SPERM MAINTENANCE MEDIUM WITH GLYCEROL

K991337 · Irvine Scientific Sales Co., Inc. · MQL · Jul 8, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991337
• Device Name: SPERM MAINTENANCE MEDIUM WITH GLYCEROL
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Sperm Maintenance Medium with Glycerol is intended for use in assisted reproductive procedures that involve the manipulation of gametes. Specifically, Sperm Maintenance Medium with Glycerol is intended to be used as a cryopreservation medium for human sperm.

Device Story

Sperm Maintenance Medium with Glycerol is a synthetic, defined medium used for cryopreservation of human sperm; protects sperm cells from damage during freezing, storage, and thawing. Composition includes salts, physiologically compatible substances, glycerol (cryoprotectant), and human serum albumin (protein supplement). Used in clinical settings for sperm banking prior to assisted reproductive procedures. Product is analyzed via sperm cryopreservation and motility recovery assay, endotoxin testing, and sterility testing prior to market release. Healthcare providers use the medium to prepare sperm for long-term storage; ensures viability for future use in fertility treatments.

Clinical Evidence

No clinical trials were conducted. Evidence relies on historical information from professional literature, a history of satisfactory clinical use, and bench testing. Bench testing includes a sperm cryopreservation and motility recovery assay, endotoxin testing, and sterility testing performed as a condition of lot release to ensure functionality and absence of toxic components.

Technological Characteristics

Synthetic, defined medium containing salts, glycerol (cryoprotectant), and human serum albumin (protein supplement). Supplied in 100 mL volumes. Functionality is verified via sperm cryopreservation and motility recovery assay, endotoxin testing, and sterility testing.

Indications for Use

Indicated for the cryopreservation of human sperm in assisted reproductive procedures involving gamete manipulation.

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

JIII - 8 1999

K991337

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IRVINE SCIENTIFIC

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

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 16, 1999

#### Device Identification:

| Trade Name: | Sperm Maintenance Medium with Glycerol |
|----------------------|----------------------------------------|
| Common Name: | Sperm Cryopreservation Medium |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |

#### Predicate Device:

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

### Description:

Sperm Maintenance Medium with Glycerol is a synthetic, defined medium composed of a mixture of salts and other physiologically compatible substances, with glycerol as a cryoprotectant and human serum albumin as a protein supplement. It is supplied in fill volumes of 100 mL.

Sperm Maintenance Medium with Glycerol

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#### Intended Use:

Sperm Maintenance Medium with Glycerol is intended for the cryopreservation of human sperm prior to assisted reproductive procedures.

#### Technological Characteristics:

Sperm Maintenance Medium with Glycerol is used to protect human sperm during cryopreservation for future assisted reproductive procedures. Sperm is routinely saved, or "banked" for a variety of reasons. Products with ingredients such as glycerol protect the cells from damage during the initial freezing process, the storage and the thawing prior to use.

#### Performance Data:

Sperm Maintenance Medium with Glycerol will be analyzed by a sperm cryopreservation and motility recovery assay prior to release to market. This assay assures that the product is both functional for its intended use, the cryopreservation of human sperm, and that no toxic components are present in the formulation. Sperm Maintenance Medium 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 one of the standard media used for the cryopreservation of human sperm.

### Additional Information:

The sperm cryopreservation and motility recovery assay will be performed as a condition of release for this product, as well as endotoxin and sterility testing. Results of all release assays performed 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 the historical information contained in professional literature and a history of satisfactory use,

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shows that Sperm Maintenance Medium with Glycerol is suitable for its intended use, and meet 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

JUL - 8 1999

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

Re: K991337 Sperm Maintenance Medium with Glycerol Dated: April 16, 1999 Received: April 19, 1999 Requlatory Class: Il 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 (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 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 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 requlations.

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 Compilance 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 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 [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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Irvine Scientific

#### (page 1 of 1) INDICATIONS FOR USE STATEMENT

K991337 510(K) Number:_

Device Name: Sperm Maintenance Medium with Glycerol

Indications for Use:

Sperm Maintenance Medium with Glycerol is intended for use in assisted reproductive procedures that involve the manipulation of gametes. Specifically, Sperm Maintenance Medium with Glycerol is intended to be used as a cryopreservation medium for human sperm.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev

510(k) Number K941321

Prescription Use
(Per 21 CFR 801.109)