(52 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical properties of the catheter kit, with no mention of AI or ML capabilities.
No.
The device is described as an "aid for catheterization" and is used for "performing parenteral infusional or nutritional therapy and to withdraw blood samples," not for treating a disease or condition itself.
No
The device is a central venous catheter kit used for therapeutic purposes (parenteral infusion, nutritional therapy) and to withdraw blood samples, which is a collection activity, not a diagnostic interpretation. Its primary function is to provide access to the central venous system, not to diagnose a condition.
No
The device description clearly outlines physical components (syringe/inserter, guidewire, catheter) and performance studies related to physical properties (tensile strength, bond strength, etc.), indicating it is a hardware medical 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 catheterization of the superior vena cava for parenteral therapy, nutritional therapy, and blood withdrawal. These are all procedures performed on the patient's body, not on samples from the patient's body for diagnostic purposes.
- Device Description: The device components (syringe/inserter, guidewire, catheter) are all designed for accessing and delivering substances into or withdrawing substances from the central venous system in vivo.
- No Mention of Diagnostic Testing: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on the use of this device.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a medical device used for therapeutic and procedural purposes within the body.
N/A
Intended Use / Indications for Use
The EmmeBi Lepstep Central Venous Catheter Kit is intended for short term use as an aid for catheterization of the superior vena cava for the purpose of performing parenteral infusional or nutritional therapy and to withdraw blood samples where the peripheral venous system is not practicable.
Product codes
FOZ
Device Description
The Emmebi Central Venous Catheter Kit is comprised of three main components; 1. Syringe/inserter 2. guidewire (J-Wire) and 3. central venous catheter. The catheter kit is intended for short term use as an aid to access the central venous system.
The Syringe/inserter simplifies the technique used by physicians to perform catheterization.
The guidewire (J-Wire) is designed to fit inside a percutaneous catheter for the purpose of directing the catheter being introduced.
The catheters are available in 14-> 22 gauge sizes with 4, 5, 6 and 7 Fr. diameter sizes in either a single, double or triple lumen. Circular lumen passages have soft flexible tapered tips. Lumens are connected to extensions containing hubs and catheter fixing wings. The lumens are printed with depth markings. Catheter markings are radiopaque.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superior vena cava
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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
Performance data for the Emmebi Central Venous Catheter Kit with Lestep® Introducer including tensile strength, bond strength test, bend test, air and liquid leakage, performance demonstrate that this device is substantially equivalent to legally marketed devices intended for central venous catheterization.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains a logo with the text "ENICOL" in a stylized font. Below the logo, there is the text "MEDICAL TECHNOLOGICAL APPLICATIONS" enclosed in a rounded rectangle. The text is in all caps and appears to be part of the company's branding or description.
FEB - 4 2005
PREMARKET NOTIFICATION 510(K) SUMMARY
T043446
P. 1 of 2
SUMMARY OF SAFETY AND EFFICACY
A. The submitter's name, address, telephone number, contact person and date of preparation.
| Submitter's Name: | Emmebi, srl |
|---|---|
| Submitter's Address: | Via Albettoniera, 50/E |
| 35030 Bastia Di Rovolon | |
| Submitter's Phone Number | (614) 501-9340 |
| (800) 338-0855 | |
| Contact Person: | Marjorie Bush |
| Contact Person's Phone Number: | (616) 957-1677 |
| Date of Preparation: | 11/01/04 |
B. The name of the device including trade or proprietary name if applicable, the common or usual name and the classification name.
| Name: | Central Venous Catheter with
Lestep® Introducer |
|----------------------|-----------------------------------------------------------|
| Brand: | EmmeBi Central Venous Catheter with
Lestep® Introducer |
| 1. Common Name: | Emmebi Central Venous Catheter |
| Classification Name: | Intravascular Catheter |
| 2. Common Name: | Guidewire |
| Classification Name: | Catheter guidewire |
| 3. Common Name: | Lestep® Introducer |
| Classification Name: | Intrroducer, Catheter |
C. An identification of the predicate or legally marketed device(s) to which substantial equivalence is claimed:
| Predicate Device: Arrow International | Arrowg⁺ard Blue Plus Multi-Lumen
Central Venous Catheter |
|------------------------------------------------|-------------------------------------------------------------|
| Predicate Device: Cook Critical Care | Triple Lumen Central Venous
Catheter |
| Predicate Device: Medcomp | Quad Lumen Central Venous
Catheter |
| Predicate Guidewire: Lake Region
Mfg., Inc. | K963320 |
| Predicate Introducer Raulerson
Syringe | K971281 – One Step Guidewire
Insertion Bulb Needle |
| Predicate Introducer Micro Stick | Unknown |
1
D. A description of the device that is the subject of the Premarket Notification submission:
The Emmebi Central Venous Catheter Kit is comprised of three main components; 1. Syringe/inserter 2. guidewire (J-Wire) and 3. central venous catheter. The catheter kit is intended for short term use as an aid to access the central venous system.
The Syringe/inserter simplifies the technique used by physicians to perform catheterization.
The guidewire (J-Wire) is designed to fit inside a percutaneous catheter for the purpose of directing the catheter being introduced.
The catheters are available in 14-> 22 gauge sizes with 4, 5, 6 and 7 Fr. diameter sizes in either a single, double or triple lumen. Circular lumen passages have soft flexible tapered tips. Lumens are connected to extensions containing hubs and catheter fixing wings. The lumens are printed with depth markings. Catheter markings are radiopaque.
- E. Statement of intended use of the device: The EmmeBi Central Venous Catheter with Lestep® Introducer is intended for short term use as an aid for the catheterization of the superior vena cava for the purpose of performing parenteral infusional or nutritional therapy and to withdraw
- F. Statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in 510K submission:
blood samples where the peripheral venous system is not practicable.
The technological characteristics of Emmebi's Central Venous Catheter Kit with Lestep® Introducer are substantially equivalent to the predicate devices in terms of intended use, insertion method, anatomical location, design, materials, performance, manufacturing process and sterilization method.
- G. Performance data for the Emmebi Central Venous Catheter Kit with Lestep® Introducer including tensile strength, bond strength test, bend test, air and liquid leakage, performance demonstrate that this device is substantially equivalent to legally marketed devices intended for central venous catheterization.
Andy Yaden
David L. Yoder Statutory Agent/EmmeBi, srl
1/18/05 Date
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 4 2005
Emmebi SRL C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K043446
Trade/Device Name: Emmebi Central Venous Catheter Kit with Lestep® Introducer Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: January 18, 2005 Received: January 21, 2005
Dear Mr. Devine:
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.
3
Page 2 - Mr. Devine
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 and iboms (s 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.
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), rt you dontact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(K) Number: K043446
Device Name: Emmebi Central Venous Catheter Kit with Lestep® Introducer
Indications for Use:
The EmmeBi Lepstep Central Venous Catheter Kit is intended for short term use as an aid for catheterization of the superior vena cava for the purpose of performing parenteral infusional or nutritional therapy and to withdraw blood samples where the peripheral venous system is not practicable.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a Physician.
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Over-the-Counter Use:
Cinton V. King
Insion Sign-Off) Offision of Anesthesiology, General Hospital, Intection Control, Dental Devices
2(k) Number K1943446