(257 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a disposable syringe, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a feeding syringe used to deliver fluids into the gastrointestinal system; it does not directly treat a disease or condition, but rather aids in the nutritional support of a patient.
No
This device is described as a dispenser, measuring device, and fluid transfer device used to deliver fluids into the gastrointestinal system, not to diagnose a medical condition.
No
The device description clearly outlines physical components made of materials like polyisoprene synthetic rubber and a barrel with an ENFit connector, indicating it is a hardware device. The performance studies also focus on physical characteristics like biocompatibility, sterilization, and bench performance testing of the physical syringe.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver fluids into the gastrointestinal system. This is a direct interaction with the patient's body for therapeutic or supportive purposes.
- Device Description: The device is a syringe designed for fluid delivery. It does not involve the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, shelf life, and bench performance related to fluid delivery and connection standards. There are no studies related to analyzing biological samples or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Disposable Enteral Feeding Syringe with Enfit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral feeding syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
Product codes (comma separated list FDA assigned to the subject device)
PNR
Device Description
The proposed device is a disposable enteral feeding syringe provided in a variety of size from 1ml-60ml (1ml, 2ml, 2.5ml, 3ml, 5ml, 10ml, 30ml, 50ml and 60ml). The device is composed by barrel with ENFit connector, piston (plunger and plunger stopper), lubricant and tip cap (with or without). The piston is made of polyisoprene synthetic rubber, without DEHP or natural latex. This device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit connector. They are two types of syringe: Side connector ENFit syringe and central connector ENFit syringe. The size of the central connector ENFit syringes range from 1ml to 5ml, and they are the low dose tip syringes; and side connector ENFit syringes range from 10ml to 60ml, and they are the standard syringes. The Disposable Enteral Feeding Syringe with Enfit Connector relies on the interference matching between piston and inner chamber wall of the barrel to ensure the sealing of liquid in the inner chamber of the barrel. The plunger and the plunger stopper constitute a sealing assembly. By pushing and pulling the plunger, the plunger stopper can be driven to move freely inside the barrel, similar to the piston structure, so as to realize the suction and infusion of fluid. The proposed syringe is sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10 ° and supplied sterility maintenance package which could maintain the sterility of the device during the shelf of five years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal system
Indicated Patient Age Range
all age groups
Intended User / Care Setting
users ranging from laypersons (under the supervision of a clinician) to clinicians, in clinical or home care setting
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)
Biocompatibility testing: Biocompatibility of the Disposable Enteral Feeding Syringe with Enfit Connector was evaluated in accordance with the FDA Bguidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," and ISO 10993-1:2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The following tests were performed, as recommended: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity. The Disposable Enteral Feeding Syringe with Enfit Connector contacts indirectly with the human body for a duration of less than 24 hours.
Sterilization and shelf life testing: The sterilization method has been validated according to ISO 11135:2014 Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices, which has thereby determined the routine control and monitoring parameters. The shelf life of the Disposable Enteral Feeding Syringe with Enfit Connector is determined based on the accelerated aging test. And after the accelerated aging test, the performance test and package integrity test performed on the proposed device.
Bench performance testing: Connector testing performed on the proposed device, in accordance with ISO 80369-3:2016/AMD 1:2019, Small-bore connectors for liquids and gases in healthcare applications- Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications- Part 20: Common test methods. The testing demonstrates the proposed devices conform to the requirements of ISO 80369-3:2016/AMD 1:2019. Syringe testing performed on the proposed device in accordance with ISO 7886-1:2017, sterile hypodermic syringes for single use — Part 1: Syringes for manual use. The testing demonstrates the proposed device conform to the requirements of ISO 7886-1: 2017. Aging performance and sterile packaging integrity tests were also performed.
Clinical Testing: Based on the similarities of the device specifications, intended use, indications for use between the proposed device Disposable Enteral Feeding Syringe and its predicate devices, no clinical studies were needed to support this 510(k) Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 12, 2020
Shinva Ande Healthcare Apparatus Co., Ltd. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No. 26 Quinglan Street, Panyu District Guangzhou, 510006 CHINA
Re: K193657
Trade/Device Name: Disposable Enteral Feeding Syringe with Enfit Connector Classification Number: 21 CFR 876.5980 Classification Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PNR Dated: August 5, 2020 Received: August 10, 2020
Dear Mike Gu:
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.
1
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,
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
2
Indications for Use
510(k) Number (if known)
Device Name
Disposable Enteral Feeding Syringe with Enfit Connector
Indications for Use (Describe)
The Disposable Enteral Feeding Syringe with Enfit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral feeding syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, 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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Image /page/3/Picture/1 description: The image shows a stylized letter 'A' in black against a white background. The 'A' is designed with a curved top, resembling a swooping shape, and a solid, bold base. A small circle with a number '1' inside is positioned in the upper right corner of the 'A', possibly indicating a trademark or design element.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
SUBMITTER l.
SHINVA ANDE Healthcare Apparatus Co., Ltd.
No.77 Development Zone North Road, Zibo, Shandong, 255086, China Phone: +86-533-3917821
Fax: +86-533- 3918218
Primary Contact Person: Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. Tel: (+86)-20-6231 6262 Fax: (+86) -20-8633 0253
| Secondary Contact Person: Xiaolei Tian |
|---|
| R&D Director |
| SHINVA ANDE Healthcare Apparatus Co., Ltd |
| Tel: (+86)-533-3917821 |
| Fax: (+86)- 533- 3918218 |
Sep 12, 2020 Date prepared
II. DEVICE
| Name of Device: | Disposable Enteral Feeding Syringe with Enfit
Connector |
|-----------------|-------------------------------------------------------------|
| Common Name: | Disposable Enteral Feeding Syringe with Enfit
Connector |
| Model/size: | 1ml, 2 ml,2.5 ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml,
60ml |
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Image /page/4/Picture/0 description: The image shows a stylized, black-and-white logo. The logo features a curved, abstract shape resembling a stylized letter 'A' or a swooping bird. In the upper right corner of the shape, there is a small, filled circle with a white number '1' inside, suggesting a trademark or branding element.
| Classification Number: | 21 CFR 876.5980 |
|---|---|
| Classification Name: | Gastrointestinal tube and accessories |
| Device Panel | Gastroenterology/Urology |
| Regulatory Class: | II |
| Product Code: | PNR |
III. PREDICATE DEVICE
Predicate device K161979, ENFit Enteral Syringe This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The proposed device is a disposable enteral feeding syringe provided in a variety of size from 1ml-60ml (1ml, 2ml, 2.5ml, 3ml, 5ml, 10ml, 30ml, 50ml and 60ml). The device is composed by barrel with ENFit connector, piston (plunger and plunger stopper), lubricant and tip cap (with or without). The piston is made of polyisoprene synthetic rubber, without DEHP or natural latex. This device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit connector.
They are two types of syringe:
Side connector ENFit syringe and central connector ENFit syringe. The size of the central connector ENFit syringes range from 1ml to 5ml, and they are the low dose tip syringes; and side connector ENFit syringes range from 10ml to 60ml, and they are the standard syringes.
The Disposable Enteral Feeding Syringe with Enfit Connector relies on the interference matching between piston and inner chamber wall of the barrel to ensure the sealing of liquid in the inner chamber of the barrel. The plunger and the plunger stopper constitute a sealing assembly. By pushing and pulling the plunger, the plunger stopper
5
Image /page/5/Picture/1 description: The image shows a stylized letter 'A' in black, with a curved shape above it that resembles a swoosh or an arc. There is a small circle with a number '1' inside it, positioned in the upper right corner of the swoosh. The overall design is simple and modern, suggesting a logo or symbol for a brand or organization.
can be driven to move freely inside the barrel, similar to the piston structure, so as to realize the suction and infusion of fluid.
The proposed syringe is sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10 ° and supplied sterility maintenance package which could maintain the sterility of the device during the shelf of five years.
INDICATION FOR USE V.
The Disposable Enteral Feeding Syringe with Enfit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral feeding syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Disposable Enteral Feeding Syringe with Enfit Connector has the same technological characteristics and fundamental design as the predicate devices. The Disposable Enteral Feeding Syringe with Enfit Connector and the predicate devices are all designed to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow.
The Disposable Enteral Feeding Syringe with Enfit Connector has same indications for use, patient population with the predicates.
At a high level, the subject and predicate device are based on the following same technological elements:
- . They are all disposable for single use.
- . Their operation mode are all manual use.
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Image /page/6/Picture/0 description: The image shows a stylized letter 'A' in black, with a curved design. Above and to the right of the 'A', there is a small circle with a number '1' inside, likely indicating a registered trademark symbol. The logo appears simple and modern.
- They all have the same configuration that composed by barrel with ENFit connector, piston (plunger and plunger stopper), lubricant and tip cap.
- . Their connection type is the small-bore connector featuring ISO 80369-3:2016/AMD 1:2019, Small-Bore Connectors for Liquids and Gases in Healthcare Applications - Part 3: Connectors For Enteral Applications.
The subject device has different sizes compared with the predicate device in low dose and standard dose type. This difference does not raise concerns of safety and effectiveness.
Therefore, the Disposable Enteral Feeding Syringe with Enfit Connector are substantially equivalent to the cleared predicate device (K161979).
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Disposable Enteral Feeding Syringe with Enfit Connector was evaluated in accordance with the FDA Bguidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," and ISO 10993-1:2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The following tests were performed, as recommended:
- . Cytotoxicity
- . Irritation
- Sensitization
- Acute Systemic Toxicity
The Disposable Enteral Feeding Syringe with Enfit Connector contacts indirectly with the human body for a duration of less than 24 hours.
7
Image /page/7/Picture/0 description: The image shows a logo that appears to be a stylized letter 'A' or 'D' in a bold, sans-serif font. The letter is black and has a dynamic, forward-leaning appearance, suggesting movement or progress. There is a small circle with a number '1' inside it, positioned in the upper right corner of the logo, possibly indicating a trademark or a version number. The logo is set against a white background, and there is a thin black line at the bottom of the image, possibly indicating the edge of a document or a border.
Sterilization and shelf life testing
The sterilization method has been validated according to ISO 11135:2014 Sterilization Of Health-Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices, which has thereby determined the routine control and monitoring parameters. The shelf life of the Disposable Enteral Feeding Syringe with Enfit Connector is determined based on the accelerated aging test. And after the accelerated aging test, the performance test and package integrity test performed on the proposed device.
Bench performance testing
Connector testing performed on the proposed device, in accordance with ISO 80369-3:2016/AMD 1:2019, Small-bore connectors for liquids and gases in healthcare applications- Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications- Part 20: Common test methods. The testing demonstrates the proposed devices conform to the requirements of ISO 80369-3:2016/AMD 1:2019. Syringe testing performed on the proposed device in accordance with ISO 7886-1:2017, sterile hypodermic syringes for single use — Part 1: Syringes for manual use. The testing demonstrates the proposed device conform to the requirements of ISO 7886-1: 2017.
Aging performance and sterile packaging integrity tests were also performed.
Clinical Testing
Based on the similarities of the device specifications, intended use, indications for use between the proposed device Disposable Enteral Feeding Syringe and its predicate devices, no clinical studies were needed to support this 510(k) Premarket Notification.
VIII. CONCLUSION
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Image /page/8/Picture/0 description: The image shows a stylized letter 'A' in black. The 'A' is designed with a curved top, resembling a swoosh or an arc. There is a small circle with a number '1' inside it, positioned at the upper right of the 'A' symbol. The logo has a clean and modern appearance.
The proposed device Disposable Enteral Feeding Syringe with Enfit Connector is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.