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.

Device Description

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.

AI/ML Overview

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, <85>	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, <85>	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.

Summary

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Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K150758

1. Date of Preparation: 05/22/2015
1. Sponsor Identification

Jiangyin Caina Technology Co., Ltd. No.2, Taifu Road, Huashi Town, Jiangyin, Jiangsu, 214421, China

Establishment Registration Number: 3005670221

Contact Person: Jun Lu Position: General Manager Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu@cainamedical.com

1. Identification of Proposed Device
  Trade Name: Safelock Disposable Insulin Syringe Common Name: Insulin syringe with needle

Regulatory Information

Classification Name: Syringe, Piston Classification: II; Product Code: FMF, MEG Regulation Number: 21CFR 880.5860 Review Panel: General Hospital;

Intended Use Statement:

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.

Device Description

Safelock Disposable Insulin Syringes are provided sterile, single use, which consist of five pieces 1 / 5

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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.

1. Identification of Predicate Device
  510(k) Number: K103011 Product Name: UltiMed UltiCare Safety Insulin Syringe Manufacturer: UltiMed Inc
ર : Identification of Reference Device
510(k) Number: K113091 Product Name: Syringes and Needles Manufacturer: Jiangyin Caina Technology Co., Ltd.

The patient contact materials of the proposed device are identical to those of the legally marketed device, Syringes and Needles, as cleared in K113091 on 10/28/2011, which is also manufactured by Jiangyin Caina Technology Co., Ltd.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The tests provided in this submission include:

Physical, Mechanical and Chemical Tests performed on the proposed device (Syringe):

Freedom from extraneous matter	Clause 5 of ISO 8537:2007
Limits for acidity and alkalinity	Clause 6.1 of ISO 8537:2007
Limits for extractable metals	Clause 6.2 of ISO 8537:2007
Lubrication of syringes and needles	Clause 7 of ISO 8537:2007
Range of sizes	Clause 8 of ISO 8537:2007
Scale	Clause 9.1 of ISO 8537:2007
Numbering of scale	Clause 9.2 of ISO 8537:2007
Dimensions	Clause 10.1 of ISO 8537:2007
Finger grips	Clause 10.2 of ISO 8537:2007
Piston/plunger assembly	Clause 11.1 of ISO 8537:2007
Fit of piston in barrel	Clause 11.2 of ISO 8537:2007
Needle tubing for syringes	Clause 13.2 of ISO 8537:2007
Dead space	Clause 14.1 of ISO 8537:2007

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Freedom from leakage at needle Liquid and air leakage past piston Clause 14.2 of ISO 8537:2007 Clause 14.3 of ISO 8537:2007

Physical, Mechanical and Chemical Tests performed on the proposed device (Needle):

Materials	Clause 3 of ISO 9626:1991/AMD-1:2001
Surface finish	Clause 4 of ISO 9626:1991/AMD-1:2001
Cleanliness	Clause 5 of ISO 9626:1991/AMD-1:2001
Limits for acidity and alkalinity	Clause 6 of ISO 9626:1991/AMD-1:2001
Size designation	Clause 7 of ISO 9626:1991/AMD-1:2001
Dimensions	Clause 8 of ISO 9626:1991/AMD-1:2001
Stiffness	Clause 9 of ISO 9626:1991/AMD-1:2001
Resistance to breakage	Clause 10 of ISO 9626:1991/AMD-1:2001
Resistance to corrosion	Clause 11 of ISO 9626:1991/AMD-1:2001

Sterile Barrier Packaging Testing performed on the proposed device:

Seal strength	ASTM F88/F88M-09
Internal pressure	ASTM F1140/F1140M-13

Sterilization and Shelf Life Testing performed on the proposed device:

EO residue	ISO 10993-7:2008
ECH residue	ISO 10993-7:2008
Bacteria Endotoxin Limit	USP37-NF 32, <85>
Shelf Life Evaluation	Physical, Mechanical Chemical, Package and Sterility Testwere performed on accelerated aged samples to verify theclaimed shelf life of the device.

Biocompatibility Testing:

The patient-contact materials of Safelock Disposable Insulin Syringes devices are identical to the previously cleared Syringes and Needles (K113091), and therefore additional biocompatibility testing to ISO 10993 standards is not required.

Simulate Clinical Study performed on the proposed device:

A simulated clinical study was performed according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005, to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

Safety Feature Testing performed on the proposed device:

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Safety feature tests were performed on the proposed device to determine the force to activate the safety mechanism (Protective shield) and the force to detach/destroy the safety mechanism (Protective shield). The results demonstrated that the performances of the safety mechanism of proposed device met the pre-established criteria.

1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Substantially Equivalent (SE) Comparison

Item	Proposed device	Predicate DeviceK103011	Reference DeviceK113091
Product	Safelock Disposable InsulinSyringe	UltiMed UltiCare Safety InsulinSyringe	Syringes and Needles
Product Code	MEG, FMF	MEG, FMF, FMI	/
Regulation Number	21 CFR 880.5860	21 CFR 880.5860 &21 CFR880.5570	/
Intended Use	Safelock disposable insulinsyringe is intended to injectU-100 insulin into the humanbody and aid in theprevention of accidentalneedle stick injuries.	The UltiCare Safety InsulinSyringe is intended to injectU-100 insulin into the body. Thesafety mechanism aids in theprevention of needle stickinjuries.	/
Feature	Orange Needle cap,Fixed Needle;Piston;Plunger;Barrel;Orange Protective end cap;Safety feature	Orange Needle cap,Fixed Needle;Piston;Plunger;Barrel;Orange Protective end cap;Safety feature (Protective shield)	/
Sterile	Yes	Yes	/
Single Use	Yes	Yes	/
Color Coding	Yes	Yes	/
Performance	ISO 9626:1991,AMENDMENT 1 2001ISO 8537:2007	ISO 9626:1991, AMENDMENT1 2001ISO 8537:2007	/
Biocompatibility	Conforms to the requirementof ISO 10993 seriesStandards	Conforms to the requirement ofISO 10993 seriesStandards	Conforms to the requirementof ISO 10993 seriesStandards
Patientcontact	PlungerBarrel	PP (polypropylene)PP (polypropylene)	UnknownUnknown	PP (polypropylene)PP (polypropylene)

Table 1 Comparison between proposed device and predicate device

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material	Piston	Polysoprene	Unknown	Polysoprene
	Needle	304 Stainless steel	Stainless steel	304 Stainless steel
	Lubricant	Polydimethylsiloxane	Unknown	Polydimethylsiloxane

Substantially Equivalent (SE) Conclusion 9.
Based on the comparison, the intended use, features and safety mechanism of proposed devices are determined to be Substantially Equivalent (SE) to the predicate device, K103011; both the proposed device and predicate device, K103011, are complied with FDA recognized performance standard, ISO 8537:2007 and ISO 9626:1991, AMENDMENT 1 2001. Comparison tests were also performed to demonstrate that the performance of safety mechanism of both proposed device and predicate device, K103011, are substantially equivalent. The materials used in predicate device, K103011, were not available, materials of proposed devices are not compared with those of predicate device, K103011; however, materials used in the proposed devices are exactly identical to the reference device, K113091.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A 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 male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).