(128 days)
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
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No
The device description and intended use clearly define the product as a synthetic culture medium, with no mention of AI or ML capabilities.
No.
These devices are culture media used in assisted reproductive technology procedures and are not directly used to treat a disease or condition in a patient.
No
Explanation: The device is described as a culture medium used for manipulation of gametes and embryos in assisted reproductive technology procedures. Its function is to support growth, transport, and storage, not to diagnose a condition or disease.
No
The device description clearly states that the device is a "synthetic, defined media," which is a chemical substance, not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that HTF and Modified HTF are for use in "assisted reproductive technology procedures that involve the manipulation of gametes or embryos." These procedures are performed in vitro (outside the body) to aid in diagnosis and treatment related to fertility.
- Device Description: The description reinforces that these are "synthetic, defined media intended for use in assisted reproductive technology procedures."
- Function: The media are designed to "simulate the substances found in the human, female reproductive system" and support processes like sperm processing, oocyte retrieval, fertilization, embryo culture, and embryo transport. These are all in vitro manipulations of biological materials.
- Performance Studies: The performance studies mention "mouse embryo assay" to assure functionality for "the support of embryonic growth," which is an in vitro assessment of the media's ability to support biological processes.
While the text doesn't explicitly use the phrase "In Vitro Diagnostic," the described intended use and function of the device align perfectly with the definition of an IVD, which is a medical device used to examine specimens taken from the body to help diagnose or monitor a medical condition. In this case, the specimens are gametes and embryos, and the examination/manipulation is for the purpose of addressing fertility issues.
N/A
Intended Use / Indications for Use
HTF and Modified HTF are intended for the retrieval, culture, transport, storage and transfer of human gametes and embryos.
HTF 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 HTF 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 HTF 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. Therefore, HTF is primarily used as a medium to support embryo growth, development, and culture in vitro.
HTF and Modified HTF are intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, HTF 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. Modified HTF is intended for use as a sperm-processing medium in washing procedures, as an oocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo. Both HTF and Modified HTF are intended to simulate the substances found in the human, female reproductive system.
Product codes (comma separated list FDA assigned to the subject device)
85MQL
Device Description
HTF and Modified HTF (mHTF) are synthetic, defined media intended for use in assisted reproductive technology procedures. Both have been formulated to mimic the composition of the fluid found in human fallopian tubes. Modified HTF differs from HTF by the buffer system used. HTF uses a sodium bicarbonate buffering system, and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation. Modified HTF utilizes a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1piperazineethanesulfonic 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human fallopian tubes, human, female reproductive system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Assisted reproductive laboratories
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)
HTF and modified HTF are assaved 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, and that no toxic components are present in the formulation. HTF and modified HTF 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.
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
K93586
October 9, 1998
Image /page/0/Picture/2 description: The image shows the logo for Irvine Scientific. The logo consists of a stylized, white "IS" monogram set against a black square. Below the square, the words "IRVINE SCIENTIFIC" are printed in a simple, sans-serif font, with the word "IRVINE" stacked directly above "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: October 9, 1998
Device Identification:
| Trade Name: | HTF Medium
Modified HTF Medium-HEPES
HTF Powder (without antibiotics)
Modified HTF Powder-HEPES
(without antibiotics)
Modified HTF Powder-HEPES |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Gamete and embryo retrieval, storage and
transfer medium |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
HTF and Modified HTF (mHTF) are synthetic, defined media intended for use in assisted reproductive technology procedures. Both have been formulated
Human Tubal Fluid (HTF
1
to mimic the composition of the fluid found in human fallopian tubes. Modified HTF differs from HTF by the buffer system used. HTF uses a sodium bicarbonate buffering system, and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation. Modified HTF utilizes a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1piperazineethanesulfonic 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:
HTF and modified HTF are intended for the retrieval, culture, transport, storage and transfer of human gametes and embryos.
Technological Characteristics:
Modified HTF is has utility for a variety of assisted reproductive procedures. It has been used for a number of years as a sperm-washing medium. 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 HTF is used to suspend the semen, the sample is centrifuged to pellet the viable sperm, and, after the supernatant is decanted, the pellet is resuspended 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 HTF 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 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 mHTF for transport and
2
October 9, 1998
implantation into the patient. Modified HTF is therefore intended for use as a sperm-washing medium, an oocyte retrieval medium, and as a transport and storage medium.
HTF intended for use as a culture medium, with appropriate protein supplementation, for the support of fertilized embryos. Fertilization is also allowed to occur in HTF 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 HTF 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. Therefore, HTF is primarily used as a medium to support embryo growth, development, and culture in vitro.
Performance Data:
HTF and modified HTF are assaved 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, and that no toxic components are present in the formulation. HTF and modified HTF 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 performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.
3
Conclusion:
The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that HTF and modified HTF are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
Human Tubal Fluid (HTF) Modified Human Tubal Fluid (mHTF)
4
PROPOSED LABELING
Three copies of the proposed labeling for HTF and modified HTF are enclosed with this submission, beginning on the following page. These labels include vial/bottle labels, and the proposed package insert. Some information, such as results of endotoxin tests and mouse embryo assays, will be included in the lot-specific certificate of analysis provided with the product. An example of the format for these certificates of analysis, and of the information supplied in them, may be found in Appendix E to this submission.
5
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1999
Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific 2511 Daimler Street Santa Ana, CA 92705
Re: K983586 HTF Medium, Modified HTF Medium-Hepes, HTF Powder Dated: January 14, 1999 Received: January 19, 1999 Regulatory Class: II 21 CFR 884.6180/Procode: 85MQL
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 Cosmelic 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 dass 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 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 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 intemet 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
6
Irvine Scientific
INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number:
Device Name: HTF Medium and Modified HTF Medium - HEPES.
Indications for Use:
HTF and Modified HTF are intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, HTF 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. Modified HTF is intended for use as a sperm-processing medium in washing procedures, as an oocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo. Both HTF and Modified HTF are intended to simulate the substances found in the human, female reproductive system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
ustive. Abdominal, ENT,
Human Tubal Fluid (HTF) Modified Human Tubal Fluid (mHTF)