(140 days)
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Not Found
No
The summary describes a paraffin oil used as an overlay in cell culture and micromanipulation techniques. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device description and intended use clearly state that LG Paraffin Oil PG is used as an overlay for culturing and micromanipulation techniques in a lab setting, not for treating any medical condition or disease in a patient.
No
Explanation: The "Intended Use / Indications for Use" states that LG Paraffin Oil PG is "designed for use as an overlay when culturing in microdrops of media to prevent evaporation and to isolate media from changes of pH and osmolarity. Also for use as an overlay during the micromanipulation techniques of ICSI and assisted hatching." This describes a supportive or protective function within laboratory procedures, not a function that identifies, measures, or monitors a disease, injury, or other condition. Therefore, it is not a diagnostic device.
No
The device description explicitly lists "LG Paraffin Oil" and "LG Hyaluronidase" as components, which are physical substances, not software.
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 as an overlay for culturing in microdrops of media and for use during micromanipulation techniques like ICSI and assisted hatching. These are laboratory procedures related to cell culture and manipulation, not diagnostic testing performed in vitro on specimens from the human body to provide information about a physiological state, health, or disease.
- Device Description: The device is described as part of a "Micromanipulation Media System," further reinforcing its use in laboratory manipulation rather than diagnostic testing.
- Lack of Diagnostic Information: The description does not mention any intended use for diagnosing, monitoring, or screening for any disease or condition.
IVDs are specifically designed to analyze biological samples (like blood, urine, tissue) to provide diagnostic information. This device's function is to facilitate laboratory procedures, not to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
LG Paraffin Oil PG is designed for use as an overlay when culturing in microdrops of media to prevent evaporation and to isolate media from changes of pH and osmolarity. Also for use as an overlay during the micromanipulation techniques of ICSI and assisted hatching.
Product codes
MQL
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
Not Found
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
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
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY - 9 2006
Mr. Michael D. Cecchi President International, Inc. 393 Soundview Road GUILFORD CT 06437
Re: K053551
Trade/Device Name: LG Hvaluronidase and LG Paraffin Oil Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: April 26, 2006 Received: May 1, 2006
Dear Mr. Cecchi:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/0/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular seal with the words "1906-2006 FDA Centennial" around the edge. In the center of the seal is the FDA logo. Below the seal is the text "Protecting and Promoting Public Health".
1
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 (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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
international, inc. 510(K) Submission
INDICATIONS FOR USE
1
Kos3551 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510 (k) Number (if known)___
Device Names: Micromanipulation Media System: LG Hyaluronidase, LG Paraffin Oil
Trade Name: LG Paraffin Oil
Indication for Use:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
LG Paraffin Oil PG is designed for use as an overlay when culturing in microdrops of media to prevent evaporation and to isolate media from changes of pH and osmolarity. Also for use as an overlay during the micromanipulation techniques of ICSI and assisted hatching.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
Division of Reproductive, Abdominal, and Radiological Devices
| 510(k) Number | K053551 |
|---|---|
| --------------- | --------- |
| Prescription Use | X or Over-the Counter Use |
|---|---|
| ------------------ | ------------------------------------------------------------------------------------------------------------------------------ |