MYLAB30, MODEL 7300

K071996 · Esaote, S.p.A. · IYO · Aug 3, 2007 · Radiology

Device Facts

• Record ID: K071996
• Device Name: MYLAB30, MODEL 7300
• Applicant: Esaote, S.p.A.
• Product Code: IYO · Radiology
• Decision Date: Aug 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Esaote's Model 7300 (MyLab30) is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Device Story

MyLab30 is a compact ultrasound system for diagnostic imaging. Inputs: ultrasonic signals from phased, convex, linear array, and Doppler probes. Processing: B-Mode, M-Mode, Doppler, 3D/4D, Color Flow Mapping, and Tissue Enhancement Imaging (TEI). Output: real-time 2D/3D/4D images displayed on an optional LCD. Used in clinical settings by physicians/technicians for general diagnostic studies, biopsy guidance, and needle/catheter placement. Output assists clinicians in visualizing anatomical structures and guiding interventional procedures, potentially improving procedural accuracy and patient safety.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on the device's established technological characteristics and its ability to perform diagnostic imaging consistent with previously cleared ultrasound systems.

Technological Characteristics

Compact ultrasound system; supports phased, convex, linear array, and Doppler probes. Modes: B-Mode, M-Mode, Doppler, 3D/4D, Color Flow Mapping, TEI. Optional LCD display. Manufactured under ISO 9001:2000 and ISO 13485. Connectivity includes standard ultrasound imaging interfaces.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in patients requiring Cardiac, Transesophageal, Peripheral Vascular, Neonatal/Adult Cephalic, Small organ (Thyroid, Breast, Testicles), Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative Abdominal, and Urologic exams. Includes guidance for biopsy, needle/catheter placement, and peripheral nerve blocks.

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

• 7300 (MyLab30) (K040596)
• 7300 (MyLab30) (K052805)
• 7300 (MyLab30) (K060827)
• MicroMaxx (K033367)

Submission Summary (Full Text)

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K07/1996

510(k) Summary MyLab30 System Esaote, S.p.A.

# 510(k) Summary

AUG - 3 2007

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR¶807.92(a).

807.92(a)(1)

# Submitter Information

Allison Scott The Anson Group 11460 N Meridian St., Ste 150 Carmel, Indiana 46032 Phone: [phone] x106 Facsimile: [phone]

| Contact Person: | Allison Scott |
|-------------------------|----------------------------------------------------------------------------------------------------|
| Date: | July 20, 2007 |
| 807.92(a)(2) | |
| Trade Name: | MyLab30 System |
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulse doppler imaging system 892.1550<br>Ultrasonic pulsed echo imaging system 892.1560 |
| Classification Number: | 90IYN; 90IYO |

## 807.92(a)(3)

# Predicate Device(s)

| K040596<br>K052805<br>K060827 | 7300 (MyLab30) | Esaote, S.p.A. |
|-------------------------------|----------------|----------------|
| K033367 | MicroMaxx | SonoSite |

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510(k) Summary MyLab30 System Esaote, S.p.A.

#### 807.92 (a)(4)

## Device Description

The 7300 (MyLab30) ultrasound system is used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, M-Mode, Doppler, 3D/4D and Color Flow Mapping and, on lower frequency probes, Tissue Enhancement Imaging (TEI). The systems are equipped with an optional LCD Color Display and can drive phased (PA), convex (CA) and linear array (LA) and Doppler probes. The MyLab30 system is able to produce Real Time 2D images and 3D images (in manual mode) with all probes. The system, in combination with the BC431 or BS230 probes, offers the possibility to also produce automatic 3D and Real Time 4D images. The 7300 (MyLab30) is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

#### 807.92(a)(5)

### Intended Use(s)

Esaote's Model 7300 (MyLab30) is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

807.92(a)(6)

### Technological Characteristics

The difference between the MyLab30 system cleared via K040596, K052805, K060827 and the MyLab30 system to be cleared via this 510(k) is that in this 510(k), the system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2007

Esaote, S. p. A. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K071996

Trade Name: MyLab30 (Model 7300) 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 Regulatory Class: II Product Code: IYO, IYN, and ITX Dated: July 25, 2007 Received: July 26, 2007

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the MyLab30 (Model 7300), as described in your premarket notification:

#### Transducer Model Number

#### LA523 CA123

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 form 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 r any Federal statutes and regulations administered by other Federal agencies. You must comply with all the

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Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

Sincerely yours,

Hebert Remer 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):

Device Name: MyLab30 Ultrasound System

Indications For Use:

Esaote's Model 7300 (MyLab30) is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative: Abdominal, and Other: Urologic. The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles and catheters in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Prescription Use × (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)

Hulu Reiner

Page 1 of 1

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices K071996

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#### Diagnostic Ultrasound Indications for Use Form

#### Model 7300 (MyLab30)

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

| | 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) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | P [2] | P [3], P[4] |
| Abdominal | | P | P | P | | P | P | | P [2] | P [3], P[4] |
| Intraoperative<br>(Abdominal) | | P | P | P | | P | P | | P [2] | P [3] |
| Intraoperative<br>Neurological | | | | | | | | | | |
| Pediatric | | P | P | P | P | P | P | | P [2] | P [3], P[4] |
| Small Organ (specify) [1] | | P | P | P | P | P | P | | P [2] | P [3] |
| Neonatal Cephalic | | P | P | P | P | P | P | | P [2] | |
| Adult Cephalic | | P | P | P | P | P | P | | P [2] | |
| Cardiac | | P | P | P | P | P | | | P [2] | P [3], P[4] |
| Transesophageal | | P | P | P | P | P | P | | P [2] | |
| Transrectal | | P | P | P | | P | P | | P [2] | |
| Transvaginal | | P | P | P | | P | P | | P [2] | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | P | | P [2] | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | P | P | P | P | P | P | | P [2] | |
| Musculo-skeletal<br>Superficial | | P | P | P | P | P | P | | P [2] | |
| Other (Urological) | | P | P | P | P | P | P | | P [2] | |

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+CW+CFM+PD

- [3] Tissue Enhancement Imaging (TEI)
Compound Imaging

VPAN

Tissue Velocity Mapping (TVM)

- CMM
CnTI

[4] 3D/4D Imaging

Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures. Also included in this 510(k) is imaging to assist in the placement of needley and catheters in vascular or other anatomical structures. (PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED

concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071996

11

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#### Diagnostic Ultrasound Indications for Use Form

#### Transducer: LA523

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

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

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

Additional Comments:

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

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

[3] Tissue Enhanced Imaging (TEI); [4] 3D Freehand

Included in this 510(k) is an expanded intended use for imaging guidance for peripheral nerve block procedures. Also included in this 510(k) is imaging to assist in the placement of needles and catheters in vascular or other anatomical structures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive. A Radiolo 510(k) Nu

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F

#### Diagnostic Ultrasound Indications for Use Form

#### Fill out one form for each ultrasound system and each transducer.

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

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

Additional Comments: 1) Applicable combined modes: B+PW+CFM+M+PD;3) Tissue Enhanced Imaging (TEI); [4] 3D Freehand

Included in this 5 l (k) is an expanded intended use for peripheral nerve block procedures. Also included in this 510(k) is imaging to assist in the placement of needles and cather or other anatomical structures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K071996