(76 days)
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
No
The document describes a culture medium and its performance testing, with no mention of AI or ML technologies.
No.
The device is a culture medium used to support early stages of embryonic growth in assisted reproductive procedures, not to treat a disease or condition.
No
The device is a culture medium designed to support embryonic growth, not to diagnose a condition or disease. Its performance is assayed for functionality and absence of toxic components, not diagnostic accuracy.
No
The device is a culture medium, 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 explicitly states "assisted reproductive procedures, which include gamete and embryo manipulation." This involves working with biological samples (gametes and embryos) outside of the body.
- Device Description: The description states it's a "culture medium" designed to "support early stages of embryonic growth." Culture media used for growing biological samples for diagnostic or therapeutic purposes are typically considered IVDs.
- Performance Studies: The performance studies involve a "mouse embryo assay," which is a biological test performed in vitro to assess the functionality and safety of the medium.
While the document doesn't explicitly use the term "diagnostic," the nature of the intended use (manipulating gametes and embryos for assisted reproduction) and the function of the device (supporting their growth in vitro) align with the definition of an IVD. IVDs are not limited to just diagnostic tests; they also include reagents, media, and other products used in in vitro procedures related to health and disease.
The reference to the "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335" further supports this, as this docket number is related to the classification of assisted reproductive technology devices, many of which are regulated as IVDs.
N/A
Intended Use / Indications for Use
Early Cleavage Medium (ECM) is intended for use in assisted reproductive procedures, which include gamete and embryo manipulation. These procedures include the use of Early Cleavage Medium (ELM) is Intended to use in assisted to procedures include the use of which include gamete and embrys mailip ECM as a culture medium through day 3 of development.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
Early Cleavage 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Early Cleavage Medium 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. Parallel mouse embryo studies have been performed on P-1 and ECM to assure the performance of ECM. These studies are similar to those previously performed, and submitted for 510K of P-1 Medium (K983589).
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.
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
Irvine Scientific
3462
October 31, 2003
Page 1 of 3
JAN 1 5 2004
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: Wendell Lee
Date Submitted: October 31, 2003
Device Identification:
| Trade Name: | Early Cleavage Medium (ECM) |
|---|---|
| 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:
Early Cleavage 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).
1
October 31, 2003
Intended Use:
Early Cleavage Medium is intended for assisted reproductive procedures that involve the manipulation of gametes and embryos. These procedures include the use of Early Cleavage Medium as a culture medium through day three of development.
Technological Characteristics:
After retrieval of oocytes from the patient, the oocytes are placed in a culture dish containing Early Cleavage 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 Early Cleavage 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:
Early Cleavage Medium 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. Parallel mouse embryo studies have been performed on P-1 and ECM to assure the performance of ECM. These studies are similar to those previously performed, and submitted for 510K of P-1 Medium (K983589).
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
2
Irvine Scientific
October 31, 2003
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 review of the historical information contained in professional literature shows that Early Cleavage Medium 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
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized symbol. The symbol is a depiction of an abstract eagle or bird-like figure, with three curved lines representing the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Wendell Lee, Pharm. D. Vice President, Quality Systems and Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588
Re: K033462
Trade/Device Name: Early Cleavage Medium (ECM) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II
Product Code: 85 MQL Dated: October 31, 2003 Received: October 31, 2003
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register,
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
4
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): X o 3 3 46 2
Device Name:__Early Cleavage Medium (ECM)
Indications For Use:
Early Cleavage Medium (ECM) is intended for use in assisted reproductive procedures,
the use of Early Cleavage Medium (ELM) is Intended to use in assisted to procedures include the use of
which include gamete and embryo manipulation. These procedures include the use of which include gamete and embrys mailip
ECM as a culture medium through day 3 of development.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below This line-continue on another Page if NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033462
Radiological Devices
510(k) Number K033462