(141 days)
Not Found
Not Found
No
The summary provides no information about the device's technology, and there are no mentions of AI, ML, image processing, or any related concepts. The intended use describes a standard indirect laryngoscope.
No
The device is described as an indirect laryngoscope used for examinations and inspections, not for treating conditions.
Yes
The device is used for "examinations" and "inspecting for causes of abnormal conditions," which are diagnostic activities.
No
The 510(k) summary describes an "Indirect Laryngoscope," which is a physical medical instrument used for examining the larynx and nasopharynx. There is no mention of software as the primary component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used for direct visual examination of the larynx and nasopharynx. This is a physical examination procedure, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: While the description is "Not Found," the intended use strongly suggests a device used for direct visualization, such as a scope or mirror.
- Lack of IVD Indicators: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) for direct visual inspection.
N/A
Intended Use / Indications for Use
The LFRE Indirect Laryngoscope may be used for examinations of the larynx and nasopharynx
- while conducting normal, routine physical examinations.
- while inspecting for causes of abnormal conditions (e.g., hoarseness, pain) presented by the patient.
- while inspecting for causes of abnormal conditions indicated by referring facilities.
Product codes
EOB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
larynx and nasopharynx
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2003
Astralite Corporation c/o Dorian Swartz, President 7701 Woodley Avenue Van Nuys, CA 91406
Re: K023004
Trade/Device Name: LFRE Indirect Laryngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: December 7, 2002 Received: December 10, 2002
Dear Mr. Swartz:
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.
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 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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Dorian Swartz, President
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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
A helyi korenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Astralite/LFRE/Indications for Use Statement
Page I of 1
INDICATIONS FOR USE STATEMENT
LFRE Indirect Laryngoscope K023004
INDICATIONS FOR USE:
The LFRE Indirect Laryngoscope may be used for examinations of the larynx and nasopharynx
-
- while conducting normal, routine physical examinations.
-
- while inspecting for causes of abnormal conditions (e.g., hoarseness, pain) presented by the patient.
-
- while inspecting for causes of abnormal conditions indicated by referring facilities.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription for use (Per 21 CFR 801.109)
Keren Baker
(Division Sian-Off Division of Ophthalmic Ea Nose and Throat Devis
510(k) Number K023004