(315 days)
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No
The device description and performance studies focus on the chemical composition and biological efficacy of a cryopreservation medium, with no mention of AI or ML technologies.
No
The device is a medium for cryopreservation of biological material (spermatozoa and testicular tissue), not a therapeutic intervention applied to a patient.
No
This device is described as a "Sperm Freeze Medium" for cryopreservation and its performance studies focus on sperm viability and binding ability, not on diagnosing medical conditions.
No
The device description clearly states it is a "Medi-Cult Sperm Freeze Medium" composed of chemical solutions, indicating it is a physical substance, 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 "For the cryopreservation of human spermatozoa and tissue from testicular biopsies." While cryopreservation itself isn't a diagnostic test, the purpose of preserving these biological samples is often for subsequent in vitro procedures, including diagnostic testing (e.g., fertility assessments, genetic testing).
- Device Description: The description details a medium used to treat biological samples (spermatozoa and testicular tissue) outside of the body. This aligns with the definition of an in vitro device.
- Performance Studies: The performance studies evaluate the effectiveness of the medium in preserving key characteristics of the sperm (motility, viability, morphology, binding ability) after freezing and thawing. These characteristics are often assessed as part of in vitro diagnostic evaluations of fertility. The comparison to a "TEST-Yolk buffer" further suggests its use in a laboratory setting for evaluating biological samples.
While the document doesn't explicitly state "diagnostic," the context of preserving biological samples for potential future in vitro analysis, coupled with the evaluation of parameters relevant to fertility assessment, strongly indicates that this product falls under the category of an In Vitro Diagnostic device. It's a reagent or medium used in the preparation and handling of samples for subsequent in vitro procedures, which can include diagnostic tests.
N/A
Intended Use / Indications for Use
"Medi-Cult Sperm Freeze Medium" is intended for the cryopreservation of human spermatozoa and tissue from testicular biopsies.
Product codes
MQL
Device Description
"Medi-Cult Sperm Freeze Medium" Cat.No. 1067 -
The product formulation: Modified Tyrodes with HEPES buffer containing sucrose, glucose and sodium lactate Assisted Reproduction Technique Supplement, (ARTS) Glycerol Human Serum Albumin (HSA) Penicillin Streptomycin.
The product testing control contents:
- Bioburden, production-test
- -Integrity filter testing, production-test
- Sterility, QC-test .
- pH, QC-test
- Endotoxin, QC-test ・
- -Sperm Survival, QC-test
The product contains small amounts of potentially hazardous Human Serum Albumin, which has been obtained from a U.S licensed source (U.S license No.140). It origins from larger pools of screened healthy donors, tested negative for HBbsAg, Anti-HCV, anti HIV-1/2. Levels of ALT (GPT) in the plasma are determined and donations are rejected if the values found are above the upper limit of the specifications. Donors of the source material have been screened for CJD.
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
Comparative study: At the Rochester Regional Cryobank and Andrology Laboratory, University of Rochester Medical Center, Rochester, NY, the Medi-Cult Sperm Freezing medium have been compared with TEST-Yolk buffer (TYB, Irvine Scientific, Irvine CA).
Sample size: Not specified.
Key results: No differences between sperm frozen with SFM or with TYB were found in this study.
Comparative study: Dr Mary Mahonev at The Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, Norfolk, USA, have evaluated the ability of frozen/thawed spermatozoa to bind to isolated zona pellucidae using the "hemi-zona assay". Sperm frozen and thawed in Medi-Cult Sperm Freezing medium and in TEST-Yolk buffer form Irvine Scientific was compared.
Sample size: Not specified.
Key results: SFM showed significantly higher HZA binding (149.0 ± 10.4) compared to TYB (103.9 ± 6.0), with p
§ 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
510(k) Summary Summary of Safety and Effectiveness Information FEB 2 8 2000 Supporting a Substantially Equivalent Determination (K991333)
The product
"Medi-Cult Sperm Freeze Medium" Cat.No. 1067 -
Indications for use:
"Medi-Cult Sperm Freeze Medium" is intended for the cryopreservation of human spermatozoa and tissue from testicular biopsies.
The product formulation:
Modified Tyrodes with HEPES buffer containing sucrose, glucose and sodium lactate Assisted Reproduction Technique Supplement, (ARTS) Glycerol Human Serum Albumin (HSA) Penicillin Streptomycin
The product testing control contents:
- Bioburden, production-test
- -Integrity filter testing, production-test
- Sterility, QC-test .
- pH, QC-test
- Endotoxin, QC-test ・
- -Sperm Survival, QC-test
The culture media from Medi-Cult have been used by many European IVF-units since the end of the 1980's. (Produced and distributed by GEA-Biotech 1987 to 1989 and by Medi-Cult a/s from 1989). The Medi-Cult media were at that time introduced as a replacement for in-house prepared culture media.
The Medi-Cult products for cryopreservation is in general formulated according to data published in peer reviewed international iournals by internationally recognised scientists in the field.
Medi-Cult has recently introduced a medium for the crypreservation of human spermatozooa. Medi-Cult Sperm Freezing Medium (SFM) is composed from a modified Tyrodes Solution that has been Hepes buffered. The cryoprotective is Glycerol (15% v/v) and its crypprotective properties have been enhanced by the addition of Assisted Reproduction Technique Supplement (ARTS) and human serum albumin.
The product contains small amounts of potentially hazardous Human Serum Albumin, which has been obtained from a U.S licensed source (U.S license No.140). It origins from larger pools of screened healthy donors, tested negative for HBbsAg, Anti-HCV, anti HIV-1/2. Levels of ALT (GPT) in the plasma are determined and donations are rejected if the values found are above the upper limit of the specifications. Donors of the source material have been screened for CJD.
At the Rochester Regional Cryobank and Andrology Laboratory, University of Rochester Medical center, Rochester, NY, the Medi-Cult Sperm Freezing medium have been compared with TEST-Yolk buffer (TYB, Irvine Scientific, Irvine CA). The following results were obtained:
1
| Motility % | Viability % | Normal cells % | VSL* | |
|---|---|---|---|---|
| Fresh semen | 61.1(3.6) | 50.0 (6.1) | 43.1 (3.1) | |
| SFM** | 20.6(2.4) | 40.7(4.2) | 53.8(5.1) | 31.5(1.5) |
| TYB *** | 19.1 (1.0) | 49.6(1.7) | 49.3(5.5) | 29.7(1.6) |
*VSL: straight line velocity
**SFM: Sperm Freezing Medium from Medi-Cult
***TYB: TEST-Yolk buffer from Irvine Scientific
No differences between sperm frozen with SFM or with TYB were found in this study.
Binding of the spermatozoa to the zona pellucida (ZP) is a necessary step in fertilisation both in vivo and in vitro (IVF). Freezing/thawing might have a detrimental effect on the receptors on the surface of sperm cells and thus impair binding to the zona pellucida. Dr Mary Mahonev at The Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, Norfolk, USA, have evaluated the ability of frozen/thawed spermatozoa to bind to isolated zona pellucidae using the "hemi-zona assay". Sperm frozen and thawed in Medi-Cult Sperm Freezing medium and in TEST-Yolk buffer form Irvine Scientific was compared.
Table 1. Hemi-zona assay (HZA) after freezing/thawing in Sperm Freezing Medium from Medi-Cult (SFM) or TEST-Yolk buffer from Irvine Scientific (Test-Yolk)
| HZA binding in TEST-Yolk | HZA Binding in SFM | HZA-SFM/HZA-TEST-yolk % |
|---|---|---|
| Mean ± SE | Mean ± SE | Mean ± SE |
| 103.9 ± 6.0 | 149.0 ± 10.4* | 152.3 ± 10.2 |