Predicate Devices

K023512, K00288, K003725, K002357, K022928

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard ultrasound imaging and manual measurement tools, with no mention of AI or ML capabilities.

Therapeutic

No
The device is used for diagnostic ultrasound imaging to evaluate the extent of wounds and measure their parameters, not for treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" states that the systems are for "general noninvasive and invasive diagnostic high resolution ultrasound imaging studies." The "Device Description" also notes that the information gathered is "used for the medical specialist to evaluate the efficacy of a particular treatment in the reduction of the wound area," which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it uses a linear or convex array ultrasound transducer, which is a hardware component. The software is part of an ultrasound imaging system, not a standalone software device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
Device Function: The description clearly states that this device is an ultrasound imaging system. It uses ultrasound waves to create images of internal structures and wounds.
Method of Use: The device is used externally or internally (transrectal, transvaginal, intraoperative) to visualize and measure anatomical structures and wounds in situ. It does not involve the analysis of specimens taken from the body.
Intended Use: The intended use is for "general noninvasive and invasive diagnostic high resolution ultrasound imaging studies" and "evaluating the extent of wounds." This is consistent with diagnostic imaging, not in vitro testing.

The use of sterile coupling gel and couplant sheets for wound imaging is a method to facilitate the ultrasound imaging process, not a method for analyzing a biological specimen.

Therefore, this device falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Pie Medical's Picus, Parus, Falco & Aquila Ultrasound Imaging Systems are to be used by or under the direction of a physician to perform general noninvasive and invasive diagnostic high resolution ultrasound imaging studies, to include: fetal, cardiac, transrectal, transvaginal, abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular, musculoskeletal (conventional and superficial) and wounds.

Product codes

90IYO, 90ITX, 90 IYN

Device Description

Wound imaging is a method for evaluating the extent of wounds, using high resolution ultrasound for image acquisition and applying the online measurement package of the ultrasound system to measure either the wounds' linear parameters, or the circumference and depth for volume determination. This information is used for the medical specialist to evaluate the efficacy of a particular treatment in the reduction of the wound area.

The proposed wound imaging method uses a commercially available ultrasound couplant sheet, such as the Civco's HydroScan Couplant Sheet (Class 1), to cover a wound filled with a sterile coupling gel, such as Curasol (K953450). A linear or convex array ultrasound transducer is scanned over the covered wound to image the extent of the wound. Note that it is important that the cover not be sealed with adhesive edges area, as there is a potential to cause damage to the sensitive skin area adjacent to the wound. We believe that this is a significant advantage over previously described methods which use an adhesive material on the edge of the couplant sheet, and risk damaging the sensitive skin area proximal to the wound. To prevent contamination of the wound during the scan the ultrasound probe is covered with a commercially available sterile sheath, such as those available from Civco (K970515).

The clinician can choose to perform area length or circumference measurements to evaluate the dimensions of the wound, the circumference yielding a better determination of the wounds extent in situations where the wound has an irregular geometry.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

fetal, cardiac, transrectal, transvaginal, abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular, musculoskeletal (conventional and superficial), wounds. Small organs include Thyroid, Breast and Testicles.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

by or under the direction of a 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)

K023512 / K00288, K003725, K002357, K022928

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

K041675

510(k) Summary Picus. Parus. Falco & Aquila Ultrasound stems Pie Medical

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

Carri Graham, Official Correspondent
7992 Castleway Drive
Indianapolis, IN 46250
Phone:	(317) 849-1916, extension 103
Facsimile:	(317) 577-9070

Contact Person: Carri Graham

Date: June 18, 2004

807.92(a)(2)

Trade Name:	Ultrasound Imaging Systems
Common Name:	Ultrasound Imaging System
Classification Name(s):	Ultrasonic pulsed echo imaging system
Diagnostic Ultrasonic Transducer	892.1560
892.1570
Classification Number:	90IYO/90ITX
807.92(a)(3)	Predicate Device(s)
Pie Medical	Picus	K023512 / K00288
Pie Medical	Parus	K003725
Pie Medical	100LC/100S/485	K002357
Hudson Diagnostic Imaging	Hudson 2020/2040/2060
Ultrasound Scanners	K022928

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

1

510(k) Summarv Picus, Parus. Falco & Aquila Ultrasound Imaging Systems Pie Medical

807.92(a)(4)

Device Description

Wound imaging is a method for evaluating the extent of wounds, using high resolution ultrasound for image acquisition and applying the online measurement package of the ultrasound system to measure either the wounds' linear parameters, or the circumference and depth for volume determination. This information is used for the medical specialist to evaluate the efficacy of a particular treatment in the reduction of the wound area.

The proposed wound imaging method uses a commercially available ultrasound couplant sheet, such as the Civco's HydroScan Couplant Sheet (Class 1), to cover a wound filled with a sterile coupling gel, such as Curasol (K953450). A linear or convex array ultrasound transducer is scanned over the covered wound to image the extent of the wound. Note that it is important that the cover not be sealed with adhesive edges area, as there is a potential to cause damage to the sensitive skin area adjacent to the wound. We believe that this is a significant advantage over previously described methods which use an adhesive material on the edge of the couplant sheet, and risk damaging the sensitive skin area proximal to the wound. To prevent contamination of the wound during the scan the ultrasound probe is covered with a commercially available sterile sheath, such as those available from Civco (K970515).

The clinician can choose to perform area length or circumference measurements to evaluate the dimensions of the wound, the circumference yielding a better determination of the wounds extent in situations where the wound has an irregular geometry.

Intended Use(s) 807.92(a)(5)

Pie Medical's Picus, Parus, Falco & Aquila Ultrasound Imaging Systems are to be used by or under the direction of a physician to perform general noninvasive and invasive diagnostic high resolution ultrasound imaging studies, to include: fetal, cardiac, transrectal, transvaginal, abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular, musculoskeletal (conventional and superficial) and wounds.

2

| General
characteristics | ' Pie Medical
Picus, Parus, Falco &
Aquila Systems
This Submission | Pie Medical
Picus, Parus, Falco &
Aquila Systems
K002880/023513/
003725 | Hudson Diagnostic
Imaging
Hudson
2020/2040/2060
Systems
K022928 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Intended Use | Fetal, Abdominal, Pediatric,
Small Organ, Intraoperative
abdominal, Peripheral
vascular, Cardiac,
Transrectal, Transvaginal,
Musculoskeletal-
conventional & superficial,
Abdominal, Neonatal
Cephalic & Wounds | Fetal, Abdominal,
Pediatric, Small Organ,
Intraoperative
abdominal, Peripheral
vascular, Cardiac,
Transrectal,
Transvaginal,
Musculoskeletal-
conventional &
superficial, Abdominal,
Neonatal Cephalic &
Wounds | Wounds |
| Transducer Type | Linear | 8.0 Mhz 30C/40mm
(#410647)
7.5 Mhz 40mm
(#410503) | 8.0 Mhz 40mm
(#402198)
6-8 Mhz 60mm
(#410054)
5.0 Mhz 40mm
(#410503) |
| | | 8.0 Mhz 30C/40mm
(#410647)
7.5 Mhz 40mm
(#410503) | |
| General
characteristics | ¹ Pie Medical
Picus, Parus, Falco &
Aquila Systems
This Submission | Pie Medical
Picus, Parus, Falco &
Aquila Systems
K002880/023513/
003725 | Hudson Diagnostic
Imaging
Hudson
2020/2040/2060
Systems
K022928 |
| Imaging Modes | 2D / M-mode | 2D / M-mode
3D (Picus) | 2D / M-mode |
| Safety | | | |
| Electrical Safety | EN60601-1 | EN60601-1 | EN60601-1 |
| Ultrasound Safety | Track 1/3 | Track 1/3 | Track 1/3 |

3

8007.92(a)(6)

4

Image /page/4/Picture/1 description: The image shows a circular seal with an emblem in the center. The emblem consists of three parallel, curved lines that resemble a stylized bird or wing design. Encircling the emblem is text that reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the perimeter of the circle, with the emblem positioned in the center.

Public Health Service

JUL 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pie Medical % Ms. Carrie Graham Consultant The Anson Group 7992 Castleway Drive INDIANAPOLIS IN 46250

Re: K041675

Trade Name: Picus, Parus, Falco, and Aquila Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Name: 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: June 18, 2004 Received: June 21, 2004

Dear Ms. Graham:

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, Parus, Falco, and Aquila Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

7.5 MHz L40, Picus 8MHz LA DF 30C/40mm, Parus, Falco, & Aquila

5

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 it may or secreer to basis 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 or any I vith 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 11 you the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.

Sincerely yours,

David A. Lyman

Image /page/5/Picture/8 description: The image contains a handwritten word, "for", in cursive script. The word is written in black ink on a white background. The letter "f" has a long, curved descender, and the "o" and "r" are connected. The writing appears to be somewhat stylized.

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

Enclosure(s)

6

Diagnostic Ultrasound Indications for Use Form - Appendix F

Parus System

		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		P	P				P [2]
Abdominal		P	P				P [2]
Intraoperative (Abdominal)		P	P
Intraoperative Neurological
Pediatric		P	P				P [2]
Small Organ (specify) [1]		P	P				P [2]
Neonatal Cephalic		P	P				P [2]
Adult Cephalic
Cardiac		P	P				P [2]
Transesophageal
Transrectal		P	P				P [2]
Transvaginal		P	P				P [2]
Transurethral
Intravascular
Peripheral Vascular		P	P				P (2)
Laparoscopic
Musculo-skeletal
Conventional		P	P				P [2]
Musculo-skeletal Superficial		P	P				P [2]
Other - Wounds		N

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+B; B+M

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Leyman

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

7

Falco System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows.
--------------------------------------------------------------------------------------------------	--	--

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		P	P				P [2]
Abdominal		P	P
Intraoperative (Abdominal)		P	P				P [2]	-
Intraoperative Neurological
Pediatric		P	P				P [2]
Small Organ (specify) [1]		P	P				P [2]
Neonatal Cephalic		P	P				P [2]
Adult Cephalic
Cardiac		P	P				P[2]
Transesophageal
Transrectal		P	P
Transvaginal		P	P
Transurethral
Intravascular
Peripheral Vascular		P	P				P [2]
Laparoscopic
Musculo-skeletal
Conventional		P	P				P [2]
Musculo-skeletal Superficial		P	P				P [2]
Other - Wounds		N

N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

[1] Small organs include Thyroid, Breast and Testicles.

[2[ Applicable combined modes: B+B; B+M

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

Daniel C. Boyann

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

8

Aquila System

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
Ophthalmic
Fetal		P	P				P [2]
Abdominal		P	P				P [2]	-
Intraoperative (Abdominal)		P	P				P [2]
Intraoperative Neurological
Pediatric		P	P				P [2]
Small Organ (specify) [1]		P	P				P [2]
Neonatal Cephalic		P	P				P [2]
Adult Cephalic
Cardiac		P	P				P [2]
Transesophageal
Transrectal		P	P				P [2]
Transvaginal		P	P				P [2]
Transurethral
Intravascular
Peripheral Vascular		P	P				P [2]
Laparoscopic
Musculo-skeletal
Conventional		P	P				P [2]
Musculo-skeletal Superficial		P	P				P [2]
Other - Wounds		N

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable Combined Modes: B+B; B+M

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Damil A. Sypm

(Division Sign-Off) Division of Reproductive, Al and Radiological Devices 1 ( ( ) Number __

9

Picus System

	Mode of Operation
Clinical Application	A	B	M	PWD
(D)	CWD	Color
Doppler
(CD)	Amplitude
Doppler
(AD)	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
3D
Ophthalmic
Fetal		P	P	P	P	P	P[2]	P
Abdominal		P	P	P	P	P	P[2]	P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify) [1]		P	P	P	P	P	P[2]	P
Neonatal Cephalic		P	P	P	P	P	P[2]	P
Adult Cephalic
Cardiac		P	P	P	P	P	P[2]	P
Transesophageal
Transrectal		P	P	P	P	P	P[2]	P
Transvaginal		P	P	P	P	P	P[2]	P
Transurethral
Intravascular
Peripheral Vascular		P	P	P	P	P	P[2]	P
Laparoscopic
Musculo-skeletal
Conventional		P	P	P	P	P	P[2]
Musculo-skeletal Superficial		P	P	P	P	P	P[2]
Other - Wounds		N

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+D; B+CD+D; B+AD+D

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Severson

(Division Sign-Division of Reprodu and Radiological De 510(k) Numbe

10

Probe #410503 - Picus 7.5 MHz L40

| Clinical Application | A | B | M | PWD
(D) | CWD | Color
Doppler
(CD) | Amplitude
Doppler
(AD) | Color
Velocity
Imaging | Combined
(specify) | Other
(specify)
3D |
|----------------------------------|---|---|---|------------|-----|--------------------------|------------------------------|------------------------------|-----------------------|--------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | - | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) [1] | | P | P | P | | P | P | | P [2] | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | P | P | P | | P | P | | P [2] | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | P | P | P | | P | P | | P[2] | |
| Musculo-skeletal Superficial | | P | P | P | | P | P | | P[2] | |
| Other - Wounds | | N | | | | | | | | |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+D; B+CD+D; B+AD+D

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

Concurrence of CDRH, Otfice of Device Evaluation (ODE)

Daniel G. Ingram

(Division Sign-Off Division of and Radiolog 510(k) Number

11

Diagnostic Ultrasound Indications for Use Form - Appendix F

Probe# 410647 - Parus, Falco & Aquila 8MHz LA DF 30C/40mm

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(specify)	Other
(specify)
3D
Ophthalmic
Fetal
Abdominal							P [2]
Intraoperative (Abdominal)	P	P	P				P [2]
Intraoperative Neurological
Pediatric		P	P				P [2]
Small Organ (specify) [1]		P	P				P [2]
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		P	P				P [2]
Laparoscopic
Musculo-skeletal
Conventional		P	P				P [2]
Musculo-skeletal Superficial		P	P				P [2]
Other - Wounds	N	N

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N=new indication; P=previously cleared by FDA; E= added under Appendix E Additional Comments:

[1] Small organs include Thyroid, Breast and Testicles.

[2] Applicable combined modes: B+B; B+M

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Seymour

(Division Sign-O nroductive and Radi 510(k) Num