50S TRINGA ULTRASOUND IMAGING SYSTEM

K020112 · Pie Medical · IYO · Apr 19, 2002 · Radiology

Device Facts

• Record ID: K020112
• Device Name: 50S TRINGA ULTRASOUND IMAGING SYSTEM
• Applicant: Pie Medical
• Product Code: IYO · Radiology
• Decision Date: Apr 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

Pie Medical's 50S Tringa ultrasound system is used by or under the direction of a physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, small organ & cardiac applications.

Device Story

50S Tringa is a portable ultrasound imaging system; utilizes mechanical annular array probes (3.5/5.0 MHz and 5.0/7.5 MHz) to acquire acoustic data; transforms signals into 2D and M-mode images displayed on an integrated 5.4-inch LCD monitor; operated by physicians or under their direction in clinical settings; supports digital archival and VCR recording; provides diagnostic visualization for abdominal, fetal, cardiac, peripheral vascular, and small organ applications; assists clinicians in diagnostic decision-making through real-time anatomical imaging.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mechanical annular array probes; 3.5/5.0/7.5 MHz frequencies; 5.4-inch LCD display; 2D and M-mode imaging; digital archival and VCR support; electrical safety per EN60601-1; ultrasound safety per Track 1.

Indications for Use

Indicated for physician-directed non-invasive diagnostic ultrasound imaging in abdominal, peripheral vascular, fetal, cardiac, and small organ (thyroid, breast, testicles) applications.

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

• Pie Medical 100S (K002357)

Reference Devices

• Esaote 7200 (Caris) (K981293)

Submission Summary (Full Text)

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510(k) Summary 50S Tringa Pie Medical

K020112

## APR 1 9 2002

# 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)

Esaote

### Submitter Information

| Colleen Densmore, Official Correspondent | | |
|------------------------------------------|---------------------------------------|----------|
| 8000 Castleway Drive | | |
| Indianapolis, IN 46250 | | |
| Phone: | [phone] | |
| Facsimile: | (317) 5779070 | |
| Contact Person: | Colleen Densmore | |
| Date: | December 20, 2001 | |
| 807.92(a)(2) | | |
| Trade Name: | 50S Tringa Ultrasound Imaging System | |
| Common Name: | Ultrasound Imaging System | |
| Classification Name(s): | Ultrasonic pulsed echo imaging system | 892.1560 |
| Classification Number: | 90IYO | |
| 807.92(a)(3) | | |
| | Predicate Device(s) | |
| Pie Medical | 100S | K002357 |

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

7200 (Caris)

RA
//

SKI4

K981293

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510(k) Summary 50S Tringa Pie Medical

807.92(a)(5)

.

### Device Description

### Intended Use(s)

Pie Medical's 50S Tringa ultrasound system is used by or under the direction of a physician to perform general non-invasive diagnostic ultrasound imaging studies, to include: abdominal, peripheral vascular, fetal, small organ & cardiac applications.

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510(k) Summary 50S Tringa Pie Medical

| General characteristics | Pie Medical<br>50S Tringa<br>This submission | Pie Medical<br>Scanner 100S<br>K002357 | Esaote<br>7200 (Caris)<br>K981293 |
|-------------------------------|----------------------------------------------|----------------------------------------------------|----------------------------------------|
| Intended use | | | |
| Fetal | Yes | Yes | Yes |
| Abdominal | Yes | Yes | Yes |
| Pediatric | Yes | Yes | Yes |
| Small Organ | Yes | Yes | Yes |
| Neonatal Cephalic | No | Yes | Yes |
| Adult Cephalic | No | No | Yes |
| Cardiac | Yes | Yes | Yes |
| Transesophageal | No | No | Yes |
| Transrectal | No | Yes | No |
| Transvaginal | No | Yes | No |
| Transurethral | No | No | No |
| Intravascular | No | No | No |
| Peripheral Vascular | Yes | Yes | Yes |
| Musculoskeletal | No | No | No |
| Transducer type | | | |
| Annular Array | Yes | Yes | Yes |
| Linear | No | No | No |
| Convex | No | No | No |
| 2D Freq MHz | 3.5/5.0/7.5 | 3.5/5.0/7.5 | 2.5/3.5/5.0/7.5/10 |
| CFM/Doppler Freq MHz | N/A | N/A | 2.0/2.5/3.3/5.0/6.6 |
| Biopsy Guidance | No | Yes | No |
| Display type | LCD | B/W | SVGA and LCD |
| Imaging modes | 2D / M-Mode | 2D / M-Mode | 2D / M-Mode / PW<br>/ CW / CFM |
| Monitor size (inches) | 5.4 | 9 | 15 (SVGA) and 10<br>(LCD) |
| Digital archival capabilities | Yes | Yes | Yes |
| VCR | Yes | Yes | Yes |
| M&A capabilities | Cardiac, Fetal,<br>Abdominal | Cardiac,Fetal,<br>Obstetrics,<br>Abdominal Urology | Cardiac, Vascular,<br>Fetal, Abdominal |
| Safety | | | |
| Electrical safety | EN60601-1 | EN60601-1 | EN60601-1 |
| Ultrasound safety | Track 1 | Track 1 | Track 3 |

### Comparison Chart for Substantial Equivalence

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... .

:

:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### APR 1 9 2002

Pie Medical % Ms. Colleen J. Densmore Official Correspondent The Anson Group, LLC 7992 Castleway Drive INDIANAPOLIS IN 46250

Re: K020112

Trade Name: 50S Tringa Ultrasound 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: 90 IYO, and 90 ITX Dated: March 26, 2002 Received: March 27, 2002

Dear Ms. Densmore:

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 50S Tringa Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

#### 3.5/5.0 MHz Mechanical Probe 5.0/7.5 MHz Mechanical Probe

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

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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. nay publish farther announ's issuance of a substantial equivalence determination does not mean I loase oc advised that I Dr i resum that your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any I catal statutes and equirements, 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 form in the quant) Bystellions (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 noutheation. The I Drice results in 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 desire of Compliance at [phone]. Additionally, for questions on the comaci the Office of other of your device, please contact the Office of Compliance at (301) 594promotion and and the regulation entitled, "Misbranding by reference to premarket 4057. Also, prouse note ale 807.97). Other general information on your responsibilities under the nothrough (2) Or Crained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

Sincerely yours,

Nancy C. Bugdon

Nancy C. Brogdon C Director. Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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.

### Diagnostic Ultrasound Indications for Use Form 50S Tringa

:

#### 50S Tringa (410697)

.

| Clinical application | A | B | M | PWD<br>(D) | Color<br>Doppler<br>(CD) | Amplitude<br>Doppler<br>(AD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
|------------------------------|---|---|---|------------|--------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | |
| Fetal | | N | N | | | | | N | |
| Abdominal | | N | N | | | | | N | |
| Intraoperative (specify) | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (specify) | | N | N | | | | | N | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | N | N | | | | | N | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | N | |
| Laparoscopic | | | | | | | | | |
| Musculoskeletal Conventional | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | |
| Other (specify) | | | | | | | | | |

N=new indication

Combined is: B+B mode and B+M mode

Additional comments:

* Small organs include Thyroid, Breast and Testicles

STORE

**Prescription Use**
(Per 21 CFR 801.109)

Nancy C. Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

Image /page/5/Picture/12 description: The image shows the logo for Pie Medical. The words "Pie Medical" are in large, bold, sans-serif font. Below the company name is the tagline "THE IMAGE OF INNOVATION" in a smaller, sans-serif font. The text is black and the background is white.

(Per 21 CFR 801.109)

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### Diagnostic Ultrasound Indications for Use Form 50S Tringa

### 3.5/5.0 MHz Mechanical probe (410047)

| | Mode of Operation | | | | | | | | |
|------------------------------|-------------------|---|---|---------|--------------------|------------------------|------------------------|--------------------|-----------------|
| Clinical application | A | B | M | PWD (D) | Color Doppler (CD) | Amplitude Doppler (AD) | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | N | N | | | | | N | |
| Abdominal | | N | N | | | | | N | |
| Intraoperative (specify) | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (specify) | | N | N | | | | | N | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | N | N | | | | | N | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | N | |
| Laparoscopic | | | | | | | | | |
| Musculoskeletal Conventional | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | |
| Other (specify) | | | | | | | | | |

N=new indication

Combined is: B+B mode and B+M mode

Additional comments:

- * Small organs include Thyroid, Breast and Testicles
**Prescription Use**
(Per 21 CFR 801.109)

Nancy Broydon

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

Image /page/6/Picture/13 description: The image shows the logo for Pie Medical. The text "Pie Medical" is in large, bold, sans-serif font. Below the company name, in a smaller font, is the tagline "THE IMAGE OF INNOVATION."

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### Diagnostic Ultrasound Indications for Use Form 50S Tringa

### 5.0/7.5 MHz Mechanical probe (410048)

| Mode of Operation | | | | | | | | | |
|------------------------------|---|---|---|------------|--------------------------|------------------------------|------------------------------|-----------------------|--------------------|
| Clinical application | A | B | M | PWD<br>(D) | Color<br>Doppler<br>(CD) | Amplitude<br>Doppler<br>(AD) | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | |
| Fetal | | N | N | | | | | N | |
| Abdominal | | N | N | | | | | N | |
| Intraoperative (specify) | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (specify) | | N | N | | | | | N | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | N | N | | | | | N | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheral Vascular | | N | N | | | | | N | |
| Laparoscopic | | | | | | | | | |
| Musculoskeletal Conventional | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | |
| Other (specify) | | | | | | | | | |

N=new indication

Combined is: B+B mode and B+M mode

Additional comments:

- * Small organs include Thyroid, Breast and Testicles
**Prescription Use**
**(Per 21 CFR 801.109)**

Nancy Broodon

(Division Sign-Off)

Division of Reprodu and Radiological Devic 510k) Num

Image /page/7/Picture/13 description: The image shows the logo for Pie Medica. The text "Pie Medica" is in a bold, sans-serif font. Below the company name is the tagline "THE IMAGE OF INNOVATION" in a smaller, sans-serif font. The logo is simple and professional.

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