(185 days)
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:
- 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. - 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.
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.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Demonstrate mechanical integrity | Functional testing performed successfully |
| Demonstrate retention | Functional testing performed successfully |
2. Sample size used for the test set and data provenance:
The document does not explicitly state the sample size used for the test set. It only mentions that "Functional testing has been performed." The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
This information is not provided in the document. The testing appears to be purely functional/mechanical rather than involving expert assessment of diagnostic accuracy.
4. Adjudication method for the test set:
Not applicable, as the testing described is functional/mechanical and does not involve human interpretation or adjudication.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical medical accessory (catheter extender/repair kit), not an AI-assisted diagnostic or interpretive tool. Therefore, an MRMC study related to human reader performance with or without AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm. The testing described is for the device's mechanical integrity and retention, which is inherently "standalone" in that it tests the device itself.
7. The type of ground truth used:
The ground truth for the functional testing appears to be based on engineering specifications or performance standards for mechanical integrity and retention, rather than expert consensus, pathology, or outcomes data typically used for diagnostic devices.
8. The sample size for the training set:
Not applicable. This device is a physical medical accessory. There is no mention of a "training set" in the context of an algorithm or AI.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an algorithm described, there is no ground truth establishment for a training set.
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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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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.
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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 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
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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 AshAdvantage TM catheters in the event one of two situations described below should occur: |
-
- 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.
- Extender Application
-
- 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.
- Repair Application
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) |
13
§ 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.