(224 days)
Q-HTF is intended for the retrieval, culture, transport, storage and transfer of human gametes and embryos.
Q-HTF Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes and embryos. Specifically, Q-HTF is intended for use a a culture medium for the embryo after fertilization, when used with an incubator, and as a nedim to support in vitro fertilization. Q-HTF is intended to simulate the substances fourd in the human to female reproductive system.
Q-HTF is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). Q-HTF uses a sodium bicarbonate buffering system and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation.
Q-HTF is intended for use as a culture medium, with appropriate protein supplementation, for the support of fertilized embryos. Fertilization is also allowed to occur in Q-HTF when in vitro fertilization techniques are used. The fertilized gamete is then allowed to grow in the media and supplement, which are replenished as needed, until the desired state of development, usually up to three days post fertilization. Since Q-HTF utilizes a sodium bicarbonate buffer system, it is intended to be used in those procedures that require a carbon dioxide atmosphere, as is found in the incubators used by assisted reproductive laboratories. Therefore Q-HTF is primarily used as a medium to support embryo growth, development and culture in vitro.
The provided text describes the Q-HTF Medium, a synthetic culture medium for assisted reproductive technology procedures. Here's an analysis of the acceptance criteria and study as requested:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functionality for Intended Use | Support of embryonic growth | "Assures that the product is both functional for its intended use, the support of embryonic growth..." |
| Toxicity | Absence of toxic components | "...and that no toxic components are present in the formulation." |
| Sterility | Product is sterile | Performed as a "condition of release," results reported on lot-specific certificate. |
| Endotoxin Content | Acceptable endotoxin levels | Performed as a "condition of release," results reported on lot-specific certificate. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The text states, "Q-HTF medium is assayed by a mouse embryo assay prior to its release to market." However, it does not specify the number of mouse embryos or assays conducted for the performance testing described.
- Data Provenance:
- Country of Origin: Not specified for the mouse embryo assay.
- Retrospective or Prospective: Not explicitly stated, but "prior to its release to market" suggests a prospective, pre-market evaluation for each lot.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the text. The mouse embryo assay is described as ensuring functionality and absence of toxicity, but details on how the "truth" of successful embryonic growth or toxicity is established (e.g., specific criteria or expert interpretation) are absent.
4. Adjudication method for the test set:
This information is not provided in the text. There is no mention of multiple reviewers or adjudication processes for the mouse embryo assay results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
A multi-reader, multi-case (MRMC) comparative effectiveness study is not applicable to this device. The Q-HTF Medium is a culture medium, not an AI-assisted diagnostic tool. Therefore, there is no discussion of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a culture medium and does not involve an algorithm or AI.
7. The type of ground truth used:
- For the performance testing (mouse embryo assay), the "ground truth" for functionality appears to be successful embryonic growth in the medium, and for safety, the absence of toxic effects. These are determined by the outcome of the biological assay itself, rather than external expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.
- The document also refers to a "review of published historical information contained in the professional literature" which supports the intended use and meets criteria, implicitly using historical clinical outcomes and scientific literature as a form of ground truth for the broader effectiveness of Human Tubal Fluid (HTF) media.
8. The sample size for the training set:
There is no mention of a "training set" in the context of this device. As a biological culture medium, it would not typically involve machine learning or AI models that require training data. The product's formulation is "defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498)" based on mimicking fallopian tube fluid, which represents a foundational scientific basis rather than a data-driven training process.
9. How the ground truth for the training set was established:
As there is no training set for this device, this question is not applicable.
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: Submitted by: InVitroCare, Inc. 11408 Sorrento Valley Rd. Suite 202 San Diego, CA 92121 Telephone: (858) 452-1986 Facsimile: (858) 452-1828 E-mail: Invitroc@aol.com Contact: Robert E. Lovins, PhD Date Submitted: October 13,1999 Device Identification: Trade Name: Q-HTF Medium Common Name: Gamete and embryo culture, storage and transfer Medium, Human Tubal Fluid medium Classification Name: Reproductive Media (21CFR, 886.6180)
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 and 510(k) Reference Number K983586
Description:
Q-HTF is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). Q-HTF uses a sodium bicarbonate buffering system and is appropriate for those procedures requiring the use of a carbon dioxide atmosphere during incubation.
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Intended Use:
K 993484
page 2 of 2
Q-HTF is intended for the retrieval, culture, transport, storage and transfer of human gametes and embryos.
Design Characteristics:
Q-HTF is intended for use as a culture medium, with appropriate protein supplementation, for the support of fertilized embryos. Fertilization is also allowed to occur in Q-HTF when in vitro fertilization techniques are used. The fertilized gamete is then allowed to grow in the media and supplement, which are replenished as needed, until the desired state of development, usually up to three days post fertilization. Since Q-HTF utilizes a sodium bicarbonate buffer system, it is intended to be used in those procedures that require a carbon dioxide atmosphere, as is found in the incubators used by assisted reproductive laboratories. Therefore Q-HTF is primarily used as a medium to support embryo growth, development and culture in vitro.
Performance Data:
Q-HTF medium is assayed by a mouse embryo assay prior to its release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth and that no toxic components are present in the formulation. Human Tubal Fluid medias have been used in a variety of clinical settings, for the intended use for a number of years. In that time the product has become the standard media used for the retrieval, growth, storage and transport of human gametes and embryos.
Additional Information:
Mouse embryo testing will be performed as a condition of release for Q-HTF medium as well as endotoxin and sterility testing. Results of all release assays will be reported on a lot-specific certificate of analysis and will be indicated on the labeling.
Conclusion:
The conclusion from performance testing, as well as a review of published historical information contained in the professional literature shows that Q-HTF is suitable for its intended use and meets the criteria outlined in the Final Rule, 63 FR48428, Docket number 97N-0335.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle's head, represented by three curved lines that suggest the shape of the head and beak.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2000
Robert E. Lovins, Ph.D. President InVitroCare, Inc. 11408 Sorrento Valley Road Suite 202 San Diego, CA 92121
Re: K993484 Q-HTF (Assisted Reproductive Medium) Dated: March 9, 2000 Received: March 13, 2000 Requiatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Dr. Lovins:
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 Pracice 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 requlation may result in requlatory 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 yith 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 Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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InVitroCare, Inc.
October , 1999
INDICATIONS FOR USE STATEMENT (Page 1 of 1)
510(k) number: K0931484
Device Names: Q-HTF Medium
Indications for Use:
Q-HTF Medium is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes and embryos. Specifically, Q-HTF is intended for use a a culture medium for the embryo after fertilization, when used with an incubator, and as a nedim to support in vitro fertilization. Q-HTF is intended to simulate the substances fourd in the human to female reproductive system.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.
Prescription Use
(per 21 CFR 801.109)
§ 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.