PH-100, MODEL 2104

K991346 · Vitrolife Sweden AB · MQL · Feb 24, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K991346
• Device Name: PH-100, MODEL 2104
• Applicant: Vitrolife Sweden AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Feb 24, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

pH™-100 is intended to be used as a visual indicator for CO2/pH control in the culture dish or incubator. It is not intended for the preparation or culture of cells.

Device Story

pH™-100 is a bicarbonate-buffered pH-indicator solution containing Phenol Red and Penicillin-G preservative. It functions as a visual indicator for CO2/pH levels within culture dishes or incubators. The device requires equilibration at 37°C and 5% CO2 before use. It is utilized by laboratory personnel in assisted reproduction facilities to monitor environmental conditions. The visual output allows clinicians to verify appropriate CO2/pH levels, ensuring the environment remains suitable for procedures, though the product itself is not used for cell culture or preparation.

Clinical Evidence

No clinical data. Safety and effectiveness established through long-term clinical experience in assisted reproduction facilities. Bench testing includes Limulus Amebocyte Lysate (LAL) assay for toxin levels per lot.

Technological Characteristics

Bicarbonate-buffered solution containing Phenol Red and Penicillin-G. Liquid form. Requires 37°C and 5% CO2 equilibration. No software or electronic components.

Indications for Use

Indicated for visual CO2/pH control in assisted reproduction laboratory settings. Not intended for cell culture or preparation.

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

• Reproductive Media (21 C.F.R. § 884.6180) as provided in the FDA's Notice of Final Rule, 63 Fed. Reg. 48428, 48430 (Sept. 10, 1998)

Submission Summary (Full Text)

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K991346 Page 1 of 2

# FEB 2 4 2000

# PREMARKET NOTIFICATION SUMMARY

| Submitted by: | Scandinavian IVF Sciences AB<br>Mölndalsvägen 30<br>SE-412 63 Gothenberg<br>SWEDEN |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Eiler Anderson<br>Vitrolife AB<br>Mölndalsvägen 30<br>SE-412 63 Gothenberg<br>SWEDEN<br>Tele: [phone]<br>Fax: [phone] |
| Date Prepared: | April 16, 1999 |
| Trade Name: | pH TM-100 |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements<br>(21 C.F.R. § 884.6180) |
| Predicate Device: | Substantial equivalence established by comparison to<br>category of Reproductive Media (21 C.F.R. §<br>884.61800) as provided in the FDA's Notice of Final<br>Rule. 63 Fed. Reg. 48428, 48430 (Sept. 10. 1998) |

#### Description of the Device:

pH™100 is a bicarbonate-buffered pH-indicator containing Phenol Red. It is used as a visual CO2/pH indicator in the culture dish or incubator. Readyto-use after equilibrium at +37 °C and 5% CO2. pH™-100 includes Penicillin-G as a preservative.

### Intended Use:

pH™-100 is intended to be used as a visual indicator for CO»/pHcontrol in the culture dish or incubator. It is not intended for the preparation or culture of cells.

## Technological Characteristics:

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The technological characteristics of pH™-100 are identical to other legally marketed media classified under 21 C.F.R. § 884.6180, Reproductive Media and Supplements.

#### Testing Performed:

Prior to and as a condition for market release, each lot of pHTM-100 is assayed by Limulus Amebocyte Lysate (LAL) Assay. This assay is intended to assure that the media does not contain unacceptable levels of toxins. Information on the assay is provided in the labeling of the products and on a LOT-specific Certificate of Analysis provided with each delivery.

The Mouse Embryo Assay is not performed on pH™-100 because the composition of the product is neither intended for nor compatible with embryo development.

pH™-100 has been used for CO2/pH control during culture for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use.

50054096.2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2000

Scandinavian IVF Sciences AB c/o Mr. Gary L. Yingling McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108 Re: K991346

pH™ -100, Assisted Reproduction Media Dated: November 30, 1999 Received: November 30, 1999 Requiatory Class: Il 21 CFR \$884.6180/Procode: 85 MQL

Dear Mr. Yingling:

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 diagnostic devices), please 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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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# VIII. INDICATIONS FOR USE STATEMENT

510(k) Number:

K991346

Device Name:

pH™ -100 Assisted Reproduction Media

Indications For Use:

For visual CO2/pH control. Not for culture.

David C. Segrom
(Division Sign-Off)

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

(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 C.F.R. § 801.109)

OR

Over-the Counter Use_