(128 days)
P-1® medium is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, P-1® is intended for use as a culture medium through day three of embryo development.
P-1 medium is a synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth (up to three days post-fertilization). P-1 has been formulated without glucose and phosphate, which may be detrimental to blastocyst development. P-1 may be used as a stand-alone medium, or as the first stage of a sequential medium protocol.
Here's an analysis of the acceptance criteria and study information for the P-1® (Preimplantation Stage One) Medium, based on the provided text:
Device: P-1® (Preimplantation Stage One) Medium
Study Goal: To demonstrate that P-1® medium is suitable for its intended use (supporting early stages of embryonic growth) and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| I. Functional for intended use (support of embryonic growth) | P-1® is assayed by mouse embryo assay prior to release to market, which "assures that the product is both functional for its intended use, the support of embryonic growth." |
| II. Absence of toxic components in the formulation | P-1® is assayed by mouse embryo assay prior to release to market, which "assures that... no toxic components are present in the formulation." Additionally, endotoxin and sterility testing will be performed as a condition of release. |
| III. Compliance with 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 P-1 is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
Study Details
-
Sample size used for the test set and the data provenance:
- Mouse Embryo Assay: The text states, "P-1 is assayed by mouse embryo assay prior to release to market." This indicates a prospective testing protocol for each lot produced. The specific sample size for a typical mouse embryo assay (e.g., number of embryos, number of replicates) is not specified in the document.
- Clinical Settings: "P-1 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 the standard media used for the early development of human embryos in vitro." This suggests a large, retrospective collection of real-world usage data. No specific sample size (e.g., number of patients, number of cycles, number of embryos) is provided for this historical data, nor is a specific country of origin mentioned for these "clinical settings."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that the mouse embryo assay serves as the primary method for establishing the functional integrity and non-toxicity of each lot. The "experts" involved in conducting and interpreting these assays are not explicitly quantified or qualified. However, standard laboratory practices for such assays would typically involve trained embryologists or laboratory technicians.
- For the "historical information contained in professional literature" and the device becoming "the standard media," this would rely on the collective expertise of the assisted reproductive technology (ART) community, but no specific number or qualifications of experts are cited as being part of this specific submission's ground truth establishment.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method for the mouse embryo assay results or the review of historical clinical use. For a standard laboratory assay, internal quality control and interpretation by trained personnel would be the norm, but a formal adjudication process (like 2+1) is not indicated.
-
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:
- No MRMC study was performed. This device is a culture medium, not an imaging or diagnostic device requiring human interpretation, nor does it involve AI assistance. Therefore, this type of study is irrelevant to this submission.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a culture medium and does not involve an algorithm or human-in-the-loop performance in the way a diagnostic software would. The "performance" is the biological outcome of supporting embryo development, which is observed directly, not through an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mouse Embryo Assay: This involves direct observation of biological outcomes (embryonic development and viability) in a controlled animal model, serving as a proxy for human embryo development. The "ground truth" here is the observed developmental stage and absence of toxicity in the mouse embryos.
- Historical Clinical Use: This relies on human clinical outcomes data from actual assisted reproductive procedures, observed over time by clinicians and embryologists, implicitly leading to the consensus that it has become a "standard media."
-
The sample size for the training set:
- This concept is not applicable to this device. As a biological culture medium, there is no "training set" in the context of machine learning or algorithm development. The "training" in a biological sense would be the extensive research and development that led to the P-1 formulation, but this isn't analogous to a training set for an AI model.
-
How the ground truth for the training set was established:
- As there is no "training set" for an algorithm, this question is not applicable. The development of the medium's formulation would have been based on established scientific principles of embryology and cell culture, empirical testing, and historical knowledge of nutrient requirements for embryo development.
{0}------------------------------------------------
2/18/99
Irvine Scientific
Image /page/0/Picture/1 description: The image shows a handwritten text that reads "K98 3589" on the top line. Below this line, the text "October 9, 1998" is printed in a clear, legible font. The handwritten text appears to be a combination of letters and numbers, possibly a code or identifier. The date below provides a specific temporal context to the image.
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: October 9, 1998
Device Identification:
| Trade Name: | P-1® (Preimplantation Stage One) Medium |
|---|---|
| Common Name: | In vitro embryo culture medium |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
P-1 medium is a synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth (up to three days post-fertilization). P-1 has been formulated without glucose and phosphate, which may be detrimental to blastocyst development. P-1 may be used as a stand-alone medium, or as the first stage of a sequential medium protocol.
{1}------------------------------------------------
October 9, 1998
Intended Use:
P-1 is intended for assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include the use of P-1 as a culture medium through day three of growth.
Technological Characteristics:
After retrieval of oocytes from the patient, the oocytes are placed in a culture dish containing P-1 medium and the desired type and amount of protein supplementation. Fertilization is allowed to take place, and the zygote is removed to a fresh dish containing fresh P-1 medium and protein. This culture dish is placed into a carbon dioxide incubator, and the embryo is allowed to develop, in vitro, until the desired stage of development has been achieved, usually up to three days post fertilization. At that time, the embryo may be transferred to the patient, or to a second, more complex medium for continued growth.
Performance Data:
P-1 is assayed by mouse embryo assay prior to 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. P-1 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 the standard media used for the early development of human embryos in vitro.
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.
{2}------------------------------------------------
Conclusion:
The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that P-1 is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
{3}------------------------------------------------
PROPOSED LABELING
Three copies of the proposed labeling for P-1 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 C to this submission.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo and text for the Department of Health & Human Services. The logo is on the left side of the image and consists of a symbol with three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the right side of the image. The text is in all capital letters and is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1999
Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific 2511 Daimler Street Santa Ana, CA 92705-5588 Re: K983589
P-1® (Pre-implantation Stage One) Medium Dated: January 14, 1999 Received: January 19, 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 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 requlations 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 verily such assumptions. Failure to comply with the GMP regult 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 vours.
J.J.
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
{5}------------------------------------------------
INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number: K983589
Device Name:_P-1® (Preimplantation Stage One) Medium
Indications for Use:
P-1® medium is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, P-1® is intended for use as a culture medium through day three of embryo development.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number.
§ 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.