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DMC Medical Single-Use Polycarbonate Syringe is offered in the same configurations as the predicate. It is made from a calibrated hollow barrel, and a moveable piston with a plunger tip at the end of the piston. The piston shaft does not contact any part of the fluid path, rather the tip which attaches to the shaft and the barrel are fluid path components. Individual components are made from properly tested materials included in this submission. Additionally, there is a small amount of lubricant for moving the piston shaft smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals.

AI/ML Overview

The information provided in the document focuses on demonstrating the substantial equivalence of the DMC Medical Single-Use Polycarbonate Syringe to a predicate device (ICU Medical Single-Use Syringe) rather than providing detailed acceptance criteria and a study proving the device meets those criteria in a typical clinical or AI/algorithm performance context.

This regulatory submission (510(k)) is for a medical device (syringe), not a software algorithm or AI model, so the "study" described is primarily non-clinical testing against recognized standards to demonstrate equivalence.

Here's an attempt to structure the available information into the requested format, with the recognition that some sections will be "N/A" or "Not Applicable" given the nature of the device and submission:

Acceptance Criteria and Device Performance for DMC Medical Single-Use Polycarbonate Syringe

The acceptance criteria for the DMC Medical Single-Use Polycarbonate Syringe are primarily based on conformity to the international standard ISO 7886-1 for sterile single-use hypodermic syringes and the biological safety standard ISO 10993-1, as well as demonstration of substantial equivalence to the predicate device, K070856.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Material Equivalence	Syringe Barrel: Polycarbonate	Polycarbonate
	Plunger Tip: Polyisoprene (predicate) / Elastomer (submitted)	Elastomer (considered equivalent in function)
	Lubricant: Medical Grade Oil	Medical Grade Oil
Functional Equivalence	Calibrated Barrel Volume	YES
	Sterilization Method: EtO	EtO
	Operational Characteristics: Identical to predicate device	Operations are identical to the predicate, allowing accurate fluid measurement via printed external housing in ml.
Safety & Performance Standards	Conformity to ISO 7886-1 (Sterile Single-use Hypodermic Syringes)	All syringes conform to ISO 7886-1
	Sterility Assurance Level (SAL): 10-6	SAL has been established to meet the 10-6 level
	Conformity to ISO 10993-1 (Biological evaluation of medical devices)	All syringes conform to ISO 10993-1, including minimizing residual gases.
	Pressure Testing to Failure	Tested to failure; devices meet healthcare professional needs.
Packaging	Minimizing residual gases; discourage re-use	Packaged to ensure conformity with ISO 10993-1, minimizing residual gases, and discouraging re-use.

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

Sample Size: Not explicitly stated as a numerical value for a specific test set. The submission mentions "All syringes conform to..." and "DMC Medical syringes are tested to...", implying testing was performed on a representative sample to ensure compliance.
Data Provenance: The testing was "Non-clinical Testing" performed by DMC Medical Ltd. to demonstrate conformity to ISO standards and substantial equivalence. No country of origin for a clinical data set is applicable, as this is a device submission based on bench testing and material equivalence.

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

Not Applicable. This submission is for a physical medical device (syringe) and relies on objective, standardized non-clinical testing (e.g., pressure testing, material analysis, sterility testing) against ISO standards, rather than expert-established ground truth from clinical interpretation.

4. Adjudication Method for the Test Set

Not Applicable. As there is no "ground truth" derived from expert consensus or interpretation, an adjudication method for such a ground truth is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for imaging or diagnostic algorithms where human readers interpret cases. This filing is for a physical syringe and does not involve human readers interpreting data.
- Effect Size of AI Improvement: Not applicable.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is not an algorithm or AI device. The "standalone performance" is the inherent function and safety of the syringe itself as demonstrated through non-clinical testing.

7. The Type of Ground Truth Used

Objective Standards and Physical Testing Results: The "ground truth" for this device is its adherence to established international standards (ISO 7886-1, ISO 10993-1), material specifications, and performance characteristics (e.g., pressure resistance, accurate volume measurement) as verified through non-clinical laboratory testing. The predicate device's established safety and effectiveness also serve as a comparative ground.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires training data. The syringe components and manufacturing process are developed and refined through engineering practices, not machine learning training sets.

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

Not Applicable. No training set or associated ground truth is relevant for this device.

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K Number

K992932

Device Name

CIPA (ADULTS) CIPI (INFANTS)

Manufacturer

DMC MEDICAL LTD.

Date Cleared

2000-06-07

(281 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K781990

Intended Use

The cardiac insulation pad is indicated for use in patients undergoing heart surgery where there is a need to reduce undesirable re-warming of the mvocardium and protect the left phrenic nerve from cold injury during local cooling of the heart.

Device Description

The Cardiac Insulation Pad is a thin, pliable, foam pad which can be cut to conform to the shape of the heart. The pad covers the posterior cardiac wall or the mvocardium. When the surgeon is finished using the pad, it can be easily removed by pulling the PVC locator tape. The cardiac pad is available in two sizes; adult and infant.

The Cardiac Insulation Pad isolates the myocardium from warmer tissues (descending thoracic aorta, liver, and surrounding pericardial tissues) and thus reduces undesirable re-warming of the myocardium. In addition, it protects the left phrenic nerve from cold injury during local cooling of the heart.

Material: Crosslinked, closed cell polyolefin foam

AI/ML Overview

The Cardiac Insulation Pad is indicated for use in patients undergoing heart surgery where there is a need to reduce undesirable re-warming of the myocardium and protect the left phrenic nerve from cold injury during local cooling of the heart.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Prevention of Left-Sided Diaphragmatic Paralysis (Phrenic Nerve Protection)	Guinn GA et al. study (1990): The cardiac insulation pad "prevented left-sided diaphragmatic paralysis in 52 of 58 patients" (89.7%).
Esposito RA, Spencer, FC study (1987): A pericardial insulation pad "prevented diaphragm paralysis in 83% of the patients."
Conclusion: "Thus it was concluded that the cardiac insulation pad protects the phrenic nerve from the cold during heart surgery where the heart is cooled."
Reduction of Undesirable Myocardial Re-warming	The predicate device description (Cardiac Insulation Pad by Shiley, Inc.) also cites this indication. The submitted device states: "The Cardiac Insulation Pad isolates the myocardium from warmer tissues (descending thoracic aorta, liver, and surrounding pericardial tissues) and thus reduces undesirable re-warming of the myocardium." No explicit separate performance metric is provided for this aspect in the 510(k) summary, but its effect is generally implied through the mechanism of insulation. The clinical studies focus on the phrenic nerve, but the overall function of insulation would inherently contribute to reduced re-warming.

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

Guinn GA et al. study: 58 patients. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the 510(k) summary. Given the journal (Texas Heart Institute Journal), it is likely to be US-based, and clinical studies of this nature are typically prospective, but this is an assumption.
Esposito RA, Spencer, FC study: The number of patients is not explicitly stated in the provided abstract, only "83% of patients." The journal (Annals of Thoracic Surgery) suggests it is a clinical study, likely prospective.

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

This information is not provided in the 510(k) summary. These were clinical studies (likely medical professionals, surgeons, or cardiologists), but the specific number of experts or their qualifications for establishing the outcome (diaphragmatic paralysis) are not detailed.

4. Adjudication method for the test set

This information is not provided in the 510(k) summary. For clinical outcomes like diaphragmatic paralysis, the assessment would typically be made clinically by the treating physicians, but no specific adjudication method (e.g., 2+1, 3+1 consensus) is described.

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

No, a multi-reader, multi-case comparative effectiveness study was not done. This device is a physical medical device (an insulation pad), not an AI/software device that would involve human readers interpreting images or data. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

No, this is not an AI/software device. Standalone algorithm performance is not relevant.

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

The ground truth used was clinical outcomes data, specifically whether left-sided diaphragmatic paralysis occurred or was prevented, as determined by medical professionals in the context of a clinical study.

8. The sample size for the training set

This is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set. The studies cited are clinical performance studies, not dataset training.

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

This is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set.