(27 days)
Oil for Embryo Culture is intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation.
Oil for Embryo Culture is a solution intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Oil for Embryo Culture" device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Support embryonic growth | Confirmed: Assayed by mouse embryo assay which "assures that the product will support embryonic growth." |
| Absence of toxic components | Confirmed: Assayed by mouse embryo assay which "assures...that no toxic components are present." |
| Sterility | Confirmed: Sterility testing is performed as a condition of release. |
| Endotoxin levels | Confirmed: Endotoxin testing is performed as a condition of release. |
| Meets "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335" | Confirmed: "The conclusion from performance testing as well as a review of the historical information contained in professional literature shows that Oil for Embryo Culture is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
Critique: The information provided about "acceptance criteria" is somewhat vague. It broadly states that the device must "support embryonic growth" and not contain "toxic components," and also meet specific regulatory requirements. The performance data section directly addresses these broad criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions a "mouse embryo assay" but doesn't provide the number of mouse embryos or assays conducted.
- Data Provenance: The mouse embryo assay is a laboratory test, not human clinical data. The "historical information contained in professional literature" suggests a review of existing scientific knowledge, but no specific data provenance (e.g., country of origin, retrospective/prospective) for that literature is given in relation to this specific device's performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The ground truth for this device is established primarily through direct laboratory assays (mouse embryo assay, endotoxin, sterility testing) rather than human expert interpretation of data from the device itself. The "review of the historical information contained in professional literature" would involve expert scientific review, but the document does not specify the number or qualifications of those experts for this submission.
4. Adjudication Method for the Test Set:
Not applicable. As the testing involves objective laboratory assays, an adjudication method for human interpretation is not relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or interpretation tasks where multiple human readers assess cases with and without AI assistance. The "Oil for Embryo Culture" is a laboratory consumable, not an AI-powered diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable in the context of an AI algorithm. The device itself (the oil) is the "standalone" product being tested, and its performance is evaluated directly through biological and chemical assays.
7. The Type of Ground Truth Used:
- Biological Response/Outcomes Data: The primary ground truth is derived from the biological outcome of the mouse embryo assay (ability to support embryonic growth, absence of toxic effects).
- Direct Measurement/Laboratory Standards: Sterility and endotoxin testing rely on established laboratory standards and direct measurements.
- Regulatory Compliance: The ultimate ground truth also involved meeting the criteria outlined in a specific regulatory notice (63 FR 48428, Docket number 97N-0335).
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm, so there is no training set in the traditional machine learning sense. The "training" for the manufacturing process would be internal R&D and process validation, but this is not discussed as a "training set" for the device's performance evaluation.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for an AI algorithm. For the manufacturing process and quality control, ground truth would be established through established laboratory protocols, internal specifications, and compliance with Good Manufacturing Practices (GMP).
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JUL 1 8 2001
2011938
p. 1 of 2
June 15, 2001
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
Irvine Scientific Sales Co., Inc. Submitted by: 2511 Daimler Street Santa Ana, CA 92705-5588
Telephone: (800) 437-5706 Facsimile: (949) 261-6522
Contact: Wendell Lee, Pharm. D.
Date Submitted: June 15, 2001
Device Identification:
| Trade Name: | Oil for Embryo Culture |
|---|---|
| Common Name: | Oil for Embryo Culture |
| Classification Name: | Reproductive Media (21 CFR 884.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
Oil for Embryo Culture is a solution intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation.
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K011938
p. 2 of 2
June 15, 2001
Intended Use:
Oil for Embryo Culture is intended for use in as an overlay to cover small volumes of culture media during embryo and gamete manipulation.
Technological Characteristics:
Oil for Embryo Culture is primarily used as an accessory solution to ina overlay medium to support in vitro fertilization and post fertilization embryo growth. The embryo is allowed to grow in the solution until the desired state of development is reached.
Performance Data:
Oil for Embryo Culture is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will support embryonic growth and that no toxic components are present.
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 Oil for Embryo Culture is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
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Public Health Service
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JUL 1 8 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wendell Lee, Pharm. D. Vice President, Quality Systems and Regulatory Affairs IRVINE SCIENTIFIC 2511 Daimler Street SANTA ANA CA 92705-5588
Re: K011938 OIL FOR EMBRYO CULTURE Dated: June 15, 2001 Received: June 21, 2001 Regulatory Class: II 21 CFR 884.6180/Procode: 85 MQL
Dear Dr. Lee:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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. Bogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
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Irvine Scientific
June15, 2001
INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number:_KO11938
Device Name: Oil for Embryo Culture
Indications for Use:
Oil for Embryo Culture is intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
Nancy C. Broadlon
§ 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.