PBS, PBSW WITH CATIONS AND PHENOL RED

K020490 · Conception Technologies · MQL · Mar 28, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K020490
• Device Name: PBS, PBSW WITH CATIONS AND PHENOL RED
• Applicant: Conception Technologies
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Mar 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

Phosphate Buffered Saline With Cations and Phenol Red (PBSW) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s). Phosphate Buffered Saline (PBS) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s).

Device Story

PBS and PBSW are liquid media used in clinical embryology laboratories. They serve as buffers for handling gametes and embryos during in vitro procedures, including oocyte recovery, washing, micromanipulation, and embryo transfer. They also function as a base for cryopreservation when supplemented with cryoprotective agents. The media are used by embryologists or trained laboratory personnel in a clinical setting. The output is a stable, physiological environment for reproductive cells, facilitating laboratory procedures and supporting patient fertility treatments.

Technological Characteristics

Phosphate buffered saline solutions; PBSW includes cations and phenol red. Used as reproductive media for in vitro handling of gametes and embryos. Class II device.

Indications for Use

Indicated for in vitro procedures including oocyte recovery, gamete washing, micromanipulation, embryo transfer, and cryopreservation of gametes and embryos (with added cryopreservative agents).

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2002

Conception Technologies, L.P. % Ms. Grace Holland Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606

Re: K020490

Trade/Device Name: PBS (Phosphate Buffered Saline), and PBSW (Phosphate Buffered Saline with Cations and Phenol Red) Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: January 31, 2002 Received: February 13, 2002

Dear Ms. Holland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associoin 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 nouticate 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), please If you desire specific acrising at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Other or Compilance w ( notification" (21 CFR Part 807.97). Other general information on by relevented to promative the Act may be obtained from the Division of Small Manufacturers, your responsibilities and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:Phosphate Buffered Saline With Cations and Phenol Red

Indications For Use:

Phosphate Buffered Saline With Cations and Phenol Red (PBSW) is a medium that is used for in vitro procedures such as oocyte a modiam that to washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Nancy C. Brogdon |
|---------------------------------------------------------------|------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K020490 |

| Prescription Use | <div>✓</div> <div>(Per 21 CFR 801.109)</div> |
|------------------|----------------------------------------------|
|------------------|----------------------------------------------|

OR

| Over-The-Counter Use | |
|----------------------|--------------------------|
| | (Optional Format 1-2-96) |

| REGULATORY SPECIALISTS | Page 11 |
|------------------------|---------|
|------------------------|---------|

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Premarket Notification - Conception Technologies, L.P. - PBS

Page_

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:Phosphate Buffered Saline Solution

Indications For Use:

Phosphate Buffered Saline (PBS) is a medium that is used for in vitro procedures such as oocyte recovery, gamete washing, micromanipulation, or embryo transfer. It may also be used for cryopreservation of gametes and embryos after the addition of appropriate cryopreservative agent(s).

KD20490

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Nancy C Brogdon |
|---------------------------------------------------------------|-----------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K020490 |

| Prescription Use (Per 21 CFR 801.109) | <div>✓</div> | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---------------------------------------|--------------|----|-----------------------------------------------|
|---------------------------------------|--------------|----|-----------------------------------------------|

REGULATORY SPECIALISTS