(112 days)
Not Found
Not Found
No
The 510(k) summary describes a sperm freezing medium, which is a chemical substance, not a device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is intended for the cryopreservation of sperm, which is a process of preserving biological material rather than directly treating a medical condition or disease.
No
Explanation: The device is a medium for sperm cryopreservation, which is a treatment or preservation method, not a diagnostic one.
No
The device is a sperm freezing medium, which is a biological substance used for cryopreservation, not a software application.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the cryopreservation of human sperm." This process is performed in vitro (outside the body) on a human specimen (sperm).
- Nature of the Device: A "sperm freezing medium" is a reagent or solution used to prepare a biological sample for preservation. This aligns with the typical definition of an IVD, which includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While cryopreservation isn't strictly "diagnosis," it's a process performed on a human specimen in vitro for a medical purpose (often related to fertility or assisted reproductive technology).
Why it's not definitively confirmed from this text alone:
- Lack of Device Description: The "Device Description" is listed as "Not Found." A detailed description would provide more specific information about the composition and function of the medium, which could further solidify its classification as an IVD.
- No Mention of Diagnostic Purpose: While cryopreservation is an in vitro process, the text doesn't explicitly state that the freezing medium is used for a diagnostic purpose. However, the broader definition of IVD includes determining the state of health, and sperm cryopreservation is often related to assessing or preserving reproductive health.
In summary: The intended use of cryopreserving human sperm in vitro strongly suggests that LG Sperm Freezing Medium falls under the category of an In Vitro Diagnostic device. While a full device description would provide absolute certainty, the provided information is a strong indicator.
N/A
Intended Use / Indications for Use
LG Sperm Freezing Medium is intended to be used for the cryopreservation of human sperm.
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
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
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or strokes, which are meant to represent the human form.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Michael D. Cecchi President International, Inc. 393 Soundview Rd GUILFORD CT 06437
Re: K070689
Trade/Device Name: LG Sperm Freezing Medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: May 31, 2007 Received: June 21, 2007
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 a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1906-1906" are displayed. Below the letters, the word "Centennial" is written in a curved font. Three stars are located at the bottom of the logo.
Prototing and Promoting Public Hoatth
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C. Hogdon
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
K070689 510 (k) Number (if known)
Device Name: Sperm Freezing Medium
Indications for Use:
LG Sperm Freezing Medium is intended to be used for the cryopreservation of human sperm.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use or Over-the Counter Use
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K070689