(75 days)
Sydney IVF Follicle Flush Buffer is intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection.
Sydney IVF Fertilization Medium is intended for use during in vitro procedures for insemination of oocytes.
Sydney IVF Cleavage Medium is intended for use during in vitro fertilization procedures for culture and transfer of cleavage stage embryos.
Sydney IVF Blastocyst Medium is intended for use during in vitro fertilization procedures for extended culture and transfer of embryos.
The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are used for processing eggs and embryos during in vitro fertilization procedures.
Sydney IVF Follicle Flush Buffer is used to flush the follicles during oocyte recovery. It contains Gentamicin (0.01mg/mL) and is available in 100 mL vials.
Sydney IVF Fertilization Medium maintains oocytes in a 6% CO2 environment until insemination and fertilization is complete. Sydney IVF Fertilization Medium contains Humans Serum Albumin (HSA) (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials.
Sydney IVF Cleavage Medium facilitates the first two days of embryonic growth post fertilization. Sydney IVF Cleavage Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials.
Once an embryo has reached the Day 3 (eight-cell) stage, it is then transferred into Sydney IVF Blastocyst Medium. This medium has been metabolically balanced to maximize blastocyst development rates and is suitable for blastocyst transfer. Sydney IVF Blastocyst Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20 or 50 mL vials.
The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.
This document describes the FDA 510(k) clearance for Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, and Sydney IVF Blastocyst Medium. It is not a study proving a device meets acceptance criteria through clinical trials or performance metrics of an AI/software device. Instead, it demonstrates substantial equivalence to a predicate device based on similar technological characteristics and performance specifications for the storage and use of IVF media.
Therefore, many of the requested elements are not applicable in this context. Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Specifications) | Reported Device Performance (Validation/Testing) |
|---|---|
| Endotoxin: < 0.40 EU/mL | Included in stability tests |
| MEA (Mouse Embryo Assay): Used to screen for embryo toxicity | Included in stability tests |
| pH: Similar to predicate | Included in stability tests |
| Osmolality: Similar to predicate | Included in stability tests |
| Sterility: | Included in stability tests (aseptic filtration) |
| Concentrations of constituents: (pyruvate, amino acids (proline and lysine), HSA by-product ammonia) | Included in stability tests |
| Shelf-life: 20 weeks at 2-8°C | Validated in stability studies |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify exact sample sizes for the stability tests. It mentions "stability studies" and "stability tests included endotoxin, MEA, pH, osmolality, sterility and the concentrations of pyruvate, amino acids (proline and lysine), and the HSA by-product ammonia." This implies various batches of the manufactured media were tested over time.
- Data Provenance: Not specified, but the manufacturing company is William A. Cook Australia Pty Ltd, so the testing data would likely originate from their facilities. The studies were likely internal validation studies conducted by the manufacturer. Whether retrospective or prospective is not explicitly stated, but stability studies are typically prospective, monitoring product characteristics over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable. This is a submission for in vitro fertilization media (a consumable medical device), not a diagnostic device or AI algorithm that requires expert interpretation to establish ground truth for performance. The "ground truth" here is adherence to chemical, biological, and physical specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters, which is not the case here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not applicable. This submission is for IVF media, not an AI/software device. No human readers or AI assistance are involved in performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not applicable. This is IVF media, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" in this context is based on established scientific and regulatory standards for reproductive media, including:
- Chemical specifications (pH, osmolality, constituent concentrations)
- Biological specifications (MEA for embryo toxicity, sterility)
- Physical specifications (shelf-life stability)
- These "ground truths" are not established by expert consensus in a clinical diagnostic sense, but rather by adherence to validated analytical methods and predefined acceptable ranges for critical quality attributes.
8. The sample size for the training set
- This information is not applicable. This is IVF media, not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- This information is not applicable. No training set exists for this type of device.
In summary, this document is a regulatory submission for a traditional medical device (IVF media) seeking substantial equivalence to a predicate device. It demonstrates compliance through laboratory-based performance testing against predefined specifications, rather than clinical trials or AI algorithm validation studies.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2016
William A. Cook Australia Pty, Ltd. Gordana Pozvek Senior Regulatory Affairs Specialist 95 Brandl Street Brisbane Technology Park, Eight Mile Plains Brisbane OLD 4113. Australia
- Re: K153290
Trade/Device Name: Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: December 21, 2015 Received: December 28, 2015
Dear Gordana Pozvek,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153290
Device Name
Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium
Indications for Use (Describe)
Sydney IVF Follicle Flush Buffer is intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection.
Sydney IVF Fertilization Medium is intended for use during in vitro procedures for insemination of oocytes.
Sydney IVF Cleavage Medium is intended for use during in vitro fertilization procedures for culture and transfer of cleavage stage embryos.
Sydney IVF Blastocyst Medium is intended for use during in vitro fertilization procedures for extended culture and transfer of embryos.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 201.5 Subject to Rx) | ☐ Over-The-Counter Use (21 CFR 201.5 Subject to OTC) |
|---|---|
| ------------------------------------------------------------------------------------------------------ | ------------------------------------------------------ |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Attachment 5-2
Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif font at the top. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font.
WILLIAM A. COOK AUSTRALIA PTY. LTD. 95 BRANDL STREET BRISBANE TECHNOLOGY PARK, EIGHT MILE PLAINS BRISBANE, QLD 4113, AUSTRALIA PHONE: 1800.777.222 FAX: +61.7.3841.1288 WWW.COOKMEDICAL.COM
510(k) Summary
SUBMITTED BY:
William A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains QLD 4113 Australia
| Contact Person: | Gordana Pozvek Ph.D. |
|---|---|
| Tel: | +61 (7) 3841 1188 |
| Fax: | +61 (7) 3841 3905 |
| E-mail: | Gordana.Pozvek@CookMedical.com |
Date Prepared: November 10, 2015
DEVICE IDENTIFICATION:
| Trade Name: | Sydney IVF Follicle Flush Buffer (Product code: K-SIFB)Sydney IVF Fertilization Medium (Product code: K-SIFM)Sydney IVF Cleavage Medium (Product code: K-SICM)Sydney IVF Blastocyst Medium (Product code: K-SIBM) |
|---|---|
| Common Name: | Egg/Embryo Processing Solutions |
| Regulation No: | 21 CFR 884.6180, Reproductive Media & Supplements |
| Regulatory Class: | II |
| Product Code: | MQL - Media, Reproductive |
PREDICATE DEVICE:
Cook IVF Follicle Flushing Buffer, Cook IVF Oocyte Wash Buffer, Cook IVF Fertilization Medium, Cook IVF Cleavage Medium and Cook IVF Blastocyst Medium (K002385), cleared September 18, 2000.
DEVICE DESCRIPTION:
The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are used for processing eggs and embryos during in vitro fertilization procedures.
Sydney IVF Follicle Flush Buffer is used to flush the follicles during oocyte recovery. It contains Gentamicin (0.01mg/mL) and is available in 100 mL vials.
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Sydney IVF Fertilization Medium maintains oocytes in a 6% CO2 environment until insemination and fertilization is complete. Sydney IVF Fertilization Medium contains Humans Serum Albumin (HSA) (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials.
Sydney IVF Cleavage Medium facilitates the first two days of embryonic growth post fertilization. Sydney IVF Cleavage Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20, 50 or 100 mL vials.
Once an embryo has reached the Day 3 (eight-cell) stage, it is then transferred into Sydney IVF Blastocyst Medium. This medium has been metabolically balanced to maximize blastocyst development rates and is suitable for blastocyst transfer. Sydney IVF Blastocyst Medium contains HSA (5 mg/mL) and Gentamicin (0.01 mg/mL). It is available in 20 or 50 mL vials.
The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are provided in glass vials with Fluorotec® coated rubber stoppers held in place with a tamper evident seal. These products are single use, sterile (aseptic filtration) devices.
INDICATIONS FOR USE:
Sydney IVF Follicle Flush Buffer is intended for use during in vitro fertilization procedures for follicle flushing and oocyte collection.
Sydney IVF Fertilization Medium is intended for use during in vitro procedures for insemination and incubation of oocytes.
Sydney IVF Cleavage Medium is intended for use during in vitro fertilization procedures for culture and transfer of cleavage stage embryos.
Sydney IVF Blastocyst Medium is intended for use during in vitro fertilization procedures for extended culture and transfer of embryos.
The only differences in the intended use listed above and that of the predicate device are:
- In the indications for use for Sydney IVF Cleavage Medium the wording "for culture and transfer of cleavage stage embryos" replaces "for culture and transfer of embryos" which is used in the predicate device. This is an update to clarify the purpose of the device. There is no change to the clinical use of the device.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium and the predicate device (K002385)
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have the same fundamental technology and similar technological characteristics including the following:
- Similar chemical formulation
- . Similar pH and osmolality specifications
- . Similar performance specifications:
- Endotoxin < 0.40 EU/mL —
- A Mouse Embryo Assay (MEA) is used to screen the product for embryo toxicity.
- Same method of manufacturing process aseptic filtration. ●
- Same packaging borosilicate type 1 vials with FluroTec coated stopper and tamper ● evident seals.
The modification that was made to the predicate device was a change in shelf-life from 8 weeks at 2-8°C (for predicate device) to 20 weeks at 2-8°C. In addition, minor changes were made to the formulations and specifications.
The technological characteristics of Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium are comparable to the predicate device.
PERFORMANCE DATA:
The shelf-life of Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium has been validated in stability studies to 20 weeks at 2 - 8°C. Stability tests included endotoxin, MEA, pH, osmolality, sterility and the concentrations of pyruvate, amino acids (proline and lysine), and the HSA by-product ammonia.
CONCLUSION:
The results of the testing provide reasonable assurance that the Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium and Sydney IVF Blastocyst Medium is as safe and effective as the predicate device and supports a determination of substantial equivalence.
§ 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.