The Disposable Enteral Feeding Sets is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents, and adults.

Device Description

The proposed device, Disposable Enteral Feeding Sets, is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents and adults. The proposed device is provided sterile or non-sterile and single use.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for a medical device called "Disposable Enteral Feeding Sets". The document largely focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed information typically found in a study description for evaluation of AI/algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets acceptance criteria in an AI/algorithm context. The document describes standard performance testing for a physical medical device, not a software or AI device.

Here's why and what information can be extracted regarding general acceptance criteria and testing:

Why the requested information cannot be fully provided from this document:

No AI/Algorithm Focus: The device is a "Disposable Enteral Feeding Set," which is a physical medical device for enteral nutrition. There is no indication that it incorporates any AI, machine learning, or complex algorithms that would require the kind of performance studies (e.g., standalone performance, MRMC studies, ground truth establishment by experts) typically associated with AI/ML-driven medical devices.
"Acceptance Criteria" for Physical Device: The term "acceptance criteria" here refers to the performance specifications and safety standards for a physical product (e.g., leak integrity, flow rate, material biocompatibility, sterility), not diagnostic accuracy or clinical utility of an AI.
"Study" for Physical Device: The "study" mentioned refers to non-clinical performance tests (chemical, physical, sterility, ENfit physical performance) conducted on the physical device to ensure it meets established safety and performance standards relevant to its physical function. It is not a clinical efficacy study or an AI performance study.

Information that can be extracted relevant to general performance and acceptance (for a non-AI physical device):

A table of acceptance criteria and the reported device performance:
The document does not provide a specific table of acceptance criteria paired with reported device performance values. It states that "the test result showed that the aged proposed device met the acceptance criteria" for various tests. The specific acceptance criteria are implicitly those defined by the referenced international standards and internal procedures.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 20695:2020 Annex C & D	Met
Compliance with ISO 8536-4:2022 Annex B	Met
Compliance with ISO 8536-4:2020 Annex B.4	Met
Compliance with ISO 80369-20:2015	Met
Compliance with USP <71> Sterility Tests	Met
Final product inspection procedure specifications	Met
Performance of bag part (e.g., integrity, capacity)	Met
Performance of spike part (e.g., connection integrity)	Met
Biocompatibility (for patient-contact material)	Met (no adverse effects)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes for the non-clinical performance tests. The data provenance is implied to be from the manufacturer's testing in China, as the applicant is "Beijing L&Z Medical Technology Development Co., Ltd." These are non-clinical lab tests, not human data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML diagnostic or prognostic devices. For a physical device like an enteral feeding set, performance is evaluated against engineering specifications and international standards, not against expert human interpretations of data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for a physical device's non-clinical performance testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device is a physical feeding set, not an AI or imaging device that would involve human readers or AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. Performance is measured against physical and chemical standards and specifications (e.g., sterility, dimensional accuracy, material integrity, flow rates), not a ground truth derived from expert consensus, pathology, or outcomes data.
The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/ML model that requires training data.
How the ground truth for the training set was established:
Not applicable.

In summary, the provided FDA 510(k) clearance letter and summary pertain to a physical medical device and therefore do not contain the information requested regarding AI/algorithm performance studies.

Summary

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Image /page/0/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.

July 3, 2024

Beijing L&Z Medical Technology Development Co., Ltd. Zhiling Li Product Registry Specialist No.8. M2-5 Block, Xinggu Industrial Developing Zone, Pinggu District Beijing, 101200 China

Re: K240052

Trade/Device Name: Disposable Enteral Feeding Sets Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: PIF Dated: January 8, 2024 Received: June 5, 2024

Dear Zhiling Li:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. Stephanie Cole -S

for Anthony C. Lee, PhD, MBA Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known) K240052

Device Name

Disposable Enteral Feeding Sets

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K240052

510(k) #: K240052	510(k) Summary	K240052Page 1 of 2Prepared on: 2024-07-01
-------------------	----------------	-------------------------------------------

Contact Details	21 CFR 807.92(a)(1)
Applicant Name	Beijing L&Z Medical Technology Development Co., Ltd.
Applicant Address	No.8, M2-5 Block, Xinggu Industrial Developing Zone, Pinggu District 101200 BEIJING, P.R. CHINA. Beijing 101200 China
Applicant Contact Telephone	15104955040
Applicant Contact	Ms. Zhiling Li
Applicant Contact Email	lizl@lingze.com

Device Name	21 CFR 807.92(a)(2)
Device Trade Name	Disposable Enteral Feeding Sets
Common Name	Gastrointestinal tube and accessories
Classification Name	Gastrointestinal Tubes With Enteral Specific Connectors
Regulation Number	21 CFR 876.5980
Product Code(s)	PIF

Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
------------------------------------	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K142539	Enteralite Infinity Enteral Pump Delivery Set, 1200 ML Enteral Fee	PIF

Device Description Summary	21 CFR 807.92(a)(4)
----------------------------	---------------------

The proposed device, Disposable Enteral Feeding Sets, is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect toconnecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents and adults.

The proposed device is provided sterile or non-sterile and single use.

Intended Use/Indications for Use

The Disposable Enteral Feeding Sets is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasogastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to a prefilled container. The device is used for children, adolescents and adults.

Indications for Use Comparison

Indication for Use:

Proposed Device: The Disposable Enteral Feeding Sets is intended to be used for enteral feeding nutrition into gastrointestinal tract by connecting with nasgastric tube by gravity. The devices may include a bag to contain the feeding nutrition and/or a spike to connect to a prefilled container. The device is used for children, adolescents and adults.

Predicate Device: The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.

21 CFR 807.92(a)(5)

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Different - Indication for Use

The predicate device can be used for gravity feeding. 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.

Technological Comparison

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 proposed device offers more options. However, the bag is just used to store the nutritional formula. In addition, the performed on the proposed device and the test result of bag part showed that 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 - Spike types

The Soike types of the proposed device is different from that of the proposed device offers more options. However, the spike is just used to connect to a prefilled container. In addition, the performance test has been performed on the proposed device and the test result of spike part showed that the performance of the pro-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 - Patient-contact material

The patient-contact material of the proposed device is different from that of 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 on the patient. Therefore, this difference will not raise new question on the new safety and effectiveness of the proposed device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The performance test was conducted on the proposed device to evaluate the proposed device according to Final product inspection procedure, ISO 20695:2020 Annex C and Annex D, ISO 8536-4:2022 Annex B, ISO 8536-4:2020 Annex B.4,1SO 80369-20:2015 and USP <71> Sterility Tests. The specification BEEGA1 22211, BEEGA1 32211, BEEGA1 4221, BEEGA1 52211, BEEGA1 62211, BEEGB1 53211, BEEGB1 13011 have already covered the variation of all specifications of Disposable Enteral Feeding Sets. Therefore, the specification BEGA1 22211, BEEGA1 32211, BEEGA1 42211, BEEGA1 52211, BEEGA1 62211, BEEGB1 53211, BEGB1 13011 were selected to conduct the performance test and the test result showed that the aged proposed device met the acceptance criteria. Copies of the test report are provided in as follow:

Tab #24 Chemical Performance Test Report Tab #25 Physical Performance Test Report Tab #26 Sterility Test Exhibit #29 ENfit Physical Performance Test Report

21 CFR 807.92(a)(6)

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.