(230 days)
K-944198, K-952241, K-900093
Not Found
No
The device description focuses on simple physical barriers made of plastic, with no mention of computational or analytical capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device acts as a physical barrier for infection control and does not have a therapeutic effect on the patient.
No
Explanation: The device is described as a disposable plastic shield acting as a physical barrier for infection control and to simplify cleaning, not for diagnostic purposes.
No
The device description explicitly states it is made of disposable plastic shields and describes their physical form and material, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as acting as a physical barrier to augment infection control and simplify clean-up and disinfection. This is a physical function, not a diagnostic one.
- Device Description: The description details disposable plastic shields for covering dental instruments and equipment. This aligns with a physical barrier function.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting diseases, or providing information for diagnosis.
- Predicate Devices: The predicate devices listed (surgical microscope drape, overglove, shield) are all examples of physical barriers used for infection control, not IVDs.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
These disposable plastic shields are for use with various small hand-held dental instruments such as handpieces, ultrasonic scalers, jet polishers, contra angle handpieces, and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, headpieces, accessory trays, x-ray heads, and others. These shields act as as physical barriers which augment existing infection control techniques and simplify existing clean-up and disinfection methods. They do not obviate, in any way, existing good dental practices such as sterilizing handpieces, hand instruments, etc between each patient. The products will be sold non-sterile, prepackaged, and are disposable, single use only.
Product codes
80MMP
Device Description
These disposable plastic shields are for use with various small hand-held dental instruments such as handpieces, ultrasonic scalers, jet polishers, contra angle handpieces, and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, headpieces, accessory trays, x-ray heads, and others. They are manufactured from clear polyethylene and formed to provide excellent tactile control combined with simple coverage and removal from the instrument. These shields act as as physical barriers which augment existing infection control techniques and simplify existing clean-up and disinfection methods. They do not obviate, in any way, existing good dental practices such as sterilizing handpieces, hand instruments, etc between each patient. The various products are designed to slip over the ends of the respective devices, allowing for attachment and/or protrusion of those parts of the devices that are inserted into the patient's mouth (instruments), or otherwise contact the patient (chair covers). The products will be sold non-sterile, prepackaged, and are disposable, single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K-944198, K-952241, K-900093
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
XII. SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY FETY AND EFFECTIVENESS. May 25, 1996. [Separate Pages]
A. Submitter: Thomas Lansing, Pres. Pinnacle Products, Inc. St. Paul, MN 55107.
I. Classification Names and numbers: Barrier, Cover, Protective, 80MMP
II. Common/Usual Name: Infection Control Barrier
- III. Proprietary Names. Cover-All, Chair Sleeve, Drape-it-All, Tray Sleeve, related products.
- IV. Establishment Registration Number: 2184071
V. Classification: This device has not been classified but is listed under code 80MMP in FDA 95-4246, "Classification Names for Medical Devices ... " In the past, these devices were treated as accessories to the medical devices with which they were used, such as K-900093 which was cleared as an accessory to the dental handpiece, 76EFB, CFR 872.4200.
- VI. Performance Standard: None established under section 514.
VII. Description of the Device: These disposable plastic shields are for use with various small hand-held dental instruments such as handpieces, ultrasonic scalers, jet polishers, contra angle handpieces, and similar hand instruments.
In other forms, they are used to cover various devices such as dental chairs, headpieces, accessory trays, x-ray heads, and others.
They are manufactured from clear polyethylene and formed to provide excellent tactile control combined with simple coverage and removal from the instrument.
These shields act as as physical barriers which augment existing infection control techniques and simplify existing clean-up and disinfection methods. They do not obviate, in any way, existing good dental practices such as sterilizing handpieces, hand instruments, etc between each patient.
The various products are designed to slip over the ends of the respective devices, allowing for attachment and/or protrusion of those parts of the devices that are inserted into the patient's mouth (instruments), or otherwise contact the patient (chair covers).
The products will be sold non-sterile, prepackaged, and are disposable, single use only.
VIII. Labels of the product and competitive devices are provided.
- IX. Substantial Equivalence Statement. The "510(k) "Substantial Equivalence" Decision process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below: 1. These products have the same intended use, to act as a physical barrier, augmenting existing infection control techniques and make clean-up and disinfection easier. These are
1
the same as those of the predicate devices. These products also have the same intended uses as similar products currently cleared for marketing by the 510(k) process.
-
The technological characteristics for this product are the same as those for the predicate devices and those currently on the market.
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Predicate devices: This device is substantially equivalent to preamendment devices classified as shown above. Pinnacle Infection Control Products are substantially equivalent to many currently on the market, some of which have been cleared by the 510(k) process. Some recent examples cleared under the code MMP are: Hydro-Med Product's "Surgical Microscope Drape," K-944198 and Cottrell's "Protouch Overglove," K-952241. Earlier examples include Dentsply's "Disposa-Shield", K-900093.
End of Summary