(412 days)
Enteral Feeding Bag and Set is intended to delivery, via a feeding pump, liquid nutrition formulas to an enteral access device (e.g. a feeding tube).
The proposed device, Enteral Feeding Bag and Set, has two models: one is enteral feeding set integrated with bag, the other is an individual enteral feeding set with a puncture needle which can be used along with other pre-filled formula container. Other components include: Roller Clamp, which is used to adjust the feeding rate; Tubings, which are used to connected components; Drip Chamber, which is intended for the user to observe the feeding condition; Echelon Fitting, which is a non-luer fitting, to connect Enteral Access Device. This fitting is provided to avoid mis-connection with I.V. devices.
This submission describes an Enteral Feeding Bag and Set, a Class II medical device, intended to deliver liquid nutrition formulas via a feeding pump to an enteral access device. The submission focuses on demonstrating substantial equivalence to a predicate device, Hospira Enteral Feeding Sets (K061432).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list specific acceptance criteria as quantitative targets (e.g., flow rate must be X +/- Y%). Instead, it states that "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device." This suggests that the acceptance criteria were based on meeting internal design specifications and demonstrating performance comparable to the predicate device.
| Acceptance Criteria Category (Deduced) | Reported Device Performance |
|---|---|
| Functional Performance | Met all design specifications |
| Safety Features | Met all design specifications |
| Material Compatibility | Met all design specifications |
| Biocompatibility | Met all design specifications |
| Sterility | Met all design specifications |
| Substantial Equivalence | Demonstrated as substantially equivalent to Hospira Enteral Feeding Sets (K061432) |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "Laboratory testing".
2. Sample Size Used for the Test Set and Data Provenance:
The document states "Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications..." However, it does not specify the sample size used for this testing. The data's provenance is from the manufacturer, ShanDong WeiGao Group Medical Polymer Co., Ltd, located in Weihai City, Shangdong, China. The testing would have been prospective, as it was conducted to validate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device submission. The "ground truth" for an enteral feeding bag and set is typically established through engineering specifications, international standards (e.g., ISO standards for medical devices), and comparison with the performance of a legally marketed predicate device. It does not involve expert interpretation of medical images or clinical data in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of medical cases (e.g., for diagnostic accuracy). The laboratory testing for this device would have involved objective measurements against specifications rather than subjective expert consensus.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers' performance with and without AI assistance is being evaluated. For an enteral feeding set, the comparison is primarily based on functional performance against a predicate device and engineering specifications.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the device is not an algorithm or an AI system. The testing performed was on the physical medical device itself.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance was established by:
- Engineering Design Specifications: The device was tested to ensure it met its own predetermined design specifications.
- Performance of the Predicate Device: The device was tested to demonstrate "substantial equivalence" to the legally marketed predicate device (Hospira Enteral Feeding Sets, K061432). This implies that the predicate device's established performance served as a benchmark for acceptable "ground truth" performance.
- Compliance with relevant standards (deduced): Although not explicitly stated as "ground truth," medical devices like this typically adhere to various international and national standards (e.g., ISO standards for medical devices, biocompatibility standards), which would form part of the underlying "ground truth" for safety and performance.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a physical medical product, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this device.
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Exhibit #5 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number is: K102741
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- Date Prepared: April 05, 2011
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- Sponsor Information
ShanDong WeiGao Group Medical Polymer Co., Ltd No.312 Shichang Road Weihai City, Shangdong, China
Contact Person: Mrs. Zhao Suxia, Quality Manager Tel: +86-631-5621632 Fax: +86-631-5620555 E-Mail: Zsx9001@sina.com
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- Submission Correspondent
Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Consulting Co., Ltd P.O. BOX 237-023 Shanghai, 200237, China
- Submission Correspondent
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- Device Name and Classification:
Device Trade Name: Enteral Feeding Bag and Set; Classification Name: Tubes, gastrointestinal (and accessories); Classification: Class II; Product Code: KNT; Regulation Number: 21 CFR 876.5980; Review Panel: Gastroenterology/Urology
- Device Name and Classification:
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K102741 page 2
Premarket Notification Submission -510(k) Summary
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- Predicate Device Identification:
510(k) Number: K061432; Predicate Device Name: Hospira Enteral Feeding Sets;
- Predicate Device Identification:
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- Intended Use:
Enteral Feeding Bag and Set is intended to delivery, via a feeding pump, liquid nutrition formulas to an enteral access device (e.g. a feeding tube).
- Intended Use:
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- Device Description:
The proposed device, Enteral Feeding Bag and Set, has two models: one is enteral feeding set integrated with bag, the other is an individual enteral feeding set with a puncture needle which can be used along with other pre-filled formula container.
- Device Description:
Other components include:
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Roller Clamp, which is used to adjust the feeding rate;
- ア Tubings, which are used to connected components;
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Drip Chamber, which is intended for the user to observe the feeding condition;
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Echelon Fitting, which is a non-luer fitting, to connect Enteral Access Device. This fitting is provided to avoid mis-connection with I.V. devices.
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- Test Conclusion resignation
Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device.
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- Substantially Equivalent Conclusion:
The proposed device, Enteral Feeding Bag and Set, is substantially equivalent to the predicate device, Hospira Enteral Feeding Sets.
- Substantially Equivalent Conclusion:
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Shandong Weigao Group Medical Polymer Co., Ltd. % Ms. Diana Hong, General Manager Shanghai Midlink Consulting Co., Ltd. P.O. Box 237-023 SHANGHAI 200030 CHINA
NOV - 8 2011
Re: K102741
Trade/Device Name: Enteral Feeding Bag and Set Regulation Number: 21 CFR$ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: October 15, 2011 Received: October 19, 2011
Dear Ms. 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. 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
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and · Radiological Health.
Enclosure
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Premarket Notification Traditional Section 510(k) Submission Indication for Use Form
Exhibit #6 Indication for Use Form
510(k) Number: K102741 Device Name: Enteral Feeding Bag and Set
Indications for Use:
Enteral Feeding Bag and Set is intended to deliver, via a feeding pump, liquid nutrition formulas to an enteral access device (e.g. a feeding tube).
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Halim
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102741
§ 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.