PICUS ULTRASOUND IMAGING SYSTEMS

• K Number: K023512
• Device Name: PICUS ULTRASOUND IMAGING SYSTEMS
• Manufacturer: PIE MEDICAL
• Date Cleared: 2003-01-24 ( 95 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

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 Description

Not Found

Predicate Devices

K002880, K000931

Reference Devices

K002880, K000931

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related concepts in the intended use, device description, or other sections. The focus is on general diagnostic ultrasound capabilities.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" intended to "perform general diagnostic ultrasound studies," indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the system is "intended to be used by a physician to perform general diagnostic ultrasound studies".

SaMD (Software as a Medical Device)

No

The device is described as an "ultrasound system," which inherently includes hardware components for image acquisition. The summary also mentions "general diagnostic ultrasound studies," further indicating a hardware-based imaging system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is used by a physician to perform general diagnostic ultrasound studies. This involves imaging the internal structures of the body using ultrasound waves.
• IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.

The Picus 3D ultrasound system is an in vivo diagnostic device, meaning it is used to diagnose conditions within the living body, not on samples taken from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

90IYN, 90IYO, ITX

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

cardiac, peripheral vascular, fetal, abdominal, small organ (Thyroid, Breast, Testicles), neonatal cephalic, transrectal, transvaginal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K002880, K000931

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
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.(b)
Classification. Class II.

Summary

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
Ultrasonic pulsed echo imaging system 892.1560
Classification Number:	90IYN
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
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
Transrectal	Transvaginal
Transrectal
Laparoscopic
Intraoperative	Transvaginal
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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
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
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
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
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(specify) | Other
(specify)
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
Company of Children
第一位被害者有官方法

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Clinical application ------
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:	PWD
Color .
Doppler	Amplitude
Doppler	. Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
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

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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