(148 days)
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Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related terms, nor does it describe any image processing or algorithmic analysis that would typically indicate the use of such technologies. The description focuses on a "Test Kit" used in combination with conventional visual examination.
No
The device is a test kit used for diagnosis and risk assessment, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states the kit is used for "cardification, evaluation, and examination" to assess an "increased risk for oral cancer," which indicates a diagnostic purpose.
No
The summary describes a "Test Kit" which strongly implies a physical component is involved, not just software. The lack of a device description prevents definitive confirmation, but the term "Test Kit" is inconsistent with a software-only device.
Based on the provided information, it is highly likely that the OralLite Test Kit is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the kit is used "in combination with conventional visual oral mucosal in The OralLite Test Kit, when used in other used in cardification, evaluation, and examination by nealth care providers, improved facilities in the reased risk for oral cancer." While the wording is a bit garbled, the core idea is that the kit is used to aid in the evaluation and assessment of risk for oral cancer. This strongly suggests it's analyzing something from the patient (likely a sample) to provide diagnostic information.
- Anatomical Site: The mention of "oral mucosal" further supports the idea that a sample from this area is being analyzed.
- Lack of Imaging/AI/ML: The absence of mentions of image processing, AI, DNN, or ML suggests the device is not relying on analyzing images or complex algorithms. This aligns with the typical nature of IVD tests which often involve chemical, biological, or immunological reactions on a sample.
What's missing that would definitively confirm it as an IVD?
The most crucial missing piece is the Device Description. A description of how the kit works would clarify what kind of sample is used (e.g., saliva, tissue swab) and what is being measured or detected. This would provide a definitive answer.
In summary: While the description is incomplete, the intended use and anatomical site strongly point towards the OralLite Test Kit being an IVD device used to analyze a sample from the oral mucosa to assess the risk of oral cancer.
N/A
Intended Use / Indications for Use
The OralLite Test Kit, when used in combination with conventional visual oral mucosal examination by health care providers, improves facilities in the detection, evaluation, and monitoring of oral mucosal abnormalities that may be at increased risk for oral cancer.
Product codes
MPU
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
oral mucosal
Indicated Patient Age Range
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Intended User / Care Setting
health care providers
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
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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)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 7 2001
Dr. Martin L. Lonky President Trylon Corporation 970 West 190th Street, Suite 850 Torrance, California 90502-1037
Re: K012070
Trade/Device Name: ViziLite™ Comprehensive Exam Tray Regulation Number: 888.4530 Regulation Name: OB-GYN Specialized Manual Instrument Regulatory Class: II Product Code: MPU Dated: October 8, 2001 Received: October 9, 2001
Dear Dr. Lonky:
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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include venurements for annual registration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 will), it they of burger 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.
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 modified in any Federal statutes and regulations administered by other Federal agencies.
1
Page 2 - Dr. Lonky
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Q. Alalout
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
Page 1 of 1
KO12070
510(k) Number (if known):
OralLite Test Kit Device Name:
Indications For Use:
The OralLite Test Kit, when used in combination with conventional visual oral mucosal in The OralLite Test Kit, when used in other used in cardification, evaluation, and examination by nealth care providers, improved facilities in the reased risk for oral cancer.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use v (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Russe
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number -