(59 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical and material properties of enteral feeding sets, with no mention of AI or ML.
No
A therapeutic device is used to treat or prevent a disease or condition. This device is used to dispense nutrition, which supports a patient but does not directly treat a disease or condition.
No
Explanation: The device is an enteral feeding set designed to dispense liquid nutrition. Its function is to deliver food, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly outlines physical components like bags, spikes, and connections, indicating it is a hardware device for dispensing liquid nutrition.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dispense liquid nutrition (feeding solutions) at a user controlled rate." This is a delivery mechanism for nutrition, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description details the physical components and how they function to deliver feeding solution. There is no mention of reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for the delivery of nutrition directly into a patient's feeding tube, which is a therapeutic or supportive function, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
PIF, KNT
Device Description
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.
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
infants, children, adolescents and adults.
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)
Biocompatibility testing was conducted in accordance with ISO 10993-1:2009, including tests for Cytotoxicity, Sensitization, and Skin Irritation. The device contacts indirectly with the human body for less than 24 hours. Testing complied with ISO 10993-5:2009 and ISO 10993-10:2010, demonstrating that the materials are non-cytotoxic, non-sensitizing, and non-irritating.
Performance testing was conducted on the CONOD Enteral Feeding Sets according to EN 1615, ISO 80369-3, ISO 11737 and IEC 62366. The tests included:
- Fluid leakage test
- Stress cracking test
- Resistance to separation from axial load test
- Resistance to separation from unscrewing test
- Resistance to overriding test
- Disconnection by unscrewing test
- Tensile Properties
- Liquid leakage test
- Flow rate test
- Bioburden test
- Usability test
Animal studies and clinical studies were not required to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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 contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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)
| 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:
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 | |
| 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
-
- 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
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
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 may include a bag to contain the feeding
solution and/or spike to connect to a pre-filled
container. The device is used for infants,
children, adolescents and adults. | 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. | same |
| Product code | PIF, KNT | PIF, KNT | Same |
| Classification
regulation | 21 CFR 876.5980 | 21 CFR 876.5980 | Same |
| Device configurations | - Medline Enteral Feeding Pump Bag Set
(1000ml)
- Medline Enteral Feeding Pump Spike Set
- Medline Enteral Feeding Gravity Bag Set
(1000ml) | - CONOD Feeding Pump Set (1200ml) - CONOD Safety spike plus Pump Set
- CONOD Gravity Feeding Set (1200ml) | similar |
| Assemble parts | Enteral feeding bag, tubing, drip chamber,
piercing spike, roller clamp and Distal Tip
ENFit connectors | Enteral feeding bag, tubing, drip
chamber, piercing spike, roller clamp and
Distal Tip ENFit connectors | Same |
| Specification | Predicate Device | Proposed Device | Discussion of
Differences |
| Design feature | Non DEHP material sets featuring ISO
80369-3:2016 connector | Non DEHP material sets featuring ISO
80369-3:2016 connector | same |
| Materials | Same with the predicate device | | Same |
| Prescription use or
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
Spike set: 60cm+157cm
Gravity set: 170cm | Pump set: 60cm+157cm
Spike set: 60cm+157cm
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
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.