(29 days)
The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.
The clinical environments where Philips EPIQ diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
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. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.
However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
The intended use of the Affiniti Series Diagnostic Ultrasound Systems is ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, and clinical point-of-care 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. Systems are to be operated only by appropriately trained healtheare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the following two new Liver Fat Quantification software features:
- (1) Attenuation Quantification: a measure of the attenuation coefficient in dB/cm-MHz of a region of interest in the liver
- (2) Hepato-Renal Index Quantification: a ratio measure of the echogenicity ('brightness') of the liver parenchyma relative to that of the adjacent renal cortex
The features provide the end user with the capability to calculate attenuation of the liver and an hepato-renal index ratio during an ultrasound exam using Philips EPIQ or Affiniti Ultrasound System. Previously cleared liver quantification tools available to the end user include Shear Wave Point Quantification (ElastPQ, cleared via K17207 on 04 Oct 2017) and Shear Wave Imaging (ElastQ, cleared via K181485 on 27 Jul 2018). These existing quantification features measure liver stiffness on real-time and retrospective images.
The provided text describes specific features related to liver fat quantification (Attenuation Quantification and Hepato-Renal Index Quantification) for Philips Ultrasound systems. However, it does not contain detailed information about acceptance criteria, the specific study that proves the device meets those criteria, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment methods, or the results of any multi-reader multi-case (MRMC) comparative effectiveness studies.
The document is a 510(k) summary for regulatory clearance, which primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and general design control activities. It mentions "Software Verification and Validation testing" and "Non-clinical bench performance testing" but does not provide the results of these tests in a detailed, quantitative manner against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The document confirms the device's intended use and regulatory classification but lacks the specifics of performance studies that would typically include acceptance criteria and detailed study results.
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September 24, 2021
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Philips Ultrasound, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k SAINT PAUL MN 55114
Re: K212704
Trade/Device Name: Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OBJ, QIH Dated: August 25, 2021 Received: August 26, 2021
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.
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
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801 and Part 809); 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 531-542 of the Act); 21 CFR 1000-1050.
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 mediation-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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)
K212704
Device Name Philips EPIQ Diagnostic Ultrasound System
Indications for Use (Describe)
The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transvaginal, Lung.
The clinical environments where Philips EPIQ diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
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. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.
However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.
| 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.
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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."
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Indications for Use
510(k) Number (if known)
K212704
Device Name Philips Affiniti Diagnostic Ultrasound System
Indications for Use (Describe)
The intended use of the Affiniti Series Diagnostic Ultrasound Systems is ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:
Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, and clinical point-of-care 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. Systems are to be operated only by appropriately trained healtheare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.
| Type of Use ( Select one or both, as applicable ) | ||
|---|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) [ ] Over-The-Counter Use (21 CFR 801 Subpart C) | [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
| [X] 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 Druq 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."
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510(k) # K212704
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR $807.92
| I. | Submitter | |
|---|---|---|
| Manufacturer Name and Address | Philips Ultrasound, Inc.22100 Bothell Everett HwyBothell, WA 98021-8431 | |
| Contact Information | Tamara DanielsSenior Manager, Regulatory Affairs22100 Bothell Everett HwyBothell, WA 98021-8431Phone: 203.213.6862 | |
| Secondary Contact Information | Anne RossiDirector, Regulatory Affairs22100 Bothell Everett HwyBothell, WA 98021-8431Phone: 425.256.0664 | |
| Date Prepared | September 21, 2021 | |
| II. | Device Proprietary Name | Philips EPIQ Diagnostic Ultrasound SystemPhilips Affiniti Diagnostic Ultrasound System |
| Common Name | Diagnostic Ultrasound System and Transducers | |
| Regulation Description: | Ultrasonic pulsed doppler imaging system Ultrasonic pulsed echoimaging system Diagnostic ultrasound transducerDiagnostic intravascular catheterMedical image management and processing | |
| Product Code;Regulation Description;Regulation Number | IYN; Ultrasonic Pulsed Doppler Imaging System; 21 CFR 892.1550IYO; Ultrasonic Pulsed Echo Imaging System; 21 CFR 892.1560ITX; Diagnostic Ultrasonic Transducer; 21 CFR 892.1570OBJ; Diagnostic Intravascular Catheter; 21 CFR 870.1200OIH; Picture archiving and communications system; 21 CFR 892.2050 |
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TRADITIONAL 510(K) Philips Ultrasound Liver Fat Quantification Module
| Device Class | Class II |
|---|---|
| Classification Panel | Radiology |
III. Predicate & Reference Devices
Primary Predicate Devices:
-
K202216 EPIQ Diagnostic Ultrasound System ●
Reference Predicate Device: -
K201012 Affiniti Diagnostic Ultrasound System
-
K161843 Aplio I900/1800/1700 Diagnostic Ultrasound System, V2.0 Toshiba Medical ● Systems Corporation (also marketed under Canon)
IV. Device Description
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the following two new Liver Fat Quantification software features:
- (1) Attenuation Quantification: a measure of the attenuation coefficient in dB/cm-MHz of a region of interest in the liver
- (2) Hepato-Renal Index Quantification: a ratio measure of the echogenicity ('brightness') of the liver parenchyma relative to that of the adjacent renal cortex
The features provide the end user with the capability to calculate attenuation of the liver and an hepato-renal index ratio during an ultrasound exam using Philips EPIQ or Affiniti Ultrasound System. Previously cleared liver quantification tools available to the end user include Shear Wave Point Quantification (ElastPQ, cleared via K17207 on 04 Oct 2017) and Shear Wave Imaging (ElastQ, cleared via K181485 on 27 Jul 2018). These existing quantification features measure liver stiffness on real-time and retrospective images.
The Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems were selected as the primary predicate for the subject device. The technology is similar to the cleared Aplio 1900/1800/1700 Diagnostic Ultrasound System, V2.0. This product contains attenuation and hepato-renal index quantification features.
V. Indications for Use
Device
Indications for Use
2
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| Philips EPIQDiagnostic UltrasoundSystem | The intended use of Philips EPIQ series diagnostic ultrasound systems isdiagnostic ultrasound imaging and fluid flow analysis of the human body,with the following indications for use:Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, CerebralVascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric,Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular),Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal(Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ(Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal,Transvaginal, Lung.The clinical environments where Philips EPIQ diagnostic ultrasound systemscan be used include clinics, hospitals, and clinical point-of-care for diagnosisof patients.When integrated with Philips EchoNavigator, the systems can assist theinterventionalist and surgeon with image guidance during treatment ofcardiovascular disease in which the procedure uses both live X-ray and liveecho guidance.The systems are intended to be installed, used, and operated only inaccordance with the safety procedures and operating instructions given in theproduct user information. Systems are to be operated only by appropriatelytrained healthcare professionals for the purposes for which they weredesigned. However, nothing stated in the user information reduces yourresponsibility for sound clinical judgement and best clinical procedure. |
|---|---|
| Philips AffinitiDiagnostic UltrasoundSystem | The intended use of the Affiniti Series Diagnostic Ultrasound Systems isdiagnostic ultrasound imaging and fluid flow analysis of the human bodywith the following Indications for Use:Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, CerebralVascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric,Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac),Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other:Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid,Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.The clinical environments where the Affiniti Diagnostic Ultrasound Systemscan be used include Clinics, Hospitals, and clinical point-of-care fordiagnosis of patients.The systems are intended to be installed, used, and operated only inaccordance with the safety procedures and operating instructions given in theproduct user information. Systems are to be operated only by appropriatelytrained healthcare professionals for the purposes for which they weredesigned. However, nothing stated in the user information reduces yourresponsibility for sound clinical judgment and best clinical procedure. |
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TRADITIONAL 510(K) Philips Ultrasound Liver Fat Ouantification Module
VI. Comparison of Technological Characteristics with the Predicate Device
The selection of the predicate device (K202216, K201012) is based on the similarity in indications for use, clinical use scenarios, and principles of operation among devices. The introduction of the Liver Fat Quantification software features does not modify the Philips EPIQ and Affiniti Ultrasound System indications. The current Liver Quantification tools available to the end user include Shear Wave Point Quantification (ElastPQ) and Shear Wave Imaging (ElastQ).
The Liver Fat Quantification software feature functionalities allow the end user to perform the following measurements during an ultrasound exam:
- (1) Attenuation Quantification: a measure of the attenuation coefficient in dB/cm-MHz of a region of interest in the liver
- (2) Hepato-Renal Index (HRI) Quantification: a ratio measure of the echogenicity ("brightness") of the liver parenchyma relative to that of the adjacent renal cortex
The selection of the reference device (K161843) is based on the similar of software feature functionality. This reference device contains the software features (attenuation and hepato-renal index ratio quantifications) included in this submission.
VII. Performance Data
The proposed Philips Liver Fat Quantification software features were tested in accordance with Philips internal processes. Design Control activities to assure the safe and effective performance of the Liver Fat Quantification software features include but are not limited to the following:
- Requirements Review
- . Risk Analysis and Management
- Product Specifications .
- Design Reviews .
- Software Verification and Validation
Non-clinical bench performance testing was also conducted for attenuation imaging on the Canon device to the proposed Liver Fat Quantification software features.
Software Verification and Validation testing were used to support evidence for the new Liver Fat Quantification software features. The software documentation is presented in accordance with the FDA's Guidance for Content of Premarket Submissions for Software Contained in Medical Devices issued May 11, 2005.
VIII. Conclusion
Based on adherence to the aforementioned Philips internal processes and the successful verification and validation testing, the proposed Liver Fat Quantification software features are similar to the software feature in the reference device K161843. The proposed devices meet the defined requirements and performance claims and are substantially equivalent to the proposed primary predicate device (K202216).
§ 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.