MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM

K061755 · Esaote Europe B.V. · IYO · Aug 7, 2006 · Radiology

Device Facts

• Record ID: K061755
• Device Name: MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
• Applicant: Esaote Europe B.V.
• Product Code: IYO · Radiology
• Decision Date: Aug 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Intraoperative: Abdominal, Other: Urological, Musculoskeletal (Conventional and Superficial).

Device Story

Compact console ultrasound system; performs general diagnostic studies. Inputs: ultrasonic signals via various probes (linear, convex, endocavity, mechanically driven 3D convex array). Processing: B-Mode, M-Mode, PW Doppler, Color Flow Mapping, Tissue Enhancement Imaging (TEI); produces real-time 2D, 3D (manual), and 4D (automatic with BC432P probe) images. Used in clinical settings by physicians. Output: visual display on 15" CRT/LCD or 19" LCD monitors; supports digital archival, VCR, and video printing. Assists clinicians in diagnostic visualization of anatomy and pathology; facilitates clinical decision-making through real-time imaging and measurement/analysis (M&A) capabilities.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological comparison and adherence to established safety standards for diagnostic ultrasound systems.

Technological Characteristics

Compact console ultrasound; 15" CRT/LCD or 19" LCD monitor. Transducers: linear, convex, endocavity, mechanically driven 3D convex array. Frequencies: 2.7-15 MHz. Modes: B, M, PW Doppler, Color Flow, Amplitude Doppler, TEI, 3D/4D. Electrical safety: EN60601-1. Connectivity: digital archival, VCR/printer support. Optional ECG. Software-based image processing.

Indications for Use

Indicated for physicians performing general diagnostic ultrasound studies on fetal, pediatric, and adult patients. Applications include abdominal, small organ (thyroid, breast, testicles), neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, musculoskeletal, and intraoperative abdominal imaging.

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

• Technos Esaote, S.p.A. (K014168)
• MyLab15/20 Ultrasound System Pie Medical (K043588)
• MyLab15/20 Just3D/4D Pie Medical (K053154)

Submission Summary (Full Text)

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510(k) Summary NIvLab15/20 Esaote Europe BV

K061755
510(k) Summary

AUG - 7 2006

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR 1807.92(a).

807.92(a){ })

## Submitter Information

| Carri Graham, Official Correspondent | 11460 N Meridian St., Ste 150 |
|--------------------------------------|-------------------------------|
| Carmel, Indiana 46032 | |
| Phone: | [phone] |
| Facsimile: | [phone] |

| Contact Person: | Carri Graham |
|-----------------|---------------|
| Date: | June 21, 2006 |

| 807.92(a)(2) | |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| Trade Name: | MyLab15/20 New Indications Ultrasound System |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulsed echo imaging system 892.1560<br>Ultrasonic pulsed Doppler imaging system 832.1550 |
| Classification Number: | 90IYO<br>90IYN |

| 807.92(a)(3) | Predicate Device(s) |
|--------------|---------------------|
|--------------|---------------------|

| K014168 | Technos Esaote, S.p.A. |
|---------|------------------------------------------|
| K043588 | MyLab15/20 Ultrasound System Pie Medical |
| K053154 | MyLab15/20 Just3D/4D Pie Medical |

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

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510(k) Summary MyLab15/20 Esaote Europe BV

K061755

807.92(a)(4)

#### Device Description

The MyLab15/20 is a compact console ultrasound system used to perform general diagnostic ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, PW Doppler and Color Flow Mapping and Tissue Enhancement Imaging (TEI). MyLab15/20 is able to produce real time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the probe BC432P, offers the possibility to also produce automatic 3D and real time 4D images

#### 807.92(a)(5)

### Intended Use(s)

Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Intraoperative: Abdominal, Other: Urological, Musculoskeletal (Conventional and Superficial).

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510(k) Summary MyLab15/20 Esaote Europe BV

K061755

# Comparison Chart for Substantial Equivalence

| General<br>Characteristics | Esaote MyLab15/20<br>K043588, K053154 | Esaote Technos<br>K014168 | Esaote MyLab15/20<br>Current 510(k) |
|------------------------------|---------------------------------------|---------------------------|-------------------------------------|
| Applications | | | |
| Intraoperative:<br>Abdominal | No | Yes | Yes |
| Other: Urological | No | Yes | Yes |

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510(k) Summary
MyLab15/20
Esaote Europe BV

| | 1<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -----------------------------------<br>Un 12 1 1 1 1 1 1 1 1 1 | 400000<br>annono | Frenta Mul 2115/20 |

| General<br>Characteristics | Esaote MyLab15/20<br>K043588, K053154 | Esaote Technos<br>K014168 | Esaote MyLab15/20<br>Current 510(k) |
|----------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Transducer Type | | | |
| Linear | Yes | Yes | Yes |
| Convex | Yes | Yes | Yes |
| 2D Freq MHz | 2.7 - 15 | 2.8 - 12.5 | 2.7 - 15 |
| Multifrequency | Yes | Yes | Yes |
| Special probes | • Endocavity probe<br>• Mechanically<br>Driven 3D Convex<br>Array | • Endocavity<br>probe<br>• Mechanically<br>Driven 3D<br>Convex Array<br>• CW Doppler<br>Probe | • Endocavity probe<br>• Mechanically<br>Driven 3D Convex<br>Array |
| Biopsy attachments | | | |
| Convex | Yes | Yes | Yes |
| Linear | Yes | Yes | Yes |
| Imaging modes | | | |
| Real Time 2D | Yes | Yes | Yes |
| M-mode | Yes | Yes | Yes |
| PW Doppler | Yes | Yes | Yes |
| CW Doppler | No | Yes | No |
| CFM Doppler | Yes | Yes | Yes |
| Amplitude Doppler | Yes | Yes | Yes |
| Triplex | Yes | Yes | Yes |
| 3D/4D | Yes | Yes | Yes |
| Monitor size (inches) | • 15" CRT<br>monitor<br>• 15" LCD | 15" Color VGA<br>CRT Monitor | • 15" CRT<br>monitor<br>• 15" LCD<br>• 19" LCD |
| ECG | Optional | Optional | Optional |
| Digital archival<br>capabilities | Yes | Yes | Yes |
| VCR & Video<br>printers | Yes | Yes | Yes |
| M&A capabilities | Yes | Yes | Yes |
| Safety | | | |
| Electrical safety | EN60601-1 | EN60601-1 | EN60601-1 |

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 7 2006

Esaote Europe BV % Ms. Carri Graham Consultant The Anson Group 11460 N Meridian St, Ste 150 CARMEL IN 46032

Re: K061755

·

Trade Name: MyLab 15/MyLab 20 Systems 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: IYO, IYN, and ITX Dated: June 19, 2006 Received: June 21, 2006

Dear Ms. Graham:

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 MyLab 15/MyLab 20 Systems, as described in your premarket notification:

Image /page/4/Picture/10 description: The image shows a logo for the FDA Centennial 1906-2006. The logo is circular and contains the letters FDA in the center. The words "Centennial" are below the letters FDA. The text below the logo reads "Protecting and Promoting Public Health."

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#### Transducer Model Number

| IOE323 |
|----------|
| CA123 |
| C5-2 R13 |

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. may publish hat FDA's issuance of a substantial equivalence determination does not mean r loase be devices and i bre broundevice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 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 CI It Fat 607); adoning (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 I notification. The FDA finding of substantial equivalence of your device to a legally marketed nonification. - 11.0 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

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Page 3 - Ms. Graham

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

If you have any questions regarding the content of this letter, please contact Ralph Shuping at [phone].

Sincerely yours,

Daniel B. Leyron

for

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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# Indications for Use

510(k) Number (if known):

K 061755

MyLab15/MyLab20 Systems Device Name:

Indications For Use:

Esaote's MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician to perform general diagnostic ultrasound studies including Fetal, Abdominal, Pediatric, Small organ, Neonatal Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal (Conventional and Superficial), Intraoperative: Abdominal, and Other: Urological.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Severson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K061755

.

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Image /page/8/Picture/0 description: The image shows the text "K061755" in a handwritten style on the top line. Below that, the text "MyLab15/20 Systems" is printed in a clear, sans-serif font. The handwritten text appears to be a code or identifier, while the printed text likely refers to a product or system name.

| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | |
|----------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|---------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | P [2] | P[3], P[4],<br>P[5] | |
| Abdominal | | P | P | P | | P | P | | P [2] | P[3], P[4],<br>P[5] | |
| Intraoperative Abdominal | | N | N | N | | N | N | | N[2] | N[3], N[4] | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | P | P | P | | P | P | | P [2] | P[3], P[4],<br>P[5] | |
| Small Organ (specify) [1] | | P | P | P | | P | P | | P [2] | P[3], P[4] | |
| Neonatal Cephalic | | P | P | P | | P | P | | P [2] | P[3], P[4] | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | P | P | P | | P | P | | P [2] | P[3] | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | P | P | P | | P | P | | P [2] | P[3], P[4] | |
| Transvaginal | | P | P | P | | P | P | | P [2] | P[3], P[4] | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | | P [2] | P[3], P[4] | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | | P | P | | P [2] | P[3], P[4] | |
| Musculo-skeletal Superficial | | P | P | P | | P | P | | P [2] | P[3], P[4] | |
| Other: Urological | | N | N | N | | N | N | | N[2] | N[3], N[4] | |

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+ CFM+Amplitude Doppler

[3] Tissue Enhancement Imaging (TEI)

[4] 3D Imaging

(5) 4D Imaging

Daniel H. Ingram

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

{9}------------------------------------------------

K061755
IOE323

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | N (2) | N (3) |
| Intraoperative (Abdominal) | | N | N | N | | N | N | | N (2) | N (3) |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) [1] | | N | N | N | | N | N | | N [2] | N [3] |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N [2] | N [3] |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | N | N | N | | N | N | | N [2] | N [3] |
| Muscolo-skeletal<br>Superficial | | N | N | N | | N | N | | N [2] | N [3] |

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

[1] Small organs include Thyroid, Breast and Testicles.

(2) Applicable combined modes: B+M+PW+CFM+PD

[3] Tissue Enhancement Imaging (TEI)

iplease do not write below this line. Continute on another Page if needed)

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David be. Semon

(Division Sign-Off) Division of Reproductive, Abdoo and Radiological Devices 510(k) Numb

ート アルバイト (1) 2017 - 10:20

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K061755
CA123

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N (2) | N [3] |
| Abdominal | | N | N | N | | N | N | | N (2) | N (3) |
| Intraoperative (Adominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) [1] | | N | N | N | | N | N | | N (2) | N [3] |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | | N | N | | N (2) | N [3] |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N (2) | N [3] |
| Laparoscopic<br>Muscolo-skeletal | | | | | | | | | | |
| Conventional<br>Muscolo-skeletal | | | | | | | | | | |
| Superficial | | | | | | | | | | |
| Other: Urological | | N | N | N | | N | N | | N (2) | N [3] |

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CFM+PD

[3] Tissue Enhancement Imaging (TEI)

(PLEASE DO NOT WRITE BELOW THIS LIKE. CONTINUE OF ANOTHER PAGE IF KELDED)

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Severson

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

ા ર

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# Ko61755

C5-2 R13

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-------------|-------------|---------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD<br>(PW) | CWD<br>(CW) | Color<br>Doppler<br>(CFM) | Amplitude<br>Doppler<br>(PD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N [2] | N [3] |
| Abdominal | | N | N | N | | N | N | | N [2] | N [3] |
| Intraoperative (Adominal) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) [1] | | N | N | N | | N | N | | N [2] | N [3] |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | N | N | N | | N | N | | N [2] | N [3] |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | N | N | N | | N | N | | N [2] | N [3] |
| Laparoscopic | | | | | | | | | | |
| Muscolo-skeletal<br>Conventional | | | | | | | | | | |
| Muscolo-skeletal<br>Superficial | | | | | | | | | | |
| Other: Urological | | N | N | N | | N | N | | N [2] | N [3] |

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

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+M+PW+CFM+PD

[3] Tissue Enhancement Imaging (TEI)

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEBOED)

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David A. Styrone

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

16