(120 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a simple guide wire, with no mention of AI or ML capabilities.
No
The device is described as a guide wire intended to stiffen a catheter to simplify its placement. Its function is purely mechanical to aid in the delivery of another device (the Edi Catheter), not to treat or prevent a disease or condition itself.
No
The device is a guidewire intended to stiffen a feeding catheter to simplify its placement, not to diagnose a condition.
No
The device description clearly states it is a physical guide wire made of stainless steel and PFTE, and the performance studies include mechanical strain and animal testing, 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 to stiffen a catheter to simplify its placement in a patient. This is a direct medical intervention on the patient's body.
- Device Description: The device is a physical tool (a guide wire) used to facilitate a medical procedure (catheter placement).
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue to provide diagnostic information. This device is used in vivo (inside the body) as a tool for a medical procedure.
N/A
Intended Use / Indications for Use
The guide wire is intended to be used as a stylet inserted into the MAQUET Edi Catheter to stiffen it in order to simplify its placement in the intended patient population comprising adult, pediatric, infant and neonatal patients.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The function of the Guide wire for Edi Catheter is to provide the necessary stiffness to facilitate the clinician in the placement of the MAQUET naso-gastric feeding tube called Edi Catheter. The guide wire is inserted as a stylet into the feeding lumen of the catheter prior to insertion of the Edi Catheter in the patient and is removed right after the placement of the Edi Catheter is completed.
The Guide wire for Edi Catheter consists of symmetrical stainless steel wire surrounded by a spiral stainless steel wire which is PFTE (polytetrafluoro- ethylene) coated. It also has soft and rounded ends. A safety ribbon runs thru the length of the Guide wire and is welded at each end to contain the coil of the spring. The Guide wire for Edi Catheter is provided in a non-sterile package and is for single use only. The individually packed Guide wires are delivered to the customer in an outer plastic bag containing five (5) Guide wires.
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
adult, pediatric, infant and neonatal 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 Guide wire for Edi Catheter has been subjected to performance testing which included: mechanical strain, biocompatibility, physical properties and animal testing. These tests have demonstrated that the device is as safe and as effective as the predicate legally marked devices.
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.
K831840, K894857, K960632, K920884
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
K101199
GETINGE GI
510(k) Summary
| Summary as required by section 807.92 | ||
|---|---|---|
| Date of preparation: | August 26th 2010 | |
| Sponsor/Manufacturer: | MAQUET Critical Care AB | |
| Röntgenvägen 2 | ||
| SE-171 54, Solna, Sweden | AUG 27 2010 | |
| Contact person for this | ||
| Submission: | Gunilla Lidin | |
| Direct phone: (011) 46 8 730 79 58 | ||
| gunilla.lidin@maquet.com | ||
| U.S. Contact Person: | Whitney G. Törning | |
| . Director of Regulatory Affairs | ||
| MAQUET, Inc. | ||
| 45 Barbour Pond Drive | ||
| Wayne, NJ 07470 | ||
| Phone: 973.709.7994 | ||
| Fax: 973.709.7016 | ||
| whitney.torning@MAQUET.com |
| Trade name | Model | Model
number |
|--------------------------------|------------------------------------------|-----------------|
| Guide wire for Edi
Catheter | For 6 French neonate/infant Edi Catheter | 66 71 270 |
| Guide wire for Edi
Catheter | For 8 French pediatric Edi Catheter | 66 71 272 |
| Guide wire for Edi
Catheter | For 8 French adult Edi Catheter | 66 71 292 |
- Note - The terms "stylet" and "guide wire" are to be considered interchangeable.
| Common Name | Classification Number | Class | Regulation Number |
|---|---|---|---|
| Catheter Placement Stylet | KNT | II | 21 CFR 876.5980 |
Device description including technological characteristics
The function of the Guide wire for Edi Catheter is to provide the necessary stiffness to facilitate the clinician in the placement of the MAQUET naso-gastric feeding tube called Edi Catheter. The guide wire is inserted as a stylet into the feeding lumen of the catheter prior to insertion of the Edi Catheter in the patient and is removed right after the placement of the Edi Catheter is completed.
The Guide wire for Edi Catheter consists of symmetrical stainless steel wire surrounded by a spiral stainless steel wire which is PFTE (polytetrafluoro- ethylene) coated. It also has soft and rounded ends. A safety ribbon runs thru the length of the Guide wire and is welded at each end to contain the coil of the spring. The Guide wire for Edi Catheter is provided in a non-sterile package and is for single use only. The individually packed Guide wires are delivered to the customer in an outer plastic bag containing five (5) Guide wires.
1
K101199
MAQUET GETINGE GROUP
Indications for Use
The guide wire is intended to be used as a stylet inserted into the MAQUET Edi Catheter to stiffen it in order to simplify its placement in the intended patient population comprising adult, pediatric, infant and neonatal patients.
Predicate Devices
The Guide wire for Edi Catheter is substantially equivalent in intended use, indications, technological characteristics and principles of operations as the following devices.
Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| FEEDING TUBE PLACEMENT STYLET (BIOSEARCH MEDICAL | |
| PRODUCTS, INC) | K831840 |
| PEDI-TUBE(R) STYLET (BIOSEARCH MEDICAL PRODUCTS, INC) | K894857 |
| KANGAROO FEEDING TUBE PLACEMENT STYLET (SHERWOOD | |
| MEDICAL CO) | K960632 |
| GUIDE WIRE, VARIOUS TYPES (ACME-MONACO CORP) (material & design only) | K920884 |
Substantial Equivalence Conclusion
- The indications for use are SE with Biosearch Medical Product's stylets (K831840 . & K894857) and Sherwood Medical stylet (K960632). Since the Edi Catheter is a naso-gastric feeding tube, the Guide wire for Edi Catheter is intended to stiffen the catheter in order to simplify catheter placement.
- The Guide wire of Edi Catheter's indication for use is different compared to the . identical AMCE Monaco Guide wire K920884 since their device is intended for cardiovascular use. Maquet Critical Care AB believes that using our Guide wire during placement of a naso gastric feeding tube is associated with less risk than using the identical device in the cardiovascular system, with regards to operation time, mechanical strain and biocompatibility considerations.
- The Guide wire function is SE to Biosearch Medical Product's stylets (K831840 & . K894857) and Sherwood Medical stylet (K960632).
- The Guide wire basic design is SE to AMCE Monaco Guide wire K920884, . Biosearch Medical Product's stylets (K831840 & K894857) and Sherwood Medical stylet (K960632).
- . . The Guide wire's material (Stainless steel) is SE with Biosearch Medical Product's stylets (K831840 & K894857) and Sherwood Medical stylet (K960632). Stainless steel has been used on market in this application for almost 30 years.
- The Guide wire's material (PTFE- Polytetrafluoro Ethylene) is SE with ACME . Monaco Corp. Guide wire K920884. PTFE- Polytetrafluoro Ethylene is a well known coating and has been used in medical devices for 40 years.
Performance testing
The Guide wire for Edi Catheter has been subjected to performance testing which included: mechanical strain, biocompatibility, physical properties and animal testing. These tests have demonstrated that the device is as safe and as effective as the predicate legally marked devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MAQUET Critical Care AB % Ms. Whitney Torning Director, Regulatory Affairs MAOUET Cardiovascular 45 Barbour Pond Drive WAYNE NJ 07470
AUG 27 2010
Re: K101199
Trade/Device Name: Guide Wire for Edi Catheter Regulation Number: 21 CFR $876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: August 13, 2010 Received: August 18, 2010
Dear Ms. Torning:
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
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/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,
Hubert Lehman MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Guide wire for Edi Catheter
Indications For Use: The guide wire is intended to be used as a stylet inserted into the MAQUET Edi Catheter to stiffen it in order to simplify its placement in the intended patient population comprising adult, pediatric, infant and neonatal patients.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
TINGE GI
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Helen Lewis
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number