PET-512MC TRANSESOPHAGEAL TRANSDUCER

K103629 · Toshiba America Medical Systems, In.C · ITX · Feb 2, 2011 · Radiology

Device Facts

• Record ID: K103629
• Device Name: PET-512MC TRANSESOPHAGEAL TRANSDUCER
• Applicant: Toshiba America Medical Systems, In.C
• Product Code: ITX · Radiology
• Decision Date: Feb 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The PET 512MC is a multiplane transesophageal transducer (TEE) designed for use with Toshiba Diagnostic Ultrasound Systems for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.

Device Story

Multiplane transesophageal transducer (TEE) for use with Toshiba diagnostic ultrasound systems; phased array scanning; 5MHz frequency. Inserted into esophagus via mouth; captures real-time ultrasound images of heart and surrounding structures. Operated by trained clinicians (physicians/sonographers) in clinical settings. Output displayed on compatible ultrasound system monitor; assists in cardiac assessment and diagnostic decision-making. Benefits include non-invasive visualization of cardiac anatomy and function through esophageal wall.

Clinical Evidence

Bench testing only. Device complies with IEC 60601-1, IEC 60601-2-37, and AIUM-NEMA UD2/UD3 standards for ultrasound output and safety. No clinical trial data provided.

Technological Characteristics

Phased array transducer; 5MHz frequency; multiplane TEE form factor. Complies with IEC 60601-1 (electrical safety), IEC 60601-2-37 (ultrasound safety), and AIUM-NEMA UD2/UD3 (output measurement/display). Connectivity via proprietary interface to Toshiba diagnostic ultrasound systems. Sterilization/disinfection per manufacturer instructions for TEE probes.

Indications for Use

Indicated for real-time ultrasound visualization of the heart and other organs in adult and pediatric patients via transesophageal approach.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Toshiba APLIO XG Diagnostic Ultrasound System MODEL SSA-790A V4.0 R001, PET-510MB (K092179)
• Zonare Medical Systems Inc., z.one Ultra P8-3T (K101091)

Submission Summary (Full Text)

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K103629
FEB - 2 2011

# 510(k) Summary

| Submitter's Name: | Toshiba America Medical Systems, Inc. |
|-------------------|--------------------------------------------------------|
| Address: | PO Box 2068, 2441 Michelle Drive Tustin, CA 92781-2068 |
| Contact: | Paul Biggins, Director Regulatory Affairs |
| Telephone No.: | [phone] |

#### Device Proprietary Name: Multiplane Transesophageal Transducer Model PET-512MC

Common Name:

Transesophageal Transducer

### Classification:

- Regulatory Class: II .
- . Review Category: Tier II
- Ultrasonic Pulsed Doppler Imaging System -- Product Code: 90-IYN . [Fed. Reg. No.: 892.1550]
- . Ultrasonic Pulsed Echo Imaging System - Product Code: 90-IYO [Fed. Reg. No.: 892.1560]
- Diagnostic Ultrasonic Transducer Product Code: 90-ITX . [Fed. Reg. No.: 892.1570]

# Identification of Predicate Devices:

Toshiba America Medical Systems believes that this device is substantially equivalent to:

- . Toshiba APLIO XG Diagnostic Ultrasound System MODEL SSA-790A V4.0 R001, PET-510MB - 510(k) K092179
- . Zonare Medical Systems Inc., z.one Ultra P8-3T - 510(k) K101091

# Device Description:

The PET-512MC is a multiplane transesophageal transducer (TEE) designed for use with Toshiba Diagnostic Ultrasound Systems. It conforms to Track 3 when connected to the compatible ultrasound diagnostic systems. The scanning type of this transducer is a phased array with a frequency of 5MHz.

# Indications for Use:

The PET 512MC is intended for visualization of the heart (and other organs) as a realtime ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.

Company Confidential December 2010

510(k) PET-512MC 16 of 1063

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# Declaration of Conformity:

This transducer is designed and manufactured in conjunction with the Quality System Regulation, This device complies with IEC 60601-1 (applicable portions), IEC60601-2-37 (applicable portions), the AIUM-NEMA UD2 Output Measurement Standard as applied to Track 3 Ultrasound Systems and the AIUM-NEMA UD3 Output Display Standard, when connected to diagnostic ultrasound systems.

## Standards Form:

Please see the attached standard form of the IEC 60601-1-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37 and IEC 62304.

### Clinical Trials Form:

Please see the attached Clinical Trials Form FDA-3674

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Paul Biggins Director, Regulatory Affairs Toshiba America Medical Systems, Inc. 2441 Michelle Drive TUSTIN CA 92780

FEB - 2 201

Re: K103629

Trade/Device Name: PET-512MC Transesophageal Transducer Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX, IYO, and IYN Dated: December 8, 2010 Received: December 13, 2010

Dear Mr. Biggins:

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 PET-512MC Transesophageal Transducer, as described in your premarket notification:

Transducer Model Number

# PET-512MC

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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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); 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.

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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

Sincerely Yours,

Arnholt D'Aureum for

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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# INDICATIONS FOR USE

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# 510(K) Number (if known):

Device Name: PET-512MC Transesophageal Transducer

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#### Aplio Artida v2.7 SSH-880CY System:

Transducer. BET-212MC

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Intended Use: Diagnostic uttrasound imaging or Buid flow analysis of the human body as follows:

| Clinical Application<br>Specific<br>(Tracks 3) | Mode of Operation | | | | | | | | | | | | |
|------------------------------------------------|-------------------|---|-----|-----|------------------|-----------------------|-----|-----------------|-------|-----------|----|-----------------|--|
| | B | M | PWD | CWD | Color<br>Doppler | Combined<br>(Specify) | THI | Dynamic<br>Flow | Power | CHI<br>2D | 3D | Other<br>[Note] | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intra-operative (Abdominal) | | | | | | | | | | | | | |
| Intra-operative (Neuro) | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (Specify) (1) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | | | | |
| Trans-esoph. (non-Card.) | | | | | | | | | | | | | |
| Musculo-skeletal<br>(Conventional) | | | | | | | | | | | | | |
| Musculo-skeletal (Superficial) | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | | |
| Intravascular (Cardiac) | | | | | | | | | | | | | |
| Trans-esoph. (Cardiac) | P | P | P | P | P | 3 | P | | | | | 4 | |
| Intra-cardiac | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | | | | |
| Other (Specify) | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA; E = added under this appendix
Previous S IO(k) of the transducer: K090158

Note I Small organ includes thyroid, breast and testicle.

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD

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Note 3 Combined mode includes BIM, BPWD, BDF/PWD, BDF/MDF/ BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 TDI

**Note 4 TDI**

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Note 5 ApliPure Note 6 MicroPurc Note 7 Precision Imaging

Note & STIC - 19 Note 9 3D color Note 10 STIC Color Note 11 Elastography (New)

Prescription Use Only (Per 21 CRF801.109)

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510(k) PET-512MC 134 of 1063