(195 days)
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No
The device description and performance studies focus on the chemical composition and biological testing of a sperm washing medium, with no mention of AI or ML technologies.
No
The device is a medium used for processing and manipulating sperm, which is a preparatory step for assisted reproduction procedures like IVF, but it does not directly treat a disease or condition in a patient.
No
The device is a medium used for processing sperm prior to assisted reproduction procedures (sperm washing), not for diagnosing a condition.
No
The device description clearly states that the device is a "synthetic, defined media composed of a mixture of salts and other physiologically compatible substances," which are physical components, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the media are for "sperm processing procedures prior to intrauterine or in vitro fertilization procedures" and "assisted reproduction procedures that require the processing or manipulation of human sperm prior to insemination or in vitro fertilization." These procedures involve the manipulation and preparation of biological samples (sperm) outside of the body for diagnostic or therapeutic purposes related to reproduction.
- Device Description: The description details the composition of the media, which are used to process the sperm sample.
- Performance Studies: The mention of a "mouse embryo assay" to assure the product contains no toxic components is a type of quality control or performance testing relevant to the intended use with biological samples.
- Predicate Device: The reference to a "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335" is likely related to the classification or regulation of devices used in assisted reproduction, which often fall under the IVD category.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use of processing human biological samples (sperm) for procedures performed outside the body strongly aligns with the definition of an IVD. The media are not being used in vivo (within the body) for diagnosis or treatment, but rather in vitro (outside the body) to prepare a biological sample for a subsequent procedure.
N/A
Intended Use / Indications for Use
Sperm Washing Medium and Modified Sperm Washing Medium are intended for sperm processing procedures prior to intrauterine or in vitro fertilization procedures.
Sperm Washing Medium and Modified Sperm Washing Medium are intended for assisted reproduction procedures that require the processing or manipulation of human sperm prior to insemination or in vitro fertilization.
Product codes
85 MQL
Device Description
Sperm Washing Medium and Modified Sperm Washing Medium are synthetic, defined media composed of a mixture of salts and other physiologically compatible substances. The two products differ only in their protein supplementation. Sperm Washing Medium contains 5 mg/mL of human serum albumin, while Modified Sperm Washing Medium contains the same concentration of bovine serum albumin.
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
Sperm Wash and Modified Sperm Wash are assayed by mouse embryo assay prior to their release to market. This assay assures that the product contains no toxic components. Both Sperm Wash and Modified Sperm Wash have been used in a variety of clinical settings, for their original, intended use, for a number of years. In that time, the products have become the standard media used for the processing of human sperm prior to assisted reproductive procedures.
Mouse embryo testing will be performed as a condition of release for these products, 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.
Key Metrics
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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.
0
K9835F8
4/26/99
Irvine Scientific
October 9, 1998
Image /page/0/Picture/4 description: The image is a black and white graphic of a logo. The logo is a stylized design with a combination of straight lines and geometric shapes. The logo is enclosed within a square border. The letters 'TM' are visible in the lower right corner of the image.
IRVINE SCIENTIFIC
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
Irvine Scientific Sales Co., Inc. Submitted by: 2511 Daimler Street Santa Ana, CA 92705-5588
Telephone: (800) 437-5706 Facsimile: (949) 261-6522
Contact: Roberta L. Johnson
Date Submitted: October 9, 1998
Device Identification:
| Trade Name: | Sperm Washing Medium
Modified Sperm Washing Medium |
|----------------------|-------------------------------------------------------|
| Common Name: | Sperm processing media |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
Sperm Washing Medium and Modified Sperm Washing Medium are synthetic, defined media composed of a mixture of salts and other physiologically compatible substances. The two products differ only in their protein supplementation. Sperm Washing Medium contains 5 mg/mL of human serum albumin, while Modified Sperm Washing Medium contains the same concentration of bovine serum albumin.
Sperm Washing Medium
1
October 9, 1998
Intended Use:
Sperm Washing Medium and Modified Sperm Washing Medium are intended for sperm processing procedures prior to intrauterine or in vitro fertilization procedures.
Technological Characteristics:
Sperm Washing Medium and Modified Sperm Washing Medium are used to purify and concentrate sperm prior to use in assisted reproductive procedures. The goal of such sperm "washing" procedures is to concentrate and purify viable sperm, and separate them from the non-sperm constituents of seminal fluid, simulating the filtering effect of cervical mucous. A higher concentration of viable sperm increases the chance of successful insemination, either in vitro, or intrauterine. When performed with a culture medium such as Sperm Washing Medium, semen is suspended in the medium, centrifuged to concentrate the viable sperm, and the supernatant, containing seminal debris, is removed. The sperm pellet is then resuspended in fresh medium, and recentrifuged. During this process, viable sperm are concentrated in the medium, and are then aspirated and used for the fertilization procedure.
Performance Data:
Sperm Wash and Modified Sperm Wash are assayed by mouse embryo assay prior to their release to market. This assay assures that the product contains no toxic components. Both Sperm Wash and Modified Sperm Wash have been used in a variety of clinical settings, for their original, intended use, for a number of years. In that time, the products have become the standard media used for the processing of human sperm prior to assisted reproductive procedures.
2
Additional Information:
Mouse embryo testing will be performed as a condition of release for these products, 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 history of satisfactory use for sperm processing prior to intrauterine insemination, shows that Sperm Washing Medium and Modified Sperm Washing Medium are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird in flight, composed of three curved lines. The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 1999
Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific 2511 Daimler Street Santa Ana, CA 92705-5588 Re: K983588
Sperm Washing Medium, Modified Sperm Washing Medium Dated: February 12, 1999 Received: February 16, 1999 Regulatory Class: II 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 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 Compliance 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
4
INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number:_K983588
Device Name: Sperm Washing Medium, Modified Sperm Washing Medium
Indications for Use:
Sperm Washing Medium and Modified Sperm Washing Medium are intended for assisted reproduction procedures that require the processing or manipulation of human sperm prior to insemination or in vitro fertilization.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription
David A. Segner
Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological De 510(k) Number
Sperm Washing Medium
Modified Sperm Washing Medium