The Retractable Safety Insulin Syringe is a sterile, single use, disposable and non-reusable, automatically retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.

Device Description

The Retractable Safety Insulin Syringe has the same technological characteristics as the Retractable Safety Syringe(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03. The difference between the Retractable Safety Insulin Syringe and the 1ml Retractable Safety Syringe is only the scale.

The Retractable Safety Insulin Syringe works like a conventional insulin syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe plunge, the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.

The Retractable Safety Insulin Syringe is available in various specifications. The proposed device consists of eleven components: (1) plunger. (2) piston. (3) barrel. (4) needle cap. (5) sealing plug. (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.

The proposed device is provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

AI/ML Overview

The provided text is a 510(k) Summary for a Retractable Safety Insulin Syringe (proposed device) and focuses on demonstrating its substantial equivalence to a predicate device (U&U Insulin Syringe with/without Safety Retractable Device). The acceptance criteria and supporting study details provided are primarily non-clinical, comparing the proposed device against established standards and to the predicate.

Here's the information extracted and organized as requested, with "N/A" where the document does not provide the specific detail, indicating it was likely not part of this specific submission or the type of device.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Standard/Test)	Reported Device Performance	Comments/Context
Biocompatibility	ISO 10993-7:2008 (Ethylene Oxide Sterilization Residuals)	Complies	Part of comprehensive ISO 10993 testing.
	ISO 10993-5:2009 (In vitro cytotoxicity)	Complies	Part of comprehensive ISO 10993 testing.
	ISO 10993-10:2010 (Irritation and delayed-type hypersensitivity)	Complies	Part of comprehensive ISO 10993 testing.
	ISO 10993-11:2017 (Systemic toxicity)	Complies	Part of comprehensive ISO 10993 testing.
	USP <151> Pyrogen Test	Complies
	ASTM F756-17 (Assessment of Hemolytic Properties)	Complies
	ISO 10993-4:2017 (Selection of tests for interactions with blood)	Complies	Part of comprehensive ISO 10993 testing.
Packaging & Sterility Maintenance	ASTM F1929-15 (Detecting seal leaks by dye penetration)	Complies
	ASTM F88/F88M-15 (Seal strength of flexible barrier materials)	Complies
	ASTM F1886/F1886M-16 (Integrity of Seals by Visual Inspection)	Complies
	USP <85> Bacterial Endotoxins Test	Complies
	SAL of 10^-6 for Ethylene Oxide Gas sterilization	Achieved	Sterility maintained for five years shelf life.
Needle & Syringe Performance	ISO 7864:2016 (Sterile hypodermic needles for single use)	Complies
	ISO 9626:2016 (Stainless steel needle tubing)	Complies
	ISO 8537:2016 (Sterile Single-use syringes, with or without needle, for insulin)	Complies	Differences in needle length between proposed and predicate addressed through this standard.
	ISO 23908:2011 (Sharps injury protection)	Complies	Addresses differences in safety feature principle between proposed and predicate devices.
Specific Device Performance (Safety Features)	Force to activation: not be more than 25N	10.48-20.91 N	Within acceptable range.
	Force to move plunger (to activate safety): not be less than 70N	83.67-116.97 N	Design ensures safety feature activation. (Predicate did not specify this as "NA")
	Force to separate plunger lid (for reuse prevention): not be less than 20N	25.14-32.67 N	Within acceptable range.
	Reuse prevention mechanism performance (for plunger being "stuck")	Achieved by barrel barb and convex point	The plunger cannot be re-moved after being pushed to the bottom.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for each test, but standard test methods (e.g., ISO, ASTM) typically specify lot sizes or sample numbers for compliance testing. The provided values for force measurements (e.g., 10.48-20.91 N) are ranges, suggesting multiple units were tested.
- Data Provenance: The tests were non-clinical, conducted by the manufacturer (Jiangsu Caina Medical Co., Ltd., China) as part of their substantial equivalence submission. The studies are by nature prospective tests performed on the manufactured device.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: N/A. This was a non-clinical device performance and materials testing study, not a study involving expert human interpretation or ground truth establishment in a clinical sense (e.g., image-based diagnosis). The "ground truth" here is compliance with established international and national standards for medical devices and their components.
- Qualifications of Experts: N/A. The compliance is assessed by technical testing, not expert consensus on interpretations.
Adjudication Method for the Test Set:
- Adjudication Method: N/A. As a non-clinical, standards-based compliance study, there was no "adjudication" in the sense of reconciling differing expert opinions. Test results are objective measurements against predefined criteria.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No. The document explicitly states: "Simulated clinical study was not conducted on proposed device," and "No clinical study is included in this submission." This type of study is common for diagnostic AI, not for a mechanical medical device like a syringe.
- Effect Size of Human Readers Improvement: N/A, as no MRMC study was performed.
If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
- Standalone Performance: N/A. This device is a mechanical syringe, not an algorithm. The "performance" discussed is the mechanical, biological, and material compliance of the device itself.
The Type of Ground Truth Used:
- Ground Truth: The ground truth for this device's acceptance is adherence to established international and national standards (e.g., ISO, ASTM, USP) for the performance, safety, and biocompatibility of syringes and their components, as well as comparison to a legally marketed predicate device. For example, the "ground truth" for "Force to activation" is that it must be <= 25N as per internal specifications driven by standard requirements.
The Sample Size for the Training Set:
- Training Set Sample Size: N/A. This is a manufactured medical device, not an AI/machine learning algorithm. There is no "training set" in this context. The manufacturing process and design are validated through the non-clinical tests described.
How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: N/A, as this is not an AI/ML context. The device's design and manufacturing processes are based on established engineering principles and existing standards for similar devices.

Summary

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July 20, 2020

Jiangsu Caina Medical Co.,Ltd. Xinyan Ruan Quality Engineer No.23, Huanxi Road, Zhutang Town Jiangyin, 214415 Cn

Re: K193022

Trade/Device Name: Retractable Safety Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: June 18, 2020 Received: June 22, 2020

Dear Xinyan Ruan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Tab 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: K193022

1. Date of Preparation: 04/29/2020
1. Sponsor Identification

Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214415, China

Establishment Registration Number: 3005670221

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

1. Designated Submission Correspondent
  Mr. Jianwei pan (Primary Contact Person) Email: jianwei.pan@cainamed.com Ms. Xinyan Ruan (Alternative Contact Person) Email: sherry.ruan@cainamed.com Tel: +86-510-86866666-8027 Fax: +86-510-86866666-8009
1. Identification of Proposed Device
  Trade Name: Retractable Safety Insulin Syringe

Regulatory Information Classification Name: Syringe, Anitstick Classification: II Product Code: MEG Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital

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Indications for Use Statement:

ર. Device Description

న్. Identification of Predicate Device
Predicate Device 510(k) Number: K152808 Product Name: U&U Insulin Syringe with/without Safety Retractable Device

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 results demonstrated that the proposed device complies with the following standards:

A ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization

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Residuals

ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and A delayed-type hypersensitivity
ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
USP <151> Pyrogen Test
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
ISO 10993-4:2017 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
A ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
USP <85> Bacterial Endotoxins Test
ISO 7864:2016 Sterile hypodermic needles for single use-requirements and test method.
A ISO 9626:2016 Stainless steel needle tubing for the manufacture of the medical devices-requirements and test method
ISO 8537:2016 Sterile Single-use syringes, with or without needle ,for insulin
ISO 23908:2011 Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

The structure principle, safety function and operation method of the proposed devices are identical with Retractable Safety Syringes(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03.Simulated clinical study was not conducted on proposed device.

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

ITEM	Proposed Device	Predicate DeviceK152808	Comment
Product code	MEG	MEG and FMF	Same
RegulationNo.	21 CFR 880.5860	21 CFR 880.5860	Same

Table 1 Comparison of Technology Characteristics with K152808

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Class	II	II	Same
Indicationsfor use	The Retractable SafetyInsulin Syringe is a sterile,single use, disposable andnon-reusable, automaticallyretractable safety insulinsyringe intended forinjection of U-100 insulininto the body, while reducingthe risk of sharps injuriesand the potential for insulinsyringe reuse.	The U&U Insulin Syringewith Safety RetractableDevice a sterile, single use,disposable and non-reusable,manual retractable safetyinsulin syringe intended forinjection of U-100 insulininto the body, while reducingthe risk of sharps injuriesand the potential for insulin syringereuse.The U&U insulin syringe isa sterile, single use,disposable and non-reusable,insulin syringe intended forinjection of U-100 insulininto the body.	Same
Configuration	PistonPlungerBarrelNeedle HubNeedleSafety feature	PistonPlungerBarrelNeedle HubNeedleSafety feature	Same
Sterilitycondition	EO Sterilized	EO Sterilized	Same
Environmentof use	Home or Hospital	Home or Hospital	Same
Safety featureprinciple	Spring retraction	manual retraction	See Comment 1
Volume	1ml	1ml	Same
Needle gauge	27-31G (0.25mm~0.40mm)	27-31G	Same
Needle length	8mm,10mm,13mm	Unknown	See Comment 2
Single use	Yes	Yes	Same
Operationmode	For Manual Use Only, ForSingle Use only	For Manual Use Only, ForSingle Use only	Same
Label/labeling	Complied with 21 CFR part801	Complied with 21 CFR part801	Same
Materials	PP, Polysoprene, TPE,Stainless Steel, MABS and	PP,TPE,StainlessSteel Silicone Oil	See Comment 3

	Polydimethysiloxane
PerformanceTesting	Conform to:	Conform to:	Same
	ISO 7864	ISO 7864
	ISO 9626	ISO 9626
	ISO 8537	ISO 8537
	ISO 23908	ISO 23908
	Force to activation: not bemore than 25N;test value 10.48-20.91	Test value 10.18-20.45N;	Same
	Force to move plunger: notbe less than 70N;test value 83.67-116.97	NA;	Comment 4
Safety FeaturePerformance	Reuse prevention:It is achieved through thebarrel barb and convex pointare stuck when the plunger ispushed to the bottom.	Reuse prevention:It is achieved throughpulling back the plunger andsnapped off.
	Force to separate plungerlid: not be less than 20N;test value 25.14-32.67	Test value 25.18-32.92N;	Same
	Biocompatibility	Cytotoxicity	Conforms to ISO10993(Part1:Evaluation andtesting, Part 4: Selection oftests for interactions withblood, Part 5: Tests for invitro cytotoxicity, Part 7:Ethylene oxide sterilizationresiduals,Part 10: Tests forirritation and delayed-typehypersensitivity, Part 11:Tests for systemic toxicity)
		Sensitization
		Irritation
Acute systemic toxicity
Material mediatedpyrogenicity
Hemocompatibility
Subchronic toxicity
Particulate matters

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Comment 1

Differences in safety feature principle between the predicate and subject device were addressed through ISO 23908 Safety Feature Performance Test.The safety feature principle of subject devicer is identical with Retractable Safety Syringes(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03.

Comment 2

Differences in needle length between the predicate and subject device were addressed through ISO 8537 performance testing.

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Comment 3

Differences in materials between the predicate and subject device were addressed through Biocompatibility Statement and copy of test report.

Comment 4

Differences in reuse prevention, for the predicate device this is achieved through pulling back the plunger and snapped off, for the proposed device a convex point is designed on the plunger and a barrel barb is designed in the barrel. When the plunger is pushed to the bottom, the barb and convex point are stuck, the plunger can not be re-moved to prevent reuse. At the same time, the front end of the slide bushing opens the barrel to release the needle hub and activate the safety function. Under the spring, the needle hub falls back into the plunger, and the needle tube is shielded inside the plunger. Force to re-move plunger have be tested in Safety Feature Performance Test Report, which is more than 70N. Proposed Device and Predicate Device are different designs, however performance demonstrated the differences do not raise any new safety concerns.

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 device.

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).