(224 days)
Not Found
No
The document describes a culture medium for assisted reproductive technology and does not mention any AI or ML components or functionalities.
No
The device is a culture medium used in assisted reproductive technology procedures and does not directly treat a disease or condition in a patient.
No.
The device is a culture medium intended for the growth, storage, and transfer of human gametes and embryos in assisted reproductive technology procedures, not for diagnostic purposes.
No
The device description clearly states that Q-HTF is a "synthetic, defined culture medium" and describes its chemical composition and intended use as a physical substance for supporting embryo growth. This is a biological/chemical product, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that Q-HTF is for the "retrieval, culture, transport, storage and transfer of human gametes and embryos" and for use in "assisted reproductive technology procedures that involve the manipulation of gametes and embryos." While it's not directly diagnosing a disease, it is used in vitro (outside the body) to support and manipulate biological materials (gametes and embryos) for a medical purpose (assisted reproduction).
- Device Description: The description reinforces its use as a "synthetic, defined culture medium intended for use in assisted reproductive technology procedures." It's designed to mimic the environment of the fallopian tubes, where fertilization and early embryo development occur in vivo.
- Performance Studies: The performance studies mention a "mouse embryo assay" to assure functionality and lack of toxicity, which is a common type of testing for IVD devices used in reproductive medicine.
While the device doesn't directly diagnose a condition, its function is to support and facilitate biological processes in vitro that are essential for a medical procedure (assisted reproduction). This aligns with the general definition of an IVD, which includes reagents, instruments, and systems intended for use in the examination of specimens derived from the human body to provide information for medical purposes. In this case, the "specimens" are the gametes and embryos, and the "medical purpose" is achieving pregnancy through assisted reproductive technology.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
assisted reproductive technology procedures, incubators used by assisted reproductive laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for InVitroCare INCORPORATED. Below the logo is the address 11408 Sorrento Valley Road, Suite 202. The text is in black and the background is white.
Page 1 of 2
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.
1
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.
2
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)
3
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)