(177 days)
Not Found
No
The 510(k) summary describes a simple gravity-fed enteral feeding set and makes no mention of AI or ML capabilities. The performance testing focuses on physical and chemical properties, not algorithmic performance.
No
The device is described as an "Enteral Feeding Set," which is used to deliver nutrition into the gastrointestinal tract. While it supports a medical process, it does not directly treat or cure a disease or condition; rather, it facilitates the administration of nutrition.
No
The device is intended for the delivery of enteral feeding nutrition, not for diagnosing medical conditions.
No
The device description clearly indicates a physical device (Disposable Enteral Feeding Sets) that includes components like bags and spikes, and is subject to performance testing related to physical and chemical properties, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering enteral feeding nutrition directly into the gastrointestinal tract. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how they are used for feeding, not for analyzing samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies described focus on the physical and chemical properties of the device for safe and effective delivery of nutrition, not on the accuracy or reliability of diagnostic results.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) for the purpose of delivering nutrition.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
PIF
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
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)
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 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
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.
0
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
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)
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.
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.
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| 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)
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 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