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Cary is indicated for removal of fluids from the upper airway. The device creates a negative pressure (vacuum) that draws fluids through disposable suction tube that is connected to a disposable collection canister. The fluids are captured in the collection canister for proper disposal. Cary is for use only on the order of a physician or other licensed practitioner (e.g. Emergency Medical Technician in field use).

[Cary] is a handheld, electrically powered medical suction device used to clear the upper airway during emergency care. It consists of a reusable drive unit and disposable collection container (pumpister) and tubing. The drive unit powers a piston pump, creating negative pressure (vacuum) in the disposable collection container. The vacuum draws fluids and other matter through a disposable tubing connected to the container, where they are collected for disposal. The size and shape of the device enable use by one hand, and a rechargeable lithium-ion battery allows field and transport use of the device.

The provided FDA 510(k) clearance letter and summary for the "Cary" device ([K251111](https://510k.innolitics.com/search/K251111)) primarily discuss non-clinical performance testing to demonstrate substantial equivalence to a predicate device. This document does not describe a clinical study (e.g., MRMC or standalone human-in-the-loop study) involving human readers or expert panels for establishing ground truth, as would typically be seen for AI/ML-driven diagnostic devices. Instead, the testing focuses on the physical and functional performance of the suction pump itself against recognized consensus standards.

Therefore, many of the requested points regarding clinical study design, expert panels, ground truth, and MRMC studies are not applicable based on the provided text.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests with implied or explicit acceptance criteria based on industry standards and comparison to the predicate device.

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Puritan Opti-Tranz Cary-Blair Collection and Transport System is intended for use in the collection and transport of clinical fecal and rectal swab specimens to preserve the viability of enteric bacteria during transport from the collection site to the testing laboratory for bacteriological examination and culture.

Puritan Opti-Tranz Cary-Blair Collection and Transport System is comprised of a sterile peel pouch containing a rayon tipped swab applicator for collecting specimens and a polypropylene tube containing 5 ml of Cary-Blair medium.

Cary-Blair medium is a nonnutritive balanced salt solution containing disodium phosphate to provide buffering capability, sodium chloride and calcium chloride to provide essential ions that help maintain osmotic balance. Agar is a solidifying agent and gives a semisolid texture to the medium. Sodium thioglycollate provides a reduced environment. It is recommended for maintaining the viability of enteric bacteria during the transport to the laboratory.

The document describes the Puritan Opti-Tranz Cary-Blair Collection and Transport System, a device for collecting and transporting clinical fecal and rectal swab specimens to preserve enteric bacteria viability for bacteriological examination and culture.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for specific tests (e.g., microbial recovery, pH stability). For microbial recovery, "known inoculum of clinically significant ATCC type culture microorganisms" were used, along with "three representative challenge organisms" for the fecal material impact test. For pH stability, "random samples from three different lots" were used.
• Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." All studies appear to be laboratory-based performance tests conducted by the manufacturer, Puritan Medical Products LLC, for regulatory submission purposes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable as the device is not an AI/diagnostic device that requires expert-derived ground truth from an image or clinical assessment. The ground truth for this device's performance relates to objective laboratory measurements (e.g., microbial viability, pH levels, cytotoxicity, sterility).

4. Adjudication Method for the Test Set

• This information is not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies among human readers in diagnostic studies.

5. 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

• This information is not applicable. This is a medical device for specimen collection and transport, not an AI diagnostic tool or software.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• This information is not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the performance claims of this device is established through:
  • Objective laboratory measurements: Microbial counts/viability for recovery testing.
  • Predicate device comparison: Performance is compared against a legally marketed predicate device (Copan Venturi Transystem Cary-Blair Medium product (132C)).
  • Standardized methods: Adherence to guidelines like CLSI M40-A2 for microbial recovery and ANSI/AAMI/ISO 11137:2006 for sterilization.
  • Physicochemical tests: pH measurements, cytotoxicity assays.

8. The Sample Size for the Training Set

• This information is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable for the same reason as point 8.

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Para-FixTM Cary Blair Medium provides a method for collecting and preserving fecal specimens for the culture of intestinal enteric bacteria. Because the medium is capable of maintaining the bacteria for 96 hours, immediate transportation and processing of the specimen is not necessary.

Para-Fix Cary Blair Medium is a non-nutritive, buffered, isotonic solution with a pH indicator added. The medium also contains agar and sodium thioglycolate to maintain a low oxygen tension for the preservation of anaerobic species. The phenol red indicator will turn yellow when the solution is acidic and the conditions are not optimal for recovery of the intended organisms. Each 30 mL vial contains 15 ml of solution and a built in sample collection spoon. The kit is available with or without a multilingual instruction sheet and re-sealable bag.

The provided text describes the acceptance criteria and a study demonstrating the performance of the MCC Para-Fix™ Cary Blair Medium device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The performance criterion as specified by Clinical and Laboratory Standards Institute (CLSI), M40-A2, is that the number of viable organisms remains within ±2 log10 of the original inoculum.

Study 2: Enteric Organism Recovery (with fecal matrix - Roll-Plate Method)
For Salmonella enterica, Vibrio parahaemolyticus, and Escherichia Coli, the log changes at 120 hours were within the ±2 log10 range at both 2-8°C and 20-25°C. For organisms that were "Too numerous to count" (N/A in the table), it indicates growth, which would still meet the non-reduction criterion given the initial inoculum.

Study 3: Enteric Organism Recovery (with fecal matrix - Swab Elution Method)
For Salmonella enterica, Vibrio parahaemolyticus, and Escherichia Coli, the log changes at 120 hours were within the ±2 log10 range at both 2-8°C and 20-25°C. For organisms that were "Too numerous to count" (N/A in the table), it indicates growth, which would still meet the non-reduction criterion given the initial inoculum.

Stability Testing:
Bacterial counts after 96 hours were within ±2 log10 for both newly manufactured vials and vials exceeding the 18-month expiration dating. |

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size (Test Set): The document reports results for 10 distinct enteric organisms tested in various conditions (temperature, presence/absence of fecal matrix, and over different time points). For each condition, the "Average CFU's" are reported, implying multiple experimental replicates were performed, but the exact number of replicates for each organism and condition is not explicitly stated.
  • Study 1 (without fecal matrix): 10 organisms, 2 temperatures (20 total conditions).
  • Study 2 (with fecal matrix, Roll-Plate): 3 organisms, 2 temperatures (6 total conditions), sampled at 0, 72, 96, 120 hours.
  • Study 3 (with fecal matrix, Swab Elution): 3 organisms, 2 temperatures (6 total conditions), sampled at 0, 72, 96, 120 hours.
• Data Provenance: The document does not specify the country of origin of the data. It appears to be a laboratory-based study conducted by Medical Chemical Corporation to support their 510(k) submission. It is a prospective study designed to assess the device's performance under specified conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable as the ground truth for this device (a transport medium) is based on quantitative microbiological assays (colony-forming unit - CFU counts), not expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth is established objectively through laboratory assays and statistical analysis of CFU counts, not through expert consensus or arbitration.

5. 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

This is not applicable. The device is a "Transport Culture Medium" and does not involve AI, human readers, or image interpretation. Its effectiveness is measured by its ability to preserve bacterial viability, not by improving human diagnostic performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medium for specimen transport, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for this study is quantitative microbiological data (CFU counts). This data directly measures the viability and growth/reduction of specific bacterial species under controlled experimental conditions, which is the direct performance metric for a transport medium. The criteria are based on CLSI standard M40-A2.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of a physical medical device like a transport medium. The studies described are performance validation studies.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for this device.

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Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Clinical Transport Media, (Cary-Blair Transport Media Option) is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.

Devices are composed of two plastic parts:

• The top plastic part holds 0.4 mL of clinical transport media and a plastic . shaft, Rayon® tipped swab. Configuration of the CULTURE-PAK™ Collection and Transport System, Clinical Transport Media, will also provide two plastic shaft, Rayon® tipped swabs; an aluminum shaft, Rayon® Mini-Tip swab for collection of either male urethral or nasopharyngeal specimens.
• The bottom plastic part protects the swab(s) or brush ( hereafter referred to . as: collection device ) and fits tightly into the top plastic part. The CULTURE-PAK™ Collection and Transport System is packaged sterile.
• Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for both devices.

The provided text describes a medical device, the CULTURE-PAK™ Collection and Transport System with Clinical Transport Media (Cary-Blair Transport Media Option), and claims substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the typical sense of a novel AI/software medical device.

Therefore, the information for some requested fields will be "Not Applicable" or "Not Provided" because the submission is for a collection and transport system, not an AI or software-based device that would typically undergo such a study.

Here's an attempt to answer based on the provided text, interpreting where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a transport media and not an AI or diagnostic device with accuracy metrics, explicit "acceptance criteria" in terms of performance thresholds (e.g., sensitivity, specificity) are not provided in the text. The "performance" described is in relation to its intended function of preserving and transporting microbiological specimens. The claim is substantial equivalence to predicate devices.

• Option: two plastic shaft, Rayon® tipped swabs; or an aluminum shaft, Rayon® Mini-Tip swab.
• Bottom plastic part protects swab(s) and fits tightly into the top.
• Plastic plug holds media, which can be broken by bending the top 45°. |
  | Methods for Use | Same as predicate devices (CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media and Modified Amies Transport Media). |
  | Safety | "All used materials should be treated as potentially infectious and biohazardous. Proper handling and disposal methods should be employed." (Standard safety consideration, no specific performance metric provided). |

Study Details:

The provided text outlines a 510(k) Notification for a medical device. This type of submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting new-performance studies with hard acceptance criteria in the way an AI diagnostic device would.

Therefore, many of the typical study-related questions are not directly applicable or the information is not provided in the scope of this regulatory document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. This document does not describe a clinical study in this manner. The "test set" would primarily refer to the device itself and its components, and comparisons to predicate devices.

3. 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)

• Not Applicable / Not Provided. Ground truth for typical diagnostic tests is not established in this type of device submission. The "ground truth" for a transport media would be its ability to maintain microbial viability, which is typically established through laboratory validation methods (not expert consensus on a test set).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided. This type of adjudication method is relevant for expert-driven diagnostic interpretations, which is not the nature of this device or its submission.

5. 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

• Not Applicable. This is a collection and transport system, not an AI or diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided in this document. For a transport media, the "ground truth" would be the demonstrated viability and recovery rate of various microorganisms after transport, as determined by standard microbiological culture techniques. This document focuses on substantial equivalence rather than presenting such detailed validation data.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Not Applicable. This device does not involve a "training set" or a ground truth established in this manner.

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