Feeding Tube
Device Facts
| Record ID | K222773 |
|---|---|
| Device Name | Feeding Tube |
| Applicant | Anhui Tiankang Medical Technology Co., Ltd. |
| Product Code | PIF · Gastroenterology, Urology |
| Decision Date | Aug 17, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Indications for Use
This product is intended for use in neonatal and pediatric patients to provide nutrition via nasal or orogastric placement. The Polyurethane Feeding Tube is not intended for use beyond 30 days. The PVC Feeding Tube is not intended for use beyond 24 hours.
Device Story
Feeding tube consists of single-lumen catheter (polyurethane or PVC) with enteral-only connector hub and tethered closure plug; includes radiopaque barium sulfate stripe for X-ray visualization; features side holes for flow/aspiration. Used in clinical settings for neonatal and pediatric patients; operated by trained personnel. Device delivers nutrition via nasal or orogastric route. Output is enteral access for nutrition delivery; assists clinicians in managing patient nutritional intake. Benefits include safe, temporary enteral feeding access.
Clinical Evidence
No clinical data. Bench testing only, including biocompatibility (ISO 10993), sterilization validation (ISO 11135), shelf-life/packaging integrity (ASTM F1980, F88, F1929, F1886), and mechanical performance (ISO 80369-3, ISO 80369-20, ISO 20695).
Technological Characteristics
Materials: TPU/PVC catheter, TPU/ABS hub, PVC tethered bolt. Radiopaque barium sulfate stripe. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: ISO 80369-3 compliant enteral connectors. Dimensions: 4-12 French sizes; 40-109cm lengths. Standards: ISO 10993-1, ISO 20695:2020, ISO 80369-3/20.
Indications for Use
Indicated for neonatal and pediatric patients requiring enteral nutrition via nasal or orogastric placement. Polyurethane tubes limited to 30 days; PVC tubes limited to 24 hours.
Regulatory Classification
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).
Special Controls
*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.
Predicate Devices
- Pediatric Nasogastric Feeding Tubes - Single ENFit Port (K210598)
Submission Summary (Full Text)
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August 17, 2023
Anhui Tiankang Medical Technology Co., Ltd. Zhang Yong Management No. 228, Weiyi Road, Economic Development Zone Tianchang, Anhui 239300 China
Re: K222773
Trade/Device Name: Feeding Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: PIF Dated: December 5, 2022 Received: December 6, 2022
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
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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
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# Indications for Use
510(k) Number (if known) K222773
Device Name Feeding Tube
Indications for Use (Describe)
This product is intended for use in neonatal and pediatric patients to provide nutrition via nasal or orogastric placement. The Polyurethane Feeding Tube is not intended for use beyond 30 days. The PVC Feeding Tube is not intended for use beyond 24h
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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# 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: Feeding Tube Common Name: Gastrointestinal tubes with enteral specific connectors Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product code: PIF Review Panel: Gastroenterology/Urology
# III Predicate Device 1
| Trade name: | Pediatric Nasogastric Feeding Tubes - Single ENFit Port |
|-------------------------|---------------------------------------------------------|
| Regulation name: | Gastrointestinal tube and accessories |
| Classification: | Class II |
| Product Code: | PIF |
| Premarket Notification: | K210598 |
| Manufacturer: | Cair Lgl |
#### IV Device description
The Feeding Tube consists of the following main components: a feeding tube single lumen catheter and an enteral only connector hub with integral tethered connection closure plug. The catheter tubing is made of Polyurethane or PVC. The catheter tubing has an orange or purple radiopaque stripe of barium sulfate embedded in the tubing wall which can be visualized on x-ray, for exact placement of the tip. The single lumen catheter tubing has side holes for better flow and to provide multiple openings for aspiration.
The proposed Feeding Tube 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.
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# V Indications for use
This product is intended for use in neonatal and pediatric patients to provide nutrition via nasal or orogastric placement.The Polyurethane Feeding Tube is not intended for use beyond 30 days. The PVC Feeding Tube is not intended for use beyond 24 hours.
# VI Comparison of technological characteristics with the predicate devices
The Feeding Tube are substantially equivalent to the currently marketed predicate Pediatric Nasogastric Feeding Tubes - Single ENFit Port. Table 6-1 is a detailed comparison of the Feeding Tube to the predicate devices regarding substantial equivalence.
| Device feature | Subject Device | Predicate Device K210598 | Comment |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Product | Feeding Tube | Pediatric Nasogastric Feeding<br>Tubes - Single ENFit Port | |
| Product code | PIF | PIF | Same |
| Regulation<br>Number | 21CFR 876.5980 | 21CFR 876.5980 | Same |
| Indications<br>for<br>use | This product is intended for<br>use in neonatal and pediatric<br>patients to provide nutrition<br>via nasal or orogastric<br>placement. The Polyurethane<br>Feeding Tube is not intended<br>for use beyond 30 days. The<br>PVC Feeding Tube is not<br>intended for use beyond 24<br>hours. | The Pediatric Nasogastric<br>Feeding Tubes - Single ENFit<br>Port are intended for enteral<br>feeding to deliver nutrition,<br>fluids, and medications to the<br>patient from an enteral feeding<br>syringe or feeding set designed<br>with ENFit connectors for<br>enteral applications.<br>This product is single use for no<br>longer than 29 days. | Difference<br>Comment 1 |
| Environment of<br>Use | Unspecified -Prescription<br>Only | Unspecified -Prescription Only | Same |
| Intended Users | Trained personnel well<br>versed in anatomical<br>landmarks, safe technique,<br>and potential complications<br>must perform the procedure.<br>Neonatal and Pediatric<br>patients | Physicians, nurses, and<br>trained clinicians (by facility<br>policy) | Same |
| Patient<br>Population | Neonatal and Pediatric patients | | |
| Single Use | Single Use | Single Use | Same |
| Device feature | Subject Device | Predicate Device K210598 | Comment |
| Connector | Compliant with ISO 80369-3 | Compliant with ISO 80369-3 | Same |
| Radiopacity<br>Verification | Compliant with ISO<br>20695:2020 | Compliant with ISO 20695:2020 | Same |
| Tube Markings | Compliant with ISO<br>20695:2020 | Compliant with ISO 20695:2020 | Same |
| French Sizes | 4,5,6.5,8,10,12 | 4, 5, 6, 8, 10, 12 | Difference<br>Comment 2 |
| Lengths | 40cm, 60cm, 90cm, 105cm,<br>109cm | 40cm, 60cm, 90cm | Difference<br>Comment 3 |
| Liquid Leakage<br>Testing | Feeding tube set shall not<br>show signs of leakage<br>sufficient to form a falling<br>drop of water while being<br>subjected to the internally<br>applied pressure of 50 kPa to<br>60 kPa. | Tested and met updated<br>standard ISO 20695:2020<br>Enteral Feeding Systems -<br>Design and Testing | Same |
| Component and<br>Material | Head Melted Tube: TPU/PVC<br>Hub: TPU/ABS<br>Tethered Bolt: PVC | Tube: Polyurethane<br>Cap: Polypropylene<br>Connector: ABS<br>Tether: thermoplastic<br>polyurethane | Difference<br>Comment 4 |
| Tensile Testing | Tested and met updated<br>standard ISO 20695:2020<br>Enteral Feeding Systems -<br>Design and Testing | Tested and met updated<br>standard ISO 20695:2020<br>Enteral Feeding Systems -<br>Design and Testing | Same |
| Fluid Leakage:<br>Connector | The connector shall not leak<br>applied pressure of between<br>300 kPa and 330 kPa per<br>ISO 80369-3 and ISO<br>80369-20. | Tested per ISO 80369-20 and<br>met the standards of 80369-3<br>for fluid leakage. | Same |
| Stress<br>Cracking:<br>Connector | The connector shall have<br>adequate resistance to stress<br>cracking per ISO 80369-3<br>80369-20. | Tested per ISO 80369-20 and<br>met the standards of ISO<br>80369-3 for stress cracking. | Same |
| Resistance to<br>separation from<br>axial load:<br>connector | The connector shall not<br>separate from the reference<br>connector applied axial force<br>per ISO 80369-3 and ISO<br>80369-20. | Tested per ISO 80369- 20 and<br>met the standards of ISO<br>80369-3 for resistance to<br>separation from axial load. | Same |
| Device feature | Subject Device | Predicate Device K210598 | Comment |
| Resistance to<br>separation from<br>unscrewing:<br>connector | The connector shall separate<br>from the reference connector<br>applied unscrewing torque<br>less than 0.26 N.m per ISO<br>80369-3 and ISO 80369-20. | Tested per ISO 80369-20 and<br>met the standards of ISO<br>80369-3 for separation from<br>unscrewing. | Same |
| Resistance to<br>overriding:<br>connector | The connector shall not<br>override the threads or lugs<br>of the reference connector<br>applied torque of between<br>0.15 N.m to 0.17 N.m per<br>ISO 80369-3 and ISO<br>80369-20. | Tested per ISO 80369-20 and<br>met the standards of ISO<br>80369-3 for resistance to<br>overriding. | Same |
| Connector | The connector shall be<br>compatible with ISO 80369-3<br>reference connectors. | Evaluated per ISO 80369-3 for<br>ENFit dimensional verification | Same |
| Connector | Non- ENFit Connector | None | Difference<br>Comment 5 |
| Biocompatibility | Compliant with Use of<br>International Standard ISO<br>10993-1, “Biological<br>evaluation of medical devices<br>– Part 1: Evaluation and<br>testing within a risk<br>management process” | Compliant with Use of<br>International Standard ISO<br>10993-1, “Biological evaluation<br>of medical devices – Part 1:<br>Evaluation and testing within a<br>risk management process” | Same |
| Sterility<br>Condition | Sterile | Sterile | Same |
| Sterile Method | EO Sterilized | EO Sterilized | Same |
#### Table 6-1 Substantial equivalence discussion for Feeding Tube
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# Difference comment 1
The difference between subject device and predicate device is only in textual expressions, and the actual indications for use are not different, which will not affect the safety and performance of the device.
# Difference comment 2
The french sizes of predicate device are covered by subject device, so this difference will not affect the safety and performance of the device
Difference comment 3
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The lengths of 105cm and 109cm of the predicate device are not covered by the predicate device. The operator will select the corresponding length of the device according to the clinical needs. At the same time, the device has passed the performance test, so the difference will not affect the safety and performance of the device.
#### Difference comment 4
subject device is different from predicate device in material, the biocompatibility test has been performed on subject 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.
# Difference Comment 5
The predicate device does not contain a Non-ENFit Connector, and since the subject device has been tested by the connector and the results show that it does not present the risks contemplated by ISO 80369-1, this does not affect the safety and effectiveness of the product device
#### VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
#### Biocompatibility testing
Biocompatibility of the Feeding Tube 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 "prolonged ( > 24h to 30d)". 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 |
| Acute systemic toxicity | ISO 10993-11:2017 |
| Subacute toxicity | ISO 10993-11:2017 |
| Implantation effects | ISO 10993-6:2017 |
# 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:
| EO residue | ISO 10993-7:2008 |
|-------------|------------------|
| 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 affer
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environmental conditioning and simulated transportation. All packaging deemed 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
Performance testing is performed according to the following standards:
- 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
- A ISO 20695 Enteral feeding systems - Design and testing
# XI Clinical Test Conclusion
No clinical study is included in this submission.
#### X Conclusion
The Feeding Tube 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.
