MyLabSix CrystaLine

K162290 · Esaote, S.p.A. · IYN · Oct 14, 2016 · Radiology

Device Facts

• Record ID: K162290
• Device Name: MyLabSix CrystaLine
• Applicant: Esaote, S.p.A.
• Product Code: IYN · Radiology
• Decision Date: Oct 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Esaote's Model 6425 Ultrasound System is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Device Story

Model 6425 is a mainframe ultrasound system for diagnostic imaging and fluid flow analysis. It accepts inputs from various ultrasound probes (phased, convex, linear, Doppler, volumetric) and processes signals to generate B-mode, M-mode, Amplitude Doppler, Tissue Enhancement Imaging (TEI), Multi View (MView), Tissue Velocity Mapping (TVM), Color Flow Mapping (CFM), Pulse Wave Doppler, and 3D/4D images. Operated by clinicians in clinical settings, the system features a height-adjustable keyboard and dual LCD displays, including a touch-screen control panel. Acquired images are displayed for real-time visualization, biopsy guidance, and needle placement assistance. Data is stored internally or exported via LAN/USB to external media. The device aids healthcare providers in diagnostic decision-making by providing high-resolution anatomical and hemodynamic information, potentially improving diagnostic accuracy and procedural precision.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electromagnetic, and mechanical safety testing per recognized standards.

Technological Characteristics

Mainframe ultrasound system with height-adjustable keyboard and dual LCD displays (one touch-screen). Supports phased, convex, linear, Doppler, and volumetric probes. Imaging modes: B, M, Amplitude Doppler, TEI, MView, TVM, CFM, PW Doppler, 3D/4D. Connectivity: LAN/USB for external storage. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3. Manufactured under ISO 9001/13485.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in cardiac, vascular, abdominal, fetal, pediatric, neonatal/adult cephalic, small organs, musculoskeletal, transesophageal, transrectal, transvaginal, intraoperative, and urological applications. Includes needle guidance for biopsy and peripheral nerve blocks.

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

• 6400 - MyLabSeven (K161359)

Reference Devices

• 6420 - MyLabSix (K141486)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 that resembles three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 14, 2016

Esaote S.p.A % Allison Scott, RAC Managing Consultant Navigant Consulting, Inc. 9001 Wesleyan Road, Suite 200 INDIANAPOLIS IN 46268

Re: K162290

Trade/Device Name: Model 6425 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: September 28, 2016 Received: September 29, 2016

Dear Ms. Scott:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K162290

Device Name Model 6425 Ultrasound System

# Indications for Use (Describe)

Esaote's Model 6425 Ultrasound System is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, Laparoscopic and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Prescription Use Only Per 21 CFR 801 Part D Concurrence of
CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

aote SpA 6425 510(K)
Esaote 6425 Ultrasound System 510

| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) |
|-----------------------------------|---|---|-----|-----|---------------|------------------------|--------------|------------------------------|------------------------|-----------------|
| Ophthalmic | N | N | N | N | N | N | N | N | N | N:5, 7 |
| Fetal | N | N | N | N | N | N | N | N | N | N:5, 7 |
| Abdominal | N | N | N | N | N | N | N | N | N | N:5 |
| Intraoperative (Abdominal) | N | N | N | N | N | N | N | N | N | N:5 |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | N | N:5 |
| Pediatric | N | N | N | N | N | N | N | N | N | N:5 |
| Small Organs [1] | N | N | N | N | N | N | N | N | N | N:5 |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N:5 |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N:5 |
| Cardiac [2] | N | N | N | N | N | N | N | N | N | N:5 |
| Transesophageal (Cardiac) | N | N | N | N | N | N | N | N | N | N:5 |
| Transesophageal (Non Cardiac) | N | N | N | N | N | N | N | N | N | N:5 |
| Transrectal | N | N | N | N | N | N | N | N | N | N:5, 7 |
| Transvaginal | N | N | N | N | N | N | N | N | N | N:5, 7 |
| Transurethral | N | N | N | N | N | N | N | N | N | N:5 |
| Intravascular | N | N | N | N | N | N | N | N | N | N:5 |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N:5 |
| Laparoscopic | N | N | N | N | N | N | N | N | N | N:5 |
| Musculo-skeletal Conventional [3] | N | N | N | N | N | N | N | N | N | N:5 |
| Musculo-skeletal Superficial [3] | N | N | N | N | N | N | N | N | N | N:5 |
| Other (Urological) | N | N | N | N | N | N | N | N | N | N:5, 7 |

6425

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| Intended use: Diagnostic ultrasound Imaging or fluid flow analysis of human body as follows: | | | | | | | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------|---------------------------|----------|------------|------------|--------------------------|---------------------------------------------------------------------|---------------------|-----------------------------------------|-----------------------------------|------------------|------|
| Clinical Application | <b>Mode of Operations</b> | | | | | | | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler (AD) | Combined [4] | | | | |
| Ophthalmic | P | P | P | P | P | P | P | | | | |
| Fetal | P | P | P | P | P | P | P | | | | |
| Abdominal | P | P | P | P | P | P | P | | | P: 5 | |
| Intraoperative (Abdominal) | | | | | | | | | P | P: 5 | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | | | P: 5 | |
| Small Organs [1] | P | P | P | P | P | P | P | | | P: 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | | P | P: 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | | P | P: 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | P | P | P | P | | P | P: 5 | |
| Other (Urological) | P | P | P | P | P | P | P | | P | P: 5 | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | | P | P: 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Other (Urological) | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | | P | P: 5 | |
| Transvaginal | P | P | P | | P | P | P | | P | P: 5 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional<br>[3] | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5 | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | P | | P | P: 5 | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | | P | P: 5 | |
| Transvaginal | P | P | P | | P | P | P | | P | P: 5 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5 | |
| he TLC 3-13 probe is already clea | red via K161359 | | | | | | | | | | |
| IIH 6-18<br>Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | | P | P | P | | P | P: 5 | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative (Abdominal) | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | | P | P: 5 | |
| Small Organs [1] | P | P | P | | P | P | P | | P | P: 5 | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | P | P | P: 5 | |
| Transesophageal (Non Cardiac) | | | | | | | | P | P | P: 5 | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | | P | P: 5 | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Musculo-skeletal Superficial [3] | P | P | P | | P | P | P | | P | P: 5 | |
| Other (Urological) | P | P | P | | P | P | P | | P | P: 5 | |
| | <b>Mode of Operations</b> | | | | | | | | | | |
| <b>Clinical Application</b> | <b>B</b> | <b>M</b> | <b>PWD</b> | <b>CWD</b> | <b>Color<br/>Doppler</b> | <b>Amplitude<br/>Doppler (AD)</b> | <b>Combined [4]</b> | <b>Color Velocity<br/>Mapping (TVM)</b> | <b>Harmonic<br/>Imaging (TEI)</b> | <b>Other (sp</b> | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | P | P | P | P | P | P | P | P | P | P: 5 | |
| Abdominal | P | P | P | P | P | P | P | P | P | P: 5 | |
| Intraoperative (Abdominal) | P | P | P | P | P | P | P | P | P | P: 5 | |
| Intraoperative Neurological | | | | | | | | | | | |
| LP 4-13<br>ntended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler<br>(AD) | Combined<br>[4] | Color Velocity<br>Mapping (TVM) | Harmonic<br>Imaging (TEI) | Other (specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | | P | P: 5 | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | P | P | P | | P | P | P | | P | P: 5 | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial [3] | | | | | | | | | | | |
| Other (Urological) | | | | | | | | | | | |
| he LP 4-13 probe is already cleared via K161359 | | | | | | | | | | | |
| SB3123<br>Intended use: Diagnostic ultrasound imaging or fluid flow analysis of human body as follows: | Mode of Operations | | | | | | | | | | |
| Clinical Application | B | M | PWD | CWD | Color Doppler | Amplitude Doppler (AD) | Combined [4] | Color Velocity Mapping (TVM) | Harmonic Imaging (TEI) | Other (specify) | |
| Ophthalmic | P | P | P | | P | P | P | | | | |
| Fetal | | | | | | | | | P | P: 5, 7 | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (Abdominal) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organs [1] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [2] | | | | | | | | | | | |
| Transesophageal (Cardiac) | | | | | | | | | | | |
| Transesophageal (Non Cardiac) | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | | P | P: 5, 7 | |
| Transvaginal | P | P | P | | P | P | P | | P | P: 5, 7 | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | |…