(311 days)
pH™-100 is intended to be used as a visual indicator for CO»/pHcontrol in the culture dish or incubator. It is not intended for the preparation or culture of cells.
For visual CO2/pH control. Not for culture.
pH™100 is a bicarbonate-buffered pH-indicator containing Phenol Red. It is used as a visual CO2/pH indicator in the culture dish or incubator. Readyto-use after equilibrium at +37 °C and 5% CO2. pH™-100 includes Penicillin-G as a preservative.
The provided document describes the pH™-100, a bicarbonate-buffered pH-indicator for visual CO2/pH control in culture dishes or incubators. The information focuses on its regulatory classification and equivalence to existing devices, rather than detailed performance studies with acceptance criteria in the context of typical AI/ML device evaluations.
Here's an analysis based on the provided text, addressing your questions to the best of my ability given the nature of the device and the document:
Device Type: This is not an AI/ML device. It's a chemical indicator used in assisted reproduction. Therefore, many of the questions regarding AI/ML specific studies (like MRMC studies, standalone algorithm performance, training set details) are not applicable. The "study" described is primarily about demonstrating its safety and long-standing use, not a performance study as would be conducted for a diagnostic device.
Acceptance Criteria and Device Performance
Given that this is a chemical indicator and not a diagnostic device with specific performance metrics like sensitivity or specificity, the "acceptance criteria" are implied by its intended use and chemical properties rather than quantitative thresholds for diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety (Biological) | Does not contain unacceptable levels of toxins (e.g., endotoxins). | LAL Assay: Each lot is assayed by Limulus Amebocyte Lysate (LAL) Assay to assure the media does not contain unacceptable levels of toxins. Information on the assay is provided in the labeling and on a LOT-specific Certificate of Analysis. Mouse Embryo Assay: Not performed on pH™-100 because its composition is neither intended for nor compatible with embryo development (thus, not relevant for this safety aspect given its intended use). |
| Functionality (Intended Use) | Effectively functions as a visual CO2/pH indicator. | Clinical Experience (Historical): "pH™-100 has been used for CO2/pH control during culture for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use." |
| Technological Equivalence | Identical to other legally marketed media for its category. | "The technological characteristics of pH™-100 are identical to other legally marketed media classified under 21 C.F.R. § 884.6180, Reproductive Media and Supplements." This implies that its chemical formulation and mechanism of action are consistent with established, safe, and effective indicators. |
| Sterility/Preservation | Contains preservative for stability (and potentially sterility). | "pH™-100 includes Penicillin-G as a preservative." (While specific criteria for preservative efficacy aren't stated, its inclusion is a characteristic relevant to product integrity). |
Study Details (as applicable to a non-AI/ML device)
2. Sample size used for the test set and the data provenance:
- LAL Assay: The document states that "each lot of pHTM-100 is assayed." This implies 100% inspection for manufactured lots. The "sample" here would be representative aliquots from each production batch. The provenance is internal manufacturing quality control.
- Clinical Experience: No specific "test set" sample size is mentioned for the clinical experience. The document refers to "many years at many different assisted reproduction facilities," which is a general statement about real-world usage and not a controlled study. This would be considered retrospective observational data gathered over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable in the context of this device. The "ground truth" for the LAL assay is a quantitative measurement of endotoxin levels, interpreted against a standard. The "ground truth" for pH indication is the actual pH of the solution. The clinical experience relies on the judgment of the IVF facility staff over many years regarding the successful use of the indicator. There's no panel of experts adjudicating a "test set" in the way one would for diagnostic imaging.
4. Adjudication method for the test set:
- Not applicable. There is no "adjudication method" described for a test set in the traditional sense. Quality control (LAL assay) follows established laboratory protocols. Clinical effectiveness is based on the long-term, widespread acceptance and absence of reported issues in IVF settings.
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 an AI device, so an MRMC study comparing human readers with and without AI assistance is entirely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device, so there is no algorithm or standalone performance to evaluate. The device itself is a visual indicator that provides a direct, observable output.
7. The type of ground truth used:
- LAL Assay: The ground truth is objective quantitative measurement of endotoxin levels against defined thresholds (standards for bacterial endotoxins).
- Clinical Experience: The "ground truth" for effectiveness is established by the observed utility and absence of negative impact in real-world clinical use over many years, by practitioners in assisted reproduction facilities. This relies on real-world outcomes and expert consensus-in-practice over time regarding the indicator's performance.
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
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K991346 Page 1 of 2
FEB 2 4 2000
PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Scandinavian IVF Sciences ABMölndalsvägen 30SE-412 63 GothenbergSWEDEN |
|---|---|
| Contact Person: | Mr. Eiler AndersonVitrolife ABMölndalsvägen 30SE-412 63 GothenbergSWEDENTele: +46 31 721 80 00Fax: +46 31 721 80 99 |
| Date Prepared: | April 16, 1999 |
| Trade Name: | pH TM-100 |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements(21 C.F.R. § 884.6180) |
| Predicate Device: | Substantial equivalence established by comparison tocategory of Reproductive Media (21 C.F.R. §884.61800) as provided in the FDA's Notice of FinalRule. 63 Fed. Reg. 48428, 48430 (Sept. 10. 1998) |
Description of the Device:
pH™100 is a bicarbonate-buffered pH-indicator containing Phenol Red. It is used as a visual CO2/pH indicator in the culture dish or incubator. Readyto-use after equilibrium at +37 °C and 5% CO2. pH™-100 includes Penicillin-G as a preservative.
Intended Use:
pH™-100 is intended to be used as a visual indicator for CO»/pHcontrol in the culture dish or incubator. It is not intended for the preparation or culture of cells.
Technological Characteristics:
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The technological characteristics of pH™-100 are identical to other legally marketed media classified under 21 C.F.R. § 884.6180, Reproductive Media and Supplements.
Testing Performed:
Prior to and as a condition for market release, each lot of pHTM-100 is assayed by Limulus Amebocyte Lysate (LAL) Assay. This assay is intended to assure that the media does not contain unacceptable levels of toxins. Information on the assay is provided in the labeling of the products and on a LOT-specific Certificate of Analysis provided with each delivery.
The Mouse Embryo Assay is not performed on pH™-100 because the composition of the product is neither intended for nor compatible with embryo development.
pH™-100 has been used for CO2/pH control during culture for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use.
50054096.2
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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 is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2000
Scandinavian IVF Sciences AB c/o Mr. Gary L. Yingling McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108 Re: K991346
pH™ -100, Assisted Reproduction Media Dated: November 30, 1999 Received: November 30, 1999 Requiatory Class: Il 21 CFR $884.6180/Procode: 85 MQL
Dear Mr. Yingling:
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. 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 (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 QS 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) 594-4591. 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,
Daniel G. Schultz, M.D.
Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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VIII. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
pH™ -100 Assisted Reproduction Media
Indications For Use:
For visual CO2/pH control. Not for culture.
David C. Segrom
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 C.F.R. § 801.109)
OR
Over-the Counter Use_
§ 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.