(31 days)
Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination
The product is comprised of a conical shaped centrifuge tube containing Sodium Acetate-Acetic Acid-Formalin (SAF) solution. A stand is provided to keep the tube in the upright position. A spoon is attached to the cap and contained within the tube. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifinge tube and the cap/spoon assembly is securely closed. The collection tube is shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The tube also contains an integral filter which separates large debris from the specimen and facilitates concentration of the specimen. The sample can be used for permanent staining, concentration, and/or wet mount procedures. The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tube containing the sample.
The provided text describes a pre-market notification for the STP™ System - SAF, a fixative-preservative for intestinal parasite examination. The goal is to demonstrate substantial equivalence to Meridian's Para-Pak® SAF Fixative.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The text doesn't explicitly state quantitative acceptance criteria in terms of specific percentages or thresholds (e.g., "sensitivity of X%"). Instead, the acceptance is based on a qualitative functional evaluation that aims to ensure the device performs comparably to established methods for preparing stool specimens for parasite examination.
| Acceptance Criteria (Implied) | Reported Device Performance (STPTM System - SAF) |
|---|---|
| Smear adheres well to glass slides after permanent staining. | Achieved ("For a satisfactory functional evaluation the smear must adhere well to the glass slides after permanent staining to allow for a thorough microscopic examination...") |
| Thorough microscopic examination is possible. | Achieved ("...to allow for a thorough microscopic examination...") |
| Added cells (from human buffy coat) are well-fixed. | Achieved ("...the added cells from the human buffy coat must be well-fixed...") |
| Added cells (from human buffy coat) display typical morphology and color when examined under permanent stains and wet mounts. | Achieved ("...and display typical morphology and color when the permanent stains and wet mounts are examined under a microscope.") |
| Overall functional performance is satisfactory. | Achieved ("Product function was evaluated as either satisfactory or unsatisfactory. For a satisfactory functional evaluation...") and explicitly stated in the conclusion: "The STPTM System - SAF, when used according to current instructions, results in a successful microscopic examination of human stool specimens for parasites." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "Specimens were evaluated at independent clinical laboratories," but does not provide the number of specimens or the number of units of the device tested.
- Data Provenance: Not explicitly stated. It mentions "independent clinical laboratories," but the country of origin is not specified. The study appears to be prospective in nature as it describes a specific testing procedure for evaluating the functional performance of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The evaluation involved "microscopic evaluation of permanent slides and wet mounts," implying trained laboratory personnel or medical professionals, but their specific qualifications (e.g., medical technologists, parasitologists) are not detailed.
4. Adjudication Method
- Adjudication Method: Not described. The evaluation concluded with a binary outcome ("satisfactory or unsatisfactory"), but the process by which this determination was made, especially if multiple evaluators were involved, is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focuses on the functional performance of the device itself rather than comparing human reader performance with and without AI assistance. The context is a device for specimen preparation, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study: Yes, in a sense, a standalone device performance study was done. The evaluation assessed the device's ability to fix and preserve specimens, leading to well-prepared slides suitable for microscopic examination, without human variability being the primary focus of the performance measure. The "algorithm" here is the physical and chemical mechanism of the fixative and filter, not a computational AI algorithm. The performance was assessed based on the quality of the prepared slides directly attributed to the device's function.
7. The Type of Ground Truth Used
- Ground Truth: The ground truth for evaluating the device's performance was based on artificially spiked samples and expert interpretation of the quality of the prepared slides. White blood cells (buffy coat from uncoagulated human blood) were used "in lieu of parasites" and added to human stool specimens. The "ground truth" for the device's function was that these added cells should be well-fixed, display typical morphology and color, and allow for thorough microscopic examination. This is an objective assessment of the device's preservation and preparation capabilities.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable/not provided. This device is a physical product (fixative-preservative system), not a machine learning model that requires a training set. The "training" in this context refers to standard laboratory procedures and established chemical principles.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth: Not applicable. As mentioned above, this is not an AI/ML device requiring a training set with established ground truth. The "ground truth" for its development would be the known efficacy of SAF solution and the physical design for specimen collection and preparation.
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Image /page/0/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and features a stylized, bold font. The word "SAGE" is in large letters, and "PRODUCTS INC" is in smaller letters below it. The logo has a simple, modern design.
NOV
- 7 1996
Pre-Market Notification: STP™ System - SAF
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| · CARRA II A | |||
| Submitter Name | Karen Pinto, Regulatory Affairs Manager |
|---|---|
| Company Name | Sage Products Inc. |
| Street Address | 815 Tek Drive, Crystal Lake, IL 60014 |
| Contact Person | Karen Pinto, Regulatory Affairs Manager |
| Telephone of Contact Person | 815-455-4700 ext. 1383 |
| Fax of Contact Person | 815-455-5599 |
| Date of Summary Preparation | September 30, 1996 |
| Device Name | |
| Trade or Proprietary Name | STP™ System- SAF |
| Common Name | Fixative-preservative for intestinal parasite examination |
| Classification Name | Microbiological specimen collection and transport device(866.2900) |
| Intended Use | Collection, transport, preservation and preparation of stoolspecimens containing intestinal parasites for microscopicexamination |
"Innovative health care product : since 1971"
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Image /page/1/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white, with the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC" in smaller letters. The logo has a simple, modern design.
Pre-Market Notification: STP™ System - SAF
Description
The product is comprised of a conical shaped centrifuge tube containing Sodium Acetate-Acetic Acid-Formalin (SAF) solution. A stand is provided to keep the tube in the upright position.
A spoon is attached to the cap and contained within the tube. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifinge tube and the cap/spoon assembly is securely closed. The collection tube is shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The tube also contains an integral filter which separates large debris from the specimen and facilitates concentration of the specimen. The sample can be used for permanent staining, concentration, and/or wet mount procedures.
The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tube containing the sample.
Substantial Equivalence Comparison
The Sage STP™ System - SAF is substantially equivalent in principle and clinical performance to Meridian's Para-Pak® SAF Fixative for the routine collection, transport, preservation and preparation of stool specimens for identification of intestinal parasites by microscopic examination.
Similarities between the Sage and Meridian Products are listed below:
- Both products have one tube designed for the safe and convenient collection of a 1. standardized quantity of stool specimen. They both have a spoon-in-cap design.
- The tubes in both products contain a Sodium Acetate-Acetic Acid -Formalin solution. 2.
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- The solutions have widespread use and acceptance for the purpose of fixing and preserving stool specimens. Both products allow for the standard methods of sample preparation for microscopic examination of stool specimens for parasites by permanent staining and/or concentration and wet mount.4
"Innovative health care products since 1971"
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Image /page/2/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white, with the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC" in smaller letters. A line underlines the phrase "PRODUCTS INC".
Pre-Market Notification: STP™ System - SAF
mmary (Contin) STO(k)
Performance Test Summary
l
| Test Name: | Performance Evaluation |
|---|---|
| Purpose: | To evaluate the functional performance of Sage's StoolTransport Processing System - Sodium Acetate-Acetic Acid-Formalin, using a standardized testing procedure. |
| Summary of Method: | Specimens were evaluated at independent clinical laboratories.The quality control test method described in the instruction sheetfor the product was used for assessing functional performance.This method is based on the procedure reported by Garcia andBruckner1 where white blood cells are used in lieu of parasites.White blood cells (buffy coat from uncoagulated human bloodwith high WBC count) are added to product tubes containinghuman stool specimens. Written instructions were then followedfor the preparation and microscopic evaluation of permanentslides and wet mounts. Product function was evaluated as eithersatisfactory or unsatisfactory. For a satisfactory functionalevaluation the smear must adhere well to the glass slides afterpermanent staining to allow for a thorough microscopicexamination, and the added cells from the human buffy coat mustbe well-fixed and display typical morphology and color when thepermanent stains and wet mounts are examined under amicroscope. |
| Conclusion: | The STPTM System - SAF, when used according to currentinstructions, results in a successful microscopic examination ofhuman stool specimens for parasites. |
Garcia, L.S. and Bruckner, D.A., Diagnostic Medical Parasitology, 2nd Edition, Washington, D.C., American Society for Microbiology, 1993
"Innovative health care products since 197 !"
§ 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.