(68 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended uses are straightforward clinical procedures.
Yes
The device applies topical anesthetic and tests the vitality of teeth, which are therapeutic interventions. Cooling orthodontic wires can also be considered a therapeutic measure to manage heat sensitivity.
Yes
The device's intended use includes "PULP TEST THE VITALITY OF TEETH", which is a diagnostic function to assess the health of the tooth pulp.
Unknown
The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components. The intended uses suggest potential interaction with physical materials or the body, but without a description, it's impossible to confirm the device's nature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The listed intended uses (cooling orthodontic wires, topical anesthetic, pulp testing) are all procedures performed directly on or in relation to the patient's body or dental materials.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
The device's functions are related to dental procedures and patient comfort, not the analysis of biological samples.
N/A
Intended Use / Indications for Use
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- COOLING HEAT SENSITIVE ORTHODONTIC WIRES
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- TOPICAL ANESTHETIC
-
- PULP TEST THE VITALITY OF TEETH
Product codes
EAT, MLY, DYJ and EKZ
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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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.)
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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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.1720 Pulp tester.
(a)
Identification. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a simple, bold font. The text is arranged on a single line, with each word clearly legible. The background is plain and does not distract from the text.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2001
Mr. William A. Ploumis President Heat Shield, Incorporated 110 Lockwood Avenue New Rochelle, New York 10801
KOII666 Re : Trade/Device Name: Chillit 872.1720 Requlation Number: II Requlatory Class: EAT, MLY, DYJ and EKZ Product Code: Dated: May 5, 2001 May 30, 2001 Received:
Dear Mr. Ploumis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the device references (for the indications for use stated in the enclosure) to legally marketed predicate abe beacod in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to che chat have been reclassified in accordance with the devices that have boom il Food, Drug, and Cosmetic Act (Act). 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 provision, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements
1
Page 2 - Mr. Polumis
concerning your device in the Federal Register. Please note: conceining your acvrospremarket notification submission does this response to your premaince not have under sections 531 not arrect any obligation of the Electronic Enrough 542 Of the Act 101 actions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your 510 (x) promation of your device to a legally marketed predicate device results in a classification for your marketed predicate device robates in the to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulacion (21 crk Fare 301 and contact the Office of VILLO dragnoscic devices// produblionally, for questions on Compriance at (30) advertising of your device, please contact the promocion and adversibility of Journals (1301) Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers obtained from the Division of Bilais e at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address ('000') - 350 - 20 - 20 - 20 - 20 - 20 - 20 - 20 - 20 - 20 - 20 - 20 - 20 - 20 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Page 2 of ...
510(k) Number (if known): #KO11666
Device Name: CHIVIT
Indications for Use:
-
- COOLING HEAT SENSITIVE ORTHODONTIC WIRES
-
- TOPICAL ANESTHETIC
-
- PULP TEST THE VITALITY OF TEETH
(PLEABL DO MOT WRITE BELOW THIS LINE - CONTINUE ON ANDITHER PACE IF HE - "+"D
Prescription Use (Por 21 CFR 801.109)
OR
Over-the-Counter Usa
(Optional Formula: 1-m.)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _