(64 days)
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No
The 510(k) summary describes a chemical medium for embryo biopsy, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis that would suggest the use of these technologies.
No
The device is a medium used for aspiring blastomeres for genetic diagnosis, not for treating a disease or condition.
No
The device is a medium used to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis, not a diagnostic device itself. It's a component or tool used in a diagnostic process.
No
The device is described as an aqueous solution provided in glass vials, indicating it is a physical substance and not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis." Pre-implantation genetic diagnosis is a laboratory test performed on cells (blastomeres) to assess genetic characteristics. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an "aqueous solution containing electrolytes and buffering agents." This is a reagent or medium used in a laboratory procedure.
- Lack of Direct Patient Contact: The device is used to process a sample (blastomeres) outside of the patient's body.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and device description strongly indicate that it falls under this category. The reference to "pre-implantation genetic diagnosis" is a key indicator of an IVD application.
N/A
Intended Use / Indications for Use
Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.
Product codes
87MQL
Device Description
Sydney IVF Embryo Biopsy Medium is an aqueous solution containing electrolytes and buffering agents, and is provided in glass vials with silicone rubber stoppers. Sydney IVF Embryo Biopsy Medium will be available in 20 mL fill volumes.
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
Sydney IVF Embryo Biopsy Medium was subjected to testing to assure satisfactory operating parameters. Sydney IVF Embryo Biopsy Medium passed the requirements of all tests.
Key Metrics
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Predicate Device(s)
63 FR 48428, September 10, 1998
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
510(k) Summary ਰ
JAN 2 2 2003
| Submitted By: | Debbie Schmitt, Regulatory Affairs |
|---|---|
| COOK OB/GYN™ | |
| 1100 West Morgan Street | |
| Spencer, Indiana, 47460 | |
| 812 829-6500 |
November 18, 2002
Names of Device:
| Trade Name: | Sydney IVF Embryo Biopsy Medium |
|---|---|
| Common/Usual Name: | IVF culture media |
| Classification Name: | Reproductive media and supplements |
| 21 CFR §884.6180 (87MQL); Class II | |
| Predicate Device: | 63 FR 48428, September 10, 1998 |
Device Description:
Sydney IVF Embryo Biopsy Medium is an aqueous solution containing electrolytes and buffering agents, and is provided in glass vials with silicone rubber stoppers. Sydney IVF Embryo Biopsy Medium will be available in 20 mL fill volumes.
Intended Use:
Sydney IVF Embryo Biopsy Medium is intended for use in assisted reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.
Substantial Equivalence:
Sydney IVF Embryo Biopsy Medium is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Discussion of Tests and Test Results:
Sydney IVF Embryo Biopsy Medium was subjected to testing to assure satisfactory operating parameters. Sydney IVF Embryo Biopsy Medium passed the requirements of all tests.
Conclusions Drawn from Tests:
This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings and head. The eagle is facing to the right.
JAN 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Debbie Schmitt Regulatory Affairs Manager Cook OB/GYN™ 1100 W. Morgan Street SPENCER IN 47460
Re: K023850 Trade/Device Name: Sydney IVF Embryo Biopsy Medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MOL Dated: November 18, 2002 Received: November 19, 2002
Dear Ms. Schmitt:
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. Iisting 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.
2
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. 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" (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
Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
3
510(k) Number (if known) 10238 SO
Sydney IVF Embryo Biopsy Medium Device Name:
Sydney IVF Embryo Biopsy Medium is intended for use in assisted Indications For Use: reproduction technologies to facilitate the aspiration of blastomeres for pre-implantation genetic diagnosis.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 22850 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR