K Number

Device Name

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM

Manufacturer

PHILIPS ULTRASOUND, INC.

Date Cleared

2004-01-08

(15 days)

Product Code

IYN ITX IYO

Regulation Number

892.1550

Intended Use

Diagnostic ultrasound imaging and fluid flow analysis of the human body.

Device Description

The HDI 5000 system and transducer(s) function in a manner identical to all diagnostic ultrasound systems and transducers. The system circuitry generates an electronic voltage pulse which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow. The HDI 5000 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K961459, K991671, K002003, K003525, K940942, K023720

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on traditional ultrasound technology, signal processing, and Doppler functions, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as a "diagnostic ultrasound imaging and fluid flow analysis" system, and its function is to "detect and graphically display the Doppler shifts of these tissues as flow" and "measure anatomical structures" to "make a diagnosis," which are all diagnostic, not therapeutic, purposes.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging and fluid flow analysis of the human body." Additionally, the "Device Description" mentions that the system "gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis."

SaMD (Software as a Medical Device)

The device description explicitly details hardware components like transducers, piezo electric arrays, and system circuitry that generate and process ultrasonic waves. This is not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The intended use is "Diagnostic ultrasound imaging and fluid flow analysis of the human body." This describes a device that interacts directly with the patient's body to produce images and analyze physiological processes in vivo.
Device Description: The description details how the system generates and transmits ultrasonic waves into the body and receives echoes. It specifically mentions processing Doppler shifts from "moving targets (such as blood)" within the body. This is characteristic of in vivo diagnostic imaging.
Lack of mention of in vitro samples: There is no mention of analyzing samples taken from the human body (like blood, urine, tissue biopsies, etc.) outside of the body. IVD devices are specifically designed to perform tests on these types of samples.

In summary, the device's function and intended use are clearly focused on in vivo diagnostic imaging and analysis within the human body, which is the domain of diagnostic imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HDI 5000 system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body.

Product codes (comma separated list FDA assigned to the subject device)

90-IYN, 90-IYO, 90-ITX

Device Description

The HDI 5000 system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Ophthalmic, Fetal, Abdominal, Intra-operative (Abdominal, Spine, Vascular), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (breast, thyroid, testicle), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skel. (Conventional), Musculo-skel. (Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Fetal Echo, Peripheral vessel, Cerebral Vascular.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Competent health care professionals.

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K961459, K991671, K002003, K003525, K940942, K023720

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

JAN - 8 2004

Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is the text "K034003" in a handwritten style. Below the word "PHILIPS" is the text "Page 1 of 2" also in a handwritten style.

Philips Medical Systems

510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness information is submitted in accordance with 21CFR §807.92.

Submitter's name, address, telephone number, contact person

Philips Ultrasound 22100 Bothell Everett Highway Telephone: (425) 487-7312 Facsimile: (425) 487-8666 E-mail: Lynn.harmer@philips.com

Contact Person: Lynn Harmer

Date prepared: 26 November 2003

2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:

Common/Usual Name:	Diagnostic ultrasound system with accessories
Proprietary Name:	HDI 5000 ultrasound system

Classification Name	21 CFR Section	Product Code
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasonic Transducer	892.1570	90-ITX

3) Substantially Equivalent Devices

Philips Ultrasound believes that the HDI 5000 system and transducers are substantially equivalent to the following currently marketed ultrasound system and transducers: HDI 5000, K961459, K991671, K002003; GE Voluson 730, K003525; Voluson 530, K940942; Antares, K023720.

4) Device Description & Technical Comparison to Predicate Devices

Image /page/0/Picture/16 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in uppercase letters above a shield-shaped emblem. Inside the shield, there are wavy lines representing water, a star-like symbol at the top, and a grid-like pattern at the bottom. The logo is black and white.

Sales and Service Region - North Amer
22100 Bothell Everett Highway
Bothell, Washington 98021
Tel: 425-487-7000
Web: www.philips.com

KOZYOO3

Phaye 2082

converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of this system process the Doppler shift frequencies from the echoes of moving targets (such as blood), to detect and graphically display the Doppler shifts of these tissues as flow.

5) Intended Use

The HDI 5000 system and transducers are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body.

6) Conclusion

The HDI 5000 system and transducers are substantially equivalent in safety and effectiveness to the predicate systems and transducers listed in item 3 above.

The systems are intended for diagnostic ultrasound imaging and fluid flow analysis. .
The systems have the same gray-scale and Doppler capabilities. .
The systems use essentially the same technologies for imaging, Doppler functions and . signal processing.
The systems have acoustic output levels below the applicable FDA limits. .
The systems are manufactured of materials with materials that have been evaluated . and found to be safe for its application.
The systems are designed and manufactured to applicable electrical and physical . safety standards.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human figures.

Public Health Service

JAN - 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Ultrasound, Inc. % Ms. Laura Danielson Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K034003

Trade Name: HDI 5000 Diagnostic Ultrasound 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 23, 2003 Received: December 24, 2003

Dear Ms. Danielson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your 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 mendments, or to devices that have been reclassified in accordance with the provisions of the Ameliuments, of to device 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 the general volument pro 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 HDI 5000 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3D6-2 Trans- Abdominal Broadband Curved Array C8-4v/8.0-4.0 MHz/11mm Curved Array

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device to such additional controls. Existing major regulations affecting your device it may be subject to saon addinental 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 i Tease of advised that I Drivision that your device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must or any I caefar statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fut 807), huseves (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 determination of substantial equivalence is granted on the condition that prior to shipping I 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 m / rependix es (entry Clearance of Diagnostic Ultrasound Systems and Transducers." If the special beening 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 (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".

Page 3 - Ms. Danielson

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Daniel A. Syzm

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

Enclosure(s)

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

HDI 5000 Ultrasound System

510(k) Number: System: Transducer: Intended Use:

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

Clinical Application		Mode of Operation ("includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic	P	P	P		P	Notes 1, 3	Notes 5, 6, 8,10,12, 13
	Fetal	P	P	P		P	Notes 1, 2, 3	Notes 5, 6, 7, 8, 10,
12, 13
Fetal Imaging
& Other	Abdominal	P	P	P		P	Notes 1, 2, 3	Notes 5, 6, 7, 8, 10,
11, 12, 13
	Intra-operative
(Abdominal, Spine, Vascular)	P	P	P		P	Notes 1, 3	Notes 5, 6, 8,10,12, 13
	Intra-operative (Neuro.)	P	P	P		P	Notes 1, 3	Notes 3, 5, 6, 10, 12,
13
	Laparoscopic	P	P	P		P	Notes 1, 3	Notes 8, 10, 12, 13
	Pediatric	P	P	P		P	Notes 1, 2, 3	Notes 5, 6, 8, 9, 10, 12,
13
	Small Organ (breast, thyroid,
testicle)	P	P	P		P	Notes 1, 2, 3	Notes 5, 6, 8, 10, 11,
12, 13
	Neonatal Cephalic	P	P	P		P	Notes 1, 3	Notes 5, 8, 10, 12, 13
	Adult Cephalic	P	P	P	P	P	Notes 1, 3, 4	Notes 10, 13
	Trans-rectal	P	P	P		P	Notes 1, 3	Notes 5,6,10,12, 13
	Trans-vaginal	P	P	P		P	Notes 1, 2, 3	Notes 5, 6, 7,10,12, 13
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)	P	P	P		P	Notes 1, 2, 3	Notes 5, 6, 8,10, 12,13
	Musculo-skel. (Superficial)	P	P	P		P	Notes 1, 2, 3	Notes 5, 6, 8, 10,
12,13
	Intra-luminal
	Other: Urology	P	P	P		P	Notes 1, 3	Notes 5, 10, 12
Cardiac	Cardiac Adult	P	P	P	P	P	Notes 1,2,3,4	Notes 10, 13
	Cardiac Pediatric	P	P	P	P	P	Notes 1,2,3,4	Notes 10, 11, 13
	Trans-esophageal (Cardiac)	P	P	P	P	P	Notes 1,2,3,4	Note 10
	Other (Fetal Echo)	P	P	P	P	P	Notes 1,2,3,4	Notes 5,10, 12, 13
Peripheral
Vessel	Peripheral vessel	P	P	P		P	Notes 1, 2, 3	Notes 2, 3, 5, 6, 7, 8,
10, 12, 13
	Cerebral Vascular	P	P	P		P	Notes 1, 2, 3	Notes 5, 6, 8, 10, 12,
13

N= new indication; P= previously cleared; E= added under Appendix E

Additional Comments:

*Color Doppler includes Color Amplitude Doppler

Color Doppier Includes Oolor Alipintados Dolor, B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note o: Oombined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoČT

Note 6: Imaging for guidance of biopsy

Note of . Infertility monitoring of follole development (Added to trans-vaginal in this submission.)

Note 8: Extended Field of View (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES (Added to trans-vaginal in this submission.)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CRF 801.109)

David h. Sym

Pres

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number_

Section 4.3

DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE STATEMENT

510(k) Number: System: Transducer: Intended Use:

HDI 5000 Ultrasound System 3D6-2 Trans- Abdominal Broadband Curved Array Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation ("includes simultaneous B-mode) Clinical Application Combined* Other B M PWD CWD Color Specific General (Spec.) (Spec.) (Tracks I & III) Doppler (Track I only) Ophthalmic Ophthalmic N Notes 1, 3 Notes 5, 6, 8, 10, N ત્વ N Fetal 12, 13 Notes 5, 6, 8, 10, Notes 1,3 N N N N Abdominal 12, 13 Intra-operative Intra-operative (Neuro.) Fetal Imaging Laparoscopic Pediatric & Other Small Organ Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Cardiac) Musculo-skel. (Conventional) Musculo-skel. (Superficial) Intra-luminal Other (Specify) Cardiac Adult Cardiac Pediatric Cardiac Trans-esophageal (Cardiac) N Notes 1, 2, 3 Notes 5, 10, 12,13 N N N Fetal Echo Peripheral vessel Peripheral Cerebral Vascular Vessel

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

*Color Doppler includes Color Amplitude Doppler

Ook 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 2: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Gombined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guidance of biopsy

Note 7: Infertility monitoring of follicle development

Note 7. Infentify mishitoring of telliforing of telludes SonoCT imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CRF 801.109)

David A. Lyman

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

Section 4.3

System:

510(k) Number: HDI 5000 Ultrasound System

Transducer: Intended Use:

C8-4v/8.0-4.0 MHz/11mm/Curved Array

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

Clinical Application		Mode of Operation (*Includes simultaneous B-mode)
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler*	Combined*
(Spec.)	Other
(Spec.)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	Notes 1, 3	Notes 5, 6, 10, 12
	Abdominal	P	P	P		P	Notes 1,2,3	Notes 5, 6, 7, 10, 12
	Intra-operative
	Intra-operative (Neuro.)
Fetal Imaging
& Other	Laparoscopic
	Pediatric
	Small Organ
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal	P	P	P		P	Notes 1, 2, 3	Notes 5, 6, 7, 10,
12, 13
	Trans-urethral
	Trans-esoph. (non-Cardiac)
	Musculo-skel. (Conventional)
	Musculo-skel. (Superficial)
	Intra-luminal
	Other (Urology)	P	P	P		P	Notes 1, 3	Notes 5, 10, 12
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Trans-esophageal (Cardiac)
	Fetal Echo
Peripheral
Vessel	Peripheral vessel
	Cerebral Vascular

N= new Indication; P= previously cleared; E= added under Appendix E Additional Comments:

*Color Doppler includes Color Amplitude Doppler

Note 1: Combined modes include: B+PWD; B+Color; B+Amplitude; B+M;

Note 2: Combined modes include: B+M+Color

Note 3: Combined modes include: B+Color+PWD; B+Amplitude+PWD

Note 4: Combined modes include: B+CWD; B+Color+CWD; B+Amplitude+CWD

Note 5: SonoCT

Note 6: Imaging for guldance of biopsy

Note 7: Infertility monitoring of folicle development (Added to trans-vaginal in this submission.)

Note 7. Inchality frentioning ew (EFOV), AKA Panoramic Imaging includes SonoCT imaging

Note 9: EFOV including Amplitude Doppler (N)

Note 10: Harmonic Imaging

Note 11: Contrast Imaging

Note 12: 3D Imaging

Note 13: XRES (Added to trans-vaginal in this submission.)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CRF 801.109)

Daniel A. Sinner

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