(75 days)
Not Found
Not Found
No
The provided text describes a device for sperm washing and incubation, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The description states the device is used for sperm washing and incubation, which is an in vitro procedure. Therapeutic devices are used to treat a condition or disease in a living organism.
No
The device, "AllGrad Wash," is described as being used for "sperm washing procedures such as in vitro washing and incubation of sperm in Assisted Reproduction techniques." This describes a therapeutic or preparatory function, not a diagnostic one. There is no mention of it being used to identify or characterize a disease, condition, or state.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use describes a procedure, not the device itself.
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 explicitly states "in vitro washing and incubation of sperm in Assisted Reproduction techniques." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVD devices. These procedures are performed on biological samples (sperm) outside of the patient's body to aid in diagnosis or treatment (in this case, assisted reproduction).
While the other sections are "Not Found," the intended use alone strongly points towards an IVD classification. IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Sperm washing and incubation for assisted reproduction fall under this umbrella as they are procedures performed on a human specimen (sperm) to facilitate a medical procedure (assisted reproduction).
Therefore, based on the intended use, AllGrad Wash is almost certainly an IVD.
N/A
Intended Use / Indications for Use
AllGrad Wash is used for sperm washing procedures such as in vitro washing and incubation of sperm in Assisted Reproduction techniques
Product codes
85 MQL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
§ 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/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair and facial features. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
NOV 2 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael D. Cecchi President genX International 393 Soundview Rd. GUILFORD CT 06443 Re: K023033
Trade/Device Name: AllGrad Wash (Hepes Buffered Wash Medium) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II
Product Code: 85 MQL Dated: September 9, 2002 Received: September 12, 2002
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 (PMA), it may be subject to 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.
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.
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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely vours.
Nancy C. Snigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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international, inc. 510(K) Submission
INDICATIONS FOR USE
KO23033 510 (k) Number (if known)
Device Names; AllGrad Wash Hepes Buffered Wash Medium
AllGrad Wash is used for sperm washing procedures such as in Indication for Use: vitro washing and incubation of sperm in Assisted Reproduction techniques
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
Division Sian-Off Division of Reproductive. Abdomin and Radiological Devices 023734
Prescription Use
or
nter Use