(78 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, safety, and functionality of a standard syringe and tip cap, with no mention of AI or ML capabilities.
No.
The device is described as a dispenser and a measuring device used to deliver fluids enterally, indicating it is for administration of substances rather than for direct therapeutic effect itself.
No
The device is described as a dispenser and measuring device for delivering fluids enterally, indicating a functional role rather than a diagnostic one.
No
The device description clearly outlines physical components (syringe barrel, plunger, gasket, tip cap) and the performance studies focus on physical characteristics and testing of these components, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used as a dispenser and measuring device to deliver fluids into the body enterally. This describes a device used for administering substances to a patient, not for testing samples from the body to diagnose a condition.
- Device Description: The description details a standard syringe with an ENFit connector designed for enteral feeding. This aligns with the intended use of delivering fluids into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information. The performance studies focus on the physical and functional aspects of the syringe for fluid delivery and safety, not on analytical performance related to biological samples.
In summary, the device is an enteral syringe, which is a medical device used for administering fluids, not an in vitro diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
NeoConnectTM Enteral Syringe with ENFit™ Connector:
The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.
NeoConnect™ NeoSecure™ Tip Cap:
A NeoConnect™ Enteral Syringe with ENFit™ connector accessory used to prevent fluid loss and contamination of syringe contents until ready for use.
Product codes
PNR, PIF
Device Description
The NeoMed NeoConnect™ Enteral Syringes with ENFit™ connector are standard piston style syringes consisting of a syringe barrel with an integral ENFit™ syringe tip, syringe plunger, syringe gasket, and supplied with or without a syringe tip cap. They are provided in varying sizes ranging from 0.5 mL to 100 mL nominal capacity. The integral syringe tip is a female ENFit™ connector which is compatible only with enteral access devices having ENFit™ male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.
The NeoConnect™ NeoSecure™ Tip Cap is supplied with the NeoConnect™ Enteral Syringe with ENFit™ connector or sold separately (sterile or non-sterile). It is an ENFit™ compatible closure cap for the tip of the syringe.
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
all age groups
Intended User / Care Setting
It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing has been conducted:
- Finished Device .
- o Risk Analysis including design, user and process FMEA (Failure Modes and Effects Analysis) in accordance with EN ISO 14971:2012
- o Human Factors and Usability Validation
- Biocompatibility O
- · ISO 10993-5: Cytotoxicity
- . ISO 10993-10: Irritation and sensitization
- I ISO 10993-11: Acute Toxicity
- o Chemical Testing
- Extractables and Leachables .
- o Finished Device Verification Testing
- Critical Dimension verification ■
- Ink Adhesion
- ISO 7886
- Capacity Tolerance ●
- Graduated Scale .
- Piston Fit in Barrel .
- Air and Liguid Leakage Testing .
- Device Performance and Packaging Stability Testing (3 years) O
- Syringe Tip (ISO 80369-3 (ENFit™) female connector) ●
- Enteral Connector Misconnection Assessment O
- ENFit Connector Risk Management Report (including misconnections FMEA) O
- Human Factors Validation Study o
- Dimensional verification O
- O Liquid Leakage Testing
- Stress Cracking O
- Resistance to separation from axial load O
- Resistance to separation form unscrewing o
- Resistance to overriding O
- o Disconnection by unscrewing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2016
NeoMed. Inc. Melinda Harrison Smith, RAC, ASQ-CBA Director. Quality and Regulatory Affairs 100 Londonderry Court, Suite 112 Woodstock, GA 30188
Re: K152857
Trade/Device Name: NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal Tube and accessories Regulatory Class: II Product Code: PNR Dated: October 16, 2015 Received: October 19, 2015
Dear Melinda Harrison Smith,
This letter corrects our substantially equivalent letter of December 17, 2015.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
For Division
Douglas Silverstein -S 2016.09.29 0 -04'00'
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152857
Device Name
NeoMed NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible NeoSecure™ Tip Caps
Indications for Use (Describe)
NeoConnectTM Enteral Syringe with ENFit™ Connector:
The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.
NeoConnect™ NeoSecure™ Tip Cap:
A NeoConnect™ Enteral Syringe with ENFit™ connector accessory used to prevent fluid loss and contamination of syringe contents until ready for use.
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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TRADITIONAL 510(K) SUMMARY (21 CFR § 807.92)
| I. SUBMITTER | NeoMed, Inc.
100 Londonderry Court
Suite 112
Woodstock, GA 30188
Tel: 770-516-2225
Fax: 770-516-2448 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact: | Melinda Harrison Smith, RAC, CBA
mharrison@neomedinc.com |
| Date Prepared: | 16 December 2015 |
| Establishment
Registration Number: | 3006520777 |
II. DEVICE
Trade Name:
| Trade Name: | NeoMed NeoConnect™ Enteral Syringes with ENFit™
Connector and compatible NeoSecure™ Tip Caps |
|----------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Enteral Syringe |
| Classification Name: | Gastrointestinal tube and accessories (21 CFR § 876.5980) |
| Regulatory Class: | II |
| Product Code : | PIF |
PREDICATE DEVICE III.
- A. NeoMed NeoConnect™ Enteral Svringes with ENFit Connector (K143344)
- B. Covidien Kangaroo™ Enteral Feeding Syringes with ENFit Connector (K142128) These predicates have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The NeoMed NeoConnect™ Enteral Syringes with ENFit™ connector are standard piston style syringes consisting of a syringe barrel with an integral ENFit™ syringe tip, syringe plunger, syringe gasket, and supplied with or without a syringe tip cap. They are provided in varying sizes ranging from 0.5 mL to 100 mL nominal capacity. The integral syringe tip is a female ENFit™ connector which is compatible only with enteral access devices having ENFit™ male connectors to form a dedicated system that prevents wrong-route administration of fluids. They possess translucent barrels to provide visualization of fluid contents and volume.
4
The NeoConnect™ NeoSecure™ Tip Cap is supplied with the NeoConnect™ Enteral Syringe with ENFit™ connector or sold separately (sterile or non-sterile). It is an ENFit™ compatible closure cap for the tip of the syringe.
V. INDICATIONS FOR USE
This 510(k) changes the indications for use of K143344 to extend the patient population to include all ages and extend the use environment to include home use.
NeoConnect™ Enteral Syringe with ENFit™ connector:
The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.
NeoConnect™ NeoSecure™ Tip Cap:
A NeoConnect™ Enteral Syringe with ENFit™ connector accessory used to prevent fluid loss and contamination of syringe contents until ready for use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
The NeoMed NeoConnect™ Enteral Syringes with ENFit™ connector and the NeoSecure™ compatible Tip Caps have the same intended use, principles of operation, materials, and device designs as the predicate device K143344. The NeoMed NeoConnect™ Enteral Syringes with ENFit™ connector have similar indications for use as the predicate device K143344.
The NeoMed NeoConnect™ Enteral Syringes with ENFit™ connector have the same intended use, principles of operation, patient population and use environment as the predicate device K142128.
VII. PERFORMACE DATA (BENCH)
The following performance testing has been conducted:
- Finished Device .
- o Risk Analysis including design, user and process FMEA (Failure Modes and Effects Analysis) in accordance with EN ISO 14971:2012
- o Human Factors and Usability Validation
- Biocompatibility O
- · ISO 10993-5: Cytotoxicity
- . ISO 10993-10: Irritation and sensitization
- I ISO 10993-11: Acute Toxicity
- o Chemical Testing
- Extractables and Leachables .
- o Finished Device Verification Testing
- Critical Dimension verification ■
- Ink Adhesion
- ISO 7886
- Capacity Tolerance ●
- Graduated Scale .
5
- Piston Fit in Barrel .
- Air and Liguid Leakage Testing .
- Device Performance and Packaging Stability Testing (3 years) O
- Syringe Tip (ISO 80369-3 (ENFit™) female connector) ●
- Enteral Connector Misconnection Assessment O
- ENFit Connector Risk Management Report (including misconnections FMEA) O
- Human Factors Validation Study o
- Dimensional verification O
- O Liquid Leakage Testing
- Stress Cracking O
- Resistance to separation from axial load O
- Resistance to separation form unscrewing o
- Resistance to overriding O
- o Disconnection by unscrewing
CONCLUSIONS VIII.
The NeoMed NeoConnect™ Enteral Syringes with ENFit™ Connector and compatible tip caps are substantially equivalent to the NeoConnect™ Enteral Syringe with ENFit Connector (K143344) and the Covidien Kangaroo™ Feeding Syringes with ENFit Connector.