If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck™ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Flex-Neck™ PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC® System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

Device Description

The current Tenckhoff peritoneal catheter is generally successful in providing peritoneal access for fluid infusion and drainage. The Flex-Neck™ PD Catheter is extruded of medical long-term implantable silicone basically identical to the existing Tenckhoff peritoneal catheters. All these peritoneal catheters include one or two Dacron® cuffs, the "deep" cuff in the abdominal musculature and the "superficial" cuff near the skin exit site of the catheter. Ingrowth of fibrous tissue over a few weeks period results in a thick fibrous plug preventing passage of bacteria around the Dacron® cuff. The coiled or straight intraperitoneal portion of the catheters contains multiple holes: 0.75mm in the Flex-Neck™ and 1.0mm in the Tenckhoff. Generally, the smaller the hole, the less likely omentum is to become trapped within the holes. During infusion of PD fluid, most of the flow is through the tip of the catheter. During outflow of the fluid, the soft surfaces of the peritoneum over bowel loops and omentum may be drawn to the tip, however, outflow continues through the multiple side holes.

AI/ML Overview

The provided text, K970159, describes a 510(k) premarket notification for the Flex-Neck™ PD Catheter. This document asserts the substantial equivalence of the new device to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a study.

Therefore, the information required to populate the fields regarding acceptance criteria and a study demonstrating performance is not present in the provided text. The document is generally focused on comparing the new device's characteristics to existing devices to establish substantial equivalence for regulatory approval.

Specifically:

A table of acceptance criteria and the reported device performance: Not provided. The document focuses on comparing physical characteristics (material, dimensions, number of cuffs, hole diameter) to predicate devices, not performance against acceptance criteria.
Sample size used for the test set and the data provenance: Not mentioned, as no study demonstrating performance against acceptance criteria is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no study with a test set requiring ground truth establishment is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (catheter), not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (catheter), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study with a test set requiring ground truth is described.
The sample size for the training set: Not applicable. This is a medical device, and the concept of a "training set" is not relevant here.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

K970159

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is

SEP - 5 1997

Applicant Information

Date Prepared Name Address

January 6, 1997 MEDIGROUP, Inc. (Division of Janin Group, Inc.) 615 Enterprise Street, Aurora, IL 60504-8138

Contact Person Phone Number Fax Number

Pamela L. Swatkowski (630) 585-1991 (630) 585-5480

Device Information

Trade Name Common Name Classification Name

Flex-Neck™ PD Catheter Peritoneal Catheter Peritoneal Catheter; long-term, indwelling

Equivalent Device

Name

Peritoneal Dialysis Catheter Swan Neck Peritoneal Dialysis Catheter Tenckhoff Catheter

Device Description

{1}------------------------------------------------

The Flex-Neck™ PD Catheter can be inserted via conventional surgical methods or via the Quill® Guide of the Y-TEC® peritoneoscopic system.

Intended Use

ráis

If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Flex-Neck™ PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Flex-Neck™ PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC* System of peritoneoscopic implantation enables inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.

Comparison to Predicate Device

The following table displays the similarities and differences of the new device to the legally marketed device to which equivalency is claimed.

CharacteristicsCompared	Subject DeviceFlex-Neck™PD Catheter	Predicate DeviceSwan Neck™ Coiled	Predicate DeviceTenckhoff
1. Material: Catheter	Silicone	Silicone	Silicone
2. Material: Cuff	Dacron® Felt	Dacron® Felt	Dacron® Felt
3. # of Cuffs	1-2	1-2	1-2
4. Outside Diameter (OD)	3.5 - 5.0 mm	5.0 mm	5.0 mm
5. Inside Diameter (ID)	2.0 - 3.5 mm	2.7 mm	2.7 mm
6. Length	Varies 43-62	Varies 43-62	Varies 43-62
7. Radiopaque stripe	Blue	White	White
8. Distal (deep) cufflocation	within the rectus	within the rectus	within the rectus
9. Diameter of inflow/outflow holes	0.75 mm	1.00 mm	1.00 mm
10. Proximal (superficial)cuff location relative todistal cuff	Varies	Varies	Varies
11. Exit site direction(location) choicesrelative toimplantationsite	Any place betweenlateral and caudal30 - 90° bend	Caudal 60 nominal	0-15 straight toslight lateral
12. Durometer	50	65	70 - 65

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a semi-circle around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1997

Re: K970159

Flex-Neck™ PD Catheter Dated: June 6, 1997 Received: June 9, 1997 Regulatory class: II 21 CFR §876.5630/Product code: 78 FJS

Ms. Pamela L. Swatkowski Quality Assurance & Regulatory Affairs Manager MEDIGROUP, Inc. (Division of Janin Group, Inc.) 615 Enterprises Street Aurora, Illinois 60504-8138

Dear Ms. Swatkowski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 market 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h. T. liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known):

Device Name: Flex-Neck™ PD Catheter

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Roker 2 ratt (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number J 1697015 4970/59 OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109) (Optional Format 1/2/96)

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.