TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L

K033604 · Pie Medical · IYO · Dec 15, 2003 · Radiology

Device Facts

• Record ID: K033604
• Device Name: TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L
• Applicant: Pie Medical
• Product Code: IYO · Radiology
• Decision Date: Dec 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Pie Medical's 50L Tringa ultrasound system is to be used by or under the direction of a physician to perform general non-invasive and invasive diagnostic ultrasound imaging studies, to include: abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular and musculoskeletal (conventional and superficial). The system provides ultrasound guidance for freehand or biopsy guided placement of needles and catheters in vascular or other anatomical structures.

Device Story

50L Tringa is a portable, battery/mains-operated ultrasound scanner; acquires 2D and M-mode images via linear probe. Used by physicians in clinical settings for diagnostic imaging and procedural guidance (biopsy/vascular access). System displays images on 5-inch LCD; supports digital archival and VCR recording. Provides real-time visualization to assist clinicians in anatomical assessment and interventional placement of needles/catheters. Benefits include portability for point-of-care use and diagnostic utility across multiple clinical applications.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Portable ultrasound system; 5-inch LCD display; linear transducer (10-5 MHz); 2D and M-mode imaging. Powered by rechargeable battery or mains. Complies with EN60601-1 electrical safety and Track 1 ultrasound safety standards. Digital archival and VCR connectivity.

Indications for Use

Indicated for patients requiring diagnostic ultrasound imaging of abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs (thyroid, breast, testicles), intraoperative (abdominal/vascular), and musculoskeletal (conventional/superficial) structures. Includes guidance for needle/catheter placement.

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 50S Tringa (K020112)
• SonoSite i Look 25 (K021628)

Submission Summary (Full Text)

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Ko33604

# DEC 1 5 2003

## 510(k) Sommarv

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

Colleen Densmore, Official Correspondent 8000 Castleway Drive Indianapolis, IN 46250 [phone] Phone: [phone] Facsimile:

Colleen Densmore Contact Person:

November 11, 2003 Date:

807.92(a)(2)

| Trade Name: | 50L 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) | | |
| Pie Medical | 50S Tringa | K020112 |
| SonoSite | i Look 25 | K021628 |

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

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### Device Description

The 50L Tringa ultrasound system is a lightweight, low-output, portable, real-time, ultrasound scanner used to acquire and display images in 2D, M or a combination of these modes. The 50L Tringa system has one linear probe and can be operated via rechargeable battery and/or mains connection.

#### 807.92(a)(5)

### Intended Use(s)

Pie Medical's 50L Tringa ultrasound system is to be used by or under the direction of a physician to perform general non-invasive and invasive diagnostic ultrasound imaging studies, to include: abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular and musculoskeletal (conventional and superficial). The system provides ultrasound guidance for freehand or biopsy guided placement of needles and catheters in vascular or other anatomical structures.

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| | Pie Medical<br>50L Tringa<br>This Submission | Pie Medical<br>50S Tringa<br>K020112 | Sonosite<br>iLook 25<br>K021628 |
|-------------------------------------------------|----------------------------------------------|--------------------------------------|---------------------------------|
| General characteristics | | | |
| Intended Use | | | |
| Pediatric | Yes | No | Yes |
| Small Organs | Yes | Yes | Yes |
| Intraoperative<br>(abdominal and vascular) | Yes | No | Yes |
| Peripheral Vascular | Yes | Yes | Yes |
| Musculoskeletal<br>(Conventional & Superficial) | Yes | No | Yes |
| Abdominal | Yes | Yes | Yes |
| Neonatal Cephalic | Yes | No | Yes |
| Transducer Type | | | |
| Linear | Yes | No | Yes |
| 2D Freq MHz | 10 - 5 | 3.5/5.0/7.5 | 10 - 5 |
| Biopsy Guidance | Yes | No | Yes |
| Free-Hand Vascular Access | Yes | No | Yes |
| Display Type | LCD | LCD | LCD |
| Imaging Modes | 2D / M-mode | 2D / M-mode | 2D - Color<br>Doppler |
| Monitor Size | 5 inch | 5 inch | 5 inch |
| Digital Archival capabilities | Yes | Yes | Yes |
| VCR | Yes | Yes | Yes |
| Safety | | | |
| Electrical Safety | EN60601-1 | EN60601-1 | EN60601-1 |
| Ultrasound Safety | Track 1 | Track 1 | Track 3 |

# Comparison Chart for Substantial Equivalence i

9

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.

Public Health Service

DEC 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033604

Trade Name: 50L 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 ITX Dated: November 11, 2003 Received: November 17, 2003

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

Transducer Model Number

#### LA/7.5 MHz/L20/64el

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.

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);

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labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality fabeling (21 OF R 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 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, alease note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

David A. Syzman

Nancy C. Brogdor 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

| | | | | | Mode of Operation | | | | |
|---------------------------------|---|---|---|-----|-------------------|------------------|------------------------------|----------|-------|
| Clinical application | A | B | M | PWD | Color<br>Doppler | Ampl.<br>Doppler | Color<br>Velocity<br>Imaging | Combined | Other |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | (2) | (1) | |
| Abdominal | | N | N | | | | | (2) | (1) |
| Pediatric | | N | N | | | | | (2) | (1) |
| Small organs | | N | N | | | | | (2) | (1) |
| Neonatal cephalic | | N | N | | | | | | |
| Cardiac | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Intra-operative<br>(abdominal) | | N | N | | | | | (2) | (1) |
| Intra-operative | | N | N | | | | | (2) | (1) |
| (vascular) | | | | | | | | | |
| Peripheral vascular | | N | N | | | | | (2) | (1) |
| Laparoscopic | | | | | | | | (2) | (1) |
| Musculoskeletal<br>conventional | | N | N | | | | | (2) | (1) |
| Musculoskeletal<br>superficial | | N | N | | | | | (2) | (1) |
| Other | | | | | | | | | |

aning System ound Im ﺔ ﺍﻟ

N = new indication

Additional comments:

Additional comments:
(1) Small organs include Thyroid, Breast and Testicles, Included within this 510(k) is (1) Small organs include Thyrold, Breast and resticals, models with the many of ther anatomical structures

arratornical sa society of mode and B+M mode

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|------------------|--|
|------------------|--|

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | 1033604 |

લુકાઓ પૈકીના એક એવા દિવસાય તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્

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## Diagnostic Ultrasound Indications for Use Form

| LA /7.5MHz / L20 /64el | | | | | | | | | |
|---------------------------------|---|---|---|-----|------------------|------------------|------------------------------|----------|-------|
| Mode of Operation | | | | | | | | | |
| Clinical application | A | B | M | PWD | Color<br>Doppler | Ampl.<br>Doppler | Color<br>Velocity<br>Imaging | Combined | Other |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | (2) | (1) | |
| Abdominal | | N | N | | | | | (2) | (1) |
| Pediatric | | N | N | | | | | (2) | (1) |
| Small organs | | N | N | | | | | (2) | (1) |
| Neonatal cephalic | | N | N | | | | | (2) | (1) |
| Cardiac | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Intra-operative<br>(abdominal) | | N | N | | | | | (2) | (1) |
| Intra-operative<br>(vascular) | | N | N | | | | | (2) | (1) |
| Peripheral vascular | | N | N | | | | | (2) | (1) |
| Laparoscopic | | | | | | | | | |
| Musculoskeletal<br>conventional | | N | N | | | | | (2) | (1) |
| Musculoskeletal<br>superficial | | N | N | | | | | (2) | (1) |
| Other | | | | | | | | | |

#### 1 4 / 7 5MHz / 1 20 / 64el

N = new indication

Additional comments:

Additional comments.
(1) Small organs include Thyroid, Breast and Testicles, Included within this 510(k) is (1) Small organs include Thylod, Dreast and Toboase, Misl. 2007
imaging to assist in the placement of needles and catheters in vascular or other anatomical structures

(2) Combined is: B+B mode and B+M mode

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Deyice Evaluation (ODE)

*Prescription Use*

Daniela Salzman

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices NUSBJ 0(k) Number __ 2/18/2009 ALCH