ENFit Disposable Enteral Syringe

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June 28, 2021 Shantou Wealy Medical Instrument Co., Ltd. % Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, Shanghai 200122 CHINA Re: K203410 Trade/Device Name: ENFit Disposable Enteral Syringe Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PNR Dated: May 27, 2021 Received: May 27, 2021 Dear Eva Li: 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 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, 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) K203410 #### Device Name ENFit® Disposable Enteral Syringe (Model:WE1mlLD, WE2.5mlLD, WE5mlLD, WE10ml, WE30ml, WE30ml, WE100ml, WE100ml ) #### Indications for Use (Describe) Wealy ENFit® Disposable Enteral Syringe 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 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) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China > K203410 Page 1 Of 5 # 510(K) Summary ### A. Applicant Shantou Wealy Medical Instrument Co., Ltd. Address: North Jinhuan Road (near of Qishan Mid-school) 515064 Shantou, China Contact Person: Yang Songling Tel: +8615816758600 Fax: 0086-754-82121654 Date Prepared: June 27, 2021 Submission Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com ### B. Device Trade Name: ENFit® Disposable Enteral Syringe Common Name: Enteral feeding Syringe with ENFit Connector Model: WE1mlLD, WE2.5mlLD, WE5mlLD, WE10ml, WE20ml, WE30ml, WE60ml, WE100ml Regulatory Information Classification Name: Gastrointestinal tube and accessories Regulatory Class: 2 Product code: PNR Regulation Number: 876.5980 Device Panel: Gastroenterology/Urology C. Predicate device: K161979 ENFit Enteral Syringe Jiangyin Caina Technology Co, Ltd. {4}------------------------------------------------ Shantou Wealy Medical Instrument Co., Ltd. North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China D. Indications for Use: Wealy ENFit® Disposable Enteral Syringe 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 syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinicians, in all age groups. # E. Device Description: The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml~100ml. This device incorporates a female ENFit® connector for connection to an enteral access device with male ENFit® connector. The proposed syringe is 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 life of three years. # F. Comparison with predicate device Table 1 General Comparison | Device | Proposed Device | Predicate Device | Comparison | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Manufacturer | Shantou Wealy Medical<br>Instrument Co., Ltd. | Jiangyin Caina Technology Co,<br>Ltd. | -- | | 510(K)<br>number | K203410 | K161979 | -- | | Product Code | PNR | PNR | Same | | Regulation<br>Number | CFR 876.5980 | CFR 876.5980 | Same | | Indications<br>for Use | Wealy ENFit ™ Enteral Syringe<br>is indicated for use as a<br>dispenser, a measuring<br>device, and a fluid transfer<br>device. It is used to deliver<br>fluids into the gastrointestinal<br>system of a patient who is<br>physically unable to eat and<br>swallow. The enteral syringes<br>are intended to be used in<br>clinical or home care setting<br>by users ranging from<br>laypersons (under the<br>supervision of a clinician) to<br>clinicians, in all age groups. | The proposed device is<br>indicated for use as a<br>dispenser, a measuring<br>device, and a fluid transfer<br>device. It is used to deliver<br>fluids into the gastrointestinal<br>system of a patient who is<br>physically unable to eat and<br>swallow. The enteral syringes<br>are intended to be used in<br>clinical or home care setting<br>by users ranging from<br>laypersons (under the<br>supervision of a clinician) to<br>clinicians, in all age groups. | Same | | Configuration | Barrel with ENFit connector<br>Purple Plunger | Barrel with ENFit connector<br>Purple Plunger | Similar* | {5}------------------------------------------------ | North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China | | | | | | |-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------| | | Piston | Piston<br>Tip cap | | | | | Size | Low dose tip<br>ENFitTM syringe | 1ml,<br>2.5ml,<br>5ml | Low dose<br>tip ENFitTM syringe | 1ml,3ml | Similar* | | | Standard ENFitTM<br>syringe | 10ml-<br>100ml | Standard<br>ENFitTM<br>syringe | 5ml-60ml | | | Sterile | Yes | | Yes | | Same | | Single use | Yes | | Yes | | Same | | Biocompatibility | Conforms to the requirement<br>of ISO<br>10993 series Standards<br>No Cytoxicity<br>No Irritation to Skin<br>No significant evidence of<br>sensitization | | Conforms to the requirement<br>of ISO<br>10993 series Standards<br>No Cytoxicity<br>No Irritation to Skin<br>No significant evidence of<br>sensitization | | Same | ### Shantou Wealy Medical Instrument Co., Ltd. North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China ## *Similar discussion The proposed device don't configure the tip cap, it will not affect the safety and effectiveness of the proposed device. The size of the proposed device of the low dose tip syringe or standard syringe is similar, all the size of the proposed are pass the acceptance criteria of the related performance standard requirements, so it will not affect the safety and effectiveness of the proposed device. # G. Summary of Non-Clinical Performance Testing 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: - A ISO 80369-3:2016, Small-bore connectors for liquids and gases in healthcare application-Part3: Connectors for enteral applications; - A ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare application-Part 20: Common test methods; - > ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for 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; - A ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity - > ASTM F 88/F88M-09, Standard test method for seal strength of flexible barrier materials; - A USP38-NF33 <85> Bacterial Endotoxins Limit. - A ISO 7886-1:2017 Sterile hypodermic syringe for single use-Part 1: Syringe for manual {6}------------------------------------------------ ## Shantou Wealy Medical Instrument Co., Ltd. North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China use Biocompatibility testing has demonstrated the biological safety of the proposed devices which may indirectly contact the patients. Product performance after Real-time Aging test and Package Integrity after Accelerated Aging test evaluated the properties of the enteral feeding syringes after accelerated aging in support of the labeling. Connector testing performed on the proposed device included the items listed below, in accordance with ISO 80369-3:2016 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 ISO80369-3:2016. | Individual test Defined in ISO 80369-3:2016 | Test Method Defined<br>in ISO 80369-20:2015 | |---------------------------------------------|---------------------------------------------| | Fluid Leakage | Annex B | | Sub-atmospheric pressure Air Leakage | Annex D | | Stress Cracking | Annex E | | Resistance to separation from axial load | Annex F | | Resistance to separation from unscrewing | Annex G | | Resistance to overriding | Annex H | | Disconnection by unscrewing | Annex I | Table2: Testing Item according ISO 80369-3:2016 Syringe testing performed on the proposed device included the items listed below, in accordance with ISO 7886-1:2017 Sterile hypodermic syringes for single use-Part 1: Syringe for manual use, using the test methods provided in ISO 7886-1:2017. The testing demonstrates the proposed devices conform to the requirements of ISO 7886-1:2017. Table3: Testing Item according ISO 7886-1:2017 | Individual test Defined in ISO 7886-1:2017 | Requirement Defined in ISO 7886-1:2017 | |---------------------------------------------------|----------------------------------------| | Appearance | Clause 5 | | Overall Length of Scale to Norminal Capacity Line | Clause 9.3 | | Push-button Distance | Clause 11 | | Force to Operate the Plunger | Clause 13.3 | | Freedom from air and liquid leakage past piston | Clause 13.2 | | Limits for Acidity or Alkalinity | Clause 6.2 | | Limits for Extractable Metals | Clause 6.3 | | Tolerance on graduated capacity | Clause 8 | | Dead Space | Clause 13.1 | | Lubricant | Clause 7 | | Cleanliness | Clause 5 | | Graduated Scale | Clause 9 | {7}------------------------------------------------ | Shantou Wealy Medical Instrument Co., Ltd. | | |-------------------------------------------------------------------|--| | North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China | | | Barrel | Clause 11 | |-------------------------|-----------| | Piston/Plunger Assembly | Clause 13 | # H. Summary of Clinical Performance Test No clinical study is included in this submission. ## I. Conclusion Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, ENFit Enteral Syringe cleared under K161979.