(80 days)
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No
The device description and performance studies focus on the chemical composition and functional performance of a cryopreservation medium, with no mention of AI or ML technologies.
No
This device is a cryopreservation medium for human sperm, used prior to and during assisted reproductive procedures. It does not directly treat or diagnose a disease or condition in a patient.
No
Explanation: The device is a medium for cryopreservation of human sperm, which is a treatment-related procedure, not a diagnostic one. It doesn't identify, detect, or monitor a medical condition.
No
The device is a chemical medium (liquid) intended for cryopreservation, not a software program.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "cryopreservation of human sperm prior to assisted reproductive procedures" and "for use in assisted reproductive procedures that involve the manipulation of gametes." These procedures involve working with biological samples (sperm) outside of the body.
- Device Description: It's a "synthetic, defined medium" used to maintain the viability of sperm. This medium is applied to the biological sample (sperm) in a laboratory setting.
- Performance Studies: The performance is evaluated using a "sperm cryopreservation and motility recovery assay," which is a test performed on the biological sample (sperm) to assess the effectiveness of the medium.
While it doesn't directly diagnose a disease, it is a reagent or medium used in a laboratory setting to prepare and process a human biological sample (sperm) for a medical procedure (assisted reproduction). This falls under the scope of in vitro diagnostics, which includes products used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, it's for compatibility and preparation for a medical procedure.
N/A
Intended Use / Indications for Use
Sperm Maintenance Medium with Glycerol is intended for the cryopreservation of human sperm prior to assisted reproductive procedures.
Sperm Maintenance Medium with Glycerol is intended for use in assisted reproductive procedures that involve the manipulation of gametes. Specifically, Sperm Maintenance Medium with Glycerol is intended to be used as a cryopreservation medium for human sperm.
Product codes
85 MQL
Device Description
Sperm Maintenance Medium with Glycerol is a synthetic, defined medium composed of a mixture of salts and other physiologically compatible substances, with glycerol as a cryoprotectant and human serum albumin as a protein supplement. It is supplied in fill volumes of 100 mL.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sperm Maintenance Medium with Glycerol will be analyzed by a sperm cryopreservation and motility recovery assay prior to release to market. This assay assures that the product is both functional for its intended use, the cryopreservation of human sperm, and that no toxic components are present in the formulation. Sperm Maintenance Medium has been used in a variety of clinical settings, for its intended use, for a number of years. In that time, the product has become one of the standard media used for the cryopreservation of human sperm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
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.
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Irvine Scientific
JIII - 8 1999
Image /page/0/Picture/4 description: The image is a black and white graphic of an abstract design. The design features a combination of straight lines and geometric shapes, creating an open, modern look. The contrast between the black and white areas is sharp, highlighting the structure of the design. The image is simple, yet visually striking.
IRVINE SCIENTIFIC
IRVINE SCIENTIFIC 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
Submitted by:
Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588
Telephone: (800) 437-5706 Facsimile: (949) 261-6522
Contact: Roberta L. Johnson
Date Submitted: April 16, 1999
Device Identification:
| Trade Name: | Sperm Maintenance Medium with Glycerol |
|---|---|
| Common Name: | Sperm Cryopreservation Medium |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
Sperm Maintenance Medium with Glycerol is a synthetic, defined medium composed of a mixture of salts and other physiologically compatible substances, with glycerol as a cryoprotectant and human serum albumin as a protein supplement. It is supplied in fill volumes of 100 mL.
Sperm Maintenance Medium with Glycerol
Page 24 of 29
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Intended Use:
Sperm Maintenance Medium with Glycerol is intended for the cryopreservation of human sperm prior to assisted reproductive procedures.
Technological Characteristics:
Sperm Maintenance Medium with Glycerol is used to protect human sperm during cryopreservation for future assisted reproductive procedures. Sperm is routinely saved, or "banked" for a variety of reasons. Products with ingredients such as glycerol protect the cells from damage during the initial freezing process, the storage and the thawing prior to use.
Performance Data:
Sperm Maintenance Medium with Glycerol will be analyzed by a sperm cryopreservation and motility recovery assay prior to release to market. This assay assures that the product is both functional for its intended use, the cryopreservation of human sperm, and that no toxic components are present in the formulation. Sperm Maintenance Medium has been used in a variety of clinical settings, for its intended use, for a number of years. In that time, the product has become one of the standard media used for the cryopreservation of human sperm.
Additional Information:
The sperm cryopreservation and motility recovery assay will be performed as a condition of release for this product, as well as endotoxin and sterility testing. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.
Conclusion:
The conclusion from performance testing, as well as a review of the historical information contained in professional literature and a history of satisfactory use,
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shows that Sperm Maintenance Medium with Glycerol is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
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Image /page/3/Picture/0 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 an eagle or bird in flight, with three curved lines representing the wings and body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the image. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 1999
Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific, Inc. 2511 Daimler Street Santa Ana, CA 92705
Re: K991337 Sperm Maintenance Medium with Glycerol Dated: April 16, 1999 Received: April 19, 1999 Requlatory Class: Il 21 CFR §884.6180/Procode: 85 MQL
Dear Ms. Johnson:
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 (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 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 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 requlation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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 requlations.
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 Compilance 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
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Irvine Scientific
(page 1 of 1) INDICATIONS FOR USE STATEMENT
K991337 510(K) Number:_
Device Name: Sperm Maintenance Medium with Glycerol
Indications for Use:
Sperm Maintenance Medium with Glycerol is intended for use in assisted reproductive procedures that involve the manipulation of gametes. Specifically, Sperm Maintenance Medium with Glycerol is intended to be used as a cryopreservation medium for human sperm.
(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, ENT, and Radiological Dev
510(k) Number K941321
Prescription Use
(Per 21 CFR 801.109)