Oral/Enteral Syringe with ENFit connector

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text. August 17, 2023 Anhui Tiankang Medical Technology Co., Ltd. Zhang Yong Management No. 228, Weiyi Road, Economic Development Zone Tianchang, Anhui 239300 China Re: K222772 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: July 10, 2023 Received: July 17, 2023 Dear Zhang Yong: 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 {1}------------------------------------------------ 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 (OS) 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 mediation-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, Sivakami Venkatachalam -S 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) K222772 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 ofa 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) | ### 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 ### l Submitter Device submitter: Anhui Tiankang Medical Technology Co., Ltd. No.228, Weiyi Road, Economic Development Zone, Tianchang City, Anhui, China. Contact person: Name: Zhang yong Title: Management representative Phone: +86-13705505106 Fax: +86-550-7309158 E-mail: zy@tkmedical.com ## II Device Trade Name of Device: Oral/Enteral Syringe with ENFit connector Common Name: Enteral Syringes With Enteral Specific Connectors Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product code: PNR Review Panel: Gastroenterology/Urology ## III Predicate Device 1 | Trade name: | Oral/Enteral Syringe with ENFit connector | |-------------------------|-------------------------------------------| | Regulation name: | Gastrointestinal tube and accessories | | Classification: | Class II | | Product Code: | PNR | | Premarket Notification: | K211025 | | Manufacturer: | Ningbo Tianyi Medical Appliance Co., Ltd. | ## IV Device description The Oral/Enteral Syringe with ENFit connector is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. The Oral/Enteral Syringe with ENFit connector consists of plunger, gasket/piston, barrel with ENFit connector, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The proposed syringe is 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. ### V Indications for use {4}------------------------------------------------ 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. ### VI Comparison of technological characteristics with the predicate devices The Oral/Enteral Syringe with ENFit connector has the same intended use, technology, design and biocompatibility is either identical or substantially equivalent to existing legally marketed predicate devices. The comparison between the subject device and the predicate devices are listed in below tables: | Device feature | Subject Device | Predicate Device K211025 | Comment | | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Product | Oral/Enteral Syringe with<br>ENFit connector | Oral/Enteral Syringe with<br>ENFit connector | / | | | Product code | PNR | PNR | Same | | | Regulation<br>Number | 21CFR 876.5980 | 21CFR 876.5980 | Same | | | Indications for use | The device is intended 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 intended for<br>use as a dispenser, a<br>measuring device and an oral<br>fluid transfer device. It is<br>intended to be used to deliver<br>fluids into the body orally or<br>enterally. It is intended to be<br>used in clinical or home care<br>settings by operators ranging<br>from qualified medical<br>practitioners to laypersons<br>(under the supervision of a<br>qualified medical<br>practitioners) in all age<br>groups. | Same | | | | Configuration | Piston/Gasket;<br>Plunger; | Piston;<br>Plunger | Difference<br>Comment 1 | | | Device feature | Subject Device | Predicate Device K211025 | Comment | | | | Barrel with ENFit connector; | Barrel with ENFit connector; | | | | | Tip cap | Tip cap | | | | Single Use | Single Use | Single Use | Same | | | Product Size<br>(nominal<br>volumes) | TKESNC001, TKESNC002,<br>TKESNC003, TKESNC004:<br>0.5ml, 1ml, 2.5ml, 3ml, 5ml,<br>6ml, 10ml, 12ml, 20ml,30ml<br>, 35ml, 60ml. | Low dose tip ENFit syringe:<br>0.5ml, 1ml, 3ml, 6ml; | Difference | | | | TKESNC005: 0.5ml, 1ml,<br>2.5ml, 3ml, 5ml, 6ml, 10ml,<br>12ml, 20ml, 30ml,35ml<br>, 60ml. | Standard ENFit syringe:<br>12ml, 20ml, 35ml, 60ml; | Comment 2 | | | Product<br>Performance | Complied with:<br>ISO 80369-3<br>ISO 80369-20<br>ISO 7886-1 | Complied with:<br>ISO 80369-3<br>ISO 80369-20<br>ISO 7886-1 | Same | | | Materials | Barrel: Polypropylene (PP),<br>Polypropylene (PP) and<br>Amber Pigment;<br>Plunger: Polypropylene (PP) and White Pigment,<br>Polypropylene (PP) and Purple Pigment;<br>Gasket: S1Si;<br>Piston: Polyisoprene Rubber<br>Tip Cap: PP and Purple Pigment, PP and Orange Pigment, PP and White Pigment; | Barrel: Polypropylene (PP)<br>Plunger: Polypropylene (PP) and white pigment<br>Piston: Silicone rubber<br>Tip Cap: Polypropylene (PP) and Orange pigment or<br>polypropylene (PP) and purple pigment | Difference<br>Comment 3 | | | Biocompatibility | No Cytotoxicity;<br>No Irritation;<br>No Sensitization; | No Cytotoxicity;<br>No Irritation;<br>No Sensitization; | Same | | | Sterile | Sterile | Sterile or non-sterile | Same | | Sterile Method | EO Sterilized | EO Sterilized | Same | | | SAL | 10-6 | 10-6 | Same | | ### Table 6-1 Substantial Equivalence Discussion- Oral/Enteral Syringe with ENFit connector {5}------------------------------------------------ Difference comment 1 The Gasket of the subject device is not covered by the predicate device, but the Oral/Enteral Syringe with ENFit connector of the structure has passed the verification of ISO 80369-3, ISO 80369-20 and ISO 7886-1 standard tests, and the results meet the {6}------------------------------------------------ requirements. Therefore, this difference does not raise new safety and effectiveness issues for the device. #### Difference comment 2 The product size for subject device is different from predicate device. The subject device includes 12 sizes, 0.5ml, 1ml, 2.5ml/3ml, 10ml/12ml, 20ml, 30ml, 30ml, 35ml, 60ml all of which are covered by predicative device. but after the test of product performance, the safety and effectiveness of the product have been verified. 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. ### Difference comment 3 subject device is different from predicate device in material, but the main material of the device is PP. 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. #### VII Performance data The following performance data were provided in support of the substantial equivalence determination. #### Biocompatibility testing Biocompatibility of the Oral/Enteral Syringe with ENFit connector was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface medical device-mucosal membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: | In Vitro Cytotoxicity Test | ISO 10993-5: 2009 | |--------------------------------|--------------------| | Intracutaneous Reactivity Test | ISO 10993-10: 2010 | | Skin Sensitization Test | ISO 10993-10: 2010 | ### Sterilization and shelf life testing The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The testing is performed according to the following standards: ISO 10993-7:2008 EO residue ECH residue ISO 10993-7:2008 The shelf life of three years is determined based on stability studies which include ageing test according to FDA recognized standard ASTM F1980-16. Package integrity testing was conducted on the final, packaged, and sterile devices after environmental conditioning and simulated transportation. All packaging deemed {7}------------------------------------------------ acceptable for protection of product and sterility maintenance. The testing is performed according to the following standards: | Seal strength | ASTM F88/F88M-15 | |------------------------------------|-------------------------| | Blue Dye Penetration | ASTM F 1929-2015 | | Seal Integrity (Visual Inspection) | ASTM F 1886/ F 1886M-16 | # Performance testing | Testing Name | | standards | No. | |--------------------|----------|----------------------------|------------------| | report of PP 5090T | | ASTM D638-22, ASTM D790-17 | SHMR221101124301 | | | | Procedure A | | | dose | accuracy | ISO7886-1 | 1888-0009 | | testing | | | | | Performance report | | ISO 80369-3:2016 | QDHL2210015086MD | Performance testing is performed according to the following standards: - ISO 7886-1:2017: Sterile hypodermic syringes for single use Part 1: Syringes for > manual use - A ISO 80369-1:2018: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements - > 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 ## VIII Clinical Test Conclusion No clinical study is included in this submission. ## IX Conclusion The Oral/Enteral Syringe with ENFit connector is substantially equivalent to its predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.