Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) by Jiangsu Micsafe Medical Technology Co., Ltd

The subject 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

Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) are basically enteral syringes that can also be used for oral uses. There are two different types of models of the syringes, which are Type A and Type B. The Type A syringes of a polypropylene barrel and plunger rod and a synthetic rubber gasket stopper manufactured from polyisoprene. The Type B syringes consist of a polypropylene barrel and plunger rod and a silicone O-ring. The 10 to 60 mL syringes come with the standard female ENFit connector and the 1 to 5 mL syringes come with a female ENFit connector incorporating a low dose tip design.

AI/ML Overview

The provided text focuses on establishing substantial equivalence for an Oral/Enteral Syringe, primarily through comparison to a predicate device and adherence to recognized standards. It does not contain information about an AI/ML powered medical device, or the kind of acceptance criteria and study designs that would be typical for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, including specifics like sample size for test and training sets, expert ground truth establishment, MRMC studies, or standalone performance, as this information is not present in the provided document for this particular medical device.

The document discusses non-clinical tests performed to ensure the device's effectiveness and safety, primarily focusing on:

Biocompatibility: Adherence to ISO 10993 series standards (in vitro cytotoxicity, irritation, skin sensitization, systemic toxicity).
Performance safety and effectiveness (according to ISO 7886-1): Cleanliness, lubricant, limits of extractable metals, limits for acidity/alkalinity, tolerance on graduated capacity, graduated scale, dead space, barrel configuration, nozzle design verification, piston/plunger assembly, freedom from air and liquid leakage, force to operate the piston.
Performance safety and effectiveness (according to ISO 80369-3 for connectors): Fluid leakage, stress cracking, resistance to separation from axial load, resistance to unscrewing, resistance to overriding, disconnection by unscrewing.
Additional Performance tests: Dimensional verification (to ISO 80369-3, low dose tips, syringes), risk management report, dosing accuracy testing (for low dose tips and oral administration).

The conclusion states that the "subject device will be as safe and effective for usage as the listed predicate device," based on these non-clinical tests and the comparison of technological characteristics. No clinical tests were performed for this submission.

Summary

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

October 11, 2018

Jiangsu Micsafe Medical Technology Co., Ltd % Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, Building 3, Hangqian Street, Lucheng District Wenzhou. Zhejiang 325000 China

Re: K181426

Trade/Device Name: Oral/Enteral Syringe (10 mL to 60 mL) Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) Regulation Number: 21 CFR& 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: August 13, 2018 Received: August 13, 2018

Dear Helen Nan:

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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

FDA

Jeffrey W. Cooper - S 2018.10.11 17:43:14 -04'00'

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K181426

Device Name

Oral/Enteral Syringe(10mL to 60mL) Low Dose Tip Oral/Enteral Syringe(ImL to 5mL)

Indications for Use (Describe)

The subject 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 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.

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)

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FORM FDA 3881 (7/17)

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Image /page/3/Picture/1 description: The image shows the logo for Micsafe med. The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the word "Micsafe" in black, bold letters. Below "Micsafe" is the word "med" in smaller, black letters.

K181426

510(k) Summary

(As required by 21 CFR 807.92(a))

7.1 Submitter Information

・ Company: Jiangsu Micsafe Medical Technology Co., Ltd.
· Address: Xituan Industrial Park, Dafeng District, Yancheng City, Jiangsu Province,224125, China
・ Phone: 086-13651929266
Contact: Tony Yang, General Manager
Date: May 12, 2018

7.2 Device Information

· Trade/Device Name: Oral/Enteral Syringe(10mL to 60mL)
Low Dose Tip Oral/Enteral Syringe(1mL to 5mL)
Model/Size:

Oral/Enteral Syringe:

Type A (Gasket Type): 10ml, 20ml, 60ml

Type B (O-Ring Type): 10ml, 20ml, 60ml

Low Dose Tip Oral/Enteral Syringe:

Type A (Gasket Type): 1ml, 3ml, 5ml

Type B (O-Ring Type): 1ml, 3ml, 5ml

· Common Name: Oral/Enteral Syringes

• Classification: Device: Enteral Syringes With Enteral Specific Connectors

Regulation Description: Gastrointestinal tube and accessories

Review Panel: Gastroenterology/Urology

Product Code: PNR

Submission Type: 510(k)

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Image /page/4/Picture/2 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the word "Micsafe" in black, with the word "med" in smaller font below it. The background of the logo is white.

Regulation Number: 876.5980 Device Class: 2

7.3 Predicate Device Information

NeoConnect 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) [510K Number: K161039; submitted by NeoMed, Inc.]

7.4 Device Description

7.5 Indications for Use

7.6 Comparison of Technological Characteristics with the Predicate Device

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MICSAFE MEDICAL GROUPImage: MicSafe logo
Comparison Items	Subject Device	Predicate Device
		(K161039)
Classification & Intended Use
Classification	PNR & Class 2	PNR & Class 2
Indications for Use	The subject device isindicated for use as adispenser, a measuringdevice and a fluid transferdevice. It is used todeliver fluids into thebody orally or enterally.It is intended to be usedin clinical or home caresettings by users rangingfrom clinicians tolaypersons (under thesupervision of aclinician) in all agegroups.	The device is indicated foruse as a dispenser, ameasuring device and a fluidtransfer device. It is used todeliver fluids into the bodyorally or enterally. It isintended to be used inclinical or home care settingsby users ranging fromclinicians to laypersons(under the supervision of aclinician) in all age groups.

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Image /page/6/Picture/1 description: The image contains the logo for Micsafe med. The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the text "Micsafe" in a bold, sans-serif font, with the word "med" underneath in a smaller font. The logo is simple and modern, and the colors are bright and eye-catching.

Technological Characteristics
Configurations	Barrel	Barrel with ENFit connector
	Transparent/PurplePlungerSeal	Purple PlungerPiston
	No Tip Cap	Tip cap
	Size	Oral/Enteral Syringe(10mL to 60mL)And Low Dose TipOral/Enteral Syringe(1mL to 5mL)
		Sterile	Yes
Single Use	Yes	Yes
Safety & Effectiveness
Biocompatibility	Conforms to therequirement of ISO 10993 series StandardsNo CytoxicityNo Irritation to SkinNo Significant evidence of	Conforms to therequirement of ISO 10993 series StandardsNo CytoxicityNo Irritation to SkinNo Significant evidence of
		No systemic toxicity	Not applicable.
	Performance safety &effectivness	Conforms with therequirements of ISO7886-1 and 80369-3	Conforms with therequirements of ISO7886-1 and 80369-3

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Image /page/7/Picture/1 description: The image shows the logo for Micsafe med. The logo consists of four squares, two red and two blue, arranged in a 2x2 grid. To the right of the squares is the text "Micsafe" in bold, black letters. Below "Micsafe" is the text "med" in a smaller font size.

Brief Summary

First, the subject device enjoys identical classification and intended use with the predicate device, which forms the foundation of their substantial equivalence.

Secondly, the subject device boasts similar technological characteristics with the predicate device, such as they are both sterile and for single use. Though they differ slightly in configurations and size, such differences have been further verified by FDA recognized standards - ISO 7886-1 and ISO 80369-3, which ensures that the subject device is safe and effective for usage. Such facts further supports that the two devices are substantial equivalent.

Last but not least, the biocompatibility of both devices has been ensured by relevant ISO 10993 standards, which ensures that the subject device will be as safe for use as the predicate device.

7.7 Discussion of Tests Performed

7.7.1 Clinical Test

Clinical testing was not performed for the subject device as part of the submission.

7.7.2 Non-Clinical Tests

The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:

Biocompatibility according to ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity; ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization; and ANSI AAMI

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Image /page/8/Picture/2 description: The image shows the logo for Micsafe. The logo consists of two red squares stacked on top of two blue squares, followed by the word "Micsafe" in bold, black letters. Below "Micsafe" is the word "medical" in a smaller font.

ISO 10993-11:2006/(R)2010 Biological evaluation of medical devices - Part 11

Tests for systemic toxicity.

1. Performance safety and effectiveness according to ISO 7886-1 Second edition2017-05, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use:
. Cleanliness
Lubricant
Limits of extractable metals ●
. Limits for acidity/alkalinity
Tolerance on Graduated Capacity
Graduated Scale ●
Dead Space ●
. Barrel Configuration
Nozzle Design Verification ●
. Piston/Plunger Assembly
Freedom from air and liquid leakage ●
Force to operate the piston of the syringe .
1. Performance safety and effectiveness according to ISO 80369-3 First Edition 2016-

07-01 Small-bore connectors for liquids and gases in healthcare applications -

Part 3: Connectors for enteral applications:

Fluid leakage
· Stress Cracking
Resistance to separation from axial load
Resistance to separation from unscrewing .
Resistance to overriding

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Image /page/9/Picture/2 description: The image contains a logo for "Micsafe medical". The logo consists of two stacked squares on the left, with the top square being red and the bottom square being blue. To the right of the squares is the word "Micsafe" in a bold, sans-serif font. Below "Micsafe" is the word "medical" in a smaller font size.

Disconnection by unscrewing
1. Additional Performance safety and effectiveness for the Oral/Enteral

Syringe(10mL to 60mL) Low Dose Tip Oral/Enteral Syringe(1mL to 5mL):

Dimensional Verification to ISO 80369-3 ●
. Dimensional Verification of Low Dose Tips
Dimensional Verification of Syringes
Risk Management Report ●
. Dosing Accuracy Testing for Low Dose Tips
. Dosing Accuracy Testing for Oral Administration

7.8 Conclusion

From the above analysis, it is proper to conclude that the subject device will be as safe and effective for usage as the listed predicate device that are already cleared for the U.S. market.

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.