(26 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would indicate the use of AI or ML.
No.
The device is intended for "diagnostic Ultrasound imaging" and "diasound imaging and fluid flow analysis," not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems "are intended for diagnostic Ultrasound imaging." Additionally, the "Device Description" refers to them as "diagnostic ultrasound systems."
No
The device description explicitly states it is a "general purpose, compact, battery or alternating current (AC) powered, software controlled, diagnostic ultrasound systems" and lists hardware components such as the monitor, control panel, transducer receptacles, ECG/physio receptacles, and AC adapter/battery charger.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "diagnostic Ultrasound imaging" and "fluid flow analysis." This involves using ultrasound waves to create images of internal structures and assess blood flow, which is a non-invasive imaging technique performed directly on the patient.
- Device Description: The description details a "diagnostic ultrasound system" that acquires and displays ultrasound data. This aligns with in-vivo imaging, not in-vitro testing of samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body. IVD devices are specifically designed for testing these types of samples to diagnose conditions.
Therefore, the Philips 5000 Compact Series Ultrasound Systems are diagnostic imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
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.
Mentions image processing
- The systems emplov the same fundamental scientific technology for imaging. doppler ● functions, and signal processing and have the same grayscale and doppler capabilities
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Types of users: appropriately trained healthcare professionals
Clinical environments: hospitals, surgery centers, clinics, physicians' office, diagnostic centers, critical care and emergency room environments, point-of-care clinical settings for diagnosis of patients.
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)
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 ●
For testing, all pre-determined acceptance criteria were met. Results of these tests show that the proposed 5000 Compact Series Ultrasound Systems (...) meet their intended use.
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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)
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.
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) |
|---|---|
| --------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Systems
Marketed under the following models:
Ultrasound System 5500G
Ultrasound System 5500P
Ultrasound System 5500W
Ultrasound System 5500CV
Ultrasound System 5300G
Ultrasound System 5300P
Ultrasound System 5300W |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Names: | Ultrasonic pulsed doppler imaging system
Ultrasonic pulsed echo imaging system
Diagnostic ultrasonic transducer |
4
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.
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.
4. Device Description Summary
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
5
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.
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
6
- . 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/
Technology
Characteristics | Proposed Philips
5000 Compact Series
Ultrasound Systems | Predicate
EPIQ/Affiniti
Ultrasound System
(K200304) | Reference CX50
Ultrasound Systems
(K162329) |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II | Class II |
| Product Codes | IYN
IYO
ITX | IYN
IYO
ITX | IYN
IYO
ITX |
| Classification
Regulation Numbers | 21 CFR 892.1550
21 CFR 892.1560
21 CFR 892.1570 | 21 CFR 892.1550
21 CFR 892.1560
21 CFR 892.1570 | 21 CFR 892.1550
21 CFR 892.1560
21 CFR 892.1570 |
| Indications for Use
and Modes of
Operation | 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, Small
Organ (Breast,
Thyroid, Testicle),
Cephalic (Neonatal),
Cephalic (Adult),
Transrectal,
Transvaginal
Musculoskeletal
(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), Peripheral
Vessel, Other
(Carotid), Trans-rectal
Modes of Operation:
Sparq
B (or 2-D), M-mode
(including
Anatomical 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 for
guidance of biopsy,
Panoramic Imaging,
Color Power Angio
(CPA), Harmonic
Imaging, Contrast,
3D/4D Imaging,
XRES | Doppler, Color
Doppler, Tissue
Doppler Imaging and
Harmonics (Tissue
and Contrast)
CX50
B (or 2-D), M-mode
(including
Anatomical M-mode),
Pulse Wave Doppler,
Continuous Wave
Doppler, Color
Doppler, Tissue
Doppler Imaging and
Harmonics (Tissue
and Contrast) modes |
| Transducers | Modes of Operation:
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), Combined
modes | Affiniti
3D9-3v, 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, S5-1
S7-3t, S8-3, S12-4,
V6-2, VL13-5, X7-
2t, V9-2, mC7-2
EPIQ
C5-1, C8-5, C9-2,
C10-3v, C10-4ec,
D2cwc, D5cwc,
eL18-4, L12-3, L12-5
50, 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 | C5-1
C8-5
C9-3io
C9-3v
C10-3v
D2cwc
D5cwc
L10-4 lap
L12-3
L12-5 50
L15-7io
S5-1
S8-3
S12-4
S7-3t
X7-2t
C6-2
C9-4v
L12-4
S4-2 |
| | No new transducers
introduced as part of
5000 Compact Series.
All transducers that
are part of the 5000
Compact Series are
already cleared in
K200304 or
K162329. | | |
| Power Supply | Same | Rechargeable lithium
ion batteries, AC
Adapter | Rechargeable lithium
ion batteries, AC
Adapter |
| Optional
Accessories/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 cart
Sparq= 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 Network
Functions | Integrated on PC module
Wired and wireless | Integrated on PC module
Wired and wireless | Wired Ethernet
Wireless USB
Adapter |
| Software Features | Imaging Modes
Patient Data Entry
Patient Database and Storage
Generic Measurement Tools
Analysis and Calculation Packages
Annotations | Imaging Modes
Patient Data Entry
Patient Database and Storage
Generic Measurement Tools
Analysis and Calculation Packages
Annotations | Imaging Modes
Patient Data Entry
Patient Database and Storage
Generic Measurement Tools
Analysis and Calculation Packages
Annotations |
| Clinical Options | Abdomen Clinical Option
Adult Cardiology
Clinical Option | Abdomen Clinical Option
Adult Cardiology
Clinical Option | Abdomen Clinical Option
Adult Cardiology
Clinical 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. | | |
7
8
9
10
11
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 ●
12
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.