(67 days)
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Not Found
No
The device description and intended use clearly define a culture medium, and there is no mention of any computational or analytical capabilities that would involve AI/ML.
No.
The device is a temporary culture medium used during embryo biopsy procedures, which involves manipulation of embryos; it is not described as treating or preventing any disease or condition.
No
Explanation: The device is a culture medium used in assisted reproductive technology procedures for the temporary culture of embryos during biopsy, not for diagnosing a condition or disease.
No
The device description clearly states it is a "defined media," which is a physical substance (liquid) used in a laboratory procedure, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "assisted reproductive technology procedures that involve the manipulation of embryos," specifically as a "temporary culture medium during embryo biopsy blastomere removal procedures." This describes a medium used outside the body to support and manipulate biological material, not to diagnose a condition or disease based on in vitro examination of specimens.
- Device Description: The description reinforces its use as a "defined media intended for use in assisted reproductive technology procedures," formulated to "mimic the composition of the fluid found in human fallopian tubes." This further supports its role as a culture medium for external manipulation.
- Lack of Diagnostic Claims: There are no mentions of analyzing specimens, detecting markers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance study described is a "mouse embryo assay" to ensure the product "will not adversely impact embryonic growth and that no toxic components are present." This is a quality control measure for the medium itself, not a validation of its diagnostic accuracy.
- Predicate Device: The predicate device reference is to a "Notice of Final Rule," which is likely related to the regulation of assisted reproductive technology products, not necessarily IVDs.
IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to support and facilitate a procedure involving embryos outside the body.
N/A
Intended Use / Indications for Use
Embryo Biopsy Medium is intended for use during embryo biopsy procedures of human embryos.
Embryo Biopsy Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of embryos. Specifically, Embryo Biopsy Medium is intended for use as a temporary culture medium during embryo biopsy blastomere removal procedures.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
Embryo Biopsy Medium is a defined media intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in human fallopian tubes. Embryo Biopsy Medium uses a combination of HEPES/sodium bicarbonate buffering system and is appropriate for those procedures that do 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
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)
Embryo Biopsy Medium is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will not adversely impact embryonic growth and that no toxic components are present. The equivalent of Embryo Biopsy Medium has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium used for the fertilization and growth of human gametes and embryos.
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
5 2002 ர்பட
April 15, 200
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, Pharm, D.
Date Submitted: April 15, 2002
Device Identification:
| Trade Name: | Embryo Biopsy Medium |
|---|---|
| Common Name: | Embryo Biopsy Medium |
| Classification Name: | Reproductive Media (21 CFR, 884.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
Embryo Biopsy Medium is a defined media intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in human fallopian tubes. Embryo Biopsy Medium uses a combination of HEPES/sodium bicarbonate buffering system and is appropriate for those procedures that do not require the use of a carbon dioxide incubator.
Intended Use:
Embryo Biopsy Medium is intended for use during embryo biopsy procedures of human embryos.
Embryo Biopsy Medium
1
K021358
April 15, 2002 Page 2 of 2
Technological Characteristics:
Embryo Biopsy Medium prevents compaction of cleavage-stage embryos and allows for easier separation and removal of 1-2 blastomers during embryo biopsy procedures. Embryo Biopsy Medium contains a combined sodium bicarbonate/HEPES Buffer system to maintain physiological pH in ambient atmosphere (does not require CO2 incubator).
Performance Data:
Embryo Biopsy Medium is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will not adversely impact embryonic growth and that no toxic components are present. The equivalent of Embryo Biopsy Medium has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium used for the fertilization and growth of human gametes and embryos.
Additional Information:
Mouse embryo, endotoxin and sterility testing will be performed as a condition of release for this product. Results of all release assays performed will be indicated on the labeling and reported on a lot-specific certificate of analysis.
Conclusion:
The conclusion from performance testing as well as a review of the historical information contained in professional literature shows that Embryo Biopsy Medium is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ப்பட 5 2002
Wendell Lee, Ph.D. Quality Systems and Regulatory Affairs IRVINE Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588
Re: K021358
Trade/Device Name: Embryo Biopsy Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II
Product Code: 85 MQL Dated: April 15, 2002 Received: April 29, 2002
Dear Dr. 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 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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (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" (21 CFR Part 807.97). 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
4
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:_Embryo Biopsy Media
Indications For Use:
Embryo Biopsy Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of embryos. Specifically, Embryo Biopsy Medium is intended for use as a temporary culture medium during embryo biopsy blastomere removal procedures.
(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)
Nancy C. Hogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number