(238 days)
No
The description details a simple gravity-fed enteral feeding set with basic components like a bag, tube, and roller clamp. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The performance studies focus on non-clinical testing against standards, not on algorithmic performance.
No
This device is an enteral feeding set, which delivers nutritional formulas, not a therapeutic agent itself.
No
Explanation: The device is an enteral feeding set, which is used to deliver liquid nutritional formulas or water to a patient's feeding tube. Its function is to administer substances, not to diagnose a condition or disease.
No
The device description explicitly lists multiple physical components such as a bag, tube, drip chamber, and connectors, indicating it is 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 to "deliver liquid nutritional formulas or water to patient's enteral access device (feeding tube)." This describes a device used for administering substances directly into the body for nutritional support, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The components listed (bag, tube, drip chamber, connectors, etc.) are all consistent with a system for delivering fluids, not for performing diagnostic tests.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples (blood, urine, tissue, etc.), or any other activities typically associated with in vitro diagnostics.
- Performance Studies: The performance studies mentioned focus on verifying design specifications and compliance with standards related to material safety, connectors, and physical properties, not on diagnostic accuracy or performance metrics like sensitivity or specificity.
In summary, the device is clearly described as an enteral feeding set, which is a medical device used for delivering nutrition, not for performing diagnostic tests outside of the body.
N/A
Intended Use / Indications for Use
Enteral feeding set is intended to use gravity to deliver liquid nutritional formulas or water to patient's enteral access device (feeding tube). The device includes a bag to contain the feeding solution.
Product codes
PIF, PIO
Device Description
The proposed device is provided non-sterile and single use. It has two types (Type A and Type B). Type A has more component (ENFit transition adapter) than Type B.
The Type A includes 5 models, ENF02G-1000R-T, ENF02G-1000B-T, ENF02G-1200R-T, ENF02G-1200B-T and ENF02-500R-T, which have the same components including 1) filling port, 2) bag, 3) tube, 4) drip chamber, 5) roller clamp, 6) ENFit female connector, 7) ENFit transition adaptor and 8) protecting cover. The difference between the 5 models is the specification of bag and tube.
The Type B includes 5 models, ENF02G-1000R, ENF02G-1000B, ENF02G-1200R, ENF02G-1200B and ENF02-500R, which have the same components including 1) filling port, 2) bag, 3) tube, 4) drip chamber, 5) roller clamp, 6) ENFit female connector and 7) protecting cover. The difference between the 5 models is the specification of bag and tube.
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
Not Found
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
- ISO 80369-3:2016 Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 3: Connectors for Enteral Applications
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- USP 43 NF 38 Pyrogen Test
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 22, 2021
KB Medical (Group) Inc. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.Box 120-119 Shanghai, 200120 China
Re: K210854
Trade/Device Name: Enteral Feeding Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF, PIO
Dear Diana Hong:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 16, 2021. Specifically, FDA is updating this SE letter as an administrative correction for an incorrect 510(k) Summary.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Elena Choong, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, (301)-796-6161, Elena.Choong@fda.hhs.gov.
Sincerely,
Shanil P. Haugen -S
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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 16, 2021
KB Medical (Group) Inc. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai. 200120 CHINA
Re: K210854
Trade/Device Name: Enteral Feeding Set Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF, PIO Dated: August 17, 2021 Received: October 15, 2021
Dear Diana Hong:
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.
2
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 (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.
Shanil P. Haugen -S
Shanil P. Haugen, PhD. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210854
Device Name
Enteral feeding set
Indications for Use (Describe)
Enteral feeding set is intended to use gravity to deliver liquid nutritional formulas or water to patient's enteral access device (feeding tube). The device includes a bag to contain the feeding solution.
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Type of Use (Select one or both, as applicable)
4
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K210854
-
- Date of Preparation: 09/03/2021
-
- Sponsor Identification
KB MEDICAL (GROUP) INC.
9650 RESEARCH DR.SUITE A Irvine, CA USA 92618
Establishment Registration Number: 3015433750
Contact Person: Chunsheng Sheng Position: Chief Executive Officer (CEO) Tel: +1(949) 491-0797 Fax: +1(949) 409-0206 Email: susansheng571@gmail.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
5
4. Identification of Proposed Device
Trade Name: Enteral feeding set Common Name: Enteral Feeding Sets
Regulatory Information Classification Name: Gastrointestinal Tube and Accessories Classification: II; Product Code: PIF, PIO Regulation Number: 876.5980 Review Panel: Gastroenterology/Urology
Indication for Use:
Enteral feeding set is intended to use gravity to deliver liquid nutritional formulas or watent's enteral access device (feeding tube). The device includes a bag to contain the feeding solution.
Device Description:
The proposed device is provided non-sterile and single use. It has two types (Type A and Type B). Type A has more component (ENFit transition adapter) than Type B.
The Type A includes 5 models, ENF02G-1000R-T, ENF02G-1000B-T, ENF02G-1200R-T, ENF02G-1200B-T and ENF02-500R-T, which have the same components including 1) filling port, 2) bag, 3) tube, 4) drip chamber, 5) roller clamp, 6) ENFit female connector, 7) ENFit transition adaptor and 8) protecting cover. The difference between the 5 models is the specification of bag and tube.
The Type B includes 5 models, ENF02G-1000R, ENF02G-1000B, ENF02G-1200R, ENF02G-1200B and ENF02-500R, which have the same components including 1) filling port, 2) bag, 3) tube, 4) drip chamber, 5) roller clamp, 6) ENFit female connector and 7) protecting cover. The difference between the 5 models is the specification of bag and tube.
- న్. Identification of Predicate Device
510(k) Number: K142539 Product Name: Enteralite Infinity Enteral Pump Delivery Set, 1200 ML Enteral Feeding Delivery Set (Selected as predicate device)
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies
6
with the following standards:
-
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
-
ISO 80369-3:2016 Small-Bore Connectors for Liquids and Gases in Healthcare Applications-Part 3: Connectors for Enteral Applications
-
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
USP 43 NF 38 Pyrogen Test
-
- Clinical Test Conclusion
No clinical study is included in this submission.
7
ITEM Proposed Device Predicate Device K142539 Remark 1200 ML Enteral Feeding Enteral feeding set / Product Name Delivery Set Product Code PIF, PIO PIF, PIO Same Regulation No. 876.5980 876.5980 Same Class II II Same The devices in this product family are used to dispense liquid nutrients (feeding solution) at a Enteral feeding set is intended to preprogrammed pump or user use gravity to deliver liquid controlled rate. These enteral feeding sets interface with the nutritional formulas or water to Indication for patient's enteral access device patient's feeding tube and may Different Use (feeding tube). The device use gravity or an enteral feeding includes a bag to contain the pump to dispense feeding feeding solution. solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container. Single-Use Yes Yes Same Filling port Inlet port Bag Bag Tube Tube Drip chamber Main Roller clamp Roller clamp Different Configuration Inlet port cap ENFit Female connector ENFit connector ENFit transition adapter (only for Christmas Tree shaped Type A) transitional stepped connector Protecting cover Different Bag capacity 500ml, 1000ml, 1200ml 1200ml Length of tube 1800±5 Unknown Different (mm) For ENF02G-1000R-T, ENF02G-1200R-T, Tube inner ENF02-500R-T, ENF02G-1000R, Unknown Different diameter (mm) ENF02G-1200R, ENF02-500R: Ф2.85±0.1;
8. Summary of Technological characteristics
Table 1 SE Comparison
8
| | For
ENF02G-1000B-T,
ENF02G-1200B-T,
ENF02G-1000B,
ENF02G-1200B: $\Phi$ 4.0±0.1 | | | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Tube
out
diameter (mm) | For
ENF02G-1000R-T,
ENF02G-1200R-T,
ENF02-500R-T, ENF02G-1000R,
ENF02G-1200R, ENF02-500R:
$\Phi$ 4.05±0.05; | | Unknown | Different |
| | For
ENF02G-1000B-T,
ENF02G-1200B-T,
ENF02G-1000B,
ENF02G-1200B: $\Phi$ 6.0±0.1 | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| Mechanism of
Action | Gravity | | Gravity | Same |
| ENFit connector | Conform with ISO 80369-3 | | Conform with ISO 80369-3 | Same |
| Patient-contact
material | Polyvinyl chloride (PVC)
DINCH
Cinquasia Pink
Heliogen Blue
Acrylonitrile Butadiene Styrene (ABS)
Polypropylene (PP)
Purple | | Non-DEHP PVC tubing,
extruded film (bags), inlet port
and outlet port;
Polyethylene inlet port cap;
Polycarbonate connector/pump
interface (cassette);
silicone pump tubing segment;
ABS distal (stepped) connector. | Different |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | Cytotoxicity | No cytotoxicity | | |
| | Skin Irritation | No irritation | | |
| | Sensitization | No
sensitization | | Different |
| | | | | |
| Biocompatibility | Acute Systemic
Toxicity | No acute
Systemic
Toxicity | Complies with ISO 10993 | |
| | | | | |
| | | | | |
| | Subchronic | No subchronic
Systemic
Toxicity | | |
| | Systemic | | | |
| | Toxicity | | | |
| | Pyrogen | No pyrogen | | |
| Sterility | Non-sterile | | Non-sterile | Same |
| Shelf life | 3-yr | | 1-yr | Different |
| Label/Labeling | Complied with 21 CFR part 801 | | Complied with 21 CFR part 801 | Same |
The proposed device and the predicate device have the same design and energy source. Although the
9
material composition of the proposed device and the predicate device are not exactly the same, biological and performance tests have proved that the proposed device will not raise any questions regarding its safety and effectiveness. The details of the differences in technical characteristics are summarized below:
Different - Indication for Use
The predicate device can be used for gravity feeding or pump feeding, and it is available in various configurations with bag or without bag. Therefore, the description of the indication for use of the proposed device differs from that of the predicate device. The proposed device only uses gravity to dispense feeding solution. The indications for use of the proposed device is covered by that of the predicate device. Therefore, this difference will not raise new question on the safety and effectiveness of the proposed device.
Different - Main Configuration
The configuration of the proposed device is the same as that of the predicate device (1200 ML Enteral Feeding Delivery Set), only the naming of the components is different. Therefore, this difference will not raise new question on the new safety and effectiveness of the proposed device.
Different- Bag capacity
The Bag capacity of the proposed device is different from that of the predicate device, and the proposed device offers more options. However, the bag is just used to store the nutritional formula. In addition, the performance test has been performed on the proposed device and the test result of bag part showed that the performance of the proposed device met the pre-determined acceptance criteria. Therefore, this difference on bag capacity will not raise new question on the new safety and effectiveness of the proposed device.
Different - Length of tube
The length of the predicate device is unknown. In addition, the performance test has been performed on the proposed device and the test result of tube part showed that the performance of the proposed device met the pre-determined acceptance criteria. Therefore, this difference on bag capacity will not raise new question on the new safety and effectiveness of the proposed device.
Different - Tube inner diameter
The inner diameter of the tube of the predicate device is unknown. The performance test has been performed on the proposed device and the test result of tube part showed that the diameter of the proposed device does not raise new question on the new safety and effectiveness of the proposed device.
Different - Tube outer diameter
The outer diameter of the tube of the predicate device is unknown. The performance test has been performed on the proposed device and the test result of tube part showed that the diameter of the proposed device does not raise new question on the new safety and effectiveness of the proposed device.
10
Different - Patient-contact material
The patient-contact material of the proposed device is different from that of the predicate device. However, the biocompatibility test has been performed on the proposed device and the test results show that the materials of proposed device will not have the adverse effect on the patient. Therefore, this difference will not raise new question on the new safety and effectiveness of the proposed device.
Different - Biocompatibility
The detail biocompatibility testing item of predicate device is unknown. But both of them comply with standard ISO 10993. Therefore, this difference will not raise new question on the new safety and effectiveness of the proposed device.
Different - Shelf life
The shelf life of proposed device and predicate device is different. However, the performance test after aging has been performed on the proposed device and the test result showed that the performance of the proposed device met the pre-determined acceptance criteria. Therefore, this difference will not raise new question on the new safety and effectiveness of the proposed device.
9. Conclusion
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K142539.