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Baxter Sterile Water for Device Care and Sterile Saline for Device Care are indicated for irrigation and flushing of medical devices. Baxter Sterile Water for Device Care and Sterile Saline for Device Care are not indicated for intravascular injection.

Sterile Water for Device Care and Sterile Saline for Device Care in 250 mL plastic containers for single use.

The provided document, K051370, is a 510(k) premarket notification for "Sterile Water for Device Care" and "Sterile Saline for Device Care." This is a regulatory submission for medical devices, specifically for irrigation and flushing solutions. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/software performance metrics (like accuracy, sensitivity, specificity) is not applicable here.

Instead, the "acceptance criteria" for such a device are related to demonstrating substantial equivalence to a legally marketed predicate device, focusing on material composition, manufacturing processes, sterility, and intended use. The "study" that proves the device meets these criteria is typically a demonstration of equivalence through non-clinical tests (e.g., biocompatibility testing, stability testing, sterility testing, chemical characterization), rather than a clinical trial or a performance study with human readers or AI algorithms.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is not a performance study for an AI or diagnostic device, a direct table of statistical acceptance criteria and reported device performance (e.g., sensitivity, specificity) is not relevant. Instead, the "acceptance criteria" revolve around demonstrating equivalence to predicate devices in terms of:

2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is a sterile solution, not an AI or diagnostic device that uses a "test set" of data for performance evaluation in the traditional sense.

3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth in the context of AI or diagnostic imaging is irrelevant for this type of device.

4. Adjudication Method for the Test Set
Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or a device involving human interpretation, so MRMC studies are irrelevant.

6. Standalone (Algorithm only without human-in-the-loop performance) Study
Not applicable. This is not an algorithm or AI device.

7. Type of Ground Truth Used
Not applicable.

8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established
Not applicable.

Study Proving Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification process itself, which involves providing documentation demonstrating substantial equivalence to predicate devices.

The document states:

• "The subjects of this submission are a name change for a previously cleared medical device and the addition of Sterile Water for Device Care to the product line."
• "The proposed Sterile Saline for Device Care is the existing Baxter Sterile Saline for Catheter Care. Only the name is changed."
• "The Sterile Water for Device Care is the same as Sterile Saline for Catheter Care except for the solution, which is sterile water instead of saline. The container-closure system, plastic materials, and sterilization are the same as those used in marketed Baxter Sterile Saline for Catheter Care products."
• "There are no new issues of safety or effectiveness."

These statements constitute the manufacturer's rationale and evidence that the proposed devices are substantially equivalent to the predicate devices and therefore meet the safety and effectiveness requirements. The FDA's issuance of the 510(k) clearance signifies their agreement with this assessment, based on the nonclinical tests and data submitted (which are not fully detailed in this summary document but would have been part of the complete submission).

In summary, for this type of device, the "acceptance criteria" are regulatory benchmarks for substantial equivalence and the "study" is the comprehensive documentation and testing (non-clinical) provided to the FDA to demonstrate that equivalence.

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Sterile Water and Saline Solutions are defined as an accessory to a device that is intended For Device Cleaning and Irrigation.

Automated Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers.

The irrigation bottle is manufactured of 100% low density polyethylene (LDPE) and contains no color or chemical additives.

The two solutions are sterile, aseptically filled and are hermetically sealed for single use only.

The provided document is limited to a 510(k) summary for Sterile Water and Saline Bottles for Irrigation. This type of document is for a medical device and typically does not contain the detailed clinical study information such as acceptance criteria, statistical analysis, and expert adjudication that would be found in a submission for an AI/ML-driven diagnostic device.

Here's an analysis based on the lack of this information in the provided document, addressing each point:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not specified in the document. For a product like sterile water and saline solutions, acceptance criteria would likely relate to sterility, chemical composition (e.g., sodium chloride concentration), pH, particulate matter, and container integrity, as well as biological compatibility with ISO 10993 standards. However, specific thresholds are not provided.
   • Reported Device Performance: The document states, "All materials used in the fabrication of Sterile Water and Saline Solutions were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." No specific performance metrics (e.g., success rates, purity levels, sterility assurance levels) or quantitative results are provided.

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

   • This information is not applicable and not present in the document. The testing described is material qualification and product performance testing (e.g., sterility, biological safety), not a clinical trial with a test set of patient data.

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):

   • This information is not applicable and not present. Ground truth, in the context of diagnostic AI/ML, refers to a definitive diagnosis or outcome. For this device, "ground truth" would relate to laboratory test results (e.g., sterility tests, chemical analysis) rather than expert clinical interpretation of patient data.

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

   • Not applicable and not present. Adjudication methods are used in clinical studies where multiple human readers or experts disagree on an outcome. The testing performed for this device would involve laboratory methods with pre-defined pass/fail criteria.

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 and not present. This type of study is relevant for AI-powered diagnostic tools that assist human interpretation. The sterile water and saline solutions are not an AI device.

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

   • Not applicable and not present. This refers to the performance of an AI algorithm independently. The device in question is a physical product (sterile solutions), not an algorithm.

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

   • The "ground truth" for this device's performance would be established through laboratory testing results (e.g., microbiological cultures for sterility, chemical assays for composition, physical testing for container integrity) against established standards (e.g., USP monographs, ISO 10993 for biocompatibility). The document vaguely refers to "biological qualification safety tests as outlined in ISO 10993 Part-1" and "industry recognized test methods."

8. The sample size for the training set:

   • Not applicable and not present. Training sets are used for machine learning models. The manufacturer performed product performance and material safety testing, not AI model training.

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

   • Not applicable and not present. As there is no AI model or training set, this question is not relevant to the provided document.

Summary for the given document:

The provided 510(k) summary for Sterile Water and Saline Bottles for Irrigation, USP, describes a conventional medical device. It focuses on demonstrating substantial equivalence to a predicate device based on intended use and performance attributes. The "study" mentioned is the "Summary of testing" which involved:

• Evaluating materials through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices."
• Testing materials "in accordance with industry recognized test methods."

The objective of these tests was to confirm that the materials and the final product were "acceptable for the intended use" (device cleaning and irrigation) and met safety standards, rather than proving diagnostic accuracy or human reader improvement for an AI/ML product. The document does not provide specific data, acceptance criteria thresholds, sample sizes for these tests, or details about how the ground truth for these tests was established beyond adherence to "industry recognized test methods" and ISO 10993.

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Not for injection, for suction catheter procedures. Hydrox Sterile Saline 0.9% Sodium Chloride Solution is intended to be used in device lubrication, moistening and flushing. It is not intended for wound irrigation or IV or IM administration and is labeled as such.

Sterile Saline 0.9% Sodium Chloride Solution

In the provided text, the FDA 510(k) letter for "Hydrox Saline Solution 0.9% Sodium Chloride" (K974759) does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The letter focuses on the substantial equivalence determination of the device to pre-existing legally marketed devices, in this case, "Orion 0.9% Sodium Chloride Solution K943834 and Kit Pak Sterile 0.9% Sodium Chloride Solution." The FDA's decision is based on the device's indications for use being the same as the predicate devices, and an assumption of compliance with Good Manufacturing Practice (GMP) requirements.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

This type of detailed study information is not typically included in an FDA 510(k) clearance letter for a Class II device like a saline solution, especially when the clearance is based on substantial equivalence to predicate devices, where the focus is on whether the new device is as safe and effective as a legally marketed device.

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Not for injection, for suction catheter procedures. Hydrox Sterile Water is intended to be used in device lubrication, moistening and flusling. It is not intended for wound irrigation or IV or IM administration and is labeled as such.
The intended use of this device is the same as the intended use of similar devices currently in the market.

Hydrox Sterile Water 4 oz. Cup 120 ml, Trade Name: Hvdrox Sterile Water 100 ml Bottle

The provided text is a 510(k) premarket notification letter from the FDA regarding "Hydrox Sterile Water." This document does not describe an AI/ML medical device, nor does it contain any information related to acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the input document does not contain this type of information. It is a regulatory clearance letter for a sterile water product, not an AI/ML device study report.

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Baxter Sterile Saline for Catheter Care is intended for use in flushing urinary drainage and suction catheters.
Baxter Sterile Saline for Catheter Care is indicated for flushing or cleaning urinary drainage and suction catheters.

Baxter Healthcare Corporation intends to manufacture and market Sterile Saline for Catheter Cares in 250 mL containers.

This 510(k) premarket notification for "Sterile Saline for Catheter Care" from Baxter Healthcare Corporation is a re-classification of an existing device (Sterile Saline for Respiratory Therapy Solutions) with a new indication for use. As such, the submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data for device performance against specific acceptance criteria.

Therefore, the requested information components related to device performance studies (acceptance criteria, reported performance, sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance) are not explicitly described or provided in the given document.

Here's how we can address the request based on the provided text, highlighting the absence of typical clinical study details:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not specified. This submission is for a re-purposed device, and performance criteria for the new indication are not explicitly defined or measured in a study within this document. The argument for safety and effectiveness relies on the device being identical to a previously cleared product for a different, but similar, use.
• Reported Device Performance: Not reported. There are no performance metrics provided for the "Sterile Saline for Catheter Care" for its new indication because no new performance study was deemed necessary.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not applicable. No new test set or clinical data for the "Sterile Saline for Catheter Care" is discussed.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. No ground truth for a test set was established as no new clinical study was conducted.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No test set was adjudicated.

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

• MRMC Study: No. This is a medical device (saline solution), not an AI algorithm.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This is not an algorithm; it's a physical medical device (saline solution).

7. The type of ground truth used

• Type of Ground Truth: Not applicable. No new clinical ground truth was established for this submission. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set

• Sample Size: Not applicable. This is not a machine learning model, so there is no "training set."

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

• Ground Truth Establishment: Not applicable.

Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets acceptance criteria, in this context, is the demonstration of substantial equivalence to a previously cleared predicate device.

• Study Design: This was essentially a comparative analysis of the proposed device against a predicate device, focusing on technological characteristics and intended use. It is not a clinical performance study.

• Key Argument: The core argument provided by Baxter Healthcare Corporation is:

  • "The proposed Sterile Saline for Catheter Care is the same as existing Baxter Respiratory Therapy Solutions, except for the labeling."
  • "The solution of normal saline and the container-closure system are the same as those used in the existing Baxter Respiratory Therapy Solutions."
  • "The subject of this submission is a change in the indication for a previously cleared medical device. There are no new issues of safety or effectiveness."

• Conclusion: The FDA agreed with this assessment, stating, "We have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." This determination implies that the safety and effectiveness for the new indication are considered equivalent to the predicate device, given the identical composition and container system. The "acceptance criteria" were therefore met by demonstrating this substantial equivalence rather than through new performance data.

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The sterile water and sterile saline are indicated for device irrigation only.
The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.

The Welcon Sterile Water and Sterile 0.9% Normal Saline for Device Irrigation are individual, single-use 4 oz. (120 ml.) cups of fluid intended to be used for irrigation. The individual container consists of a plastic cup with a heat-sealed, adhesive-backed foil lid.

The provided text is for a 510(k) premarket notification for "Sterile Water/Saline for Device Irrigation." This product is a medical device, but it is not an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable to this document.

The document explicitly states: "Substantial equivalence for these devices was based solely on design characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Welcon devices are identical to those of the Intermed predicate devices."

The only "testing" mentioned is: "USP bacterial endotoxin testing was performed to verify that the sterile water and saline solutions conform with USP requirements." This is a quality control test to ensure the product meets a basic sterility standard, not a performance study as would be conducted for an AI/ML device.

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The device is a single patient use, disposable device that can be used in a setting when a suction tube is used on a patient-for oral suctioning-whether for anesthesia. nursing home, ambulatory, ICU, respiratory, or ER situations. It will provide a clean, conveniently located receptacle wherein to store the suction tube and its attached suction hose while needed/used on one patient. It also will secure the suction hose in a manner which will eliminate the constant hissing. It will hold other contaminated disposables at the end of patient use, or a case, to allow for safe, efficient clean-up. It would be used whenever blood and body secretions (as saliva) contained on the suction tube is a concern.

The device is a single patient use, disposable device that can be used in a setting when a suction tube is used on a patient-for oral suctioning-whether for anesthesia. nursing home, ambulatory, ICU, respiratory, or ER situations. It will provide a clean, conveniently located receptacle wherein to store the suction tube and its attached suction hose while needed/used on one patient. It also will secure the suction hose in a manner which will eliminate the constant hissing. It will hold other contaminated disposables at the end of patient use, or a case, to allow for safe, efficient clean-up. It would be used whenever blood and body secretions (as saliva) contained on the suction tube is a concern.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for the "Germ Trapper Suction Tube Holder" (later referred to as "Secretion Trapper TM Suction Tube Holder").

This letter states that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. However, it does not contain any information about specific acceptance criteria, performance metrics, or details of a study (such as sample sizes, ground truth establishment, or expert qualifications) that would typically be performed to demonstrate device performance and meet those criteria.

The document primarily focuses on:

• Confirming the 510(k) clearance.
• Stating the regulatory class (Class II).
• Listing the product code (JOL).
• Providing the indications for use for the device.
• Referencing general controls provisions of the Act (like annual registration, GMP, labeling).

Therefore, I cannot provide the requested information from the given text.

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