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510(k) Data Aggregation
(62 days)
The TERUMO® SurGuard 2™ SAFETY NEEDLE device is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes.
Additionally, after withdraw of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The SurGuard 2™ Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the connector hub. The safety sheath contains a locking mechanism which is activated when the sheath is manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath against a firm surface. The locking mechanism is located at a designated position within the body of the short or long sheath appropriate for the needle size it is to contain. The needle gauge sizes are 18gauge to 25gauge and the needle lengths are 5/8" to 1 ½". The hinge feature allows the user to set the sheath to the desired position for use. For user convenience, when the needle is in the "bevel up" position the sheath is located to the right. The SurGuard 2™ Safety Needle will be individually packaged and sterilized as a safety needle only or as a safety needle with attached Terumo syringe (as cleared under K771205 and K980181).
Here's a breakdown of the acceptance criteria and the study information for the TERUMO® SurGuard 2™ Safety Needle, based on the provided document.
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission seeking substantial equivalence, the acceptance criteria are not explicitly defined as pass/fail thresholds in the same way they would be for a de novo or PMA application. Instead, the "acceptance criteria" are implied by the comparison to predicate devices and the demonstration that the new device performs similarly and does not raise new safety or effectiveness issues. The reported device performance is presented as a list of tests conducted, with the overarching conclusion that these tests support substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance similar to predicate devices for safety features | Activation Force, Deactivation Force, Puncture Resistance, Sheath Removal Force, Collar Removal Force, Sheath Radial Force, Protector Fit, Simulated Use Study |
| Biocompatibility of blood-contacting materials | Biocompatibility testing per FDA G95-1 (ISO-10993 Part 1) |
| Sterility Assurance Level (SAL) per recognized standard | SAL of 10^-6 validated according to ANSI/AAMI/ISO 11137-1994 |
| No new issues of safety and effectiveness compared to predicates | Risk analysis conducted; "None of the data raises any new issues of safety and effectiveness." |
Study Details
This 510(k) submission primarily relies on bench testing/performance testing rather than a clinical study involving human subjects or AI algorithms. As such, many of the requested categories (e.g., sample size for test set, experts for ground truth, MRMC study, training set) are not applicable in their typical sense for this type of device.
1. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated in terms of number of devices tested for each performance criterion. The document states "The following tests were performed on the SurGuard 2TM Safety Needle," implying that a sufficient number of devices were tested to draw conclusions.
- Data Provenance: The tests were performed internally by Terumo Medical Corporation (the manufacturer). The country of origin for the data is implied to be the USA, given the submission is to the FDA in the US. The data is prospective as it was generated specifically for this 510(k) submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a mechanical safety device undergoing bench testing, "ground truth" is established by direct measurement and standardized test methods, not expert consensus on interpretations.
3. Adjudication method for the test set:
- Not Applicable. As per point 2, ground truth is based on direct measurement, not assessment by humans requiring adjudication.
4. 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 medical device (safety hypodermic needle), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation was performed.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device does not incorporate an AI algorithm.
6. The type of ground truth used:
- For the performance tests (e.g., Activation Force, Puncture Resistance), the "ground truth" is the measured physicochemical and mechanical properties of the device, assessed against pre-defined engineering specifications or comparative data from predicate devices.
- For biocompatibility, the ground truth is established by laboratory testing results compliant with ISO-10993 Part 1.
- For sterility, the ground truth is established by sterilization validation results compliant with ANSI/AAMI/ISO 11137-1994.
7. The sample size for the training set:
- Not Applicable. There is no training set as no AI/machine learning algorithm is involved.
8. How the ground truth for the training set was established:
- Not Applicable. As there is no training set.
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(350 days)
The SHANCHUAN Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.
The SHANCHUAN Insulin Syringe is design for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange.
The syringe fluid path is sterile, non-toxic, non-pyrogen and single use, disposable.
The SHANCHUAN Piston Syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a nozzle for fitting the hub of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.
The Hypodermic Single Lumen Needle is a device intended to inject below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a hub designed syringe or an intravascular administration set.
The Insulin Syringe is a piston syringe, typically sterile, single-use with a needle, used for subcutaneous injection of insulin.
The provided text describes a 510(k) submission for the SHANCHUAN Syringe, claiming substantial equivalence to predicate devices (Terumo Disposable Hypodermic Syringe and BD Insulin Syringe). It is primarily a comparison against existing devices, rather than a study with specific acceptance criteria and detailed performance metrics to "prove" the device meets them as would be seen in a clinical trial for a novel AI device.
Therefore, many of the requested categories for a study proving acceptance criteria are not directly applicable or are not explicitly stated in this type of regulatory submission for a medical device like a syringe. The submission focuses on demonstrating that the new device is as safe and effective as previously cleared devices.
Here's an attempt to populate the table and answer the questions based on the provided text, highlighting where information is not available:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Piston Syringe | ||
| 1. Intended Uses | Intended to be used for injecting fluids or withdrawing fluids from the body. | SHANCHUAN Piston Syringe is intended to be used for injecting fluids or withdrawing fluids from the body (substantially equivalent to predicate). |
| 2. Labeling | Includes identity (type, size, needle gauge/length) and quantity; prescription statement according to 801.109(b)(1) (except insulin syringes). | SHANCHUAN Piston Syringe labeling includes identity (type, size, needle gauge/length) and quantity; prescription statement according to 801.109(b)(1) (substantially equivalent to predicate). |
| 3. Design and Materials | Comprised of barrel, plunger, gasket, needle. Materials are medical polypropylene (barrel, plunger, hub), rubber (gasket - no emulsion/natural rubber), X2C,N;18-9 stainless steel (needle), medical silicon oil (lubricant). | SHANCHUAN Piston Syringe design (barrel, plunger, gasket, needle) and materials (medical polypropylene, rubber gasket, stainless steel needle, medical silicon oil lubricant) are basically the same as the predicate (substantially equivalent). |
| 4. Specifications | Physical specifications are basically the same, mechanical and biological according to the same international standard. | SHANCHUAN Piston Syringe physical specifications are basically the same as the predicate (difference in syringe sizes and needle length noted, but not raising new safety/effectiveness issues). Mechanical and Biological specifications are according to the same international standard (substantially equivalent). |
| 5. Performance (Bench) | Performs equivalently to predicate devices and is effective when used as intended. | The bench test results demonstrate that the SHANCHUAN Piston Syringe performs equivalent to the predicate devices and is effective when used as intended. |
| 6. Performance (Clinical) | Has been used in clinic for many years, ensuring effectiveness. (This is a statement about the predicate, implying the new device is equivalent). | "Both of them have been used in clinic for many years, which ensure the effectiveness of the SHANCHUAN Piston Syringe." (This refers to predicate devices, and by substantial equivalence, implies the SHANCHUAN Piston Syringe meets this criterion through its equivalence to existing clinically used devices). |
| Insulin Syringe | ||
| 1. Intended Uses | Intended for the subcutaneous injection of insulin. | SHANCHUAN Insulin Syringe is intended for the subcutaneous injection of insulin (substantially equivalent to predicate). |
| 2. Labeling | Includes identity (type, needle gauge/length) and quantity; "For use with U-100 insulin only" and graduations printed on barrel according to 801.403. | SHANCHUAN Insulin Syringe labeling includes identity (type, needle gauge/length) and quantity; includes "For use with U-100 insulin only" and graduations printed on barrel (substantially equivalent to predicate). |
| 3. Design and Materials | Comprised of barrel, plunger, gasket, needle. Materials are basically the same as predicate (difference noted in gasket and lubricant). | SHANCHUAN Insulin Syringe design (barrel, plunger, gasket, needle) and materials are basically the same as the predicate (difference in gasket and lubricant noted, but not raising new safety/effectiveness issues). |
| 4. Specifications | Physical specifications are basically the same, mechanical and biological according to the same international standard. | SHANCHUAN Insulin Syringe physical specifications are basically the same as predicate (differences in syringe sizes, needle gauge sizes, and needle length noted, but not raising new safety/effectiveness issues). Mechanical and Biological specifications are according to the same international standard (substantially equivalent). |
| 5. Performance (Bench) | Performs equivalently to predicate devices and is effective when used as intended. | The bench test results demonstrate that the SHANCHUAN Insulin Syringe performs equivalently to the predicate devices and is effective when used as intended. |
| 6. Performance (Clinical) | Has been used in clinic for many years, ensuring safety and effectiveness. (This is a statement about the predicate, implying the new device is equivalent). | "Both of them have been used in clinic for many years, which ensure the safety and effectiveness of the SHANCHUAN Insulin Syringe." (This refers to predicate devices, and by substantial equivalence, implies the SHANCHUAN Insulin Syringe meets this criterion through its equivalence to existing clinically used devices). |
| General Safety & Effectiveness (both devices) | No new issues of safety or effectiveness should be raised by differences compared to predicate devices. The device should be sterile, non-toxic, non-pyrogen, and single use, disposable. | "Any noted differences between the two devices do not raise new issues of the safety and effectiveness." (Repeated for both piston and insulin syringes). "All the results demonstrate that the SHANCHUAN Piston Syringe performs equivalently to the predicate devices and is safe and effective when used as intended." (Similar statement for Insulin Syringe). The syringe fluid path is stated to be sterile, non-toxic, non-pyrogen, and single use, disposable. |
Study Details for Acceptance Criteria
The provided text is a 510(k) Summary, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than providing a detailed report of a formal study with specific acceptance criteria and performance results in the context of, for example, an AI/imaging device. For a syringe, "performance" is assessed through bench testing and comparison to established device standards and predicate devices' proven clinical use.
Therefore, for most of the detailed questions regarding study design, sample sizes, ground truth, and expert involvement (which are typical for AI/diagnostic device studies), the information is not applicable or not provided in this type of submission.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document refers to "bench test results" but does not specify sample sizes for these tests. Data provenance is not mentioned.
-
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. For a mechanical device like a syringe, "ground truth" is typically established through adherence to engineering specifications and international standards, and comparison to predicate devices, rather than expert interpretation of a test set in the way it would be for a diagnostic AI.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None specified. This is a concept related to human-expert review of diagnostic outcomes, not applicable to the bench testing of a syringe.
-
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, not done. This type of study is specifically for diagnostic AI tools that assist human interpreters. A syringe is a mechanical medical device with no interpretation component.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance. A syringe is a manually operated device. The "performance" is its physical characteristics and functionality.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a syringe, "ground truth" is likely defined by adherence to specified engineering standards (e.g., ISO standards) for physical dimensions, material properties, sterility, force required for plunger movement, leakage, etc. The document states: "Both of the Mechanical and Biological are according to the same international standard." It also heavily relies on comparison/equivalence to predicate devices that are already considered safe and effective, rather than a novel "ground truth" derived from clinical outcomes or expert consensus on new data.
-
The sample size for the training set:
- Not applicable/Not provided. "Training set" is a concept for machine learning or AI models. This device is a physical product, not an AI.
-
How the ground truth for the training set was established:
- Not applicable. As above, this is for AI models.
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(78 days)
The Terumo Syringe with/without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
The Terumo Syringe with/without needle consists mainly of 3 parts or 4 parts: a barrel, a plunger, a gasket and a needle (for the needle type). Barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The gasket is made from a highly inert thermoplastic elastomer material facilitates smooth movement of the plunger and aids the user in controlling dosage. The needle is made from stainless steel and the needlepoint is carefully designed to minimize resistance at the skin surface and aids in smooth, easy insertion. The Terumo Syringe with/without Needle is individually packed in peel blister that ensures the sterility of the device until the package is opened.
This document describes the 510(k) summary for the Terumo Syringe with/without Needle. It demonstrates substantial equivalence to a predicate device, K980181, rather than proving performance against specific acceptance criteria in a quantitative study. Therefore, some of the requested information, such as sample sizes, expert qualifications, and specific effect sizes, are not applicable or not provided in the given text.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a table of specific quantitative acceptance criteria with corresponding performance metrics. Instead, it lists various tests performed to demonstrate safety and efficacy and asserts that the device is "safe and effective during handling and for the duration of its expiration." The implicit acceptance criterion for each test is that the new device performs acceptably and equivalently to the predicate device.
| Performance Test | Reported Device Performance |
|---|---|
| Cleanliness | Not explicitly quantified, but implied to be acceptable. |
| Leakage Test | Not explicitly quantified, but implied to be acceptable. |
| Sliding Resistance | Not explicitly quantified, but implied to be acceptable. |
| Plunger and Gasket Fit Force | Not explicitly quantified, but implied to be acceptable. |
| Nozzle-needle Fit Force | Not explicitly quantified, but implied to be acceptable. |
| Initial Movement Force | Not explicitly quantified, but implied to be acceptable. |
| Stopper Force | Not explicitly quantified, but implied to be acceptable. |
| Dead Space | Not explicitly quantified, but implied to be acceptable. |
| Equal to Nominal Capacity Graduation Tolerance | Not explicitly quantified, but implied to be acceptable. |
| Between Main Capacity Graduation Tolerance | Not explicitly quantified, but implied to be acceptable. |
| Primary Container Seal Strength | Not explicitly quantified, but implied to be acceptable. |
| Silicone Amount Determination | Not explicitly quantified, but implied to be acceptable. |
| Elution Test Method | Not explicitly quantified, but implied to be acceptable. |
| Analysis of Heavy Metals | Not explicitly quantified, but implied to be acceptable. |
| Determination of pH | Not explicitly quantified, but implied to be acceptable. |
| Sterility Assurance Level (SAL) | 10⁻⁶ (validated in accordance with ISO 11137) |
| Performance (aged and non-aged devices) | Aging process does not adversely affect device performance. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the various performance tests. The data provenance is Terumo (Philippines) Corporation, and the tests were likely conducted prospectively as part of the device development and validation process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a medical device clearance based on substantial equivalence, not an AI or diagnostic tool requiring expert ground truth for a test set. The "ground truth" here is compliance with established performance standards and equivalence to a predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is a medical device clearance based on substantial equivalence, not an assessment requiring adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a manual syringe, and its performance evaluation does not involve human readers interpreting diagnostic cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a manual syringe, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is based on:
- Compliance with recognized standards: For tests like cleanliness, leakage, and sterility (ISO 11137).
- Engineering specifications and design requirements: For physical and mechanical properties.
- Demonstrated performance of the legally marketed predicate device: The new device must perform comparably to the predicate.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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