CONOD Enteral Feeding Sets

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July 12, 2018 Conod Medical Co., Limited % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 911 floor, R&D Building, No. 26, Oinglan Street, Planyu Distict Guangzhou, Guangdong 510006 China Re: K181276 Trade/Device Name: CONOD Enteral Feeding Sets Regulation Number: 21 CFR& 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PIF, KNT Dated: May 15, 2018 Received: May 17, 2018 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. 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. {1}------------------------------------------------ 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/6 description: The image shows the letters FDA on the left side of the image. On the right side of the image, the text "Jeffrey W. C 2018.07.12 -04'00'" is present. The text is aligned to the left. Jeffrey W. Cooper -S 2018.07.12 11:40:34 for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K181276 Device Name CONOD Enteral Feeding Sets #### Indications for Use (Describe) CONOD Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a piercing spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults. 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. 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "CONOD" in bold, black letters. The letters are all capitalized and evenly spaced. The background is plain white, which makes the text stand out. The font appears to be sans-serif. K181276 # 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: ### 1. SUBMITTER Conod Medical Co., Limited No.38 Hongfeng Road, Baimao Industrial Park, Changshu, Jiangsu, China Phone: (+86) 0571-81958619 Fax: (+86) 571-81958601 | Primary Contact | Mike Gu | |-------------------|-----------------------------------------------------------------| | Person: | Regulatory Affairs Manager | | | Guangzhou Osmunda Medical Device Technical Service<br>Co., Ltd. | | | Tel: (+86)-20-6231 6262 | | | Fax: (+86) -20-8633 0253 | | Secondary Contact | Run Cheng | | Person: | Product Manager | Conod Medical Co., Limited Tel: (+86) 0571-81958619 Fax: (+86) 571-81958601 Date prepared Jul 10, 2018 - 2. DEVICE | Device Name: | CONOD Enteral Feeding Sets | |----------------------|---------------------------------------| | Common/Usual Name: | Enteral Feeding Sets | | Classification Name: | Gastrointestinal tube and accessories | | Regulation number | 21 CFR 876.5980 | | Regulation Class: | II | | Product Code: | PIF, KNT | ### 3. PREDICATE DEVICE K150286, Medline Enteral Feeding Sets This predicate has not been subject to a design-related recall. No reference devices were used in this submission. {4}------------------------------------------------ #### DEVICE DESCRIPTION 4. The CONOD Enteral Feeding Sets have three models, CONOD safety spike plus pump set, CONOD gravity feeding set and CONOD feeding pump set. The CONOD Feeding Pump Set (1200ml) and gravity feeding set both have a structure of a 1200ml formula bag with 100ml graduations and a protective closure cap. The difference is the former is droved by pump and the latter is droved by gravity. CONOD Safety spike plus Pump Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is a single-use, non-sterile device. ## 5. INDICATIONS FOR USE CONOD Enteral Feeding Sets are intended to dispense liquid nutrition (feeding solutions) at a user controlled rate. These enteral feeding sets interface with a patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets include a bag to contain the feeding solution and/or a piercing spike to connect to a pre-filled container. The device is used for infants, children, adolescents and adults. {5}------------------------------------------------ #### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | Specification | Predicate Device | Proposed Device | Discussion of<br>Differences | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | Device name | Medline Enteral Feeding Sets | CONOD Enteral Feeding Sets | | | K number | K150286 | K181276 | | | Indications for Use | Medline Enteral Feeding Sets are intended to<br>dispense liquid nutrition (feeding solutions) at a<br>user controlled rate. These enteral feeding sets<br>interface with a patient's feeding tube and may<br>use gravity or an enteral feeding pump to<br>dispense feeding solution. The enteral feeding<br>sets may include a bag to contain the feeding<br>solution and/or spike to connect to a pre-filled<br>container. The device is used for infants,<br>children, adolescents and adults. | CONOD Enteral Feeding Sets are intended to<br>dispense liquid nutrition (feeding solutions) at<br>a user controlled rate. These enteral feeding<br>sets interface with a patient's feeding tube<br>and may use gravity or an enteral feeding<br>pump to dispense feeding solution. The<br>enteral feeding sets include a bag to contain<br>the feeding solution and/or a piercing spike<br>to connect to a pre-filled container. The<br>device is used for<br>infants,<br>children,<br>adolescents and adults. | same | | Product code | PIF, KNT | PIF, KNT | Same | | Classification<br>regulation | 21 CFR 876.5980 | 21 CFR 876.5980 | Same | | Device configurations | - Medline Enteral Feeding Pump Bag Set<br>(1000ml)<br>- Medline Enteral Feeding Pump Spike Set<br>- Medline Enteral Feeding Gravity Bag Set<br>(1000ml) | - CONOD Feeding Pump Set (1200ml)<br>- CONOD Safety spike plus Pump Set<br>- CONOD Gravity Feeding Set (1200ml) | similar | | Assemble parts | Enteral feeding bag, tubing, drip chamber,<br>piercing spike, roller clamp and Distal Tip<br>ENFit connectors | Enteral feeding bag, tubing, drip<br>chamber, piercing spike, roller clamp and<br>Distal Tip ENFit connectors | Same | | Specification | Predicate Device | Proposed Device | Discussion of<br>Differences | | Design feature | Non DEHP material sets featuring ISO<br>80369-3:2016 connector | Non DEHP material sets featuring ISO<br>80369-3:2016 connector | same | | Materials | Same with the predicate device | | Same | | Prescription use or<br>not | Prescription use | Prescription use | Same | | Disposable or not | Disposable for single use | Disposable for single use | Same | | Intended use time | No longer than 24 hours | No longer than 24 hours | same | | Sterile or not | Non-sterile | Non-sterile | Same | | Shelf-life | 5 years | 5 years | same | | Available tube lengths | Pump set: 60cm+157cm<br>Spike set: 60cm+157cm<br>Gravity set: 170cm | Pump set: 60cm+157cm<br>Spike set: 60cm+157cm<br>Gravity set: 170cm | same | ### Table 6.1 Comparison with Predicate Device {6}------------------------------------------------ # CONOD CONOD Enteral Feeding Sets has the same intended use and design specifications with the predicate device. CONOD Enteral Feeding Sets is substantial equivalent with the predicate device. {7}------------------------------------------------ #### PERFORMANCE DATA 7. The following performance data were provided in support of the substantial equivalence determination. #### Biocompatibility testing The biocompatibility evaluation for the CONOD Enteral Feeding Sets was conducted in accordance with the International Standard ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests: - Cytotoxicity - Sensitization - Skin Irritation The CONOD Enteral Feeding Sets are considered to contact indirectly with the human body for a duration of less than 24 hours. Testing for cytotoxicity, sensitization and skin irritation complied with ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Testing demonstrates that the materials are non-cytotoxic, non-sensitizing, and non-irritating. #### Performance testing Performance testing was conducted on the CONOD Enteral Feeding Sets according to EN 1615, ISO 80369-3, ISO 11737 and IEC 62366, the tests are as follows: - Fluid leakage test a) - b) Stress cracking test - Resistance to separation from axial load test c) - Resistance to separation from unscrewing test d) - Resistance to overriding test e) - f) Disconnection by unscrewing test - Tensile Properties g) - Liquid leakage test h) - i) Flow rate test - j) Bioburden test - k) Usability test #### Animal Study The subject of this premarket submission, CONOD Enteral Feeding Sets, did not require animal studies to support substantial equivalence. #### Clinical Study {8}------------------------------------------------ # CONOD K181276 The subject of this premarket submission, CONOD Enteral Feeding Sets, did not require clinical studies to support substantial equivalence. ## 8. CONCLUSION The differences between the CONOD Enteral Feeding Sets and its predicate device do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the CONOD Enteral Feeding Sets should perform as intended in the specified use conditions. From the results of non-clinical data including the performance testing described, Conod Medical concludes that the CONOD Enteral Feeding Sets is as safe and as effective as the predicate device.