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510(k) Data Aggregation
(267 days)
The Meduloc Intramedullary Fracture Fixation (IFF) System is intended for use in the fixation of long bone fractures in both adult and pediatric applications.
The Meduloc Intramedullary Fracture Fixation (IFF) System is intended to treat small, long-bone fractures. It consists of three implants: Intramedullary Wire, Bone Anchor, and Locking Screw. The implants are provided in various sizes to accommodate varying patient anatomy. The system also contains a set of ancillary instruments. All elements of the System are Gamma sterilized and provided sterile-packed and are single-use.
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(243 days)
The Medi Lift Essential Eye Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.
The Medi Lift Essential Eye Mask ("Medi Lift Eye") is composed of a mask made of silicone rubber which is worn on the upper part of the user's face, and covers the upper cheek and the periocular region outside the orbital rim. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The mask also contains a heater to warm the upper cheek area for user relaxation, not for a medical purpose. The stimulation and heating functions are provided in separate modes and cannot be used simultaneously. The controllers attached to the mask contain two charging pins which allow for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable that is provided as part of the device. The device is not operated during charging.
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(260 days)
Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.
The Medline Bag Decanter is a non-pyrogenic, single use, disposable device, which is supplied sterile. The device comprises of a one-piece transfer device with protective flexible caps at either end. The device is an injection molded hollow tube with a spiked end used to access the source container and withdraw fluid. The spike component is designed with a built-in splash guard. The device is designed for use in transferring IV fluids/medication from a bag to an IV fluid administration device.
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(88 days)
The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light based device.
- Red light: Treatment of full-face wrinkles.
- Blue light (only suitable model JML1, JML3, JML5, JML6, JML9 Face mask): Treatment of mild to moderate inflammatory acne.
The MEGELIN LED Light Therapy Mask uses blue light (460nm) to treat acne. The MEGELIN LED Light Therapy Mask uses red light (660nm) to irradiate on the facial skin that help reduce wrinkles.
JML1, JML3, JML5, JML6, JML9 are face masks, with the only difference in energy density setting, while JML2, JML4, JML7, JML8, JML10 are neck masks with the only difference in energy density setting.
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(226 days)
The MetaFore Small Screw System is indicated for the fixation of bone fractures and for bone reconstruction in hand and forefoot surgery.
The MetaFore Small Screw System consists of implantable screws, and accessories for use in arthrodesis procedures of the hand and forefoot. The screws consist of 2.0mm solid snap-off, 2.5 and 3.0mm cannulated headless and 3.0 and 4.0mm cannulated beveled available in various overall lengths and thread lengths. The screws are manufactured from titanium alloy (Ti-6Al-4V ELI) and provided sterile-packed. The instruments are manufactured primarily from surgical grade stainless steel and titanium and provided non-sterile.
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(86 days)
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(29 days)
MEDRAD® Centargo CT Injection System is an automated contrast injection system that is indicated for the controlled, automatic administration, via the venous route, of a contrast agent and 0.9% Sodium Chloride Injection USP (saline) to patients undergoing examinations in computed tomography (CT).
The system is intended for use by and under direct quasi-continuous supervision of trained healthcare professionals to assure the integrity of the contrast agent and the injection system, in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of a contrast agent.
For a complete list of compatible contrast agents for use with the MEDRAD® Centargo CT Injection System, refer to the Centargo CT Injection System Operation Manual.
The Day Set is used for a maximum time of twenty-four (24) hours, or for a maximum of 25 bottles of contrast agents, whichever comes first. The Patient Line must be discarded after each patient procedure. The Replacement Spike is for single-container use only and must be discarded with the fluid container. Contrast agent containers are to be discarded after their respective use times have expired or the Day Set use life has expired, whichever occurs first.
Saline should only be used to deliver multiple single doses to multiple patients when used with the MEDRAD® Centargo CT Injection System and the provided Saline Tag. Once the port of the saline container is punctured, it should not be removed from the work area during the entire period of use. Saline containers are to be discarded with the Day Set.
The ISI2 Module is indicated for the specific purpose of allowing an injector to interface with an imaging scanner.
The MEDRAD® Centargo CT Injection System (Centargo) is an automated contrast injection system intended to be used to inject intravenous contrast agents and saline into humans for diagnostic studies in CT applications. Centargo is intended for use with the approved contrast agent in a single-dose container and Imaging Bulk Package (IBP)
Centargo is based on well-established technologies for injection, using a piston-based electromechanical device. The system is designed to protect the patient against air injection by incorporating multiple sensors to detect air within the fluid pathway. The system is comprised of two main modules:
- Scan Room Unit – responsible for handling the contrast/saline and delivering injections
- Control Room Unit - controls, monitors, and communicates with the Scan Room Unit through wired or wireless connection
The Scan Room Unit is located within the scan room whereas the Control Room Unit is not. When communicating via wired or wireless connection, the Control Room Unit can remotely control the Scan Room Unit and initiate and execute injections. However, the Scan Room Unit can operate independently without the use of the Control Room Unit via the Scan Room Unit's graphical user interface (GUI).
The Scan Room Unit is available in two different configurations:
- Pedestal with battery and AC power
- Overhead mount with AC power only
The fluids are delivered from a multi-patient disposable set (Day Set) through a single use patient line (Patient Line). The Day Set is labeled for 24 hours or for a maximum of 25 bottles of contrast agents, whichever comes first. Fluid source spikes (Replacement Spike) are for single container use.
The system is intended to be used in a CT suite. It is intended to be operated by personnel with training and experience in CT procedures and use of CT injection systems. Operators will consist of radiological technologists trained in the use of the equipment. This system is intended for use on the general patient population, including adults and pediatrics.
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(109 days)
Microtek decanters are intended for the aseptic transfer of solutions (eg. IV fluids and medications) from IV containers
- Bag decanters are for use in transferring IV fluids and medication from a bag to an IV fluid administration device.
- Vial decanters are for use in transferring IV fluids and medications from a vial to an IV fluid administration device.
- Transfer devices are for use in transferring IV fluids and medications from a vial or medication container to an IV fluid administration device.
Microtek decanters are suitable for adult and pediatric patients. The use of decanters is at the discretion of the healthcare professional.
Microtek decanters and transfer devices are provided sterile and for use in a single procedure only. They consist of a hollow tube with protective removable caps at either end. The injection molded hollow tube has at least one spiked end used to access the source container to initiate fluid transfer. The vial decanter includes a built-in splash guard.
Decanters and transfer devices are designed to transfer medical fluids (e.g.: medications and solutions) between various containers.
| Model Number(s) | Description | Container Configuration | Overall Length (of finished device without caps) | Materials |
|---|---|---|---|---|
| 2000S | C-Flo Bag Decanter, Sterile | Bag to an IV fluid administration device | 8.25" | PMMA |
| 2002S | Bag Decanter II, Sterile | Bag to an IV fluid administration device | 8.25" | HIPS825 |
| 2006S | Vial Decanter, Sterile | Vial to an IV fluid administration device | 6" | HIPS825, ABS |
| 2008S | Transfer Device, Sterile | Vial or medication container to an IV fluid administration device | 3" | ABS |
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(796 days)
The MediLight device (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
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(219 days)
The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.
Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.
The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).
The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.
The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.
The mainstream gas analyzers are characterized by the following features:
- Low system integration complexity
- Low power consumption
- Fast startup time
- Low weight < 30g
- Visual status indicator
The provided document is a 510(k) clearance letter and summary for the Medical Gas Analyzer (AG200). It does not contain information about a study proving the device meets its acceptance criteria.
The document states: "the subject device does not require clinical test data to support substantial equivalence." This means that the device was cleared based on its similarity to existing devices and bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in a real-world setting.
Therefore, I cannot provide the requested information about the study proving the device meets acceptance criteria, the sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, or training set details as they are not present in the provided text.
However, I can extract the acceptance criteria as reported in the document through comparison with the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "device performance" parameters.
1. Table of Acceptance Criteria and Reported Device Performance (as implied by comparison to predicate/reference devices):
| Parameter | Medical Gas Analyzer (AG200) Reported Performance | Predicate Device (K123043) | Acceptance Criteria (Implied by Substantial Equivalence) |
|---|---|---|---|
| CO2 Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | Within ±(0.2 vol% + 2% of reading) for 0 to 15 vol% |
| N2O Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 100 vol%, ±(2 vol% + 2% of reading) | 0 to 100 vol%, ±(2 vol% + 2% of reading) | Within ±(2 vol% + 2% of reading) for 0 to 100 vol% |
| Halothane, Enflurane, Isoflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 8 vol% |
| Sevoflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 10 vol% |
| Desflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 22 vol% |
| CO2 Accuracy (all conditions) | ±(0.3 vol% + 4% of reading) | ±(0.3 vol% + 4% of reading) | Within ±(0.3 vol% + 4% of reading) |
| N2O Accuracy (all conditions) | ±(2 vol% + 5% of reading) | ±(2 vol% + 5% of reading) | Within ±(2 vol% + 5% of reading) |
| Agents Accuracy (all conditions) | ±(0.2 vol% + 10% of reading) | ±(0.2 vol% + 10% of reading) | Within ±(0.2 vol% + 10% of reading) |
| Respiration Rate Range | 0 to 150 breaths/min | 2 to 150 breaths/min | 0 to 150 breaths/min (implied by compliance with ISO 80601-2-55 despite difference in predicate's lower limit) |
| Respiration Rate Accuracy | ±1 breaths/min | ±1 breaths/min | Within ±1 breaths/min |
| Anaesthetic Agents Threshold | 0.2 vol% | 0.15 vol% (with caveats) | 0.2 vol% deemed acceptable as verified by bench test and compliance with ISO 80601-2-55. |
| Warm-up time | 10-180 seconds | < 20 seconds (agent identification enabled and full accuracy) | 10-180 seconds, as verified by bench test and consistent with specified operating temperature range. |
| Data Update Frequency | 20Hz | 20Hz | 20Hz |
| Total System Response Time | <1 second | <1 second | <1 second |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "bench tests" and "software validation testing" but does not provide details on the number of samples or test cases used.
- Data Provenance: Not applicable, as no human clinical or retrospective/prospective data is mentioned. The testing described is "bench testing" and "software validation testing," which are laboratory-based and device-centric.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe the establishment of a ground truth by experts for a test set. Testing was primarily technical compliance ("bench tests") and software validation. For the manual anesthetic agent selection, it mentions "qualified clinicians" but no specific number or qualifications are provided, nor is their role in establishing "ground truth" for the device's performance defined.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of an adjudication method, as the tests were not clinical studies requiring expert review of medical data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. No MRMC comparative effectiveness study was conducted. The device is a Medical Gas Analyzer, not an AI-assisted diagnostic or interpretive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The testing described, primarily "bench tests" and "software validation testing," assesses the device's performance in a standalone capacity (algorithm only). However, the results are presented as "Pass" for compliance with standards rather than specific performance metrics (e.g., accuracy, precision) in a standalone context beyond what is listed in the performance table. The distinction of "standalone performance" as it typically applies to AI algorithms is not explicitly made, but the listed performance characteristics are inherent to the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench tests, the ground truth would be established by reference measurement devices or calibrated gas mixtures with known concentrations, as well as adherence to the requirements outlined in standards like ISO 80601-2-55. This is typically a known, controlled input.
8. The sample size for the training set:
- Not applicable. The device is a hardware-based gas analyzer with software; it is not an AI/machine learning device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, the device does not use a "training set" in the context of machine learning.
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