K Number
K974240
Device Name
LIGHTLINE-M
Date Cleared
1997-12-22

(40 days)

Product Code
Regulation Number
892.1610
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LightLine-M is intended for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bean.
Device Description
Not Found
More Information

Not Found

Not Found

No
The summary describes a collimator, a mechanical device for restricting the x-ray beam, with no mention of AI or ML.

No
This device is for diagnostic radiography, specifically for limiting an x-ray field, not for treating any condition.

No
The device, LightLine-M, is described as restricting the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam. This indicates it is a component used in diagnostic radiography, but it does not perform the diagnostic function itself (i.e., identifying or diagnosing a disease or condition). Its function is to shape the x-ray beam, not to analyze or interpret medical data for diagnostic purposes.

No

The device description is not found, but the intended use clearly describes a physical device (collimator) that restricts an x-ray beam, which is a hardware function.

Based on the provided information, the LightLine-M is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states it's for "general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field". This describes a device used during an imaging procedure on a patient, not a test performed on a sample outside the body.
  • Input Imaging Modality: The input is "diagnostic x-ray", which is an imaging technique used on living subjects.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on the results of such tests.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The LightLine-M's function is to shape the X-ray beam during an imaging procedure, which is a different category of medical device.

N/A

Intended Use / Indications for Use

The LightLine-M is intended for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bean.

Product codes

90 IZX

Device Description

LightLine-M (Diagnostic x-ray beam-limiting device)

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

x-ray

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)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1610 Diagnostic x-ray beam-limiting device.

(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(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 § 892.9.

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1997

Kristi White Quality Manager Wuestec Medical, Inc. 421 Holcolmbe Avenue Mobile, AL 36606

Re:

LightLine-M (Diagnostic x-ray beam-limiting device) Dated: October 17, 1997 Received: November 12, 1997 Regulatory class: II 21 CFR 892.1610/Procode: 90 IZX

Dear Ms. White:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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.

K974240

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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, 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 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.Lilian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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INTENDED USE

The LightLine-M is intended for use in general purpose diagnostic radiography to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray bean.

See the following pages describing operation taken from the operator manual.

for DAS

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

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