(84 days)
Para-Pak SPINCON is for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.
Para-Pak SPINCON involves passing a surfactant treated, preserved stool specimen through a preliminary screen by gravity flow. The surfactant helps to break down fecal aggregates, thus freeing parasites. The specimen is then forced by centrifugation through a series of two screens with successively smaller mesh. The series of screens, not present in other devices, trap stool debris, yet allow even the larger parasites to pass through. This second filtration step eliminates the need for organic solvent extraction of the stool specimen. The resulting pellet may be examined for the presence of parasites by standard wet mount procedures.
SPINCON Devices: 200/500 SPINCON Caps: 200/500 SPINCON Preliminary Funnel Screens: 200/500 Para-Pak Surfactant: 33ml
The provided text describes a medical device called Para-Pak SPINCON used for concentrating parasites from fecal specimens. The acceptance criteria and the study proving the device meets these criteria are outlined as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent performance and recovery to predicate device (Para-Pak CON-Trate) | Clinical studies demonstrate equivalent performance and recovery. |
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 or the data provenance (e.g., country of origin, retrospective or prospective). It simply refers to "Clinical studies."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It compares the device's performance to a predicate device, but not in the context of human reader improvement with or without AI assistance.
6. Standalone Performance Study:
A standalone performance study was conducted to demonstrate the device's ability to concentrate eggs, larvae, and protozoa from preserved fecal specimens. The "Performance" section explicitly states "Clinical studies demonstrate equivalent performance and recovery" in comparison to the predicate device. This implies the device was evaluated on its own merits for this purpose.
7. Type of Ground Truth Used:
The ground truth used appears to be the detection and recovery of parasites from fecal specimens, with the predicate device (Para-Pak CON-Trate) serving as the benchmark for "equivalent performance and recovery" in clinical studies. This suggests a benchmarking against an established and validated method.
8. Sample Size for the Training Set:
The document does not provide information on a training set sample size. This device is a concentration system, not an AI or machine learning algorithm that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established:
As this is a physical device for specimen concentration and not an AI algorithm, the concept of a "training set" and establishing "ground truth for the training set" as it relates to AI is not applicable. The device's performance is likely evaluated through laboratory and clinical studies demonstrating its ability to correctly concentrate parasites from known positive and negative samples, as well as samples from clinical cases.
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KA80077
APR - 2 1998
Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Para-Pak SPINCON
APPENDIX A - 510(k) Summary
A. Identification Information
- Submitter's Information: 1)
- a) Submitter's Name and Address:
Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, OH 45244
- b) Phone Number: 1-800-543-1980
- c) Contact Person: Allen D. Nickol, Ph.D. Director of Scientific and Regulatory Affairs
- d) Date Summary Prepared: December 24, 1997
- Name of Device: Para-Pak SPINCON. 2)
Classification Name: Device, Parasite Concentration 83LKS
- Predicate Equivalent Device: Para-Pak CON-Trate 3)
- Description of Device: Para-Pak SPINCON involves passing a surfactant treated, 4) preserved stool specimen through a preliminary screen by gravity flow. The surfactant helps to break down fecal aggregates, thus freeing parasites. The specimen is then forced by centrifugation through a series of two screens with successively smaller mesh. The series of screens, not present in other devices, trap stool debris, yet allow even the larger parasites to pass through. This second filtration step eliminates the need for organic solvent extraction of the stool specimen. The resulting pellet may be examined for the presence of parasites by standard wet mount procedures.
SPINCON Devices: 200/500 SPINCON Caps: 200/500 SPINCON Preliminary Funnel Screens: 200/500 Para-Pak Surfactant: 33ml
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Meridian Diagnostics, Inc. Cincinnati, OH 45244
ﻟ
- Intended Use: Para-Pak SPINCON is a unique, patent pending system for the ર) concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.
- Comparison with Predicate Device: The following comparison of the use, 6) technology, function and performance supports the Statement of Equivalence with the predicate device.
| Method | Para-Pak®SPINCON | Para-Pak®CON-Trate |
|---|---|---|
| Intended Use | System for concentrating and recovering helminth eggs, larvae, and protozoan cysts from feces | |
| Results | Final pellet consists of concentrated parasites | |
| Technology | Utilizes filtration and centrifugation | |
| Function | Treat stool with surfactant.Filter through primary funnel with mesh screen.Add saline.Centrifuge through series of smaller meshscreens.Remove supernatant.Resuspend in fixative.Prepare wet mount. | Treat stool with surfactant.Filter through primary Funnel with mesh screen.Add saline.Centrifuge.Remove supernatant.Resuspend in buffered formalin and ethylacetate.Centrifuge.Remove supernatant.Prepare wet mount. |
| Final Pellet | Useable for saline or iodine wet mount microscopic evaluation | |
| Performance | Clinical studies demonstrate equivalent performance and recovery |
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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 eagle with three heads, representing the department's commitment to health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Allen D. Nickol, Ph.D. Director of Scientific and Regulatory Affairs Meridian Diagnostics, Inc. 3471 River Hills Drive Cincinnati, Ohio 45244
APR - 2 1998
Re: K980077 Trade Name: Para-Pak® SPINCON Regulatory Class: I Product Code: LKS Dated: June 30, 1997 Received: March 25, 1998
Dear Dr. Nickol:
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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 at (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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Meridian Diagnostics, Inc. Cincinnati, OH 45244
510(k) Notification Para-Pak SPINCON
Indications for Use Statement: C.
510(k) Number (if known): __ NA K980077
Device Name: Para-Pak® SPINCON
Indications For Use: Para-Pak SPINCON is for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bla
(Division Sign-Off)
Division of Clinical Laboratory Devices K980077 510(k) Number_
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
S1-1
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.