K Number
K012502
Device Name
MEDIGROUP CATHETER EXTENDER/REPAIR KIT
Manufacturer
Date Cleared
2002-02-04

(185 days)

Product Code
Regulation Number
876.5630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for use with Flex-Neck catheters and Ash Advantage catheters in the event one of two situations described below should occur: 1. Extender Application In some patients, the external portion of the PD catheter may be too short for them to comfortably use. For example, obese patients may need an extender kit to be able to work with the external part of the catheter. Other patients may require the external end of the catheter to be more centrally located than it normally might be. 2. Repair Application If a peritoneal dialysis catheter develops a fracture in the external portion, the catheter must be trimmed to eliminate the fracture. Doing so, by definition, will shorten the catheter and may make it impractical or difficult or even unsuitable for use. Rather than replace the entire catheter, it is desirable to retain the catheter by extending the external part of the catheter with new tubing. In either situation, this device enables qualified medical staff to extend and/or repair the external part of an existing Flex-Neck catheter or Ash Advantage catheter by adding a 20 cm long tube to the existing and /or remaining catheter tubing.
Device Description
This device consists of four components per kit, a double male connector, a catheter connector, a cap and a 20cm long silicone tube, to be assembled in an aseptic manner by qualified personnel.
More Information

K/DEN: 8888717001

Not Found

No
The device description and intended use describe a mechanical kit for extending or repairing peritoneal dialysis catheters, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No.
The device is intended to extend or repair existing peritoneal dialysis catheters, not to treat a disease or condition itself.

No

The device is intended for extending or repairing existing peritoneal dialysis catheters, not for diagnosing any medical condition. Its function is purely mechanical, allowing for the practical use of a catheter that might otherwise be too short or fractured.

No

The device description explicitly lists four physical components: a double male connector, a catheter connector, a cap, and a 20cm long silicone tube. This indicates it is a hardware-based medical device kit.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes the device as being used to extend or repair the external portion of peritoneal dialysis catheters. This is a surgical or procedural device used directly on a patient's medical device (the catheter), not for testing samples in vitro (outside the body).
  • Device Description: The components (connectors, tube, cap) are consistent with a device used for connecting and extending tubing, not for performing diagnostic tests on biological samples.
  • Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
  • Anatomical Site: While not explicitly stated, the use with peritoneal dialysis catheters implies use related to the peritoneal cavity, which is an anatomical site, not an in vitro setting.
  • Predicate Devices: The predicate devices mentioned are also described as "Extender/Repair Kit," further supporting its classification as a procedural or surgical accessory rather than an IVD.

In summary, the device's function is to physically modify an existing medical device (the catheter) for patient comfort or repair, which falls outside the scope of in vitro diagnostics.

N/A

Intended Use / Indications for Use

This device is intended for use with Flex-Neck TM catheters and Ash Advantage TM catheters in the event one of two situations described below should occur:

  1. Extender Application
    In some patients, the external portion of the PD catheter may be too short for them to In some patients, the extemple, obese patients may need an extender kit to be able to work with the external part of the catheter. Other patients may require the external end of the catheter to be more centrally located than it normally might be.

  2. Repair Application
    If a peritoneal dialysis catheter develops a fracture in the external portion, the catheter must be trimmed to eliminate the fracture. Doing so, by definition, will shorten the catheter and may make it impractical or difficult or even unsuitable for use. Rather than replace the entire catheter, it is desirable to retain the catheter by extending the external part of the catheter with new tubing.

In either situation, this device enables qualified medical staff to extend and/or repair the external part nf order briam.com, and do atheter or Ash Advantage catheter by adding a 20 cm long tube to the existing and /or remaining catheter tubing.

Product codes

78 FJS

Device Description

This device consists of four components per kit, a double male connector, a catheter connector, a cap and a 20cm long silicone tube, to be assembled in an aseptic manner by qualified personnel.

The intended role of this device is to be used with Flex-Neck catheters and with Ash Advantage catheters in the event one of the two situations described below should occur.

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

qualified personnel, trained medical staff

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)

Functional testing has been performed to demonstrate mechanical integrity and retention.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Kendall, Quinton #8888717001, 510(k) # unknown

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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.

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K012502

page 1 of 2

FEB 01 2002

SMDA Information 7.

510(k) Summary of Safety and Effectiveness 7.1.

  • 7.1.1. Basic Data
Date Prepared:June 18, 2001
Company:MEDIGROUP, Inc.
Contact:John A. Navis, President
Phone:(630) 428-4143
Fax:(630) 428-4148
E-mail:jnavis@medigroupinc.com
  • 7.1.2. Device Information:
    Classification Name: Common Name:

Peritoneal Catheter Accessory Catheter Extender/Repair Kit

7.1.3. Predicate Device

This device is substantially equivalent to the Extender/Repair Kit marketed by Kendall, Quinton #8888717001, 510(k) # unknown.

  • 7.1.4. Device Description & Intended Use
    This device consists of four components per kit, a double male connector, a catheter connector, a cap and a 20cm long silicone tube, to be assembled in an aseptic manner by qualified personnel.

The intended role of this device is to be used with Flex-Neck catheters and with Ash Advantage catheters in the event one of the two situations described below should occur.

7.1.4.1. Extender Application

In some patients, the external portion of the PD catheter may be too short for them to comfortably use. For example, obese patients may need an extender kit to be able to work with the external part of the catheter. Other patients may require the external end of the catheter to be more centrally located than it normally might be.

  • 7.1.4.2. Repair Application
    If a peritoneal dialysis catheter develops a fracture in its external portion, the catheter must be trimmed to eliminate the fracture. Doing so, by definition, will shorten the catheter and may make it impractical or difficult or even unsuitable for use. Rather than replace

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K012502

Page 2 of 2

FEB 0 1 2002

... ... .. .. ..

the entire catheter, it is desirable to retain the catheter by extending the external part of the catheter with new tubing.

In either situation, this device enables trained medical staff to extend and/or repair the external part of an existing Flex-Neck catheter or Ash Advantage catheter by adding a 20 cm long tube to the existing and /or remaining catheter tubing.

  • 7.1.5. Testing
    Functional testing has been performed to demonstrate mechanical integrity and retention.

2

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized eagle-like symbol with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 1 2002

Mr. John Navis President MEDIGROUP, Inc. Division of Janin Group, Inc. 505 Weston Ridge Drive NAPERVILLE IL 60563

:

Re: K012502

Trade/Device Name: Medigroup Catheter Extender/Repair Kit, CE-1350 Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: 78 FJS Dated: November 19, 2001

Received: November 19, 2001

Dear Mr. 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.

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); 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.

3

This letter will allow you to begin marketing your device as described in your 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:

8xx.1xxx(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx(301) 594-4654
Other(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

4

8. Indications for Use

510(k) Number:K012502
Device Name:Medigroup Catheter Extender/Repair Kit
Indications for Use:This device is intended for use with Flex-Neck TM catheters and Ash
Advantage TM catheters in the event one of two situations described below should occur:
    1. Extender Application
      In some patients, the external portion of the PD catheter may be too short for them to In some patients, the extemple, obese patients may need an extender kit to be able to work with the external part of the catheter. Other patients may require the external end of the catheter to be more centrally located than it normally might be.
    1. Repair Application
      If a peritoneal dialysis catheter develops a fracture in the external portion, the catheter must be trimmed to eliminate the fracture. Doing so, by definition, will shorten the catheter and may make it impractical or difficult or even unsuitable for use. Rather than replace the entire catheter, it is desirable to retain the catheter by extending the external part of the catheter with new tubing.

In either situation, this device enables qualified medical staff to extend and/or repair the external part nf order briam.com, and do atheter or Ash Advantage catheter by adding a 20 cm long tube to the existing and /or remaining catheter tubing.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
------------------------------------------------------------
Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use
(Optional Format 1-2-96)

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