(164 days)
Sperm Washing Media is used for sperm washing procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (IUI).
Sperm Washing Media is used for sperm washing procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (IUI). Sperm Washing Media is based upon the formulation of Modified Human Tubal Fluid (HTF).
The provided text describes a 510(k) submission for " Sperm Washing Media." The focus is on regulatory approval and substantial equivalence to existing devices. Therefore, the document does not contain the detailed study information typically requested for AI device performance.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
The provided document describes quality control testing for the Sperm Washing Media, not an AI-powered device. Therefore, the "acceptance criteria" and "device performance" relate to the media's biological and physical characteristics, not to diagnostic accuracy metrics like sensitivity or specificity.
| Acceptance Criteria Category | Reported Device Performance (Quality Control Tests) |
|---|---|
| Biocompatibility/Embryotoxicity | Mouse Embryo Assay (MEA) Testing |
| Sterility | Sterility Testing |
| Endotoxin Content | Endotoxin (LAL) Testing |
| Physicochemical Properties | pH and Osmolality tests |
Important Note: The document states, "We will provide clear information to the user about each testing, method, criteria and result in the label and in the Quality Control report enclosed with the product." This indicates specific numerical acceptance criteria and results were likely provided to the FDA in the full submission, but are not detailed within this summary document.
As this is a 510(k) summary for a medical device (sperm washing media) and not an AI-powered diagnostic tool, the following sections (2-9) are largely not applicable or cannot be fully answered from the provided text, as they pertain to AI algorithm validation studies.
2. Sample size used for the test set and the data provenance
Not applicable in the context of an AI device. For the sperm washing media, the "test set" would refer to the lots of media produced. The document doesn't specify the sample size (number of lots or individual samples per lot) for the quality control tests. The provenance of materials used for MEA or other tests is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the AI context refers to the correct diagnosis or outcome labeled by experts. For the sperm washing media, "ground truth" would be the verified quality of the media based on standardized laboratory assays. These assays are performed by trained laboratory personnel, not typically "experts" in the sense of clinical specialists establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies among expert readers in diagnostic AI studies. For laboratory quality control tests, the results are typically objectively measured and compared against predefined specifications, not adjudicated by multiple experts.
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. MRMC studies are used to evaluate the impact of AI on human reader performance. This document concerns a biological media, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This question refers to the performance of an AI algorithm on its own. The device described is a sperm washing media, which is a physical product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the sperm washing media, the "ground truth" for its quality is established through standardized laboratory assays, such as:
- Mouse Embryo Assay (MEA): This is a biological assay to assess embryotoxicity, indicating the media's suitability for sensitive biological processes. The "ground truth" is typically defined by a certain percentage of embryos developing to a specific stage.
- Sterility Testing: Confirms the absence of microbial contamination.
- Endotoxin (LAL) Testing: Measures the level of bacterial endotoxins.
- Physicochemical tests (pH and Osmolality): Confirms the physical and chemical properties are within specified ranges.
These are objective laboratory measurements, not expert consensus or pathology in the clinical diagnostic sense.
8. The sample size for the training set
Not applicable. There is no AI algorithm being "trained" for this device.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm being "trained" for this device.
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9 1999 SEP
international, inc. 510(K) Submission
510K Summary
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- Device Name: Propriety Name: Sperm Washing Media
Classification: Reproductive Media
- Device Name: Propriety Name: Sperm Washing Media
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- Submission Date: March 26, 1999
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Submitted by: 3.
international, inc 170 Fort Path Road Madison, CT 06443
Establishment Registration No .: 9003605
Tel: 203-245-4901 Fax: 203-245-4994 E-mail: genxintl@aol.com
Contact Individual: Michael D. Cecchi President
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- Classification: Class II Assisted Reproductive Media Product: Sperm Washing Media Procode: 85 MQL CFR#: 884.6180
- ട. Performance Standards:
No Performance Standards have been developed by Food and Drug Administration under Section 514 of the Act for this device. However, certain Special Controls have been identified in order to provide reasonable assurance of the safety and effectiveness of the device used in assisted reproduction procedures.
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- Proposed labels, Labeling and Advertising: The product labeling is included in this application in the appropriate section. The catalogue number for Sperm Washing Media is GMSW-250 for 250mL and GMSW-500 for 500 mL, etc.
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- Substantially Equivalence Comparison
This product is substantially equivalent to several products currently sold in the market See Section 2.0 for this data.
- Substantially Equivalence Comparison
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- Device Description, Intended Use
Sperm Washing Media is used for sperm washing procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (IUI).
- Device Description, Intended Use
> Sperm Washing Media is based upon the formulation of > Modified Human Tubal Fluid (HTF).
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- Quality Control Testings and Report
Each lot of Sperm Washing Media undergoes the following: Mouse Embryo Assay (MEA) Testing Endotoxin (LAL) Sterility Physicochemical tests which includes pH and Osmolality tests.
- Quality Control Testings and Report
We will provide clear information to the user about each testing, method, criteria and result in the label and in the Quality Control report enclosed with the product.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human face in profile, composed of three curved lines. To the left of the face is the text "DEPARTMENT OF HEALTH & HUM." arranged vertically.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 1999
Mr. Michael D. Cecchi President International, Inc. 170 Fort Path Road, Unit 14 Madison, CT 06443
Re: K991022 Sperm Washing Media Dated: June 14, 1999 Received: June 16, 1999 Regulatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Mr. Cecchi:
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). 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 III (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 regulation (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 regulations.
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 requlation 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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INDICATIONS FOR USE
510 (k) Number (if known)
Device Names: Sperm Washing Media
Indication for Use:
Sperm Washing Media is used for sperm washing procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), intrauterine insemination (IUI).
The indications for use of this media is based on the general procedures for preparation of semen for Intrauterine Insemination described by Paul S. Weatherbee, Ph.D. and Lawrence B. Werlin, M.D., Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of California, Invine Medical Center.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the Counter Use _
David A. Seymor
or
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D
Radiological E
510(k) Number K991022
B
§ 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.