(151 days)
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No
The 510(k) summary describes a simple accessory (sleeves) for a dental instrument and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device is described as an accessory to a dental instrument, indicating it supports the function of another device rather than providing therapy itself.
No
The device, TIDIShield Curing Light Sleeves, is described as an accessory to a dental instrument that is non-sterile and for single patient use. Its intended use does not involve diagnosing any medical condition or disease.
No
The 510(k) summary describes "Curing Light Sleeves," which are physical accessories for dental instruments. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as an accessory to a dental instrument (curing light sleeves). This is a physical barrier/cover for a medical device used in a clinical setting.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used for diagnosis, monitoring, or screening.
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. The TIDIShield Curing Light Sleeves are simply protective covers for a dental tool.
N/A
Intended Use / Indications for Use
The TIDIShield Curing Light Sleeves are indicated for used as an accessory to dental instrument. These sleves are non-sterile and are intended for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
PEM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
February 18, 2014
TIDI Products, LLC Mr. Dion Brandt Quality Manager 570 Enterprise Drive Neenah, WI 54956
Re: K132953
Trade/Device Name: TIDIShield TM Curing Light Sleeve Regulation Number: 21 CFR 878.4370 Regulation Name: Dental Barriers and Sleeves Regulatory Class: Class II Product Code: PEM Dated: September 17, 2013 Received: January 15, 2014
Dear Mr. Brandt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Brandt
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97), For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Image /page/1/Picture/5 description: The image shows a signature and some text. The text includes the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director." The word "FOR" is also visible in the lower right corner of the image. The signature is illegible.
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Slatement on last page.
510(k) Number (if known) K132953
Device Name TIDIShield Curing Light Sleeve
| Indications for Use (Describe) | ||
|---|---|---|
| The TIDIShield Curing Light Sleves are indicated for used as an accessory to dental instrument. These sleves | ||
| are non-sterile and are intended for single patient use only. | ||
| Part Number | Model | Custom Fit For: |
| 21103 | TIDIShield Curing Light Sleeve | SmartLite Max/Dentsply Curing Light |
| 21102 | TIDIShield Curing Light Sleeve | BluePhase/Ivoclar Curing Light |
| 21101 | TIDIShield Curing Light Sleeve | Eliphar S10/3M Curing Light |
| 21100 | TIDIShield Curing Light Sleeve | Demil Iltra/Kerr Curing Light |
Type of Use (Select one or both, as applicable)
[] Prescription Use (Part 21 CFR 801 Subpart D)
[x] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
11 ***** FOR FOR FOR FOR FOR LY 。 : ﺎﺭ. .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Elizabeth F. Claverie -S 2014.02.14 23:59:46 -05"00
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