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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Disposable Insulin Syringe (K162180) by Berpu Medical Technology Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device (K072739).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with various international standards for medical devices and specific tests. The table below summarizes these, acting as both acceptance criteria and reported performance (as the tests were performed to verify compliance).

Acceptance Criteria (Standard & Clause)	Reported Device Performance
For materials (ISO 9626:1991/AMD-1:2001)
Clause 3: Materials	Complies
Clause 4: Surface finish	Complies
Clause 5: Cleanliness	Complies
Clause 6: Limits for acidity and alkalinity	Complies
Clause 7: Size designation	Complies
Clause 8: Dimensions	Complies
Clause 9: Stiffness	Complies
Clause 10: Resistance to breakage	Complies
Clause 11: Resistance to corrosion	Complies
For sterility/cleanliness (ISO 7864:1993)
Clause 4: Cleanliness	Complies
Clause 5: Limits for acidity or alkalinity	Complies
Clause 6: Limits for extractable metals	Complies
Clause 7: Size designation	Complies
Clause 8: Colour coding	Complies
Clause 9: Needle hub	Complies
Clause 10: Sheath	Complies
Clause 11: Needle tube	Complies
Clause 12: Needle point	Complies
Clause 13: Performance	Complies
For insulin syringes (ISO 8537:2007)
Clause 5: Freedom from extraneous matter	Complies
Clause 6: Limits for extraneous matter	Complies
Clause 7: Lubrication of syringes and needles	Complies
Clause 8: Range of size	Complies
Clause 9: Graduated scale	Complies
Clause 10: Barrel	Complies
Clause 11: Piston/plunger assembly	Complies
Clause 13: Needle tubing and needles	Complies
Clause 14: Performance of assembled syringe	Complies
Clause 9.1: Dose Accuracy testing	Complies
Sterile Barrier Packaging Testing
ASTM F88/F88-09: Seal strength	Complies
ASTM F1140/F1140M-13: Internal pressure	Complies
ASTM F1929-12: Dye penetration	Complies
Sterilization and Shelf Life Testing
SAL: 10-6	Achieved SAL 10-6
Validation method: ISO 11135:2014	Validation performed
EO residue: ISO 10993-7:2008	Complies with ISO 10993-7:2008
ECH residue: ISO 10993-7:2008	Complies with ISO 10993-7:2008
Bacteria Endotoxin Limit: USP 38-NF 33 <85>	Complies (No evidence of pyrogens)
LAL Pyrogen Test: ISO 10993-11:2006	Complies (No evidence of pyrogens)
Shelf Life Evaluation (Physical, Mechanical, Chemical, Package, Sterility)	Tests performed on accelerated aging samples to verify claimed shelf life
Biocompatibility Testing (ISO 10993 standards)
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
Pyrogen (mentioned again in comparison table)	No evidence of pyrogens

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each of the physical, mechanical, chemical, packaging, sterilization, or biocompatibility tests. It broadly states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is implied to be from internal testing conducted by Berpu Medical Technology Co., Ltd in China, as they are the sponsor. The studies are prospective in the sense that they are conducted on the device being submitted for approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The ground truth for these types of device performance tests is typically established by compliance with international standards and validated testing methodologies, rather than expert consensus on individual cases.

4. Adjudication method for the test set

This information is not provided, as the studies are device performance tests against pre-defined standards, not typically involving adjudication of subjective outcomes by experts.

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

A MRMC comparative effectiveness study was not done. This device is a disposable insulin syringe, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is not applicable to a disposable insulin syringe, which is a physical medical device and not an algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance of the Disposable Insulin Syringe is largely based on compliance with established international and national standards (ISO 9626, ISO 7864, ISO 8537, ISO 11135, ISO 10993-7, ISO 10993-11, USP 38-NF 33 <85>, ASTM F88/F88-09, ASTM F1140/F1140M-13, ASTM F1929-12). These standards define acceptable ranges, limits, and methodologies for evaluating the physical, mechanical, chemical, and sterility properties of such devices.

8. The sample size for the training set

This is not applicable. The device is a physical medical instrument, not an AI model, and therefore does not have a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
1. 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: +86-577-86651999 Fax: +86-577-86630389 Email: BERPU@BERPU.COM

1. 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: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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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 available in 0.3ml, 0.5ml and 1ml volumes.

1. 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 SterilityTests were performed on accelerated aging samples toverify 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 DeviceK072739
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 withISO 9626ISO 7864ISO 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.

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).