(415 days)
Not Found
No
The description details a simple mechanical device (a tube) for gastric decompression and drainage. There is no mention of any computational or analytical capabilities, let alone AI/ML.
Yes
Explanation: The device is intended for gastric decompression, which is a medical procedure to relieve or prevent gastric distension, making it a therapeutic device.
No
The device is intended for gastric decompression and drainage of stomach contents, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a physical tube made of medical grade PVC, intended for insertion into a patient. It also details performance testing related to physical properties like dimensions, leakage, flow rate, and tensile properties, which are characteristic of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "gastric decompression" and "to drain undesirable contents from the stomach, or decompress the stomach." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the tube and its function in draining the stomach. It doesn't mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Performance Studies: The performance studies listed are related to the physical integrity, flow rate, tensile strength, and biocompatibility of the tube. These are typical performance tests for a medical device used for drainage, not for an IVD.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This Stomach Tube does not perform such functions.
N/A
Intended Use / Indications for Use
The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The device is available in sizes 6Fr to 22Fr for use in adults only.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The Stomach Tube is a sterile, single-use tube manufactured in various sizes from medical grade PVC. The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The tube is inserted into a patient's stomach through the patient's nose or mouth.
The Stomach Tube is supplied in French size ranging from 6 to 22, consists of main tube and connector. The stomach tube connector connects to suction device for suctioning, The tube is available in open tip and closed tip form. It is composed of biologically safe materials and supplied sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stomach
Indicated Patient Age Range
adults only
Intended User / Care Setting
Not Found
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 testing was conducted for the Stomach Tube:
- General performance testing including:
- Dimensions
- Leakage
- Flow Rate Test
- Tensile Properties
- Suction Tubing Collapse Test
Testing datas and results are included in this submission, and demonstrated that the Stomach Tube meets all the pre-determined testing and acceptance criteria.
2) Biocompatibility testing as per ISO 10993-1:2009 including:
- Cytotoxicity as per ISO 10993-5:2009
- Irritation as per ISO 10993-10:2010
- Sensitization as per ISO 10993-10:2010
Biocompatibility testing reports are included in this submission, and demonstrated that the device componets that are in contact with the patient are biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 11, 2017
Well Lead Medical Co., Ltd Huang Kai gen Regulatory Affairs Manager C-4# Jinhu Industrial Estate, Hualong, Panyu Guangzhou, Guangdong 511434 China
Re: K162340
Trade/Device Name: Stomach Tube Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: September 13, 2017 Received: September 15, 2017
Dear Huang Kai gen:
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); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Joyce M. Whang -S
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
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Indications for Use
510(k) Number (if known) K162340
Device Name Stomach Tube
Indications for Use (Describe)
The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The device is available in sizes 6Fr to 22Fr for use in adults only.
| 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) |
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 2017/10/10 |
|---|---|
| Submitter: | WELL LEAD MEDICAL CO., LTD. |
| Address:C-4 # Jinhu Industrial Estate, Hualong, Panyu, | |
| Guangzhou, 511434, P.R. China | |
| Contact Person: | Huang Kaigen |
| Regulatory Affairs Manager | |
| WELL LEAD MEDICAL CO., LTD. | |
| Email: huangkg@welllead.com.cn | |
| Tel: +86-20-84758878 | |
| Fax:+86-20-84758224 | |
| Device Name: | |
| Common Name: | |
| Regulation Number: | |
| Classification Name: | Stomach Tube |
| Levin Tube | |
| 876.5980 Gastrointestinal tube and accessories | |
| Gastrointestinal tube and accessories | |
| Product Code: | |
| Regulatory Class: | KNT |
| Class II |
Predicate Device(s): K022112-All Silicone Stomach (Gastric) Tube
1. Intended Use
The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The device is available in sizes 6Fr to 22Fr for use in adults only.
2. Device Description
The Stomach Tube is a sterile, single-use tube manufactured in various sizes from medical grade PVC. The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The tube is inserted into a patient's stomach through the patient's nose or mouth.
The Stomach Tube is supplied in French size ranging from 6 to 22, consists of main tube and connector. The stomach tube connector connects to suction device for suctioning, The tube is available in open tip and closed tip form. It is composed of biologically safe materials and supplied sterile and intended for single use only.
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3. Substantial Equivalence-Comparison to Predicate Devices
The Stomach Tube described in this 510(k) have similar technological and performance characteristics to the predicate devices. The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix which has been included in Section 12 of this submission. These differences have no effect on safety and effectiveness, or raise different questions of safety and effectiveness.
Similarities Between Proposed and Predicate Device
The proposed Stomach Tube and the predicate devices, All Silicone Stomach (Gastric) Tube and Pediatric Enteral Feeding Tube, have the similar intended use, principle of operation, performance characteristics and scientific technology.
Differences Between Proposed and Predicate Device
The differences between proposed and predicate devices, as shown in the following: (1) Material
The proposed Stomach Tube is made from PVC while the predicate devices are made from PVC, silicone and PU material.
Although they are made from different materials, but the human contact components are manufactured from materials that meet all the requirements of biocompatibility, the materials in contact were tested as per ISO 10993-1. This minor differences in the tubes do not introduce new issues of safety and efficacy.
(2) Size
The proposed device is available in 6-22Fr while the predicate devices Silicone Stomach (Gastric) Tube is available in 8-18Fr and Pediatric Enteral Feeding Tube is available in 4Fr, 5Fr, 6.5Fr, 8Fr, 10Fr only. Sizes proposed (6, 20, and 22 Fr) are outside of the size range for the predicate device.
There are many FDA cleared stomach tubes which are available in various sizes. Therefore, this difference in tube diameter does not raise any new safety or effectiveness concerns as both devices are intended to be used in the same populations.
Thus, the Stomach Tube is substantially equivalent to the All Silicone Stomach (Gastric) Tube(K022112) and Pediatric Enteral Feeding Tube(K092628).
4. Summary of Non-Clinical Performance Testing
The following performance testing was conducted for the Stomach Tube:
1) General performance testing including:
- · Dimensions
- · Leakage
- Flow Rate Test
- · Tensile Properties
- · Suction Tubing Collapse Test
5
Testing datas and results are included in this submission, and demonstrated that the Stomach Tube meets all the pre-determined testing and acceptance criteria.
2) Biocompatibility testing as per ISO 10993-1:2009 including:
- · Cytotoxicity as per ISO 10993-5:2009
- · Irritation as per ISO 10993-10:2010
- · Sensitization as per ISO 10993-10:2010
Biocompatibility testing reports are included in this submission, and demonstrated that the device componets that are in contact with the patient are biocompatible.
Conclusions Drawn from the Non-Clinical Testing
The results of these tests demonstrate that the device is as safe, as effective, and performs as well as the identified predicate and support a determination of substantial equivalence.
5. Conclusion
The Stomach Tube is substantially equivalent to predicate device All Silicone Stomach (Gastric) Tube (K022112). Based on the intended use, principle of operation, performance characteristics, and technological characteristics, the proposed Stomach Tube is substantially equivalent to and as safe, as effective and performs as the legally marketed predicate device.