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510(k) Data Aggregation
(125 days)
The Unity DX instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of anterior and posterior ocular structures and measurement of anterior segment and biometric parameters including:
- Axial Length
- Anterior Chamber Depth
- Central Corneal Thickness
- Lens Thickness
The Reference Image functionality is intended for use as an ocular image capture tool.
The UNITY DX instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of anterior and posterior ocular structures and measurement of anterior segment and biometric parameters including axial length, anterior chamber depth, corneal thickness, lens thickness, and reference image. The UNITY DX device has four (4) measurement modalities: HP-OCT, wavefront measurement, reference image, and reflective topography.
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(85 days)
UpDoc is a software as a medical device (SaMD) intended to provide medication management for patients aged 18 years and older who have been diagnosed with type 2 diabetes.
UpDoc provides patients with insulin treatment plan instructions based on a healthcare provider (HCP)-specified treatment plan.
UpDoc contains two user-interactive software components:
• Patient User Interface (UpDoc mobile application): Intended for use by patients with type 2 diabetes as an aid in optimizing insulin management. Patients use the mobile application to log blood glucose, meal, symptom, and medication adherence data, and receive treatment plan instructions. Data may be entered manually or reported via voice or text-based interactions. The application may also receive blood glucose data via a Bluetooth-enabled glucometer or continuous glucose monitor.
• HCP User Interface (UpDoc web portal): Intended for use by trained healthcare providers to configure and manage the patient-specific insulin treatment plan. This includes insulin dosing instructions (type, starting and maximum doses, adjustment algorithm, and blood glucose targets) and safety protocols to address non-emergency hypoglycemia, hyperglycemia, and related symptoms.
Insulin instructions are computed in UpDoc's cloud-based application based on the HCP-defined treatment parameters.
UpDoc is a software as a medical device (SaMD) designed to assist patients aged 18 years and older with insulin management for type 2 diabetes. Healthcare providers (HCPs) set an individualized treatment plan for their patients that includes monitoring and insulin titration instructions. UpDoc engages with patients to help them follow their designated treatment plan and supports HCPs in monitoring reported health data, medication adherence, and treatment progress.
UpDoc is composed of three modular software components: a provider-facing web portal (UpDoc Provider Portal), a patient mobile application (UpDoc Patient App), and a cloud-based application consisting of a Conversation Service (UpDoc Agent) and a Clinical Service. These components work together to support safe and effective provider-directed insulin therapy.
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(224 days)
The UltraSight Guidance is intended to assist medical professionals (not including expert sonographers) in acquiring cardiac ultrasound images. UltraSight Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems. UltraSight Guidance is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
UltraSight Guidance is a software application based on machine learning that uses artificial intelligence to provide dynamic real-time guidance on the position and/or orientation of the transducer to help non-expert users acquire diagnostic quality tomographic views of the heart. The system provides guidance for ten standard cardiac views.
Main features:
• Quality Bar: The system displays an image quality bar that is continuously updated while the user scans the subject, while attempting to find the maximal quality. The quality bar is a score for image diagnosability. It represents the classification between high and low quality images, where high quality images are defined as grade 3 or more based on American College of Emergency Physicians (ACEP) guidelines (Rachel B. Liu et al., "Emergency Ultrasound Standard Reporting Guidelines", 2018, American College of Emergency Physicians)
• Probe Guidance: The probe guidance feature provides graphic on-screen instructions for the user to emulate how a sonographer would manipulate the transducer to acquire the target cardiac view. The five possible guidance cues are rotation, tilt, rock, and slides in the lateral-medial and up/down directions (with respect to the subjects' head).
The guidance user interface (UI) is composed of a 3D probe display that shows orientation guidance cues (rotations, tilts and rocks) and a cross that shows slide guidance cues (slides in x and y directions). The users infer the maneuver they should perform from viewing the 3D probe display and the slides cross. Supporting text messages appear on the screen regarding guidance cues.
This device is a modification of a previously marketed device, where the main modification introduced is the addition of a pre-processing step done prior to feeding images as an input to the device. This modification is aimed to enable future compatibility with potentially additional ultrasound probes that meet pre-requisites as part of a pre-determined change control plan.
Here's a breakdown of the acceptance criteria and study details for the UltraSight Guidance device, based on the provided FDA 510(k) clearance letter:
UltraSight Guidance: Acceptance Criteria and Study Details
The UltraSight Guidance device focuses on two main features: the "Quality Bar" and "Probe Guidance." The performance testing for each is described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Quality Bar | Mean Area Under the ROC Curve (AUC) > 0.8 | Mean AUC was within the pre-defined acceptance criteria of AUC > 0.8 with 95% CI showing good classification performance relative to the success criteria. (p. 10) |
| Mean False Positive Rate (FPR) < 0.2 | The mean false positive rate (FPR) met the acceptance criteria of FPR < 0.2 with 95% CI showing good classification performance. (p. 10) | |
| Probe Guidance | Mean Area Under the ROC Curve (AUC) > 0.8 (for each guidance cue) | The mean AUC was within the acceptance criteria of AUC > 0.8 with 95% CI showing good classification performance. (p. 13) (Note: This is stated for each guidance cue, implying individual performance met this criterion, though not explicitly broken down per cue in the summary). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Quality Bar: 134 patients, comprising 26,362 ultrasound clips.
- Probe Guidance: 134 patients, comprising 2.4 million ultrasound frames.
- Data Provenance: The test dataset was collected from clinical sites geographically distinct from those used for the development dataset.
- Countries of Origin: 111 patients from the US and 23 patients from Israel.
- Retrospective/Prospective: Not explicitly stated as retrospective or prospective, but the description of "collected from clinical sites" and "comprising [number] ultrasound clips/frames" suggests it was likely retrospective collection of existing data or data collected for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Quality Bar: Two expert cardiologists initially annotated the clips for diagnosability.
- Probe Guidance: Ground truth was established by expert sonographers and/or cardiologists.
- Qualifications of Experts: The document explicitly states "expert cardiologists" and "expert sonographers and/or cardiologists," implying recognized professionals in their respective fields, but does not provide specific details on years of experience or board certifications.
4. Adjudication Method for the Test Set
- Quality Bar: 2+1 Adjudication. Initially, two expert cardiologists provided annotations. In case of disagreement, a third cardiologist provided additional annotation, and the final label was determined by majority vote among the three experts. (p. 9-10)
- Probe Guidance: Not explicitly detailed. The statement "Ground truth was established by expert sonographers and/or cardiologists" (p. 13) does not specify an adjudication method for potential disagreements among multiple experts, or if a single expert reviewed each case.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No MRMC comparative effectiveness study was specifically described for the initial clearance in the provided text. The testing focuses on the standalone performance of the algorithm (AI model) for the Quality Bar and Probe Guidance features.
- It does mention a "Clinical utility test" as a potential future testing method as part of the PCCP for "Expanded list of cardiac views": "Clinical utility test will evaluate the ability of non-expert users to obtain diagnostic-quality cardiac images using UltraSight software for the newly added cardiac views." (p. 12). This might involve comparing performance with and without the device, but it is for future modifications, not the current clearance, and details are scarce.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Yes, standalone performance (algorithm only) was done for both the Quality Bar and Probe Guidance features. The studies describe the classification performance of the algorithm against expert-established ground truth without human users interacting with the device for the testing itself. For example, for the Quality Bar, the device's classification of "diagnosable/non-diagnosable" was compared to expert labels. For Probe Guidance, the algorithm's prediction of guidance cues was compared to expert-defined optimal probe positions.
7. The Type of Ground Truth Used
- Quality Bar: Expert Consensus (diagnosability label). The ground truth ("diagnosable / non-diagnosable") was established by two expert cardiologists, with a third cardiologist resolving disagreements through majority vote. (p. 9-10)
- Probe Guidance: Expert-established optimal probe position/orientation. Ground truth was established by "expert sonographers and/or cardiologists using the recorded probe position during ultrasound acquisition." This defined the "required rotation, tilt, rock and slides adjustments" against which the algorithm's guidance was compared. (p. 13)
8. The Sample Size for the Training Set
- The document states that the test dataset was "collected from clinical sites geographically distinct from those used for the development dataset" (p. 9). However, the specific sample size of the training (development) set is not provided in the clearance letter summary.
9. How the Ground Truth for the Training Set Was Established
- Similar to the training set sample size, the method for establishing ground truth for the training (development) set is not explicitly detailed in the provided text. It is generally assumed that similar expert annotation processes would have been followed for the training data, but the document does not specify this.
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(23 days)
The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.
The proposed unscented menstrual tampons are cylindrical devices designed to absorb menstrual blood during a women's period. They consist of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (except for the digital style). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip for ease of insertion. According to different composition materials and design styles, the unscented menstrual tampons of this submission are divided into 3 categories (Unscented menstrual long applicator tampon, Unscented menstrual Cardboard Applicator Tampon, Unscented menstrual Digital Tampons) and 7 sub-categories (Cotton + cardboard tube, Organic cotton + cardboard tube, Cotton (digital style), Organic cotton(digital style), viscose (digital style), Cotton + plastic tube and Viscose + cardboard tube). For applicator-style tampons, they feature a built-in applicator made of plastic or cardboard that helps the users insert the tampons into the vagina by pushing the tampon out of the applicator. The digital style tampons consist of a plain tampon designed to be inserted manually using the fingers.
The tampons are provided in 4 absorbencies: Light(L) (≤6g), Regular(R) (6-9g), Super (S)(9-12g) and Super Plus (SP)(12-15g). For Cotton + cardboard tube and Organic cotton + cardboard tube, L and SP are applicable for this application. For Cotton (digital style), Organic cotton (digital style) and Viscose (digital style), only L is applicable. For Cotton + plastic tube and Viscose + cardboard tube, all those four absorbencies are applicable for this application.
Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.
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(182 days)
Unimed Reusable SpO₂ Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused, when applied to the finger. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with Mindray M12, and are supplied non-sterile.
Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in finger clip type.
The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.
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(182 days)
Unimed Reusable SpO₂ Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused, when applied to the finger. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject devices are Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensors are designed for compatibility with Nonin 9847, and are supplied non-sterile.
Each sensor consists of a connector, a cable, and a reusable patient-contacting sensor element incorporating a light-emitting diode (LED) and photodetector (PD). The sensors are available in multiple configurations, including finger clip, wrap, and soft-tip types, to accommodate various patient needs and anatomical sites.
The subject devices operate on the same principle and share similar design features, materials, and performance characteristics as the predicate device.
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(152 days)
Digital Medical X-ray Imaging System is intended to acquire X-ray images of the human body by a qualified technician, examples include acquiring two-dimensional X-ray images of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. The visualization of such anatomical structures provide visual evidence to radiologists and clinicians in making diagnostic decisions. This device is not intended for mammography.
uDR Arria and uDR Aris are two models of Digital Medical X-ray Imaging System developed and manufactured by Shanghai United Imaging Healthcare Co., Ltd(UIH). The system is equipped with imaging chain components and utilizes enhanced processing technology, so it can offer radiographic images with high image quality. The intuitive user interface and easy-to-use functions provide clinical users with a experience during patient examination and image processing.
The system is intended to acquire X-ray images of the human body by a qualified technician, examples include acquiring two-dimensional X-ray images of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. The visualization of such anatomical structures provide visual evidence to radiologists and clinicians in making diagnostic decisions. This device is not intended for mammography.
Here's a breakdown of the acceptance criteria and study details for the uDR Arria and uDR Aris devices, based on the provided FDA 510(k) clearance letter:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary provided details for two specific optional software functions: uVision and uAid. Other aspects of the device are X-ray imaging systems, for which the primary "performance" is image quality, which is evaluated subjectively through clinical image evaluation rather than quantitative metrics and acceptance criteria.
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| uVision (Optional) | When users employ the uVision function for automatic positioning, the automatically set system position and field size will meet clinical technicians' criteria with 95% compliance. | In 95% of patient positioning processes, the light field and equipment position automatically set by uVision can meet the clinical positioning and shooting requirements. In the remaining 5% of cases, based on the light field and system position automatically set by the equipment, technicians still need to make manual adjustments. |
| uAid (Optional) | A 90% pass rate for "Grade A" images, aligning with industry standards (e.g., European Radiology and ACR-AAPM-SPR Practice Parameter guidelines which state Grade A image rates in public hospitals generally range between 80% and 90%).Implicitly, for specific criteria: Sensitivity and specificity of whether there is a foreign body, whether the lung field is intact, and whether the scapula is open all exceed 0.9. | Average time of uAid algorithm: 1.359 seconds (longest does not exceed 2 seconds).Maximum memory occupation of uAid algorithm: not more than 2GB.Sensitivity and specificity of whether there is a foreign body, whether the lung field is intact, and whether the scapula is open all exceed 0.9.The uAid function can correctly identify four types of results: Foreign object, Incomplete lung fields, Unexposed shoulder blades, and Centerline deviation, making classifications (Green: qualified, Yellow: secondary, Red: waste). |
| Clinical Image Quality | Each image was reviewed with a statement indicating that image quality is sufficient for clinical diagnosis. | Sample images of chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided. A board-certified radiologist evaluated the image quality for sufficiency for clinical diagnosis. |
2. Sample Size Used for the Test Set and Data Provenance
uVision:
- Sample Size: The evaluation results provided are from a single week's worth of data, totaling 328 chest cases and 20 full spine or full lower limb stitching cases from the specified period (2024.12.17 - 2024.12.23).
- Data Provenance: The device with uVision function (serial number 11XT7E0001) has been in use for over a year at a hospital. The testing data includes individuals of all genders and varying heights capable of standing independently. It is prospective in the sense that it was collected during routine clinical operation after installation and commissioning. The country of origin is not explicitly stated but implied to be China, given the manufacturer's location.
uAid:
- Sample Size: The document does not provide a single total number for the test set. Instead, it breaks down the data by age/gender distribution and the distribution of positive/negative cases for each criterion.
- Age/Gender Distribution: Total 5680 patients (sum of all male/female/no age/no age, no gender categories).
- Criterion-specific counts:
- Lung field segmentation: 465 Negative, 31 Positive
- Spinal centerline segmentation: 815 Negative, 68 Positive
- Shoulder blades segmentation: 210 Negative, 1089 Positive
- Foreign object: 1078 Negative, 3080 Positive
- Data Provenance: Data collection started in October 2017, from the uDR 780i and "different cooperative hospitals." The study was approved by the institutional review board. The data is stored in DICOM format. It is retrospective, collected from existing hospital data. Country of origin not explicitly stated but implied to be China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
uVision:
- Number of Experts: The results were "statistically analyzed by clinical experts." The exact number is not specified, but the term "experts" suggests more than one.
- Qualifications: "Clinical experts" is a general term. Specific qualifications (e.g., radiologist, radiologic technologist, years of experience) are not provided.
uAid:
- Ground truth establishment for uAid's classification categories (Foreign object, Incomplete lung fields, Unexposed shoulder blades, Centerline deviation) is not explicitly described in terms of experts or their qualifications. The acceptance criteria reference "relevant research and literature" and "industry guidelines and standards," suggesting that the ground truth for image quality categorization might be derived from these established definitions.
Clinical Image Quality (General):
- Number of Experts: "A board certified radiologist." This indicates one expert.
- Qualifications: "Board certified radiologist." This is a specific and high qualification for evaluating radiographic images.
4. Adjudication Method for the Test Set
uVision:
- The document states that the results were "statistically analyzed by clinical experts." This implies some form of review and judgment, but a formal adjudication method (e.g., 2+1, 3+1) is not described. It's presented as an evaluation of the system's compliance with technician criteria.
uAid:
- The method for establishing ground truth classifications for uAid's criteria (Foreign object, Incomplete lung fields, Unexposed shoulder blades, Centerline deviation) is not detailed, so an adjudication method is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not explicitly described for either uVision or uAid or the overall device. The studies focused on evaluating the standalone performance of the AI features and the overall clinical image quality (subjective expert review), rather than comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, standalone performance was evaluated for both uVision and uAid.
- uVision: The reported performance is how well the "automatically set system position and field size" meet "clinical technicians' criteria" when the uVision function is used for automatic positioning. While technicians use the function, the performance metric itself is about the accuracy of the system's automatic output before manual adjustment.
- uAid: The reported performance metrics (sensitivity, specificity, processing time, memory usage) are direct measurements of the algorithm's output in categorizing image quality criteria. The system classifies images and presents the evaluation "instantly accessible to radiologic technologists," but the evaluation itself is algorithmic.
7. The Type of Ground Truth Used
uVision:
- The ground truth for uVision appears to be clinical technicians' criteria. The metric is "meet clinical technicians' criteria with 95% compliance," implying that the "correct" positioning is defined by the standards and expectations of experienced technicians.
uAid:
- The ground truth for uAid's image quality classification is based on established clinical quality control criteria for chest X-rays. The acceptance criteria explicitly reference "mature industry guidelines and standards, such as those from European Radiology and the ACR-AAPM-SPR Practice Parameter." This suggests an expert consensus-driven or guideline-based ground truth for what constitutes a "Grade A" image or the presence of specific issues like foreign objects or incomplete lung fields.
8. The Sample Size for the Training Set
uVision:
- The sample size for the training set for uVision is not provided. The document explicitly states that the "testing dataset was collected independently from the training dataset, with separated subjects and during different time periods."
uAid:
- The sample size for the training set for uAid is not provided. It is mentioned that "The data collection started in October 2017... from different cooperative hospitals" for the overall data reservoir, but specific numbers for training versus testing are not given. Similar to uVision, the testing data is stated to be "entirely independent and does not share any overlap with the training data."
9. How the Ground Truth for the Training Set Was Established
uVision:
- The method for establishing the ground truth for the training set for uVision is not provided.
uAid:
- The method for establishing the ground truth for the training set for uAid is not provided. While the testing set's ground truth is implied to be based on industry guidelines and clinical criteria, the process for prospectively labeling training data is not detailed.
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(51 days)
UltraPrint-Dental Denture UV is indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures.
UltraPrint-Dental Denture UV is intended for continuous use in the oral environment, exclusively for professional dental work.
UltraPrint-Dental Denture UV can be used in combination with a 3D printer using a 385nm light source. A 3D-printer is not part of the device.
The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of full or partial denture base. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of full or partial denture base.
The Subject device is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are prescription-only devices.
Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties.
The Subject device is intended to be sold by the bottle and used with compatible hardware 3D printers and their nesting software, and post-curing devices.
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(119 days)
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150)
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of the following contrast media:
- Gadobutrol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
- Gadopiclenol Injection in SD container or IBP
- Gadobenate dimeglumine Injection in SD container
- Gadoterate meglumine Injection in SD container
Easy-Click-Cassette – flex Max 2M and Easy-Click-Cassette – flex Max 3 are used for a maximum time of twenty-four (24) hours or a maximum of 96 bottles of contrast media, whichever comes first.
Use time expiration per SD container is a maximum of four (4) hours, unless otherwise stated by the contrast media labeling.
Use time expiration per IBP or saline container is a maximum of twenty-four (24) hours, unless otherwise stated by the media labeling.
Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for high-pressure angiography.
ulricheasyINJECT Max 3 (XD 10180)
ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of the following contrast media:
- Gadobutrol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
- Gadopiclenol Injection in SD container or IBP
- Gadobenate dimeglumine Injection in SD container
- Gadoterate meglumine Injection in SD container
ulricheasyINJECT Max is a syringeless contrast media management system that is designed for the controlled, automatic venous administration of contrast media in conjunction with physiological saline solution to human subjects undergoing diagnostic examinations in Magnetic Resonance Imaging (MRI or PET MRI).
The ulricheasyINJECT Max device consists of a terminal, injector, and tubing system. The injector is a mobile pedestal device that consists of an injector head and injector base with rechargeable battery. The tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The tubing system consists of the following three components:
- Spikes,
- Easy-Click-Cassette – flex
- Patient Tubing
The ulricheasyINJECT Max uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, cassette, and patient tubing). ulricheasyINJECT Max is intended to be used with the following components that are not supplied with the system:
- Saline containers,
- Single-dose contrast media bottles,
- Imaging Bulk Package (IBP) contrast media containers, and
- Cannula.
ulricheasyINJECT Max is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detectors to detect the presence of air in the tubing system without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.
The ulricheasyINJECT Max is provided in three models:
- ulricheasyINJECT Max 2M (XD 10140),
- ulricheasyINJECT Max 3 (XD 10150), and
- ulricheasyINJECT Max 3 (XD 10180).
The Max 3 models have 3 media connection points: 1 NaCl and 2 Contrast Media connections. The Max 2M has 2 media connection points: 1 NaCl and 1 Contrast Media connections. Max 2M and Max 3 are technically identical except the different available media connection points.
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(169 days)
Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject device (U403S-06) is Unimed Reusable SpO2 Sensor and are fully compatible for use with BCI SPECTRO2 10. The sensor is supplied non-sterile.
The subject sensor consists of a plug/connector (BCI DB9 sensor connector), a cable (1.1 m), and a patient-contacting sensor (soft tip: U403S-06) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensor shares the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Also, the subject sensor has identical material composition and performance characteristics to the predicate device.
The purpose of the submission is to receive clearance to market U403S-06 under their own 510k.
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