Oral/Enteral Syringe

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 28, 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: K210621 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: February 25, 2021 Received: March 2, 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, 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K210621 Device Name Oral/Enteral Syringe Indications for Use (Describe) The device is indicated 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. 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." {3}------------------------------------------------ # 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: K210621 - 1. Date of Preparation: 04/21/2021 - 2. 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 - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person) 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 {4}------------------------------------------------ #### Identification of Proposed Device 4. Trade Name: Oral/Enteral Syringe Common Name: Enteral Feeding 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: The device is indicated 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. The enteral feeding syringe 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 tapered connector. Please refer to Figure 1. Image /page/4/Figure/11 description: The image shows two close-up shots of the tip of a syringe. The syringe is clear with orange writing on the side. The tip of the syringe is also clear and has a small opening. There is a black ring around the base of the tip. Figure 1 Illustration of Tapered Tip There are 2 types of the syringe: Side connector tapered syringe and central connector tapered syringe. The sizes of the central connector tapered syringe range from 0.5ml to 3ml; and side connector tapered syringe range from 6ml to 60ml. The proposed syringe is sterile or non-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 {5}------------------------------------------------ the device during the shelf life of three years. - న. Identification of Predicate Device Primary Predicate Device 510(k) Number: K192179 Trade Name: Oral/Enteral Syringe Secondary Predicate Device 510(k) Number: K122373 Product Name: NeoMed Oral/Enteral Syringe (0.5ml to 100ml) - 6. Non-Clinical Test Conclusion 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 80369-1:2018 Small-bore connectors for liquids and gases in healthcare applications Part 1: > General requirements - ) 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; Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device. The test results show that the device meets the requirements of related standards. | Item | Standard | |---------------------------------|-----------------------------| | General requirements | Clause 5 of ISO 7886-1:2017 | | Extraneous matter | Clause 6 of ISO 7886-1:2017 | | Lubricant | Clause 7 of ISO 7886-1:2017 | | Tolerance on graduated capacity | Clause 8 of ISO 7886-1:2017 | | Graduated scale | Clause 9 of ISO 7886-1:2017 | {6}------------------------------------------------ | Barrel | Clause 10 of ISO 7886-1:2017 | |------------------------------------------|--------------------------------| | Piston/ plunger assembly | Clause 11 of ISO 7886-1:2017 | | Nozzle | Clause 12 of ISO 7886-1:2017 | | Performance | Clause 13 of ISO 7886-1:2017 | | Item | Standard | | Fluid leakage | Clause 6.1 of ISO 80369-3:2016 | | Stress cracking | Clause 6.2 of ISO 80369-3:2016 | | Resistance to separation form axial load | Clause 6.3 of ISO 80369-7:2016 | | Disconnection by unscrewing | Clause 6.6 of ISO 80369-7:2016 | Sterile barrier packaging testing were performed on the proposed device, which include seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity. Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Shelf life test result showed that the device can maintain its performance during the claimed shelf life. | Item | Standard | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------| | EO residue | ISO 10993-7:2008 | | ECH residue | ISO 10993-7:2008 | | Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests<br>were performed on aging samples to verify the<br>claimed shelf life of the device | ### Biocompatibility testing The contact level of the proposed device is mucosal membrane, indirect, and the contact duration is limited contact (<24 hours). The proposed device was evaluated for the following tests. The results for the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device. - > Cytotoxicity, - > Sensitization, - > Irritation, #### Connector Incompatibility A connector incompatibility test was performed on proposed device according to FDA Guidance, {7}------------------------------------------------ Guidance for Industry and FDA Staff: Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications, issued on February 11, 2015, ISO 80369-1:2010 and ISO 14971:2007 to evaluate the incompatibility of the proposed device. The results demonstrated that the proposed device, were unable to connect with other device as specified in ISO 80369-1:2010. (Intravenous, hypodermic applications, breathing systems and driving gases, urethral/urinary, ENFit connector, limb cuff inflation, and neuraxial applications device) #### Dose Accuracy Test for Syringe The dose accuracy test of the enteral syringe is carried out by simulating clinical conditions, the test results show that enteral syringes are accurate to ±10% when the syringe is filled with a minimum dose of 20% of the overall syringe capacity. #### Dimensional Verification of Tapered Tip The tapered tip was dimensional tested, and the test results show that the tip dimensional meets the acceptance standard. - 7. Clinical Test Conclusion No clinical study is included in this submission. {8}------------------------------------------------ #### K210621 #### 8. Summary of Technology Characteristics | Item | Proposed Device | Primary Predicate<br>Device K192179 | Secondary Predicate<br>Device K122373 | Remark | | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|-----------| | Product<br>name | Oral/Enteral Syringe | Oral/Enteral Syringe | NeoMed Oral/Enteral<br>Syringe (0.5 mL to<br>100mL) | / | | | Product<br>Code | PNR | PNR | FMF | Different | | | Regulati<br>on<br>Number | 21CFR 876.5980 | 21CFR 876.5980 | 21CFR 880.5560 | Different | | | Class | II | II | II | Same | | | Indicatio<br>ns for<br>Use | The device is indicated for<br>use as a dispenser, a<br>measuring device and an<br>oral fluid transfer device. It<br>is intended to be used to<br>deliver fluids into the body<br>orally or enterally. It is<br>intended to be used in<br>clinical or home care<br>settings by operators<br>ranging from qualified<br>medical practitioners to<br>laypersons (under the<br>supervision of a qualified<br>medical practitioners) in all<br>age groups. | The device is indicated<br>for use as a dispenser, a<br>measuring device and a<br>fluid transfer device. It<br>is used to deliver fluids<br>into the body orally or<br>enterally. It is intended<br>to be used in clinical or<br>home care settings by<br>users ranging from<br>clinicians to laypersons<br>(under the supervision<br>of a clinician) in all age<br>groups. | The device is indicated<br>for use as a dispenser, a<br>measuring device and an<br>oral fluid transfer<br>device. It is used to<br>inject fluids into the<br>body via extension sets<br>and feeding tubes in<br>neonatal and small<br>pediatric patients. | Different | | | Configur<br>ation | Piston;<br>Plunger;<br>Barrel with tapered<br>connector;<br>Tip cap | Barrel;<br>Plunger (Rubber Stopper<br>or Rubber Pad);<br>Piston | Syringe Gasket;<br>Syringe Plunger;<br>Syringe Barrel with<br>tapered connector;<br>Syringe Tip;<br>Syringe Cap; | Different | | | Product<br>Size<br>(nominal<br>volumes) | 0.5ml, 1ml, 3ml, 6ml,<br>12ml, 20ml, 35ml, 60ml | 1ml, 3ml, 5ml, 10ml,<br>20ml, 60ml | 0.5ml to 100ml | Different | | | Product<br>Performance | | | | | | | Complied with:<br>ISO 7886-1<br>ISO 80369-1; | Complied with:<br>ISO 7886-1;<br>ISO 80369-3;<br>ISO 80369-20; | Complied with:<br>ISO 7886<br>ISO 80369-1 | Different | | | | Material | Barrel | Polypropylene (PP) | Polypropylene (PP) | Unknown | Different | | | Plunger | Polypropylene (PP) and<br>white pigment | Polypropylene (PP) and<br>purple pigment | | | | | Piston | Silicone<br>rubber | Isoprene rubber or<br>silicone rubber | | | | | Tip Cap | Polypropylene<br>(PP) and<br>Orange<br>pigment<br><br>Or<br>polypropylene<br>(PP) and<br>purple<br>pigment | / | | | | | | | | | | | | | | | | | | Biocompatibility | Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Conform with ISO<br>10993 | Different | | | Skin<br>Irritation | No Irritation | No Irritation | | | | | Sensitization | No<br>Sensitization | No Sensitization | | | | Sterile | Sterile or non-sterile | | Sterile | Sterile | Different | | Sterile Method | EO Sterilized | | EO Sterilized | EO Sterilized | Same | | SAL | 10-6 | | 10-6 | 10-6 | Same | | Single Use | Single Use | | Single Use | Single Use | Same | ## Table 1 Comparison of Technology Characteristics {9}------------------------------------------------ Different 1- Regulation Number and Product Code The regulation number and product code of the proposed device and primary predicate device are same, but regulation number and product code of the proposed device and secondary predicate device are difference. The product code and the regulation number are different because the PNR code was assigned for the Oral/Enteral Syringe by the FDA in recent years. The secondary predicate device that {10}------------------------------------------------ cleared in 2012, so it was classified under the FMF code. This caused the difference between the product code and the regulatory number of the proposed device and secondary predicate device. This difference between the product code and the regulatory number will not affect the safety and effectiveness. #### Different 2- Indication for Use The indication for use of the proposed device and primary predicate device are same, with only slightly different in the verbal descriptions. The indication for use of the proposed device and secondary predicate device are not exactly the same. The proposed devices and secondary predicate device are indicated for use as a dispenser, a measuring device and an oral fluid transfer device. However, the applicable people of the proposed devices and primary predicative device are same, and the applicable people of the secondary predicate device are neonatal and small pediatric patients. This product is only for delivering liquids to the human body, so different applicable people will not affect the intended use of the product. Now, many oral/enteral syringe that have been marketed are suitable for people of all ages groups. The use environment of the proposed devices and primary predicative device are same, and the indication for use of the secondary predicate device does not clearly state the use environment. Many of the oral/enteral syringe that have been marketed for indication for use claim that the product can be used in clinical or home care settings. In addition, laypersons are required to use under the supervision of medical practitioners in the indication for use. In summary, this difference does not raise new safety and effectiveness issues for the device. #### Different 3- Configuration The primary predicate device has not tip cap, which is used to prevent fluid loss and contamination of contents until ready for use and seal the device after using. This difference does not affect intended use. The configuration of the proposed device and secondary predicate device are exactly the same, but the name is different. The secondary predicate device used the tip as a component, but the design of the tip of the proposed device and the secondary predicate device is exactly the same. Therefore, different configuration names do not raise new safety and effectiveness issues for the device. #### Different 4 - Product Size The product size for proposed device is different from primary predicate device and secondary predicate device. The proposed device includes 8 sizes, 0.5 ml, 12ml, 20ml, 35ml, 60ml, all of which are covered by secondary predicate device and the product size is similar to the primary predicate 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 5- Product Performance {11}------------------------------------------------ The product performance of proposed device and secondary predicate device are same, and the biocompatibility of proposed device and primary predicate device are similar. ISO 80369-1 is a general standard. Therefore, this difference does not raise new safety and effectiveness issues for the device. #### Different 6- Material The material for proposed device is different from primary predicate device and the material for the secondary predicate device 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. #### Different 7- Biocompatibility The biocompatibility of proposed device and primary predicate device are same, and the biocompatibility of proposed device and secondary predicate device are different. But 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. ### Different 8- Sterilization The proposed device is available in sterile and non-sterile two types. The proposed sterile method is same as the primary predicate device and secondary predicate device. Whether the device is sterilized or not does not affect the indication for use of the device and its performance. 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 K210621, the Oral/Enteral Syringe is as safe, as effective, and performs as well as or better than the legally marketed predicative device cleared under K192179 and K122373.