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510(k) Data Aggregation
(143 days)
Wellmed Dental Medical Supply Co., Ltd
The Self Sealing Sterilization Pouches are intended to be used to enclose another medical devices that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The Self Sealing Sterilization Pouches are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The recommended sterilization cycles are as follows:
• Steam Sterilization: 4 minutes at 132°C (270°F); 10 minutes dry time for gauze and plastic loads, and 20 minutes dry time for metal loads.
• Ethylene Oxide (ETO) Sterilization: 8 hours at 50°C (122°F); relative humidity between 30%-90%; ethylene oxide concentration is 700mg/L, 7 days aeration time at 23°C(73.5°F).
The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The Self Sealing Sterilization Pouch maintains the sterility of the enclosed devices for up to 6 months post Steam or ETO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process. Sterilization indicator will change color according to the sterilization method (ethylene oxide, steam). Ethylene oxide sterilization indicator color change from pink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark green after sterilization.
The Self Sealing Sterilization Pouches are made with medical grade paper and medical compound film. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or ETO sterilization process.
I'm sorry, but the provided FDA 510(k) Clearance Letter for "Self Sealing Sterilization Pouches" does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an Artificial Intelligence (AI) or software-based medical device.
The document is a clearance letter for a physical medical device (sterilization pouches) and details its intended use, sterilization methods, material properties, and maximum load capacity. It also outlines regulatory requirements for such devices.
There is no mention of AI, algorithms, software, ground truth, expert readers, retrospective/prospective studies, or any of the other specific questions related to AI/software device performance evaluation.
Therefore, I cannot provide the requested information based on this document.
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(63 days)
Wellmed Dental Medical Supply Co., Ltd
Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
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The provided text is a 510(k) clearance letter from the FDA for a device named "Dental Barrier and Sleeves." It explicitly states that the device is a physical barrier and not an AI/software device. Therefore, the questions related to AI/software performance acceptance criteria, test sets, ground truth, expert opinions, and training sets are not applicable to this document.
The document discusses regulatory aspects of a Class II medical device, including:
- Trade/Device Name: Dental Barrier and Sleeves
- Regulation Number/Name: 21 CFR 878.4370, Surgical Drape And Drape Accessories
- Regulatory Class: Class II
- Product Code: PEM, PUI
- Indications for Use: Intended to be used as a disposable barrier for dental instruments and equipment. Non-sterile and intended for single patient use only.
Since the device is a physical product and not an AI or software-based system, the acceptance criteria would relate to its physical properties, material safety, effectiveness as a barrier, and manufacturing quality, rather than algorithms or data performance. Such tests would typically involve:
- Material Biocompatibility: Testing to ensure the materials are not toxic or irritating when in contact with patients or users.
- Barrier Integrity/Effectiveness: Physical testing to confirm its ability to prevent the passage of fluids, microorganisms, or other contaminants.
- Physical Properties: Tensile strength, tear resistance, and dimensions to ensure it performs as intended under typical dental use conditions.
- Sterility (if applicable, though this device is noted as non-sterile): If it were a sterile barrier, testing would confirm the absence of viable microorganisms.
- Shelf Life: Stability testing to ensure the product remains effective and safe over its intended storage period.
- Manufacturing Quality Control: Adherence to Good Manufacturing Practices (GMP) to ensure consistent quality.
None of this information is detailed in the provided FDA clearance letter, as the letter primarily serves to confirm substantial equivalence to a predicate device and outlines regulatory obligations, not to present detailed study results for a non-AI/software device.
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(58 days)
Wellmed Dental Medical Supply Co., Ltd.
The Disposable Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical For use in infection control practices to reduce the potential exposure to blood and body fluids.This is a single use, disposable device(s), provided non-sterile.
The Proposed device(s) are blue color, and pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene ,metal wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (DF3-001) to verify its performance and safety.
1. Table of acceptance criteria and the reported device performance:
| Item | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance ASTM F1862 | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | 29 out of 32 pass at 160 mmHg for level 3 | Lot1, Lot2, Lot3: 32 out of 32 pass at 160 mmHg (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS |
| Particulate Filtration Efficiency ASTM F2299 | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | Lot1: 99.35% | |
| Lot2: 99.46% | ||||
| Lot3: 98.69% (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS | |||
| Bacterial Filtration Efficiency ASTM F2101 | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | ≥ 98% | Lot1: 99.88% | |
| Lot2: 99.87% | ||||
| Lot3: 99.88% (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS | |||
| Differential Pressure (Delta P) EN 14683 Annex C | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask |
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