(25 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical components and chemical fixatives used for specimen collection and preparation for microscopic examination. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI/ML.
No.
This device is designed for the collection, transport, preservation, and preparation of stool specimens for microscopic examination to identify intestinal parasites, not for treating a disease or condition.
No
Explanation: The device is designed for the collection, transport, preservation, and preparation of stool specimens for microscopic examination, not for performing the microscopic examination itself or providing a diagnosis. It facilitates the diagnostic process but is not a diagnostic device in itself.
No
The device description clearly outlines physical components (centrifuge tubes, stand, spoons, mixing balls, integral filter, bag) and their functions in the collection, preservation, and preparation of stool specimens. There is no mention of software as a component of this device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination." This clearly indicates the device is used in vitro (outside the body) to prepare a biological specimen for diagnostic purposes (identifying intestinal parasites).
- Device Description: The description details how the device is used to process a biological sample (stool) with chemical reagents (PVA with Mercury and 10% Buffered Formalin) to preserve and prepare it for subsequent analysis (microscopic examination).
- Anatomical Site: The anatomical site is "Stool specimens," which is a biological sample collected from the body for diagnostic testing.
- Intended User / Care Setting: The intended users are "Independent clinical laboratories," which are settings where in vitro diagnostic testing is performed.
- Performance Studies: The description of performance studies focuses on evaluating the device's ability to prepare specimens for microscopic examination to identify parasites, which is a diagnostic activity. The evaluation criteria (satisfactory or unsatisfactory functional evaluation based on microscopic examination) further support its role in the diagnostic process.
The device is designed to prepare a biological sample for a diagnostic test (microscopic examination for parasites), which falls squarely under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Collection, transport, preservation and preparation of stool specimens containing intestinal parasites for microscopic examination
Product codes (comma separated list FDA assigned to the subject device)
866.2900
Device Description
The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Mercury 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test Name: Performance Evaluation
Purpose: To evaluate the functional performance of Sage's Stool Transport Processing System - Polyvinyl Alcohol with Mercury, using a standardized testing procedure.
Summary of Method: Specimens were evaluated at independent clinical laboratories. The quality control test method described in the instruction sheet for the product was used for assessing functional performance. This method is based on the procedure reported by Garcia and Bruckner where white blood cells are used in lieu of parasites. White blood cells (buffy coat from uncoagulated human blood with high WBC count) are added to product tubes containing human stool specimens. Written instructions were then followed for the preparation and microscopic evaluation of permanent slides and wet mounts. Product function was evaluated as either satisfactory or unsatisfactory. For a satisfactory functional evaluation the smear must adhere well to the glass slides after permanent staining to allow for a thorough microscopic examination, and the added cells from the human buffy coat must be well-fixed and display typical morphology and color when the permanent stains and wet mounts are examined under a microscope.
Conclusion: The STPTM System - PVA with Mercury, when used according to current instructions, results in a successful microscopic examination of human stool specimens for parasites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for SAGE Products. The word "SAGE" is written in large, bold, black letters. Below the word "SAGE" is the word "PRODUCTS" in smaller letters. The logo has a modern and industrial look.
Pre-Market Notification: STP™ System- PVA with Mercury NOV = 1 K
964027
| 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- PVA with Mercury |
| 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 stool |
| specimens containing intestinal parasites for microscopic | |
| examination |
"Innovative health care products since 1971
1
Image /page/1/Picture/0 description: The image shows the logo for SAGE Products Inc. The logo is in black and features a stylized font. The word "SAGE" is in large, bold letters, and below it, in smaller letters, is "PRODUCTS INC."
Pre-Market Notification: STP™ System- PVA with Mercury
Description
The product contains two conical shaped centrifuge tubes. One tube contains Polyvinyl Alcohol with Mercury 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 Mercury is substantially equivalent in principle and clinical performance to Meridian's Para-Pak® LV-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. Polyvinyl Alcohol with Mercury solution and the other tube contains 10% buffered Formalin.
-
- The solutions have widespread use and acceptance for the purpose of fixing and preserving 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. 1
"Innovative health care products since 1971"
2
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. There is a horizontal line above the phrase "PRODUCTS INC".
Pre-Market Notification: STP™ System- PVA with Mercury
Performance Test Summary
16 510(k) Summary (Contin
| Test Name: | Performance Evaluation |
|---|---|
| Purpose: | To evaluate the functional performance of Sage's Stool |
| Transport Processing System - Polyvinyl Alcohol with Mercury, | |
| using a standardized testing procedure. | |
| Summary of Method: | Specimens were evaluated at independent clinical laboratories. |
| The quality control test method described in the instruction sheet | |
| for the product was used for assessing functional performance. | |
| This method is based on the procedure reported by Garcia and | |
| Bruckner1 where white blood cells are used in lieu of parasites. | |
| White blood cells (buffy coat from uncoagulated human blood | |
| with high WBC count) are added to product tubes containing | |
| human stool specimens. Written instructions were then followed | |
| for the preparation and microscopic evaluation of permanent | |
| slides and wet mounts. Product function was evaluated as either | |
| satisfactory or unsatisfactory. For a satisfactory functional | |
| evaluation the smear must adhere well to the glass slides after | |
| permanent staining to allow for a thorough microscopic | |
| examination, and the added cells from the human buffy coat must | |
| be well-fixed and display typical morphology and color when the | |
| permanent stains and wet mounts are examined under a | |
| microscope. | |
| Conclusion: | The STPTM System - PVA with Mercury, when used according to |
| current instructions, results in a successful microscopic | |
| examination 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