Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm

K153461 · Maquet Critical Care AB · KNT · Dec 11, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K153461
• Device Name: Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
• Applicant: Maquet Critical Care AB
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Dec 11, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Guide wire functions as stylet for Maquet Edi Catheter; provides stiffness to facilitate nasogastric feeding tube placement. Clinician inserts wire into feeding lumen prior to catheter insertion; removes wire immediately after placement. Device consists of stainless steel core wire, PTFE-coated spiral stainless steel wire, and safety ribbon. Used in clinical settings by healthcare providers. Benefits patient by simplifying catheter insertion process. Subject device differs from predicate only by removal of PFOA from coating manufacturing process.

Clinical Evidence

No clinical data. Bench testing only: biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity per ISO 10993-1) and functional verification (fracture, flex, corrosion resistance, particulate matter).

Technological Characteristics

Materials: stainless steel wire, PTFE-coated spiral stainless steel, safety ribbon. Form factor: symmetrical wire with soft, rounded ends. Single-use, non-sterile. Biocompatibility testing per ISO 10993-1.

Indications for Use

Indicated for adult, pediatric, infant, and neonatal patients requiring placement of a Maquet Edi Catheter.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Guide wire for Edi Catheter (K101199)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> 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: [phone] Fax: [phone] Registration number: 8010042

Contact Persons for this submission:

Mirva Boothe Phone; (011) 46 10 335 7864 Email: [e-mail]

USA Contact:

Linda Slutzky Regulatory Affairs Specialist II Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, NJ 07470 Direct 973-709-7973 Fax [phone] E-mail: [e-mail] Registration number: 1225700

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#### Trade name

Guide wire for Edi Catheter

#### Device Classification

| Common Name | Classification<br>Product Code | Class | Regulation<br>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.