(125 days)
Not Found
No
The device description and performance studies focus on the mechanical function of a surgical tool and do not mention any AI or ML components.
No
This device is a surgical tool used to create a tunnel for a peritoneal dialysis catheter; it does not provide any therapeutic effect itself.
No
The Faller Trocar is a surgical tool used to create a tunnel for a peritoneal dialysis catheter. Its purpose is to physically assist in the placement of a catheter, not to diagnose a condition, provide information about a disease, or monitor physiological parameters.
No
The device description clearly states it is a surgical tool made of stainless steel or plastic, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Faller Trocar Function: The description clearly states the Faller Trocar is a surgical tool used to create a subcutaneous tunnel for a peritoneal dialysis catheter. It is used during a surgical procedure to facilitate the placement of a catheter within the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status. Its function is purely mechanical and procedural.
Therefore, the Faller Trocar falls under the category of a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FJS
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.
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
Not Found
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 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.
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
§ 876.5630 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.
0
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
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.
Intended 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.
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".
1
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".
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 wavy lines extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
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
3
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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
4
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
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