(120 days)
Zevex Spike Pump Set LG0010
Not Found
No
The summary describes a simple mechanical adapter for connecting feeding containers and sets, with no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as an "Enteral Feeding Spike Adapter" used for dispensing liquid nutrients. It serves as a connection between a feeding container and an enteral set. It does not exert a therapeutic effect on the patient. Its function is to facilitate the delivery of nutrients, not to treat or diagnose a disease or condition.
No
The device is described as an "Enteral Feeding Spike Adapter" used for "dispensing liquid nutrients (feeding solutions)" and connecting to a patient's feeding tube. Its function is to facilitate the delivery of nutrients, not to diagnose a condition or disease.
No
The device description clearly states it is a physical "Enteral Feeding Spike Adapter" used for connecting feeding containers and enteral sets, 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 clearly described as dispensing liquid nutrients (feeding solutions) and connecting feeding containers to feeding tubes. This is a direct administration of substances into the body, not the examination of specimens taken from the body.
- Device Description: The device is described as a connection between a feeding container and an enteral set for administration. This aligns with its role in delivering nutrients, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting diseases, conditions, or states of health, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is entirely focused on the delivery of nutrients, which is an in vivo process.
N/A
Intended Use / Indications for Use
For connecting a universal enteral spike set to a feeding container having a SpikeRight™ connection port.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
Enteral Feeding Spike Adapter to be used for enteral administration. This device serves as a connection between the feeding container and the enteral set (gravity or pump fed).
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
Not Found
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)
Not Found
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.
Zevex Spike Pump Set LG0010
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 a stylized, cursive text logo that reads "Cedic". The font is bold and black, with exaggerated curves and flourishes. The letter "C" is large and prominent, with a sweeping curve that extends below the baseline. The "i" has a unique design, with a circular element above it, resembling a stylized dot or accent mark.
Cedic s.r.l. - Divisione Biome Via Liberazione, 63/11 20068 Peschiera Borromeo (Milano) - Italy Tel. +39 02.55.30.01.74 - Fax +39 02.55.30.14.87
Image /page/0/Picture/3 description: The image is a black and white logo for TUV Management Service. The logo is an octagon with the letters "TUV" in the center. Below the letters is the text "MANAGEMENT SERVICE". The text "ISO 9001" is on the left side of the octagon, and the text "ISO 13485" is on the right side of the octagon. There is a recycling symbol at the top of the octagon.
JAN 18 2008
18 September 2007
510(k) Summary
510(k) owner = Cedic Srl Via Liberazione 63/9 20068 Peschiera Borromeo Milano Italy
Contact Person = 1) Giancarlo Gagliardoni Cedic General Manager Via Liberazione, 63/9 20068 Peschiera Borromeo (MI) Italy Tel. +3902 5530 0174 ext 105 Fax. +3902 5530 1487 E-mail giancarlo@cedicsrl.it
- Riccardo Rossi Cedic Technical Director Via Liberazione, 63/9 20068 Peschiera Borromeo (MI) Italy Phone +39 02 5530 0174 ext 111 Fax +39 02 5530 1487 E-mail Riccardo.Rossi@cedicsrl.it
This summary was prepared on September 10th 2007.
Trade Name = Enteral Feeding Spike Adapter
Common Name = Accessory for Enteral Feeding Set
Classification Name = Tube, Gastrointestinal (and Accessories) (21 CFR 876.5980, Product Code KNT)
Predicate Device = Zevex Spike Pump Set LG0010, manufactured by Zevex, Inc, Salt Lake City, UT 84123, USA
Device Description = Enteral Feeding Spike Adapter to be used for enteral administration. This device serves as a connection between the feeding container and the enteral set (gravity or pump fed).
1
Cedice
-hiera Borromen (Milano) - Itals 02.55.30.01.74 - Fax +39 02.55.30.14.87
Image /page/1/Picture/2 description: The image is a black and white logo for TUV Management Service. The logo is an octagon shape with the letters "TUV" in the center. Below the letters are the words "MANAGEMENT SERVICE". The logo also includes the text "ISO 9001" on the left side and "ISO 13485" on the right side.
Materials Used: Gasket: 3-ply co-extruded material: Foamed core of In the food pathway = foamed EPE between 2 layers of solid PE-EVA Non-vented oval spike and revolving spike lock: ABS -HF 380 + dye Remafin violet PE43076356-ZT Bag fitment: Soft PVC - Nakan FMA919N Cap for spike and bag fitment: LDPE - Ribiene MM20 + Not in the food pathway = dye Remafin violet PE43076356-ZT Label: Lacquered paper 70 lb weight, printed both sides with red Pantone 185 C
Intended Use of Cedic Enteral Feeding Spike Adapter = For use in dispensing liquid nutrients (feeding solutions) by connecting an enteral feeding container to a patient's feeding tube.
Brief comparison with predicate device:
(1) The Cedic Enteral Feeding Adapter and Spike Adapter from the Zevex Enteral Feeding Set have the same intended use -- "For use in dispensing liquid nutrients (feeding solutions) by connecting an enteral feeding container to a patient's feeding tube";
(2) They have similar indications for use:
Cedic Enteral Feeding Spike Adapter: "For connecting a universal enteral spike set to a feeding container having a SpikeRight™ connection port. "
Zevex Enteral Feeding Set: [Referring to the entire set] "The devices in this product family are used to dispense liguid mutrients (feeding solution) at a user controllable rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or spike to connect to a pre-filled container. "
It is clear from this indications for use statement that the spike adapter within the Zevex set has the same indication for use as the Cedic Enteral Feeding Spike Adapter, with the exception that the Cedic adapter is designed to connect to a feeding container having the SpikeRight™ type of connection port, whereas the Zevex design is 'universal'.
(3) Both the Cedic spike adapter and Zevex spike adapter from within the feeding set have the same therapeutic purpose of connecting an enteral feeding container to enteral feeding tube, both spike adapters being parts of enteral feeding systems that contain the same types of devices;
2
Image /page/2/Picture/0 description: The image shows a stylized text logo that reads "Cedic". The text is in a cursive font, with the letters connected in a flowing manner. The letter "C" is capitalized and larger than the other letters, and there is a design element above the "i" that resembles a crescent moon or a stylized accent mark.
Image /page/2/Picture/2 description: The image shows the contact information for Cedic s.r.l. - Divisione Biomedicale. The address is Via Liberazione, 63/11, 20068 Peschiera Borromeo (Milano), Italy. The telephone number is +39 02.55.30.01.74 and the fax number is +39 02.55.30.14.87.
Image /page/2/Picture/3 description: The image shows a black and white logo for TUV Management Service. The logo is in the shape of an octagon with a smaller octagon inside. The letters "TUV" are in the center of the inner octagon. The text "ISO 9001" and "ISO 13485" are on the bottom left and right sides of the logo, respectively.
(4) Both the Cedic spike adapter and Zevex spike adapter from within the feeding set have similar principles of operation, providing a food pathway between an enteral feeding container and an enteral feeding tube;
(5) All materials used in the food pathways of both devices are USP Class VI, and any colorants used are approved by the FDA for food grade applications.
From this comparison, it is concluded that the Cedic Enteral Feeding Spike Adapter is "substantially equivalent" to the spike adapter from the Zevex Enteral Feeding Set.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The image is black and white and appears to be a scan or photocopy.
JAN 1 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Riccardo Rossi Technical Director / QA Manager Cedic Srl Via Liberazione, 63/9 Peschiera Borromeo Milan (Lomb) ITALY 20068
K072652 Re:
Trade/Device Name: Enteral Feeding Spike Adapter Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 14, 2008 Received: January 14, 2008
Dear Mr. Rossi:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Anclosure
5
510(k) Number (if known): to be assigned
Device Name: Enteral Feeding Spike Adapter
Indications for Use:
For connecting a universal enteral spike set to a feeding container having a SpikeRight™ connection port.
Prescription Use: ﮨﮯ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
KU+ 4 4 6 8
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulas Reemen
(Division Sign-Off) Division of Reproductive, Abdomina Radiological Devices 510(k) Number