(144 days)
Complete Modified Ham's F-10 Medium and Complete Modified Ham's F-10 Medium HEPES are intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, Complete Modified Ham's F-10 Medium is intended for use as a culture medium for the embryo after fertilization, when used with an incubator, and as a medium to support in vitro fertilization. Complete Modified Ham's F-10 Medium HEPES is intended for use as a sperm-processing medium in washing or ICSI® procedures, as an oocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo. Both Modified Ham's F-10 Medium and Modified Ham's F-10 Medium HEPES are supplied to customers as liquid basal media and 50X lyophilized supplements. Users are instructed to reconstitute the lyophilized supplement with the basal liquid media to form the complete media at the time of use.
Modified Ham's F-10 Basal Medium and Modified Ham's F-10 Basal Medium HEPES are synthetic, defined media intended for use in assisted reproductive technology procedures. They are designed to be used with a 50X lyophilized supplement. Reconstitution of the supplement yields a complete medium. Modified Ham's F-10 Medium differs from Modified Ham's F-10 Medium HEPES by the buffer system used. Modified Ham's F-10 Medium uses a sodium bicarbonate buffering system, and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation. Modified Ham's F-10 Medium HEPES utilizes a HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffer. This buffering system provides maintenance of physiological pH (7.2 to 7.4), and does not require the use of a carbon dioxide incubator.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional for intended use: Support embryonic growth | "Assayed by mouse embryo assay prior to their release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth..." |
| Absence of toxic components: | "...and that no toxic components are present in the formulation." |
| Meets criteria outlined in Notice of Final Rule, 63 FR 48428, Docket number 97N-0335: | "The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that Modified Ham's F-10 Medium and Modified Ham's F-10 Medium HEPES are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
| Endotoxin testing: | "Mouse embryo testing will be performed as a condition of release for these products, as well as endotoxin and sterility testing." |
| Sterility testing: | "Mouse embryo testing will be performed as a condition of release for these products, as well as endotoxin and sterility testing." |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to a "mouse embryo assay" as the primary performance test.
- Sample Size: The exact sample size (number of mouse embryos or assays) for the test set is not specified in the provided text. It only mentions that the assay is performed "prior to their release to market" and "as a condition of release for these products."
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given it's a pre-market release assay, it would inherently be prospective data collection for each batch/lot of the product. The location of Irvine Scientific (Santa Ana, CA) suggests the testing would likely occur in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of human experts to establish ground truth for the mouse embryo assay. The assay itself is the objective measure of "support of embryonic growth" and "absence of toxic components."
4. Adjudication Method for the Test Set
Not applicable. The mouse embryo assay is a laboratory-based, objective test, not requiring human adjudication in the context of this study description.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on the performance of the media itself, not comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a culture medium, not an algorithm or AI system. The performance study described is the "mouse embryo assay," which tests the biological efficacy of the medium.
7. The Type of Ground Truth Used
The ground truth used is based on biological outcomes/functional performance as measured by the mouse embryo assay. The criteria are:
- Ability to support embryonic growth.
- Absence of toxic components.
Additionally, compliance with the "Notice of Final Rule" implies an regulatory/legal ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is a culture medium, not a machine learning model, so there is no concept of a "training set" in the context of this document.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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SEP | 4 1995
Irvine Scientific
Image /page/0/Picture/2 description: The image shows the date April 19, 1999. The text is written in a simple, sans-serif font. The date is written in a standard format, with the month, day, and year clearly indicated. The text is black against a white background.
Image /page/0/Picture/3 description: The image shows the logo for Irvine Scientific. The logo consists of a stylized, white "IS" inside of a black square. Below the square is the text "IRVINE SCIENTIFIC" in a sans-serif font.
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 19, 1999
Device Identification:
| Trade Name: | Modified Ham's F-10 Basal MediumModified Ham's F-10 Basal Medium HEPESModified Ham's F-10 Supplement (50X)lyophilized |
|---|---|
| Common Name: | Gamete and embryo retrieval, storage andtransfer medium |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
Modified Ham's F-10 Basal Medium and Modified Ham's F-10 Basal Medium HEPES are synthetic, defined media intended for use in assisted reproductive technology procedures. They are designed to be used with a 50X
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lyophilized supplement. Reconstitution of the supplement yields a complete medium. Modified Ham's F-10 Medium differs from Modified Ham's F-10 Medium HEPES by the buffer system used. Modified Ham's F-10 Medium uses a sodium bicarbonate buffering system, and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation. Modified Ham's F-10 Medium HEPES utilizes a /HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffer. This buffering system provides maintenance of physiological pH (7.2 to 7.4), and does not require the use of a carbon dioxide incubator.
Intended Use:
Modified Ham's F-10 Medium and Modified Ham's F-10 Medium HEPES are intended for the retrieval, culture, transport, storage and transfer of human gametes and embrvos.
Technological Characteristics:
Modified Ham's F-10 Medium HEPES has utility for a variety of assisted reproductive procedures, including sperm washing, oocyte retrieval, embryo transfer and implantation and for processing sperm for ICSI procedures. During sperm wash procedures, viable sperm cells are separated from the other constituents of seminal fluid in an effort to concentrate the viable sperm and increase the number available for fertilization. A culture medium, such as Modified Ham's F-10 Medium HEPES is used to suspend the semen, the sample is centrifuged to pellet the viable sperm, and, after the supernatant is decanted, the pellet is re-suspended in fresh medium. After a brief incubation during which motile sperm "swim-up" into the fresh medium. the sperm are aspirated and used for the desired fertilization procedure. Modified Ham's F-10 Medium HEPES is also used as an oocyte retrieval medium, in procedures that flush oocytes from the patient's fallopian tubes. Once the oocyte has been retrieved, it is placed into a culture dish with an appropriate amount of culture medium, and fertilized. After fertilization, the embryo is allowed to develop in
Modified Ham's F-10 Basal and Supplement Modified Ham's F-10 Basal Medium HEPES and Supplement
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the culture medium, until an appropriate developmental stage is reached. At that time, the embryo is removed from the incubation dish, placed into an suitable amount of Modified Ham's F-10 Medium HEPES for transport and implantation into the patient.
Modified Ham's F-10 Medium is intended for use as a culture medium, with appropriate protein supplementation, for the support of fertilized embryos. Fertilization is also allowed to occur in Modified Ham's F-10 Medium when in vitro fertilization techniques are used. The fertilized gamete is then allowed to grow in the media and supplement, which are replenished as needed, until the desired state of development, usually up to three days post fertilization. Since Modified Ham's F-10 Medium utilizes a sodium bicarbonate buffer system, it is intended to be used in those procedures that require a carbon dioxide atmosphere, as is found in the incubators used by assisted reproductive laboratories.
Performance Data:
Modified Ham's F-10 Basal Medium, Modified Ham's F-10 Basal Medium HEPES and the common 50X lyophilized supplement are assayed by mouse embryo assay pricr to their release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth, and that no toxic components are present in the formulation. Modified Ham's F-10 Medium and Modified Ham's F-10 Medium HEPES have been used in a variety of clinical settings, for their intended use, for a number of years. In that time, the products have become the standard media used for the retrieval, growth, storage and transport of human gametes and embryos.
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
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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 shows that Modified Ham's F-10 Medium and Modified Ham's F-10 Medium HEPES are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
SEP 1 4 1999
Image /page/4/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588
Re: K991419
Modified Ham's F-10 Basal and 50X Lyophilized Supplement and Modified Ham's F-10 Basal Medium HEPES and 50X Lyophilized Supplement Dated: August 26, 1999 Received: August 30, 1999 Requiatory 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 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 diagnosic devices), piease 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
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(page 1 of 1) INDICATIONS FOR USE STATEMENT
510(K) Number: K991419
Device Name: Modified Ham's F-10 Basal and 50X Supplement and Modified Ham's F-10 Basal Medium HEPES and 50X Supplement
Indications for Use:
Complete Modified Ham's F-10 Medium and Complete Modified Ham's F-10 Medium HEPES are intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, Complete Modified Ham's F-10 Medium is intended for use as a culture medium for the embryo after fertilization, when used with an incubator, and as a medium to support in vitro fertilization. Complete Modified Ham's F-10 Medium HEPES is intended for use as a sperm-processing medium in washing or ICSI® procedures, as an cocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo. Both Modified Ham's F-10 Medium and Modified Ham's F-10 Medium HEPES are supplied to customers as liquid basal media and 50X lyophilized supplements. Users are instructed to reconstitute the lyophilized supplement with the basal liquid media to form the complete media at the time of use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Offige of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Modified Ham's F-10 Basal and Supplement Modified Ham's F-10 Basal Medium HEPES and Supplement Page 2 of 44
§ 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.