The Faller Trocar is used to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.

Device Description

The Faller Trocar is a surgical tool, made of either stainless steel or approved plastic, with a barbed section on one end and a sharp tip on the other end. The device is curved so that the physician using it can follow a tunnel path to lead the catheter from the initial catheter implantation site to the exit-site in an ante-grade manner.

AI/ML Overview

This document describes a 510(k) premarket notification for the Faller Trocar Catheter Tunneling Device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested data points (like sample sizes, ground truth establishment, MRMC studies, or standalone algorithm performance) are not applicable or not provided in the document for this type of medical device submission.

Here's an analysis of the provided information in relation to your request:

1. Table of acceptance criteria and the reported device performance:

Specific numerical acceptance criteria and reported performance metrics (e.g., sensitivity, specificity, AUC) are not provided in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through material, design, and functional comparisons, along with a historical safety record of predicate devices.

Acceptance Criteria (Not Explicitly Stated as Numerical)	Reported Device Performance (as demonstrated by comparison to predicates)
Ability to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site.	Functions as designed and intended, similar to predicate devices.
Separation of tissue as it leads the catheter through to the skin exit-site.	Functions as designed and intended, similar to predicate devices.
Safe and effective operation during indicated use.	As safe and effective as predicate devices with a proven record of more than twenty years of successful use.
Barbed ends for catheter attachment function correctly.	Barbed ends were tested in-house with acceptable comparisons to predicate devices.
Sharp tip for opening tunnel path functions correctly.	Cutting tip was tested in-house with acceptable comparisons to predicate devices.
Material compatibility and durability.	Made of the same materials (stainless steel or approved plastic) as predicate devices.
Similar shape and bend (for stainless steel version).	Similar to predicate Covidien's Trocar (Faller Stylet).
Similar curvature (for plastic version).	Similar to predicate Medigroup's Tunnelor® Tool.

2. Sample size used for the test set and the data provenance:

Test set sample size: Not applicable. The submission does not describe a clinical study with a "test set" in the context of an AI/ML device. Instead, "in-house testing" and "historical data of the predicate devices" are mentioned.
Data provenance: "In-house" testing for barbed ends and cutting tip. "Journal articles and historical data of the predicate devices" for overall safety and effectiveness. The country of origin for the historical data is not specified, but the predicate devices have been on the market for 20+ years. This would be considered retrospective data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of experts establishing ground truth for a test set in the context of an AI/ML device. The evaluation relies on comparisons to predicate devices and historical performance.

4. Adjudication method for the test set:

Not applicable. No test set or adjudication method is described.

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:

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" for this device's performance relies on:
- Functional comparison: Direct comparison of the new device's components (barbed ends, cutting tip) with those of the predicate devices through "in-house testing."
- Historical outcomes data: The safety and effectiveness of the predicate devices are based on their long history of use (more than twenty years) and cited "Journal articles and historical data." The new device is deemed safe and effective due to its "substantial equivalence" to these predicates.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, and no training set is described.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

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K120130 R

MAY 2 1 2012

Image /page/0/Picture/2 description: The image shows the logo for MEDIGROUP, Inc. The logo consists of a stylized heart shape above the text "MEDIGROUP, Inc." The heart shape is made up of two interlocking shapes, with diagonal lines filling the space between them.

510(k) Summary

Basic Information

Submitter:	Medigroup Inc
------------	---------------

14A Stonehill Rd

Oswego IL 60543

Establishment Registration Number: #1450420 Contact: Irene K. Navis Vice-President, Finance & Regulatory Telephone: 630-254-2533 Fax: 630-554-2535 E-mail: inavis@medigroupinc.com Date of Submission: January 13, 2012

Device Information

Trade Name: Common Name: Product Code: Class:

Faller Trocar Catheter Tunneling Device FJS, Accessory =

Predicate Devices

K910786 Trocar (Faller Stylet) K823331 Tunnelor Tool

Product Description

Intended Use

MEDIGROUP, Inc

14 A Stonehill Road, Oswego, IL 60543-9400 USA 1 (630) 524-5533 | (800) 323-5389 | E (630) 254-5235 www.medigroupinc.com

Image /page/0/Picture/21 description: The image contains two logos. The logo on the left is a circular seal with the letters 'R' in the center. The text around the circle reads 'LLOYD'S REGISTER QUALITY ASSURANCE ISO 14001'. The logo on the right is a square with the letters 'UL' inside.

Image /page/0/Picture/22 description: The image shows a logo with a crown on top of a check mark. Below the check mark is the text "UKAS" in bold letters. Underneath "UKAS" are two lines of smaller text that are difficult to read. At the very bottom of the logo is the number "001".

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K12015

Image /page/1/Picture/1 description: The image shows the logo for MEDIGROUP, Inc. The logo consists of a stylized heart shape above the text "MEDIGROUP, Inc." The heart shape is black and has a striped pattern at the bottom.

Substantial Equivalence

The new Faller Trocars have the same Indications for Use as the two predicate devices. They are all used to create a subcutaneous tunnel through which to lead the catheter from the initial implantation site through the exit-site. The predicate device Tunnelor® Tool does this in a retro-grade manor, as opposed to an ante-grade manner, but the end result is the same - getting the distal end of the catheter out through the exit-site in the skin.

The new Faller Trocars also have a barbed end to which the catheter is attached. This barbed end is exactly the same as the predicate, Tunnelor® Tool. The new Faller Trocars both have a sharp tip, just as the predicate Covidien's Trocar (Faller Stylet), which is inserted into the initial implantation site to open up the tunnel path through the subcutaneous tissue.

The new Faller Trocars are made of the same materials as the predicate devices, stainless steel like Covidien's Trocar (Faller stylet) and an approved plastic like Medigroup's Tunnelor® Tool. The shape and bend of the new stainless steel Faller Trocar is similar to the predicate Covidien's Trocar (Faller Stylet). The curvature of the new plastic Faller Trocar is similar to the predicate Medigroup's Tunnelor® Tool. The two different shapes give an option to the implanting surgeon to use which one he prefers.

Testing

The barbed ends and the cutting tip were tested in-house with acceptable comparisons between the new Faller Trocars and the two predicate devices. In addition, both of the predicate devices have been used by physicians for twenty years or more. Evaluation of Journal articles and historical data of the predicate devices indicate their safety and effectiveness. Because of the equivalency of the new Faller Trocars to those predicates, the new devices will function as safely and effectively.

Conclusions

The Faller Trocars, either made of stainless steel or an approved plastic, will function as designed and intended. Because of their substantial equivalence to the two predicate devices, they will be as safe and effective as the predicates which have a proven record of more than twenty years of successful use.

Image /page/1/Picture/12 description: The image contains two logos. The logo on the left is a circular logo with the text "LLOYD'S REGISTER QUALITY ASSURANCE" surrounding a large letter "R". Below the "R" is the text "ISO 1485". The logo on the right is a square logo with a crown above a check mark. Below the check mark is the text "UKAS QUALITY MANAGEMENT 001".

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Irene Navis Vice-President, Finance & Regulatory Medigroup, Inc. 14 A Stonehill Road OSWEGO IL 60543

MAY 2 1 2012

Re: K120130

Trade/Device Name: Faller Trocar Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FJS Dated: May 14, 2012 Received: May 16, 2012

Dear Ms. Navis:

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 (reporting of medical

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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,

Sincerery, yours,

Benjamin K. Evans

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): · K120130

Device Name: Faller Trocar

Indications for Use: The Faller Trocar is used to create an ante-grade subcutaneous tunnel for a peritoneal dialysis catheter from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.

Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helene Leun

luctive, Gastro-Renal, and

Page 1 of 1

Regulation Number and Section

§ 876.5630 Peritoneal dialysis system and accessories.

(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.