(139 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a standard syringe, with no mention of AI or ML.
No
The device is described as a dispenser, measuring device, and fluid transfer device used to deliver fluids. It does not exert any direct therapeutic action on the body.
No
The device is described as a dispenser, measuring device, and fluid transfer device used to deliver fluids into the body. This function does not involve diagnosing conditions or identifying diseases.
No
The device description clearly outlines physical components (syringe barrel, plunger, gasket, tip cap) and the performance studies focus on physical characteristics and functionality of these components, not software.
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 for dispensing, measuring, and transferring fluids into the body via extension sets and feeding tubes. This is a direct interaction with the patient's body for therapeutic or nutritional purposes.
- Device Description: The description details a standard syringe with an ENFit connector designed for enteral feeding. This is a delivery mechanism for substances into the gastrointestinal tract.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to analyze blood, urine, tissue, etc., outside of the body.
Therefore, the NeoMed NeoConnect™ Enteral Syringe is a medical device used for administering fluids to patients, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
PNR
Device Description
The NeoMed NeoConnect™ Enteral Syringes are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied with a syringe tip cap. They are provided in varying sizes ranging from 0.5ml to 100ml nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with feeding tubes and extension sets that have 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.
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
neonatal and small pediatric patients.
Intended User / Care Setting
Hospital, Disposable and for single patient use only
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 was conducted on the NeoConnect™ Enteral Syringe:
- Finished Device
- Risk Analysis including design, user and process FMEA (Failure Modes and Effects Analysis) in accordance with EN ISO 14971:2012
- Human Factors and Usability Validation
- Biocompatibility
- ISO 10993-5: Cytotoxicity
- ISO 10993-10: Irritation and sensitization
- ISO 10993-11: Acute Toxicity
- Chemical Testing
- Extractables and Leachables
- Finished Device Verification Testing
- Critical Dimension verification
- Ink Adhesion
- Capacity Tolerance
- Graduated Scale
- Piston Fit in Barrel
- Air and Liquid Leakage Testing
- Syringe Tip (ENFit connector)
- Enteral Connector Misconnection Assessment
- ENFit Connector Risk Management Report (including misconnections FMEA)
- Human Factors Validation Study
- Dimensional verification
- Liquid Leakage Testing
- Stress Cracking
- Resistance to separation from axial load
- Resistance to separation form unscrewing
- Resistance to overriding
- Disconnection by unscrewing
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its 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
K143344 Re:
Trade/Device Name: NeoMed NeoConnect™ Enteral Syringes with ENFit Connector Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PNR Dated: March 11, 2015 Received: March 13, 2015
Dear Melinda Harrison Smith,
This letter corrects our substantially equivalent letter of April 7, 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 for use bared in the 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 I he goneral ocharing 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
Page 2 - Melinda Harrison Smith, RAC, ASQ-CBA
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/Resourcesfor You/Industry/default.htm.
Sincerely,
For Division
Douglas Silverstein -S 2016.09. -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) K143344
Device Name
NeoMed NeoConnect™ Enteral Syringes with ENFit Connector
Indications for Use (Describe)
The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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: | 18 November 2014 |
| Establishment
Registration Number: | 3006520777 |
ll. DEVICE
| Trade Name: | NeoConnect™ Enteral Syringes |
|---|---|
| Common Name: | Enteral Syringe |
| Classification Name: | Gastrointestinal tube and accessories (21 CFR § 876.5980) |
| Regulatory Class: | II |
| Product Code : | PIF |
lll. PREDICATE DEVICE
NeoMed Oral / Enteral Syringe (0.5ml to 100ml) (K122373) This predicate had not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The NeoMed NeoConnect™ Enteral Syringes are standard piston style syringes consisting of a syringe barrel with integral ENFit syringe tip, syringe plunger, syringe gasket, and supplied with a syringe tip cap. They are provided in varying sizes ranging from 0.5ml to 100ml nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with feeding tubes and extension sets that have 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.
V. INDICATIONS FOR USE
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 via extension sets and feeding tubes in neonatal and small pediatric patients.
4
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
| Feature | PREDICATE DEVICE | SUBJECT DEVICE |
|---|---|---|
| Indications for Use / | ||
| Intended Use | ||
| Statement | The device is indicated for use as | |
| a dispenser, a measuring device | ||
| and an oral fluid transfer device. It | ||
| is used to inject fluids into the body | ||
| via extension sets and feeding | ||
| tubes in neonatal and small | ||
| pediatric patients. | 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 via | ||
| extension sets and feeding tubes in | ||
| neonatal and small pediatric | ||
| patients. | ||
| Patient Population / | ||
| Environment of Use | Neonates and Small Pediatrics/ | |
| Hospital, Disposable and for single | ||
| patient use only | Neonates and Small Pediatrics/ | |
| Hospital, Disposable and for single | ||
| patient use only | ||
| Description of Device | An oral / enteral syringe consisting | |
| of a syringe barrel with integral tip | ||
| (tapered), plunger, gasket, barrel | ||
| lubricant and supplied with a | ||
| syringe tip cap. | An enteral syringe consisting of a | |
| syringe barrel with integral tip | ||
| (ENFit), plunger, gasket, barrel | ||
| lubricant and supplied with a | ||
| syringe tip cap. | ||
| Syringe Type | Oral / Enteral Syringe | Enteral Syringe |
| Principle of Operation | Piston Style Syringe | Piston Style Syringe |
| Syringe Tip Type | Tapered | ENFit |
| (Dimensional compliance to | ||
| AAMI/CN3:2014 (PS) Part 3 Table | ||
| B.2 Female Enteral Small-Bore | ||
| Connector). | ||
| Syringe Sizes | ||
| (nominal volumes) | 0.5ml to 100ml sizes | 0.5ml to 100ml sizes |
| Syringe Barrel with | ||
| integral syringe tip and | ||
| volume graduations | Barrel - Polypropylene, class VI | |
| Graduation Ink - Orange | Barrel - Polypropylene, class VI | |
| Graduation Ink - Orange or Purple | ||
| Integral Syringe Tip | ||
| Flexural Modulus | 9500 Kg/cm² (932 MPa) | 9500 Kg/cm² (932 MPa) |
| Syringe Plunger | Inert Polypropylene, class VI | |
| White Colorant | Inert Polypropylene, class VI | |
| White Colorant | ||
| Syringe Gasket | Silicone, Class VI, Black Colorant | Silicone, class VI, Black Colorant |
| Syringe Tip Cap | Inert Polypropylene, class VI | |
| Orange Colorant | Inert Polypropylene, class VI | |
| Orange or Purple Colorant | ||
| Barrel Lubricant | Polydimethylsiloxane class VI | Polydimethylsiloxane class VI |
| Packaging Material | Tyvek or medical grade paper / | |
| film primary pouch, Double Flute | ||
| paper corrugate case box | Tyvek or medical grade paper / film | |
| primary pouch, Double Flute paper | ||
| corrugate case box | ||
| Sterilization Method, | ||
| SAL | Ethylene Oxide (EO), 10-6 SAL | Ethylene Oxide (EO), 10-6 SAL |
| Human Factors and | ||
| Usability | Design Validation | Design Validation |
| Device Master File #MAF2258 | ||
| Risk Analysis | Device Risk Assessment including | |
| Design and User FMEA | Device Risk Assessment including | |
| Design and User FMEA | ||
| Device Master File #MAF2258 |
5
VII. PERFORMACE DATA (BENCH)
The following performance testing was conducted on the NeoConnect™ Enteral Syringe:
-
. Finished Device
O -
Risk Analysis including design, user and process FMEA (Failure Modes and o 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 .
- . ISO 10993-11: Acute Toxicity
-
Chemical Testing o
- Extractables and Leachables .
- Finished Device Verification Testing
- Critical Dimension verification .
- . Ink Adhesion
- =
- Capacity Tolerance ●
- Graduated Scale ●
- Piston Fit in Barrel .
- Air and Liquid Leakage Testing ●
-
Syringe Tip (ENFit connector) ●
- Enteral Connector Misconnection Assessment o
- ENFit Connector Risk Management Report (including misconnections FMEA) O
- Human Factors Validation Study o
- Dimensional verification O
- Liquid Leakage Testing O
- O Stress Cracking
- Resistance to separation from axial load O
- Resistance to separation form unscrewing O
- Resistance to overriding O
- Disconnection by unscrewing o
CONCLUSIONS VIII.
The NeoMed NeoConnect™ Enteral Syringes are substantially equivalent to the NeoMed Oral / Enteral Syringe (K122373).