(29 days)
FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.
The subject device provides HEL, HFF, LLC-MK2, Mv1Lu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under S10(k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
The provided text is a 510(k) summary for a medical device (FreshCells™) and does not describe a study that uses acceptance criteria and reports device performance in the way typically expected for an AI or imaging device submission. Instead, it's about the substantial equivalence of cell cultures for virus isolation. Therefore, many of the requested categories are "Not Applicable" or cannot be extracted from the given information.
Here is an attempt to structure the information based on the request, highlighting where information is not available for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Technological Characteristics (Comparison to Predicate) | ||
| Source of Cell Line | ATCC or another approved supplier (Same as predicate device). | "Same as predicate device." - Implies FreshCells™ cell lines are sourced from ATCC or other approved suppliers, meeting this criterion. |
| Provision as nearly confluent monolayers | Cells are provided routinely as nearly confluent monolayers (Same as predicate device). FreshCells™ are provided "as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period." | "Same as predicate device." - Implies FreshCells™ meet this criterion. The description explicitly states they are provided "as nearly confluent monolayers ready for use upon receipt." |
| Intended Use | Isolation & Confirmation of specific viruses (Same as predicate device). FreshCells™ are "to be used as hosts for the isolation and identification of specific viruses." | "Same as predicate device." - Implies FreshCells™ meet this criterion. The listed viruses for each cell line further specifies the performance for isolation and identification, consistent with the intended use. (e.g., HEL/Human Embryonic Lung: Susceptible to Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV.) |
| Non-Clinical Test Results | ||
| Appearance | Implicitly, acceptable visual characteristics for cell cultures. | Non-clinical tests were conducted to characterize the product, including "appearance." The document implies that the appearance was acceptable, as the device received 510(k) clearance. (Specific quantitative performance not provided). |
| Growth Characteristics | Implicitly, acceptable growth rates and morphology for the specified cell lines. | Non-clinical tests included "growth characteristics." The document implies these were acceptable. (Specific quantitative performance not provided). The description states cells are "nearly confluent monolayers ready for use," indicating good growth. |
| Sterility | Implicitly, absence of contaminating microorganisms. | Non-clinical tests included "sterility." The document implies these were acceptable. (Specific quantitative performance not provided). |
| Isoenzyme Analysis | Consistent isoenzyme profiles for the respective cell lines. | Non-clinical tests included "isoenzyme analysis." The document implies these were acceptable, confirming cell line identity. (Specific quantitative performance not provided). |
| Virus Susceptibility | The specific cell lines must be susceptible to the listed viruses. (e.g., HEL/Human Embryonic Lung must be susceptible to Adenovirus, CMV, Echovirus, HSV, etc.) | Non-clinical tests included "virus susceptibility." The table in section a.5. lists the specific viruses each cell line is susceptible to, indicating that the device performs as expected in hosting these viruses. (e.g., HEL is explicitly stated to be susceptible to the listed viruses, demonstrating it meets this specific aspect of performance.) The 510(k) clearance confirms these characteristics were deemed acceptable for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The non-clinical tests involved "characterizing the product," which would include testing batches of the cell lines for the listed parameters. The specific number of cell batches or individual cell cultures tested is not provided.
- Data Provenance: Not explicitly stated, but based on the nature of cell culture characterization tests, the data would be generated internally by Diagnostic Hybrids, Inc. It's prospective in the sense that these tests were performed on the manufactured product to demonstrate its characteristics. Country of origin would be the USA (Diagnostic Hybrids, Inc., Athens, OH).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable in the context of this device. The "ground truth" for cell culture characterization and virus susceptibility is established through standard laboratory methodologies and accepted scientific benchmarks (e.g., ATCC standards for cell lines, established virology protocols).
- Qualifications of Experts: Not applicable. The work would be performed by qualified laboratory personnel following established protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not a study requiring expert adjudication of results. The results of the non-clinical tests (e.g., sterility, isoenzyme analysis, growth characteristics, virus susceptibility) are objective laboratory measurements against defined standards.
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
- MRMC Study: No. This device is a cell culture medium, not an AI or imaging device with human readers.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth is based on established scientific principles and laboratory standards for cell biology and virology.
- Cell Line Identity: Confirmed through methods like isoenzyme analysis against known ATCC (American Type Culture Collection) standards.
- Sterility: Absence of microbial growth in standard sterility tests.
- Growth Characteristics: Expected cell morphology and proliferation rates for the specific cell lines.
- Virus Susceptibility: Demonstrated ability of the cell line to support replication of specific viruses based on established virological assays.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set. The cell lines themselves are "trained" over passages based on established cell culture techniques, but this is not data-driven training in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. (See #8). The "ground truth" for the cell lines' characteristics is inherent in their established biological properties and validated through standard cell culture and molecular biology methods.
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SEP 25 397
510 (k) Summary
- a.1. Diagnostic Hybrids, Inc. 1 President Street Athens, OH 45701 (614) 593-1784 FAX: (614) 593-0980 Attn: J.L. Brown Date of Preparation: June 10, 1997
- Trade Name: FreshCells™ a.2. Cells, Animal and Human, Cultured. Classification Name:
- A predicate device is that of BioWhittaker, marketed as cell cultures, a.3. Appendix II, pp. A-11 to A-13 of this 510(k) Notification.
- The subject device provides HEL, HFF, LLC-MK2, MVILu, NCI H292, Vero/and a.4. WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under S10(k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
- Intended Use: Cell cultures to be used as hosts for the isolation and a.5. identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, Mv1Lu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples:
| CELL LINE/ORIGIN | SPECIFIC VIRUSES |
|---|---|
| HEL/Human Embryonic Lung | Adenovirus, CMV, Echovirus, HSV,Poliovirus, Rhinovirus, Vesicular stomatitis(Indiana Strain) virus and VZV. |
| HFF/Human Foreskin Fibroblasts | Adenovirus, CMV, Echovirus, HSV, Mumps,Poliovirus, Rhinovirus, VZV. |
| LLC-MK2, Original/Rhesus Monkey Kidney | Poliovirus type 1, Enterovirus, Rhinovirus,Myxovirus and Poxvirus groups. |
| Mv1Lu/Mink Lung | HSV, CMV. |
| NCI-H292/Human, Pulmonary muco-epidermoid carcinoma. | Vaccinia virus, HSV, Adenovirus, BKpolyomavirus, Reoviruses, Measles virus,RSV, some strains of Influenza type A, mostEnteroviruses and Rhinoviruses, Parainfluenzaand Mumps. |
| Vero/African Green Monkey | Adenovirus, Coxsackie B, HSV, Measles,Mumps, Poliovirus type 3, Rotavirus, Rubella |
| WI-38/Human Lung | Adenovirus, CMV, Echovirus, HSV.,Influenza, Mumps, Poliovirus, Rhinovirus,RSV, VZV. |
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a.6. A comparison of Technological Characteristics:
| Characteristics | Predicate Device | Subject Device |
|---|---|---|
| Source of Cell Line. | ATCC or another approved supplier. | Same as predicate device. |
| Provided as nearly con-fluent monolayers. | Cells are providedroutinely as nearlyconfluent monolayers. | Same as predicate device. |
| Intended Use. | Isolation & Confirmationof specific viruses. | Same as predicate device. |
- b.1. The non-clinical tests consist of those used to characterize the product such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility.
- b.2. Not applicable.
- b.3. Not applicable.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 5 1997
James L. Brown Vice President Product Development and · Regulatory Affairs Diagnostic Hybrids, Inc. One President Street Athens, Ohio 45701
Re: K973209 Trade Name: Fresh Cells™ Vero Regulatory Class: I Product Code: KIR Dated: August 22, 1997 Received: August 27, 1997
Dear Mr. Brown:
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 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). 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 (OS) 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.
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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 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 (301) 594-4588. 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 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510 (k) Number (if known) :
FreahCella™ in Multiwell Plates, Shell Vials and Tubes. Device Name:
FreshCells™ are indicated for use in the isolation of Indications for Use: various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.
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DIVISION Sign .. : of Childed Laboratory Devices
510(k) Number
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Use
§ 864.2280 Cultured animal and human cells.
(a)
Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.