(94 days)
Phenol Red Stock Solution is intended for use at 1X (5mg/L) concentration in media without phenol red to serve as a visual aid to monitor the pH in vitro in a control dish (not intended for culture).
A 100X concentrated solution of phenol red in normal saline will be provided in 20 mL fill using 30mL vials, to complement the phenol red free media for gamete and embryo culture.
Here's a breakdown of the acceptance criteria and study information for the Irvine Scientific Phenol Red Stock Solution, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Supports embryonic growth | Assayed by mouse embryo assay prior to release, ensuring product supports embryonic growth |
| No toxic components present | Assayed by mouse embryo assay prior to release, ensuring no toxic components |
| Meets criteria outlined in Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 | Performance testing and review of historical professional literature confirm suitability for intended use and meeting criteria. |
(Note: The specific quantitative criteria of the "Notice of Final Rule" are not detailed in the provided text, only that the device meets them.)
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: The exact sample size for the mouse embryo assay (number of embryos, number of replicates) is not specified in the provided document. It only states "assayed by mouse embryo assay."
- Data Provenance: Not explicitly stated, but as the company is Irvine Scientific in Santa Ana, CA, and the submission is to the FDA, it is highly likely the data is from the USA and is prospective (conducted specifically for product release testing).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: This information is not provided. The mouse embryo assay is a laboratory test, not typically reliant on expert consensus for interpreting individual results but rather on established biological protocols and scientific interpretation.
- Qualifications of Experts: This information is not provided.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: None explicitly mentioned as this is a laboratory assay with pre-defined endpoints (e.g., embryonic development stages, viability).
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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:
- MRMC Study: No. This device is a chemical solution (Phenol Red Stock Solution) and not an AI-powered diagnostic or imaging device. Therefore, a MRMC study is not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable. This is a laboratory reagent, not an algorithm. The "performance" is its biological effect in a mouse embryo assay, which is a standalone test of the product itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: The ground truth is based on the biological outcome of the mouse embryo assay. This typically involves assessing embryonic development (e.g., cleavage to blastocyst stage) and viability as per established scientific protocols for embryo toxicity testing. This is a form of outcomes data in a controlled biological setting.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a chemical reagent, not a machine learning model, so there is no concept of a "training set" in this context. The mouse embryo assay is a release test.
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How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable for the reasons stated above.
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Irvine Scientific
September 15, 2003
DEC 1 9 2003
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: September 15, 2003
Device Identification:
| Trade Name: | Phenol Red Stock Solution |
|---|---|
| Common Name: | Phenol Red Stock Solution |
| Classification Name: | Reproductive Media (21 CFR 884.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
A 100X concentrated solution of phenol red in normal saline will be provided in 20 mL fill using 30mL vials, to complement the phenol red free media for gamete and embryo culture.
Intended Use:
Phenol Red Stock Solution is a solution intended for use at 1X (5mg/L) in media without phenol red to serve as a visual aid to monitor the pH in vitro in a control dish.
Technological Characteristics:
Phenol Red Stock Solution is primarily used as an accessory product for A.R.T. use.
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pung
202
Performance Data:
Phenol Red Stock Solution 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 Phenol Red Stock Solution 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2003
Wendell Lee, Pharm. D. Vice President, Quality Systems and Regulatory Affairs Irvine Scientific 2511 Daimler Street SANTA ANA CA 92705-5588
Re: K032887
Trade/Device Name: Phenol Red Stock Solution Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements
Regulatory Class: II Product Code: 85 MQL Dated: September 15, 2003 Received: September 26, 2003
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 such 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Indications for Use
510(k) Number (if known): K032887
Device Name: Phenol Red Stock Solution
Indications For Use:
Phenol Red Stock Solution is intended for use at 1X (5mg/L) concentration in media without phenol red to serve as a visual aid to monitor the pH in vitro in a control dish (not intended for culture).
Prescription Use _ X
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AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Seymm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.