(128 days)
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
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No
The description focuses on the chemical composition and biological function of a culture medium, with no mention of AI or ML technologies.
No
The device is a culture medium used in assisted reproductive technology procedures to support early stages of embryonic growth, not to diagnose, cure, mitigate, treat, or prevent disease.
No
The device is a culture medium used to support early embryonic growth in assisted reproductive technology, not to diagnose a condition or disease.
No
The device description clearly states it is a "synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances," which is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that P-1 medium is for use in "assisted reproductive technology procedures that involve the manipulation of gametes or embryos." This involves working with biological samples (gametes and embryos) outside of the body.
- Device Description: The description details a "synthetic, defined medium composed of a balanced mixture of salts and other nutrient substances designed to support early stages of embryonic growth." This is a reagent or substance used in a laboratory setting to facilitate a biological process (embryonic growth) for diagnostic or therapeutic purposes related to reproduction.
- Performance Studies: The mention of a "mouse embryo assay" to assure functionality and lack of toxic components is a form of quality control and performance testing typically associated with IVD products used in sensitive biological applications.
While the document doesn't explicitly use the term "diagnostic," the context of assisted reproductive technology and the manipulation of gametes and embryos strongly aligns with the definition of an IVD, which includes products used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the medium is essential for the in vitro development of embryos, which is a critical step in assisted reproductive procedures and provides information about the viability and development of those embryos.
The reference to the "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335" is likely related to the regulation of assisted reproductive technology devices, which often fall under the purview of IVD regulations.
N/A
Intended Use / Indications for 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.
P-1reg medium is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, P-1reg is intended for use as a culture medium through day three of embryo development.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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
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.
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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.
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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.
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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
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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.