(35 days)
Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination
The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Zinc and the other 10% Buffered Formalin. A stand is provided to keep the tubes in the upright position. Both tubes have a spoon contained within the tube which is attached to the cap. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifuge tubes and the cap/spoon assembly is securely closed. The collection tubes are shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative. The sample in PVA can be used for permanent staining techniques. The tube with the 10% Buffered Formalin also contains an integral filter which separates large debris from the specimen facilitating concentration of the specimen for wet mount examination. The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tubes containing samples.
The provided document describes the Pre-Market Notification for the STPTM System - PVA with Zinc, a fixative-preservative for intestinal parasite examination. The study described focuses on the functional performance of the device.
Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Satisfactory Functional Evaluation: | The STPTM System - PVA with Zinc, when used according to current instructions, results in a successful microscopic examination of human stool specimens for parasites. This includes: |
| 1. Smear Adherence | The smear must adhere well to the glass slides after permanent staining to allow for a thorough microscopic examination. |
| 2. Cell Fixation and Morphology (Permanent) | The added cells from the human buffy coat must be well-fixed and display typical morphology and color when the permanent stains are examined under a microscope. |
| 3. Cell Fixation and Morphology (Wet Mount) | The added cells from the human buffy coat must be well-fixed and display typical morphology and color when the wet mounts are examined under a microscope. (Note: The document implicitly states this for wet mounts by mentioning "microscopic evaluation of permanent slides and wet mounts" and then the criteria for "well-fixed and display typical morphology and color EITHER with permanent stains AND wet mounts" implying it applies to both.) |
Note: The document only provides qualitative acceptance criteria and a statement of successful performance against those criteria. It does not provide quantitative metrics such as sensitivity, specificity, accuracy, or a numerical "reported device performance" value.
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document mentions "Specimens were evaluated at independent clinical laboratories," but does not specify the number of specimens or the number of product units tested.
- Data Provenance: Not explicitly stated. The evaluation was done at "independent clinical laboratories," but the geographic location is not specified. It is likely prospective, as it describes a "performance evaluation" of the product.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document states "microscopic evaluation," implying trained laboratory personnel, but no specific professional titles or experience levels are provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. The evaluation involved subjective assessment of "satisfactory" or "unsatisfactory" functional performance, but the process for reaching this determination (e.g., single reader, consensus, majority vote) is not described.
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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
- MRMC Study: No. This study is a functional performance evaluation of a medical device (specimen collection and preservation system), not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a manual specimen collection and preservation system, not an algorithm. Its performance is entirely dependent on human-in-the-loop procedures for preparation and microscopy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for functional performance was established by observing ideal characteristics of microscopy slides. Specifically, it was determined by observing:
- Adherence of the smear to glass slides.
- Well-fixed cells with typical morphology and color, examined under a microscope.
- The "presence of parasites" (mentioned in the conclusion) is the ultimate diagnostic goal, but the study focused on the functional performance of the fixative to allow for that examination, using white blood cells as a proxy for parasites in the testing methodology.
- Type of Ground Truth: The ground truth for functional performance was established by observing ideal characteristics of microscopy slides. Specifically, it was determined by observing:
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The sample size for the training set
- Sample Size for Training Set: Not applicable. This pre-market notification describes a performance evaluation of a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set in this context.
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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 white and features 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.
nov. 8, 1996
Pre-Market Notification: STPTM System - PVA with Zinc
| 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 | STPTM System- PVA with Zinc |
| 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 products since 1971"
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Image /page/1/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The word "SAGE" is in large, bold, sans-serif font. Below it, "PRODUCTS INC" is written in a smaller, sans-serif font. A horizontal line underlines the entire phrase "PRODUCTS INC".
Pre-Market Notification: STPTM System - PVA with Zinc
1
(Sontinued
Description
The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Zinc and the other 10% Buffered Formalin. A stand is provided to keep the tubes in the upright position.
Both tubes have a spoon contained within the tube which is attached to the cap. The cap/spoon is removed and used to obtain a sample of the stool specimen. The sample is placed into the centrifyge tubes and the cap/spoon assembly is securely closed. The collection tubes are shaken causing the mixing balls to disrupt the specimen allowing complete coverage of the specimen with the fixative.
The sample in PVA can be used for permanent staining techniques. The tube with the 10% Buffered Formalin also contains an integral filter which separates large debris from the specimen facilitating concentration of the specimen for wet mount examination.
The product is contained in a bag labeled with the biohazard symbol which can be used for transport of the tubes containing samples.
Substantial Equivalence Comparison
The Sage STP™ System-PVA with Zinc is substantially equivalent in principle and clinical performance to Meridian's Para-Pak ZN-PVA/Formalin Kit 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 two tubes designed for the safe and convenient collection of a standardized 1. quantity of stool specimen. They both have a spoon-in-cap design.
- The tubes in both products contain general laboratory fixative solutions: One tube contains a 2. Polyviny! Alcohol with Zinc solution and the other tube contains 10% buffered Formalin.
- The solutions have widespread use and acceptance for the purpose of fixing and preserving 3. stool specimens. PVA allows permanent stain slides to be prepared from the specimen. Formalin is a fixative that is used primarily for preserving a specimen which will be concentrated and wet mounted on a slide.
"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 features a bold, sans-serif font. The word "SAGE" is on the top line, and the words "PRODUCTS INC" are on the bottom line. A horizontal line separates the two lines of text.
Pre-Market Notification: STPTM System - PVA with Zinc
mmary (Continued)
Performance Test Summary
l
| Test Name: | Performance Evaluation |
|---|---|
| Purpose: | To evaluate the functional performance of Sage's StoolTransport Processing System - Polyvinyl Alcohol with Zinc,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 STPTTM System - PVA with Zinc, when used according tocurrent instructions, results in a successful microscopicexamination of human 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 1971"
815 TEK DRIVE ■ P.O. BOX 9693 ■ CRYSTAL LAKE, IL 60014-9693 815-455-4700 ■ 800-323-2220 ■ Fax: 815-455-5599
page 22 of 23
§ 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.