(80 days)
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.
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.
The provided text describes a 510(k) submission for "Sperm Maintenance Medium with Glycerol." The document focuses on regulatory approval rather than a detailed device performance study with specific acceptance criteria and outcome metrics in the conventional sense of AI/Software as a Medical Device (SaMD).
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of submission, as it concerns a physical reproductive medium rather than a software algorithm or AI model.
Here's the information that can be extracted and a clear indication of what is not present in the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (What is assured by the test) | Reported Device Performance (How the device meets the criteria) |
|---|---|
| Functional for intended use: Cryopreservation of human sperm. | Sperm cryopreservation and motility recovery assay: This assay assures the product is functional. |
| Absence of toxic components: Ensuring safety of the formulation. | Sperm cryopreservation and motility recovery assay: This assay also assures that no toxic components are present. |
| Sterility: Product must be free from microbial contamination. | Sterility testing: Performed as a condition of release. |
| Endotoxin levels: Product must meet specified endotoxin limits. | Endotoxin testing: Performed as a condition of release. |
| Meeting regulatory criteria: Complies with the Notice of Final Rule. | Conclusion from performance testing, review of historical information, and history of satisfactory use: The medium is deemed suitable for its intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335. (Note: The specific quantitative criteria from this rule are not detailed in the provided text, but the claim is that the product meets them). |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The document describes a "sperm cryopreservation and motility recovery assay" that will be performed prior to release, but it does not specify the sample size of sperm donors or samples used in this assay, nor the provenance (country of origin, retrospective/prospective). It mentions the product has been used in a "variety of clinical settings" for "a number of years," implying historical usage data but without specific study details.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. This is not relevant for a physical medium. Ground truth in this context would likely be defined by laboratory assay results and clinical outcomes, not expert consensus on image interpretation or diagnosis.
4. Adjudication method for the test set:
- Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are typically for reconciling discrepancies in expert opinions for ground truth establishment in studies involving human interpretation. This is not applicable to the assay of a physical medium.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document pertains to a physical cryopreservation medium, not an AI or software device that would interact with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not a software algorithm.
7. The type of ground truth used:
- For the performance assessment of the medium (sperm cryopreservation and motility recovery assay): The "ground truth" is defined by laboratory assay results (e.g., sperm viability, motility post-thaw, absence of toxicity markers) which are quantitative and objective measurements.
- For the general suitability and meeting regulatory criteria: This includes a review of historical information (professional literature) and a history of satisfactory use in clinical settings. This implies real-world outcomes data and established scientific understanding.
8. The sample size for the training set:
- Not applicable. This product is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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Irvine Scientific
JIII - 8 1999
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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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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)
§ 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.