(22 days)
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Not Found
No
The device description and performance studies focus on the transport medium's ability to maintain microbial viability, with no mention of AI or ML technologies.
No.
The device is described as a collection and transport system intended for maintaining the viability of clinical specimens for laboratory analysis, not for treating any medical condition or disease.
No
Explanation: The device is intended for maintaining the viability of clinical specimens during transportation to the laboratory for subculturing and growth characteristics, not for making a diagnosis itself.
No
The device description clearly describes a physical system ("selfcontained, sterile and intended for maintaining the viability of clinical specimens during transportation") and the performance studies involve physical samples and culture media, indicating it is a hardware device.
Based on the provided information, the Starswab Culture Collection and Transport System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: While the "Intended Use / Indications for Use" section is marked as "Not Found," the "Device Description" clearly states its purpose: "intended for maintaining the viability of clinical specimens during transportation to the laboratory." This indicates it's used in the process of preparing and transporting samples for diagnostic testing performed in vitro (outside the body) in a laboratory setting.
- Function: The device's function is to preserve the integrity of clinical specimens (which contain biological material from a patient) so that they can be analyzed in a laboratory to aid in diagnosis. This is a core function of IVD devices.
- Performance Study: The "Summary of Performance Studies" describes testing the device's ability to recover microorganisms from inoculated samples after storage. This type of performance evaluation is typical for IVD devices that handle biological specimens for diagnostic purposes.
- Predicate Device: The mention of "Predicate Device(s)" and listing "Amies CultureSwab™ Transport Systems" further supports its classification as an IVD. Predicate devices are used in the regulatory process for IVDs to demonstrate substantial equivalence to a legally marketed device.
The fact that it doesn't involve image processing, AI, or specific anatomical sites doesn't preclude it from being an IVD. IVDs encompass a wide range of devices used in laboratory testing, including those for specimen collection and transport.
N/A
Intended Use / Indications for Use
The Starswab Culture Collection and Transport System is selfcontained, sterile and intended for maintaining the viability of clinical specimens during transportation to the laboratory.
Product codes
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Device Description
The Starswab Culture Collection and Transport System is selfcontained, sterile and intended for maintaining the viability of clinical specimens during transportation to the laboratory. The medium contains sodium thioglycollate as a reducing agent and the moisture and media depth provide an ideal environment for the survival of both aerobic and anaerobic microorganisms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Known inocula of ATCC type cultures and clinically significant microorganisms were inoculated in the Starswab and Difco transport media and stored at room temperature for 24 and 48 hours prior to subculturing onto an appropriate culture media then checked for growth characteristics. No significant differences in recovery were detected between samples obtained from Starswab vs. Difco transport medium and the results were judged to be equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SUMMARY OF SAFETY AND EFFECTIVENESS
CONTACT NAME AND ADDRESS 1.
APR - 3 1996
MEHDI KARAMCHI 50 STEINWAY BLVD. ETOBICOKE, ONTARIO, CANADA мэм буз
TELEPHONE: (416) 674-7474
2 . DEVICE NAME
| Classification Name: | Transport System, Aerobic/Anaerobic |
|---|---|
| Common Name: | Sterile Microbiological Specimen |
| Collection and Transport System | |
| Proprietary Name: | Starswab Culture Collection and |
| Transport System |
3 . PREDICATE DEVICE
Amies CultureSwab™ Transport Systems with and without charcoal are marketed by Difco Laboratories, P.O. Box 331058, Detroit MI, 48232-7058, U.S.A.
DEVICE DESCRIPTION 4 .
The Starswab Culture Collection and Transport System is selfcontained, sterile and intended for maintaining the viability of clinical specimens during transportation to the laboratory. The medium contains sodium thioglycollate as a reducing agent and the moisture and media depth provide an ideal environment for the survival of both aerobic and anaerobic microorganisms.
5. SUBSTANTIAL EQUIVALENCE DETERMINATION
Starswab Culture Collection and Transport System is The similar in design, manufacturing and intended usage to Amies Amies Medium without charcoal currently Medium and manufactured and marketed by Difco Laboratories. This substantial equivalence claim is supported by manufacturing, medium formulation, packaging and clinical evaluations. Known inocula of ATCC type cultures and clinically significant microorganisms were inoculated in the Starswab and Difco transport media and stored at room temperature for 24 and 48 hours prior to subculturing onto an appropriate culture media then checked for growth characteristics. No significant differences in recovery were detected between samples obtained from Starswab vs. Difco transport medium and the results were judged to be equivalent.