(156 days)
No
The device is a mechanical valve and the summary does not mention any AI or ML components or capabilities.
No
The device is a fluid flow control system for enteral feeding, medication, and water administration, rather than a device that directly treats a medical condition or disease.
No
Explanation: The device is described as a multi-port connector/valve closed system for controlling fluid flow (nutrition, medication, and water) between ENFit compatible devices. Its function is to manage the delivery of substances, not to diagnose a condition.
No
The device description and performance studies clearly indicate that this is a physical medical device (a valve/stopcock) and not a software-only device. The testing performed relates to the physical properties and performance of the valve.
Based on the provided text, the Medline Quick Switch Valve with ENFit Connector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "controlling fluid flow (nutrition, medication and water) between ENFit compatible devices" for enteral feeding. This is a direct interaction with the patient's body for therapeutic or supportive purposes, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description reinforces its function as a "three-way stopcock valve intended to control fluid flow between ENFit enteral devices." This is a mechanical device for managing fluid delivery.
- Lack of Diagnostic Purpose: There is no mention of analyzing samples, detecting substances, or providing any kind of diagnostic information about the patient's health status.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, and flow rate, which are relevant to a device used for fluid delivery, not for diagnostic testing.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The Medline Quick Switch Valve does not perform this function.
N/A
Intended Use / Indications for Use
The Medline Quick Switch Valve with ENFit Connector is a multi-port connector/valve closed system indicated for controlling fluid flow (nutrition, medication and water) between ENFit compatible devices, while reducing the frequency of disconnections between the associated ENFit devices. The Medline Quick Switch Valve with ENFit Connector can be used in pediatric (infants over 10kg, children, and adolescents) and adult patients, for up to 30 days.
Product codes
PIF
Device Description
The Medline Quick Switch Valve with ENFit Connector is a three-way stopcock valve intended to control fluid flow between ENFit enteral devices (i.e., Gastrostomy tubes, enteral syringes, extension sets, feeding sets) used for different enteral functions (i.e., liquid nutrition, water, or medication administration), reducing the frequency of disconnections between the associated enteral devices.
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
pediatric (infants over 10kg, children, and adolescents) and adult patients
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)
Non-clinical verification of The Medline Quick Switch Valve with ENFit Connector has been conducted to evaluate its safety, performance and functionality. The results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination of Medline Quick Switch Valve with ENFit Connector to the predicate, ICU Medical Lopez Valve (K915171). A summary of testing is presented below.
Biocompatibility Testing
The biological evaluation for the Medline Quick Switch Valve with ENFit Connector 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."
Based on the indications for use, the proposed device has been classified as follows: Per nature of body contact Surface device, indirectly contacting mucosal membrane (gastrointestinal). Per contact duration Prolonged (>24 hours to 30 days)
Based on the proposed device indications for use, its categorization, and its material composition the following biocompatibility tests were performed on the final finished sterilized device:
- E-MEM Elution Cytotoxicity Test per ISO 10993-5: 2009 "Biological Evaluation of Medical Devices, Part 5: Tests for in vitro Cytotoxicity."
- Intracutaneous Irritation 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."
The biocompatibility test results indicate that the Medline Quick Switch Valve with ENFit Connector is considered to be non-cytotoxic, non-sensitizing, and a non-irritant. Collectively, the test results indicate that the product meets the biocompatibility requirements and is considered safe for its intended use.
Phthalates Testing
Phthalates testing supports that the Medline Quick Switch Valve with ENFit Connector is not made with DEHP or BPA.
Bioburden Testing
The environmental controls and bioburden monitoring supports safe bioburden levels for the indications for use.
Performance Testing (Bench)
To evaluate the performance of the proposed device, the Medline Quick Switch Valve with ENFit Connector was subjected to:
- Metrology per ISO 80369-3
- Positive Pressure Liquid Leakage per ISO 80369-3 § 6.1.3
- Stress Cracking per ISO 80369-3 § 6.2
- Resistance to Separation from Axial Load per ISO 80369-3 § 6.3
- Resistance to Separation from Unscrewing per ISO 80369-3 § 6.4
- Resistance to Overriding per ISO 80369-3 § 6.5
- Disconnection by Unscrewing per ISO 80369-3 § 6.6
- Flow Rate*
-
- Tensile testing
-
- Torque testing
*Predicate device included for comparison in testing.
- Torque testing
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K160642, K082241, K151628, K150286
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food & 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.
December 4, 2019
Medline Industries, Inc. Dinah Rincones Regulatory Affairs Specialist Three Lakes Drive Northfield, IL 60093
Re: K191759
Trade/Device Name: Medline Quick Switch Valve with ENFit Connector Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: November 5, 2019 Received: November 6, 2019
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
1
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 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,
for
Shani P. Haugen, Ph.D. Acting 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
2
Indications for Use
510(k) Number (if known)
Device Name
Medline Quick Switch Valve with ENFit Connector
Indications for Use (Describe)
The Medline Quick Switch Valve with ENFit Connector is a multi-port connector/valve closed system indicated for controlling fluid flow (nutrition, medication and water) between ENFit compatible devices, while reducing the frequency of disconnections between the associated ENFit devices. The Medline Quick Switch Valve with ENFit Connector can be used in pediatric (infants over 10kg, children, and adolescents) and adult patients, for up to 30 days.
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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Image /page/3/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked on top of a white abstract star shape. The background is a solid dark blue color. The logo is simple and clean, and the colors are contrasting.
ledline Industries, Inc. Three Lakes Drive Northfield, II 60093
K191759 Page 1 of 8
K191759 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
Contact Person
Dinah Rincones Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Phone: 847-949-2687 Fax: 224-931-1271 Email: DRincones@medline.com
Summary Preparation Date
November 26th, 2019
Type of 510(k) Submission
Traditional
Device Information
Type of 510(k) Submission: Traditional Device Common Name: Gastrointestinal tube valve Medline Quick Switch Valve with ENFit Connector Trade Name: Regulation Name: Gastrointestinal tube and accessories Regulation Number: 21 CFR §876.5980 Class: Class II Review Panel: Gastroenterology/Urology Product Code: PIF (Gastrointestinal tubes with enteral specific connectors)
Predicate Device
ICU Medical Lopez Valve K915171
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Image /page/4/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue background and consists of the word "MEDLINE" in white, bold sans-serif font, positioned to the left of a stylized white cross. The cross is oriented diagonally, with its arms extending outwards from the center, creating a dynamic and modern look. The overall design is clean and professional, reflecting the company's focus on healthcare solutions.
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
K191759 Page 2 of 8
Reference Device
Medline ENFit Syringe K160642
Dale Medical Products, Inc. Dale ACE Connector (Access Controller for Enteral) K082241
Medline ENFit Connectors K151628
Medline Enteral Feeding Sets K150286
Device Description
The Medline Quick Switch Valve with ENFit Connector is a three-way stopcock valve intended to contro
fluid flow between ENFit enteral devices (i.e., Gastrostomy tubes, enteral syringes, extension sets, feedin g sets) used for different enteral functions (i.e., liquid nutrition, water, or medication administration), reducing the frequency of disconnections between the associated enteral devices.
TABLE:1 Quick Switch Valve with ENFit Connector Offerings
| Item | Description |
|---|---|
| ENFit9000S | Medline Quick Switch Valve with ENFit Connector sterile |
| ENFit9000NS | Medline Quick Switch Valve with ENFit Connector non-sterile |
Indications for Use
The Medline Quick Switch Valve with ENFit Connector is a multi-port connector/valve closed system indicated for controlling fluid flow (nutrition, medication and water) between ENFit compatible devices, while reducing the frequency of disconnections between the associated ENFit devices. The Medline Quick Switch Valve with ENFit Connector can be used in pediatric (infants over 10kg, children, and adolescents) and adult patients, for up to 30 days.
Summary of Technological Characteristics
The Medline Quick Switch Valve with ENFit Connector is similar in design and technological characteristics to the predicate device cleared under K915171, ICU Medical Lopez Valve. Variations from the predicate device design are nonsignificant. The table below shows a side-by-side comparison of the key attributes associated with the proposed device and the predicate device.
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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is written in a bold, sans-serif font, stacked on top of a white, stylized symbol that resembles a cross or a stylized star. The logo is simple and clean, with a focus on the company name and a recognizable symbol.
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
TABLE 2: Comparison of the Proposed Device with the Predicate
| Device Characteristic | Proposed Device | Predicate Device
(K915171) | Comparison
Analysis |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Medline Quick Switch
Valve with ENFit
Connector | ICU Medical Lopez Valve | N/A |
| Intended Use | Intended for use in
providing access to
enteral systems without
opening or breaking the
fluid delivery lines. | Intended for use in
providing access to enteral
systems without opening
or breaking the fluid
delivery lines. | Same |
| Indications for Use | The Medline Quick
Switch Valve with ENFit
Connector is a multi-port
connector/valve closed
system indicated for
controlling fluid flow
(nutrition, medication and
water) between ENFit
compatible devices, while
reducing the frequency of
disconnections between
the associated ENFit
devices. | Note: The predicate's
device 510(k) Summary or
Indications for Use
Statement are not publicly
available. | N/A |
| Device Characteristic | Proposed Device | Predicate Device
(K915171) | Comparison
Analysis |
| Regulation
Name/Number | 21 CFR §876.5980 -
Gastrointestinal tube and
accessories | 21 CFR §876.5980 -
Gastrointestinal tube and
accessories | Same |
| Product Code | PIF | KNT | Different
Note: Currently this
device's design has
been updated to
include ENFit
connector. Refer to its
promotional material
in Appendix C. |
| Materials | Valve Body:
Polycarbonate
Valve Knob: High
Density Polyethylene
Valve Plate: High
Density Polyethylene
Female/Mate ENFit
Connector: Polycarbonate
Cap: Polycarbonate
Tether: PVC | Valve Body:
Polycarbonate.
Valve Core: Low linear
density polyethylene.
Cap: Polyethylene. | Similar |
| Design Features | Three-way stopcock.
One female ENFit
end/connector. | Three-way stopcock.
One female ENFit
end/connector. | Similar |
| Device Characteristic | Proposed Device | Predicate Device
(K915171) | Comparison
Analysis |
| | Two male ENFit
ends/connectors with
tethered caps.
On-Off 360° rotation
handle. | One male ENFit
end/connector w/o cap.
One male ENFit
end/connector with
tethered cap.
On-Off 360° rotation
handle. | |
| Product Configurations | Sterile and non-sterile
configurations | Sterile and non-sterile
configurations | Same |
| Packaging | Individually packaged in
a soft poly film pouch
with Tyvek lid. | Individually packaged in a
soft poly film pouch with
Tyvek lid. | Same |
| Performance
Characteristics | The following
performance
characteristics are
equivalent to the
predicate device:
• Flow rate
• ENFit connectors
compliant with
ISO 80369-3 | The following
performance
characteristics are
equivalent to the
predicate device:
• Flow rate
• ENFit connectors
compliant with
ISO 80369-3 | Same |
| Prescription vs. OTC | Prescription only | Prescription only | Same |
| Duration of Use | 24 hours to 30 days)
Based on the proposed device indications for use, its categorization, and its material composition the following biocompatibility tests were performed on the final finished sterilized device:
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Image /page/9/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo is set against a blue square background. The word "MEDLINE" is written in white, bold sans-serif font. A white, stylized cross-like symbol is positioned behind the text, with its center aligned with the middle of the word "MEDLINE."
Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
-
- E-MEM Elution Cytotoxicity Test per ISO 10993-5: 2009 "Biological Evaluation of Medical Devices, Part 5: Tests for in vitro Cytotoxicity."
-
- Intracutaneous Irritation 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."
The biocompatibility test results indicate that the Medline Quick Switch Valve with ENFit Connector is considered to be non-cytotoxic, non-sensitizing, and a non-irritant. Collectively, the test results indicate that the product meets the biocompatibility requirements and is considered safe for its intended use.
Phthalates Testing
Phthalates testing supports that the Medline Quick Switch Valve with ENFit Connector is not made with DEHP or BPA.
Bioburden Testing
The environmental controls and bioburden monitoring supports safe bioburden levels for the indications for use.
Performance Testing (Bench)
To evaluate the performance of the proposed device, the Medline Quick Switch Valve with ENFit Connector was subjected to:
- Metrology per ISO 80369-3 ●
- Positive Pressure Liquid Leakage per ISO 80369-3 § 6.1.3
- Stress Cracking per ISO 80369-3 § 6.2
- Resistance to Separation from Axial Load per ISO 80369-3 § 6.3
- Resistance to Separation from Unscrewing per ISO 80369-3 § 6.4
- Resistance to Overriding per ISO 80369-3 § 6.5
- Disconnection by Unscrewing per ISO 80369-3 § 6.6 ●
- Flow Rate* ●
- . Tensile testing
- o Torque testing
*Predicate device included for comparison in testing.
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.
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Image /page/10/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, stacked on top of a white symbol that resembles a stylized cross or star. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a recognizable symbol.
Medline Industries, Inc Three Lakes Drive Northfield, IL 60093
K191759 Page 8 of 8
Conclusion
In accordance with 21 CFR Part 807, and based on a comparison of 'Indications for Use,' technological characteristics and performance data, Medline Industries, Inc. concludes that the proposed Medline Quick Switch Valve with ENFit Connector is substantially equivalent to the predicate device, ICU Medical Lopez Valve (K915171).