(110 days)
Not Found
No
The device description and performance studies focus on the physical design and historical performance of the catheter, with no mention of AI or ML.
Yes
The device is a peritoneal dialysis catheter, which is used in a therapy for kidney failure.
No
The device is described as a peritoneal dialysis catheter used for therapy, not for diagnosing a condition. It is an implantable medical device for treatment.
No
The device description clearly states it consists of a peritoneal dialysis catheter and accessories, which are physical hardware components.
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.
- Device Function: The Flex-Neck® ARC ™ peritoneal dialysis catheter is an implantable medical device used to facilitate peritoneal dialysis therapy. It is a physical device inserted into the body to perform a therapeutic function (allowing for the exchange of fluids in peritoneal dialysis).
- Lack of Diagnostic Testing: The description focuses on the physical characteristics of the catheter and its use in a therapeutic procedure. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FJS
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal
Indicated Patient Age Range
adults, children, and infants
Intended User / Care Setting
physician
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 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.
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
Image /page/0/Picture/0 description: The image shows a handwritten text that reads "K070730 pg. 1 of 2". The text appears to be a document identifier or page number. The handwriting is clear and legible, with distinct characters and spacing.
Image /page/0/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 made up of two interlocking shapes, one solid black and the other with diagonal lines.
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
Image /page/0/Picture/18 description: The image shows three logos related to quality assurance. The first logo on the left is a circular seal with the letters 'R' and 'Q' inside, surrounded by the text 'LLOYD'S REGISTER QUALITY ASSURANCE' and 'ISO 13485'. The middle logo features a crown above a checkmark, with the text 'UKAS QUALITY MANAGEMENT' and the number '001' below. The third logo on the right mirrors the first, but with 'ISO9001' at the bottom, indicating different ISO standards.
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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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized human figure with three arms reaching upwards, symbolizing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the figure.
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.
3
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
4
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
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