(145 days)
RHMK II is intended for use in the isolation and identification of virus from clinical specimens from patients having a viral infection.
RhMK II, (Expanded Primary Rhesus Monkey Kidney Cell Culture)
The provided text describes the acceptance criteria and a study for the BioWhittaker RhMK II cell culture device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar sensitivity to inoculated viruses | Similar sensitivity to inoculated viruses (polio 1, coxsackie B1, influenza A, parainfluenza 2, measles and mumps) |
| Performance as well as currently available Primary Rhesus Monkey Kidney Cell Culture for viral isolation in clinical specimens | Performs as well as the currently available Primary Rhesus Monkey Kidney Cell Culture for viral isolation in clinical specimens |
Note: The document implies the acceptance criteria through the conclusion of substantial equivalence. The specific quantitative acceptance thresholds are not explicitly stated, but the qualitative assessment of "similar sensitivity" and "performing as well as" serves as the criteria met by the device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of number of samples or cases. It only mentions "infectivity comparison testing" for "inoculated viruses."
Data Provenance: The document does not specify the country of origin of the data. The study appears to be a prospective comparison given it involves "infectivity comparison testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study involves comparing the performance of two cell cultures in detecting viruses, which typically relies on laboratory observation of cytopathic effects (CPE), hemadsorption, or fluorescent antibody staining. While experts in virology would interpret these results, the number and qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of a biological cell culture in isolating viruses, not on human interpretation of clinical data, with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone" performance (algorithm only) is not applicable here as the device is a cell culture, not an algorithm or AI system. The evaluation is of the biological performance of the cell culture itself.
7. The Type of Ground Truth Used
The ground truth used is based on the presence or absence of viral replication as evidenced by:
- Characteristic cytopathic effect (CPE)
- Hemadsorption
- Staining with specific virus fluorescent antibody markers
This is effectively a laboratory-established "ground truth" based on observable biological phenomena.
8. The Sample Size for the Training Set
The document does not specify a training set size. The study describes "infectivity comparison testing" rather than a machine learning model that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of an algorithm, the method for establishing ground truth for a training set is not applicable or described. The study is a direct comparison of the two cell culture types.
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KS71508
APPENDIX Ш page 1 of 1
SEP 1 7 1997 510(k) SUMMARY
BioWhittaker, Inc. 8830 Biggs Ford Road Walkersville, MD 21793 (301) 898-7025
Leif E. Olsen Contact: Vice President Regulatory Affairs
Deviče:
| Intended Use: | |||||||||||||||||||||||||||||||||||||||
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| --------------- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
Device Function:
Device Performance:
RhMK II, (Expanded Primary Rhesus Monkey Kidney Cell Culture)
BioWhittaker's RhMK II is intended to be used as an alternative to the use of Primary Rhesus Monkey Kidney Cell Culture. Use of these cells increases the yield possible from each kidney and reduces the number of animals required to satisfy cell requirements.
Cultures of live cells are the most convenient host system for the cultivation of viruses. After inoculation of the culture with a clinical specimen and incubation, the culture is observed for evidence of viral replication. Infection by virus can result in the development of characteristic cytopathic effect (CPE) and / or hemadsorption, or staining with specific virus fluorescent antibody markers.
Infectivity comparison testing between BioWhittaker's Primary Rhesus Monkey Kidney Cell Culture (a pre-1976 device) and RhMK II, an expanded Primary Rhesus Monkey Kidney Cell Culture demonstrates similar sensitivity to the inoculated viruses polio 1, coxsackie B1, influenza A, parainfluenza 2, measles and mumps.
Conclusion: BioWhittaker's RhMK II is safe and effective, performing as well as the currently available Primary Rhesus Monkey Kidney Cell Culture for viral isolation in clinical specimens.
Preparation Date:
April 22, 1997
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 7 1997
Leif E. Olsen Vice President Regulatory Affairs · Bio-Whittaker, Inc. 8830 Biggs Ford Road Walkersville, Maryland 21793-0127
Re: K971508 Trade Name: RhMK II Cell Culture Regulatory Class: I Product Code: KIR Dated: July 15, 1997 Received: July 16, 1997
Dear Mr. Olsen:
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 OS 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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Page 1 _of_1
510(k) Number (if known):____ K971508
Device Name: RHMK II Cell Culture
Indications For Use:
ﺎ" ﻫﺮ
RHMK II is intended for use in the isolation and identification of virus RHMK II is intended for use in the footation and teach of having a viral infection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | for AFP |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K971508 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 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.