This device can be used to embed most known brands and styles of PD catheters when the nephrologist determines this action is in the best interest of the patient, however, only immediately after successful catheter implantation.

The Embedding™ Tool is indicated for embedding the external portion of most PD catheters subcutaneously in anticipation of future retrieval of that part of the catheter, provided that:

The embedding procedure is done immediately following PD . catheter implantation.
Catheter patency has been completely established. .
The normally external part of the PD catheter can be embedded. .
The patient is a candidate for delayed onset of PD treatment. .
The patient is a candidate for PD. .

Device Description

The Embedding™ Tool consists of a gently curved handle portion made of rigid PVC with a detachable titanium tip and a separate titanium cap.

AI/ML Overview

The Medigroup, Inc. Embedding™ Tool (TE-1000) is a device used to temporarily embed the external portion of a peritoneal dialysis catheter subcutaneously following initial implantation, for later retrieval and initiation of peritoneal dialysis.

Here's an analysis of the provided information regarding its acceptance criteria and supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical Integrity	"Functional testing has been performed to demonstrate mechanical integrity."
Function as Intended	"Clinical evaluation at a dialysis center showed the Embedding™ Tool functioned as intended."

Note: The provided document does not explicitly state quantitative acceptance criteria or specific performance metrics (e.g., minimum tensile strength, specific success rate percentage). The statements are qualitative.

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "Clinical evaluation at a dialysis center," implying human subject participation, but no numbers are provided for this evaluation.
Data Provenance: Not explicitly stated. The "clinical evaluation at a dialysis center" suggests prospective clinical use, but the specific country of origin is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not stated.
Qualifications of Experts: The clinical evaluation was conducted at a "dialysis center," implying involvement of medical professionals familiar with peritoneal dialysis and catheter procedures. The intended users are "physicians familiar with proper catheter tunneling techniques" and "nephrologist." These suggest that the experts involved would likely be nephrologists or surgeons experienced in implanting and managing PD catheters. Specific years of experience or board certifications are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "clinical evaluation" seems to be a direct assessment of the device's function by the users/medical staff at the dialysis center.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The device's function is mechanical and procedural, not diagnostic or interpretive by multiple readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone Performance Study (Algorithm Only)

This is not an AI-powered device, and therefore, no standalone algorithm-only performance study was conducted. The device is a physical tool.

7. Type of Ground Truth Used

For "Functional testing": The ground truth would have been established through engineering specifications, material properties, and mechanical test standards (e.g., assessing strength, durability, fit, and operation as designed).
For "Clinical evaluation": The ground truth was the direct observation of the device functioning "as intended" during actual clinical use in patients undergoing peritoneal dialysis catheter implantation. This would likely involve physician assessment of successful embedding, ease of use, and absence of immediate complications related to the device.

8. Sample Size for the Training Set

There is no training set mentioned, as this is a physical medical device, not an AI/machine learning algorithm. Therefore, "sample size for the training set" is not applicable.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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K060897 Page 1 of 2

Image /page/0/Picture/1 description: The image shows the logo for MEDIGROUP, Inc. The logo consists of a stylized heart shape formed by two interlocking shapes, with diagonal lines filling the lower portion of the heart. Below the heart is the text "MEDIGROUP, Inc." in a serif font.

JUL 18 2006

510(k) Summary

Basic Information

Submitter:

Medigroup, Inc. 14 A Stonehill Road Oswego, IL 60543

Establishment Registration Number: #1450420 Contact:

Telephone: Fax: E-mail Date of Submission John A. Navis, President (630) 554-5533 (630) 554-5535 inavis@medigroupinc.com March 30, 2006

Device Information

Trade Name: Common Name: Classification Name: Class: II

Embedding TM Tool. Catheter Tunneling Device. 78 FJS, accessory.

Predicate Devices

510(k) 823331 Tunnelor® Tool, issued January 26, 1983.

Product Description

The Embedding™ Tool consists of a gently curved handle portion made of rigid PVC with a detachable titanium tip and a separate titanium cap.

Intended Use

The Embedding TM Tool is used to "embed" about 30cm of the external portion of a peritoneal dialysis catheter into the subcutaneous tissue immediately following the initial tunneling step of catheter implantation in order to be retrieved at a later time to begin peritoneal dialysis. After this secondary tunneling step, the titanium tip is unscrewed from the tool handle and functions as a plug at the catheter end. The titanium cap is then screwed onto the open end of the titanium tip to close it off.

This Embedding™ Tool is intended to be used by the same physician at the same time and setting when he is implanting the catheter initially. As such, it can be used with any patient who is a suitable candidate for delaved peritoneal dialysis catheter utilization.

Substantial Equivalence

The "handle" or tunneling part of this Embedding™ Tool is made of the same rigid polyvinyl compound (RPVC) and has a similar configuration as the Tunnelor® Tool, predicate device 510(k) 823331. The configuration of the tip of the new device is similar to the shape of the tip in the predicate device, but made of titanium instead of RPVC.

MEDIGROUP, Inc.

(Division of Janin Group, Inc.)

7-1

Image /page/0/Picture/26 description: The image contains three logos related to quality assurance. The first logo on the left is the Lloyd's Register Quality Assurance logo with the letter R in the center and the text "ISO 13485" at the bottom. The middle logo is the UKAS Quality Management logo with the number 001 at the bottom. The third logo on the right is the Lloyd's Register Quality Assurance logo with the letter R in the center and the text "ISO 9001" at the bottom.

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510(k) Summary

Testing

Functional testing has been performed to demonstrate mechanical integrity. Clinical evaluation at a dialysis center showed the Embedding™ Tool functioned as intended.

Conclusions

The Embedding™ Tool works as designed and intended. Its use is intended for use by physicians familiar with proper catheter tunneling techniques.

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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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 18 2006

Mr. John A. Navis President Medigroup, Inc. 14 A Stonehill Road OSWEGO IL 60543-9400

Re: K060897

Trade/Device Name: TE-1000 Embedding™ Tool Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FJS Dated: June 26, 2006 Received: June 27, 2006

Dear Mr. Navis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) produce is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encreater to regally that of the Medical Device Amendments, or to devices that prior to way 20, 1770, the onloanent and the provisions of the Federal Food, Drug, and Cosmetic liave bech toolassified in accordation was a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer the device, salgos to annual registration, listing of devices, good Controls provibions of allabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is elassified (500 accreen additional controls. Existing major regulations affecting your Apploval, it that be sacreer to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The logo is circular and contains the letters FDA in a stylized font.

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Page 2 -

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060897

Device Name: TE-1000 Embedding™ Tool

Indications For Use:

The Embedding™ Tool is indicated for embedding the external portion of most PD catheters subcutaneously in anticipation of future retrieval of that part of the catheter, provided that:

The embedding procedure is done immediately following PD . catheter implantation.
Catheter patency has been completely established. .
The normally external part of the PD catheter can be embedded. .
The patient is a candidate for delayed onset of PD treatment. .
The patient is a candidate for PD. .

Prescription Use X (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)

Nancy C brogdon

510(k) Number

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.