Safety Disposable Insulin Syringe

• K Number: K150758
• Device Name: Safety Disposable Insulin Syringe
• Manufacturer: JIANGYIN CAINA TECHNOLOGY CO., LTD
• Date Cleared: 2015-06-18 ( 87 days)
• Product Code: FMF MEG
• Regulation Number: 880.5860

Intended Use

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.

Predicate Devices

K103011

Reference Devices

K113091

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and mechanical aspects of a disposable insulin syringe with a safety mechanism. There is no mention of AI or ML in the intended use, device description, or performance testing.

Therapeutic

No
The device is described as an insulin syringe intended to inject insulin, which is a drug delivery device, not a therapeutic device. It aids in drug administration and needle stick prevention, but does not directly provide therapy itself.

Diagnostic

No
The device, an insulin syringe, is intended for injecting insulin and preventing needle stick injuries. Its function is to administer a substance, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a syringe barrel, needle, plunger, and safety mechanism, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to "inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries." This describes a device used for administering a substance directly into the body, not for examining specimens in vitro (outside the body) to obtain diagnostic information.
• Device Description: The description details a syringe and needle, components used for injection, not for performing diagnostic tests on biological samples.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition or disease in vitro.

IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the delivery of medication.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FMF, MEG

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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) and on the proposed device (Needle). Sterile Barrier Packaging Testing performed on the proposed device. Sterilization and Shelf Life Testing performed on the proposed 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. 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: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K103011

Reference Device(s)

K113091

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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
• 2. 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: [phone] Fax: [phone] Email: [e-mail]

• 3. 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

1

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.

• 4. 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.

• 6. 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

2

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,
Shelf Life Evaluation	Physical, Mechanical Chemical, Package and Sterility Test
were performed on accelerated aged samples to verify the
claimed 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:

3

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.

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

| Item | Proposed device | Predicate Device
K103011 | Reference Device
K113091 | |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------|
| Product | Safelock Disposable Insulin
Syringe | UltiMed UltiCare Safety Insulin
Syringe | Syringes and Needles | |
| Product Code | MEG, FMF | MEG, FMF, FMI | / | |
| Regulation Number | 21 CFR 880.5860 | 21 CFR 880.5860 &21 CFR
880.5570 | / | |
| Intended Use | 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. | The UltiCare Safety Insulin
Syringe is intended to inject
U-100 insulin into the body. The
safety mechanism aids in the
prevention of needle stick
injuries. | / | |
| 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 2001
ISO 8537:2007 | ISO 9626:1991, AMENDMENT
1 2001
ISO 8537:2007 | / | |
| Biocompatibility | Conforms to the requirement
of ISO 10993 series
Standards | Conforms to the requirement of
ISO 10993 series
Standards | Conforms to the requirement
of ISO 10993 series
Standards | |
| Patient
contact | Plunger
Barrel | PP (polypropylene)
PP (polypropylene) | Unknown
Unknown | PP (polypropylene)
PP (polypropylene) |

• Table 1 Comparison between proposed device and predicate device

4

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.