<GENX> FERTILIZATION MEDIA-HTF by <GENX> INTL., INC.

HTF Media is used as a general purpose media. May be used in procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), invitro fertilization (IVF), intrauterine insemination (IUI).

It may also be used as a holding media at the time of retrieval of the gametes and for the holding of the oocytes in day 1 and 2, prior to transfer.

The indications for use of this media is based on the general procedures for preparation of semen for Intrauterine Insemination described by Paul S. Weatherbee, Ph.D. and Lawrence B. Werlin, M.D., Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of California, Invine Medical Center.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) submission for a medical device: " Fertilization Media - HTF". This is a regulatory document seeking marketing clearance for a fertilization media, not an AI medical device. Therefore, the questions related to AI device performance metrics, such as acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth types, are not applicable to this document.

The document focuses on demonstrating substantial equivalence of the " Fertilization Media - HTF" to legally marketed predicate devices.

Here's the relevant information that can be extracted:

Acceptance Criteria and Device Performance (based on Substantial Equivalence):

The acceptance criteria for a 510(k) submission like this are generally that the new device is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.

Acceptance Criterion	Reported Device Performance (Claim of Substantial Equivalence)
Same Intended Use	HTF Media is used as a general-purpose media for in vitro washing and incubation of sperm, and as a holding media for gametes/oocytes, similar to predicate devices.
Similar Technological Characteristics	The HTF Media uses the "same original formula" first described by Patrick Quinn (Fertility and Sterility 41:202, 1984; 44:493, 1985). This formula is also referenced by the predicate devices (Irvine Scientific products).
Safety and Effectiveness	Implied through the "same original formula" and "same intended use" as legally marketed predicate devices (Sperm Capacitation Media K962816, Irvine Sperm Washing Media K872102, Irvine Capacitation Media K861166/A). The FDA's clearance (JUL 19 1999 letter) confirms that the device is deemed substantially equivalent for the stated indications for use.

Irrelevant Information for this document (due to it being a fertilization media, not an AI device):

Sample size used for the test set and the data provenance: Not applicable. This is a chemical formulation, not an algorithm tested on a dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. The "ground truth" in this context would be the established effectiveness and safety of the predicate devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No image-based or diagnostic test set requiring adjudication.
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: Not applicable. There is no AI involved.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their historical marketing and scientific literature.
The sample size for the training set: Not applicable. No AI model requiring a training set.
How the ground truth for the training set was established: Not applicable. No AI model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Gen X International. The logo consists of the text "" on the top line and the text "international" on the bottom line. The text is in a simple, sans-serif font and is black on a white background.

K91173/5001

170 Fort Path Road, Madison, CT 06443 203-245-4994 FAX 800-966-6453

510 (K) Summary

1. Proprietary name: Fertilization Media - HTF
1. Submission Date: March 26, 1999
1. Submitted by: international, Inc. 170 Fort Path Road Madison, CT 06443

Establishment Registration No .: 9003605

Tel: 203-245-4901 Fax: 203-245-4994 E-mail:genxintl@aol.com

Contact Individual: Michael D. Cecchi President

1. Classification: Class II Assisted Reproductive Media Product: HTF Media Procode: 85 MQL CFR#: 884.6180
1. Indication for Use:

HTF Media is used as a general-purpose media. May be used in procedures such as in vitro washing and incubation of sperm prior to gamete intrafallopian transfer (GIFT), in-vitro fertilization (IVF), and intrauterine insemination (IUI).

It may also be used as a holding media at the time of retrieval of the gametes and for the holding of the oocytes in day 1 and 2, prior to transfer.

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Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of California, Irvine Medical Center.

1. Comparison / Substantially Equivalence:
  HTF Media is similar to a number of mediums currently available in the marketplace. This product is substantially equivalent to our Sperm Capacitation Media (K962816), the Irvine Sperm Washing Media (K872102), Irvine Capacitation Media (K861166/A) in the following ways:
1. They have the same intended use.
1. They are of the same original formula.

The formulation of this media is equivalent to the original formula of Patrick Quinn first described in Fertility and Sterility 41:202, 1984: 44:493 1985. (Attached appendix)

These articles are referenced in the Irvine Scientific product catalogue and literature.

HTF Media is prepared as follows:

A typical batch size would be 1L

Components	Concentration/1L
NaCl	5.931g
KCI	0.35g
MgSO4 7H2O	0.049g
KH2PO4	0.05g
Nalactate	3.7ml ( Note ml not g)
Glucose	0.5g
CaCl2	0.3g
Penicillin	0.06g
NaHCO3	2.1g
Na Pyruvate	0.037g
Phenol Red	0.0025g
MQ Water	960ml

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 19 1999

Mr. Michael D. Cecchi President international, inc. 170 Fort Path Road Madison, CT 06443

Re: K991173 Fertilization Media-HTF Dated: May 21, 1999 Received: May 27, 1999 Requiatory Class: II 21 CFR §884.6180/Procode: 85 MQL

Dear Mr. Cecchi:

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 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 requlation (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 regult 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 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.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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international, inc. 510(K) Submission

INDICATIONS FOR USE

510 (k) Number (if known)_ K991173

Device Names: Ferilization Media-HTF

Indication for Use:

It may also be used as a holding media at the time of retrieval of the gametes and for the holding of the oocytes in day 1 and 2, prior to transfer.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
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orOver-the Counter Use

(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Devi 510(k) Number

Regulation Number and Section

§ 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.