PICUS ULTRASOUND IMAGING SYSTEMS

K023512 · Pie Medical · IYN · Jan 24, 2003 · Radiology

Device Facts

• Record ID: K023512
• Device Name: PICUS ULTRASOUND IMAGING SYSTEMS
• Applicant: Pie Medical
• Product Code: IYN · Radiology
• Decision Date: Jan 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Pie Medical's Picus 3D ultrasound system is intended to be used by a physician to perform general diagnostic ultrasound studies including cardiac, peripheral vascular, fetal, abdominal, small organ, neonatal cephalic, transrectal and transvaginal.

Device Story

Picus 3D is an ultrasound imaging system used by physicians in clinical settings for diagnostic imaging. It acquires ultrasound signals via various transducers (convex and linear arrays) and processes them to produce 2D, M-mode, PW Doppler, Color Doppler, Power Doppler, and 3D images. The system supports triplex imaging and optional ECG integration. It features digital archival capabilities and VCR connectivity. The device assists clinicians in visualizing anatomy and blood flow to support diagnostic decision-making across multiple clinical applications. It is intended for prescription use.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Ultrasound imaging system utilizing linear and convex array transducers. Frequency ranges: 2D (2.5-10 MHz), PW Doppler (2.5-8 MHz). Features include 3D imaging, M-mode, PW/Color/Power Doppler, and triplex mode. Electrical safety per IEC 60601-1; ultrasound output per Track 3 (AOD). Connectivity includes digital archival and VCR. System includes 10 programmable presets and optional ECG.

Indications for Use

Indicated for use by physicians for diagnostic ultrasound imaging in cardiac, peripheral vascular, fetal, abdominal, small organ (thyroid, breast, testicles), neonatal cephalic, transrectal, and transvaginal 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

• Pie 300LC (Picus) (K002880)
• Esaote AU5 3D (K000931)

Submission Summary (Full Text)

{0}------------------------------------------------

K023512

510(k) Summary Picus 3D Pie Medical

JAN 2 4 2003

# 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

Colleen Hittle, Official Correspondent

8000 Castleway Drive

Indianapolis, IN 46250

| Phone: | [phone] |
|-----------------|------------------|
| Facsimile: | (317) 5779070 |
| Contact Person: | Colleen Densmore |
| Date: | October 17, 2002 |

807.92(a)(2)

| Trade Name: | Picus Ultrasound Imaging Systems |
|-------------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Ultrasound Imaging System |
| Classification Name(s): | Ultrasonic pulsed doppler imaging system 892.1550<br>Ultrasonic pulsed echo imaging system 892.1560 |
| Classification Number: | 90IYN<br>90IYO |

807.92(a)(3)

Predicate Device(s)

| Pie | 300LC (Picus) K002880 |
|--------|-----------------------|
| Esaote | AU5 3D K000931 |

FDA/CDRH/ODE/PMO

2002 OCT 21 A 10:11

RECEIVED

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

{1}------------------------------------------------

510(k) Summary Picus 3D Pie Medical

807.92(a)(5)

# Device Description

# Intended Use(s)

Pie Medical's Picus 3D ultrasound system is intended to be used by a physician to perform general diagnostic ultrasound studies including cardiac, peripheral vascular, fetal, abdominal, small organ, neonatal cephalic, transrectal and transvaginal.

{2}------------------------------------------------

510(k) Summary
Picus 3D
Pie Medical

| Comparison Chart for Substantial Equivalence | | | |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| General characteristics | Picus K002880 | Esaote AU5 3D K000931 | Pie Medical Picus 3D<br>This submission |
| Transducer type | | | |
| Annular Array | No | Yes | No |
| Mechanical Sector | No | Yes | No |
| Linear | Yes | Yes | Yes |
| Convex | Yes | Yes | Yes |
| Phased array | No | Yes | No |
| 2D Freq MHz | 2.5-10 | 2.5 - 15 | 2.5-10 |
| PW Freq MHz | 2.5-8 | 2.25 - 10 | 2.5-8 |
| CW Freq MHz | No | 2.25 - 5.0 | No |
| Probes MHz | | | |
| Annular Array | - | 10 - 20 | - |
| Linear | 5.0-10 | 5.0 - 13 | 5.0-10 |
| Convex | 2.5-10 | 3.5 - 7.5 | 2.5 - 10 |
| Phased array | - | 2.5 - 3.5 | - |
| Multifrequency probes | Yes | Yes | Yes |
| Special probes | Transvaginal<br>Transrectal | Transvaginal<br>Transrectal<br>Laparoscopic<br>Intraoperative | Transvaginal<br>Transrectal |
| Biopsy attachments | - | - | - |
| Convex | Yes | Yes | Yes |
| Linear | Yes | Yes | Yes |
| Imaging modes | | | |
| 3D | No | Yes | Yes |
| Real time 2D | Yes | Yes | Yes |
| M-mode | Yes | Yes | Yes |
| PW Doppler | Yes | Yes | Yes |
| CW Doppler | No | Yes | No |
| CFM Doppler | Yes | Yes | Yes |
| Power Doppler | Yes | Yes | Yes |
| Triplex | Yes | Yes | Yes |
| Monitor size (inches) | SVGA 15 | SVGA 15 | SVGA 15 |
| Programmability | 10 presets | 6 presets | 10 presets |
| Pulsed Doppler | Yes | Yes | Yes |
| CW Doppler | No | Yes | No |
| Audio stereo | Yes | Yes | Yes |
| Color Doppler | Yes | Yes | Yes |
| ECG | Optional | Optional | Optional |
| General characteristics | Picus K002880 | Esaote AU5 3D K000931 | Pie Medical Picus 3D This submission |
| Digital archival capabilities | Yes | Yes | Yes |
| General characteristics | Picus K002880 | Esaote AU5 3D K000931 | Pie Medical Picus 3D |
| VCR | Yes | Yes | Yes |
| M&A Capabilities | Fetal, abdominal, small organ, neonatal cephalic, cardiac, transrectal, transvaginal & peripheral vascular | Fetal, abdominal, intraoperative abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, peripheral vascular & laparoscopic | Fetal, abdominal, small organ, neonatal cephalic, cardiac, transrectal, transvaginal & peripheral vascular |
| Safety | | | |
| Electrical | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| Ultrasound | Track 3 (AOD) | Track 3 (AOD) | Track 3 (AOD) |

# Comparison Chart for Substantial Equivalence

{3}------------------------------------------------

{4}------------------------------------------------

Image /page/4/Picture/2 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" around the perimeter. Inside the circle is an abstract image of an eagle or bird with outstretched wings.

JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023512

Trade Name: Picus Ultrasound Imaging System 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 Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: December 19, 2002 Received: December 20, 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 Picus Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

3.5 MHz R40 Convex array 3.5 MHz R60 Convex array 7.0 MHz R10 Convex array 7.5 MHz L40 Linear array

{5}------------------------------------------------

# 7.5 MHz L50 Linear array 9.5 MHz EC123 Convex array

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); 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 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, please 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 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)

{6}------------------------------------------------

Picus

| System | | | | | | | | | |
|-----------------------------|-------------------|---|---|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| | Mode of Operation | | | | | | | | |
| Clinical application | A | B | M | PWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify)<br>3D |
| Ophthalmic | | | | | | | | | |
| Fetal | | P | P | P | P | P | | | N |
| Abdominal | | P | P | P | P | P | | | N |
| Intraoperative (specify) | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (specify) * | | P | P | P | P | P | | | N |
| Neonatal Cephalic | | P | P | P | P | P | | | N |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | P | P | P | P | P | | | N |
| Transesophageal | | | | | | | | | |
| Transrectal | | P | P | P | P | P | | | N |
| Transvaginal | | P | P | P | P | P | | | N |
| Transurethral | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | | | N |
| Laparoscopic | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| Conventional | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | |
| Other (specify) | | | | | | | | | |

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

Additional comments:

* Small organs include Thyroid, Breast and Testicles

*Prescription Use*

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive" Abdominal and Radiological Devices 510(k) Number -

{7}------------------------------------------------

### Picus

### #410501

#### 3.5Mhz R40 Convex array

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

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

Additional comments:

*Prescription Use* ✓

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive A and Radiclogical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ KOZ 3512

{8}------------------------------------------------

#### Picus

#### #410502

# 3.5Mhz R60 Convex array

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

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

Additional comments:

*Prescription Use*

✓

Nancy C Brogdon

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

{9}------------------------------------------------

Picus

#### #410504

#### 7.0Mhz R10 Convex array

| Mode of Operation | | | | | | | | | |
|-----------------------------|---|---|---|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Clinical application | A | B | M | PWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify)<br>3D |
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (specify) * | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | | P | P | P | P | P | | | N |
| Transvaginal | | P | P | P | P | P | | | 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:

*Prescription Use*

Nancy C. Broaddus

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 023

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

Picus

#410503

### 7.5Mhz L40 Linear array

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

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

Additional comments:

*Prescription Use*

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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

Picus

### #410506

#### 7.5Mhz L50 Linear array

| Clinical application | A | B | M | PWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify)<br>3D |
|-----------------------------|---|---|---|-----|------------------|----------------------|------------------------------|-----------------------|--------------------------|
| Ophthalmic | | | | | | | | | |
| Fetal | | | | | | | | | |
| Abdominal | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric | | | | | | | | | |
| Small Organ (specify) * | | P | P | P | P | P | | | N |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | | | | | | | | | |
| Transvaginal | | | | | | | | | |
| Transurethral | | | | | | | | | |
| Intravascular | | | | | | | | | |
| Peripheral Vascular | | P | P | P | P | P | | | N |
| Laparoscopic | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | |
| Conventional | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | |
| Other (specify) | | | | | | | | | |

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

Additional comments:

* Small organs include Thyroid, Breast and Testicles

Prescription Use

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal

(Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ___

{12}------------------------------------------------

Picus

### #410729

### 9.5Mhz EC123 Convex array

| Mode of Operation<br>Company of Children<br>第一位被害者有官方法<br>181 01:08 PM | | | | | | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|---|--------|---------|--------------------|----------------------|--------------------------------|-----------------------|--------------------------|
| Clinical application ------<br>1990 - 2007 - 2007 - 2008 - 2008 - 2008 - 2008 - 2008 - 2008 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 - 2000 | A | B | M<br>: | PWD<br> | Color .<br>Doppler | Amplitude<br>Doppler | . Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify)<br>3D |
| Ophthalmic ------- | | | | | | | | | |
| Fetal Party - 1993 114 | | | | | | | | | |
| Abdominal Amaria. | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | |
| Pediatric ==================================================================================================================================================================== | | | | | | | | | |
| Small Organ (specify) * | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | |
| Adult Cephalic | | | | | | | | | |
| Cardiac | | | | | | | | | |
| Transesophageal | | | | | | | | | |
| Transrectal | | E | E | E | E | E | | | N |
| Transvaginal | | E | E | E | E | E | | | 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:

* Small organs include Thyroid, Breast and Testicles

*Prescription Use* /

Nancy C hogdon

l
The Company of the Children Children the Children the Children the Children the Children the Children the Children the Children the Children the Children the Children the C

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ KO225