AIM-V (R) MEDIUM, MODEL 087-0112

K022086 · Invitrogen Corporation · NDS · Dec 23, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022086
• Device Name: AIM-V (R) MEDIUM, MODEL 087-0112
• Applicant: Invitrogen Corporation
• Product Code: NDS · Gastroenterology, Urology
• Decision Date: Dec 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5885
• Device Class: Class 2

Indications for Use

AIM-V® Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.

Device Story

AIM-V® Medium is a serum-free, liquid tissue culture medium used for human ex vivo tissue and cell culture processing. It supports the growth and maintenance of human cells, including lymphoid cell lines, and is utilized in adoptive immunotherapy research and clinical applications. The medium provides a chemically defined environment containing Dulbecco's Modified Eagle Medium, HEPES buffer, human serum albumin (USP), human transferrin, and cholesterol (NF). It is used by laboratory personnel in clinical or research settings to facilitate cell survival and development. The healthcare provider uses the medium to process cells outside the body, which may then be used in therapeutic applications or clinical investigations.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by established scientific literature regarding the use of tissue culture media for ex vivo cell processing and the known efficacy of the formulation components in supporting human cell growth.

Technological Characteristics

Serum-free liquid medium. Composition: Dulbecco's Modified Eagle Medium, HEPES buffer, human serum albumin (USP), human transferrin, and cholesterol (NF). Aseptically processed. Standalone product.

Indications for Use

Indicated for human ex vivo tissue and cell culture processing applications. No specific patient population, age, or gender restrictions are defined as the product is used for laboratory processing of cells/tissues.

Regulatory Classification

Identification

Tissue culture media for human ex vivo tissue and cell culture processing applications consist of cell and tissue culture media and components that are composed of chemically defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the ex vivo development, survival, and maintenance of tissues and cells of human origin. The solutions are indicated for use in human ex vivo tissue and cell culture processing applications.

Special Controls

*Classification.* Class II (special controls): FDA guidance document, “Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Processing Applications; Final Guidance for Industry and FDA Reviewers.”

Predicate Devices

• Dulbecco's Modified Eagle Medium (K001447)

Submission Summary (Full Text)

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Koz2o86

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Image /page/0/Picture/2 description: The image shows the logo for Invitrogen life technologies. The logo consists of a stylized DNA helix symbol to the left of the word "Invitrogen" in a bold, sans-serif font. Below "Invitrogen" is the phrase "life technologies" in a smaller, lighter font. The logo is simple and modern, conveying a sense of innovation and scientific expertise.

DEC 2 3 2002

Invitrogen Corporation 3175 Staley Road Grand Island, New York 14072 P: 716 774 6700

## 510(k) Summary Invitrogen Corporation AIM-V® Medium

| Device Name: | AIM-V® Medium |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | AIM-V |
| Classification Name: | Tissue culture media for human ex vivo tissue and cell<br>culture processing applications (per 21 CFR § 876.5885) |
| Product Code: | NDS |
| Submitter: | Invitrogen Corporation<br>3175 Staley Road<br>Grand Island, New York 14072 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | Keith Gittermann |
| Date Prepared: | June 26, 2002 |
| Predicate Device: | |

| Trade Name | Manufacturer | 510(k) |
|----------------------------------|-------------------------------------------------------------|---------|
| Dulbecco's Modified Eagle Medium | Invitrogen Corporation<br>(formerly Life Technologies Inc.) | K001447 |

## Intended Use

AIM-V® Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.

#### Substantial Equivalence

Dulbecco's Modified Eagle Medium (DMEM) is the predicate device for tissue culture media intended for human ex vivo tissue and cell culture processing applications. It is composed of chemically defined nutrient materials in solution (with or without supplements) that are essential for the survival and development of tissue or cells of human or other animal origin. These nutrients are provided in liquid form for use in supporting the growth or maintenance of human tissue and cells.

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K022086

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Page 2 510(k) Summary - Invitrogen Corporation AIM-V® Medium

#### A. Intended Uses

AIM-V® Medium and DMEM tissue culture products are intended for human ex vivo tissue and cell culture processing applications. Both devices are chemically defined tissue culture media used to support the growth or maintenance of human tissue or cells in culture.

#### B. Principles of Operation and Technological Characteristics

AIM-V® is a serum-free medium developed in 1987 to support adoptive immunotherapy (lymphokine-activated killer (LAK) cells) clinical trials being conducted by Dr Steven Rosenberg (National Cancer Institute) and collaborating investigators. Many of the applications of AIM-V® are at the clinical investigation stage, although some procedures have been approved by the appropriate regulatory agency. In addition, the medium has been found to be useful in a growing list of applications, including culturing functionally differentiated lymphoid cell lines, investigating signal transduction pathways, and performing applications requiring component definition. The general use of tissue culture media products for human ex vivo tissue and cell culture processing applications has been extensively described in peer-reviewed literature.

The formula for AIM-V® has remained the same since it was first manufactured with only slight quantity variations. AIM-V® Medium is prepared from a master formulation of Dulbecco's Modified Eagle Medium, HEPES buffer, human serum albumin.USP, human transferrin, and cholesterol, NF(which help promote growth of the cells and tissue).

#### C. Conclusion

AIM-V® and Dulbecco's Modified Eagle Medium are used for human ex vivo tissue and cell culture processing applications and have the same principles of operation, technological characteristics, efficacy (generic cellular growth and maintenance) and safety (consistency in chemical content and formulation, biocompatibility with cells, and purity). Their efficacy in supporting the survival, growth, development, and maintenance of human cells or tissue culture systems has been well established in scientific publications included in this submission. Both products (AIM-V® and DMEM) are manufacturer in accordance with QSR requirements and are labeled as aseptically processed. Thus, AIM-V® Medium is substantially equivalent to the legally marketed device intended for the human ex vivo tissue and cell culture processing applications.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines curving upwards and to the right, resembling a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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Public Health Service

DEC 23 2002

Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850

Manager, Regulatory Affairs Invitrogen™ Corporation 3175 Staley Road GRAND ISLAND NÝ 14072 Re: K022086

Trade/Device Name: AIM-V® Medium Regulation Number: 21 CFR §876.5885 Regulation Name: Tissue culture media for human ex tissue and cell culture processing . applications Regulatory Class: II

Product Code: 78 NDS Dated: October 14, 2002 Received: October 16, 2002

Dear Ms. Tanzella:

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 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) 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 (OS) 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 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), please contact the Office of Compliance 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 by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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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510(k) Number (if known): Ko22086

Device Name: AIM=V® Medium

## Indications for Use:

AIM-V® is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHRE PAGE IF NEEDED)

Concurrence of CDRH, Office of Evaluation (ODE)

Daniel A. Segrove

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

Prescription Use
(Per 21 CFR 801.109)

OR

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