiac Pediatric |
| Small Organ | Trans-esophageal (card.) |
| (breast, thyroid, testicles, prostate) | |
| Neonatal Cephalic | Peripheral vessel |
6) Technological Characteristics:
SonoSite Edge and Maxx Series Ultrasound Systems are both Track 3 devices that employ the same fundamental scientific technology.
7) Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The SonoSite Edge Ultrasound System has been evaluated for electrical, thermal, mechanical and EMC safety. Additionally, cleaning/disinfection, biocompatibility, and acoustic output have been evaluated, and the device has been found to conform to all applicable mandatory medical device safety standards. The Edge system also complies with voluntary standards which are detailed in Table 1.1-1 and 1.1-2 of this premarket submission. Assurance of quality was established by employing the following elements of product development: System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. All patient contact materials are biocompatible. Reports for these product development elements are referenced in Attachment 6.
Summary of Clinical Tests:
The SonoSite Edge Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence.
The SonoSite Maxx Series Ultrasound System is designed to comply with the following standards.
| Reference No. | Title |
|---|---|
| AAMI/ANSI/ISO 10993-1 | ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation andtesting |
| AAMI/ANSI/ISO 10993-5 | ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for InVitro cytotoxicity |
| AAMI/ANSI/ISO 10993-12 | ISO 10993-12:2007, Biological evaluation of medical devices -- Part 12: Samplepreparation and reference materials |
FDA Consensus Standards
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human figures, one behind the other. The figures are connected by a flowing line that represents the interconnectedness of health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
NOV 1 5 2011
SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K113156
Trade/Device Name: SonoSite Edge TM Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and LLZ Dated: October 25, 2011 Received: October 26, 2011
Dear Mr. Job:
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 Edge ™ Ultrasound System, as described in your premarket notification:
Transducer Model Number
C8x/8-5 MHz C11x/8-5 MHz D2x/2 MHz Dual Element Circular Array C60x/5-2 MHz
HFL38x/13-6 MHz HFL50x/15-6 MHz ICTx/8-5 MHz L25x/13-6 MHz L38xi/10-5 MHz
L38x/10-5 MHz P10x/8-4 MHz P21x/5-1 MHz SLAx/13-6 MHz TEEx/8-3 MHz
{3}------------------------------------------------
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 Lauren Hefner at (301) 796-6881.
Sincerely vours.
Markut O'Keeffe fon
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
Indications for Use Form
KII 3156
510(k) Number (if known): TBD
Device Name: SonoSite Edge™ Ultrasound System
Indications for Use:
The SonoSite Edge Ultrasound System is 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/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Adult Cephalic, Trans-Rectal, 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)
Division Chief Officer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113156
Page 1 of 1
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Table 1.3-1 Diagnostic Ultrasound Indications for Use Form – SonoSite Edge™ Ultrasound System
| System: | SonoSite Edge™ 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 | |||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| Ophthalmic | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Fetal | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Abdominal | N | N | N | N | N | B+M; B+PWD;B+CWD; B+CD | Note 1 | |
| Intra-operative (Abdominalorgans and vascular) | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Intra-operative (Neuro.)Laparoscopic | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Pediatric | N | N | N | N | N | B+M; B+PWD;B+CWD; B+CD | Note 1 | |
| Small Organ (breast, thyroid,testicles, prostate) | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Neonatal Cephalic | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Adult Cephalic | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Trans-rectal | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Trans-vaginalTrans-urethralTrans-esoph. (non-Card.) | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Musculo-skel. (Convent.) | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Musculo-skel. (Superfic.)Intra-luminalOther (spec.) | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| Cardiac Adult | N | N | N | N | N | B+M; B+PWD;B+CWD; B+CD | Note 1 | |
| Cardiac Pediatric | N | N | N | N | N | B+M; B+PWD;B+CWD; B+CD | Note 1 | |
| Trans-esophageal (card.)Other (spec.) | N | N | N | N | N | B+M; B+PWD;B+CWD; B+CD | Note 1 | |
| Peripheral vesselOther (spec.) | N | N | N | N | B+M; B+PWD;B+CD | Note 1 | ||
| System: | SonoSite Edge™ Ultrasound System | |||||||
| Transducer: | C8x/8-5 MHz Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human | |||||||
| body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| ColorCombined | Other | |||||||
| B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) | ||
| Ophthalmic | ||||||||
| Fetal | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Abdominal | ||||||||
| Intra-operative (Abdominal organs and vascular) | ||||||||
| Intra-operative (Neuro.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (breast, thyroid, testicles, prostate) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| 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.) | ||||||||
| Musculo-skel. (Superfic.) | ||||||||
| Intra-luminal | ||||||||
| Other (spec.) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | ||||||||
| Other (spec.) |
Additional Comments:
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(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113156
{6}------------------------------------------------
Table 1.3-2 Diagnostic Ultrasound Indications for Use Form – C8x/8-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under this appendix
Additional Comments:
Not in Chier includes color pover Dopler Dopler liste hamonic maging, SonHD Imaging, SondHD inaging, SonolBonning ing maninia,
Close Dopler imaging (TD), inaging to guise Color Doppler includes velocity color Dopler can be combined with any imaging mode. M-Mode includes color M-Mode,
All items marked "P" were previously cleared in 510(k) K071134 and K082098.
Prescription Use (Per 21 CFR 801.109)
Michael D'Okon
Division S Division of Radielegical De Office of In Vitro Diagnostie Device Evaluation and Safety
510K K113156
Page 61 of 3239
{7}------------------------------------------------
Table 1.3-3 Diagnostic Ultrasound Indications for Use Form – C11x/8-5 Transducer
| System: | SonoSite Edge™ Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | C11x/8-5 MHz Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of thehuman body as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| 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 | 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 | ||||||||
| Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD;B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | ||||||||
| Neonatal Cephalic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| 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 Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD;B+CD | Note 1 | |
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under this appendix
Additional Comments:
Not 1: Other induces color pover Doper, contine (sea harmoin maging, SondHD imaging, SondHolle conponintaging,
issue bearinging guidance for perineral erre bicc proctures, in Mode includes color M-Mode.
All items marked *P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
hll D Dth
(Uivision Sign on of Radiological Devices Office of I ice Evaluation and Safety
510K K113156
Page 62 of 3239
{8}------------------------------------------------
Table 1.3-4 Diagnostic Ultrasound Indications for Use Form – D2x/2 Transducer
| System: | SonoSite Edge™ Ultrasound System |
|---|---|
| Transducer: | D2x/2 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 |
|---|---|
| ---------------------- | ------------------- |
| B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) | |
|---|---|---|---|---|---|---|---|
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| 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 | P | ||||||
| Cardiac Pediatric | P | ||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Additional Comments:
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113156
{9}------------------------------------------------
| Table 1.3-5 Diagnostic Ultrasound Indications for Use Form - C60x/5-2 Transducer | |||||
|---|---|---|---|---|---|
| ---------------------------------------------------------------------------------- | -- | -- | -- | -- | -- |
| System: | SonoSite Edge™ Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | C60x/5-2 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | P | P | P | P | 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 | 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.) | |||||||
| Laparoscopic | |||||||
| 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 Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
Additional Comments:
Note 1: Other includes color power Doppler, combined B and color power Doppler, tissue hamonic imaging, SonoMBMBe compound maging, tissue Dopler imaging (TDI), imaging guidance for procedures, inaging of spinal cord to provide guidance for central neve block procedures, imaging for guidance of biopsy and imaging to assist in he des and catheres in vascular or ther anatonical structures. Color Dopler includes velocity color Doppler. Color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113/5C.
{10}------------------------------------------------
| System: | SonoSite Edge™ Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | HFL38x/13-6 MHz Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| 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.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Small Organ (breast, thyroid, testicles, prostate) | 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 Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Other (spec.) |
Table 1.3-6 Diagnostic Ultrasound Indications for Use Form – HFL38x/13-6 Transducer
N= new indication; P= previously cleared by FDA; E= added under this appendix
Additional Comments:
Note 1: Other includes color power Doppler, combined B and color power Dopler, tissue hamonic imaging, SonoMBMBe compound imaging, r on one mana o one popily concerner in and brown in and province maging somble content magnic
itsue operimania (TD), maging necessary (negera naging is spiral conter contact velocity color Doppler, Color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiological Devices Office of in Vitro Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety
510K K113/56
Page 65 of 3239
{11}------------------------------------------------
| System: | SonoSite Edge™ Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | HFL50x/15-6 MHz Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | |||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| 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.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Small Organ (breast, thyroid, testicles. prostate) | 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 Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Other (spec.) |
Table 1.3-7 Diagnostic Ultrasound Indications for Use Form – HFL50x/15-6 Transducer
Additional Comments:
Note 1: Other includes color power Dopler, combined B and color power Dopler, tissue hamonic imaging, SonoHD2 imaging, SonoMBMBe compound imaging, tissue Dopler inaging (TD), imaging guidance for peripheral neve block procedures, imaging of spiral nerve block procedures, imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures. Color Doppler includes velocity color Doppler. Color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134.
Muchel DDK
(Division Sign-O Division of Radiological Devices Office of In Vitro Diagnostic Dev ice Evaluation and Safety
510K K113/56
{12}------------------------------------------------
| System: | SonoSite Edge™ Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | ICTx/8-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||
| Clinical Application | Mode of Operation | Combined(Spec.) | Other(Spec.) | ||||
| B | M | PWD | CWD | Color Doppler | |||
| Ophthalmic | |||||||
| Fetal | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles, prostate) | |||||||
| Neonatal Cephalic | |||||||
| Adult Cephalic | |||||||
| 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.) | |||||||
| Musculo-skel. (Superfic.) | |||||||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Table 1.3- 8 Diagnostic Ultrasound Indications for Use Form - ICTx/8-5 Transducer
N= new indication; P= previously cleared by FDA; E= added under this appendix
Additional Comments:
Note 1: Other includes color power Doper Doper, itsue hamnir imaging, SonoHD inaging, SonoHD inaging in analminal stuches: Color Doppler includes velocity color Doppler can be combined with any imaging mode. M-Mode indudes color M-Mode.
All items marked "P" were previously cleared in 510{k} K071134.
.(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113156
{13}------------------------------------------------
| System: | SonoSite Edge™ Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer:. | L25x/13-6 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | P | P | P | B+M; B+CD | Note 1 | ||
| Fetal | |||||||
| Abdominal | P | P | P | B+M; B+CD | Note 1 | ||
| Intra-operative (Abdominal organs andvascular) | P | P | P | B+M; B+CD | Note 1 | ||
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | P | P | P | B+M; B+CWD; 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-skel. (Convent.) | P | P | P | B+M; B+CD | Note 1 | ||
| Musculo-skel. (Superfic.) | P | P | P | B+M; B+CD | Note 1 | ||
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | B+M; B+CD | Note 1 | ||
| Other (spec.) |
Table 1.3- 9 Diagnostic Ultrasound Indications for Use Form – L25x/13-6 Transducer
Additional Comments:
Note 1: Other induces color power Doppler, combined B and color power Doppler, tissue hamonic imaging, SonoHD2 imaging, SonoMBMBe compound imaging, tissue Doppler imaging (TD), imaging guidanal neve block procedures, imaging for maging to assist it the placent in needes and catheres in vascular or other anatomical structures. Cator Dopler. Color Dopler. Color Dopler can be combined with any inaging mode. M-Mode includes color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134 and K082098.
(Division Sign Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113156
{14}------------------------------------------------
| System: | SonoSite Edge™ Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | L38xi/10-5 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||
| Clinical Application | B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | N | N | N | N | B+M; B+PWD; B+CD | Note 1 | |
| Intra-operative (Abdominal organs and vascular) | N | N | N | N | B+M; B+PWD; B+CD | Note 1 | |
| Intra-operative (Neuro.) | |||||||
| Laparoscopic | |||||||
| Pediatric | N | N | N | N | B+M; B+PWD; B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | N | N | N | N | 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.) | N | N | N | N | B+M; B+PWD; B+CD | Note 1 | |
| Musculo-skel. (Superfic.) | N | N | N | N | B+M; B+PWD; B+CD | Note 1 | |
| Intra-luminal | |||||||
| Other (spec.) | |||||||
| Cardiac Adult | |||||||
| Cardiac Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | N | N | N | N | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
Table 1.3- 10 Diagnostic Ultrasound Indications for Use Form - L38xil10-5 Transducer
Additional Comments:
Note 1: Other includes color power Dopler Dopler Dopler, lissue harmonic imaging, SonoHD2 imaging, SonoMBMBe compound maging, lissue Doppler inaging (TDI), inaging guidance for perior spinal ord to proving of to recente novelle no centen here block procently structures. Color Dopler includes velocity color Doppler. Color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.
Aadad D. Sthe
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113156
{15}------------------------------------------------
| System: | SonoSite Edge™ Ultrasound System | |||||||
|---|---|---|---|---|---|---|---|---|
| Transducer: | L38x/10-5 MHz Transducer | |||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human | |||||||
| body as follows: | ||||||||
| Clinical Application | Mode of Operation | |||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | ||
| 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.) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Small Organ (breast, thyroid, testicles, prostate) | 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 Pediatric | ||||||||
| Trans-esophageal (card.) | ||||||||
| Other (spec.) | ||||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | ||
| Other (spec.) |
Table 1.3- 11 Diagnostic Ultrasound Indications for Use Form - L38x/10-5 Transducer
Additional Comments:
Note 1: Other includes color power Doper Doper Doper I sisue harmorie inagin, SonolDida Compunis inaging.
tissue Dopler imaging (TDI), imaging guident and bock province and b ivaging for audiance of biopsy and inaging to assist in vascular or other and cathelers in vascular or other anatonical structures. Color Dopler includes velocity color Doppler. Color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
Muhal O'thun
(Division Sign Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113156
Page 70 of 3239
{16}------------------------------------------------
| System: | SonoSite Edge™ Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | P10x/8-4 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Fetal | P | P | P | P | B+M; B+PWDB+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+PWDB+CD | Note 1 | |
| Intra-operative (Neuro.) | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| 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+PWDB+CD | Note 1 | |
| Neonatal Cephalic | P | P | P | P | B+M; B+PWDB+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+PWDB+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 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
Table 1.3- 12 Diagnostic Ultrasound Indications for Use Form – P10x/8-4 Transducer
N= new indication; P= previously cleared by FDA; E= added under this appendix
Additional Comments:
Note 1: Other includes color power Doppler Dopler Dopler, tissue harmonic imaging, SonoHD2 imaging, SonoMBMBe compound imaging, tissue Dopler imaging (TD), color TD, imaging guidance for perior guidance of biosy and imaging to assist in the placement of needles and catheters in vascular or other analy color Doppler includes velocity color Doppler can be combined with any imaging mode. M-Mode includes color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
.
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic D. ice Evaluation and Safety
510K K113156
Page 71 of 3239
{17}------------------------------------------------
| Table 1.3- 13 Diagnostic Ultrasound Indications for Use Form - P21x/5-1 Transducer | |||
|---|---|---|---|
| -- | ------------------------------------------------------------------------------------ | -- | -- |
| System: | SonoSite Edge™ Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | P21x/5-1 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the humanbody as follows: | ||||||
| Clinical Application | Mode of Operation | ||||||
| B | M | PWD | CWD | ColorDoppler | Combined(Spec.) | Other(Spec.) | |
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Fetal | P | P | P | P | B+M; B+PWDB+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+PWDB+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+PWDB+CD | Note 1 | |
| Neonatal Cephalic | P | P | P | P | B+M; B+PWDB+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+PWDB+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 |
| Cardiac Pediatric | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
Additional Comments:
Note 1: Oher includes obr contined B and cover Lises hamnic inaging, SonHD inging, SondHD connound imaging
Issue Dopler inaging (TD), color Do, incinto do assist in the Ja
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
(Division Sign-Off)
Division of Radiologica! Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K113/56
Page 72 of 3239
{18}------------------------------------------------
| System: | SonoSite Edge™ Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | SLAx/13-6 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human | ||||||
| body as follows: | |||||||
| Clinical Application | Mode of Operation | ||||||
| Color | Combined | Other | |||||
| B | M | PWD | CWD | Doppler | (Spec.) | (Spec.) | |
| Ophthalmic | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Fetal | |||||||
| Abdominal | |||||||
| 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 | |
| Laparoscopic | |||||||
| Pediatric | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Small Organ (breast, thyroid, testicles. prostate) | 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 Pediatric | |||||||
| Trans-esophageal (card.) | |||||||
| Other (spec.) | |||||||
| Peripheral vessel | P | P | P | P | B+M; B+PWD; B+CD | Note 1 | |
| Other (spec.) |
Table 1.3- 14 Diagnostic Ultrasound Indications for Use Form – SLAx/13-6 Transducer
Additional Comments:
Note 1: Other includes color power Dopler, combined B and color power Doppler, tissue harmonic imaging, SonoHD2 imaging, SonoMBMBe compound imaging, tissue Dopler imaging (TD), interne a and both procedures, imaging, colonization and maging basis in the placement dreeles and cathers in vascular or ther analomical stuctures. Color Dopler. Color Doppler Color Doppler can he combined with any inaginish mode. Ma Mode includes color M-Mode.
All items marked "P" were previously cleared in 510(k) K071134 and K082098.
ision Sign-Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113156
{19}------------------------------------------------
| Table 1.3- 15 Diagnostic Ultrasound Indications for Use Form - TEEx/8-3 Transducer | |
|---|---|
| System: | SonoSite Edge™ Ultrasound System | ||||||
|---|---|---|---|---|---|---|---|
| Transducer: | TEEx/8-3 MHz Transducer | ||||||
| Intended Use: | Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | ||||||
| Clinical Application | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
| Ophthalmic | |||||||
| Fetal | |||||||
| Abdominal | |||||||
| Intra-operative (Abdominal organs and vascular) | |||||||
| Intra-operative (Neuro.) . | |||||||
| Laparoscopic | |||||||
| Pediatric | |||||||
| Small Organ (breast, thyroid, testicles. prostate) | |||||||
| 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 Pediatric | |||||||
| Trans-esophageal (card.) | P | P | P | P | P | B+M; B+PWD; B+CWD; B+CD | Note 1 |
| Other (spec.) | |||||||
| Peripheral vessel | |||||||
| Other (spec.) |
Additional Comments:
Note 1: Other includes color power Doppler, combinet B and color power Doppler, tissue harmonic imaging, SonoMBMBe compound imaging, tissue Dopler imaging (TD), color TD, imaging to guidance of biopsy and imaging to assist in the placement of rescular or ober anatomical structures. Color Doppler includes velocity color Doppier can be combined with any imaging mode. M-Mode includes color M-Moce.
All items marked "P" were previously cleared in 510(k) K071134.
Prescription Use (Per 21 CFR 801.109)
Mashal D.K
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113156
Page 74 of 3239
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.