(85 days)
No
The device description and performance studies focus on the mechanical and material properties of a syringe, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: The device is described as a dispenser, measuring device, and oral fluid transfer device for delivering fluids. While it is used in a medical context, it does not directly treat or diagnose a disease; rather, it facilitates the administration of substances that may be therapeutic.
No
The device is described as a dispenser, measuring device, and oral fluid transfer device for delivering fluids into the body, not for diagnosing conditions.
No
The device description clearly states it is a physical, disposable enteral feeding syringe made of components like a plunger, piston, barrel, and tip cap. It also mentions sterilization and packaging, indicating a hardware product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for delivering fluids into the body orally or enterally. This is a direct interaction with the patient's body, not for examining specimens in vitro (outside the body).
- Device Description: The description details a syringe used for delivering fluids into the body or connected to an enteral access device. This aligns with the intended use of administering substances to a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed for testing specimens in vitro to provide diagnostic information. This device's function is to administer substances in vivo (within the body).
N/A
Intended Use / Indications for Use
The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.
Product codes
PNR
Device Description
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. It consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The syringes (size 12ml, 35ml and 60ml) incorporate a female Standard ENFit connector; the syringes (size 0.5ml, 1ml, 3ml, 6ml) incorporate a female low dosing ENFit connector. There are 2 types of the syringe: Side connector ENFit syringe and central connector ENFit syringe. The sizes of the central connector tapered syringe range from 0.5ml and 1ml; and side connector ENFit syringe range from 3ml to 60ml. The proposed syringe is sterile or non-sterile. Sterile device was 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 three 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 operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners)
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
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 7886-1:2017 Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use;
-
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
-
ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices;
-
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;
-
ISO 80369-3:2016 Small-Bore Connectors for Liquids and Gases in Healthcare 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.
In addition, 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical study is included in this submission.
The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission, the Oral/Enteral Syringe with ENFit Connector is as safe, as effective, and performs as well as or better than the legally marketed predicative device cleared under K161039.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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.
June 30, 2021
Ningbo Tianyi Medical Appliance Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CHINA
Re: K211025
Trade/Device Name: Oral/Enteral Syringe with ENFit connector Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PNR Dated: April 2, 2021 Received: April 6, 2021
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
1
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211025
Device Name Oral/Enteral Syringe with ENFit connector
Indications for Use (Describe)
The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: K211025
-
- Date of Preparation: 06/10/2021
-
- Sponsor Identification
Ningbo Tianyi Medical Appliance Co., Ltd.
No.788, Mozhi North Road, Tourism Resort, Dongqian Lake, 315121 Ningbo, PEOPLE'S REPUBLIC OF CHINA
Establishment Registration Number: Not registered
Contact Person: Wenyu Zhang Position: Regulatory Affair Manager Tel: +86-574-55011007 Fax: +86-574-55011007 Email: vincent.zhang@tianyinb.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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Identification of Proposed Device 4.
Trade Name: Oral/Enteral Syringe with ENFit connector Common Name: Enteral Syringe with Enteral Specific connector
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:
The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.
Device Description
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. It consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The syringes (size 12ml, 35ml and 60ml) incorporate a female Standard ENFit connector; the syringes (size 0.5ml, 1ml, 3ml, 6ml) incorporate a female low dosing ENFit connector.
There are 2 types of the syringe:
Side connector ENFit syringe and central connector ENFit syringe. The sizes of the central connector tapered syringe range from 0.5ml and 1ml; and side connector ENFit syringe range from 3ml to 60ml.
The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
న. Identification of Predicate Device
510(k) Number: K161039
Product Name: Oral/Enternal Feeding Syringes with ENFit Connector (12ml to 100ml) and Low Dose Tip Oral/Enternal Feeding Syringes with ENFit Connector (0.5ml to 6ml)
5
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 7886-1:2017 Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use;
-
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
-
ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices;
-
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;
-
ISO 80369-3:2016 Small-Bore Connectors for Liquids and Gases in Healthcare 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.
In addition, 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.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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8. Summary of Technology Characteristics
| Item | Proposed Device | Predicate Device K161039 | Remark |
|---|---|---|---|
| Product Name | Oral/Enteral Syringe with ENFit | ||
| connector | Oral/Enternal Feeding Syringes with | ||
| ENFit Connector (12ml to 100ml) | |||
| and Low Dose Tip Oral/Enternal | |||
| Feeding Syringes with ENFit | |||
| Connector (0.5ml to 6ml) | / | ||
| Product Code | PNR | PNR | Same |
| Regulation | |||
| Number | 21CFR 876.5980 | 21CFR 876.5980 | Same |
| Indications for | |||
| Use | The device is intended for use as a | ||
| dispenser, a measuring device and an | |||
| oral fluid transfer device. It is | |||
| intended to be used to deliver fluids | |||
| into the body orally or enterally. It is | |||
| intended to be used in clinical or | |||
| home care settings by operators | |||
| ranging from qualified medical | |||
| practitioners to laypersons (under the | |||
| supervision of a qualified medical | |||
| practitioners) 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. | Same | ||
| Configuration | Piston; | ||
| Plunger; | |||
| Barrel with ENFit connector; | |||
| Tip cap | Piston; | ||
| Plunger; | |||
| Barrel with ENFit connector; | |||
| Tip cap | Same | ||
| Single Use | Single Use | Single Use | Same |
| Product Size | |||
| (nominal | |||
| volumes) | Low dose tip ENFit syringe: 0.5ml, | ||
| 1ml, 3ml, 6ml; | |||
| Standard ENFit syringe: 12ml, 20ml, | |||
| 35ml, 60ml; | Low dose tip ENFit syringe: | ||
| 0.5ml~6ml; | |||
| Standard ENFit syringe: | |||
| 12ml~100ml; | Different | ||
| Product | |||
| Performance | Complied with: | ||
| ISO 80369-3 | |||
| ISO 80369-20 | |||
| ISO 7886-1 | Complied with: | ||
| ISO 80369-3 | |||
| ISO 80369-20 | |||
| ISO 7886-1 | Same | ||
| Material | |||
| Barrel | Polypropylene (PP) | Unknown | Different |
| Table 1 Comparison of Technology Characteristics | ||
|---|---|---|
| -- | -- | -------------------------------------------------- |
7
| Plunger | Polypropylene (PP) and white pigment | ||
|---|---|---|---|
| Piston | Silicone rubber | ||
| Tip Cap | Polypropylene (PP) and Orange pigment | ||
| Or polypropylene (PP) and purple pigment | |||
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | Conform with ISO 10993 | Similar |
| Skin Irritation | No Irritation | ||
| Sensitization | No Sensitization | ||
| Sterile | Sterile or non-sterile | Sterile or non-sterile | SE |
| Sterile Method | EO Sterilized | EO Sterilized | SE |
| SAL | 10-6 | 10-6 | SE |
Different - Product Size
The product size for proposed device is different from predicate device. The proposed device includes 8 sizes, 0.5 ml, 1ml, 3ml, 6ml, 20ml, 35ml, 60ml, all of which are covered by predicative device. In addition, this difference is just in infusion capacity and dose not effect indication for use, and the physician can select by per patient's condition. Therefore, this difference does not raise new safety and effectiveness issues for the device.
Different- Material
The material for the predicate devices is unknown. However, the biocompatibility test has been performed on proposed device according to ISO 10993, the result does not show any adverse effect which can demonstrate the safety of proposed device. Therefore, this difference does not raise new safety and effectiveness issues for the device.
Similar- Biocompatibility
The biocompatibility of proposed device and predicate device is similar. Both of them comply with standard ISO 10993, the result does not show any adverse effect which can demonstrate the safety of proposed device. Therefore, this difference does not raise new safety and effectiveness issues for the device.
9. Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission, the Oral/Enteral Syringe with ENFit Connector is as safe, as effective, and performs as well
8
as or better than the legally marketed predicative device cleared under K161039.