(287 days)
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No
The 510(k) summary describes a sperm washing medium, which is a chemical reagent, and contains no mention of AI or ML technology.
No
The device is described as a "Sperm Washing Medium" used for "in vitro procedures involving sperm washing and incubation." This indicates it is a laboratory reagent or medium, not a device intended for direct therapeutic application to a patient's body to treat or prevent a disease.
No
Explanation: The device is described as a sperm washing medium for in vitro procedures, which aligns with a laboratory reagent or accessory, not a diagnostic tool used to identify or analyze a disease or condition in a patient. Its intended use is to prepare sperm for other procedures, not to diagnose.
No
The device description clearly states "Quinn's® Sperm Washing Medium," which is a chemical substance used in laboratory procedures, not a software application.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for in vitro procedures involving sperm washing and incubation." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The device is a "Sperm Washing Medium," which is a reagent or solution used in laboratory procedures. This aligns with the types of products classified as IVDs.
IVDs are defined as 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 this specific description doesn't mention diagnosis, the use of sperm washing medium is a crucial step in many assisted reproductive technology (ART) procedures, which are considered in vitro procedures and fall under the scope of IVDs.
The lack of information about image processing, AI, anatomical site, patient age, user, and performance studies doesn't negate its IVD status. These details are often required for regulatory submissions but are not part of the fundamental definition of an IVD.
N/A
Intended Use / Indications for Use
Quinn's® Sperm Washing Medium is for in vitro procedures involving sperm washing and incubation.
Product codes
85 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
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/0/Picture/15 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 abstract image of an eagle with three lines representing the head, body, and tail.
2 2000
Advanced Reproductive Technologies, Inc. c/o Mr. Grea Holland Holland & Associates 3722 Avenue Sausalito Irvine, CA 92606
Re: K991379
Quinn's® Sperm Washing Medium Dated: November 29, 1999 Received: November 30, 1999 Regulatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Mr. Holland:
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 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). 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 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 (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 requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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 (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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Premarket Notification - Advanced Reproductive Technologies, Inc. - Quinn's® Sperm Washing Medium
Page
510(k) Number (if known): K99)3 79
Quinn's Sperm Washing Medium Device Name:
Indications For Use:
Quinn's® Sperm Washing Medium is for in vitro procedures involving sperm washing and incubation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Use (Optional Format 1-2-96)
Daniel A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devic 510(k) Number.
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