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510(k) Data Aggregation
(9 days)
The intended use of the Simplicity Easy Access P Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.
Sterling Medivations Inc.'s ("SMI") Simplicity Easy Access P designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into thssue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Access Infusion Set, K014062 and Soft YP Infusion Set, FDA 510 (k) K011187.
The Simplicity Easy Access P Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Access Infusion Set, FDA 510 (k) K014062 and it has the same intended use.
The device consists of four main parts: (1) infusion catheters made from AISI 304 stainless steel, (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded YP connector.
The Simplicity Easy Access P Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Access Infusion Set may be used with any Paradigm infusion device that delivers continuous or intermittent flow.
The administration set attaches to the reservoir/syringe by means of a threaded YP connector, and under the surface of the skin in the patient through an indwelling needles formed from AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube.
The indwelling needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The connector needle is attached to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is connecting tubing. The connector tubing proximal end is attached to a threaded YP connector for attachment to the Paradigm medicine reservoir.
The provided document is a 510(k) premarket notification for a medical device called the "Simplicity™ Easy Access P Infusion Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a formal study with detailed acceptance criteria and performance data as might be found for a new and novel device.
Therefore, much of the requested information (acceptance criteria in terms of performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or not present in this type of regulatory document.
However, based on the information provided, here's what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly presented in the typical format of performance metrics and thresholds. Instead, the "acceptance criteria" are compliance with established medical device standards and the "reported device performance" is the demonstration that the device meets these standards, thus proving substantial equivalence.
| Acceptance Criteria (Compliance with Standards/Regulations) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| CDRH 21 C.F.R. Section 880.5440 (Intravascular administration set) | Device meets these requirements for an intravascular administration set. |
| ISO 10555 Part 1: General Requirements (Sterile, single use intravascular catheters) | Device meets these requirements for sterile, single-use catheters. |
| ISO 10555 Part 5: Peripheral Catheters (Sterile, single use intravascular catheters) | Device meets these requirements for peripheral catheters. |
| ISO 11135:1994 (Validation and routine control of ethylene oxide sterilization) | Device sterilization process validated according to this standard. |
| ISO 11138-2:1994 (Biological indicators for ethylene oxide sterilization) | Biological indicators for sterilization comply with this standard. |
| ISO 9626: 1991 (Stainless Steel needle tubing for medical devices) | Stainless steel needle tubing complies with this standard. |
| ISO 11607: 1997 (Packaging for terminally sterilized medical devices) | Device packaging complies with this standard. |
| ISO 8535: 1991 (Sterile single use syringes, with or without needle, for insulin) | Device is compatible with sterile single-use insulin syringes as per this standard. |
| FDA Guidelines on LAL Test validation | Endotoxin testing complies with FDA guidelines. |
| ODE Blue Book Memorandum #K90-1 | Device testing followed guidelines from this memorandum. |
| ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and testing) | Device biocompatibility evaluated according to this standard. |
| Center for Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS (21 CFR 820.30 and ISO 9001 Sub-clause 4.4) | Device design process adhered to these guidance documents. |
| Substantial Equivalence to Predicate Device (Simplicity™ Easy Access Infusion Set, K014062) | Device is substantially equivalent in materials, manufacturing, labeling, and intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states that the device "meets the catheter requirements of" various ISO standards and FDA guidelines, implying that relevant tests were conducted. However, the specific sample sizes for these tests are not provided in this summary.
- Data Provenance: Not specified, but implied to be from internal testing conducted by Sterling Medivations, Inc. to ensure compliance with the listed standards. This would be prospective testing for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of information is not relevant for a 510(k) submission concerning an infusion set. Ground truth, in the context of diagnostic or AI devices, refers to a definitive correct answer for a medical condition. For an infusion set, compliance is demonstrated through engineering and biocompatibility testing against established standards, not expert clinical assessment of "ground truth."
4. Adjudication method for the test set
- Not applicable/not specified. Adjudication methods are typically employed in clinical trials or studies where there's subjectivity in outcome assessment, often involving multiple expert readers. This is not reported for the testing of an infusion set.
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 device is an infusion set, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an infusion set, not an algorithm.
7. The type of ground truth used
- Not applicable in the conventional sense of clinical ground truth (e.g., pathology for a diagnosis). The "ground truth" for this device's performance is adherence to established engineering specifications, material standards (e.g., AISI 304 stainless steel), biocompatibility criteria (ISO 10993-1), sterility standards (ISO 11135), and regulatory requirements. The tests verify that the device physically functions and is manufactured safely according to these pre-defined standards.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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(20 days)
The intended use of the Simplicity QD Easy P Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.
Sterling Medivations Inc.'s ("SMI") Simplicity™ QD Easy P Infusion Set is designed to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to the MiniMed Paradigm infusion pump or syringe.
The Simplicity QD Easy P Infusion Set is designed for use by people with diabetes to provide a means to infuse or inject medication subcutaneously when attached to the MiniMed Paradigm infusion pump or syringe. It is inserted into the subcutaneous tissue of a patient and the Simplicity YP connector is attached to the medication reservoir.
The device consists of four main parts: (1) an infusion catheter made from PTFE, (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a Simplicity YP connector consisting of a needle hub and reusable pump adapter and reservoir connector.
The Simplicity QD Easy P Infusion Set is an infusion administration set, connecting to the Paradigm reservoir by means of a Simplicity YP connector consisting of a needle hub and reusable pump adapter and reservoir connector and subcutaneously in the patient through an indwelling catheter made of Polytetrafluorthylene (PTFE). The Sterling Medivations Simplicity QD Easy P Infusion Set may be used with any paradigm infusion device that delivers continuous or intermittent flow. The connecting tubing is made from a polyethylene tube.
The 25 gauge-indwelling catheter is introduced into the subcutaneous tissue by a removable 27-gauge insertion needle formed from a lumen made of AISI 304 stainless steel. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector needle mates with the indwelling catheter forming a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is connected to the connecting tubing with a connector housing. The connector tubing proximal end is attached to a Simplicity YP connector consisting of a needle hub and reusable pump adapter and reservoir connector for connection to a MiniMed Paradigm pump and reservoir. The connecting tube is solvent bonded to the connector housing and to the needle hub connector.
This 510(k) submission (K021296) for the Simplicity™ QD Easy P Infusion Set is not a submission for an AI/ML powered device. It is for a medical device that facilitates the delivery of fluids subcutaneously. As such, concepts like AI assistance, human reader improvement, and ground truth establishment for a training set are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices through compliance with established performance standards for intravascular administration sets.
Here's an analysis of the provided information, tailored to the type of device:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are defined by its adherence to various established standards for medical devices, particularly those for intravascular administration sets, and its functional similarity to predicate devices. The "reported device performance" is implicitly demonstrated by meeting these standards and showing substantial equivalence.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Standard / Requirement | Reported Device Performance |
|---|---|---|
| Intended Use | Provide means for infusion/injection of fluids into subcutaneous tissue when attached to MiniMed Paradigm pump or syringe. | The Simplicity™ QD Easy P Infusion Set is designed and identified for this intended use. It is stated to be substantially equivalent to predicate devices with the same intended use. |
| Material & Manufacturing | Substantially equivalent to predicate device materials and processes. | Stated as "substantially equivalent." |
| Labeling | Substantially equivalent to predicate device labeling. | Stated as "substantially equivalent." |
| Catheter Requirements | CDRH 21 C.F.R. Section 880.5440 Intravascular administration set. | Device "meet[s] the catheter requirements of" this regulation. |
| Sterile Intravascular Catheters (General Requirements) | ISO 10555 Part 1: General Requirements. | Device "meet[s] the catheter requirements of" this standard. |
| Sterile Intravascular Catheters (Peripheral) | ISO 10555 Part 5: Peripheral Catheters. | Device "meet[s] the catheter requirements of" this standard. |
| Ethylene Oxide Sterilization Validation | ISO 11135:1994 Medical devices -- Validation and routine control of EO sterilization. | Device adheres to this standard. |
| Biological Indicators for EO Sterilization | ISO 11138-2:1994 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for EO sterilization. | Device adheres to this standard. |
| Stainless Steel Needle Tubing | ISO 9626: 1991 Stainless Steel needle tubing for the manufacture of medical devices. | Device adheres to this standard (relevant for the 27-gauge insertion needle and 25-gauge indwelling catheter). |
| Packaging for Terminally Sterilized Medical Devices | ISO 11607: 1997 Packaging for terminally sterilized medical devices. | Device adheres to this standard. |
| Sterile Single-Use Syringes (Insulin) | ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin. | Device adheres to this standard (likely relevant to its compatibility with syringes and intended use by diabetes patients). |
| Endotoxin Testing | FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test. | Device adheres to these guidelines. |
| Design Control | ODE Blue Book Memorandum #K90-1 and FDA 21 CFR 820.30 and ISO 9001 (Sub-clause 4.4). | The design process "adhered to" these guidelines, indicating compliance with quality system regulations for medical device design. |
| Biocompatibility | ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing. | Device adheres to this standard, implying biocompatibility testing was performed and passed. |
| Functional Equivalence (with specific connector) | Connection to MiniMed Paradigm pumps/reservoirs via Simplicity YP connector. | The device incorporates this specific connector, which is also used on one of the predicate devices (Simplicity Soft YP Infusion Set K011187). The device is "otherwise similar to the Simplicity Soft QD II Infusion Set, FDA 510(k) K020990." |
Study Information (Not Applicable for AI/ML Device)
Since this is not an AI/ML device, the following points are not applicable in the traditional sense of an AI performance study. However, I can interpret them in the context of a medical device submission:
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Sample size used for the test set and the data provenance: Not directly applicable. The "test set" for this kind of device is the physical product itself, which undergoes various standardized tests (e.g., integrity tests, sterility tests, biocompatibility tests) as defined by the listed ISO standards and FDA regulations. There isn't a "data provenance" in the sense of patient data. The provenance for the performance data would be the testing laboratories and manufacturing facilities.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for establishing "ground truth" in an AI/ML context. However, the development and approval of such a device involve experts in:
- Engineering/Materials Science: For design, material selection, and manufacturing processes.
- Quality Assurance/Regulatory Affairs: To ensure compliance with all relevant standards and regulations.
- Medical Professionals/Clinicians: To define user needs and evaluate the device's functionality and safety in a clinical context (though not explicitly detailed in this summary, it's inherent in medical device development).
- The FDA reviewers (e.g., Timothy A. Ulatowski, Director of the Division of Dental, Infection Control and General Hospital Devices) act as experts who assess the submitted evidence for "substantial equivalence."
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable in the context of multi-expert adjudication for AI results. Adjudication in medical device testing typically refers to the process of resolving discrepancies in test results or ensuring that test methods and results are correctly interpreted against the acceptance criteria. This is usually managed through a robust Quality Management System (QMS) as specified by FDA 21 CFR 820.30 and ISO 9001.
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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 not an AI-assisted diagnostic device.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for "ground truth" in an AI/ML context. For this device, the "ground truth" or reference for performance is established by the compliance with recognized standards and regulations. For example:
- Sterility: Absence of viable microorganisms as per ISO 11135 and ISO 11138-2.
- Biocompatibility: No adverse biological reactions as per ISO 10993-1.
- Physical Integrity/Functionality: Ability to withstand various forces, maintain fluid path, prevent leakage, and connect properly as per ISO 10555 parts 1 and 5, and product-specific testing.
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The sample size for the training set: Not applicable. There is no artificial intelligence "training set" for this physical device.
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How the ground truth for the training set was established: Not applicable.
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