(29 days)
FreshCells™ are indicated for use in the isolation of 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, JAC-MK2, Mv1Lu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, MCCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cells™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
This document describes a 510(k) submission for "FreshCells™", which are cultured animal and human cells intended for use as hosts for the isolation and identification of specific viruses. The submission is a "Substantially Equivalent" determination, meaning the device's performance does not need to be "proven" in the same way a novel device would. Instead, the submission demonstrates that the new FreshCells™ lines are as safe and effective as a previously marketed predicate device.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy against a gold standard) because the submission is for cell lines acting as a medium, not a diagnostic test with a direct output. Instead, the "acceptance criteria" are implied by the comparison to the predicate device and the non-clinical tests performed to characterize the cell lines' capabilities.
| Characteristic / "Acceptance Criterion" | Predicate Device Performance | Subject Device Performance (FreshCells™) |
|---|---|---|
| Source of Cell Line | ATCC or another approved supplier | Same as predicate device (ATCC or another approved supplier) |
| Provided as nearly confluent monolayers | Provided routinely as nearly confluent monolayers | Same as predicate device (provided as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period) |
| Intended Use (Isolation & Confirmation of specific viruses) | Isolation & Confirmation of specific viruses | Same as predicate device (Isolation & Confirmation of specific viruses) |
| Specific Viruses Susceptible to Isolation/Confirmation | Not explicitly detailed for predicate in this summary; implied by predicate's intended use | As listed in the table in the submission for each cell line (e.g., HEL/Human Embryonic Lung is susceptible to Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV.) |
| Appearance | Not explicitly detailed | Characterized (part of non-clinical tests) |
| Growth Characteristics | Not explicitly detailed | Characterized (part of non-clinical tests) |
| Sterility | Not explicitly detailed | Characterized (part of non-clinical tests) |
| Isoenzyme Analysis | Not explicitly detailed | Characterized (part of non-clinical tests) |
| Virus Susceptibility (qualitative confirmation for specific viruses) | Not explicitly detailed | Characterized for the specific viruses listed for each cell line (part of non-clinical tests) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a traditional "test set" with a sample size for evaluating a diagnostic algorithm's performance against a ground truth. Instead, the "testing" involved characterizing the cell lines themselves. The "non-clinical tests" mentioned (appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility) would have involved a sufficient number of cell cultures/batches to demonstrate their consistency and performance.
- Sample Size: Not specified as a numerical sample size of "cases" or "patients." These are in-vitro studies characterizing batches of cell lines.
- Data Provenance: The document implies these are internal characterization studies ("The non-clinical tests consist of those used to characterize the product..."). There is no mention of country of origin of data or whether it was retrospective or prospective in the context of clinical samples, as the study is on the cell lines themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. There is no "ground truth" derived from human experts in the context of clinical images or patient data because the device is a cell culture medium, not an interpretative diagnostic device. The "ground truth" for the cell lines themselves would be established by standard cell biology, virology, and quality control methods.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication method described or required for this type of in-vitro diagnostic component.
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 device is not an AI-powered diagnostic tool, nor is it subject to an MRMC study. It is a biological product (cell cultures) used as a growth medium for viruses.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm, but a physical biological product.
7. The Type of Ground Truth Used
The "ground truth" relevant to this device is established through various scientific and quality control methods:
- Cell Line Identity and Purity: Confirmed by isoenzyme analysis, morphological assessment (appearance), and sterility testing.
- Growth Characteristics: Verified through standard cell culture techniques to ensure they form "nearly confluent monolayers."
- Virus Susceptibility: Confirmed by inoculating the cell lines with known reference viral strains and observing the expected cytopathic effects or viral replication. This is the qualitative "performance" for their intended use.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of machine learning or AI for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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510 (k) Summary
SEP 2 5 .
- Diagnostic Hybrids, Inc. a.1. l 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.3. A predicate device is that of BioWhittaker, marketed as cell cultures, Appendix II, pp. A-11 to A-13 of this 510(k) Notification.
- The subject device provides HEL HFF, JAC-MK2, Mv1Lu, NCI H292, Vero and a.4. WI-38 cells (in addition to MRC-5, MCCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cells™) as nearly confluent monolayers ready for use upon receipt a short pre-incubation period. after
- Cell cultures to be used as hosts for the isolation and a.5. Intended Use: identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, MvlLu, 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. |
| MvlLu/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 Department of Health & Human Services USA. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
SEP 2 5 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
James L. Brown Vice President Product Development and · Regulatory Affairs Diagnostic Hybrids, Inc. One President Street Athens, Ohio 45701
Re: K973214 Trade Name: Fresh Cells™ HFF 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 (QS) 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 Gutman
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) :
FreshCella™ in Multiwell Plates, Shell Vials and Tubes. Device Name:
Indications for Use: FreshCella™ are indicated for use in the isolation of Viruses and Chlamydia various viruses and Chlamydia from clinical specimens. 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.
Dula Peal
(Division Sion-Division of Clinical Laboratory Dev 510(k) Numbe
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
5
Prescription Use (Per 21 CFR 801.109)
OR
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.