(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 cell lines as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
The provided text describes a 510(k) submission for "FreshCells™" cell cultures, which are intended for use in the isolation and identification of specific viruses. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel design requiring extensive new performance data against specific acceptance criteria. Therefore, the information typically found in acceptance criteria tables and detailed study descriptions for new devices is not present.
Based on the provided text, here's an analysis of the information requested:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the format typically used for a new medical device study. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device based on technological characteristics and intended use.
The "performance" is implied by the similarity to the predicate device and the non-clinical tests performed.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Implied) |
|---|---|---|
| Source of Cell Line | ATCC or another approved supplier (same as predicate) | Same as predicate device |
| Confluence | Provided as nearly confluent monolayers (same as predicate) | Same as predicate device |
| Intended Use | Isolation & Confirmation of specific viruses (same as predicate) | Same as predicate device |
| Appearance | Acceptable appearance | Characterized (implicitly acceptable) |
| Growth | Acceptable growth characteristics | Characterized (implicitly acceptable) |
| Sterility | Sterile | Characterized (implicitly sterile) |
| Isoenzyme Analysis | Consistent with known cell line | Characterized (implicitly consistent) |
| Virus Susceptibility | Susceptible to listed viruses | Characterized (implicitly susceptible) |
2. Sample size used for the test set and the data provenance
The document does not describe a formal "test set" in the context of a clinical performance study with a specific sample size. The non-clinical tests mentioned were for product characterization (appearance, growth, sterility, isoenzyme analysis, virus susceptibility). The document does not specify the number of samples or "cases" used for these characterization tests, nor does it detail the provenance of any data (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes product characterization tests and a comparison to a predicate device, not a performance study requiring ground truth established by experts.
4. Adjudication method for the test set
Not applicable, as no formal test set requiring adjudication is described.
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 a cell culture for virus isolation, not an AI-powered diagnostic tool, and therefore no MRMC studies are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
The concept of "ground truth" as typically applied to diagnostic performance studies (e.g., pathology, outcomes data) is not explicitly detailed. For the non-clinical tests mentioned:
- Appearance, growth characteristics, sterility: Likely determined by standard laboratory methods and observations, potentially against internal controls or established specifications.
- Isoenzyme analysis: Used to confirm the identity and purity of the cell lines, with the "ground truth" being the expected isoenzyme profile for that specific cell line.
- Virus susceptibility: Determined by challenging the cell lines with known viruses and observing viral replication, with the "ground truth" being the known susceptibility of that cell line to specific viruses.
8. The sample size for the training set
Not applicable. The device is a cell culture, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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915613
510 (k) Summary
- Diagnostic Hybrids, Inc. a.1. 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, MV1Lu, NCI H292, Vero and a.4. The Subject devise proon 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 Cella™) as nearly confluent monolayers ready for use upon receipt a short pre-incubation period. after
- 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, 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. |
| Mv1Lu/Mink Lung | HSV, CMV. |
| NCI-H292/Human, Pulmonary muco-epidermoid carcinoma. | Vaccinia virus, HSV, Adenovirus, BK polyomavirus, Reoviruses, Measles virus, RSV, some strains of Influenza type A, most Enteroviruses and Rhinoviruses, Parainfluenza and 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. |
- The non-clinical tests consist of those used to characterize the product b.l. 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
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
SEP 2 5 1997
Re: K973213 Trade Name: Fresh Cells™ LLC-MK, 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 Sutman
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.
Cen Poin
Division 973213 510(k) Number _
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.