(179 days)
AIM-V® Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.
AIM-V® Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications. AIM-V® is a serum-free medium developed in 1987 to support adoptive immunotherapy (lymphokine-activated killer (LAK) cells) clinical trials. 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).
This document is a 510(k) summary for the Invitrogen Corporation's AIM-V® Medium, a tissue culture media. It is important to note that this document is for a tissue culture media, not a diagnostic device or an AI/ML-based device that would typically have the requested acceptance criteria and study information.
Therefore, many of the requested sections (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth for AI models) are not applicable to this type of regulatory submission. The submission focuses on demonstrating substantial equivalence to a predicate device (Dulbecco's Modified Eagle Medium - DMEM) based on shared intended use, principles of operation, and technological characteristics.
However, I can extract the relevant information from the provided text regarding acceptance criteria and the justification for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of product (tissue culture media), the "acceptance criteria" are not measured in terms of diagnostic performance metrics like sensitivity or specificity. Instead, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device by showing comparable:
- Intended Use
- Principles of Operation
- Technological Characteristics
- Efficacy (generic cellular growth and maintenance)
- Safety (consistency in chemical content and formulation, biocompatibility with cells, and purity)
| Acceptance Criteria Category | Reported Device Performance (AIM-V® Medium vs. Predicate DMEM) |
|---|---|
| Intended Use | Met: Both AIM-V® Medium and DMEM are intended for human ex vivo tissue and cell culture processing applications. Both are chemically defined tissue culture media used to support the growth or maintenance of human tissue or cells in culture. |
| Principles of Operation | Met: Both devices operate on the principle of providing essential chemically defined nutrient materials in solution to support the survival, growth, development, and maintenance of human tissue or cells. AIM-V® is a serum-free medium formulated to support adoptive immunotherapy and has a growing list of applications for culturing various cell lines and investigating signal transduction pathways. |
| Technological Characteristics | Met: AIM-V® Medium is prepared from a master formulation including Dulbecco's Modified Eagle Medium, HEPES buffer, human serum albumin.USP, human transferrin, and cholesterol, NF. The formula has remained consistent. This composition provides the necessary components for cellular support, similar to how DMEM functions. |
| Efficacy | Met: Both products demonstrate "generic cellular growth and maintenance." The efficacy of AIM-V® 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." |
| Safety | Met: Both products demonstrate "consistency in chemical content and formulation, biocompatibility with cells, and purity." Both are manufactured in accordance with QSR (Quality System Regulation) requirements and are labeled as aseptically processed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a 510(k) submission for tissue culture media, not a diagnostic device with performance testing against a specific test set of data. The "study" for substantial equivalence is a comparison of product characteristics and established scientific literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant for demonstrating substantial equivalence of tissue culture media. Efficacy is supported by "scientific publications."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is described or relevant for this type of submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/ML-based device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For "efficacy" (supporting cell growth and maintenance), the ground truth is established through scientific literature and established biological principles of cell culture, rather than a specific "ground truth" derived from expert consensus, pathology, or outcomes data in the context of a diagnostic AI product. The submission states efficacy is "well established in scientific publications included in this submission."
8. The sample size for the training set
- Not Applicable. This is not an AI/ML-based device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML-based device.
Summary of the Study Proving Acceptance Criteria:
The "study" described in the 510(k) summary is a comparison of characteristics and scientific justification for substantial equivalence to a predicate device (Dulbecco's Modified Eagle Medium - DMEM), rather than a traditional clinical trial or performance study against a ground truth dataset commonly associated with AI/diagnostic devices.
The justification is based on:
- Direct comparison of Intended Use: Both AIM-V® and DMEM are for human ex vivo tissue and cell culture processing.
- Comparison of Principles of Operation and Technological Characteristics: Both provide essential nutrients for cell growth and maintenance. AIM-V®'s specific components (HEPES buffer, HSA, transferrin, cholesterol) are detailed, highlighting its formulation derived from DMEM.
- Reliance on Established Scientific Literature: The efficacy of AIM-V® in supporting cell survival, growth, and maintenance is declared "well established in scientific publications included in this submission." This suggests that previous research and published studies using AIM-V® serve as the evidence base for its performance.
- Compliance with Quality System Regulations (QSR): Both devices are manufactured under QSR and aseptically processed, ensuring safety and consistency.
In essence, the "study" is a regulatory assessment demonstrating that the new device (AIM-V®) is sufficiently similar to a previously approved device (DMEM) in its purpose, composition, and expected biological performance, supported by existing scientific knowledge.
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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 cellculture processing applications (per 21 CFR § 876.5885) |
| Product Code: | NDS |
| Submitter: | Invitrogen Corporation3175 Staley RoadGrand Island, New York 14072 |
| Telephone: | (716) 774-6713 |
| Facsimile: | (716) 774-6996 |
| Contact: | Keith Gittermann |
| Date Prepared: | June 26, 2002 |
| Predicate Device: |
| Trade Name | Manufacturer | 510(k) |
|---|---|---|
| Dulbecco's Modified Eagle Medium | Invitrogen Corporation(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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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.
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
§ 876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.
(a)
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.(b)
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.”