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510(k) Data Aggregation
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(86 days)
Feather/numiere 05 06 07 (05) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the decolletage.
Feather/ numiere 05 06 07 (Models: 05) is an over-the-counter light-emitting diode (LED) device that emits energy for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 830nm ±10nm wavelengths for the treatment of wrinkles on the neck and decolletage (upper chest). The device is designed in a flexible silicone panel that contains red (630nm±10nm) and near infrared (830nm±10nm) light-emitting diodes (LEDs). The device also contains a controller that controls the power on and off of the device, and regulates the intensity of the treatment by pressing buttons, and the controller
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(36 days)
The FX CorAL hemodialyzers are intended for single use only for extracorporeal blood purification during intermittent renal replacement therapies hemodialysis (HD), hemodiafiltration (HDF) using pre-, post or mixed-dilution modes, and isolated ultrafiltration for patients suffering from renal insufficiency, including pediatric patients.
Consider body and dialyzer surface area, blood flow, body weight and extracorporeal blood volume when selecting dialyzers for use with pediatric patients.
The FX CorAL dialyzers are high-flux, single-use, steam-sterilized hemodialyzers. The dialyzers are provided blood pathway sterile and non-pyrogenic. The dialyzers allow for the transfer of water and solutes between blood and dialysate using semipermeable, hollow fiber membranes.
The FX CorAL dialyzers are high-flux, sterile devices designed for single-use acute and chronic hemodialysis. The dialyzers are configured to connect to a bloodline set which connects to a patient's vascular access system when used with a hemodialysis machine equipped with ultrafiltration control. During hemodialysis, blood is pumped from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzers contain semipermeable membranes that allow for diffusion and/or ultrafiltration to transport toxins and excess fluid from the blood compartment (fiber lumen) to the dialysate compartment. Dialyzers utilize a counter-current flow in which dialysate and blood flow in opposite directions in the dialyzer during hemodialysis. The counter-current flow maintains the concentration gradient across the membrane for waste and fluid removal.
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(76 days)
FemVue® Controlled Saline-Air Device is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
The FemVue® Controlled Saline-Air Device is a sterile dual-barrel contrast media syringe that is connected to an intrauterine catheter to instill saline-air contrast medium as part of a sono-hysterosalpingogram (Sono-HSG) procedure. Ultrasound of the fallopian tubes can be performed with or without assessment of the uterine cavity.
The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via ethylene oxide (EO) sterilization and is intended for single-use.
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(158 days)
FOP NM-10 is an ophthalmic non-mydriatic digital camera using iPhone SE3 which captures images of the fundus of the human eye and surface as well as surrounding areas of the human eye.
The FOP NM-10 is designed for imaging of the fundus and surface as well as surrounding area of the human eye, in a compact, portable format, with an inherent simplicity built in its operation and use. The application software (Remidio FOP) is loaded on top of the iOS operating system to enable the user to view, save, archive and retrieve the captured images of fundus and surface area of the human eye. It is a compact, battery-operated device that enables high-quality fundus photography without requiring pupil dilation. The device can be used in Hospitals and Ophthalmic clinics. The FOP NM-10 incorporates a 40° field of view (FOV) optical system optimized for high-resolution retinal imaging. The device employs infrared and white LED illumination to achieve adequate retinal illumination without causing discomfort to the patient. The device is built on a modular smartphone-based design, ensuring portability and ease of operation. The Remidio FOP app enables wireless control of illumination intensity, focus adjustments, capturing the images in Auto and manual modes, saving, editing and archiving images.
Physical Specifications
- a) Field of View: 40° (for a minimum pupil size of 3mm)
- b) Material: ABS, Silicone Rubber
- c) Diopter Correction: -16D to +16D
- d) Working Distance: 33mm
Output and Performance Characteristics
- a) Illumination (Light Source): Infrared LED and Cool White LED
- b) Camera Resolution: 64 line pairs per millimeter (lp/mm) (at the center)
- c) ISO Range: ISO 200 and 400
- d) Focus Adjustment: Manual and Tap to Focus
- e) Internal Fixation: 8 fixation points
- f) Operating temperature: 10° to 40°C
- g) Relative Humidity: 10% to 85%
- h) Atmospheric Pressure: 750 to 1060 hpa
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(266 days)
This product is an ultrasonic endoscope intended for the observation, diagnosis and endoscopic treatment of the esophagus, trachea, bronchus and lesions adjacent to these structures using ultrasonic images, at medical facilities under the management of physicians.
This product is not intended for use on children and infants.
EB-710US (referred to as 'the device') is a medical ultrasonic electronic endoscope. The device is inserted into a lumen, a coelom, body cavity, or inside of a body, and provides images for observation, diagnosis, photographing, or treatment. It is also used for ultrasonography by visualizing the shape, the characteristic, or the dynamics of the inside of the body.
This product is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion portion is flexible and contains glass fiber bundles, a channel, a complementary metal-oxide semiconductor (CMOS) image sensor and a ultrasonic transducer in its distal end. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The channel in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor.
This product is used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart. And the device drives ultrasonic transducer installed in the distal end of the device by being connected with a ultrasonic processor.
The driven ultrasonic transducer emits ultrasound into the body, and receives the reflected ultrasonic signal from the body. The ultrasonic processor connected to the device performs image processing using the received signal. The electric signal of the image processing is converted into video signal, and it is output to the monitor as a ultrasonic image.
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(273 days)
The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, nerves, tumors, and skin lesions.
In addition, the system is intended for use in the following indications:
Urology
- Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH)
Oncology
- Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy
Dermatology
- Ablation or freezing of skin cancers and other cutaneous disorders
- Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin
Gynecology
- Ablation of malignant neoplasia or benign dysplasia of the female genitalia
General surgery
- Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas
ENT
- Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
Thoracic Surgery
- (with the exception of cardiac tissue)
Proctology
- Ablation of benign or malignant growths of the anus or rectum
Neurology
- Freezing of nerve tissue in pain management/cryoanalgesia
The Focused Cryotherapy System is a cryoablation platform that contains the following components:
- Probe (FC-2021CD01)
- Console (FC-AR401)
- Software
The Focused Cryotherapy System is a cryoablation platform for use in the cryoablation of nerves and tumors. The Probe is a handheld, single use, cryosurgical instrument. The Probe utilizes a high-pressure cryogen (argon gas) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. In use with tumors, temperatures below -40°C is the temperature at which intracellular ice formation occurs which is lethal for cells. When applied to nerves, temperatures below -20°C cause extracellular ice formation along axonal tubes which causes cessation of action potential conduction. When high pressure argon gas is supplied to the Probe via the Console, rapid cooling is achieved via the Joule-Thomson effect. The Probe incorporates a heating element to facilitate directional cryoablation. The Console has combination gas/electrical ports to handle 4 Probes in parallel. The Console contains the Firmware and Software. The System consists of a main chassis (Console) for the cooling system, Firmware, Software, controls, touch screen and Probe ports. Safety measures of the system include audible and visual alarms, safety valves, and emergency shutoff button.
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(138 days)
Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams.
When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings:
- overriding artery
- septal defect at the cardiac crux
- abnormal relationship of the outflow tracts
- enlarged cardiothoracic ratio
- right ventricular to left ventricular size discrepancy
- tricuspid valve to mitral valve annular size discrepancy
- pulmonary valve to aortic valve annular size discrepancy
- cardiac axis deviation
Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views.
Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians. It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams.
Fetal EchoScan is not intended for use in multiple pregnancies, cases of fetal heterotaxy and postnatal ultrasound exams.
Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians. Fetal EchoScan is intended to be used as an adjunct to the interpretation of the second-trimester fetal anatomic ultrasound exam performed between 18 and 24 weeks of gestation, for pregnant women aged 18 or more.
Here's a breakdown of the acceptance criteria and study details for the Fetal EchoScan (v1.2) device, based on the provided FDA 510(k) clearance letter:
1. Table of Acceptance Criteria and Reported Device Performance (Standalone Study)
The document primarily provides performance data from a standalone study, which implies these are the acceptance criteria met by the device.
| Acceptance Criteria (Performance Measure) | Reported Device Performance (95% CI) |
|---|---|
| Any suspicious findings detection: | |
| Sensitivity (Worst-Case) | 0.984 (0.963 ; 0.993) |
| Specificity (Best-Case) | 0.970 (0.952 ; 0.981) |
| Sensitivity (Best-Case) | 0.990 (0.972 ; 0.997) |
| Specificity (Worst-Case) | 0.958 (0.938 ; 0.971) |
| Conclusive output rate: | 99.0% (98.1 ; 99.5) |
| Individual Suspicious Findings Detection (Worst-Case Sensitivity / Best-Case Specificity): | |
| Overriding artery - Sensitivity | 0.933 (0.868 ; 0.967) |
| Overriding artery - Specificity | 0.988 (0.975 ; 0.994) |
| Cardiac crux septal defect - Sensitivity | 0.917 (0.838 ; 0.959) |
| Cardiac crux septal defect - Specificity | 0.995 (0.985 ; 0.998) |
| Abnormal OT relationship - Sensitivity | 0.869 (0.781 ; 0.925) |
| Abnormal OT relationship - Specificity | 0.988 (0.975 ; 0.994) |
| Enlarged CTR - Sensitivity | 0.955 (0.876 ; 0.985) |
| Enlarged CTR - Specificity | 0.996 (0.987 ; 0.999) |
| Cardiac axis deviation - Sensitivity | 0.945 (0.851 ; 0.981) |
| Cardiac axis deviation - Specificity | 1.000 (0.993 ; 1.000) |
| PV/AV size discrepancy - Sensitivity | 0.959 (0.921 ; 0.979) |
| PV/AV size discrepancy - Specificity | 0.986 (0.972 ; 0.993) |
| RV/LV size discrepancy - Sensitivity | 0.950 (0.900 ; 0.975) |
| RV/LV size discrepancy - Specificity | 1.000 (0.993 ; 1.000) |
| TV/MV size discrepancy - Sensitivity | 0.950 (0.904 ; 0.974) |
| TV/MV size discrepancy - Specificity | 1.000 (0.993 ; 1.000) |
The document does not explicitly state the pre-defined target values for these metrics, but the presented data demonstrates the device's performance against the ground truth.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Standalone Study Test Set): 877 clinically acquired fetal ultrasound exams.
- Data Provenance: The data was acquired from 11 centers in the U.S.A. and France. The data is retrospective, as it refers to "clinically acquired fetal ultrasound exams."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Three (3)
- Qualifications of Experts: Pediatric cardiologists.
4. Adjudication Method for the Test Set
- Adjudication Method: Majority voting. Three pediatric cardiologists assessed the presence or absence of each of the eight findings, and majority voting was used to establish the reference standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Yes, a fully-crossed MRMC study was conducted.
- Effect Size of Human Readers' Improvement with AI vs. without AI assistance:
- ROC AUC for detection of any suspicious radiographic finding:
- AI-aided: 0.974 (95% CI 0.957-0.990)
- Unaided: 0.825 (95% CI 0.741-0.908)
- Increase in AUC: +14.9% (0.149, statistically significant with p=0.002)
- Mean Sensitivity for any claimed suspicious finding:
- AI-aided: 0.935 (0.892-0.978)
- Unaided: 0.782 (0.686-0.878)
- Increase in Sensitivity: +15.3%
- Mean Specificity for any claimed suspicious finding:
- AI-aided: 0.970 (0.949-0.991)
- Unaided: 0.759 (0.630-0.887)
- Increase in Specificity: +21.1%
- ROC AUC for detection of any suspicious radiographic finding:
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes, "Standalone testing" was explicitly performed and described. The results are presented in the "Table 1. Sensitivity and Specificity (with 95% CI) of Fetal EchoScan..." section.
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus (majority voting by three pediatric cardiologists).
8. Sample Size for the Training Set
- The document states, "The ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing," but it does not explicitly provide the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
- The document states, "The ultrasound examinations used for training and validation are entirely distinct from the examinations used in standalone testing."
- Similar to the test set, it is highly probable that the ground truth for the training set was established through a robust expert review process, likely involving pediatric cardiologists. However, the specific details of the training set's ground truth establishment are not provided in this document. It only confirms that the truthing process for the test set was "conducted independently of the Fetal EchoScan device."
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