(35 days)
Not Found
No
The document does not mention AI, ML, or related terms like DNN, nor does it describe training or test sets typically associated with AI/ML development. The focus is on standard X-ray imaging technology and compliance with existing standards.
No.
The device is described as a diagnostic X-ray imaging and viewing system, used for "radiological guidance and visualization during diagnostic, interventional and surgical procedures," rather than for treating a condition or disease.
Yes
The "Device Description" explicitly states, "The proposed Zenition 70 is a mobile, diagnostic X-ray imaging and viewing system."
No
The device description explicitly states it comprises two main hardware components: a C-arm stand and a mobile view station, indicating it is a hardware-based system with integrated software, not a software-only device.
Based on the provided information, the Zenition 70 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Zenition 70 Function: The description clearly states that the Zenition 70 is a "mobile, diagnostic X-ray imaging and viewing system." It is used for "radiological guidance and visualization during diagnostic, interventional and surgical procedures." This involves imaging the inside of the body using X-rays, not analyzing samples taken from the body.
The intended use, device description, and input imaging modality (X-ray) all point to it being an in vivo diagnostic and interventional imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zenition 70 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, sterile environment in a variety of procedures.
Applications:
- Orthopedic .
- · Neuro
- · Abdominal
- . Vascular
- · Thoracic
- · Cardiac
Product codes (comma separated list FDA assigned to the subject device)
OWB, OXO, JAA
Device Description
The proposed Zenition 70 is a mobile, diagnostic X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises two main components: the C-arm stand and a mobile view station
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
all patients, except neonates (birth to one month)
Intended User / Care Setting
adequately trained, qualified and authorized health care professionals; health care facilities both inside and outside the operating room, sterile as well as non-sterile environment
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 performance testing has been performed on the Zenition 70, and it demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance documents.
Non-clinical validation testing has been performed to cover the intended use, commercial claims, service needs, user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users.
Non-clinical verification and validation test results demonstrate that the Zenition 70:
- Complies with the aforementioned international and FDA recognized consensus standards and FDA guidance documents.
- Meets the acceptance criteria and is adequate for its intended use.
The Zenition 70 did not require clinical study since substantial equivalence to the primary currently marketed and predicate device Veradius Unity was demonstrated with the following attributes:
- Indication for use;
- Technological characteristics;
- Non-clinical performance testing; and
- Safety and effectiveness.
Furthermore, the optional 12-inch detector in Zenition 70 also has same design, technology and Image acquisition workflow compared to the previously cleared detector used in the marketed predicate device Veradius Unity, except difference in the dimension and pixel size. All technical detector characteristics that potentially have an influence on image quality are assessed and verified according to FDA Guidance for Industry and Food and Drug Administration Staff: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices. So Nonclinical information used to support the substantial equivalence as per FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Philips Medical Systems Nederland BV Sumit Kumar Regulatory Approbation Officer Veenpluis 4-6 Best. 5684PC THE NETHERLANDS
December 6, 2018
Re: K183040
Trade/Device Name: Zenition 70 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: October 29, 2018 Received: November 1, 2018
Dear Sumit Kumar:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indication for Use Statement 4
The Indication for Use Statement is included in the next pages.
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| 510(k) Number (if known)
K183040 | |
Device Name Zenition 70
Indications for Use (Describe)
The Zenition 70 device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, sterile environment in a variety of procedures.
Applications:
- Orthopedic .
- · Neuro
- · Abdominal
- . Vascular
- · Thoracic
- · Cardiac
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)
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 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."
FORM FDA 3881 (7/17) Publishing Services (301) 443-6740 Section 4 - Indication for Use Statement
Page 1 of 1 EF Confidential
PSC
Page 2 of 2
4
5 510 (k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | October 29, 2018 | |
|---|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| Veenpluis 4-6 | ||
| 5684 PC Best | ||
| The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Primary | ||
| Contact Person: | Sumit Kumar | |
| Regulatory Approbation Officer | ||
| Phone: +91 7028039288 | ||
| E-mail: sumit.kumar_3@philips.com | ||
| Secondary | ||
| Contact Person: | Sonavane, Neena Sandeep | |
| Regulatory Affairs Manager | ||
| Phone: +91 8446020023 | ||
| E-mail: neena.sonavane@philips.com | ||
| Device: | Trade Name: | Zenition 70 |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR §892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Primary Product Code: | ||
| Secondary Product Code: | OWB | |
| OXO, JAA | ||
| Primary | ||
| Predicate | ||
| Device: | Trade Name: | Veradius Unity |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K142708 | |
| Classification Name: | Image-intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR §892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | OWB; OXO; JAA | |
| Device | ||
| description: | The proposed Zenition 70 is a mobile, diagnostic X-ray imaging and viewing system. It | |
| is designed for medical use in healthcare facilities where X-ray imaging is needed. The | ||
| system comprises two main components: the C-arm stand and a mobile view station | ||
| Indications for | ||
| Use: | The proposed Zenition 70 is intended to be used and operated by: adequately trained, | |
| qualified and authorized health care professionals who have full understanding of the | ||
| safety information and emergency procedures as well as the capabilities and functions of | ||
| the device. | ||
| The device is used for radiological guidance and visualization during diagnostic, | ||
| interventional and surgical procedures on all patients, except neonates (birth to one | ||
| month), within the limits of the device. The device is to be used in health care facilities | ||
| both inside and outside the operating room, sterile as well as non-sterile environment in | ||
| a variety of procedures. | ||
| Applications: | ||
| • Orthopedic | ||
| • Neuro | ||
| • Abdominal | ||
| • Vascular | ||
| • Thoracic | ||
| • Cardiac | ||
| The proposed Philips Zenition 70 has identical indications to the currently marketed and | ||
| predicate device Veradius Unity | ||
| Technological | ||
| characteristics: | The proposed Zenition 70 employs the same basic construction and fundamental | |
| scientific technology as the currently marketed and predicate Veradius Unity. The | ||
| technology used in the development of the major components of the proposed Zenition | ||
| 70, which includes X-ray generator, X-ray tube, X-ray tube housing assembly, Image | ||
| detection system and beam-limiting device is identical to the currently marketed and | ||
| predicate Veradius Unity. Modifications implemented in the proposed Zenition 70 | ||
| include | ||
| • Improved system architecture with PC platform. | ||
| • Monoblock reduced height and reduced filtration | ||
| • Introduction of an optional 12"( PX2121S) Flat Detector | ||
| • Live DVD recording option no longer supported | ||
| • System service functions | ||
| • Introduction of metal exclusion | ||
| • Improved DICOM connectivity workflow | ||
| • Introduction of the security features | ||
| • Improved User Interfaces | ||
| • Improved tube heat management | ||
| • Analogue video out no longer supported | ||
| • Room interface | ||
| • Audible signals |
5
6
management activities show that all risks are sufficiently mitigated and that the overall residual risks are acceptable .The differences between the Zenition 70 and the predicate device do not raise any new questions regarding safety or effectiveness. Based on the information provided in this 510(k) submission, the Zenition 70 is considered substantially equivalent to the currently marketed predicate Veradius Unity in terms of fundamental scientific technology.
7
Non-clinical performance testing has been performed on the Zenition 70, and it Summary of Non-Clinical demonstrates compliance with the following International and FDA-recognized Performance consensus standards and FDA guidance documents. Data:
- IEC 62304 Medical device software Software life cycle processes (Edition 1.1, ● 2015). FDA/CDRH recognition number 13-79.
- ISO 14971 Medical devices Application of risk management to medical ● devices (Edition 2.0, corrected version, 2007). FDA/CDRH recognition number 5-40.
- IEC 60601-2-43 - Particular requirements for the safety of X-Ray equipment for interventional procedures (Edition 2.1, 2017). FDA/CDRH recognition number 12-308.
- IEC 60601-2-54, Medical Electrical Equipment- Part 2-54: Particular ● Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Radiography and Radioscopy (Edition 1.1 2015). FDA/CDRH recognition number 12-296.
- . IEC 60601-2-28-Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Edition 2.0 2010) FDA/CDRH recognition number 12-204.
- IEC 60601-1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance (Edition 3.1). FDA/CDRH recognition number 19-4.
- IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements ● for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests (Edition 4.0 2014). FDA/CDRH recognition number 19-8.
- IEC 60601-1-3, Medical Electrical Equipment Part 1-3: General Requirements ● for Basic Safety and Essential Performance. - Collateral Standard: Radiation Protection in Diagnostic X-Ray Equipment. (Edition 2.1 2013). FDA/CDRH recognition number 12-269.
- IEC 60601-1-6, Medical Electrical Equipment Part 1-6: General Requirements ● for Basic Safety and Essential Performance- Collateral Standard: Usability (Edition 3.1 2013). FDA/CDRH recognition number 5-89.
- IEC 62366 IEC Application of Usability Engineering to Medical Devices . (Edition 1.0 2015). FDA/CDRH recognition number 5-114
- FDA Guidance for Industry and Food and Drug Administration Staff: Guidance ● for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (document number 644)
- Pediatric information for x-ray imaging device premarket notifications (document number 1771)
- Guidance for Industry and FDA Staff Guidance for the Content of Premarket . Submissions for Software Contained in Medical Devices, May 11, 2005 (document number 337).
- . Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices(document number (1757)
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and FDA Staff (document number 1825).
8
- . Radio frequency wireless technology in medical devices- Guidance for Industry and Food and Drug Administration Staff (document number 1618).
Non-clinical validation testing has been performed to cover the intended use, commercial claims, service needs, user needs, effectiveness of safety measures, instructions for use, and usability testing with representative intended users.
Non-clinical verification and validation test results demonstrate that the Zenition 70:
- Complies with the aforementioned international and FDA recognized consensus ● standards and FDA guidance documents.
- Meets the acceptance criteria and is adequate for its intended use. .
| Summary of
Clinical
Performance
Data: | The Zenition 70 did not require clinical study since substantial equivalence to the
primary currently marketed and predicate device Veradius Unity was demonstrated with
the following attributes:
• Indication for use;
• Technological characteristics;
• Non-clinical performance testing; and
• Safety and effectiveness. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Furthermore, the optional 12-inch detector in Zenition 70 also has same design,
technology and Image acquisition workflow compared to the previously cleared detector
used in the marketed predicate device Veradius Unity, except difference in the dimension
and pixel size. All technical detector characteristics that potentially have an influence on
image quality are assessed and verified according to FDA Guidance for Industry and
Food and Drug Administration Staff: Guidance for the Submission of 510(k)'s for Solid
State X-ray Imaging Devices. So Nonclinical information used to support the substantial
equivalence as per FDA Guidance for the Submission of 510(k)s for Solid State X-ray
Imaging Devices. |
| Substantial
Equivalence
Conclusion: | The Zenition 70 is substantially equivalent to the currently marketed predicate device
Veradius Unity K142708 in terms of indications for use, fundamental scientific
technology and safety and effectiveness.
Additionally, substantial equivalence was demonstrated by non-clinical performance
tests provided in this 510(k) premarket notification. These tests demonstrate that
Zenition 70 complies with the requirements specified in the international and FDA-
recognized consensus standards and guidance, and is as safe and effective as its predicate
device without raising any new safety and/or effectiveness concerns. |