Medline ENfit OTC Feeding Syringe

K202285 · Medline Industries, Inc. · PNR · Oct 9, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K202285
• Device Name: Medline ENfit OTC Feeding Syringe
• Applicant: Medline Industries, Inc.
• Product Code: PNR · Gastroenterology, Urology
• Decision Date: Oct 9, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Medline ENFit OTC Feeding Syringe is intended for Over-The-Counter use to measure and administer enteral nutrition.

Device Story

Medline ENFit OTC Feeding Syringe is a 60mL, single-use, non-sterile, manual piston syringe; features a female ENFit connector compliant with ISO 80369-3 for secure attachment to enteral feeding tubes and extension sets. Device consists of polypropylene barrel/plunger, polyisoprene seal, and threaded cap. Intended for OTC use by laypersons or clinicians in home or clinical settings to measure and administer enteral nutrition. User fills syringe with enteral formula, attaches to feeding tube, and manually depresses plunger to deliver nutrition. Output is the controlled delivery of enteral nutrition. Benefits include standardized, secure connection to prevent misconnections and facilitate safe, accurate enteral feeding by non-professional caregivers.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-5, ISO 10993-10), mechanical performance (ISO 7886-1), connector integrity (ISO 80369-3), and usability studies validating layperson instructions.

Technological Characteristics

Materials: Polypropylene (barrel, plunger, cap), Polyisoprene (seal). Design: 3-piece manual piston syringe with ISO 80369-3 compliant female ENFit connector. Dimensions: 60mL capacity. Connectivity: None. Sterilization: Non-sterile. Shelf life: 3 years.

Indications for Use

Indicated for adults and pediatrics (excluding neonates) for the measurement and administration of enteral nutrition in clinical or home care settings.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Medline ENFit Syringe (K160642)

Submission Summary (Full Text)

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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, [phone], [e-mail].

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

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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

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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 ([e-mail]) or phone [phone] 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

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# 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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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, bold letters, stacked on top of a white, stylized starburst shape. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a visual element that suggests innovation or energy.

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: [phone] Fax: [phone] Email: [e-mail]

# 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.

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Image /page/5/Picture/0 description: The image is a logo for Medline. The logo is set on a blue background. The word "MEDLINE" is written in white, block letters. A white, stylized cross is behind the word "MEDLINE."

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<br>Characteristic | Proposed Device | Predicate Device<br>(K160642) | Comparison<br>Analysis |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Medline ENFit OTC Feeding<br>Syringe | Medline ENFit Syringe | N/A |
| Regulation<br>Name/Number | 21 CFR §876.5980 -<br>Gastrointestinal tube and<br>accessories | 21 CFR §876.5980 -<br>Gastrointestinal tube and<br>accessories | Same |
| Product Code | PNR | PIF | Different<br>Note: Product Code PNR<br>did not exist at the time of<br>K160642 submission.<br>Currently there is a<br>specific product code for<br>this type of devices<br>(PNR). |
| Intended Use | Intended to measure and<br>administer enteral nutrition. | Intended to measure and<br>administer enteral nutrition. | Same |
| Indications for<br>Use | The Medline ENFit OTC Feeding<br>Syringe is intended for Over-The-<br>Counter use to measure and<br>administer enteral nutrition. | The Medline ENFit Syringe is<br>intended to be used in clinical or<br>home care settings by users<br>ranging from clinicians to<br>laypersons (under the supervision<br>of a clinician) to measure and<br>administer enteral nutrition. | Different |
| Device<br>Characteristic | Proposed Device | Predicate Device<br>(K160642) | Comparison<br>Analysis |
| Patient<br>Population | Adults and pediatrics (but not<br>neonates). | Adults and pediatrics (but not<br>neonates). | Same |
| Prescription vs.<br>OTC | OTC | Prescription | Different<br>Note: The agency has<br>cleared ENFit OTC<br>Feeding Syringes<br>(K183540) |
| Use<br>Environment<br>and Users | Clinical or home care settings by<br>users ranging from clinicians to<br>laypersons | Clinical or home care settings by<br>users ranging from clinicians to<br>laypersons (under the supervision<br>of a clinician). | Similar |
| Design Features | 3 piece design syringe with cap.<br>Components:<br>• Syringe Barrel<br>• Syringe Plunger<br>• Syringe Plunger Seal<br>• Syringe Threaded Cap | 3 piece design syringe with cap.<br>Components:<br>• Syringe Barrel<br>• Syringe Plunger<br>• Syringe Plunger Seal<br>• Syringe Threaded Cap | Same |
| Design<br>Configurations | 60 ml non-sterile | 60 ml non-sterile | Same |
| Materials | Syringe Barrel: Polypropylene<br>Syringe Plunger: Polypropylene<br>Syringe Plunger Seal:<br>Polyisoprene<br>Syringe Threaded Cap:<br>Polypropylene<br>Packaging Material: Low Density<br>Polyethylene (LDPE). | Syringe Barrel: Polypropylene<br>Syringe Plunger: Polypropylene<br>Syringe Plunger Seal:<br>Polyisoprene<br>Syringe Threaded Cap:<br>Polypropylene<br>Packaging Material: Low Density<br>Polyethylene (LDPE). | Similar<br>Note: The type of<br>material per component is<br>the same; however, the<br>raw material supplier is<br>different. |
| Contact<br>Duration | ≤ 24 hours | ≤ 24 hours | Same |
| Sterile vs. Non-<br>Sterile | Non-Sterile | Non-Sterile | Same |
| Device<br>Characteristic | Proposed Device | Predicate Device<br>(K160642) | Comparison<br>Analysis |
| Disposable vs.<br>Non-Disposable | Disposable | Disposable | Same |
| Single Use vs.<br>Reusable | Single Use | Single Use | Same |
| Sterile vs. Non-<br>Sterile | Non-sterile | Non-sterile | Same |
| Single Use vs.<br>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:

- 1. MEM Elution Cytotoxicity Test per ISO 10993-5: 2009 "Biological Evaluation of Medical Devices, Part 5: Tests for in vitro Cytotoxicity."
- 1. Intracutaneous Reactivity Test per ISO 10993-10: 2010: "Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization."
- 2. 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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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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Image /page/9/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square background. A white star-like symbol is behind the text. The star has four points, with the top and bottom points being longer than the side points. There is a gray bar on the right side of the image.

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).