Disposable Insulin Syringe

K162180 · Berpu Medical Technology Co., Ltd. · FMF · Dec 29, 2016 · General Hospital

Device Facts

• Record ID: K162180
• Device Name: Disposable Insulin Syringe
• Applicant: Berpu Medical Technology Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Dec 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The disposable insulin syringe is intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of insulin into parts of the body below the surface skin.

Device Story

Disposable insulin syringe with fixed needle; used for manual aspiration and subcutaneous injection of U-100 insulin. Device consists of polypropylene barrel, plunger, and protective caps, polyisoprene rubber piston, and stainless steel (SUS304) needle. Available in 0.3ml, 0.5ml, and 1ml volumes with various needle gauges (27G-31G) and lengths (5mm-12mm). Operated manually by clinician or patient. Pushing plunger rod generates force to inject insulin into subcutaneous tissue. Provided sterile, single-use. Benefits include accurate insulin delivery for diabetes management.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via physical, mechanical, and chemical testing per ISO 9626, ISO 7864, and ISO 8537. Biocompatibility confirmed per ISO 10993. Sterilization validated per ISO 11135.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, caps), Polyisoprene (piston), Stainless Steel SUS304 (needle). Dimensions: 0.3-1.0ml volume; 27G-31G needles; 5-12mm lengths. Principle: Manual piston-driven injection. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ISO 9626, ISO 7864, ISO 8537, ISO 10993, ASTM F88, ASTM F1140, ASTM F1929.

Indications for Use

Indicated for patients requiring manual aspiration and subcutaneous injection of U-100 insulin.

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

• Sterile Insulin Syringe for single use with fixed needle (K072739)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 29, 2016

Berpu Medical Technology Co., Ltd % Diana Hong Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200120 CHINA

Re: K162180

Trade/Device Name: Disposable Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 28, 2016 Received: December 2, 2016

Dear Diana Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K162180

Device Name Disposable Insulin Syringe

Indications for Use (Describe)

The disposable insulin syringe is intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of insulin into parts of the body below the surface skin.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# Exhibit #2 510(k) Summary

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

The assigned 510(k) Number: __K162180

- 1. Date of Preparation: 12/22/2016
- 2. Sponsor Identification

### Berpu Medical Technology Co., Ltd

No. 14 Xingji Road, Yongxing Street, Longwan District, 325000, Wenzhou, Zhejiang Province

Establishment Registration Number: 3004496829

Contact Person: Jundong Tan Position: Management Representative Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### Identification of Proposed Device 4.

Trade Name: Disposable Insulin Syringe Common Name: Insulin syringe with needle

### Regulatory Information

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

Indication for Use:

The disposable insulin syringe is intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of insulin into parts of the body below the surface skin.

### Device Description

The proposed device is a syringe with fixed needle tube which is intended for injection the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The insulin is injected to subcutaneous tissue by pushing force generated through pushing plunger rod of the insulin syringe. The proposed devices are provided sterile, single use.

The proposed device is available in 0.3ml, 0.5ml and 1ml volumes.

- 5. Identification of Predicate Device
510(k) Number: K072739 Product Name: Sterile Insulin Syringe for single use with fixed needle

Manufacturer: ShanDong Weigao Group Medical Polymer Products 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 test provided in this submission include:

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Physical, Mechanical and Chemical Tests performed on the proposed device

| 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 |

| Cleanliness | Clause 4 of ISO 7864:1993 |
|----------------------------------|----------------------------|
| Limits for acidity or alkalinity | Clause 5 of ISO 7864:1993 |
| Limits for extractable metals | Clause 6 of ISO 7864:1993 |
| Size designation | Clause 7 of ISO 7864:1993 |
| Colour coding | Clause 8 of ISO 7864:1993 |
| Needle hub | Clause 9 of ISO 7864:1993 |
| Sheath | Clause 10 of ISO 7864:1993 |
| Needle tube | Clause 11 of ISO 7864:1993 |
| Needle point | Clause 12 of ISO 7864:1993 |
| Performance | Clause 13 of ISO 7864:1993 |

| Freedom from extraneous matter | Clause 5 of ISO 8537:2007 |
|-------------------------------------|-----------------------------|
| Limits for extraneous matter | Clause 6 of ISO 8537:2007 |
| Lubrication of syringes and needles | Clause 7 of ISO 8537:2007 |
| Range of size | Clause 8 of ISO 8537:2007 |
| Graduated scale | Clause 9 of ISO 8537:2007 |
| Barrel | Clause 10 of ISO 8537:2007 |
| Piston/plunger assembly | Clause 11 of ISO 8537:2007 |
| Needle tubing and needles | Clause 13 of ISO 8537:2007 |
| Performance of assembled syringe | Clause 14 of ISO 8537:2007 |
| Dose Accuracy testing | Clause 9.1 of ISO 8537:2007 |

Sterile Barrier Packaging Testing performed on the proposed device:

| Seal strength | ASTM F88/F88-09 |
|-------------------|----------------------|
| Internal pressure | ASTM F1140/F1140M-13 |
| Dye penetration | ASTM F 1929-12 |

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Sterilization and Shelf Life Testing performed on the proposed device:

| SAL | 10-6 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Validation method | ISO 11135:2014 |
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 38-NF 33 <85> |
| LAL Pyrogen Test | ISO 10993-11:2006 |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package and Sterility<br>Tests were performed on accelerated aging samples to<br>verify the claimed shelf life of the device |

Biocompatibility Testing

The patient-contact materials of Disposable Insulin Syringe are identified and biocompatibility testing is performed according to ISO 10993 standards

#### 7. Clinical Test Conclusion

No clinical study is included in this submission.

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#### Substantially Equivalent (SE) Comparison 8.

| Item | Proposed Device | Predicate Device<br>K072739 | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|------------------------|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Product Code | FMF | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation No. | 21CFR 880.5860 | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification | II | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Indication for Use | The disposable insulin syringe is intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of insulin into parts of the body below the surface skin. | The sterile insulin syringe for single use with fixed needle is a device 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 | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Configuration and Material | Configuration Material Protective end cap Polypropylene (PP) Plunger Polypropylene (PP) Barrel Polypropylene (PP) Piston Polyisoprene Rubber Needle Stainless Steel (SUS304) Needle cover Polypropylene (PP) | | | | | | | | | | | | | | | Configuration Material Protective end cap Polypropylene (PP) Plunger Polypropylene (PP) Barrel Polypropylene (PP) Piston Polyisoprene Rubber Needle Stainless Steel (SUS304) Needle cover Polypropylene (PP) | | | | | | | | | | | | | | |
| Syringe Volume | 0.3ml, 0.5ml, 1.0ml | 0.5ml, 1.0ml | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Needle Gauge | 31G, 30G, 29G, 28G, 27G | 30G, 29G, 28G | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Needle Diameter | 0.25mm, 0.30mm, 0.33mm,0.36mm, 0.40mm | 0.30mm, 0.33mm, 0.36mm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Needle Length | 5mm, 6mm, 8mm, 12mm | Unknown | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Performance Test | Comply with<br>ISO 9626<br>ISO 7864<br>ISO 8536 | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sterile | EO Sterilized | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Single Use | Single Use | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Biocompatibility | Cytotoxicity No cytotoxicity Irritation No irritation reactivity Sensitization No significant evidence of skin sensitization Systemic Toxicity No significant evidence of systemic toxicity Hemolysis No evidence of hemolysis | | | | | | | | | | | Conform with ISO 10993 | | | | | | | | | | | | | | | | | | |

## Table 1 Comparison of Technology Characteristics

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| K162180 | S001 | E2 510(k) Summary |
|---------|------|-------------------|
|---------|------|-------------------|

| Pyrogen | No evidence of |
|---------|----------------|
| | pyrogens |

#### 9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.