Safelock Disposable Insulin Syringe

K150758 · Jiangyin Caina Technology Co., Ltd. · FMF · Jun 18, 2015 · General Hospital

Device Facts

• Record ID: K150758
• Device Name: Safelock Disposable Insulin Syringe
• Applicant: Jiangyin Caina Technology Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Jun 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Safelock Disposable Insulin Syringe; sterile, single-use device for U-100 insulin delivery. Components: syringe barrel, permanently attached needle, needle cap, plunger, protective end cap, and integrated safety mechanism. Safety mechanism designed to prevent accidental needle stick injuries. Device used by patients or healthcare providers for subcutaneous insulin administration. Safety feature activation and detachment forces verified via simulated clinical study per FDA guidance. Performance verified through physical, mechanical, and chemical testing against ISO 8537 and ISO 9626 standards.

Clinical Evidence

No clinical study included. Bench testing performed for physical, mechanical, and chemical properties per ISO 8537 and ISO 9626. Simulated clinical study conducted per FDA guidance for sharps injury prevention features to verify safety mechanism performance. Biocompatibility established via reference to K113091.

Technological Characteristics

Materials: 304 stainless steel needle, polyisoprene piston, polydimethylsiloxane lubricant, polypropylene barrel. Standards: ISO 8537:2007 (syringes), ISO 9626:1991/AMD-1:2001 (needles), ISO 10993 (biocompatibility), ASTM F88/F88M-09 (seal strength), ASTM F1140/F1140M-13 (internal pressure). Sterilization: Ethylene Oxide (EO). Form factor: Fixed needle syringe with integrated safety shield.

Indications for Use

Indicated for patients requiring U-100 insulin injections. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• UltiMed UltiCare Safety Insulin Syringe (K103011)

Reference Devices

• Syringes and Needles (K113091)

Submission Summary (Full Text)

{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, <85> |
| Shelf Life Evaluation | Physical, Mechanical Chemical, Package and Sterility Test<br>were performed on accelerated aged samples to verify the<br>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<br>K103011 | Reference Device<br>K113091 | |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------|
| Product | Safelock Disposable Insulin<br>Syringe | UltiMed UltiCare Safety Insulin<br>Syringe | Syringes and Needles | |
| Product Code | MEG, FMF | MEG, FMF, FMI | / | |
| Regulation Number | 21 CFR 880.5860 | 21 CFR 880.5860 &21 CFR<br>880.5570 | / | |
| Intended Use | Safelock disposable insulin<br>syringe is intended to inject<br>U-100 insulin into the human<br>body and aid in the<br>prevention of accidental<br>needle stick injuries. | The UltiCare Safety Insulin<br>Syringe is intended to inject<br>U-100 insulin into the body. The<br>safety mechanism aids in the<br>prevention of needle stick<br>injuries. | / | |
| Feature | Orange Needle cap,<br>Fixed Needle;<br>Piston;<br>Plunger;<br>Barrel;<br>Orange Protective end cap;<br>Safety feature | Orange Needle cap,<br>Fixed Needle;<br>Piston;<br>Plunger;<br>Barrel;<br>Orange Protective end cap;<br>Safety feature (Protective shield) | / | |
| Sterile | Yes | Yes | / | |
| Single Use | Yes | Yes | / | |
| Color Coding | Yes | Yes | / | |
| Performance | ISO 9626:1991,<br>AMENDMENT 1 2001<br>ISO 8537:2007 | ISO 9626:1991, AMENDMENT<br>1 2001<br>ISO 8537:2007 | / | |
| Biocompatibility | Conforms to the requirement<br>of ISO 10993 series<br>Standards | Conforms to the requirement of<br>ISO 10993 series<br>Standards | Conforms to the requirement<br>of ISO 10993 series<br>Standards | |
| Patient<br>contact | Plunger<br>Barrel | PP (polypropylene)<br>PP (polypropylene) | Unknown<br>Unknown | PP (polypropylene)<br>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.