(81 days)
Not Found
No
The 510(k) summary describes a simple mechanical device for dispensing liquid nutrition and does not mention any AI or ML components or functionalities.
No
The device is described as an enteral feeding set, which dispenses liquid nutrition. While it supports patient health, it does so by managing the delivery of sustenance rather than directly treating a disease or condition. Its function is primarily supportive and delivery-oriented.
No
Explanation: The device is an enteral feeding set designed to dispense liquid nutrition. It does not perform any diagnostic functions like detecting, monitoring, or predicting a condition. Its purpose is purely therapeutic/supportive.
No
The device description clearly outlines physical components such as bags, tubing, drip chambers, spikes, and connectors, and the performance studies focus on the physical properties and interactions of these components. There is no mention of software as a component or function of the device.
Based on the provided information, the Medline Enteral Feeding Sets are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "dispense liquid nutrition (feeding solutions) at a user controlled rate" and "interface with a patient's feeding tube." This describes a device used for delivering substances into the body, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description details components like bags, tubing, spikes, and connectors, all of which are consistent with a system for delivering fluids. There is no mention of reagents, assays, or any components used for testing biological samples.
- Performance Studies: The performance studies focus on the physical and functional aspects of the feeding sets, such as misconnection assessment, human factors, leakage, strength, flow rate, and biocompatibility. These are relevant to a device used for delivering fluids, not for diagnostic testing.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical characteristics of an IVD device.
In summary, the Medline Enteral Feeding Sets are devices used for delivering nutrition directly to a patient, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PIF, KNT
Device Description
Medline Enteral Feeding Sets consist of the following three configurations:
- 1.) Medline Enteral Feeding Pump Bag Set (1000ml)
- 2.) Medline Enteral Feeding Pump Spike Set
- 3.) Medline Enteral Feeding Gravity Bag Set (1000ml)
The Medline Enteral Feeding Pump Bag Set (1000ml) is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems and features a 1000ml formula bag with 100ml graduations and a protective closure cap.
The Medline Enteral Feeding Gravity Bag Set (1000ml) uses the free flow of gravity to dispense enteral feeding solutions and features a 1000ml formula bag with 100ml graduations and a protective closure cap.
The Medline Enteral Feeding Pump Spike Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems.
Medline Enteral Feeding Sets are single-use, non-sterile and disposable enteral feeding sets consisting of an enteral feeding bag, tubing, drip chamber, piercing spike, roller clamp and Distal Tip ENFit connectors.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing was conducted on Medline Enteral Feeding Sets:
- Enteral Connector Misconnection Assessment Study
- Human Factors Validation Study: Enteral Connectors Final Report
- PG-Lock Misconnection Data with Failure Modes and Effects Analysis (FMEA)
- Performance Testing with and without Reference Connectors:
- Falling Drop Positive Pressure Liquid Leakage
- Stress Cracking
- Resistance to Separation from Axial Load
- Resistance to Separation from Unscrewing
- Resistance to overriding
- Disconnection by unscrewing
- ENFit Component Verification Testing
- ENFit Bond Strength Testing
- Risk Analysis
- Pump Compatibility Testing against predicate
- Flow Rate Testing against predicate
- ENFit Connection Strength Testing
- Bioburden Testing – against predicate
- Cross Cavity Metrology Testing
- Leachable and Extractable (L&E) Profile Analysis with comprehensive Toxicological Health Risk Assessment
- Biocompatibility Testing:
- Cytotoxicity MEM elution per ISO 10993-5;
- Irritation Intracutaneous reactivity per ISO 10993-10; and
- Delayed-Type Hypersensitivity (Sensitization) Guinea Pig Maximization Test per ISO 10993-10.
Key Results: The results of these tests have demonstrated that the replacement of the predicate's 4-step Distal Tip connector with the proposed device's ENFit connector does not alter the function or performance of the devices and does not raise additional questions or compromise the safety and/or effectiveness of the device. This testing, along with the various supporting data provided in this pre-market notification, establishes that Medline Enteral Feeding Sets are substantially equivalent to the predicate device.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 27, 2015
Medline Industries, Inc. Stephanie Blair Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060
Re: K150286
Trade/Device Name: Medline Enteral Feeding Sets Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF, KNT Dated: April 13, 2015 Received: April 14, 2015
Dear Stephanie Blair,
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); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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.
Sincerely vours.
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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)
Device Name Medline Enteral Feeding Sets
Indications for Use (Describe)
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.
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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ledline Industries, Inc. One Medline Place Mundelein, IL 60060
510(k) Notification Medline Enteral Feeding Sets All information on this page is confidential.
TRADTIONAL 510(k) SUMMARY [AS REQUIRED BY 21 CFR 807.92(a)]
SUBMITTER / 510(k) SPONSOR
Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Registration Number: 1417592
CONTACT PERSON
Stephanie Blair Regulatory Affairs Specialist Phone: 847-643-3690 Email: SBlair@medline.com
SUMMARY PREPARATION DATE
April 22, 2015
TYPE OF 510(k) SUBMISSION
Traditional
DEVICE NAME / CLASSIFICATION
Trade/Proprietary Name: Medline Enteral Feeding Sets Common Name: Tubes, Gastrointestinal and Accessories Classification Name: Gastrointestinal Tubes with Enteral Specific Connectors Product Code: PIF / KNT Device Class: II Classification Regulation: 21 CFR 876.5980 Classification Panel: Gastroenterology and Urology
PREDICATE DEVICE
Generica Medical International Enteral Feeding Sets (K133077)
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Medline Industries, Inc. One Medline Place Mundelein, IL 60060
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.
DEVICE DESCRIPTION
Medline Enteral Feeding Sets consist of the following three configurations:
- 1.) Medline Enteral Feeding Pump Bag Set (1000ml)
- 2.) Medline Enteral Feeding Pump Spike Set
- 3.) Medline Enteral Feeding Gravity Bag Set (1000ml)
The Medline Enteral Feeding Pump Bag Set (1000ml) is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems and features a 1000ml formula bag with 100ml graduations and a protective closure cap.
The Medline Enteral Feeding Gravity Bag Set (1000ml) uses the free flow of gravity to dispense enteral feeding solutions and features a 1000ml formula bag with 100ml graduations and a protective closure сар.
The Medline Enteral Feeding Pump Spike Set features a piercing spike used to connect the set to a prefilled container of enteral feeding solution. It is designed for use with Alcor Sentinel® and Nestle Compat® enteral feeding pump systems.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Medline Enteral Feeding Sets are single-use, non-sterile and disposable enteral feeding sets consiting of an enteral feeding bag, tubing, drip chamber, piercing spike, roller clamp and Distal Tip ENFit connectors. The intended use and function of Medline Enteral Feeding Sets are identical to that of the predicate. In addition, Medline Enteral Feeding Sets are offered in the same design style configurations (pump bag set, spike set, and gravity bag set) and are constructed of the same materials as the predicate.
Variation from the predicate device exists only in the replacement of the predicate's 4-Step Distal Tip Connector with the subject's Distal Tip ENFit connector tested in accordance with ISO 80369-1. The addition of the ENFit connector to Medline Enteral Feeding Sets is intended to improve device performance and safety by addressing the risk of misconnections. In addition, this variation in connector design is part of an industry-wide effort to adopt a uniform connector for enteral devices that meets the requirements of ISO 80369-1 and is in accordance with FDA Draft Guidance for Industry: Safety
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Aedline Industries. Inc One Medline Place Mundelein, IL 60060
Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications (July 27, 2012).
Biocompatibility, chemical and functional performance testing were conducted to evaluate Medline Enteral Feeding Sets with the ENFit connector incorporated into its design. The results of these tests have demonstrated that the replacement of the predicate's 4-step Distal Tip connector with the proposed device's ENFit connector does not alter the function or performance of the devices and does not raise additional questions or compromise the safety and/or effectiveness of the device. This testing, along with the various supporting data provided in this pre-market notification, establishes that Medline Enteral Feeding Sets are substantially equivalent to the predicate device.
SUMMARY OF PERFORMANCE TESTING
The following performance testing was conducted on Medline Enteral Feeding Sets:
- Enteral Connector Misconnection Assessment Study
- o Human Factors Validation Study: Enteral Connectors Final Report
- PG-Lock Misconnection Data with Failure Modes and Effects Analysis (FMEA) ●
- Performance Testing with and without Reference Connectors: o
- Falling Drop Positive Pressure Liquid Leakage o
- Stress Cracking o
- Resistance to Separation from Axial Load O
- Resistance to Separation from Unscrewing O
- Resistance to overriding O
- o Disconnection by unscrewing
- ENFit Component Verification Testing
- ENFit Bond Strength Testing ●
- Risk Analysis ●
- Pump Compatibility Testing against predicate ●
- Flow Rate Testing against predicate ●
- ENFit Connection Strength Testing
- Bioburden Testing –against predicate ●
- o Cross Cavity Metrology Testing
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Medline Industries, Inc One Medline Place Mundelein, IL 60060
- Leachable and Extractable (L&E) Profile Analysis with comprehensive Toxicological ● Health Risk Assessment
- Biocompatibility Testing: ●
- o Cytotoxicity MEM elution per ISO 10993-5;
- Irritation Intracutaneous reactivity per ISO 10993-10; and o
- Delayed-Type Hypersensitivity (Sensitization) Guinea Pig Maximization Test o per ISO 10993-10.
SUMMARY OF CLINICAL TESTING
Not applicable.
SUMMARY OF ANIMAL TESTING
Not applicable.
CONCLUSION
In accordance with 21 CFR Part 807, and based on a comparison of the Indications for Use, technological characteristics, and performance data to the predicate, Medline Industries, Inc. concludes that the Medline Enteral Feeding Sets are safe, effective and substantially equivalent to the predicate.