(199 days)
63 FR 48428, September 10, 1998
Not Found
No
The summary describes chemical solutions for cryopreservation and thawing, with no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No.
The device is used for the cryopreservation and thawing of blastocysts, which are involved in assisted reproduction technologies, but it does not directly treat a disease or condition in a patient.
No
Explanation: The device is a kit for cryopreservation and thawing of blastocysts, used in assisted reproduction technologies. Its purpose is to preserve biological material, not to diagnose a disease, condition, or state of health.
No
The device description explicitly states it is composed of aqueous solutions in glass vials with silicone rubber stoppers, indicating it is a physical product, not software.
Based on the provided information, the Sydney IVF™ Blastocyst Cryopreservation Kit and Thawing Kit are likely IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use is for "assisted reproduction technologies for cryopreservation of blastocysts" and "thawing of cryopreserved blastocysts." Blastocysts are human embryos, and these processes are performed in vitro (outside the body) on biological material.
- Device Description: The devices are described as "aqueous solutions provided in glass vials." These are reagents or media used in laboratory procedures.
- Context of Use: The intended user is in "assisted reproduction technologies," which are laboratory-based procedures involving the manipulation of human gametes and embryos in vitro.
While the document doesn't explicitly state "In Vitro Diagnostic," the nature of the device, its intended use on biological material outside the body, and the context of its use in a laboratory setting strongly align with the definition of an IVD. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the kits are used to preserve and thaw human embryos, which are specimens derived from the human body, for the purpose of assisted reproduction.
The reference to "63 FR 48428, September 10, 1998" is likely a reference to a regulatory document or guidance related to assisted reproductive technology devices, which often fall under the purview of IVD regulations.
N/A
Intended Use / Indications for Use
Sydney IVF™ Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts.
Sydney IVF™ Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
Sydney IVF™ Blastocyst Freeze/Thaw Kits are aqueous solutions provided in glass vials with silicone rubber stoppers. The Sydney IVF™ Blastocyst Freezing Kit Buffers will be available in 20 mL fill volumes, the Sydney IVF™ Blastocyst Thaw Kit Buffers will be available in 20 mL fill volumes.
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)
The Sydney IVF™ Blastocyst Freeze/Thaw Kits were subjected to testing to assure satisfactory operating performance. The Sydney IVF™ Blastocyst Freeze/Thaw Kits passed the requirements of all tests.
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.
63 FR 48428, September 10, 1998
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
Sydney IVF™ Blastocyst Freeze/Thaw Kits - 510(k) Premarket Notification February 6, 2003
AUG 2 9 2003
510(k) Summary ರಿ
Submitted By:
Brenda Davis Requlatory Affairs COOK OB/GYN™ 1100 West Morgan Street Spencer, Indiana, 47460. 812-829-6500
January 31, 2001
Names of Device:
| Trade Name: | Sydney IVF™ Blastocyst Freeze/Thaw Kits |
|---|---|
| Common/Usual Name: | Freeze/thaw kits |
| 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™ Blastocyst Freeze/Thaw Kits are aqueous solutions provided in glass vials with silicone rubber stoppers. The Sydney IVF™ Blastocyst Freezing Kit Buffers will be available in 20 mL fill volumes, the Sydney IVF™ Blastocyst Thaw Kit Buffers will be available in 20 mL fill volumes.
Intended Use:
The Sydney IVF™ Blastocyst Cryopreservation Kit is intended for use in assisted reproduction technologies for cryopreservation of blastocysts. The Sydney IVF™ Blastocyst Thawing Kit is intended for use in assisted reproduction technologies for thawing of cryopreserved blastocysts.
Substantial Equivalence:
The Sydney IVF™ Blastocyst Freeze/Thaw Kits are comparable with respect to intended use to the published predicate device description and meet the requirements for 510(k) substantial equivalence.
Discussion of Tests and Test Results:
The Sydney IVF™ Blastocyst Freeze/Thaw Kits were subjected to testing to assure satisfactory operating performance. The Sydney IVF™ Blastocyst Freeze/Thaw Kits 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
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
AUG 2 9 2003
Ms. Brenda Davis Regulatory Affairs Technical Writer Cook Ob/Gyn 1100 W. Morgan Street SPENCER IN 47460
Re: K030441 Trade/Device Name: Sydney IVFTM Blastocyst Cryopreservation Kit and Sydney IVFTM Blastocyst Thaw Kit Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: August 14, 2003 Received: August 15, 2003
Dear Ms. Davis:
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.
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, 3xxxx, 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
3
K030441 510(k) Number (if known):
Sydney IVF™ Blastocyst Cryopreservation Kit Device Name:
Sydney IVF™ Blastocyst Cryopreservation Kit is intended Indications For Use: for use in assisted reproduction technologies for cryopreservation of blastocysts.
Sydney IVF™ Blastocyst Thawing Kit Device Name:
Sydney IVF™ Blastocyst Thawing Kit is intended for use Indications For Use: in assisted reproduction technologies for thawing of cryopreserved blastocysts.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Severson
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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OR