(79 days)
Not Found
Not Found
No
The summary describes standard ophthalmic surgical accessories (tubing, bags) and makes no mention of AI, ML, image processing, or any related concepts.
No
The device is described as an "Administration Set," "Drainage Bag," and "Universal Tubing Set" used for "Irrigation and Aspiration of fluids." These are accessories used during a medical procedure (ophthalmic phacoemulsification) and do not provide a therapeutic effect themselves. They facilitate the delivery and removal of fluids, which is a supportive function, not a direct therapeutic intervention.
No
The device is described as an "Administration Set," "Drainage Bag," and "Universal Tubing Set" used for "Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures." These are tools for performing a medical procedure, not for diagnosing a condition.
No
The device description lists physical components (Administration Set, Drainage Bag, Universal Tubing Set) which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures." This describes a surgical procedure performed directly on a patient, not a test performed on a sample of bodily fluid or tissue outside the body to diagnose a condition.
- Device Description: The components listed (Administration Set, Drainage Bag, Universal Tubing Set) are typical for fluid management during surgery.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing bodily fluids or tissues.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural (managing fluids during surgery).
N/A
Intended Use / Indications for Use
Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures.
Product codes
86 MSR
Device Description
Med-Logics, Inc. Administration Set, Med-Logics, Inc. Drainage Bag, and Med-Logics, Inc. Universal Tubing
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ophthalmic
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
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or interconnectedness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 1998
Ms. Betty Ross President Med-Logics, Inc. 30251 Golden Lantern Suite E-207 Laguna Niguel, CA 92677
Re: K983448
Trade Names: Med-Logics, Inc. Administration Set, Med-Logics, Inc. Drainage Bag, and Med-Logics, Inc. Universal Tubing Regulatory Class: II Product Code: 86 MSR Dated: September 28, 1998 Received: September 30, 1998
Dear Ms. Ross:
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 (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 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 .
1
Page 2 ~Ms. Betty Ross, President
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,
A. Ralph L. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K983448
Device Name:
Med-Logics, Inc., Administration Set (UT 3004) Med-Logics, Inc., Drainage Bag (UT 3002) Med-Logics, Inc., Universal Tubing Set (UT 3000)
Indication For Use:
Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Ro hickolas
(Division Sign-Off) Division of Ophthalmic Devices Division of Opidian K983448
OR
Prescription Use
Per 21 CFR 801.109
Over-The-Counter Use ...