K Number

Device Name

Oral/Enteral Syringe

Manufacturer

Shanghai Kindly Enterprise Development Group Co., Ltd

Date Cleared

2020-05-01

(263 days)

Product Code

PNR

Regulation Number

876.5980

Intended Use

The device is indicated for use as a dispenser, a 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) in all age groups.

Device Description

The proposed device is a disposable enteral feeding syringe provided two models, including Type A and Type B, the main difference is the piston of Type A is rubber stopper made of isoprene rubber, and the piston of Type B is rubber pad made of silicone rubber. The proposed device consists of a syringe barrel, syringe plunger and piston (rubber stopper or rubber pad). They are available in 1ml, 3ml, 5ml, 10ml, 20ml, and 60ml. The enteral syringes are sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied maintenance package which could maintain the sterility of the device during the shelf life of five years.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K161039

Reference Devices

K161039

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and standard performance metrics of a syringe, with no mention of AI or ML capabilities.

Therapeutic

No
The device is described as a dispenser and measuring device for delivering fluids, not for treating a condition, which is characteristic of therapeutic devices.

Diagnostic

The device is described as a dispenser and measuring device for delivering fluids, not for diagnosing conditions or diseases.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical, disposable enteral feeding syringe made of a syringe barrel, plunger, and piston. It undergoes sterilization and physical performance testing, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as a "dispenser, a measuring device" used to "deliver fluids into the body or enterally." This describes a device used for administering substances to the body, not for testing samples from the body to diagnose or monitor a condition.
Device Description: The description details a syringe, which is a tool for delivery, not for performing diagnostic tests on biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
Performance Studies: The performance studies focus on the physical characteristics and accuracy of the syringe as a delivery device, not on its ability to detect or measure specific analytes in a sample.

In summary, the device's function is to deliver fluids, which is a therapeutic or supportive action, not a diagnostic one performed outside the body (in vitro).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

PNR

Device Description

The proposed device consists of a syringe barrel, syringe plunger and piston (rubber stopper or rubber pad). They are available in 1ml, 3ml, 5ml, 10ml, 20ml, and 60ml.

The enteral syringes are sterilized by Ethylene Oxide to achieve a SAL of 106 and supplied maintenance package which could maintain the sterility of the device during the shelf life of five years.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

all age groups.

Intended User / Care Setting

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)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 80369-3:2016 Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 3: Connectors for Enteral Applications:
ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use;
ISO 80369-20:2015 Small-Bore Connectors for Liquids And Gases in Healthcare Applications-Part 20: Common Test Methods;
A 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: Tests for Irritation and Skin Sensitization;
ISO 10993-7:2008, Biological Evaluation of Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals
A ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff

In addtion, dose accuracy testing is conducted to demonstrate the enteral syringes are accurate to +/-10% when the syringe is filled with a minimum dose of 20% of the overall syringe capacity.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K161039

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 1, 2020

Shanghai Kindly Enterprise Development Group Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai. 200120 CHINA

Re: K192179

Trade/Device Name: Oral/Enteral Syringe Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PNR Dated: March 20, 2020 Received: March 24, 2020

Dear Diana Hong:

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 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,

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

Indications for Use

510(k) Number (if known) K192179

Device Name Oral/Enteral Syringe

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

K192179

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: _K192179

1. Date of Preparation: 04/30/2020
1. Sponsor Identification

Shanghai Kindly Enterprise Development Group Co., Ltd. No.658 Gaochao Road, 201803 Shanghai, China

Establishment Registration Number: 3004577167

Contact Person: Weixin Zhang Position: General Manager Tel: +86-21-59116715 Fax: +86-21-59140057 Email: zwx@kdlchina.com

Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net

4. Identification of Proposed Device

Trade Name: Oral/Enteral Syringe Common Name: Oral/Enteral Syringe;

Regulatory Information

Classification Name: Gastrointestinal Tube and Accessories; Classification: II; Product Code: PNR; Regulation Number: 21CFR 876.5980; Review Panel: Gastroenterology/Urology;

Indication for Use Statement:

The device is indicated for use as a dispenser, a measuring device and a 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) in all age groups.

Device Description:

The proposed device consists of a syringe barrel, syringe plunger and piston (rubber stopper or rubber pad). They are available in 1ml, 3ml, 5ml, 10ml, 20ml, and 60ml.

The enteral syringes are sterilized by Ethylene Oxide to achieve a SAL of 106 and supplied maintenance package which could maintain the sterility of the device during the shelf life of five years.

5. Identification of Predicate Device

510(k) Number: K161039

Product Name: Oral/Enteral Syringe with ENFit® connector (12 mL to 100mL) and Low Dose Tip Oral/Enteral Syringes with ENFit® connector (0.5 mL to 6mL)

6. Non-Clinical Test Conclusion

A ISO 80369-3:2016 Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 3: Connectors for Enteral Applications:
ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use;
ISO 80369-20:2015 Small-Bore Connectors for Liquids And Gases in Healthcare Applications-Part 20: Common Test Methods;
A 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: Tests for Irritation and Skin Sensitization;
ISO 10993-7:2008, Biological Evaluation of Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals
A ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff

In addtion, dose accuracy testing is conducted to demonstrate the enteral syringes are accurate to ±10% when the syringe is filled with a minimum dose of 20% of the overall syringe capacity.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

Substantially Equivalent (SE) Comparison 8.

Table 1 Comparison of Technology Characteristics

Item	Proposed Device	Predicate Device K161039
Product Code	PNR	PNR
Regulation
Number	21CFR 876.5980	21CFR 876.5980
Indication for Use	The device is indicated for use as a dispenser, a measuring device, and a 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 setting by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.	The device is indicated for use as a dispenser, a measuring device, and a 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 setting by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.
Configuration	Barrel;
Plunger (Rubber Stopper or Rubber Pad);
Piston	Piston;
Plunger;
Barrel with ENFit connector;
Tip cap
Operation Mode	For Manual Use Only;	For Manual Use Only;
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801
Product
Performance	Complied with:
ISO 80369-3;
ISO 80369-20;
ISO 7886-1;	Complied with:
ISO 80369-3;
ISO 80369-20;
ISO 7886-1;
Product Size	Type A:
Low dose:1ml, 3ml, ;
Standard: 5ml, 10ml, 20ml, 60ml
Type B:
Low dose: 1ml, 3ml;
Standard: 5ml, 10ml, 20ml, 60ml	Low dose tip ENFit syringe: 0.5ml~6ml;

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.