The 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300C, Ultrasound System 5300P, Ultrasound System 5300W) are intended for diagnostic Ultrasound imaging in B (or 2D), 3D/4D, Color Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-mode (including anatomical M-mode), Harmonics (Tissue and Contrast), Color Power Angio (CPA), and Combined modes.

5000 Compact series is indicated for diasound imaging and fluid flow analysis in the following applications: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral vascular, Fetal Echo, Fetal/Obstetric, Gynecological, Intra-operative (Vascular), Lung, Musculoskeletal (conventional), Musculoskeletal (superficial), Neonatal Cephalic, Ophthalmic, Peripheral Vessel, Small Organs (breasts, testicles, thyroid), Transesophageal (cardiac), Trans-rectal, Trans-vaginal, Urology.

The clinical environments where the 5000 Compact Series Ultrasound Systems can be used are: hospitals, surgery centers, clinics, physicians' office, diagnostic centers, critical care and emergency room environments, point-of-care clinical settings for diagnosis of patients.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgment and best clinical procedure. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.

Device Description

The proposed Philips 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) are general purpose, compact, battery or alternating current (AC) powered, software controlled, diagnostic ultrasound systems. The ultrasound system is housed in a portable, laptop-style chassis. The ultrasound system function is to acquire ultrasound data and to display the data in various modes of operation. The ultrasound system components include the monitor, control panel, transducer receptacles, ECG/physio receptacles, and AC adapter/battery charger. The ultrasound system can be attached to an optional cart. The cart height is adjustable to accommodate a range of operator heights and operating positions. The cart has wheels for maneuverability and may provide isolated power for system and peripheral components (such as black and white image printer or a report printer).

The 5000 Compact Series Ultrasound Systems comprises of different configurations which differ in terms of features, transducer options, and license options (features available as purchasable options in addition to the standard features available in the system. The types of options available include clinical options, QLAB Advanced Quantification Software, protocols, imaging capabilities, connectivity capabilities, etc.). The 5500G is the primary configuration with the most available capabilities. Identical software architecture is used in all configurations and all configurations are derived from a common codebase. Similarly, the hardware is same for all configurations. All the 5000 Compact Series Ultrasound System configurations are compatible with existing Philips transducers cleared in Philips Affiniti Ultrasound System (K200304). 5500 Compact Series POC (point-of-care) configurations leverage POC features from the CX50 platform (K162329) to enable efficient POC ultrasound capability.

AI/ML Overview

There is no information in the provided text about acceptance criteria or a study proving that the device meets specific performance criteria. The document is a 510(k) premarket notification from Philips Ultrasound LLC to the FDA for "5000 Compact Series Ultrasound Systems." This type of submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove specific performance metrics against an AI.

The document states:

"The proposed 5000 Compact Series Ultrasound Systems did not require clinical data for determination of substantial equivalence since substantial equivalence was demonstrated based on the following attributes: Design features, Indications for use, Fundamental scientific technology, Non-clinical performance testing, Safety and effectiveness."
"For testing, all pre-determined acceptance criteria were met." However, it does not specify what those acceptance criteria were or what performance data was collected to meet them.

Therefore, I cannot provide the requested information from the provided text, as it does not contain details about:

A table of acceptance criteria and reported device performance.
Sample sizes for a test set or data provenance.
Number of experts or their qualifications.
Adjudication method for a test set.
MRMC comparative effectiveness study or effect size.
Standalone performance.
Type of ground truth used.
Sample size for the training set (as no training set for an AI is mentioned).
How ground truth for a training set was established.

The document focuses on demonstrating that the new ultrasound systems are substantially equivalent to existing, cleared predicate devices (Philips Affiniti Ultrasound System and Philips CX 50 Ultrasound Systems) based on their technological characteristics, intended use, and safety considerations, rather than reporting on a study with specific performance acceptance criteria for an AI or imaging diagnostic algorithm.

Summary

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September 27, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Philips Ultrasound LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K222648

Trade/Device Name: 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 31, 2022 Received: September 1, 2022

Dear Prithul Bom:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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542 of the Act); 21 CFR 1000-1050.

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Yanna Kang, Ph.D.

Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222648

Device Name

5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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K22648

5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W)

This summary of safety and effectiveness information is submitted in accordance with 21 CFR 8807.92

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

Manufacturer: Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021-8431
Contact Person: Shilpa Rapaka Senior Regulatory Affairs Specialist 22100 Bothell Everett Hwy Bothell, WA 98021-8431 Phone: 203 213 6862
Secondary Contact: Tamara Daniels Senior Regulatory Affairs Manager 22100 Bothell Everett Hwy Bothell, WA 98021-8431 Phone: 203 213 6862
Date Prepared: September 27, 2022

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

Proprietary Name:	5000 Compact Series Ultrasound SystemsMarketed under the following models:Ultrasound System 5500GUltrasound System 5500PUltrasound System 5500WUltrasound System 5500CVUltrasound System 5300GUltrasound System 5300PUltrasound System 5300W
Common Names:	Ultrasonic pulsed doppler imaging systemUltrasonic pulsed echo imaging systemDiagnostic ultrasonic transducer

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Regulation Description:

Classification Name	21 CFR Section	Product Code
System, imaging, pulsed doppler, ultrasonic	892.1550	IYN
System, imaging, pulsed echo, ultrasonic	892.1560	IYO
Transducer, ultrasonic, diagnostic	892.1570	ITX

As stated in 21 CFR parts 892.1550, 892.1560, and 892.1570, each of these generic types of devices have been classified as Class II.

Device Class: Class II

3. Indications for Use

The 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) are intended for diagnostic Ultrasound imaging in B (or 2D), 3D/4D, Color Doppler, Continuous Wave Doppler, Pulse Wave Doppler, Tissue Doppler, M-mode (including anatomical M-mode), Harmonics (Tissue and Contrast), Color Power Angio (CPA), and Combined modes.

5000 Compact series is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral vascular, Fetal Echo, Fetal/Obstetric, Gynecological, Intra-operative (Vascular), Lung, Musculoskeletal (conventional), Musculoskeletal (superficial), Neonatal Cephalic, Ophthalmic, Pediatric, Peripheral Vessel, Small Organs (breasts, testicles, thyroid), Transesophageal (cardiac), Trans-rectal, Trans-vaginal, Urology.

4. Device Description Summary

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systems. The ultrasound system is housed in a portable, laptop-style chassis. The ultrasound system function is to acquire ultrasound data and to display the data in various modes of operation. The ultrasound system components include the monitor, control panel, transducer receptacles, ECG/physio receptacles, and AC adapter/battery charger. The ultrasound system can be attached to an optional cart. The cart height is adjustable to accommodate a range of operator heights and operating positions. The cart has wheels for maneuverability and may provide isolated power for system and peripheral components (such as black and white image printer or a report printer).

5. Substantially Equivalent Devices

Primary Predicate Device: Philips Affiniti Ultrasound System (K200304)

Reference Device: Philips CX 50 Ultrasound Systems (K162329)

6. Technological Comparison to Predicate Devices

The proposed 5000 Compact Series Ultrasound Systems are substantially equivalent to the currently marketed predicate devices. The following is an overview of the similarities between the proposed 5000 Compact Series Ultrasound System and the currently marketed predicate and reference devices.

The systems emplov the same fundamental scientific technology for imaging. doppler ● functions, and signal processing and have the same grayscale and doppler capabilities
The systems are all are indicated for diagnostic ultrasonic imaging and fluid flow analysis ● for use by the same type of users in the same type of use environments
The systems have the same clinical intended uses and indications for use
The systems have the same imaging modes ●
The transducers are identical ●
The systems are manufactured with materials which have been evaluated and found to be . safe for the intended use of the device

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. The systems have acoustic power levels which are within the Track 3 FDA limits
. The systems have similar capability in terms of performing measurements, capturing digital images, reviewing, and reporting studies
. The systems have been designed and manufactured to the same electrical and physical safety standards manufactured under equivalent quality systems

A comparison of the subject 5000 Compact Series Ultrasound Systems and the predicate and reference devices is shown in Table 8-1 below.

Table 8-1. Comparison of the proposed 5000 Compact Series Ultrasound Systems to the currently marketed predicate and reference devices

Standard Feature/TechnologyCharacteristics	Proposed Philips5000 Compact SeriesUltrasound Systems	PredicateEPIQ/AffinitiUltrasound System(K200304)	Reference CX50Ultrasound Systems(K162329)
Classification	Class II	Class II	Class II
Product Codes	IYNIYOITX	IYNIYOITX	IYNIYOITX
ClassificationRegulation Numbers	21 CFR 892.155021 CFR 892.156021 CFR 892.1570	21 CFR 892.155021 CFR 892.156021 CFR 892.1570	21 CFR 892.155021 CFR 892.156021 CFR 892.1570
Indications for Useand Modes ofOperation	Abdominal,Adult Cephalic,Cardiac Adult,Cardiac Pediatric,Carotid,Cerebral vascular,Fetal Echo,Fetal/Obstetric,Gynecological,Intra-operative(Vascular),Lung,Musculoskeletal(conventional),Musculoskeletal(superficial),Neonatal Cephalic,Ophthalmic,Pediatric,Peripheral Vessel,Small Organs(breasts, testicles,thyroid),	Fetal/Obstetric,Abdominal,Intraoperative(Vascular),Intraoperative(Cardiac),Pediatric, SmallOrgan (Breast,Thyroid, Testicle),Cephalic (Neonatal),Cephalic (Adult),Transrectal,TransvaginalMusculoskeletal(Conventional),Musculoskeletal(Superficial)Gynecological, Other:Urology,Cardiac Adult,Cardiac Pediatric,Transesophageal(Cardiac),Cardiac other (Fetal).	Ophthalmic,Intracardiac echo,Intraoperative,Laparoscopic, Fetal,Abdominal, Pediatric,Small Organ,Adult Cephalic,Neonatal Cephalic,Trans-vaginal,Musculoskeletal,Gynecological,Cardiac Adult,Cardiac pediatric,Trans-Esophageal.(Cardiac), PeripheralVessel, Other(Carotid), Trans-rectalModes of Operation:SparqB (or 2-D), M-mode(includingAnatomical M-mode),Pulse Wave Doppler,Continuous Wave
	Transesophageal(cardiac),Trans-rectal,Trans-vaginal,Urology	Peripheral Vessel,Cerebral Vascular,Modes of Operation:B (2D), M, PWD,CWD, Color Doppler,Combined (B+PWD,B+Color,B+Amplitude, B+M,B+M+Color,B+Color+PWD,B+Amplitude+PWD,B+CWD;B+Color+CWD;B+Amplitude+CWD),SonoCT, Imaging forguidance of biopsy,Panoramic Imaging,Color Power Angio(CPA), HarmonicImaging, Contrast,3D/4D Imaging,XRES	Doppler, ColorDoppler, TissueDoppler Imaging andHarmonics (Tissueand Contrast)CX50B (or 2-D), M-mode(includingAnatomical M-mode),Pulse Wave Doppler,Continuous WaveDoppler, ColorDoppler, TissueDoppler Imaging andHarmonics (Tissueand Contrast) modes
Transducers	Modes of Operation:B (or 2D),3D/4D,Color Doppler,Continuous WaveDoppler,Pulse Wave Doppler,Tissue Doppler,M-mode (includinganatomical M-mode),Harmonics (Tissueand Contrast),Color Power Angio(CPA), Combinedmodes	Affiniti3D9-3v, C5-1, C6-2,C8-5, C9-2, C9-4V,C10-4ec, D2cwc,D2tcd, D5cwc, BP10-5ec, eL18-4, L12-3,L12-3ERGO, L12- 4,L12-5 50, L15-7io,L18-5, S4-2, S5-1S7-3t, S8-3, S12-4,V6-2, VL13-5, X7-2t, V9-2, mC7-2EPIQC5-1, C8-5, C9-2,C10-3v, C10-4ec,D2cwc, D5cwc,eL18-4, L12-3, L12-550, L15-7io, L18-5,S5-1, S7-3t, S8-3, S8-3t, S12-4, V6-2, X7-2t, X8-2t, D2tcd, X5-1, X6-1, VL13-5, X7-2, X8-2ti, XL14-3,3D9-3v, V9-2, mC7-2, mC12-3	C5-1C8-5C9-3ioC9-3vC10-3vD2cwcD5cwcL10-4 lapL12-3L12-5 50L15-7ioS5-1S8-3S12-4S7-3tX7-2tC6-2C9-4vL12-4S4-2
	No new transducersintroduced as part of5000 Compact Series.All transducers thatare part of the 5000Compact Series arealready cleared inK200304 orK162329.
Power Supply	Same	Rechargeable lithiumion batteries, ACAdapter	Rechargeable lithiumion batteries, ACAdapter
OptionalAccessories/Peripherals	Various hardcopy, recording and printing products, black-and-white image printer, USB storage devices, Biopsy guides, Footswitch, Barcode scanner	Various hardcopy, recording and printing devices: digital video recorder (DVR), digital video disc (DVD), report printer, thermal printer (B/W, color), USB, PercuNav Instruments, Biopsy guides, Footswitch	Various hardcopy, recording and printing devices: report printer, DVD, USB, Biopsy guides, Footswitch
Form factor	Portable Laptop that can be placed on a mobile cart	Cart based, with an articulating monitor arm	CX50= Portable Laptop that can be placed on a mobile cartSparq= Cart based, with an articulating monitor arm
Battery Life	System operates via internal battery or AC power.System battery supports up to 30 min scanning. Extended battery up to 2 hours with optional batteries	System operates on AC power. A battery is provided to put the system in Sleep mode for up to 30 minutes allowing the system to be transported to a new location without powering down the system.	The system operates via an internal battery or AC Power. System battery supports up to 30 minute scanning.
Wireless NetworkFunctions	Integrated on PC moduleWired and wireless	Integrated on PC moduleWired and wireless	Wired EthernetWireless USBAdapter
Software Features	Imaging ModesPatient Data EntryPatient Database and StorageGeneric Measurement ToolsAnalysis and Calculation PackagesAnnotations	Imaging ModesPatient Data EntryPatient Database and StorageGeneric Measurement ToolsAnalysis and Calculation PackagesAnnotations	Imaging ModesPatient Data EntryPatient Database and StorageGeneric Measurement ToolsAnalysis and Calculation PackagesAnnotations
Clinical Options	Abdomen Clinical OptionAdult CardiologyClinical Option	Abdomen Clinical OptionAdult CardiologyClinical Option	Abdomen Clinical OptionAdult CardiologyClinical Option
	Advanced	Advanced	Fetal Echo Clinical
	Capabilities Limited	Capabilities Limited	Option
	Clinical Option	Clinical Option	GYN Clinical Option
	Breast Clinical Option	Breast Clinical Option	Musculoskeletal
	Fetal Echo Clinical	Fetal Echo Clinical	Clinical Option
	Option	Option	OB Clinical Option
	GYN Clinical Option	GYN Clinical Option	Pediatric Cardiology
	Musculoskeletal	Musculoskeletal	Clinical Option
	Clinical Option	Clinical Option	Pediatric GI Clinical
	OB Clinical Option	OB Clinical Option	Option
	Pediatric Cardiology	Pediatric Cardiology	Small Parts including
	Clinical Option	Clinical Option	Breast Clinical Option
	Pediatric GI Clinical	Pediatric GI Clinical	Cerebrovascular
	Option	Option	including TCD
	Small Parts Clinical	Small Parts Clinical	Clinical Option
	Option	Option	Vascular Clinical
	TCD Clinical Option	TCD Clinical Option	Option
	Urology Clinical	Urology Clinical	Peripheral Vascular
	Option	Option	Clinical Option
	Vascular Clinical	Vascular Clinical	Regional Anesthesia
	Option	Option	Clinical Option
	POC Clinical Option		Acute Care Clinical
			Option
Performance Options	Advanced Cardiac UI	Advanced Cardiac UI	Anatomic M mode
	Anatomic Mmode	Anatomic Mmode	Auto Doppler
	Auto Doppler	Auto Doppler	Auto Scan
	Auto Scan	Auto Scan	iScan
	iScan	iScan	Contrast Card
	Contrast Card	Contrast Card	Contrast GI
	Contrast Card Low	Contrast Card Low	Freehand 3D
	MI	MI	High Q
	Contrast GI	Contrast GI	Netlink DICOM
	Freehand 3D	Freehand 3D	Ultrasound Query
	High Q	High Q	Retrieve
	MaxVue	MaxVue	Smart Exam
	MicroFlow Imaging	MicroFlow Imaging	Stress Protocol
	Netlink DICOM	Netlink DICOM
	Ultrasound Query	Ultrasound Query
	Retrieve	Retrieve
	Multi-Modality Query	Multi-Modality Query
	Retrieve	Retrieve
	Panoramic 2D	Panoramic 2D
	Smart Exam	Smart Exam
	Stress Protocol	Stress Protocol
System Options	3D Color	3D Color	3D Color
	4D Imaging	4D Imaging	Live 3D Imaging -
	aBiometry Assist	aBiometry Assist	TEE only
	aReveal	aReveal
	Barcode Scanner SW	Barcode Scanner SW	Digital Navigation
	Digital Navigation	Digital Navigation	Link
	Link	Link	Transducer Element
	FlexVue	FlexVue	Check
	Transducer Element	Transducer Element	Needle Visualization
	Check	Check	Physio SW
	Needle Visualization	Needle Visualization	Strain Elastography
	Physio SW	Physio SW	Option
	Strain Elastography	Strain Elastography	Government Security
	Option	Option	SafeGuard
	STIC	STIC	Security Plus
	TrueVue	TrueVue
	Government Security	Government Security
	SafeGuard	SafeGuard
	Security Plus	Security Plus
Quantification	a2DQ	a2DQ	a2DQ
Options	AutoStrain LV	AutoStrain LV	aCMQ
	FHN	FHN	MVN
	GI 3DQ	GI 3DQ	GI 3DQ
	IMT	IMT	3DQa
	MVI	MVI	IMT
	ROI	ROI	MVI
	Strain Elastography	Strain Elastography	ROI
	Analysis	Analysis
	Strain Elastography	Strain Elastography
	Quantification	Quantification
	Strain Q	Strain Q
Hardware platform -	Physio: ECG,	Optical Drive: CD /	Optical Drive: CD /
Related Modules	Respiration, Pulse,	DVD-RW	DVD-RW
	Phono	Physio: ECG,	Physio: ECG,
	Side I/O: USB,	Respiration, Pulse,	Respiration, Pulse,
	Display Port Video,	Phono	Phono
	Wired Ethernet	Side I/O: USB, S-	Side I/O: USB, DVI
	Monitor - 15.6 inch	Video, Aux Physio	Video, Aux Physio,
	Landscape LCD	Rear I/O: DisplayPort	Wired Ethernet
		video, USB, Ethernet	Monitor: 15.6 inch
		Monitor: 21.5 inch	LCD
		LCD
Clinical	Hospitals, surgery	Clinics, hospitals, and	Point-of-care areas in
Environments	centers, clinics,	clinical point-of-care	offices, clinical and
	physicians' office,	for diagnosis of	hospital settings for
	diagnostic centers,	patients.	diagnosis of patients.
	critical care and
	emergency room
	environments, point-
	of-care clinical
	settings for diagnosis

	of patients.

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7. Safety Considerations

The subject 5000 Compact Series Ultrasound Systems are all Track 3 Devices and comply with the referenced standards as well as the FDA ultrasound guidance document, Guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued on June 27, 2019.

8. Nonclinical Performance Data

Philips Ultrasound performed the following testing to ensure the safety and effectiveness of the proposed 5000 Compact Series Ultrasound Systems:

. ANSVAAMI ES 60601-1: Medical electrical equipment. Part 1: General requirements for basic safety and essential performance, 2005/(R)2012 and A1:2012, C1:2009((R)2012 and A2:2010/(R)2012 (consolidated text)
IEC 60601-1-2 Medical Electrical Equipment -- Part 1-2, General Requirements for Basic ● Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2014
IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements for Basic ● Safety and Essential Performance- Collateral standard: Usability, 2013
IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2015
IEC 62304: Medical Device Software Software life cycle process, 2015 ●
IEC 62359, Ultrasonics – Field characterization – Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017-09
ANSI AAMI ISO 14971: Medical devices- Applications of risk management to medical devices, 2019

Non-Clinical verification testing has been performed addressing system level requirements according to system and design specifications, and risk control measures. Design Control activities to assure the safety and effectiveness of 5000 Compact Series include but are not limited to the following:

Requirements Review
Risk Analysis and Management ●
Product Specifications
Design Reviews
Verification and Validation ●

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Biocompatibility testing is not needed for the proposed 5000 Compact Series Ultrasound Systems as the transducer patient contacting materials and manufacturing processes are not impacted by the introduction of the proposed Philips 5000 Compact Series Ultrasound Systems.

9. Clinical Data

The proposed 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) did not require clinical data for determination of substantial equivalence since substantial equivalence was demonstrated based on the following attributes:

Design features
Indications for use ●
Fundamental scientific technology
Non-clinical performance testing ●
Safety and effectiveness ●

10. Sterilization

The proposed 5000 Compact Series Ultrasound Systems are not provided sterile.

11. Conclusion

For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) meet their intended use.

While the predicate, Affiniti, is a standard, cart-based ultrasound system, 5500 Compact Series is a compact, laptop-style system which provides ease of portability for the users. Additionally, 5000 Compact Series POC (point-of-care) configurations leverage POC features from the CX50 platform to enable efficient POC ultrasound capability. These design changes do not significantly affect the use of the device, nor do they introduce any new or significantly modified risks. The differences between the subject device and predicate device do not raise new questions of safety and/or effectiveness. Therefore, the proposed 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5300G, Ultrasound System 5500CV, Ultrasound System 5300P, Ultrasound System 5300W) is similar to the predicate Philips Affiniti Series Diagnostic Ultrasound Systems in terms of indications for use, design, technological characteristics, modes of operations, safety and effectiveness.

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.