(133 days)
Not Found
No
The device is a mechanical valve for controlling fluid flow and the description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is a valve designed to control fluid flow between enteral devices, facilitating administration of nutrition, medication, and water. It does not exert a therapeutic effect on the patient.
No
The device description indicates it is a valve for controlling fluid flow (nutrition, medication, water) between medical devices. It does not mention any function for diagnosing conditions or diseases.
No
The device description clearly describes a physical, mechanical valve with ports and caps, indicating it is a hardware device. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control the flow of fluids (nutrition, medication, water) between devices used for enteral feeding. This is a mechanical function related to fluid delivery, not the analysis of biological samples to diagnose or monitor a medical condition.
- Device Description: The device is described as a valve (stopcock) with ports for connecting to feeding tubes and syringes. This is a physical device for managing fluid flow, not a reagent, instrument, or system used for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The performance studies focus on the mechanical integrity and functionality of the valve.
In summary, the Gabriel 3-way EnFit valve is a medical device used for fluid management in enteral feeding, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gabriel 3-way EnFit valve is a three-way closed system valve with three ports for control of fluid flow (nutrition, medication and water) between devices with EnFit connectors and catheter tip syringe. It can be used in pediatric, adult and elderly patients, for up to 7 days.
Product codes (comma separated list FDA assigned to the subject device)
PIF
Device Description
The Gabriel 3-way EnFit Valve is a three-way stopcock valve that is intended to control fluid flow between enteral devices (feeding tubes and feeding lines) with EnFit compatible connectors in a closed system fashion that reduces the need for frequent connection of the EnFit ports. It has one male EnFit port, one female EnFit port and one catheter tip port. The catheter tip port can be used for flushing and administration of medication using a catheter tip syringe. The male EnFit port is provided with a tethered cap and the catheter tip port is provided with a tethered cap. The ability to use a catheter tip syringe for flushing and administration of medicine in health care facilities that do not carry EnFit syringes, may facilitate adoption of feeding tubes and feeding lines with EnFit connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal
Indicated Patient Age Range
pediatric, adult and elderly 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 Gabriel 3-way EnFit valve has been conducted on devices that were manufactured 12 months earlier 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 to the predicate , ICU Medical Lopez Valve (K915171). A summary of testing is presented below.
Male EnFit Measurement Verification Test (PASS)
Female EnFit Measurements Verification Test (PASS)
Catheter Tip Port Measurement Verification Test (PASS)
Tensile Test (PASS)
Cytotoxicity test (PASS)
Sensitization Test (PASS)
Irritation Test(PASS)
Leakage by Pressure Decay Test (PASS)
Positive Pressure Liquid Leakage Test (PASS)
Stress Cracking Test (PASS)
Resistance to Separation from Axial Load Test (PASS)
Resistance to Separation from Unscrewing Test (PASS)
Thread Overriding Resistance Test (PASS)
Disconnection by Unscrewing Test (PASS)
Flexure modulus above 700 Mpa (PASS)
Feeding Formula Flow Rate Test (PASS)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & 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.
November 5, 2020
Syncro Medical Innovations, Inc. Sabry Gabriel MD. President 515 Mulberry Street Macon, GA 31201-6308
Re: K201741 Trade/Device Name: Gabriel 3 Way EnFit Valve Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: October 26, 2020 Received: October 30, 2020
Dear Sabry Gabriel:
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
1
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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K201741
Device Name
Gabriel 3-Way EnFit Valve
Indications for Use (Describe)
The Gabriel 3-way EnFit valve is a three-way closed system valve with three ports for control of fluid flow (nutrition, medication and water) between devices with EnFit connectors and catheter tip syringe. It can be used in pediatric, adult and elderly patients, for up to 7 days.
Type of Use (Select one or both, as applicable)
V | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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5. 510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
5.1 Submitter Information
| Company: | Sabry Gabriel
MD, President
Syncro Medical Innovations, Inc.
515 Mulberry Street
Macon, GA 31201-6308 USA
Telephone: (478)-335-8311
Fax: (716)-809-3504
sabrygabriel@syncromedical.com |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sabry Gabriel
MD, President
Syncro Medical Innovations, Inc.
515 Mulberry Street
Macon, GA 31201-6308 USA
Telephone: (478)-335-8311
Fax: (716)-809-3504
sabrygabriel@syncromedical.com |
| Date Summary Prepared: | October 26, 2020 |
5.2 Name of the Device
| Trade Name: | Gabriel 3-Way EnFit Valve (K201741) |
|---|---|
| Common Name: | Stopcock, 3-way valve. Gastrointestinal Tubes With Enteral Specific Connector and |
| Accessories | |
| Classification | |
| Name: | Gastrointestinal tube and accessories |
| Review Panel: | Gastroenterology & Urology (GU) |
| Regulation: | 876.5980 |
| Class: | Class II |
| Product Code: | PIF |
5.3 Equivalence Claimed to Predicate Device
The Gabriel 3-Way EnFit Valve (K201741) is equivalent to the LOPEZ VALVE TM II (K915171), manufactured by ICU MEDICAL, INC..
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5.4 Basis for Substantial Equivalence
The device has identical intended use, intended population, material and functionality as the predicate device "Lopez Valve" (K915171), cleared on 02/07/1992 and its' updated version with EnFit ports.
It is intended to control fluid flow (nutrition, medication and water) between EnFit compatible devices and catheter tip syringe, without frequent connection and disconnection of the associated devices.
The device passed all mechanical and biocompatibility tests listed in subsequent sections.
5.5 Legally Marketed Device to Which the proposed Device is Substantially Equivalent (Predicate Device):
ICU Medical Lopez Valve (K915171)
5.6 Device Description
The Gabriel 3-way EnFit Valve is a three-way stopcock valve that is intended to control fluid flow between enteral devices (feeding tubes and feeding lines) with EnFit compatible connectors in a closed system fashion that reduces the need for frequent connection of the EnFit ports. It has one male EnFit port, one female EnFit port and one catheter tip port. The catheter tip port can be used for flushing and administration of medication using a catheter tip syringe. The male EnFit port is provided with a tethered cap and the catheter tip port is provided with a tethered cap. The ability to use a catheter tip syringe for flushing and administration of medicine in health care facilities that do not carry EnFit syringes, may facilitate adoption of feeding tubes and feeding lines with EnFit connectors.
5.7 Indication for use
The Gabriel 3-way EnFit valve is a three-way closed system valve with three ports for control of fluid flow (nutrition, medication and water) between devices with EnFit connectors and catheter tip syringe. It can be used in pediatric, adult and elderly patients, for up to 7 days.
5.8 Summary of Technologic Characteristics
The Gabriel 3-way EnFit valve 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.
| Table 5.1: Table 1: Comparison of the proposed and Predicate Device | |||
|---|---|---|---|
| Attribute | Proposed Device (K201741) | Predicate Device | |
| (K915171) | Comparison | ||
| Analysis | |||
| Product Name | Gabriel 3-way EnFit valve | ICU Medical Lopez Valve | N/A |
| Intended Use | Intended for use in providing access to | ||
| enteral systems without opening or | Intended for use in | ||
| providing access to enteral | |||
| systems without opening or | Same | ||
| disconnecting the fluid delivery lines. | disconnecting the fluid delivery lines. | K201 | |
| Page | |||
| Indication for | |||
| Use | The Gabriel 3-way EnFit valve is a three-way closed system valve with three ports for control of fluid flow (nutrition, medication and water) between devices with EnFit connectors and catheter tip syringe. It can be used in pediatric, adult and elderly patients, for up to 7 days. | Note: The predicate's device 510(k) Summary or Indications for Use Statement are not publicly available. | N/A |
| 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 the predicate device's design has been updated to include EnFit connector. Refer to its promotional material | |||
| Materials | Valve Body: Copolyester | ||
| Valve Knob: High Density Polyethylene (HDPE) | |||
| Valve Ports: Methyl Methacrylate Acrylonitrile Butadiene Styrene (MABS) | |||
| Male EnFit Port Cap: ABS | |||
| Catheter port Cap and Tether: Polyolefin | |||
| Male EnFit Cap Tether: PVC | Valve Body: Polycarbonate | ||
| Valve Core: Low Linear density polyethylene. | |||
| Cap: Polyethylene. | Similar | ||
| Design | |||
| Features | Three-way stopcock with: | ||
| One rigid male EnFit port with tethered cap. | |||
| One rigid female EnFit port. | |||
| One rigid female catheter tip port with | Three way stopcock with: | ||
| One rigid male catheter tip port, one rigid female catheter tip port, one flexible female catheter tip port and On-Off 360° rotation handle . | |||
| Note: The updated three-way EnFit Lopez valve | Similar | ||
| tethered cap. | |||
| On-Off 360° rotation handle. | has: One male EnFit port | ||
| with tethered cap, one | |||
| male EnFit port without | |||
| cap, one female EnFit port | |||
| and On-Off 360° rotation | |||
| handle. | K201741 | ||
| Page 4 of | |||
| Product | |||
| Configuration | Non-sterile | Sterile and non-sterile | |
| configuration | Different | ||
| Packaging | Individually packaged in s soft poly film | ||
| pouch. | Individually packaged in | ||
| soft poly film pouch. | Same | ||
| Performance | |||
| Characteristics | The following performance | ||
| characteristics are equivalent to the | |||
| predicate device: | |||
| • Flow rate | |||
| • EnFit connectors compliant with | |||
| ISO 80369-3 | |||
| • Dimensional verification test of the | |||
| male EnFit port, female EnFit port | |||
| and catheter tip port. | |||
| • Tensile test | The following performance | ||
| characteristics | |||
| are equivalent to the | |||
| proposed device: | |||
| • Flow rate | |||
| • EnFit connectors | |||
| compliant with ISO | |||
| 80369-3 | Same | ||
| Prescription | |||
| vs. OTC | Prescription only | Prescription only | Same |
| Duration of | |||
| Use | Less than 7 days | ||
| Change valve per institutional protocol | |||
| and as needed. | Acute care: less than 7 | ||
| days | |||
| Other care settings: | |||
| May be used longer. | Same | ||
| Single Use vs. | |||
| Reusable | Single use | Single use | Same |
| Shelf Life | One year | Not stated | N/A |
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5.9 Summary of Testing (Bench)
Non-clinical verification of the Gabriel 3-way EnFit valve has been conducted on devices that were manufactured 12 months earlier 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 to the predicate , ICU Medical Lopez Valve (K915171). A summary of testing is presented below.
Male EnFit Measurement Verification Test (PASS)
Female EnFit Measurements Verification Test (PASS)
7
Catheter Tip Port Measurement Verification Test (PASS)
Tensile Test (PASS)
Cytotoxicity test (PASS)
Sensitization Test (PASS)
Irritation Test(PASS)
Leakage by Pressure Decay Test (PASS)
Positive Pressure Liquid Leakage Test (PASS)
Stress Cracking Test (PASS)
Resistance to Separation from Axial Load Test (PASS)
Resistance to Separation from Unscrewing Test (PASS)
Thread Overriding Resistance Test (PASS)
Disconnection by Unscrewing Test (PASS)
Flexure modulus above 700 Mpa (PASS)
Feeding Formula Flow Rate Test (PASS)
5.10 Biocompatibility Testing
The following biocompatibility tests were conducted on the entire Gabriel 3-way EnFit valve per ISO 10993-1:
- Cytotoxicity test (PASS).
- Sensitization test(PASS)
- Irritation test (PASS).
The biocompatibility test results indicates that the Gabriel 3-way EnFit Valve is considered to be non-cytotoxic. non-sensitizing, and non-irritant. Collectively, the test results indicate that the product meets the biocompatibility requirements and is considered safe for its intended use.
5.11 Conclusions Drawn from Non-Clinical Testing
The results of comparison of design, material, intended use, technological characteristics and bench tests demonstrate that the proposed device is as safe, as effective, and performs as the identified predicated legally marketed device (K915171) and supports a determination of substantial equivalence.
5.12 Performance Testing (Animal)
This section does not apply. No animal testing was performed.
8
5.13 Performance Testing (Clinical)
This section does not apply. No animal testing was performed.
5.14 Conclusion
The Gabriel 3-way EnFit Valve is substantially equivalent to the predicate ICU Medical Lopez Valve (K915171). Based on the indication for use, principal of operation, performance characteristics, and technological characteristics, the proposed Gabriel 3-way EnFit valve is substantially equivalent to, and as safe, as effective, and performs as the legally marketed predicate device.