SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)

K052109 · Sonosite,Inc. · IYN · Aug 11, 2005 · Radiology

Device Facts

• Record ID: K052109
• Device Name: SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)
• Applicant: Sonosite,Inc.
• Product Code: IYN · Radiology
• Decision Date: Aug 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The intended uses of the SonoSite Hand-Carried Ultrasound System (C1 Series) as defined by FDA guidance documents, are: Fetal - OB/GYN, Abdominal, Intra-operative (Abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicles, prostate), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.

Device Story

Highly portable, software-controlled diagnostic ultrasound system; utilizes C60/5-2 curved array transducer (5.0-2.0 MHz). System captures acoustic signals; transforms inputs into real-time B-mode, M-mode, and Pulsed Wave Doppler (PWD) images. Used in clinical settings by healthcare professionals for diagnostic imaging and guidance of biopsy/needle placement. Output displayed on integrated screen for clinician interpretation; aids in clinical decision-making by providing anatomical visualization of small organs (breast, thyroid, testicles, prostate). Benefits include portable, point-of-care diagnostic capability.

Clinical Evidence

Bench testing only. Evaluation included acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/mechanical safety testing. No clinical data required as the added indication is not novel and is supported by predicate device indications.

Technological Characteristics

Curved array transducer (5.0-2.0 MHz). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004, and ISO 10993 series for biocompatibility. Software-controlled; portable form factor. Connectivity and specific algorithm architecture not detailed beyond standard diagnostic ultrasound processing.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, specifically including small organ (breast, thyroid, testicles, prostate) applications for the C60/5-2 transducer.

Regulatory Classification

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.

Predicate Devices

• SonoSite Hand-Carried Ultrasound System (C1 Series) (K010374 and K014116)
• Advanced Technology Laboratories HDI 5000 Ultrasound System (K011224)

Submission Summary (Full Text)

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AUG 1 1 2005

SonoSite, Inc. 21919 30th Drive SE WA 98021-3904 USA

Telephone:[phone] imile:1.425.951.1201

www.sonosite.com

1052109

# 510(K) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of this Pre-market 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: | Daina L. Graham<br>Vice President, Regulatory Affairs and Quality Assurance |
|-------------------------|-----------------------------------------------------------------------------|
| E-mail: | [e-mail] |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date prepared: | July 29, 2005 |

- 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 Hand-Carried Ultrasound System (C1 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 |

510(K) Summary Of Safety And Effectiveness

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#### 3) ldentification of the predicate or legally marketed device:

This 510(k) adds the clinical application "Small Organ (breast, thyroid, testicles, prostate)" to the indications for use of the transducer C60/5-2 5.0-2.0 MHz Curved Arrav on the SonoSite Hand-Carried Ultrasound System (C1 Series) (K010374 and K014116). No other change, including technological change was made to this system. A predicate device that has "Small Organ" as a clinical application or indication is Advanced Technology Laboratories HDI 5000 Ultrasound System (K011224).

#### Device Description: 4)

The device referenced in this Submission is a highly portable, software-controlled, diagnostic ultrasound system with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.

By this Submission, the clinical application "Small Organ (breast, thyroid, testicles, prostate)" is being added to previously cleared indications for use to the following transducer:

| System | Transducer | Transducer<br>Type | Frequency<br>Range |
|-----------------------------------------|------------|--------------------|--------------------|
| SonoSite Hand-Carried Ultrasound System | C60/5-2 | Curved Array | 5.0 - 2.0 MHz |

FDA Recognized Consensus Standards that SonoSite Hand-Carried Ultrasound System (C1 Series) is designed to comply with, as applicable to its features, are listed below:

### Applicable Standards

| Reference No. | Title |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|
| AIUM | AIUM Medical Ultrasound Safety, American Institute of Ultrasound in Medicine<br>(1994) |
| ANSI/AAMI EC53 | ECG Cables and Electrodes except for sections 4.4 and 4.5.9 (1995) |
| AAMI/ANSI/ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO<br>10993-1:1997) |
| AAMI/ANSI/ISO 30993-4 | Biological evaluation of medical devices - Part 4: Selection of tests for<br>interactions with blood (ISO 10993-4:1992) |
| AAMI/ANSI/ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity<br>(ISO 10993-5:1999) |
| AAMI/ANSI/ISO 10993-10 | Biological evaluation of medical devices - Part 10: tests for irritation and<br>sensitization (ISO 10993-10:1995) |
| AAMI/ANSI/ISO 10993-11 | Biological evaluation of medical devices - Part 11: Tests for systematic toxicity<br>(ISO 10993-11:1993) |

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| Reference No. | Title |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI/ISO 10993-12 | Biological evaluation of medical devices - Part 12: sample preparation and<br>reference materials (ISO 10993-12:1996) |
| 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-<br>1:1988 |
| IEC 60601-1/A1 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-<br>1:1988/A1:1991 |
| IEC 60601-1/A2 | Medical electrical equipment. Part 1: General requirements for safety - IEC 601-<br>1:1988/A2:1995 + corrigendum June 1995 |
| IEC 60601-1-1 | Medical electrical equipment. Part 1: General requirements for safety - 1.<br>Collateral standard: Safety requirements for medical electrical systems - IEC<br>601-1-1:2000 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1: General requirements for safety; 2.<br>collateral standard: electromagnetic compatibility; requirements and tests - IEC<br>60601-1-2:200 |
| IEC 60601-1-4 | Medical electrical equipment - Part 1: General requirements for safety - 4.<br>Collateral standard: Programmable electrical medical systems - IEC 60601-1-<br>4:1996 Amendment A1 |
| IEC 60601-2-25 | Medical Electrical Equipment-Part 2. Particular Requirements for Safety-<br>Section 25. Specification for Electrocardiographs. (1999 |
| IEC 60601-2-37 | Medical Electrical Equipment - Part 2-37; Particular requirements for the safety<br>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<br>Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound<br>in Medicine |

The following are other standards with which the SonoSite Hand-Carried Ultrasound System (C1 Series) complies, where applicable:

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## Miscellaneous Design Standards

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:

:

| Reference No. | Title |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5276-98 | Standard Test Methods for Drop Test of Loaded Containers by Free Fall<br>(1998) |
| ASTM D999-96 | Standard Methods for Vibration Testing of Shipping Containers (1996) |
| CISPR 11 | Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment -<br>Electromagnetic Disturbance Characteristics - Limits and Methods of<br>Measurement (2003) |
| JIS-T-601-1 | Japanese Standards for Medical Electrical Equipment |
| RTCA/DO160D | Radio Technical Commission for Aeronautics, Environmental Conditions<br>and Test Procedures for Airborne Equipment, Section 21.0 Emission of<br>Radio Frequency Energy, Category B (1997) |
| UL 60601-1 | Underwriters Laboratories, Medical Electrical Equipment-Part 1:<br>General Requirements for Safety (2003) |
| UL 94 | Underwriters Laboratories, Inc., Tests for Flammability of Plastic<br>Materials for Parts in Devices and Appliances, 5th Edition |

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#### Intended Use: 5)

The intended uses of the SonoSite ultrasound system referenced herein remain The Intention accords of cleared indications, except for the addition of "Small Organ dhenanged from proviously clource to the indications for use of the transducer C60/5-2 (Dreast, Infrold, Coclinion SonoSite Hand-Carried Ultrasound System (C1 Series) as a new intended use.

The intended uses of the SonoSite Hand-Carried Ultrasound System (C1 Series) as defined by FDA guidance documents, are:

| Fetal - OB/GYN | Trans-rectal |
|-------------------------------------------------------|------------------------------|
| Abdominal | Trans-vaginal |
| Intra-operative<br>(Abdominal organs and vascular) | Musculo-skel. (Conventional) |
| Intra-operative (Neuro.) | Musculo-skel. (Superficial) |
| Pediatric | Cardiac Adult |
| Small Organ<br>(breast, thyroid, testicles, prostate) | Cardiac Pediatric |
| Neonatal Cephalic | Peripheral vessel |

#### Technologica! Characteristics: 6)

There are no technological or feature changes in this Submission to any of the legally marketed ultrasound systems, transducers, or accessories identified in Section 3 of this 1 1 2 3 3 Summary.

#### 7) Testing:

The referenced SonoSite Hand-Carried Ultrasound System (C1 Series) has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety, and has been found to conform to applicable medical device safety standards, as referenced in Section 4. Reports were previously included in the referenced predicate submissions. No additional clinical testing is required, as the added indication for use is not a novel indication as shown by the predicate devices in Section 3. The anatomical site is amenable to current transducer and post-processing ultrasound technology available with the SonoSite Hand-Carried Ultrasound System (C1 Series) and predicate devices. Additionally, the modes of operation that are indicated with this clinical application for the SonoSite Hand-Carried Ultrasound System (C1 Series) is consistent with those identified with the predicate devices.

#### Conclusion: 8)

SonoSite believes that the testing and analysis described in Section 7 demonstrates that the SonoSite Hand-Carried Ultrasound System (C1 Series) (K010374 and that the ochoone frank ounts and Organ (breast, thyroid, testicles, prostate)" indication on the transducer C60/5-2 5.0-2.0 MHz Curved Array, are substantially equivalent with respect to safety and effectiveness to the predicate device identified in Section 3.

510(K) Summary Of Safety And Effectiveness

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a caduceus, with three curved lines representing the human form and a wavy line at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2005

SonoSite, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K052109

Trade Name: SonoSite Hand-Carried Ultrasound System (C-1 Series) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX . Dated: August 2, 2005 Received: August 4, 2005

### 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 Hand-Carried Ultrasound System (C-1 Series), as described in your premarket notification:

Transducer Model Number

C60/5-2. 5.0-2.0 MHz Curved Array

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.

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 (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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket notification: The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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Page 3 - Mr. Job

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.

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If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

·

Sincerely yours,

David A. Lyon

or Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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11 - 1 - 1 - 1 - 1 -

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| System: | SonoSite Hand-Carried Ultrasound System (C1 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Spec.) | Other<br>(Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | | B+M; B+PWD | Note 1 |
| | Abdominal | P | P | P | P | | B+M; B+PWD;<br>B+CWD | Note 1 |
| | Intra-operative<br>(Abdominal organs and<br>vascular) | P | P | P | | | B+M; B+PWD | Note 1 |
| Fetal Imaging | Intra-operative (Neuro.) | P | P | P | | P | B+M; B+PWD;<br>B+CD | Note 1, 2 |
| | Laparoscopic | P | P | P | | | B+M; B+PWD | Note 1 |
| & Other | Pediatric | P | P | P | P | | B+M; B+PWD;<br>B+CWD | Note 1 |
| | Small Organ (breast,<br>thyroid, testicles,<br>prostate) | P | P | P | | | B+M; B+PWD | Note 1 |
| | Neonatal Cephalic | P | P | P | | | B+M; B+PWD | Note 1 |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | P | P | P | | | B+M; B+PWD | Note 1 |
| | Trans-vaginal | P | P | P | | | B+M; B+PWD | Note 1 |
| | Trans-urethral | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | |
| | Musculo-skel. (Convent.) | P | P | P | | | B+M; B+PWD | Note 1 |
| | Musculo-skel. (Superfic.) | P | P | P | | | B+M; B+PWD | Note 1 |
| | Intra-luminal | | | | | | | |
| | Other (spec.) | | | | | | | |
| | Cardiac Adult | P | P | P | P | | B+M; B+PWD;<br>B+CWD | Note 1 |
| Cardiac | Cardiac Pediatric | P | P | P | P | | B+M; B+PWD;<br>B+CWD | Note 1 |
| | Trans-esophageal (card.) | | | | | | | |
| | Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | P | P | P | | | B+M; B+PWD | Note 1 |
| | Other (spec.) | | | | | | | |

Table 4.3- 1 Diagnostic Ultrasound Indications for Use Form - System

N= new indication; P= previously cleared by FDA; E= added under Appendix E

### Additional Comments:

: 上一篇:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Doppler, 3-D Imaging, Tissue Harmonic Imaging, and imaging for guidance of biopsy cleared in K014116. Imaging uidance for peripheral nerve block procedures and imaging to assist in the placement of needles and catheters in vascular or other analomical structures was previously cleared in K033367.

Note 2: The clinical application Intra-operative (Neuro.) was previously cleared in K043452

Prescription Use (Per 21 CFR 801.109)

Daniel A. Sessa

Bearroriuctive Abdon

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| System: | SonoSite Hand-Carried Ultrasound System (C1 Series) | | | | | | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|---------------|------------------|---------------|
| Transducer: | C60/5-2 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<br>(Track I only) | Specific<br>(Tracks I & III) | B | M | PWD | CWD | Color Doppler | Combined (Spec.) | Other (Spec.) |
| Ophthalmic | Ophthalmic | | | | | | | |
| | Fetal | P | P | P | | | B+M; B+PWD; | Note 1 |
| | Abdominal | P | P | P | | | B+M; B+PWD; | Note 1 |
| | Intra-operative<br>(Abdominal organs and vascular) | P | P | P | | | B+M; B+PWD; | Note 1 |
| Fetal Imaging<br>& Other | Intra-operative (Neuro.) | | | | | | | |
| | Laparoscopic<br>Pediatric | P | P | P | | | B+M; B+PWD; | Note 1 |
| | Small Organ (breast,<br>thyroid, testicles,<br>prostate) | N | N | N | | | B+M; B+PWD; | Note 1 |
| | Neonatal Cephalic<br>Adult Cephalic<br>Trans-rectal<br>Trans-vaginal<br>Trans-urethral<br>Trans-esoph. (non-Card.)<br>Musculo-skel. (Convent.)<br>Musculo-skel. (Superfic.)<br>Intra-luminal<br>Other (spec.) | | | | | | | |
| Cardiac | Cardiac Adult | P | P | P | | | B+M; B+PWD; | Note 1 |
| | Cardiac Pediatric | P | P | P | | | B+M; B+PWD; | Note 1 |
| | Trans-esophageal (card.)<br>Other (spec.) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel<br>Other (spec.) | | | | | | | |

# Table 4.3- 2 Diagnostic Ultrasound Indications for Use Form - C60/5-2 Transducer

previously cleared by FDA; E= added under Appendix E

### Additional Comments:

Note 1: Other includes Color Power Doppler, combined B and Color Power Doppler, combined B and Directional Color Power Dopler, 3-D Insue Farmonic maging, imaging for guidance of biopsy and institution of assist in the placement of needes and cather and of the reasonable minging, muging of gabanes of blogs and maging to assist in the placements of the proceed

Prescription Use (Per 21 CFR 801.109)

Daniel A. Graham

(Division Sign-Off) Division of Reproductive. and Radiological Devices 510(k) Number

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