(309 days)
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No
The device description and performance studies focus on the chemical composition and biological effects of a cryopreservation solution, with no mention of AI or ML technologies.
No.
The device is a solution used for cryopreservation of sperm, which is a preparation and storage function, not a direct therapeutic intervention for a disease or condition.
No
This device is a solution used for the cryopreservation of human sperm, which is a treatment or preservation method, not a diagnostic tool.
No
The device description explicitly states it is a "solution" containing chemical components (glycerol and sucrose), indicating it is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cryopreservation of human sperm." While cryopreservation itself isn't a diagnostic test, the purpose of preserving sperm is for future use in assisted reproductive technologies (ART), which are procedures performed in vitro (outside the body) to achieve pregnancy.
- Device Description: The device is a solution used for cryopreservation of human sperm. This solution directly interacts with biological material (sperm) in vitro.
- Performance Studies: The performance studies include:
- Human Sperm Survival Assay: This is a test performed in vitro to assess the viability of sperm after exposure to the solution.
- Sperm Chromatin Structure Assay: This is another in vitro test performed on sperm.
- Clinical data: While the clinical data involves outcomes in patients, the initial step of using the SpermFreeze Solution™ is performed in vitro on the sperm before it is used in ART procedures. The fertilization and embryo development assessments are also performed in vitro.
- Key Metrics: The key metrics include the Human Sperm Survival Assay, which is an in vitro measurement of sperm motility.
The device is used to prepare biological material (sperm) for in vitro procedures (ART). The performance of the device is assessed through in vitro tests on the sperm. This aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the information provided relates to the viability and suitability of the sperm for use in in vitro fertilization procedures.
N/A
Intended Use / Indications for Use
SpermFreeze Solution™ is indicated for cryopreservation of human sperm
Product codes (comma separated list FDA assigned to the subject device)
MQL
Device Description
SpermFreeze Solution™ is a device used for cryopreservation of human sperm. SpermFreeze Solution™ is developed to protect the spermatozoa during the freezing and thawing procedure. The solution contains glycerol as cryoprotectant and sucrose.
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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Noted as "Prescription Use"
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)
Non-clinical assessments:
- Stability testing has been performed on SpermFreeze Solution™ to verify that the properties of the device are maintained during the entire shelf-life of 52 weeks.
- Each manufacturing lot of SpermFreeze Solution™ is subject to the following tests:
- Product property: pH at +20°C and ambient atmosphere, Specification: 7.45 $\pm$ 0.2
- Product property: Osmolality, Specification: 2700 $\pm$ 300 mOsm/kg
- Product property: Sterility Assurance Level (sterile filtration), Specification: 10^3
- Product property: Bacterial Endotoxins (LAL assay), Specification:
§ 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
510k Summary.
K113786
pg. 1 of 4
OCT 2 6 2012
X. PREMARKET NOTIFICATION SUMMARY
:
| Submitted by: | Vitrolife Sweden AB
Box 9080
SE-40092 Göteborg
SWEDEN |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms Nina Arvidsson
Vitrolife Sweden AB
Box 9080
SE-40092 Göteborg
SWEDEN
Phone +46 31 721 80 76
Fax +46 31 721 80 90
Email narvidsson@vitrolife.com |
| Date Prepared: | October 19, 2012 |
| Trade Name: | SpermFreeze Solution™ |
| Common Name: | Media for cryopreservation of human sperm |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | Sperm Freezing Medium (K070689) |
| Description of the Device: | SpermFreeze Solution™ is a device used for
cryopreservation of human sperm. SpermFreez
Solution™ is developed to protect the
spermatozoa during the freezing and thawing
procedure. The solution contains glycerol as
cryoprotectant and sucrose. |
| - Indication for Use: | SpermFreeze Solution™ is indicated for
cryopreservation of human sperm |
1
Technological Characteristics:
SpermFreeze Solution™ is a device used for cryopreservation of human sperm. SpermFreeze Solution™ is developed to protect the spermatozoa during the freezing and thawing procedure. The solution contains glycerol as cryoprotectant and sucrose.
The SpermFreeze Solution™ device is a modification of the Sperm Freezing Medium (K070689). The technological characteristics of SpermFreeze Solution™ are similar to those of the predicate device. None of the differences between the predicate device and SpermFreeze Solution™ raise any new questions of safety or effectiveness.
Comparison of SpermFreeze Solution™M to the predicate device:
The SpermFreeze Solution™ device is a modification of the Sperm Freezing device (K070689) marketed by Life Global for the cryopreservation of human sperm. The SpermFreeze Solution™ device is similar to the predicate device in most aspects. Both devices have the same intended use and they contain essentially the same components. For example both devices use Human Serum Albumin supplementation and contain the cryopreservation ingredients Glycerol and Sucrose. Both devices have comparable performance test requirements. However the specification for the Human Sperm Survival Assay is 260% at 45 minutes exposure for SpermFreeze Solution™ while the specification for the predicate device is >80%. The lower HSSA specification does not raise any safety or effectiveness concerns since this assessment represents an indicator of appropriate device function and is within the range of HSSA specifications for other sperm contacting devices.
The main differences between the composition of SpermFreeze Solution™ and Sperm Freezing Medium are the following:
- SpermFreeze Solution™ contains CDLC (Chemically Defined Lipid Concentrate). . CDCL contains cholesterol and fatty acids and is included to aid in maintenance of sperm cell membranes during the cryopreservation process. The addition of this material does not raise new types of questions as compared with other cleared sperm freezing medium containing lipids (e.g., from egg yolk).
- SpermFreeze Solution™ includes the broad-spectrum antibiotic Gentamicin to . reduce the potential for culture contamination. Gentamicin is a common antibiotic used in assisted reproductive media and does not raise new types of safety or effectiveness questions.
- MOPS buffer is used instead of HEPES buffers are commonly used in IVF media and have a very similar function.
Successful cryopreservation of human spermatozoa has been demonstrated in clinical studies performed on SpermFrecze SolutionTM.
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Non-clinical assessments:
Stability testing has been performed on SpermFreeze Solution™ to verify that the properties of the device are maintained during the entire shelf-life of 52 weeks.
Each manufacturing lot of SpermFreeze Solution™ is subject to the following tests:
| Product property | Specification |
|---|---|
| pH at +20°C and ambient atmosphere | $7.45 \pm 0.2$ |
| Osmolality | $2700 \pm 300$ mOsm/kg |
| Sterility Assurance Level (sterile filtration) | $10^3$ |
| Bacterial Endotoxins (LAL assay) |