TYRODE'S SOLUTION-ACIDIFIED

K991339 · Irvine Scientific Sales Co., Inc. · MQL · Dec 6, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991339
• Device Name: TYRODE'S SOLUTION-ACIDIFIED
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Dec 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Indications for Use

Tyrode's Solution, Acidified is intended for use in assisted reproductive procedures involving the manipulation of embryos. Specifically, Tyrode's Solution, Acidified, is intended for use in zona-drilling procedures.

Device Story

Tyrode's Solution, Acidified is a synthetic, defined chemical reagent with a pH of 2.1 to 2.5 used in assisted reproductive technology (ART) laboratories. During assisted hatching procedures, clinicians apply a small amount of the solution to the zona pellucida of an embryo using a pipette to chemically 'drill' or remove the noncellular covering. The embryo is observed under a microscope; once the desired effect is achieved, the embryo is washed with a neutral medium before implantation or further in vitro development. The device facilitates embryo implantation for patients with histories of failed ART or advanced maternal age. It is a manual, clinician-operated reagent.

Clinical Evidence

No clinical data provided. Performance is supported by historical use in professional literature and bench testing of release specifications (pH, endotoxin, sterility).

Technological Characteristics

Synthetic, defined chemical reagent; pH 2.1-2.5. Formulated based on standard Tyrode's Solution. Manual application via pipette. No electronic components, software, or energy sources.

Indications for Use

Indicated for use in assisted reproductive procedures involving embryo manipulation, specifically zona-drilling for assisted hatching. Intended for patients undergoing assisted reproductive technology, including those of advanced maternal age or with a history of failed procedures.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

• Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

Submission Summary (Full Text)

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Irvine Scientific

April 14, 1999 રે જેવ

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IRVINE SCIENTIFIC

# 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

DEC - 6 1999

Submitted by:

Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588

Telephone: [phone] Facsimile: [phone]

Contact: Roberta L. Johnson

Date Submitted: April 14, 1999

#### Device Identification:

| Trade Name: | Tyrode's Solution, Acidified |
|----------------------|-----------------------------------------------------------|
| Common Name: | zona-drilling reagent for assisted hatching<br>procedures |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |

#### Predicate Device:

Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

#### Description:

Tyrode's Solution, Acidified is a synthetic, defined reagent with a pH of 2.1 to 2.5. It is based on the formulation of Tyrode's Solution, a common cell culture medium.

Tyrode's Solution - Acidified

Page 25 of 30

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April 14, 1999

### Intended Use:

Tyrode's Solution, Acidified is intended to be used in zona drilling procedures, for assisted hatching.

## Technological Characteristics:

Tyrode's Solution, Acidified has been developed with a pH in the range optimal for use in the assisted hatching procedure referred to as zona drilling. In this procedure, the zona pellucida, a noncellular covering over the fertilized ovum is removed by either a chemical or mechanical "drill". This covering must be removed prior to the implantation of the blastocyst, and subsequent pregnancy. A small amount of Tyrode's Solution, Acidified is applied to the zona pellucida of the embryo with an assisted hatching pipette, the embryo observed under a microscope, and when the desired effect has been achieved, the embryo is washed with a neutral medium prior to implantation or further development in vitro. Zona drilling procedures are commonly performed on embryos from older patients, or those with a history of failed assisted reproductive procedures.

#### Performance Data:

The pH level of each newly manufactured lot of Tyrode's Solution, Acidified is verified prior to release to market. This parameter is the most important for the proper functioning of the product. Lots that do not meet the release specification are not released for sale. In addition, each lot is tested for endotoxin and sterility prior to release. Tyrode's Solution, Acidified has been used in a variety of clinical settings, for its intended use, for a number of years. In that time, the product has become the standard reagent used for chemically mediated zona drilling procedures.

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## Additional Information:

Endotoxin and sterility testing will be performed as a condition of release for this product. Results of all release assays performed will be reported on a lotspecific certificate of analysis, and will be indicated on the labeling.

### Conclusion:

The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that Tyrode's Solution, Acidified is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 1999

Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588

Re: K991339

Tyrode's Solution Acidified (for zona-drilling procedures) Dated: September 3, 1999 Received September 7, 1999 Requiatory Class: II 21 CFR \$884.6180/Procode: 85 MQL

Dear Ms. Johnson:

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 diagnosic devices), piease contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFF 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 [phone] or [phone], 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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# INDICATIONS FOR USE STATEMENT (page 1 of 1)

510(K) Number:_K99 1339

Device Name:_Tyrode's Solution, Acidified

Indications for Use:

Tyrode's Solution, Acidified is intended for use in assisted reproductive procedures involving the manipulation of embryos. Specifically, Tyrode's Solution, Acidified, is intended for use in zona-drilling procedures.

(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 CFR 801,109)

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