(110 days)
If a patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ARC ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis.
This device consists of a peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and one or two cuffs made of polyester felt. The coiled catheter has a permanent bend and is available in three adult variations, three pediatric/adolescent variations, and two infant variations. Included in the catheter package is a set of stencils (right and left) to help determine which configuration of catheter to implant and to assist the physician to locate the optimum primary and secondary incision sites. (Note: In addition to being packaged with each catheter, this stencil set will be sold sterile, packaged by itself, so the physician or other qualified personnel can use it in a clinical setting prior to the implantation.) Also packaged with the catheter will be a surgical grade marking pen, a plastic catheter connector and cap, and a packet of water-soluble lubricating gel.
The provided document is a 510(k) summary for the Medigroup, Inc. Flex-Neck® ARC™ PD Catheter & Accessories. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a new study.
Therefore, many of the requested categories for a new study are not applicable or cannot be extracted directly from this submission. The submission explicitly states: "Because of the longevity and success of the two predicate devices, no further studies have been done for this submission."
However, I can extract the rationale for substantial equivalence which serves as the "study" in this context, demonstrating that the device is believed to meet expected performance criteria based on predicate devices.
Explanation of how this device meets acceptance criteria (implied through substantial equivalence):
The acceptance criteria for the Flex-Neck® ARC™ PD Catheter are implicitly defined by the successful performance and validated design of its predicate devices: the Swan-Neck™ PD Catheter (with a 20-year history) and the Flex-Neck® PD Catheter (with a 10-year history). The new Flex-Neck® ARC™ catheter combines features of both predicate devices which have a long history of safe and effective use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Flex-Neck® ARC™) |
|---|---|
| Safety: Safe for long-term implantation and peritoneal dialysis; no adverse events associated with material or design. | Made of long-term, implantable grade silicone tubing with a radiopaque strip and polyester felt cuffs, materials validated by predicate devices. |
| Effectiveness (Flow Rate): Provides efficient fluid infusion and drainage for peritoneal dialysis. | Incorporates the larger internal diameter of the Flex-Neck® "classic" catheter, which provides faster flow rates. |
| Effectiveness (Catheter Placement/Stability): Maintains proper position within the peritoneum; aids in tunnel/exit site management. | Features a 30° permanent bend, combining the advantage of the Swan-Neck™ catheter for a consistent arcuate tunnel/exit site, and improving upon the "classic" Flex-Neck®'s variable bend if a permanent bend is desired. |
| Compatibility: Compatible with peritoneal dialysis procedures and patient anatomy (adult, pediatric, infant). | Designed for adults, children, and infants; includes stencils for optimal primary and secondary incision sites. |
| Material Biocompatibility: Materials are well-tolerated by the body. | Uses implantable grade silicone, a material well-established in predicate devices. |
| Radiopacity: Observable under imaging for placement verification. | Includes a radiopaque strip. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not applicable. No new test set was used for a prospective study. The "test set" is the cumulative clinical experience from twenty years of the Swan-Neck™ catheter and ten years of the Flex-Neck® "classic" catheter.
- Data Provenance: Retrospective, derived from the long-term clinical history and usage of the predicate devices. The document also references three articles/studies from 1985, 1995, and 1996 (Appendices F.1, F.2, F.3) that "confirm the benefit of a permanently bent peritoneal dialysis catheter," further validating the design. The specific countries of origin for this long-term data are not specified but would be global, given the widespread use of such medical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable in the context of a new, controlled study. The "ground truth" is established by the widespread acceptance and successful clinical outcomes experienced by many medical professionals over decades with the predicate devices.
- Qualifications of Experts: Thousands of physicians globally who have implanted and managed patients with the predicate Swan-Neck™ and Flex-Neck® catheters over a 20-year and 10-year period, respectively. These would be experienced nephrologists, surgeons, and other healthcare professionals involved in peritoneal dialysis. The referenced articles also involve expert clinicians and researchers in the field.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No new, isolated test set requiring adjudication was used. The validation comes from broad clinical acceptance and published literature over an extended period.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No. No such comparative effectiveness study was performed for this submission. The device's perceived benefit is a combination of known advantages from existing devices (faster flow rates from Flex-Neck®, permanent bend from Swan-Neck™).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This is a medical device (catheter), not an algorithm or AI system.
7. The type of ground truth used
- Type of Ground Truth: Clinical history and validated performance of legally marketed predicate devices, supported by published literature (Appendices F.1, F.2, F.3, F.4). This constitutes real-world outcomes and expert consensus over an extended period.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for this device's design comes from the accumulated knowledge and design iterations based on the predicate devices.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. The "ground truth" that informed the design of the Flex-Neck® ARC™ catheter was the clinical feedback, performance data, and design iterations from the 20-year history of the Swan-Neck™ catheter and the 10-year history of the Flex-Neck® "classic" catheter. This includes physician preferences for specific features (e.g., faster flow rates, permanent bend) derived from their extensive use of these devices.
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510(k) Summary
Medigroup, Inc.
JUL - 3 2007
Basic Information
Submitter:
14 A Stonehill Road Oswego, IL 60543 Establishment Registration Number: #1450420 Contact: John A. Navis, President Telephone: (630) 554-5533 Fax: (630) 554-5535 E-mail inavis@medigroupinc.com Date of Submission March 13, 2007
Device Information
Trade Name: Flex-Neck® ARCTM PD Catheter & Accessories Common Name: Peritoneal Dialysis Catheter & Accessories Classification Name: 78 FJS, accessory. Class: II
Predicate Devices
510(k) 862046 Swan-Neck™ PD Catheter issued June 19, 1986 510(k) 970159 Flex-Neck® PD Catheter issued September 5, 1997 510(k) 031351 Flex-Neck® PD Catheter, Infant, issued September 17, 2003
Product Description
This device consists of a peritoneal dialysis catheter and accessories. The catheter is made of long-term, implantable grade silicone tubing with a radiopaque strip, and one or two cuffs made of polyester felt. The coiled catheter has a permanent bend and is available in three adult variations, three pediatric/adolescent variations, and two infant variations. Included in the catheter package is a set of stencils (right and left) to help determine which configuration of catheter to implant and to assist the physician to locate the optimum primary and secondary incision sites. (Note: In addition to being packaged with each catheter, this stencil set will be sold sterile, packaged by itself, so the physician or other qualified personnel can use it in a clinical setting prior to the implantation.) Also packaged with the catheter will be a surgical grade marking pen, a plastic catheter connector and cap, and a packet of water-soluble lubricating gel.
Intended Use
The Flex-Neck® ARC™ catheter is designed for adults, children, and infants for whom peritoneal dialysis has been decided to be the mode of treatment by a physician. This catheter will be chosen by the physician who desires the faster flowrates of the Flex-Neck® conventional PD catheter as well as the uniformity of the permanent bend provided by the Swan-Neck™ catheter. The addition of accessories packaged with the catheter will enhance the implantation and use of the catheter.
MEDIGROUP. Inc. (Division of Janin Group, Inc.) 7-1
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Substantial Equivalence
The new Flex-Neck® ARC™ catheter has the same indications for use as the two predicate devices, the Flex-Neck® "classic" catheter and the Swan-Neck™ catheter. All three catheters are to be implanted in a patient needing peritoneal dialysis in order to provide access for peritoneal dialysis fluid infusion and drainage. All three are a silicone tube, with one or two cuffs for anchoring in the rectus muscle, ending in a coil. The Flex-Neck® catheters (both the "classic" style and the new ARC™ design) have a larger internal diameter than the Swan-Neck™ catheter which provides a faster flow rate for the fluid. The Flex-Neck® "classic" style is bendable into variable caudally directed exit sites, whereas the Flex-Neck® ARCTM and the Swan-Neck™ catheters have a 30° permanent bend. The Flex-Neck® ARCTM catheter therefore combines advantages of both predicate devices.
pg. 2of2
Testing
The twenty-year history of the Swan-Neck™ catheter with its permanent bend, and the ten-year history of the Flex-Neck® "classic" catheter with its larger internal diameter and variable bend have validated the design. High usage of catheters with this design further validates that a coiled silicone tube with a permanent bend is the catheter of choice for many physicians. See also three articles/ studies from 1985, 1995, and 1996 in Appendices F.1, F.2, F.3 which confirm the benefit of a permanently bent peritoneal dialysis catheter. Additional studies are referenced in F.4. Because of the longevity and success of the two predicate devices, no further studies have been done for this submission.
Conclusions
The Flex-Neck® ACR™ peritoneal dialysis catheter will function as designed and intended. It will provide a faster flowing access for peritoneal dialysis fluid and give the physician a bent tunnel portion to maintain a permanent arcuate tunnel/exit site.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 3 2007
Mr. John A. Navis President Medigroup, Inc. 14 A Stonehill Road OSWEGO IL 60543-9400
Re: K070730
Trade/Device Name: Flex-Neck® ARC™ Catheter and Accessories Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FJS Dated: June 1, 2007 Received: June 4, 2007
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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.
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Page 2 - Mr. John Navis
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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/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):
Device Name: Flex-Neck® ARC™ Peritoneal Dialysis Catheter & Accessories
Indications For Use:
If a patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck® ARC ™ peritoneal dialysis catheter can be implanted either surgically, laparoscopically, or peritoneoscopically for acute or chronic peritoneal dialysis.
Prescription Use (Part 21 CFR 801 Subpart D)
ANDIOR
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
(Division Sign-Off)
Division of Reproduct and Radiological De 510(k) Number
Page 1 of 1
§ 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.