(75 days)
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Not Found
No
The summary describes a light source for surgical instruments and does not mention any AI or ML capabilities.
No.
Explanation: The device is described as a light source for fiberoptic cables and instruments used in surgical fields, solely for illumination and not for treating a disease or condition.
No
The device is described as a light source for fiberoptic cables and instruments used in surgical fields, and its intended use does not include diagnosing medical conditions.
No
The device description clearly states "Lightsource or Illuminator M2-250TR or 1-250", which are hardware components used to generate light. The intended use also describes providing light for fiberoptic cables and instruments, which are physical devices. There is no indication that the device is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide light for fiberoptic cables and instruments used in surgical fields. This is a function related to surgical procedures and visualization, not the examination of specimens in vitro (outside the body).
- Device Description: The device is described as a "Lightsource or Illuminator." This aligns with its function of providing light, not performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status based on sample analysis
Therefore, based on the provided information, this device is a surgical light source and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource actaches to fiberoptic cable which is then attached to an instrument or headlight.
Product codes
85 HET, 78 FCW, 78 FFS, 84 HBI, 78 FCR
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
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of three abstract human figures in profile, stacked on top of each other. The figures are black and have a stylized, flowing design. The text "DEPARTMENT OF HEALTH &" is partially visible to the left of the figures.
Food and Drug Administration 9.200 Corporate Boulevard Rockville MD 20850
APR - 1 1998
Ms. Kimberly Reed Director, Advertising and Marketing Cuda Products Corporation 6000 Powers Avenue Jacksonville, FL 32217-2279
Re: K980166 I-250 and M2-250TR Lightsources Dated: September 18, 1997 Received: January 16, 1998 Regulatory Class: II 21 CFR 884.1720 Procodes: 85 HET, 78 FCW, 78 FFS, 84 HBI, 78 FCR
Dear Ms. Reed:
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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal 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 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 (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 requirements, as set forth in the Quality System Regulation (OS) 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 the Electronic Product 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 (2) CFR Part 801 and additionally 809.10 for in vitro clagnostic 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) 443-5597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours
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
Enclosure
1
510(k) Number: K980166
Device Name: Lightsource or Illuminator M2-250TR or 1-250
Indications for use:
To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource actaches to fiberoptic cable which is then attached to an instrument or headlight.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Roler asthly
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980166
Prescription USE
or
Over-The-Counter Use-........
(Optional Format 1-2-96)