The Safety Insulin Syringe is a sterile, single use and non-reusable 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 Safety Insulin Syringe is a sterile, single use and non-reusable syringe with a permanently attached needle, which is intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 26G-34G gauge needle. The safety feature will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Safety Insulin Syringe," not an AI/ML medical device. Therefore, the information required to populate the fields related to AI/ML acceptance criteria and study design (such as training sets, test sets, expert adjudication, MRMC studies, etc.) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of the physical, chemical, and performance characteristics of the syringe itself, as well as its safety features.

However, I can extract the acceptance criteria and performance data that are relevant to this type of medical device submission.

Here's a summary based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance (for a non-AI/ML medical device)

The device, a "Safety Insulin Syringe," is evaluated based on its physical, chemical, and safety performance. The acceptance criteria are typically compliance with recognized international standards and demonstration of specific functional parameters.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Needle Performance	Compliance with ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices - Requirements and methods) and ISO 7864:2016 (Sterile hypodermic needles for single use - Requirements and test methods).	Device demonstrated to be in conformance with ISO 9626 and ISO 7864:2016.
Syringe Performance	Compliance with ISO 8537:2016 (Sterile single-use syringes, with or without needle, for insulin).	Device demonstrated to be in conformance with ISO 8537:2016.
Safety Feature Performance	Compliance with ISO 23908-First edition: Sharps Injury Protection - Requirements and Test Methods - Sharps protection features for single-use hypodermic needles. Specific parameters: - Force to activate the safety mechanism: less than 5N. - Force that the safety mechanism is destroyed (resist force): greater than 20N.	The safety feature performance test for the proposed device was evaluated, and the test result conforms to requirements of ISO 23908:2011 standards. - "The force to activate the safety mechanism is less than 5N" was met. - "The force that the safety mechanism is destroyed is greater than 20N" was met.
Biocompatibility	Compliance with ISO 10993-1 for Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24 hours to 30 days). Testing includes: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility, Subacute Systemic Toxicity.	Biocompatibility evaluated and results comply with ISO 10993 requirements. Specific tests conducted were: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility, and Subacute Systemic Toxicity.
Particulate Matter	Compliance with USP <788>.	Testing performed and results not explicitly stated but implied to be compliant through lack of identified issue.
Sterilization & Residues	Validation of sterilization per ISO 11135. Compliance with ISO 10993-7:2008 for EO and ECH (Ethylene Chlorohydrin) residue limits. Compliance with USP <85> for Bacterial Endotoxin Limit.	Sterilization method validated per ISO 11135. Device found to be compliant with ISO 10993-7:2008 for EO and ECH residue and USP <85> for Bacterial Endotoxin Limit.
Shelf Life & Packaging Integrity	Shelf life of 5 years. Evaluation using physical, mechanical, chemical, and package tests on aging samples (validated using ASTM F1980-16 for accelerated aging). Simulated Transportation Test (ASTM D4169-16). Sterile Barrier Packaging Testing: Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88M-15), Dye Penetration (ASTM F1929-15).	5-year shelf life determined based on stability studies including accelerated aging. Simulated transportation test conducted according to ASTM D4169-16. Sterile barrier packaging tests performed: Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88M-15), and Dye Penetration (ASTM F1929-15) – all implied to be compliant.
Simulated Clinical Use (for Sharps Injury Prevention)	Evaluation of the safety mechanism according to FDA Guidance, "Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature" (August 9, 2005) and ISO 23908. Pre-established criteria for safe and effective activation and protection.	A simulated clinical use study was performed on 500 device samples. The results demonstrated that the proposed device met the pre-established criteria.

Since this is not an AI/ML device, the following points are not applicable and are listed as "N/A":

Sample size used for the test set and the data provenance:
- Test Set Sample Size: N/A (for AI/ML test sets). For simulated clinical use of the physical device, 500 device samples were used.
- Data Provenance: N/A (for AI/ML test sets, as no image/data input is being classified). The physical device performance testing was performed by the manufacturer, Berpu Medical Technology Co., Ltd. (China). The tests are non-clinical (laboratory/bench testing) and simulate real-world use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth based on expert review of data is established for this type of device).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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: N/A.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (for AI/ML ground truth). The "ground truth" for this medical device is adherence to physical/performance standards (e.g., ISO, ASTM, USP) and functional testing parameters for its mechanical safety features.
The sample size for the training set: N/A.
How the ground truth for the training set was established: N/A.

Summary

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August 23, 2022

Berpu Medical Technology Co., Ltd. David Yu Management Representative No. 14 Xingji Road, Yongxiing Street Wenzhou. Zhejiang 325000 China

Re: K220061

Trade/Device Name: Safety Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: July 26, 2022 Received: July 26, 2022

Dear David Yu:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 medical devices and radiation-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,

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) K220061

Device Name Safety Insulin Syringe

Indications for Use (Describe)

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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K220061

510kSummary

I. Submitter

Berpu Medical Technology Co., Ltd. NO.14 Xingji Road, Yongxing Street, Longwan District, Wenzhou, Zhejiang, China 325000

Establishment Registration Number: 3004496829

Contact person: David Yu Position: Management representative Tel.: +86-18868131179 Fax: 0577-86630389 E-mail: 274269118@qq.com

Preparation date:

Proposed Device II.

Trade Name of Device:	Safety Insulin Syringe
Common name:	Piston Syringe
Regulation Number:	21 CFR 880.5860
Regulatory Class:	Class II
Product code:	FMF, MEG
Review Panel	General Hospital

III. Predicate Devices

K202570

Insulin Syringe with Safety Retractable

IV .Device description

The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 10 ° and supplied in

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immediate package which could maintain the sterility of the device during the shelf life of 5 years.

The proposed syringes are available in different combination of syringe volumes and/or needle sizes (refer to Table 1).

Syringe volume	Needle sizes
	Needle length (mm)	Needle gauge	Wall
0.3ml	4, 5, 6, 8, 9, 10, 12,	30G, 31G, 32G,	RW
0.5ml	13	33G, 34G	TW
1ml			ETW
0.3ml	4, 5, 6, 8, 9, 10, 12,	26G, 27G, 28G,	RW
0.5ml	13	29G	TW
1ml

Table 1 specification of proposed device

V. Indication for use

Characteristic	Proposed DeviceSafety Insulin SyringeK220061	Predicate DeviceInsulin Syringe with Safety RetractableK202570
Indication for Use	The Safety Insulin Syringe is a sterile, single use and non-reusable 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.	The Insulin Syringe with Safety Retractable is a sterile, single use and non-reusable, manual 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

Discussions of differences in Indications for Use statement

There are only editorial differences to the indications for use statement between the predicate and the subject device which do not change the indications.

VI. Comparison of technological characteristics with the predicate devices

The comparison and discussion between the subject device and the predicate devices are listed in below table 2:

Item	Proposed device(K220061)	Predicate device(K202570)	Discussion

Table 2. Technological Characteristics
----------------------------------------	--

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Prescription/over-the-counteruse	Prescription Use	Prescription Use	Same
Configurationand material	1) (1) needle cap(Polypropylene)	1) Needle Cap(Polypropylene)	Same
	2) (2) needle tube (StainlessSteel 304)	2) Needle Tube(SUS304)	Same
	3) (3) Rubber piston(Polyisoprene Rubber)	3) Plunger Stopper(PolyisopreneRubber)	It's the samecomponent,just with adifferentname
	4) barrel (Polypropylene)	4) Barrel(Polypropylene)	Same
	5) plunger (Polypropylene)	5) Plunger(Polypropylene)	Same
	6) Safety protector(Polypropylene)	6) Safety-shield(Polypropylene)	It's the samecomponent,just with adifferentname
	7) Fixed hub(Polypropylene)	/	DifferentSee comment#1
	8) end cap (Polypropylene)	/
	9) Lubricant(Polydimethylsiloxane)	unknown
	10) Adhesive (UV CuringAdhesive)	unknown
Size	0.3ml, 0.5ml, 1ml	0.5ml, 1ml	Different-
Needle Gauge	26G to 34G	27G to 31G	See comment#2
Needle Length(mm)	4, 5, 6, 8, 9, 10, 12, 13	1/2", 5/16", 1/4"
Wall type	RW, TW, ETW	/

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Needleperformance	ISO 9626ISO 7864	ISO 9626ISO 7864	Same
Syringeperformance	ISO 8537	ISO 8537	Same
Safety featureperformance	The force to activate thesafety mechanism is less than5NThe force that the safetymechanism is destroyed isgreater than 20N	In-Safe mode force: notbe more than 5NResist force:60s with 20N weights,and the protective deviceshall not be opened	DifferenceSee comment# 3
Intended userpopulation	Adult and Pediatric	Adult and Pediatric	Same

Discussions of differences in technological characteristics

Comment# 1

The configurations and raw materials of Safety Insulin Syringe are different from predicate device. These differences do not raise new questions of safety or effectiveness. The biocompatibility for the subject device has been evaluated and the results comply with the requirements of ISO 10993.

Comment# 2

The needle gauge and length for proposed devices is different from the predicate devices. The differences do not raise new questions of safety or effectiveness.

Comment# 3

The Safety feature performance specification for predicate device is a little difference. The safety mechanism of proposed device is implemented by the upper and lower buckle of the vertical axis (After the injection is completed, manually pull the safety protector toward the needle tip until it cannot slide anymore, the protection mechanism is triggered, the safety protector can't return, and the needle tube is completely protected by the safety protector). while the safety mechanism of predicate device is implemented by the convex points of the vertical axis + horizontal axis. However, the safety feature performance test for proposed device has been evaluated and the test result conforms to requirements of ISO 23908:2011 standards. Therefore, the differences on configuration and materials does not affect substantially equivalence.

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VII .Non-Clinical Testing

The sterile single lumen hypodermic needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:

ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical . devices- Requirements and methods
ISO 7864:2016 Sterile hypodermic needles for single use-Requirements and test ● methods
ISO 8537: 2016 Sterile single-use syringes, with or without needle, for insulin. ●
ISO 23908- First edition: Sharps injury protection- Requirements and test methods-● Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Biocompatibility Testing:

In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hours to 30days). The following testing was conducted:

. Cytotoxicity
Sensitization ●
Irritation or intracutaneous reactivity ●
Acute systemic toxicity .
Pyrogenicity .
. Hemocompatibility
Subacute Systemic Toxicity .

Particulate Testing, USP<788>

Sterility, Shipping and Shelf Life

The sterilization method has been validated per ISO 11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Safety Insulin Syringe is 5 years, determined based on stability studies which includes accelerated aging.

Sterilization and shelf life testing listed were performed on the proposed device.

Item	Standard
EO residue	ISO 10993-7:2008
ECH residue	ISO 10993-7:2008
Bacteria Endotoxin Limit	USP <85>
Shelf Life Evaluation	Physical, Mechanical, Chemical, Package Tests wereperformed on aging samples to verify the claimed shelflife of the device. Shelf-Life of 5 years is validatedusing ASTM F1980-16

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Simulated transportation Test was conducted in accordance with ASTM D4169-16 used ● final packaged sterile device after accelerated aging, which were stored for 72 hours under the environment of temperature and humidity (-35 °C±2°C, 24 hours, 40°C±2°C, 90%RH±5%RH, 24 hours, 60°C±2°C, 24 hours).
Sterile Barrier Packaging Testing performed on the proposed device: ●
- Visual Inspection in accordance with ASTM F1886 / F1886M-16 1
- Seal Strength in accordance with ASTM F88/F88M-15 .
- Dye Penetration in accordance with ASTM F1929-15 1

Simulated Clinical Use

A simulated clinical use study was performed on 500 device samples for the safety insulin syringe according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

VIII. Clinical Testing

No clinical study is included in this submission.

IX. Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristics as the predicate device. Performance testing data demonstrates that the proposed device is substantially equivalent. Accordingly, the proposed device is substantially equivalent 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).