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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called "Guide wire for Edi Catheter" by MAQUET Critical Care AB. It aims to establish substantial equivalence to existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific thresholds for metrics like accuracy, sensitivity, or specificity. This is because the device is a physical medical instrument (a guide wire/stylet) and not a diagnostic or AI-powered imaging device. Therefore, the "acceptance criteria" are related to its functional performance, safety, and equivalence to predicate devices, rather than statistical performance metrics.

The document states:

Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance / Evidence
Safety and Effectiveness	"These tests have demonstrated that the device is as safe and as effective as the predicate legally marked devices."
Mechanical Integrity/Performance	"Performance testing which included: mechanical strain..."
Biocompatibility	"Performance testing which included: ...biocompatibility..."
Physical Properties	"Performance testing which included: ...physical properties..."
Equivalent Intended Use	"The indications for use are SE [substantially equivalent] with Biosearch Medical Product's stylets (K831840 . & K894857) and Sherwood Medical stylet (K960632)."
Equivalent Function	"The Guide wire function is SE to Biosearch Medical Product's stylets (K831840 & . K894857) and Sherwood Medical stylet (K960632)."
Equivalent Basic Design	"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)."
Equivalent Materials	"The Guide wire's material (Stainless steel) is SE with Biosearch Medical Product's stylets... "The Guide wire's material (PTFE- Polytetrafluoro Ethylene) is SE with ACME . Monaco Corp. Guide wire K920884."

2. Sample Size Used for the Test Set and the Data Provenance

The document mentions "performance testing which included: mechanical strain, biocompatibility, physical properties and animal testing."

Test Set Sample Size: The exact sample sizes for each type of performance test (mechanical strain, biocompatibility, physical properties, animal testing) are not specified in this 510(k) summary.
Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given that animal testing is mentioned, it would be prospective data collection, but details are lacking.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable/not provided in the context of this device. A guide wire/stylet for catheter placement does not typically involve a "ground truth" established by experts in the same way an AI diagnostic algorithm would. The safety and effectiveness are evaluated through engineering tests and biological assessments, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like "2+1, 3+1" are typically used for establishing ground truth in human-AI performance studies, which is not relevant for this physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable/not provided. An MRMC study is relevant for AI-assisted diagnostic devices. This submission is for a physical medical instrument (guide wire).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable/not provided. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Engineering Specifications/Standards: For mechanical strain and physical properties (e.g., stiffness, flexibility, dimensions).
Biocompatibility Standards: For assessing material safety in biological environments.
Animal Testing Outcomes: For evaluating the device's interaction with living tissue, though specific outcomes are not detailed.
Comparison to Predicate Devices: The primary "ground truth" for regulatory approval is proving substantial equivalence to already legally marketed devices, demonstrating similar safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is not an AI algorithm; therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as point 8.

Summary

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K101199

GETINGE GI

510(k) Summary

Summary as required by section 807.92
Date of preparation:	August 26th 2010
Sponsor/Manufacturer:	MAQUET Critical Care ABRöntgenvägen 2SE-171 54, Solna, Sweden	AUG 27 2010
Contact person for thisSubmission:	Gunilla LidinDirect phone: (011) 46 8 730 79 58gunilla.lidin@maquet.com
U.S. Contact Person:	Whitney G. Törning. Director of Regulatory AffairsMAQUET, Inc.45 Barbour Pond DriveWayne, NJ 07470Phone: 973.709.7994Fax: 973.709.7016whitney.torning@MAQUET.com

Trade name	Model	Modelnumber
Guide wire for EdiCatheter	For 6 French neonate/infant Edi Catheter	66 71 270
Guide wire for EdiCatheter	For 8 French pediatric Edi Catheter	66 71 272
Guide wire for EdiCatheter	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

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K101199

MAQUET GETINGE GROUP

Indications for Use

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 MEDICALPRODUCTS, INC)	K831840
PEDI-TUBE(R) STYLET (BIOSEARCH MEDICAL PRODUCTS, INC)	K894857
KANGAROO FEEDING TUBE PLACEMENT STYLET (SHERWOODMEDICAL 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.

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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

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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

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K101199

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

Regulation Number and Section

§ 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.