(58 days)
No
The device description and performance testing sections describe a standard mechanical syringe with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a feeding syringe, primarily intended for measuring and administering enteral nutrition. While it delivers nutrition, it is not described as treating, preventing, or diagnosing a disease or condition, which are characteristics of a therapeutic device.
No
This device is a feeding syringe intended to measure and administer enteral nutrition, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a standard piston syringe made of physical materials (polypropylene, polyisoprene) and incorporates a physical connector (ENFit). It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to measure and administer enteral nutrition." This involves delivering substances into the body, not testing samples from the body to diagnose conditions.
- Device Description: The description details a syringe designed for administering liquids via a feeding tube. This is a delivery mechanism, not a diagnostic tool.
- Performance Studies: The performance studies focus on the physical properties of the syringe (biocompatibility, leakage, force, dimensions, stability) and usability for administration. There are no studies related to analyzing biological samples or diagnosing conditions.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on delivering nutrition, which is a therapeutic or supportive action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Medline ENFit OTC Feeding Syringe is intended for Over-The-Counter use to measure and administer enteral nutrition.
Product codes (comma separated list FDA assigned to the subject device)
PNR
Device Description
The Medline ENFit OTC Feeding Syringe (the subject device) is a standard piston syringe which incorporates a female ENFit connector designed to interal access devices (i.e. feeding tubes) and ENFit compatible enteral feeding extension sets. The design consists of a polypropylene barrel and plunger rod, a polyisoprene plunger seal or stopper, an ISO 80369-3 compliant female ENFit connector, and a threaded cap. The Medline ENFit OTC Feeding Syringe is available in one size (60mL) and will be sold as 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
Adults and pediatrics (but not neonates).
Intended User / Care Setting
Clinical or home care settings by users ranging from clinicians to laypersons
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)
Testing was conducted to demonstrate substantial equivalence of Medline ENFit OTC Feeding Syringe to the predicate. Medline ENFit Syringe cleared under 510(k) number K160642. A summary of testing is presented below with more information provided in the applicable sections.
Biocompatibility Testing:
- MEM Elution Cytotoxicity Test per ISO 10993-5: 2009 "Biological Evaluation of Medical Devices, Part 5: Tests for in vitro Cytotoxicity."
- Intracutaneous Reactivity Test per ISO 10993-10: 2010: "Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."
- Guinea Pig Maximization Sensitization Test per ISO 10993-10: 2010: "Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."
Performance Testing (Bench) conducted on Medline ENFit OTC Feeding Syringe:
- ISO 7886-1 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
- Tolerance on Graduated Capacity per Section 9.
- Graduated Scale: Scale per Section 10.1.
- Graduated Scale: Numbering of Scale per Section 10.2.
- Overall Length of the Scale per Section 10.2.
- Position of the Scale per Section 10.4.
- Burrell Finger Grips per Section 11.2.
- Piston/Plunger Assembly Design per Section 12.1.
- Fit of Piston in Barrel per Section 12.2.
- Fiducial Line per Section 12.3.
- Dead Space per Section 14.1.
- Freedom from Liquid Leakage per Section 14.2. Freedom from Air Leakage per Section 14.2.
- Connectors for enteral applications.
- Positive Pressure Liquid Leakage per Section 6.1.3.
- Stress Cracking per Section 6.2.
- Resistance to Separation from Axial Load per Section 6.3.
- Resistance to Separation from Unscrewing per Section 6.4.
- Resistance to Overriding per Section 6.5.
- Disconnection by Unscrewing per Section 6.6.
- Force to Insert Plunger: Maximum Force (N) required to surpass the interference ring of the barrel: Met acceptance criteria.
- Metrology per ISO 80369-3 - Dimensions of Female ENFit Connector: All dimensions for the female connectors meet the specifications and tolerance listed in ISO 80369-3.
Performance Testing (Animal): This section does not apply. No animal testing was performed.
Performance Testing (Clinical): This section does not apply. No clinical testing was performed.
Phthalates Testing: Phthalates testing supports that the Medline ENFit OTC Feeding Syringe is not made with DEHP or BPA.
Stability (Shelf-Life) Testing: Stability testing has been performed on the finished product to validate a shelf life of up to three (3) years based on real time and accelerated aging conditions of 25°C/60% relative humidity (RH) and 65°C dry heat, respectively.
Usability Studies: Usability studies have been executed in order to validate the adequacy of the printed instructions for how to properly fill and administer the Medline ENFit OTC Feeding Syringe contents by the layperson.
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.
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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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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
December 7, 2020
Medline Industries, Inc. Dinah Rincones Sr. Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K202285
Trade/Device Name: Medline ENfit OTC Feeding Syringe Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PNR
Dear Dinah Rincones:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 9, 2020. Specifically, FDA is updating this SE Letter due to an inadvertent inclusion of proprietary information (contract manufacturer) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shanil Haugen, Ph.D., OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office, (301) 796-0301, Shanil.Haugen@fda.hhs.gov.
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 9, 2020
Medline Industries, Inc. Dinah Rincones Sr. Regulatory Affairs Specialist Three Lakes Drive Northfield, IL 60093
Re: K202285
Trade/Device Name: Medline ENfit OTC Feeding Syringe Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PNR Dated: August 7, 2020 Received: August 12, 2020
Dear Dinah Rincones:
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. 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 located 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.
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
2
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
Jitendra V. Virani -S
For Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K202285
Device Name Medline ENFit OTC Feeding Syringe
Indications for Use (Describe)
The Medline ENFit OTC Feeding Syringe is intended for Over-The-Counter use to measure and administer enteral nutrition.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
SECTION 5 510(k) SUMMARY
Submitter
Dinah Rincones Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Phone: 847-949-2687 Fax: 224-931-1271 Email: DRincones@medline.com
Device Information
| Device Common Name: | Enteral Syringes with Enteral Specific Connectors |
|---|---|
| Trade Name: | Medline ENFit OTC Feeding Syringe |
| Regulation Name: | Gastrointestinal Tube and Accessories |
| Regulation Number: | 21 CFR §876.5980 |
| Class: | Class II |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | PNR |
Predicate Device Information
The proposed predicate device is Medline ENFit Syringe cleared under 510(k) number K160642 on November 29, 2016.
Modification to the Predicate Device
The intent of this traditional 510(k) is to expand the intended use of the previously cleared Medline ENFit Syringe (K160642) in order to include over-the-counter (OTC) use. The device that is the subject of this submission is the same as the legally marketed device Medline ENFit Syringe (K160642), but rather than being intended for prescription use only, is intended for over-the-counter use. According to the FDA guidance document, "Deciding When to Submit a 510(k) for a Change to an Existing Device," a change from prescription use to OTC use requires the development of adequate directions for use so that the lay user is able to utilize that same device safely and effectively. Therefore, changing a device for prescription use only to a device that is labeled for OTC use requires a submission of a new 510(k). For this reason, the Medline ENFit Syringe (K160642) will be utilized as the primary predicate device in this submission.
5
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Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
Summary of Technological Characteristics
Device Description
The device that is the subject of this submission is the same device as the Medline ENFit Syringe cleared under K160642, but rather than being intended for prescription use only, is instead intended for over-thecounter use. The Medline ENFit OTC Feeding Syringe (the subject device) is a standard piston syringe which incorporates a female ENFit connector designed to interal access devices (i.e. feeding tubes) and ENFit compatible enteral feeding extension sets. The design consists of a polypropylene barrel and plunger rod, a polyisoprene plunger seal or stopper, an ISO 80369-3 compliant female ENFit connector, and a threaded cap. The Medline ENFit OTC Feeding Syringe is available in one size (60mL) and will be sold as a single use, non-sterile device.
Indications for Use
The Medline ENFit OTC Feeding Syringe is intended for Over-The-Counter use to measure and administer enteral nutrition.
| Device
Characteristic | Proposed Device | Predicate Device
(K160642) | Comparison
Analysis |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Medline ENFit OTC Feeding
Syringe | Medline ENFit Syringe | N/A |
| Regulation
Name/Number | 21 CFR §876.5980 -
Gastrointestinal tube and
accessories | 21 CFR §876.5980 -
Gastrointestinal tube and
accessories | Same |
| Product Code | PNR | PIF | Different
Note: Product Code PNR
did not exist at the time of
K160642 submission.
Currently there is a
specific product code for
this type of devices
(PNR). |
| Intended Use | Intended to measure and
administer enteral nutrition. | Intended to measure and
administer enteral nutrition. | Same |
| Indications for
Use | The Medline ENFit OTC Feeding
Syringe is intended for Over-The-
Counter use to measure and
administer enteral nutrition. | The Medline ENFit Syringe is
intended to be used in clinical or
home care settings by users
ranging from clinicians to
laypersons (under the supervision
of a clinician) to measure and
administer enteral nutrition. | Different |
| Device
Characteristic | Proposed Device | Predicate Device
(K160642) | Comparison
Analysis |
| Patient
Population | Adults and pediatrics (but not
neonates). | Adults and pediatrics (but not
neonates). | Same |
| Prescription vs.
OTC | OTC | Prescription | Different
Note: The agency has
cleared ENFit OTC
Feeding Syringes
(K183540) |
| Use
Environment
and Users | Clinical or home care settings by
users ranging from clinicians to
laypersons | Clinical or home care settings by
users ranging from clinicians to
laypersons (under the supervision
of a clinician). | Similar |
| Design Features | 3 piece design syringe with cap.
Components:
• Syringe Barrel
• Syringe Plunger
• Syringe Plunger Seal
• Syringe Threaded Cap | 3 piece design syringe with cap.
Components:
• Syringe Barrel
• Syringe Plunger
• Syringe Plunger Seal
• Syringe Threaded Cap | Same |
| Design
Configurations | 60 ml non-sterile | 60 ml non-sterile | Same |
| Materials | Syringe Barrel: Polypropylene
Syringe Plunger: Polypropylene
Syringe Plunger Seal:
Polyisoprene
Syringe Threaded Cap:
Polypropylene
Packaging Material: Low Density
Polyethylene (LDPE). | Syringe Barrel: Polypropylene
Syringe Plunger: Polypropylene
Syringe Plunger Seal:
Polyisoprene
Syringe Threaded Cap:
Polypropylene
Packaging Material: Low Density
Polyethylene (LDPE). | Similar
Note: The type of
material per component is
the same; however, the
raw material supplier is
different. |
| Contact
Duration | ≤ 24 hours | ≤ 24 hours | Same |
| Sterile vs. Non-
Sterile | Non-Sterile | Non-Sterile | Same |
| Device
Characteristic | Proposed Device | Predicate Device
(K160642) | Comparison
Analysis |
| Disposable vs.
Non-Disposable | Disposable | Disposable | Same |
| Single Use vs.
Reusable | Single Use | Single Use | Same |
| Sterile vs. Non-
Sterile | Non-sterile | Non-sterile | Same |
| Single Use vs.
Reusable | Single use | Single use | Same |
| Shelf Life | 3 years | 3 years | Same |
Table 1: Comparison of Proposed and Predicate Devices
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Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
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Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
Summary of Testing and Supporting Information
Testing was conducted to demonstrate substantial equivalence of Medline ENFit OTC Feeding Syringe to the predicate. Medline ENFit Syringe cleared under 510(k) number K160642. A summary of testing is presented below with more information provided in the applicable sections.
Biocompatibility Testing
The biological evaluation for the Medline ENFit OTC Feeding Syringe was conducted in accordance with FDA guidance document, "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' and ISO 10993-1 Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process."
Testing performed:
-
- MEM Elution Cytotoxicity Test per ISO 10993-5: 2009 "Biological Evaluation of Medical Devices, Part 5: Tests for in vitro Cytotoxicity."
-
- Intracutaneous Reactivity Test per ISO 10993-10: 2010: "Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."
-
- Guinea Pig Maximization Sensitization Test per ISO 10993-10: 2010: "Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."
Performance Testing (Bench)
The following performance testing was conducted on Medline ENFit OTC Feeding Syringe:
ISO 7886-1 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
- Tolerance on Graduated Capacity per Section 9. ●
- Graduated Scale: Scale per Section 10.1. .
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Image /page/8/Picture/0 description: The image features the logo for Medline, a healthcare company. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a stylized star-like symbol. The background is a solid blue color, and there is a gray bar on the right side of the image.
Medline Industries, Inc Three Lakes Drive Northfield. IL 60093
- Graduated Scale: Numbering of Scale per Section 10.2. ●
- Overall Length of the Scale per Section 10.2. ●
- Position of the Scale per Section 10.4.
- Burrell Finger Grips per Section 11.2. ●
- Piston/Plunger Assembly Design per Section 12.1.
- Fit of Piston in Barrel per Section 12.2.
- Fiducial Line per Section 12.3. ●
- Dead Space per Section 14.1.
- . Freedom from Liquid Leakage per Section 14.2. Freedom from Air Leakage per Section 14.2.
Connectors for enteral applications.
- Positive Pressure Liquid Leakage per Section 6.1.3. ●
- Stress Cracking per Section 6.2. ●
- Resistance to Separation from Axial Load per Section 6.3. ●
- Resistance to Separation from Unscrewing per Section 6.4. ●
- Resistance to Overriding per Section 6.5. ● Disconnection by Unscrewing per Section 6.6.
Force to Insert Plunger.
Maximum Force (N) required to surpass the interference ring of the barrel: Met acceptance criteria.
Metrology per ISO 80369-3 - Dimensions of Female ENFit Connector.
All dimensions for the female connectors meet the specifications and tolerance listed in ISO 80369-3.
Performance Testing (Animal)
This section does not apply. No animal testing was performed.
Performance Testing (Clinical)
This section does not apply. No clinical testing was performed.
Phthalates Testing
Phthalates testing supports that the Medline ENFit OTC Feeding Syringe is not made with DEHP or BPA.
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ledline Industries. Inc Three Lakes Drive Northfield II 60093
Stability (Shelf-Life) Testing
Stability testing has been performed on the finished product to validate a shelf life of up to three (3) years based on real time and accelerated aging conditions of 25°C/60% relative humidity (RH) and 65°C dry heat, respectively.
Usability Studies
Usability studies have been executed in order to validate the adequacy of the printed instructions for how to properly fill and administer the Medline ENFit OTC Feeding Syringe contents by the layperson.
Risk Analysis
A complete Use Risk Assessment was performed for the Medline ENFit OTC Feeding Syringe.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the proposed Medline ENFit OTC Feeding Syringe is as safe and as effective for its intended use as the predicate device Medline ENFit Syringe (K160642).