(56 days)
Not Found
Not Found
No
The summary describes a chemical medium for sperm preparation and does not mention any computational or algorithmic components, let alone AI/ML.
No
The device is described as a "medium for sperm preparation," which is an in vitro process used to prepare sperm for use in assisted reproductive technologies. It does not directly treat a disease or condition in a patient's body, nor does it restore, modify, or replace physiological functions in a patient. Therefore, it is not a therapeutic device.
No
The device is described as a "medium for sperm preparation," which suggests it is used to prepare biological samples rather than to diagnose a condition. Its function is to facilitate the processing of sperm, not to identify or characterize diseases.
No
The device description clearly states it is a "Bicarbonate buffered medium containing Hyaluronan," which is a physical substance (a liquid medium) and not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Medium for sperm preparation." This indicates the device is used to prepare biological samples (sperm) for analysis or use in a diagnostic or therapeutic process.
- Device Description: The description details a "Bicarbonate buffered medium containing Hyaluronan." This is a reagent or solution specifically designed to interact with biological material (sperm) outside of the body.
- Lack of In Vivo Use: There is no indication that this device is used within the human body.
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 explicitly state "diagnosis," the preparation of sperm is a crucial step in many diagnostic procedures related to fertility and reproductive health.
The fact that it's a medium for preparing a biological sample outside the body strongly aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
Medium for In Vitro Fertilization Procedures
Medium for sperm preparation.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MMTM or HSAsolution™ and pre-equilibration at +37°C and 6 % CO2.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 6 2002
PREMARKET NOTIFICATION SUMMARY IX.
KO22247
Submitted by: Vitrolife Sweden AB Mölndalsvägen 30 SE-412 63 Gothenburg SWEDEN Contact Person: Mr. Eiler Anderson Vitrolife Sweden AB Mölndalsvägen 30
Date Prepared:
Trade Name:
Common Name:
Classification Name:
Predicate Device:
Description of the Device:
Bicarbonate buffered medium containing Hyaluronan. For use after the addition of G-MMTM or HSAsolution™ and pre-equilibration at +37°C and 6 % CO2.
Intended Use: Medium for In Vitro Fertilization Procedures
Technological Characteristics: The technological characteristics of G-SPERMTM are essentially similar to those of the predicate device. The G-SPERM is a modification of the predicate device and is intended to be supplemented with albumin prior to use. Other formulation changes were made to improve the performance of the G-SPERM device. None of these differences raise new questions of safety or effectiveness.
SE-412 63 Gothenburg
Assisted Reproduction Media
(21 C.F.R. § 884.6180)
Reproductive Media and Supplements
SWEDEN
July 10, 2002
G-SPERM™
SpermRinse™
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its head and wings. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 6 2002
Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K022247
Trade/Device Name: G-SPERM™ Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II
Product Code: 85 MQL Dated: July 10, 2002 Received: July 12, 2002
Dear Mr. Yingling:
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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Page 2
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 yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
X: ~ INDICATIONS FOR USE STATEMENT
510(k) Number:
KO22247
Device Name:
G-SPERM™ Assisted Reproduction Media
Indications For Use:
Medium for sperm preparation.
R-A. Phillips NCS
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
(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 C.F.R. § 801.109)
()[ર
( )ver-the Counter Use________________________________________________________________________________________________________________________________________________________