(122 days)
Not Found
No
The description focuses on the physical characteristics and safety features of feeding tubes, with no mention of AI or ML.
No
The device, an enteral feeding tube, is used for administering liquid nutrition, which is a supportive function rather than directly treating a disease or condition therapeutically.
No
The device is described as an enteral feeding tube used for administering liquid nutritional media, not for diagnosing medical conditions.
No
The device description explicitly details physical components made of PolyUrethan and silicon, and describes their physical characteristics and connections, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of liquid nutritional media through the gastrointestinal tract. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and function of a feeding tube, which is used to deliver substances into the body. IVDs are used to examine specimens from the body to provide information about a patient's health.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVDs are devices used to perform tests on specimens such as blood, urine, or tissue, outside of the body, to diagnose diseases or other conditions. This device is clearly designed for direct patient care and administration of substances, not for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
MEDICINA enteral feeding tubes and their accessories are dedicated to the nasogastric and orogastric administration of liquid nutritional media, through the gastro intestinal tract of neonatal and pediatric patients.
Product codes
FPD, KNT
Device Description
MEDICINA feeding tubes is a complete range of devices intended to the gastro-intestinal feeding of patients, with liquid nutritional media. These feeding tubes are available in several sizes (diameter and length), and two materials: PolyUrethan (PUR) and silicon (SIL). They are equipped with connecting elements that does not incorporate a Luer, and thus eliminates the risk of inadvertently connecting the system to an Intra Veinous system. The MEDICINA feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections. Another benefit of the MEDICINA system is that it does not change the technique of the end-user, and therefore it does not require any special training.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastro intestinal tract (nasogastric and orogastric administration)
Indicated Patient Age Range
neonatal and pediatric 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)
The material of MEDICINA feeding tubes, that comes into contact with the patient, have been used for clinical purpose in enteral nutrition for a long time; they are non-irritant, non sensitizing and non cytotoxic, and found biocompatible according to ISO 10993. Risk Assessment was conducted in compliance with ISO 14971. Verification tests performed during the design process have shown that MEDICINA feeding tubes meets performance and safety requirements, and are substantially equivalent to the predicate devices.
The risk of misconnection is taken into account in design input of Medicina feeding tubes, with reference to EN 1615 (Enteral feeding catheters and enteral giving sets for single use and their connectors. Design and testing). The design of our connectors has been conducted to make the connection to intravenous devices mechanically impossible by greatly oversizing the dimension of Medicina tubes connectors. These connectors are bigger by approximately 1 mm compared to a standard IV 6% luer taper female connector. This has been demonstrated in our report RAES10042009 rev 02 attachment III EN1615 section 4.2.1. Being compliant with EN 1615 requirements, the Medicina connection systems are considered as fulfilling the requirements 4.1 and 4.2 of ANSI ID54:1996.
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.
0
| Section 5 - 510(k) summary | Rev 2.0 | |||
|---|---|---|---|---|
| Medicina | ||||
| enteral feeding tubes and accessories | ||||
| Document reference | Date | Status | Writer | 510(k) number |
| AQ022-3-00 | 26 may.-2010 | Final | B Daurelle | K100366 |
HISTORY OF MODIFICATIONS
| Date | Summary of changes | version # |
|---|---|---|
| 28 jan.-10 | Initial edition | 1.0 |
| 26 may -10 | Addition of a § about the risk of misconnection between the enteral feeding | |
| tube with a 6% luer taper connector used in intravascular device | 2.0 |
Section 5 510k) Summary
JUN 1 4 2010
3
| Applicant : | MAXTER Catheters
Village d'entreprise St Henri II
Rue Anne Gacon
13016 Marseille
FRANCE | |
|--------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact : | Bernard DAURELLE
CEO
Tel + 33 (0)4 91 46 73 05
Fax + 33 (0)4 91 46 73 48
bdaurelle@maxter-catheters.com | |
| Device : | Trade name:
Common name:
Regulation number:
Product code:
Classification name:
Class: | MEDICINA
Enteral feeding tubes and accessories
21 CFR 876.5980
FPD
Gastrointestinal tubes and accessory devices
II |
| Predicate devices: | 510k) number:
Manufacturer:
Trade name:
510k) number:
Manufacturer:
Trade name: | K060944
Vygon Corporation
Nutrisafe 2
K072881
Neomed
Neomed Enteral Feeding tube |
| | 510k) number:
Manufacturer:
Trade name: | K082238
Neomed
Neomed Polyurethan Enteral Feeding tube |
1
MEDICINA feeding tubes is a complete range of devices Device description: intended to the gastro-intestinal feeding of patients, with liquid nutritional media. These feeding tubes are available in several sizes (diameter and length), and two materials: PolyUrethan (PUR) and silicon (SIL). They are equipped with connecting elements that does not incorporate a Luer, and thus eliminates the risk of inadvertently connecting the system to an Intra Veinous system. The MEDICINA feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections. Another benefit of the MEDICINA system is that it does not change the technique of the end-user, and therefore it does not require any special training
| TABLE OF REFERENCES | |
|---|---|
| DESCRIPTION | REFERENCE |
| Feeding tubes | MGx/yy, MGx/yyW, |
| MGx/yyWSIL | |
| Syringes and syringes | |
| accessories | MDxx |
| Accessories (sets and | |
| connectors) | CxxxM, MAxx, MCxx, MFxxx |
| MKxx, MMxx, MNxx, , NPxx |
Intended use:
MEDICINA enteral feeding tubes and accessories are dedicated to the nasogastric and orogastric administration of liquid nutritional media, through the gastro intestinal tract of neonatal and pediatric patients.
Comparison with the predicates:
There are no differences between MEDICINA feeding tubes and accessories and the predicate devices; they have the same intended use and same method of use, they are made of the same material. The bench testing has demonstrated that MEDICINA feeding tubes are functionally equivalent to Nutrisafe2 and Neomed Enteral feeding tubes.
Assessment of performance and safety data:
The material of MEDICINA feeding tubes, that comes into contact with the patient, have been used for clinical purpose in enteral nutrition for a long time; they are non-irritant, non sensitizing and non cytotoxic, and found biocompatible according to ISO 10993. Risk Assessment was conducted in compliance with ISO 14971. Verification tests performed during the design process have shown that MEDICINA feeding tubes meets performance and safety requirements, and are substantially equivalent to the predicate devices.
Risk of misconnection between the enteral feeding tube with a 6% luer taper connector used in intravascular device
The risk of misconnection is taken into account in design input of Medicina feeding tubes, with reference to EN 1615 (Enteral feeding catheters and enteral giving sets for single use and their connectors. Design and testing). The design of our connectors has been conducted to make the connection to intravenous devices mechanically impossible by greatly oversizing the dimension of Medicina tubes connectors. These connectors are bigger by approximately 1 mm compared to a standard IV 6% luer taper female connector. This has been
2
demonstrated in our report RAES10042009 rev 02 attachment III EN1615 section 4.2.1. (copy attached ). Being compliant with EN 1615 requirements, the Medicina connection systems are considered as fulfilling the requirements 4.1 and 4.2 of ANSI ID54:1996.
Conclusion:
Based on performance evaluation and risk assessment, the MEDICINA feeding tubes and accessories can be declared as meeting safety and performance requirements, with respect of their intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002
Mr. Bernard Daurelle CEO Maxter Catheters Village D'Enterprises Saint Henri II, Rue Anne Gacon Marseille 13016 FRANCE
JUN 1 4 2010
Re: K100366
Trade/Device Name: MEDICINA Enteral Feeding tubes and accessories Regulation Number: 21 CFR 8876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product code: KNT Dated: May 27, 2010 Received: June 1, 2010
Dear Mr. Daurelle:
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.
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 of medical device-related
4
Page 2 –
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.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| Section 4 – Indications for use | Rev 2.0 | Image: Maxiter catheters logo | ||
|---|---|---|---|---|
| Medicina | ||||
| enteral feeding tubes and accessories | ||||
| Document reference | Date | Status | Writer | 510(k) number |
| AQ022-3-00 | 10 june.-2010 | Final | B Daurelle | K100366 |
HISTORY OF MODIFICATIONS
| Date | Summary of changes | version # |
|---|---|---|
| 28 jan.-10 | Initial edition | 1.0 |
| 10 june -10 | Brand name and common name clarification | 2.0 |
-
—Not known (Initial submission) 510 (k) number :
K100366 -
MEDICINA Enteral feeding tubes and accessories Device name :
MEDICINA enteral feeding tubes and their accessories are dedicated to Indications for use : the nasogastric and orogastric administration of liquid nutritional media, through the gastro intestinal tract of neonatal and pediatric patients.
Prescription Use ☑ (21CFR part 801 Subpart D).
:
AND/OR
Over the counter Use ■ (21CFR part 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heidi Lemon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number