COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM

K981505 · Sonosite,Inc. · IYO · May 8, 1998 · Radiology

Device Facts

• Record ID: K981505
• Device Name: COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Sonosite,Inc.
• Product Code: IYO · Radiology
• Decision Date: May 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Small Organs (breast, thyroid, testicle), Pediatric, Transvaginal, Peripheral Vessel, Cardiac, Musculo-skeletal (conventional), Neonatal Cephalic. Typical examinations performed using Cozumel system are: General abdominal and pelvic studies including organ surveys, blood flow assessment, and retroperitoneal cavity studies. Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs, superficial, and bony structures. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Neonatal head studies. General cardiac studies in adults.

Device Story

Cozumel is a portable, software-controlled diagnostic ultrasound system. It utilizes curved or linear array scanheads (2.0-7.0 MHz) to acquire ultrasound data. The system transforms reflected sound waves into 2D, M-mode, and Color Power Angio (CPA) images. Operators control system performance via a main control panel; system software automatically optimizes operating conditions (e.g., frame rate, line density) based on user inputs. The device displays mechanical and thermal indices to assist clinicians in adhering to ALARA principles. Output is viewed on a monitor to facilitate anatomical measurements and clinical diagnosis. The device is intended for use by healthcare professionals in clinical settings to support diagnostic decision-making across various anatomical regions.

Clinical Evidence

Bench testing only. The device conforms to recognized electromechanical safety standards (EN 60601-1, UL 2601-1, CSA C22.2 No. 601.1) and electromagnetic compatibility standards (EN 60601-1-2). Acoustic output performance was verified against AIUM/NEMA standards for thermal and mechanical indices. No clinical data was required for this 510(k) clearance.

Technological Characteristics

Portable ultrasound system using piezoelectric transducers. Frequency range: 2.0-7.0 MHz. Modes: 2D, M-mode, Color Power Angio. Conforms to AIUM/NEMA 1992 standards for real-time thermal/mechanical index display. Safety standards: IEC 601-1, UL 2601-1, CSA C22.2 No. 601.1, IEC 1157:1992. Biocompatible patient-contact materials. Software-controlled optimization of scanhead parameters.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, intraoperative, small organ, pediatric, transvaginal, peripheral vessel, cardiac, musculoskeletal, and neonatal cephalic applications. Includes biopsy guidance.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ATL HDI 5000
• Medison SA600
• ATL Ultramark 4

Submission Summary (Full Text)

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K981605

510(k) Premarket Notification

Cozumel Ultrasound System

#### 8 1998 MAY

## 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)

Terrence J. Sweeney Regulatory Affairs Consultant SonoSight, Inc. 22100 Bothell Everett Highway P.O. Box 3003 Bothell, WA 98041-3003 [phone]

Date prepared: March 16, 1998

- Name of the device, including the trade or proprietary name if 2) applicable, the common or usual name, and the classification name, if known:
Common/ Usual Name

Diagnostic Ultrasound System with Accessories

Proprietary Name

Cozumel Ultrasound System

### Classification Names

| Ultrasonic Pulsed Doppler Imaging System | 90-IYN | 892.1550 |
|------------------------------------------|--------|----------|
| Diagnostic Ultrasonic Scanhead | 90-ITX | 892.1570 |
| Ultrasonic Pulsed Echo Imaging System | 90-IYO | 892.1560 |

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

SonoSight, Inc. believes that Cozumel ultrasound system is substantially equivalent to the currently marketed ATL HDI® 5000 and Medison SA600 diagnostic ultrasound systems and the previously marketed ATL Ultramark® 4 system.

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#### 4) Device Description:

Cozumel is a general purpose, highly portable, software-controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, and Color Power Angio (CPA) or in a combination of modes. Cozumel also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes. Cozumel has an output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The Cozumel system is designed to accept a curved or linear scanhead. All actions affecting the performance of the scanhead are activated from the main system control panel.

The Cozumel system is designed to accept scanheads of the following types and frequency:

frequency range: 2.0 - 7.0 MHz

scanhead types: Linear array Curved linear array

Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, gain etc.

Cozumel has been designed to meet the following electromechanical safety standards:

- EN 60601-1 (IEC 601-1,) European Norm, Medical Electrical ● Equipment
- UL 2601-1, Underwriters Laboratories Standards, Medical Electrical . Equipment
- C22.2 No. 601.1, Canadian Standards Association, Medical Electrical . Equipment
- CEI/IEC 1157:1992, International Electrotechnical Commission, . Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment
- . EN 60601-1-2 (IEC 601-1-2,) European Norm, Collateral Standard: Electromagnetic Compatibility

ﺔ ﻳﺠﺎ

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#### Intended Use: 5)

Cozumel intended uses as defined FDA guidance documents are:

- Fetal OB/GYN .
- Abdominal .
- Intraoperative (abdominal organs and vascular) .
- Small Organs (breast, thyroid, testicle) .
- Pediatric .
- Transvaginal .
- Peripheral Vessel .
- Cardiac
- Musculo-skeletal (conventional) .
- Neonatal Cephalic .

Typical examinations performed using Cozumel system are:

- General abdominal and pelvic studies including organ surveys, . blood flow assessment, and retroperitoneal cavity studies.
- Study of small parts and superficial structures including breasts, . shoulders, thyroid, and the abdominal wall.
- Pediatric scans of organs, superficial, and bony structures. .
- Monitoring procedures for infertility studies (other than in vitro . fertilization).
- First, second and third trimester pregnancy studies. .
- Neonatal head studies. .
- General cardiac studies in adults. .

#### 6) Technological Characteristics:

This device operate identical to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D and M-mode images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis. The modes of this device (2D, M-mode, and Color Power Angio) are the same as predicate devices identified in item 3. Scanhead patient contact materials are biocompatible.

This device conforms to the Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (AIUM/NEMA, 1992) for an on-screen display ﺰ

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feature that provides information on potential thermal and rcavitation bioeffect mechanisms. A user education program provides cavitation blocirect inceso users may moderate the system's acoustic output in accordance with the ALARA (as low as reasonably achievable) principle.

The device's acoustic output limits are:

All Applications:

| ISPTAd | 720 mW/cm2 | (Maximum) |
|-----------------------|---------------|-----------|
| TIS/TIB/TIC | 0.1 - 4.0 | (Range) |
| Mechanical Index (MI) | 1.9 | (Maximum) |
| ISPPAd | 0 - 700 W/cm2 | (Range) |

The limits are same as predicate Track 3 devices.

y

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Image /page/4/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a larger document or heading. The words are clear and legible against a plain white background.

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1098 MAY

SonoSight, Inc. c/o Robert Mosenkis Citech 5200 Butler Pike Plymouth Meeting, PA 19462-1298

K981505 Re: Cozumel Ultrasound System April 23, 1998 Dated: Received: April 24, 1998 Regulatory class: II 21 CFR 892.1550/Procode: 90 TYN 21 CFR 892.1560/Procode: 90 İYO 90 ITX 21 CFR 892.1570/Procode:

Dear Mr. Mosenkis:

laws or regulations.

We have reviewed your section 510(k) notification of intent to market the device referenced aboye and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. You may, therefore, market the device, subject to the general controls provisions of the Act (Act). The general controls provisions of the Act include requirements for 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 Cozmel Ultrasound System, as described in your premarket notification:

Transducer Model Number

C7-4 MHz IVT L7-3 MHz Linear Array C4-2 MHz Curved Array

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal

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Page 2 - Robert Mosenkis

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 - Intel Sport Instan France
measurements based on production line devices, requested in Appendix G,
(enclosed) of the Center's September 30, 1997 "Information for Manufacture 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. T+ 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other qeneral information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Robert Phillips, Ph.D. at [phone].

Sincerely yours,

David A. Seggern
for Lillian Yin, Ph.D.

irector, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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| 510(k) Number: | TBD |
|----------------|---------------------------|
| Device Name: | Cozumel Ultrasound System |

Diagnostic ultrasound imaging or fluid flow analysis of the human body as Indications for Use: follows:

## of Operation (* includes simultaneous B-mode)

| Mode of Operation (* Includes simultaneous B mode) | | | | | | | | | | |
|-------------------------------------------------------|---|---|----|-----|-----|------------------|-----------------------|------------------------------|-----------------------|--------------------|
| Clinical Applications | A | B | M* | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler* | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | N | | | Note 1 |
| Fetal | | N | N | | | | N | | | Note 1 |
| Abdominal | | N | N | | | | N | | | Note 1 |
| Intraoperative:<br>(Abdominal organs and<br>vascular) | | N | N | | | | | | | |
| Intraoperative<br>Neurological | | | | | | | N | | | Note 1 |
| Pediatric | | N | N | | | | N | | | Note 1 |
| Small Organ<br>(breast, thyroid, testicle) | | N | N | | | | | | | |
| Neonatal Cephalic | | N | N | | | | N | | | |
| Adult Cephalic | | | | | | | N | | | |
| Cardiac<br>Transesophageal | | N | N | | | | | | | |
| Transrectal<br>Transvaginal | | N | N | | | | N | | | Note 1 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | N | N | | | | N | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | | | | N | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |

Other (Specify)
N=new indicatiion, P=previously cleared by FDA; E=added under Appendix E

Note 1: Includes imaging for guidance of biopsy

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Sezom

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number

ﺮ

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| 510(k) Number: | |
|----------------|--|
| Device Name: | |
| Transducer: | |

TBD Cozumel Ultrasound System C7-4 MHz IVT

Indications for Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Mode of Operation (* includes simultaneous B-mode) | | | | | | | | | | |
|----------------------------------------------------|---|---|----|-----|-----|------------------|-----------------------|------------------------------|-----------------------|--------------------|
| Clinical Applications | A | B | M* | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler* | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal - OB/GYN | | N | N | | | | N | | | Note 1 |
| Abdominal | | | | | | | | | | |
| Intraoperative:<br>(Specify) | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | N | N | | | | N | | | Note 1 |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | |

a (* includes simultaneous B-mode) C

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

Note 1: Includes imaging for guidance of biopsy

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel G. Symm
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number

ﺮ

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| 510(k) Number: | TBD |
|----------------|---------------------------|
| Device Name: | Cozumel Ultrasound System |
| Transducer: | L7-4 MHz Linear Array |

Diagnostic ultrasound imaging or fluid flow analysis of the human body as Indications for Use: follows:

| | | | | | | | Mode of Operation (* includes simultaneous B-mode) | | | | |
|-------------------------------------------------------|---|---|----|-----|-----|------------------|----------------------------------------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Applications | A | B | M* | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler* | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal - OB/GYN | | | | | | | N | | | | |
| Abdominal | | N | N | | | | N | | | Note 1 | |
| Intraoperative:<br>(Abdominal organs and<br>vascular) | | N | N | | | | N | | | Note 1 | |
| Intraoperative | | | | | | | | | | | |
| Neurological | | | | | | | | | | | |
| Pediatric | | N | N | | | | N | | | | |
| Small Organ<br>(breast, thyroid, testicle) | | N | N | | | | N | | | Note 1 | |
| Neonatal Cephalic | | N | N | | | | N | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | N | N | | | | N | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | N | N | | | | N | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

ם ..............................................................................................................................................................................

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

Note 1: Includes imaging for guidance of biopsy

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thind A. Segenn
(Division Sign-Off)

(Provision of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

y

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| 510(k) Number: | TBD |
|----------------|---------------------------|
| Device Name: | Cozumel Ultrasound System |
| Transducer: | C4-2 MHz Curved Array |

Indications for Use:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | | | | Mode of Operation (* includes simultaneous B-mode) | | | | | | | |
|----------------------------------------------------|---|---|----|----------------------------------------------------|-----|------------------|-----------------------|------------------------------|-----------------------|--------------------|--|
| Clinical Applications | A | B | M* | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler* | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal - OB/GYN | | N | N | | | | N | | | Note 1 | |
| Abdominal | | N | N | | | | N | | | Note 1 | |
| Intraoperative:<br>(Abdominal organs,<br>vascular) | | N | N | | | | N | | | | |
| Intraoperative<br>Neurological | | | | | | | | | | | |
| Pediatric | | N | N | | | | N | | | Note 1 | |
| Small Organ<br>(Specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | N | N | | | | N | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | |

Mode of Oneration (* includes simultaneous B-mode)

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

Note 1: Includes imaging for guidance of biopsy

,

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Symm

ivision Sign-Off) Division of Reproductive, Abdominal, EN and Radiological I 510(k) Number

ア