(10 days)
Not Found
No
The device description and intended use clearly define a purely mechanical guide wire used for stiffening a catheter, with no mention of any computational or data-driven capabilities.
No.
The device's sole purpose is to stiffen a catheter to facilitate its placement, and it is removed immediately after placement. It does not exert any therapeutic action on the patient.
No
The device is a guide wire used to stiffen a catheter for easier placement. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly details a physical guide wire made of stainless steel and PTFE, which is a hardware component.
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 aid in its placement within a patient. This is a direct interaction with the patient's body for a therapeutic or diagnostic procedure, not for examining specimens in vitro (outside the body).
- Device Description: The description details a physical guide wire used to facilitate the insertion of a catheter. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostics.
The device is clearly intended for use in vivo (within the living body) to assist in a medical procedure.
N/A
Intended Use / Indications for Use
The guide wire is intended to be used as a stylet 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 Catheters is to provide the necessary stiffness to facilitate the clinicians in the placement of the Maquet Critical Care AB nasogastric feeding tube called Edi Catheter. The guide wire is inserted as a stylet into the feeding lumen of the Edi 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 PTFE (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 following biocompatibility tests has been performed according to Annex A in ISO 10993-1 and Attachment A in ODE General Program Memorandum #G95-1:
- Cytotoxicity
- Sensitization ●
- Intracutaneous reactivity ●
Other functional verification activities performed are;
- . Fracture and Flex testing
- Corrosion resistance ●
- Particulate matter
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.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 11, 2015
Maquet Critical Care AB % Linda Slutzky Regulatory Affairs Specialist II Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, NJ 07470
Re: K153461
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: November 30, 2015 Received: December 1, 2015
Dear Linda Slutzky,
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.
1
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" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Benjamin R. Fisher -S
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) K153461
Device Name Guide wire for Edi Catheter
Indications for Use (Describe)
The guide wire is intended to be used as a stylet 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Maquet Getinge Group. The word "MAQUET" is in large, bold, blue letters. Below it, "GETINGE GROUP" is written in smaller, gray letters. The logo is simple and professional.
510(K) SUMMARY (As required by section 807.92(c))
510(k) prepared November 26, 2015
Submitters Name & Address Maquet Critical Care AB Röntgenvägen 2 SE-171 54 Solna, Sweden Tel: (011) 46 10 335 73 00 Fax: (011) 46 10 335 78 38 Registration number: 8010042
Contact Persons for this submission:
Mirva Boothe Phone; (011) 46 10 335 7864 Email: mirva.boothe@maquet.com
USA Contact:
Linda Slutzky Regulatory Affairs Specialist II Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, NJ 07470 Direct 973-709-7973 Fax 973-807-9207 E-mail: linda.slutzky@maquet.com Registration number: 1225700
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Trade name
Guide wire for Edi Catheter
Device Classification
| Common Name | Classification
Product Code | Class | Regulation
Number |
|---------------------------|--------------------------------|-------|----------------------|
| Catheter placement stylet | KNT | II | 21 CFR 876.5980 |
Predicate Device Information
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| Guide wire for Edi Catheter | K101199 |
Indication 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.
General Description
The function of the Guide wire for Edi Catheters is to provide the necessary stiffness to facilitate the clinicians in the placement of the Maquet Critical Care AB nasogastric feeding tube called Edi Catheter. The guide wire is inserted as a stylet into the feeding lumen of the Edi 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 PTFE (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.
Changes from the previous notification
The predicate device's coating was manufactured with a processing aid containing a low level of PFOA (Perfluorooctanoic acid) used in the polymerization of the coating. The processing aid should not be present in the finished coating of the predicate device since the PFOA is completely dissipated at the point the coating is cured.
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Image /page/5/Picture/0 description: The image shows the logo for Maquet Getinge Group. The word "MAQUET" is written in large, bold, blue letters. Below the word "MAQUET" is the phrase "GETINGE GROUP" written in smaller, gray letters. The logo is simple and professional.
The change in this submission is that the PFOA is removed from the manufacturing process for the coating of the subject device. This change is performed due to that the processing aid PFOA has been mandated by the US government (EPA) to be removed from industrial use.
Non-clinical testing and performance
The following biocompatibility tests has been performed according to Annex A in ISO 10993-1 and Attachment A in ODE General Program Memorandum #G95-1:
- Cytotoxicity
- Sensitization ●
- Intracutaneous reactivity ●
Other functional verification activities performed are;
- . Fracture and Flex testing
- Corrosion resistance ●
- Particulate matter
Comparison of the intended use
The intended use for the subject device is identical with the intended use of the predicate device.
Comparison of the technology used
The Guide wire for Edi Catheter has the same technical specifications and performance as the cleared Guide wire for Edi Catheters, K101199. The only difference is the updated coating process.
Conclusion
Maquet Critical Care AB believes that the subject Guide wire for Edi Catheter is substantially equivalent to the predicate Guide wire for Edi Catheters in application K101199 regarding the intended use of the device, the indication for use and the fundamental technology of the device.