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510(k) Data Aggregation
(79 days)
The disposable insulin syringe is intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The Disposable Insulin Syringes are provided sterile, single use.
For the Disposable Insulin Syringes, they consist of six components: (1) orange needle cap (2) needle (3) piston (4) plunger (5) barrel (6) orange protective end cap. The materials for all components are listed in Table 1 Component material list.
The Disposable Insulin Syringes are available in different combination of syringe volumes and needle sizes. The range of syringe volume, needle gauge and needle length are listed in Table 2 syringe and needle specification.
This document describes the premarket notification for a Disposable Insulin Syringe (K151949). It does not contain information about an AI/ML powered device. Instead, it details the substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility.
Therefore, many of the requested categories for AI/ML device studies are not applicable. I will extract the relevant information for the device's acceptance criteria and the studies conducted to meet them.
Here's the breakdown of the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Physical/Mechanical Performance: | |
| ISO 9626:1991+AMENDMENT 1 2001: Stainless steel needle tubing for the manufacture of medical devices | "The test results demonstrated that the proposed device complies with the following standards" (General statement of compliance) |
| ISO 8537: 2007: Sterile single-use syringes, with or without needle, for insulin | "The test results demonstrated that the proposed device complies with the following standards" (General statement of compliance) |
| ASTM F 88/F88M-09: Standard test method for seal strength of flexible barrier materials | "The test results demonstrated that the proposed device complies with the following standards" (General statement of compliance for seal integrity during shelf life assessment after accelerated aging) |
| ASTM F1140/F1140M-13: Standard test methods for internal pressurization failure resistance of unrestrained packages | "The test results demonstrated that the proposed device complies with the following standards" (General statement of compliance for seal integrity during shelf life assessment after accelerated aging) |
| ASTM F1886/F1886M-09 (Reapproved 2013): Standard Test Method For Determining Integrity Of Seals For Flexible Packaging By Visual Inspection | "The test results demonstrated that the proposed device complies with the following standards" (General statement of compliance for sterility packaging integrity assessment during shelf life). |
| ASTM F1929-12: Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration | "The test results demonstrated that the proposed device complies with the following standards" (General statement of compliance for sterility packaging integrity assessment during shelf life). |
| Biocompatibility: | |
| ISO 10993-7:2008: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | "The test results demonstrated that the proposed device complies with the following standards" (General statement of compliance). |
| ISO 10993 series Standards (General Biocompatibility relevant tests like Cytotoxicity, Sensitization, Irritation on Intracutaneous Reactivity, System Toxcity (Acute), Haemo-compatiblity) | "The necessary tests for biocompatibility testing including Cytotoxicity, Sensitization, Irritation on Intracutaneous Reactivity, System Toxcity (Acute) and Haemo-compatiblity have been provided in K113091 Submission. And the biocompatibility test results can demonstrate the compatibility of all of the patient-contact materials of the proposed device meets the requirements of Biocompatibility." (Compliance based on predicate device K113091) |
| Sterility/Microbiological: | |
| USP37-NF32 : Bacterial Endotoxins Limit | "The test results demonstrated that the proposed device complies with the following standards" (General statement of compliance). |
| ISO 11737-2:2009: Sterilization of medical devices - Microbiological methods - Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process | "The test results demonstrated that the proposed device complies with the following standards" (General statement of compliance for sterility assessment during shelf life). |
| ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | "The test results demonstrated that the proposed device complies with the following standards" (General statement of compliance). |
| Shelf Life: | |
| Assessment of seal integrity of sterile barrier packaging after accelerated aging | "A maximum shelf life of 5 years has been assigned to the proposed device, when stored unopened at ambient temperature, in dry conditions away from direct sources of light, in accordance with the manufacturer's recommendations. The shelf life is based on an assessment of the seal integrity of the sterile barrier packaging after accelerated aging..." |
| Performance testing of device after accelerated aging | "...performance testing of device after accelerated aging..." |
| Sterility test after accelerated aging | "...and Sterility test after accelerated aging." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. The document generally refers to "non clinical tests" being conducted.
- Data Provenance: The device manufacturer is Jiangyin Caina Technology Company Incorporated, located in Jiangyin, Jiangsu, China. The testing was conducted as part of their submission without specifying the exact location of the testing laboratories, but it would presumably be in China or by accredited labs. The data is retrospective in the sense that it's submitted to demonstrate compliance for a device manufactured by the company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: This is a submission for a non-AI/ML medical device. "Ground truth" in the context of expert consensus is not relevant here. Compliance is assessed against established international and ASTM standards for physical, chemical, and biological properties.
4. Adjudication Method for the Test Set
- Not Applicable: As this is not an AI/ML diagnostic or image interpretation device, adjudication methods by experts are not relevant. Compliance is measured against objective standards.
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 a disposable insulin syringe, not an AI/ML powered diagnostic or clinical support tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable: This device is not an algorithm.
7. The Type of Ground Truth Used
- Standards-based Compliance: The "ground truth" for this device's performance is adherence to recognized international and national standards (ISO, ASTM, USP) for medical devices. For biocompatibility, reliance was also placed on prior clearance (K113091) for materials with the same intended use.
8. The Sample Size for the Training Set
- Not Applicable: This device does not involve a "training set" in the context of AI/ML. Manufacturing processes are validated through established quality control and testing protocols.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: Not an AI/ML device.
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(87 days)
Safelock Disposable Insulin Syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries.
Safelock Disposable Insulin Syringes are provided sterile, single use, which consist of five pieces components: (1) a syringe barrel calibrated in units of insulin (U-100) with a permanently attached single lumen needle on it, (2) a needle cap, (3) plunger and (4) protective end cap and (5) an additional safety mechanism installed at the needle end of the syringe. The devices are available in different combination of syringe volumes and needle sizes.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them, structured as requested:
Device: Safelock Disposable Insulin Syringe
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary details various non-clinical tests performed according to recognized ISO and ASTM standards. The reported performance is generally stated as "met all design specifications" or "met the pre-established criteria." Specific quantitative acceptance criteria or performance metrics are largely absent from this summary but are implied by adherence to the referenced standards.
| Acceptance Criteria Category | Standard/Guidance | Reported Device Performance |
|---|---|---|
| Physical, Mechanical, and Chemical (Syringe) | ISO 8537:2007 (Clauses 5, 6.1, 6.2, 7, 8, 9.1, 9.2, 10.1, 10.2, 11.1, 11.2, 13.2, 14.1, 14.2, 14.3) | Met all design specifications (implied by adherence to ISO 8537:2007 requirements) |
| Freedom from extraneous matter | Clause 5 of ISO 8537:2007 | Met |
| Limits for acidity and alkalinity | Clause 6.1 of ISO 8537:2007 | Met |
| Limits for extractable metals | Clause 6.2 of ISO 8537:2007 | Met |
| Lubrication of syringes and needles | Clause 7 of ISO 8537:2007 | Met |
| Range of sizes | Clause 8 of ISO 8537:2007 | Met |
| Scale | Clause 9.1 of ISO 8537:2007 | Met |
| Numbering of scale | Clause 9.2 of ISO 8537:2007 | Met |
| Dimensions | Clause 10.1 of ISO 8537:2007 | Met |
| Finger grips | Clause 10.2 of ISO 8537:2007 | Met |
| Piston/plunger assembly | Clause 11.1 of ISO 8537:2007 | Met |
| Fit of piston in barrel | Clause 11.2 of ISO 8537:2007 | Met |
| Needle tubing for syringes | Clause 13.2 of ISO 8537:2007 | Met |
| Dead space | Clause 14.1 of ISO 8537:2007 | Met |
| Freedom from leakage at needle | Clause 14.2 of ISO 8537:2007 | Met |
| Liquid and air leakage past piston | Clause 14.3 of ISO 8537:2007 | Met |
| Physical, Mechanical, and Chemical (Needle) | ISO 9626:1991/AMD-1:2001 (Clauses 3-11) | Met all design specifications (implied by adherence to ISO 9626:1991 requirements) |
| Materials | Clause 3 of ISO 9626:1991/AMD-1:2001 | Met |
| Surface finish | Clause 4 of ISO 9626:1991/AMD-1:2001 | Met |
| Cleanliness | Clause 5 of ISO 9626:1991/AMD-1:2001 | Met |
| Limits for acidity and alkalinity | Clause 6 of ISO 9626:1991/AMD-1:2001 | Met |
| Size designation | Clause 7 of ISO 9626:1991/AMD-1:2001 | Met |
| Dimensions | Clause 8 of ISO 9626:1991/AMD-1:2001 | Met |
| Stiffness | Clause 9 of ISO 9626:1991/AMD-1:2001 | Met |
| Resistance to breakage | Clause 10 of ISO 9626:1991/AMD-1:2001 | Met |
| Resistance to corrosion | Clause 11 of ISO 9626:1991/AMD-1:2001 | Met |
| Sterile Barrier Packaging Testing | ASTM F88/F88M-09, ASTM F1140/F1140M-13 | Met all design specifications |
| Seal strength | ASTM F88/F88M-09 | Met |
| Internal pressure | ASTM F1140/F1140M-13 | Met |
| Sterilization and Shelf Life Testing | ISO 10993-7:2008, USP37-NF 32, | Verified claimed shelf life based on tests on accelerated aged samples |
| EO residue | ISO 10993-7:2008 | Met |
| ECH residue | ISO 10993-7:2008 | Met |
| Bacteria Endotoxin Limit | USP37-NF 32, | Met |
| Shelf Life Evaluation | Physical, Mechanical Chemical, Package and Sterility Test on accelerated aged samples | Verified claimed shelf life of the device |
| Biocompatibility | ISO 10993 series standards | Not required; materials identical to previously cleared K113091 |
| Safety Feature Testing | FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 | Met pre-established criteria; force to activate and detach safety mechanism passed |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify the sample size for any of the non-clinical tests (e.g., number of syringes tested for each ISO standard criterion, number of packages for ASTM, number of devices for safety feature testing).
The provenance of the data is that it was generated through non-clinical bench testing performed by the manufacturer, Jiangyin Caina Technology Co., Ltd. (located in China). The summary reports on tests performed on the "proposed device." It does not indicate retrospective or prospective in the typical sense of clinical studies, as these are lab-based evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
This section is not applicable as the evaluation relies on direct measurement and adherence to objective standards (ISO, ASTM, USP) rather than expert interpretation of a ground truth in a clinical or image-based context. The "ground truth" is defined by the parameters and limits set forth in the referenced standards.
4. Adjudication Method for the Test Set
This section is not applicable. The tests are objective measurements against established standard criteria, not subjective assessments requiring adjudication among multiple reviewers.
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 as the device is a medical syringe with a safety feature, not an AI-powered diagnostic or assistive technology for human readers. There is no mention of AI in this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable for the same reason as point 5. The device does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth for most tests is based on objective, internationally recognized performance standards (ISO, ASTM, USP) which define acceptable limits for physical, mechanical, chemical, and sterility properties. For the simulated clinical study and safety feature testing, the "ground truth" was derived from "pre-established criteria" and FDA guidance for sharps injury prevention devices, which likely includes defined force thresholds or functional performance checks.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device and does not involve AI or machine learning models that require a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
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