PBS, PBSW WITH CATIONS AND PHENOL RED

• K Number: K020490
• Device Name: PBS, PBSW WITH CATIONS AND PHENOL RED
• Manufacturer: CONCEPTION TECHNOLOGIES
• Date Cleared: 2002-03-28 ( 43 days)
• Product Code: MQL
• Regulation Number: 884.6180

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 Description

Not Found

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a buffered saline solution used for in vitro procedures, with no mention of AI, ML, image processing, or any computational analysis.

Therapeutic

No
The device is described as a medium used for in vitro procedures like oocyte recovery, gamete washing, micromanipulation, embryo transfer, and cryopreservation. These are laboratory procedures, not direct therapeutic interventions on a patient.

Diagnostic

No
Explanation: The intended use describes the device as a medium for in vitro procedures like oocyte recovery, gamete washing, micromanipulation, embryo transfer, and cryopreservation. These are procedural applications, not diagnostic ones. The device itself is a solution (Phosphate Buffered Saline) and does not interpret or analyze patient data for diagnosis.

SaMD (Software as a Medical Device)

No

The device description and other sections are "Not Found," but the intended use clearly describes a liquid medium (Phosphate Buffered Saline) used for in vitro procedures, which is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use explicitly states that the medium is used for "in vitro procedures" such as oocyte recovery, gamete washing, micromanipulation, and embryo transfer. These are all procedures performed outside of the living body, which is the definition of "in vitro".
• Nature of the Device: The device is a "medium" (Phosphate Buffered Saline With Cations and Phenol Red or Phosphate Buffered Saline). Media used for handling and manipulating biological materials like gametes and embryos in a laboratory setting are typically considered IVDs.

While the document lacks information about device description, image processing, AI, anatomical site, patient age, user, training/test sets, performance studies, metrics, and predicate/reference devices, the core intended use clearly places it within the realm of in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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).

Product codes

85 MQL

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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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Page 2

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

2

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	✓ (Per 21 CFR 801.109)
------------------	----------------------------------------------

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

REGULATORY SPECIALISTS