K Number

Device Name

Feeding Tube

Manufacturer

Anhui Tiankang Medical Technology Co., Ltd.

Date Cleared

2023-08-17

(337 days)

Product Code

PIF

Regulation Number

876.5980

Intended 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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K210598

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components, materials, and basic functionality of a feeding tube, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

Yes
The device is intended to provide nutrition, which is a therapeutic intervention for patients who cannot feed orally.

Diagnostic

This device is a feeding tube, designed to provide nutrition to patients. While it can be visualized by X-ray to confirm placement, its primary function is delivery of nutrition, not diagnosis of a medical condition.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components made of Polyurethane or PVC, including a catheter and connector hub. It also mentions sterilization and packaging, indicating a physical medical device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to provide nutrition via nasal or orogastric placement. This is a therapeutic and delivery function, not a diagnostic one.
Device Description: The description focuses on the physical components of a feeding tube designed for delivering substances into the body.
Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
Input Imaging Modality: While x-ray is mentioned, it's used for confirming the physical placement of the tube, not for diagnostic interpretation of the x-ray image itself.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This feeding tube does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

PIF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

neonatal and pediatric patients

Intended User / Care Setting

Trained personnel well versed in anatomical landmarks, safe technique, and potential complications must perform the procedure.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. The testing is performed according to ISO 10993-7:2008 for EO residue and ECH residue. 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: Conducted on the final, packaged, and sterile devices after environmental conditioning and simulated transportation. All packaging deemed acceptable for protection of product and sterility maintenance. The testing is performed according to ASTM F88/F88M-15 (Seal strength), ASTM F 1929-2015 (Blue Dye Penetration), and ASTM F 1886/ F 1886M-16 (Seal Integrity (Visual Inspection)).

Performance testing: 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
ISO 20695 Enteral feeding systems - Design and testing

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K210598

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
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).(b)
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.

Summary

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: 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

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

Indications for Use

510(k) Number (if known) K222773

Device Name Feeding Tube

Indications for Use (Describe)

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

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
Tubes - Single ENFit Port
Product code	PIF	PIF	Same
Regulation
Number	21CFR 876.5980	21CFR 876.5980	Same
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.	The Pediatric Nasogastric
Feeding Tubes - Single ENFit
Port are intended for enteral
feeding to deliver nutrition,
fluids, and medications to the
patient from an enteral feeding
syringe or feeding set designed
with ENFit connectors for
enteral applications.
This product is single use for no
longer than 29 days.	Difference
Comment 1
Environment of
Use	Unspecified -Prescription
Only	Unspecified -Prescription Only	Same
Intended Users	Trained personnel well
versed in anatomical
landmarks, safe technique,
and potential complications
must perform the procedure.
Neonatal and Pediatric
patients	Physicians, nurses, and
trained clinicians (by facility
policy)	Same
Patient
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
Verification	Compliant with ISO
20695:2020	Compliant with ISO 20695:2020	Same
Tube Markings	Compliant with ISO
20695:2020	Compliant with ISO 20695:2020	Same
French Sizes	4,5,6.5,8,10,12	4, 5, 6, 8, 10, 12	Difference
Comment 2
Lengths	40cm, 60cm, 90cm, 105cm,
109cm	40cm, 60cm, 90cm	Difference
Comment 3
Liquid Leakage
Testing	Feeding tube set shall not
show signs of leakage
sufficient to form a falling
drop of water while being
subjected to the internally
applied pressure of 50 kPa to
60 kPa.	Tested and met updated
standard ISO 20695:2020
Enteral Feeding Systems -
Design and Testing	Same
Component and
Material	Head Melted Tube: TPU/PVC
Hub: TPU/ABS
Tethered Bolt: PVC	Tube: Polyurethane
Cap: Polypropylene
Connector: ABS
Tether: thermoplastic
polyurethane	Difference
Comment 4
Tensile Testing	Tested and met updated
standard ISO 20695:2020
Enteral Feeding Systems -
Design and Testing	Tested and met updated
standard ISO 20695:2020
Enteral Feeding Systems -
Design and Testing	Same
Fluid Leakage:
Connector	The connector shall not leak
applied pressure of between
300 kPa and 330 kPa per
ISO 80369-3 and ISO
80369-20.	Tested per ISO 80369-20 and
met the standards of 80369-3
for fluid leakage.	Same
Stress
Cracking:
Connector	The connector shall have
adequate resistance to stress
cracking per ISO 80369-3
80369-20.	Tested per ISO 80369-20 and
met the standards of ISO
80369-3 for stress cracking.	Same
Resistance to
separation from
axial load:
connector	The connector shall not
separate from the reference
connector applied axial force
per ISO 80369-3 and ISO
80369-20.	Tested per ISO 80369- 20 and
met the standards of ISO
80369-3 for resistance to
separation from axial load.	Same
Device feature	Subject Device	Predicate Device K210598	Comment
Resistance to
separation from
unscrewing:
connector	The connector shall separate
from the reference connector
applied unscrewing torque
less than 0.26 N.m per ISO
80369-3 and ISO 80369-20.	Tested per ISO 80369-20 and
met the standards of ISO
80369-3 for separation from
unscrewing.	Same
Resistance to
overriding:
connector	The connector shall not
override the threads or lugs
of the reference connector
applied torque of between
0.15 N.m to 0.17 N.m per
ISO 80369-3 and ISO
80369-20.	Tested per ISO 80369-20 and
met the standards of ISO
80369-3 for resistance to
overriding.	Same
Connector	The connector shall be
compatible with ISO 80369-3
reference connectors.	Evaluated per ISO 80369-3 for
ENFit dimensional verification	Same
Connector	Non- ENFit Connector	None	Difference
Comment 5
Biocompatibility	Compliant with Use of
International Standard ISO
10993-1, “Biological
evaluation of medical devices
– Part 1: Evaluation and
testing within a risk
management process”	Compliant with Use of
International Standard ISO
10993-1, “Biological evaluation
of medical devices – Part 1:
Evaluation and testing within a
risk management process”	Same
Sterility
Condition	Sterile	Sterile	Same
Sterile Method	EO Sterilized	EO Sterilized	Same

Table 6-1 Substantial equivalence discussion for Feeding Tube

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

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

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.