The device is indicated for use as a dispenser, measuring device, and fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) to in all age groups.

Device Description

The device is an enteral feeding syringe for single use. The devices are piston-style syringes consisting of a syringe barrel, syringe plunger, syringe gasket, and syringe cap. The device incorporates a female ENFit connector designed to be compatible only with enteral access devices or accessories. It has ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.

The device is a disposable syringe made of the following components:

Plunger: The Plunger is a piston having a longitudinal shaft that is mechanically received into the proximal syringe barrel aperture. It is made of polypropylene and uncoated. The proximal end of the plunger is flat to allow the device user to apply uniform pressure to the plunger shaft, thereby initiating the plunger into the syringe barrel.
Barrel: The Barrel is a single, clear molded plastic hollow barrel made of polypropylene. This is the identical material used to manufacture the barrel of the predicate device. The distal end of the barrel possesses an integrally molded syringe tip. The barrel is marked on the exterior with non-toxic, biocompatible ink to create gradient volume graduation markings. The barrel is translucent to allow visualization of fluid contents and volume. The barrel is designed at an appropriate length to accommodate the nominal volume of each syringe size as labeled.
Gasket: The gasket is attached to the distal end of the syringe plunger in an o-ring orientation. It is attached to the plunger via a mechanical interference fit. The purpose of the gasket is to engage the syringe barrel to form a low-pressure seal, which is impervious to fluids.
Tip cap: The tip cap is an ENFit compatible closure cap for the syringe. The syringe tip cap is designed to be compatible with the ENFit female syringe tip of the syringe. The syringe tip cap is made of polypropylene and purple colorant.

AI/ML Overview

This document primarily discusses the substantial equivalence of a medical device (Enteral Feeding Syringes with ENFit connector) to a predicate device, focusing on non-clinical performance testing, biocompatibility, and sterility. It does not present a study proving a device meets acceptance criteria in the context of an AI/ML medical device, clinical efficacy, or human reader performance. The document explicitly states "No clinical study is included in this submission."

Therefore, based on the provided text, I cannot answer the questions related to clinical studies, human readers, AI assistance, ground truth establishment for AI/ML models, or sample sizes for training sets.

However, I can extract the acceptance criteria and performance data for the non-clinical aspects of the device.

Here's the information gleaned from the document regarding the acceptance criteria and device performance for the physical device itself:

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

The document defines acceptance criteria by referencing compliance with specific international standards and then states that the device "met all requirements" or that "All of the pre-determined acceptance criteria were met." Specific numerical performance data is provided for sterility residuals and bioburden.

Category	Acceptance Criteria	Reported Device Performance
Performance	Compliance with: - ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use - ISO 80369-3: Small-bore connectors for liquids and gases in health care applications Part 3: Connectors for enteral applications - ISO 80369-20: Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods	"For the finished device, it meets the defined performance requirements through bench testing." (Implies compliance with the listed ISO standards).
Biocompatibility	Compliance with ISO 10993-1 for indirectly contacting patients, contact duration ≤24h. Specific tests: - In Vitro Cytotoxicity (ISO10993-5: 2009) - Skin Sensitization (ISO10993-10: 2010) - Intracutaneous Reactivity Test (ISO10993-10: 2010)	"The new device complies with the biocompatibility requirement defined in ISO10993-1. The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1, the same as the predicate device. All of the pre-determined acceptance criteria were met."
Sterility	Sterilization conducted per ISO 11135-1, ISO 11737-1, ISO 11737-2, ISO 10993-7, ANSI/AAMI ST72. Sterility Assurance Level (SAL): 10-6. Residuals: - EO Residual: ≤ 4.0 mg/device - ECH Residuals: ≤ 9.0 mg/device Sterility Test Result: 0 Positives Pyrogenicity Test: Temperature rise must meet standard Endotoxin Test (Gel-Clot Limit Test): < 0.25 EU/ml	SAL: 10-6 (Met) 10 ml Syringe: - EO Residual: 2.6X10-3 mg/device - ECH Residuals: < 3.0X10-3mg/device 60 ml Control Ring Syringe: - EO Residual: 0.016 mg/device - ECH Residuals: 0.028 mg/device (All residuals well within limits.) Bioburden: - 10ml: 3.4 cfu/device - 60 ml control ring: 3.4 cfu/device Result of Sterility test: 0 Positives (Met) Result of Pyrogenicity test: - 10ml: 0.21°C, 0.00°C, 0.03°C - 60 ml control ring: 0.09℃, 0.12℃, 0.07℃ Result of Endotoxin test: Less than 0.25 EU/ml (Met) "All of the pre-determined acceptance criteria were met."
Packaging & Shelf Life	Compliance with AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11737-2, AAMI/ANSI/ISO 11607-1, ASTM F1929-98, ASTM F1980-07, ASTM D3078-02, ASTM F88/F88M-09. Support for a 5-year shelf life.	"The test result supports the five year shelf life claim for the subject device from the sterilization date. All of the pre-determined acceptance criteria were met."

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

The document does not explicitly state the sample sizes for the performance, biocompatibility, sterility, or packaging tests. It describes "bench testing" and "verification tests" which are typically done on a defined number of units, but the specific count is not provided. The data provenance is not specified in terms of country of origin, but it is implied to be from the manufacturer's testing facilities (Jiangsu Shenli Medical Production Co., Ltd in China). These tests are typically prospective for regulatory submission.

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 is not applicable as the document describes non-clinical performance and safety testing of a physical device, not an AI/ML system requiring expert interpretation of medical images or data.

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

Not applicable for tests of a physical medical device.

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

Not applicable. The document explicitly states: "No clinical study is included in this submission."

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

Not applicable. This is not an AI/ML device.

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

For the physical device testing:

Performance: Ground truth is defined by the technical specifications and requirements outlined in the referenced ISO standards (e.g., specific force required, leak integrity, volume accuracy).
Biocompatibility: Ground truth is adherence to the toxicological and biological safety requirements in ISO 10993 series.
Sterility: Ground truth is 10^-6 SAL, absence of growth in sterility tests, compliance with residual limits, and pyrogenicity/endotoxin limits.
Packaging & Shelf Life: Ground truth is maintaining integrity and sterility over the claimed shelf life as per referenced ASTM and ISO packing standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 28, 2020

Jiangsu Shenli Medical Production Co., Ltd % Charlie Mack Principal Engineer International Regulatory Consultants 2950 E Lindrick Drive Chandler, AZ 85249

Re: K200557

Trade/Device Name: Enteral Feeding Syringes with ENfit connector Model: 10 ml; 60 ml control ring Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and accessories Regulatory Class: II Product Code: PNR Dated: August 17, 2020 Received: August 21, 2020

Dear Charlie Mack:

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

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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 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,

For Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices 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) K200557

Device Name

Enteral Feeding Syringes with ENFit connector Model: 10 ml; 60 ml control ring

Indications for Use (Describe)

The device is indicated for use as a dispenser, measuring device. It is used to deliver fluids into the body or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) to in all age groups.

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

X Prescription Use (Part 21 CFR 801 Subpart D)	X
X
Over-The-Counter Use (21 CFR 801 Subpart C)

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江苏神力医用制品有限公司

Jiangsu Shenli Medical Production Co,Ltd

K200557 510(k) SUMMARY

Preparation Date:	September 26, 2020
Manufacturer's Name and Address:	Jiangsu Shenli Medical Production Co.,Ltd.No 20, Changzheng Road, Zhenglu,Changzhou City, Jiangsu Province,China 213111
Corresponding Official:	Charles Mack
Telephone Number:	931-625-4838
Email Address:	charliemack@irc-us.com
Trade Name:	Enteral Feeding Syringes with ENFitConnectorModel: 10ml, 60ml control ring
Common Name(s):	Enteral syringes with enteral specificconnectors
Regulation Name(s):	Gastrointestinal Tube and Accessories
Regulation Number(s):	21CFR876.5980
Product Code:	PNR
Requlatory Class:	Class II
Device Panel:	Gastroenterology/Urology
Predicate Device:	NeoMed Inc., Oral/Enteral Syringeswith ENFit connector (12 mL to 100mL) and Low Dose Tip Oral/EnteralSyringes with ENFit® Connector (0.5mL to 6 mL)- K161039

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Device Description:

The device is a disposable syringe made of the following components:

1. Plunger: The Plunger is a piston having a longitudinal shaft that is mechanically received into the proximal syringe barrel aperture. It is made of polypropylene and uncoated. The proximal end of the plunger is flat to allow the device user to apply uniform pressure to the plunger shaft, thereby initiating the plunger into the syringe barrel.
1. Barrel: The Barrel is a single, clear molded plastic hollow barrel made of polypropylene. This is the identical material used to manufacture the barrel of the predicate device. The distal end of the barrel possesses an integrally molded syringe tip. The barrel is marked on the exterior with non-toxic, biocompatible ink to create gradient volume graduation markings. The barrel is translucent to allow visualization of fluid contents and volume. The barrel is designed at an appropriate length to accommodate the nominal volume of each syringe size as labeled.
1. Gasket: The gasket is attached to the distal end of the syringe plunger in an o-ring orientation. It is attached to the plunger via a mechanical interference fit. The purpose of the gasket is to engage the syringe barrel to form a low-pressure seal, which is impervious to fluids.
1. Tip cap: The tip cap is an ENFit compatible closure cap for the syringe. The syringe tip cap is designed to be compatible with the ENFit female syringe tip of the syringe. The syringe tip cap is made of polypropylene and purple colorant.

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No.	Parts &Accessories	Material	MaterialSpecification	PatientContact(Direct/Indirect)?
1	Barrel	Polypropylene	R370Y	Indirect
2	Plunger	Polypropylene	R370Y	Indirect
3	Gasket	synthetic rubber	/	Indirect
4	Tip Cap	Polypropylene	R370Y	Indirect
5	Barrel Lubricant	Medical highlyactivated silicone	/	Indirect
6	VolumeGraduation Ink	Black ink	PPEC-706	Indirect
7	Colorant	purple	2700071(purple)	Indirect

The subject device may indirectly contact the patients, contact duration ≤24 hr.

Intended Use / Indications for Use

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Comparison of Technological Characteristics with the Predicate Device

Features	Proposed Device	Predicate Device	Comments
Device	Enteral Feeding Syringes withENFit Connector (10ml,60mlcontrol ring)	Oral/Enteral Syringes with ENFitconnector (12 mL to 100 mL) andLow Dose Tip Oral/EnteralSyringes with ENFit® Connector(0.5 mL to 6 mL)	N/A
Manufacturer	Jiangsu Shenli MedicalProduction Co., Ltd	NeoMed, Inc.	N/A
510(k)	N/A	K161039	N/A
IndicationforUse	The device is indicated for useas a dispenser, measuringdevice, and fluid transferdevice. It is used to deliverfluids into the body orally orenterally. It is intended to beused in clinical or home caresettings by users ranging fromclinicians to laypersons (underthe supervision of a clinician)to in all age groups.	The device is indicated for use asa dispenser, a measuring device,and a fluid transfer device. It isused to deliver fluids into the bodyorally or enterally. It is intended tobe used in clinical or home caresettings by users ranging fromclinicians to laypersons (under thesupervision of a clinician) in all agegroups.	Identical
ServiceCondition	Prescription use	Prescription use	Identical
FDAClassification	Class II, PNR, EnteralSyringes With Enteral SpecificConnectors	Class II, PNR, Enteral syringeswith enteral specific connectors	Identical
Configuration	GasketPlunger/Plunger with ControlRingBarrel with ENFit tipTip Cap	GasketPlungerBarrel with ENFit tipWith or without Tip Cap	Identical
Single-Use	Yes	Yes	Identical
Sterile	sterile	sterile or non-sterile	Identical
Operation Mode	Manual Use	Manual Use	Identical
Label/Labeling	Complied with 21 CFR part801	Complied with 21 CFR part 801	Identical
Size	10 mL;60 ml	0.5 -100 mL	Comment 1
Features	Proposed Device	Predicate Device	Comments
Performance	Complies with:ISO 7886-1ISO 80369-3	Complies withISO 7886-1ISO 80369-3	Identical
Patient-contact component and material
-Barrel	Polypropylene	Polypropylene	Identical
-Plunger	Polypropylene	Polypropylene (white colorant)	Comment 2
-Gasket	synthetic rubber	Silicone (black colorant)
-Tip Cap	Polypropylene (Purplecolorant)	Polypropylene (Orange colorant)
- VolumeGraduation ink	Black ink	Orange or purple ink
Barrel lubricant	Medical highly activatedsilicone	polydimethylsiloxane
Biocompatibility	Complied with ISO10993-1	Complied with ISO10993-1	Identical
Sterilization	EO	EO	Identical
SAL	10-6	10-6	Identical

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Discussions of differences in technological characteristics

Comment 1

The specifications of the proposed device and predicate device are different; however, both of them comply with the same recognized standards. The differences in enteral feeding syringe sizes will not raise new problems on the safety and effectiveness of the proposed device.

Comment 2

The patient-contact components of the proposed device are the same as those of the predicate device. The patient-contacting materials of the proposed device and the predicated device are different. The proposed device and the predicated devices are biocompatible and conform to ISO 10993 series standards. Therefore, the proposed device demonstrates through testing, to be substantially equivalent to the predicate devices.

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Performance Testing

Performance testing was provided in support of the substantial equivalence determination and to validate and verify that hypodermic safety needle with a syringe and hypodermic safety needle met all requirements of related international standards, including biocompatibility, sterility, and product specifications. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.

Non-clinical Testing

Performance Testing

ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
-ISO 80369-3: 2016 Small-bore connectors for liquids and gases in health care applications Part 3: Connectors for enteral applications
-ISO 80369-20: 2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods For the finished device, it meets the defined performance requirements through bench testing.

Biocompatibility

The new device complies with the biocompatibility requirement defined in ISO10993-1. Patient contact classification: indirectly contact the patients, contact duration≤24 h, Limited Contact Duration (≤24h). The verification test shows that the new devices comply with the biocompatibility requirement defined in ISO10993-1, the same as the predicate device.

In Vitro Cytotoxicity (ISO10993-5: 2009) -
-Skin Sensitization (ISO10993-10: 2010)
-Intracutaneous Reactivity Test (ISO10993-10: 2010)

All of the pre-determined acceptance criteria were met.

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Sterility Information

The devices are EO sterilized. The sterilization conducted according to below standards:

ISO11135-1 Sterilization of health care products ethylene oxide part 1: requirements for the development, validation, and routine control of a sterilization process for medical devices.
ISO11737-1 Sterilization of medical devices-Microbiological methods-Part 1: -Determination of the population of microorganisms on the product.
-ISO11737-2 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process.
ISO 10993-7 Biological evaluation of medical devices Part 7: Test of -Ethylene Oxide Residuals.
-ANSI/AAMI ST72 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing.

Validation method for the sterilization cycle: Half-cycle method

Sterility assurance level (SAL): 10-6

Sterilization residuals: Complies with standards requirement ISO10993-7: Limited exposure devices

10 ml:

EO Residual: 2.6X10-3 mg/device (Limit:4.0mg/device)

ECH Residuals: < 3.0X10-3mg/device (Limit: 9.0mg/device)

60 ml control ring:

EO Residual: 0.016 mg/device (Limit:4.0mg/device)

ECH Residuals: 0.028 mg/device (Limit: 9.0mg/device)

Bioburden test: Overall adjusted average bioburden 10ml: 3.4 cfu/device 60 ml control ring: 3.4 cfu/device.

All of the pre-determined acceptance criteria were met.

Result of Sterility test: 0 Positives

Result of Pyrogenicity test(the rabbit pyrogen test): Temperature rise: 10ml: 0.21°C, 0.00°C , 0.03°C 60 ml control ring: 0.09℃, 0.12℃ , 0.07℃

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Result of Endotoxin test (Gel-Clot Limit Test)- Less than 0.25 EU/ml

Package and Shelf Life:

We conducted package and shelf life verification test to support the shelf life claim according to the standards noted below:

AAMI/ANSI/ISO 11137-1:2006/(R) 2010 Sterilization of health care products -- Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
-AAMI/ANSI/ISO 11737-2:2009 Sterilization of medical devices Microbiological methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
-AAMI/ANSI/ISO 11607-1:2006/(R) 2010 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, 3ed.
ASTM F1929-98 (2004) Standard Test Method for Detecting Seal Leaks in -Porous Medical Packaging by Dye Penetration
ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier -Systems for Medical Devices
ASTM D3078-02 (2008), Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission. (Sterility)
-ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible Barrier Materials

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The tests were conducted as noted below:

Product Performance Inspection (Chemical performance and Physical performance)
-Sterile Test
-Vacuum Leak Test
-Dye penetration test
Agar Contact-Attack Test -
-Tensile Seal Strength Test
Accelerated Aging Test -

The test result supports the five year shelf life claim for the subject device from the sterilization date.

All of the pre-determined acceptance criteria were met.

Clinical Test:

No clinical study is included in this submission.

Conclusion Section:

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Enteral Feeding Syringes with ENFit connector Model: 10ml, 60ml control ring is as safe, as effective, and performs as well as the legally marketed predicate device the NeoMed, Inc. Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit® Connector (0.5 mL to 6 mL) cleared under K161039.

END

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.