MYLAB 15 / MYLAB 20, MODEL 2700

K043588 · Pie Medical · IYN · Jan 25, 2005 · Radiology

Device Facts

• Record ID: K043588
• Device Name: MYLAB 15 / MYLAB 20, MODEL 2700
• Applicant: Pie Medical
• Product Code: IYN · Radiology
• Decision Date: Jan 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• 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, Musculoskeletal (Conventional and Superficial).

Device Story

Compact console ultrasound system; performs general diagnostic studies. Inputs: acoustic signals from convex or linear array probes. Processing: B-Mode, M-Mode, PW Doppler, Color Flow Mapping, Tissue Enhancement Imaging (TEI). Output: real-time ultrasound images on LCD/CRT monitor. Operated by physicians in clinical settings. Features alphanumeric keyboard for data entry/annotation; internal database for fetal biometry tracking; USB storage. Output used for diagnostic visualization and clinical decision-making; benefits include non-invasive assessment of anatomy and pathology.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technical specifications, imaging modes, and intended use comparisons with predicate devices.

Technological Characteristics

Compact console ultrasound system; supports convex and linear array probes. Imaging modes: B-Mode, M-Mode, PW Doppler, Color Flow Mapping, TEI. Connectivity: USB storage, video output (S-VHS, printer). Electrical safety: EN60601-1. Display: 15" LCD or CRT. Software-based measurement and analysis for cardiac, vascular, obstetric, gynecologic, and urology applications.

Indications for Use

Indicated for physician-performed general diagnostic ultrasound imaging in fetal, abdominal, pediatric, small organ (thyroid, breast, testicles), neonatal cephalic, cardiac, transrectal, transvaginal, peripheral vascular, and musculoskeletal (conventional and superficial) applications.

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

• Esaote Picus (K023512)
• Medison 128BW (K012887)

Submission Summary (Full Text)

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JAN 25 2005

510(k) Summary My Lab 15 - My Lab 20 Pic Medical

K043588
Sizylft4

# 510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

### Submitter Information

Carri Graham, Official Correspondent

8000 Castleway Drive

Indianapolis, IN 46250

| Phone: | [phone] |
|------------|----------------|
| Facsimile: | (317) 5779070 |

Contact Person: Carri Graham

Date: December 15, 2004

807.92(a)(2)

| Trade Name: | My Lab 15 / My Lab 20 Ultrasound Imaging Systems |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| 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)**

| Pie Medical | Picus | K023512 |
|-------------|-------|---------|
| Medison | 128BW | K012887 |

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

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510(k) Summary My Lab 15 My Lab 20 Pic Medical

K043588
Page 24

#### 807.92(a)(4)

### Device Description

The MyLab15/MyLab20 is a compact console ultrasound system intended to be used by a physician 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). The MyLab15/MyLab20 is equipped with either an LCD TFT color display or a CRT color monitor. The full alphanumeric keyboard allows complete on-screen data entry of patient information and on-screen annotations. The MyLab15/MyLab20 can drive convex (CA) and linear array (LA) probes. The MyLab15/MyLab20 permits storage of images on a USB memory stick. The MyLab15/MyLab20 also saves fetal biometry data, acquired during obstetric examinations, into a database in the internal memory of the system, in order to track the fetal growth through different examinations during the same gestation. Optional accessories available for the MyLab15/MyLab20 include an S-VHS video recorder and a monochrome or color printer.

#### Intended Use(s) 807.92(a)(5)

Fsaote'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).

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5 10(k) Summary My Lab 15 . My Lab 20 Pic Medical

K043588
Page=14

## Comparison Chart for Substantial Equivalence

| General<br>Characteristics | Esaote<br>MyLab15/MyLab20 | Esaote Picus<br>(K023512) | Medison 128BW<br>(K012887) |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Applications | | | |
| Fetal | Yes | Yes | Yes |
| Abdominal | Yes | Yes | Yes |
| Pediatric | Yes | No | Yes |
| Small Organ | Yes | Yes | Yes |
| Neonatal Cephalic | Yes | Yes | Yes |
| Adult Cephalic | No | No | Yes |
| Cardiac | Yes | Yes | Yes |
| Transrectal | Yes | Yes | Yes |
| Transvaginal | Yes | Yes | Yes |
| Peripheral Vascular | Yes | Yes | Yes |
| Musculo-skeletal<br>(Conventional and<br>superficial) | Yes | No | Yes |
| General<br>Characteristics | Esaote<br>MyLab15/MyLab20 | Esaote Picus<br>(K023512) | Medison 128BW<br>(K012887) |
| | Transducer Type | | |
| Linear | Yes | Yes | Yes |
| Convex | Yes | Yes | Yes |
| 2D Freq MHz | 2.7 - 12.5 | 2.5 - 10 | 2.0 - 10 |
| PW Freq MHz | 2.7 - 6.3 | 2.5 - 8 | No |
| Multifrequency<br>probes | Yes | Yes | Yes |
| Special probes | Endocavity probe | Endocavity probe | Endocavity probe |
| | 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 | No |
| CFM Doppler | Yes | Yes | No |
| Amplitude Doppler | Yes | Yes | No |
| Triplex | Yes | Yes | - |
| Monitor size (inches) | 15" CRT monitor<br>15" LCD | 15" CRT monitor<br>10" LCD | 12" CRT monitor |
| ECG | Optional | Optional | No |
| Digital archival<br>capabilities | Yes | Yes | Yes |
| VCR & Video<br>printers | Yes | Yes | Yes |
| M&A capabilities | Cardiac, vascular,<br>Obstetric,<br>Gynaecologic,<br>Urology, and<br>general purpose<br>measurements | Cardiac, vascular,<br>Obstetric,<br>Gynaecologic,<br>Urology, and<br>general purpose<br>measurements | OB/Gyn and<br>general purpose<br>measurements |
| | Safety | | |
| Electrical safety | EN60601-1 | EN60601-1 | EN60601-1 |

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K04358
Page 44

510(k) Summary My Lab 1 5 - My Lab 20 Pic Medical

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 5 2005

Pie Medical % Ms. Carri Graham Consultant The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250

Re: K043588

Trade Name: MyLab15 / MyLab20 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Number: 21 CFR 892.1560 Regulatory Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.1570 Regulatory Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: December 21, 2004 Received: December 28, 2004

#### Dear Ms. Graham:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bowe 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 merodments, 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 the general controls pro 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 MyLab15 / MyLab20, as described in your premarket notification:

#### Transducer Model Number

| LA523<br>CA421P | EC123<br>E8-5 R10 |
|-----------------|-------------------|
|-----------------|-------------------|

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Page 2 - Ms. Graham

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 additional controls. Existing major regulations affecting your device of the It may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Posteria concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hat I DA 3 issuated or a casevice complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cachar statutes and regulations and limited to: registration and listing (21 comply with an the 7ter s requirements, normands, and manufacturing practice requirements as set CITY at 607), adomig (21 OFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I ins device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested information, merading accusation of September 30, 1997 "Information for Manufacturers In Appendix U, (cherosou) of the Senies tic 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 nis lotter will and in you ding of substantial equivalence of your device to a legally marketed nonticate 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 If you 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 other gollers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

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Page 3 – Ms. Graham

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

Sincerely yours,

Nancy C. Brogdon

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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## 4.3 Indications for Use

The following table provides the intended clinical use for the MyLab15/MyLab20:

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

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

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

[1] Small organs include Thylold, Dreast and Tostered
[2] Applicable combined modes: B+M+PW+ CFM+Amplitude Doppler
[2] Applicable combined modes: B+M+PW+ CFM+Amplitude Dopple

[2] Apphoable enhancement Imaging (TEI)

[3] Tissue enhancement imaging (TEI),

Prescription Use

Nancy C. Broadon

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices

510(k) Number K043588

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The following tables provide the intended clinical use for the MyLab15/MyLab20 probes in combination with the system:

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

### Transducer: LA523

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

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

[ [ ] Small organs melude Tiryon, Droad, Live PW+CFM+Amplitude Doppler
[2] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler

[2] Tissue Enhancement Imaging (TEI)

Prescription Use

Nancy Brodon

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

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## Transducer: CA421P

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

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

nal Comments.
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined modern (1) www.

[2] Tissue Enhancement Imaging (TEI)

Organizing Ideas

Nancy C Brogdon

(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, ari Radiological Devices 1 [((k) Number _

{10}------------------------------------------------

## Transducer: EC123

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

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

Additional Comments:

Additional Comments.
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined modes: (TED

[2] Tissue Enhancement Imaging (TEI)

្រីក្រោយក្រោះ

Narryl Brogdon
(Division Sign-Off)

(Division of Reproductive, Abdominal and Radiological Devices

510(k) Number K043588

{11}------------------------------------------------

## Transducer: E8-5 R10

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

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

Additional Comments:

Additional Comments.
[1] Applicable combined modes: B+M+PW+CFM+Amplitude Doppler.
[1] Applicable combined model ... (TEU

[2] Tissue Enhancement Imaging (TEI)

Organization Chart

Nancy Brogdon

(Division Sign-Off) Abdominal; Division of Reproductive, and Radiological Devices 643588 510(k) Number _