The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.

Device Description

The Syringe with permanently attached needle is intended for single use only. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 20G-34G gauge needle. The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years. The proposed syringes are available in different combination of syringe volumes and/or needle sizes.

AI/ML Overview

The provided document is a 510(k) summary for a "Syringe with permanently attached needle" and does not contain information about acceptance criteria for an AI/ML powered device, nor a study proving such a device meets those criteria.

The document describes a traditional medical device (a syringe) and its substantial equivalence to a predicate device based on non-clinical performance testing against established ISO and ASTM standards. Therefore, most of the requested information regarding AI/ML device performance and testing is not applicable to this submission.

Here's an analysis based on the information provided, noting where the requested AI/ML specific information is absent:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in a formal table with reported performance in the way typically expected for an AI/ML diagnostic or prognostic device. Instead, it states that "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 non-clinical tests performed are listed as compliance with various ISO and ASTM standards. The acceptance criteria for these standards are implicit within the standards themselves, and the document explicitly states the device "complies" with them and that "The test results demonstrated that the proposed device is as safe and as effective as the predicate device."

Example from document:
- Acceptance Criteria (implicit in standard): Sterile hypodermic syringes for single use must meet requirements of ISO 7886-1:2017.
- Reported Device Performance: "Syringe performance: ISO 7886-1 [Compliant]" (from Table 2) and "Test results demonstrated that the proposed device complies with... ISO 7886-1:2017".

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable/not provided as this is not an AI/ML device and no diagnostic test set or data provenance is mentioned beyond general non-clinical device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/not provided as this is not an AI/ML device and no expert-adjudicated ground truth is established. The "ground truth" for a syringe is its physical and functional properties meeting specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/not provided as this is not an AI/ML device and no adjudication method is relevant.

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

There was no MRMC comparative effectiveness study done. This is not an AI/ML device designed to assist human readers. "No clinical study is included in this submission" (Section VIII).

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

This information is not applicable/not provided as this is not an AI/ML device and therefore no standalone algorithm performance was assessed.

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

The "ground truth" for the device's performance is established by compliance with recognized international and national standards (e.g., ISO, ASTM) for the physical and biological properties of the syringe and needle, along with material specifications for biocompatibility. For instance, sterility is confirmed by SAL (Sterility Assurance Level) compliance, and material safety by ISO 10993 series standards.

8. The sample size for the training set

This information is not applicable/not provided as this is not an AI/ML device and therefore no training set was used.

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

This information is not applicable/not provided as this is not an AI/ML device and therefore no training set ground truth was established.

Summary

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July 21, 2022

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

Re: K213158

Trade/Device Name: Syringe with permanently attached needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: June 14, 2022 Received: June 21, 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) K213158

Device Name Syringe with permanently attached needle

Indications for Use (Describe)

Syringe with permanently attached needle

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

Research Use (Part 21 CFR 361.2 Label D)	Over-The-Counter Use (21 CFR 361.2 Label C)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) summary

The assigned 510(k) Number: K213158

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: July 17, 2022

II Proposed Device

Trade Name of Device:	Syringe with permanently attached needle
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

510(k) Number:	K192551
Trade name:	Syringe with permanently attached needle
Common name:	Piston Syringe
Classification:	Class II
Product Code:	FMF, MEG

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Manufacturer Jiangsu Caina Medical Co., Ltd.

IV Device description

The Syringe with permanently attached needle is intended for single use only. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 20G-34G gauge needle.

The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.

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

Device	Needle length (mm)	Needle gauge	Needle wall type	Syringe size/volume
Syringe with permanently attached needle	4, 5, 6, 8, 9, 10, 12, 13, 16, 20	34G33G	RWTWETW	0.3ml0.5ml1ml
Specification	4, 5, 6, 8, 9, 10, 12, 13, 16, 20, 22, 25, 28, 32	32G31G	RWTWETW	0.3ml0.5ml1ml
	4, 5, 6, 8, 9, 10, 12, 13, 16, 20, 22, 25, 28, 32, 35, 38, 40	30G29G28G27G26G25G24G23G22G21G20G	RWTWETW	0.3ml0.5ml1ml

Table 1 specification of proposed device

V Indication for use

Syringe with permanently attached needle

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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	Predicate device(K192551)	Discussion
Product name	Syringe withpermanently attachedneedle	Syringe withpermanently attachedneedle	same
Product Code	FMF	FMF	same
RegulationNo.	21 CFR 880.5860	21 CFR 880.5860	same
Class	II	II	same
Indication foruse	The Syringe withpermanently attachedneedle is intended foruse by health careprofessionals for generalpurpose aspiration offluid from vials,ampoules and liquidinjection below thesurface of the skin.	The Syringe withpermanently attachedneedle is intended foruse by health careprofessionals forgeneral purposeaspiration of fluidfrom vials, ampoulesand liquid injectionbelow the surface ofthe skin.	same
Prescription/over-the-counter use	Prescription Use	Prescription Use	Same
Configurationand material	(1) needle cap (PP)(2) needle (StainlessSteel 304)(3) piston (PolysopreneRubber)(4) plunger (PP)(5) barrel (PP)	(1) needle cap (PP orPE)(2) needle (StainlessSteel 304)(3) piston(Polysoprene)(4) plunger (PP)(5) barrel (PP)	Similar1
SyringeVolume	0.3ml, 0.5ml, 1ml	0.3ml, 0.5ml, 1ml	Same
NeedleGauge	20G, 21G, 22G, 23G,24G, 25G, 26G, 27G,28G, 29G, 30G, 31G,32G, 33G, 34G	21G, 23G, 25G, 26G,27G, 28G, 29G, 30G,31G	Difference2
NeedleLength (mm)	4, 5, 6, 8, 9, 10, 12, 13,16, 20, 22, 25, 28, 32,35, 38, 40	8, 10, 13, 16, 20, 25
Needle walltype	RW, TW, ETW	RW, TW
Needleperformance	ISO 9626ISO 7864	ISO 9626ISO 7864	Same
Syringeperformance	ISO 7886-1	ISO 7886-1	Same
Biocompatibility	Conforms to therequirements of ISO10993 series standards.	Conforms to therequirements of ISO10993 seriesstandards.	Same
Method	EO Sterilized	EO Sterilized	Same
SAL	10-6	10-6	Same
OperationPrinciple	For Manual Use Only,For Single Use Only	For Manual Use Only,For Single Use Only	Same
Label/Labeling	Complied with 21 CFRpart 801	Complied with 21CFR part 801	Same

Table 2 General Comparison of Syringe with permanently attached needle

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1 The configurations of Syringe with permanently attached needle are same as the configuration of predicate device, but there are some differences in raw materials. The differences on configuration and materials do not raise new questions about safety and effectiveness. Additionally, the proposed syringes' biocompatibility can be demonstrated by the reference device (K162180).

2 The needle gauge and length for proposed devices is different from the predicate devices. However, this difference is just in dimension. Different size and length device will be selected by physician per patient's condition. This difference does not affect intended use, differences in needle length and gauge between the predicate and subject device were addressed through ISO 7864:2016 and ISO 9626:2016 performance testing. The needle wall type for predicate device is unknown. However, the performance test for proposed device has been conducted and the test result

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conform with requirements of ISO 7864:2016 and ISO 9626:2016 standards. The needle bevel for proposed devices are different from the predicate device 2. However, this difference is just in dimension. Different needle bevel will be selected by physician per patient's condition. This difference does not affect intended use. In addition, differences in needle bevel between the predicate and subject device were addressed through ISO 7864:2016 and ISO 9626:2016 performance testing. Therefore, the differences on needle length, gauge, wall type and bevel does not affect substantially equivalence on safety and effectiveness.

VII Non-Clinical Testing

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:

ISO 10993-5: 2009 Biological evaluation of medical Devices-Part 5: Tests for in . Vitro Cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices- Part 10: Test for . irritation and skin sensitization.
ISO 10993-11: 2017 Biological evaluation of medical devices- Part 11: Tests for . systemic toxicity
ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for . manual use.
ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical ● Devices.
ISO 7864:2016 Sterile hypodermic needles for single use Requirements and . test methods
ISO 10993-7:2008 Biological Evaluation of Medical Devices Part 7: Ethylene . Oxide Sterilization Residuals.
USP 41-NF36:2018<85> Bacterial Endotoxin Limit ●
USP <788> Particulate Matter in injections ●
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier . Materials. (Sterility)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous . Medical Package by Dye Penetration
ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of . Seals for Flexible Packaging by Visual Inspection

Biocompatibility Testing:

The devices meet biocompatibility endpoints for cytotoxicity, irritation, sensitization, systemic toxicity, hemolysis and material-mediated pyrogens. The data was supplied in the reference device submission, K162180, and the manufacturer certified that the

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devices, in their final finished form, are identical to the K162180 reference device (cleared 12/29/2016) in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).

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 characteristic as the predicate device. Performance testing data demonstrates that the proposed device is as safe and as effective as the predicate device. 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).