The Pump Alignment Syringe is intended for use by healthcare professionals for injection of fluids for medical purposes into patients of all ages, including neonates in a controlled manner with compatible infusion pumps. The Pump Alignment Syringe can also be used for manual injection of fluids for medical purposes.

Device Description

The Pump Alignment Syringe is available in various specifications, including 3ml, 5ml, 10ml, 30ml and 60ml. The proposed device consists of three components: (1) plunger, (2) piston, (3) barrel. The connector of barrel have two types of luer-lock and luer-slip. 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 describes the submission of a 510(k) premarket notification for a Pump Alignment Syringe (K220184) and its comparison to a predicate device (K980987). However, it does not contain information regarding traditional acceptance criteria, performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) typically associated with AI/ML-based medical device studies.

The document focuses on demonstrating substantial equivalence based on non-clinical tests and a comparison of technical characteristics. The "performance testing" mentioned refers to compliance with ISO standards for syringes, not a study evaluating specific performance metrics against acceptance criteria in the context of AI/ML.

Here's an analysis based on the information provided in the document:

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

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of AI/ML. Instead, it lists standards that the device conforms to. For the purpose of this request, I will interpret "reported device performance" as the device's conformity to these standards.

Acceptance Criteria (Standard Compliance)	Reported Device Performance
Biocompatibility
ISO 10993-7:2008 (Ethylene Oxide Sterilization Residuals)	Complies
ISO 10993-5:2009 (Test for in vitro cytotoxicity)	Complies
ISO 10993-10:2010 (Test for irritation and delayed-type hypersensitivity)	Complies
ISO 10993-11:2017 (Tests for systemic toxicity)	Complies
USP <151> (Pyrogen Test)	Complies
ASTM F756-17 (Assessment of Hemolytic Properties of Materials)	Complies
ISO 10993-4:2017 (Selection of tests for interactions with blood)	Complies
Packaging/Sterility
ASTM F1929-15 (Detecting seal leaks in porous medical packaging by dye penetration)	Complies
ASTM F88/F88M-15 (Seal strength of flexible barrier materials)	Complies
ASTM F1886/F1886M-16 (Determining Integrity of Seals for Flexible Packaging by Visual Inspection)	Complies
USP <85> (Bacterial Endotoxins Test)	Complies
Physical and Functional Performance
USP <788> (Particulate Matter in Injections)	Complies
ISO 7886-1:2017 (Sterile hypodermic syringe for single use - Part 1: Syringes for manual use)	Complies
ISO 7886-2:2020 (Sterile hypodermic syringe for single use - Part 2: Syringes for use with power-driven syringe pumps)	Complies
ISO 80369-7:2021 (Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications)	Complies
Sterility Assurance Level (SAL)
10-6	Achieved 10-6

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria consists of non-clinical tests conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate device. These tests assessed biocompatibility, packaging integrity, sterility, and physical/functional performance according to the listed standards.

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

This information is not provided in the document. The document primarily reports adherence to engineering and biological safety standards, not a clinical or AI/ML performance study involving test sets of patient data.

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. The device is a physical medical device (syringe), and its performance evaluation involves compliance with established engineering and biological standards, not interpretation by experts to establish a "ground truth" on a test set (as would be typical for an AI/ML diagnostic or prognostic device).

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

This information is not applicable/not provided. Adjudication methods are relevant for studies where expert disagreement needs a resolution mechanism, which is not the case for the type of testing described (compliance with physical and biological standards).

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human interpretation, which is not the function of this Pump Alignment Syringe.

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

No, a standalone algorithm-only performance assessment was not done. The device is a physical syringe and does not involve an algorithm.

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

The "ground truth" for this device is its adherence to established international and national standards (e.g., ISO, ASTM, USP) for materials, sterility, package integrity, and functional performance. It is not based on expert consensus, pathology, or outcomes data in the traditional sense of a clinical diagnostic study.

8. The sample size for the training set:

This information is not applicable/not provided. The device is not an AI/ML product developed using training data. Its development involves engineering design and manufacturing processes, followed by testing against standards.

9. How the ground truth for the training set was established:
This information is not applicable/not provided as there is no training set for this type of device.

Summary

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July 21, 2022

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

Re: K220184

Trade/Device Name: Pump Alignment Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: June 9, 2022 Received: June 22, 2022

Dear Jianwei Pan:

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,

CAPT Alan M. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K220184

Device Name Pump Alignment 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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Tab 7 510(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: K220184

1. Date of Preparation: 06/07/2022
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

Designated Submission Correspondent 3.
Mr. Jianwei pan (Primary Contact Person) Email: jianwei.pan@cainamed.com Ms. Tracy Gong (Alternative Contact Person) Email: tracy.gong(@cainamed.com Tel: +86-510-86866666-8027 Fax: +86-510-86866666-8009
Identification of Proposed Device 4.
Trade Name: Pump Alignment Syringe

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

Indications for Use Statement:

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ર. Device Description

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.

న్. Identification of Predicate Device
Predicate Device 510(k) Number: K980987 Product Name: Becton Dickinson Single Use Hypodermic Syringes
Non-Clinical Test Conclusion 6.
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 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization 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 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
A 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.
A 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

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USP<788> Particulate Matter in Injections
ISO 7886-1:2017 Sterile hypodermic syringe for single use- Part 1: Syringes for manual use
ISO 7886-2:2020 Sterile hypodermic syringe for single use- Part 2: Syringes for use with A power-driven syringe pumps
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -Part 7:Connectors for intravascular or hypodermic applications
1. Clinical Test Conclusion

No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed DeviceK220184	Predicate DeviceK980987	Comment
Product code	FMF	FMF	Same
RegulationNo.	21 CFR 880.5860	21 CFR 880.5860	Same
RegulationName	Syringe, Piston	Syringe, Piston	Same
Class	II	II	Same
Indicationsfor use	The Pump Alignment Syringeis intended for use byhealthcare professionals forinjection of fluids for medicalpurposes into patients of allages, including neonates in acontrolled manner withcompatible infusion pumps.The Pump Alignment Syringecan also be used for manualinjection of fluids for medicalpurposes.	The BD Single Use,Hypodermic Syringe isintended for use by healthcare professionals forgeneral purpose fluidaspiration/injection.	SameThe 510ksummary ofK980987 indicatesthat this devicecan be used withthe infusion pump.
Configuration	PistonPlungerBarrel	PistonPlungerBarrel	Same
material	Polypropylene,Polysoprene,Polydimethysiloxane	Plastic,Synthetic rubber,Silicone based stopperlubricant	See Comment 1
Sterile	Sterile	Sterile or non-sterile	See Comment 2

		Table 1 Comparison of Technology Characteristics with K980987

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Sterilemethod	EtO Sterilized	EtO or Irradiationsterilization	See Comment 3
SAL	10-6	10-6	Same
User group	Healthcare professionals	Healthcare professionals	Same
Patient group	All age groups, includingneonatal	All age groups, includingneonatal	Same
Volume	3ml,5ml,10ml,20ml,30ml,60ml	1ml,3ml,5ml,10ml,20ml,30ml and 60ml1)	Same
Type of use	Prescription only(Rx)	Prescription only(Rx)	Same
Single use	Yes	Yes	Same
Operationmode	For use with infusion pumpor manual use	For use with infusion pumpor manual use	Same
Label/labeling	Complied with 21 CFR part801	Complied with 21 CFR part801	Same
PerformanceTesting	Conform to:ISO 7886-1ISO 7886-2ISO 80369-7	Conform to:ISO 7886-1ISO 7886-26% (Luer) connector	Same
Biocompatibility	CytotoxicityISO 10993-5:2009 ThirdeditionIrritationISO 10993-10:2010 ThirdeditionSensitizationISO 10993-10:2010 ThirdeditionAcute systemic toxicityISO 10993-11:2017ThirdeditionPyrogenUSP <151> USP41 NF36HemolysisASTM F756-17 Third editionSubacute toxicityISO 10993-11:2017 Thirdedition	with ISO 10993	Same

Note:1)we infer that these sizes of proposed syringe are covered by the 510(k) number K980987 According to the pump user manual (Medfusion 3500 and Alaris 8015), however, these dimensions do not appear in the summary.

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Comment 1

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

Comment 2

The subject device is provided sterile only, the predicate device is provided to include sterile and non-sterile.The difference do not affect safety and effectiveness.

Comment 3

The sterile method of subject device is Eto only, the sterile method of predicate device include Eto and Irradiation. The difference do not affect safety and effectiveness.

1. 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).