The Ash Advantage™ Peritoneal Catheter is intended to provide access for passage of dialysate during chronic peritoneal dialysis (PD) such as Continuous Ambulatory Peritoneal Dialysis (CAPD). If the patient is a suitable candidate for (PD) therapy, the Ash Advantage™ Peritoneal Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Ash Advantage™ Peritoneal 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 Ash Advantage™ Peritoneal 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 Tenckhoff catheter contains multiple 1.0 mm 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. The Ash Advantage™ Peritoneal Catheter has been developed with a thin trans-abdominal tube connecting in an inverted "T" shape to a cylindrical portion which changes to longitudinal flutes (grooves) for ports, which rest against the parietal peritoneum. The Ash Advantage™ Peritoneal Catheter can be inserted via conventional surgical methods or via the Quill® Guide of the Y-TEC® peritoneoscopic system, which is used to insert the standard Tenckhoff dialysis catheters. The fixed position of the intraperitoneal portion of this catheter is designed to prevent outward migration of the deep and superficial cuffs, avoiding pericatheter hernias, pericatheter leaks, and erosion and infection of the subcutaneous cuff. Though this Ash Advantage™ Peritoneal Catheter is a novel design for peritoneal catheters used in dialysis, it actually represents a simple combination of two catheters which are currently utilized in medical practice for peritoneal access. The portion of the catheter outside the peritoneum is exactly like the Tenckhoff catheter, with deep and superficial cuffs. The fluted portion within the abdomen is exactly like a drain used to remove fluid from the peritoneum after surgery, the Blake™ Drain by Johnson & Johnson. The Ash Advantage™ Peritoneal Catheter is extruded of medical long-term implantable silicone basically identical to existing catheters and drains. The extrusions are bonded to form the inverted "T" which is then reinforced with molded silicone.

AI/ML Overview

This document describes the Ash Advantage™ Peritoneal Catheter, a medical device, and its FDA 510(k) submission for substantial equivalence. The provided text, however, is a 510(k) summary and not a study report. Therefore, it does not contain the detailed acceptance criteria or a study proving the device meets those criteria in the way a clinical trial or performance study would.

Instead, the document asserts "substantial equivalence" to existing, legally marketed predicate devices. This means that for a 510(k) submission, the performance of the new device is compared to already accepted devices based on material, design, function, and intended use, rather than conducting a new, exhaustive clinical study to establish new performance metrics.

Based on the provided text, here's an analysis addressing your request, noting where information is not available in this type of document:

Analysis of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary for a medical device. In this context, "acceptance criteria" are not explicitly stated as quantitative performance metrics (e.g., a specific flow rate or a success rate threshold) that the device must achieve in a dedicated study. Instead, the "acceptance criteria" implicitly revolve around demonstrating substantial equivalence to existing predicate devices.

The "performance" is implicitly demonstrated through a comparison of physical characteristics and intended use. The table below summarizes the characteristics compared, acting as the basis for the FDA's "acceptance" of substantial equivalence.

Characteristic Compared	Acceptance Criteria (Implicit from Predicate Devices)	Ash Advantage™ Peritoneal Catheter Performance (Reported)
Material: Catheter	Silicone (matching predicate devices)	Silicone
Material: Cuff	Dacron® Felt (matching predicate devices)	Dacron® Felt
Number of Cuffs	1-2 (matching predicate devices)	2
Outside Diameter	3.5 mm to 7.0 mm (matching predicate devices)	3.5 mm to 7.0 mm
Inside Diameter	2.0 mm to 5.5 mm (matching predicate devices)	2.0 mm to 5.5 mm
Length [Proximal end to post distal (deep) cuff]	Variable, e.g., 29 cm to 27 cm (matching predicate devices)	Variable, 24.0 cm to 30.0 cm (trans-abdominal tube)
Intraperitoneal portion [from deep cuff to end]	E.g., 32.0 cm to 34.0 cm (matching predicate devices)	30.0 cm (includes both fluted sections)
Radiopaque stripe	Presence of a radiopaque stripe (matching predicate devices)	Yes - Blue (color may vary)
Distal (deep) cuff location	Within the rectus (matching predicate devices)	Within the rectus
Proximal (superficial) cuff location relative to distal cuff	E.g., 5.2 cm to 6.22 cm (matching predicate devices)	6.0 cm (standard adult)
Exit site direction (location), choices relative to implantation site	E.g., Caudal 60°, 0-15° straight (matching predicate devices)	Any place between lateral and caudal 30° - 90° bend
Intended Use	Peritoneal dialysis access (matching predicate devices)	Access for dialysate during chronic peritoneal dialysis (PD)

Note: The "Ash Advantage™ Peritoneal Catheter" has a novel design for its intraperitoneal portion (fluted instead of coiled/straight with side holes) which is explicitly compared to the Blake™ Drain by Johnson & Johnson, indicating a combination of features from two existing device types. The "acceptance criteria" here are that this combination does not introduce new questions of safety or effectiveness.

Study Information Breakdown

As this is a 510(k) summary focused on substantial equivalence rather than a full study report, specific details on a formal "study" with the following components are largely not provided or not applicable:

2. Sample sized used for the test set and the data provenance:

Not Applicable/Not Provided. The document describes a comparison to predicate devices based on design and material characteristics, not a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not Applicable/Not Provided. Ground truth establishment for a test set is not part of this type of substantial equivalence submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable/Not Provided. This pertains to clinical studies often involving human interpretation of data, which is not described here.

5. 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/Not Provided. This device is a peritoneal catheter, not an AI or imaging diagnostic device. MRMC studies are irrelevant to this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable/Not Provided. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not Applicable/Not Provided. For a 510(k) substantial equivalence, the "ground truth" is often implicitly understood as the established safety and effectiveness of the predicate devices based on their long-term use and FDA clearance. The new device is compared against these established characteristics.

8. The sample size for the training set:

Not Applicable/Not Provided. This concept (training set) applies to AI/machine learning models, not physical medical devices in a 510(k) submission.

9. How the ground truth for the training set was established:

Not Applicable/Not Provided. As with point 8, this is not relevant to a 510(k) submission for a physical medical device.

Summary of 510(k) Approach for this Device:

The FDA granted "substantial equivalence" based on:

Material Equivalence: The catheter is made of medical long-term implantable silicone, "basically identical to existing catheters and drains." Cuffs are Dacron® Felt, also matching predicate devices.
Design Comparison: While the intraperitoneal portion is "novel," it is described as "a simple combination of two catheters which are currently utilized in medical practice for peritoneal access." Specifically, the trans-abdominal portion is like a Tenckhoff catheter, and the fluted intraperitoneal portion is like the Blake™ Drain. The comparison table highlights that overall dimensions, number of cuffs, and other physical characteristics are within the range or identical to predicate devices.
Intended Use Equivalence: The intended use for providing access for dialysate during chronic peritoneal dialysis (PD) is identical to that of predicate peritoneal dialysis catheters.
No New Questions of Safety or Effectiveness: The submission implicitly argues that combining established features from existing devices does not raise new concerns about safety or effectiveness.

In essence, the "study" for this 510(k) clearance was a design and material comparison report demonstrating that the Ash Advantage™ Peritoneal Catheter is sufficiently similar to legally marketed devices to not require a full new clinical trial to prove its safety and efficacy.

Summary

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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

Applicant Information

Date Prepared Name Address

Contact Person Phone Number Fax Number

March 15, 1999 MEDIGROUP, Inc. (Division of Janin Group, Inc.) 615 Enterprise Street, Aurora, IL 60504-8138

John A. Navis (630) 285-1991 (630) 585-5480

Device Information

Trade Name Common Name Classification Name Ash Advantage™ Peritoneal Catheter Peritoneal Catheter Peritoneal Catheter; long-term, indwelling

Equivalent Device

Name

Peritoneal Dialysis Catheter Swan Neck™ Peritoneal Dialysis Catheter Tenckhoff Catheter Flex-Neck™ Catheter

Device Description

The current Tenckhoff peritoneal catheter is generally successful in providing peritoneal access for fluid infusion and drainage. The Ash Advantage™ Peritoneal Catheter is extruded of medical longterm 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 Tenckhoff catheter contains multiple 1.0 mm 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.

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The Ash Advantage™ Peritoneal Catheter has been developed with a thin trans-abdominal tube connecting in an inverted "T" shape to a cylindrical portion which changes to longitudinal flutes (grooves) for ports, which rest against the parietal peritoneum. The Ash Advantage™ Peritoneal Catheter can be inserted via conventional surgical methods or via the Quill® Guide of the Y-TEC® peritoneoscopic system, which is used to insert the standard Tenckhoff dialysis catheters. (See "Implantation Instructions" in Appendix B.) The fixed position of the intraperitoneal portion of this catheter is designed to prevent outward migration of the deep and superficial cuffs, avoiding pericatheter hernias, pericatheter leaks, and erosion and infection of the subcutaneous cuff.

Though this Ash Advantage™ Peritoneal Catheter is a novel design for peritoneal catheters used in dialysis, it actually represents a simple combination of two catheters which are currently utilized in medical practice for peritoneal access. The portion of the catheter outside the peritoneum is exactly like the Tenckhoff catheter, with deep and superficial cuffs. The fluted portion within the abdomen is exactly like a drain used to remove fluid from the peritoneum after surgery, the Blake™ Drain by Johnson & Johnson. The Ash Advantage™ Peritoneal Catheter is extruded of medical long-term implantable silicone basically identical to existing catheters and drains. The extrusions are bonded to form the inverted "T" which is then reinforced with molded silicone. The Ash Advantage™ Peritoneal Catheter is substantially equivalent to currently marketed devices.

Intended Use

If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, the Ash Advantage™ Peritoneal Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the Ash Advantage™ Peritoneal Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries 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.

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Comparison Table

	Characteristics Compared	New DeviceAsh Advantage™Peritoneal Catheter	Predicate DeviceFlex-Neck™ CoiledMedigroup	Predicate DeviceSwan Neck™CoiledKendall	Predicate DeviceTenckhoffKendall	Predicate DeviceJejunal GathererKendall	Predicate DeviceBlake™ DrainJohnson &Johnson
1.	Material: Catheter	Silicone	Silicone	Silicone	Silicone	Silicone	Silicone
2.	Material: Cuff	Dacron® Felt	Dacron® Felt	Dacron® Felt	Dacron® Felt	Dacron®	N/A
3.	Number of Cuffs	2	1-2	1-2	1-2	2	None
4.	Outside Diameter	3.5 mm to 7.0 mm	3.5 mm to 7.0 mm	5.0 mm	5.0 mm	5.0 mm	4.5 mm
5.	Inside Diameter	2.0 mm to 5.5 mm	2.0 mm to 5.5 mm	2.7 mm	2.7 mm	2.7 cm	3.0 mm (propor.)
6.	Length [Proximal end topost distal (deep) cuff]	variable24.0 cm to 30.0 cm(trans-abdominal tube)	variable29 cm to 27 cm	28.0 cm	28.5 cm	28.0 cm	N/A(no deep cuff)
7.	Intraperitoneal portion[from deep cuff to end ofintraperitoneal portion]	30.0 cm(includes bothfluted sections)	32.0 cm	34.0 cm	34.0 cm	5.1 cm diameterdiscs:	N/A(no deep cuff)
8.	Radiopaque stripe	Yes - Blue	Yes - Blue	Yes - White	Yes - White	Yes - White	Yes - White
9.	Distal (deep) cuff location	within the rectus	within the rectus	within the rectus	within the rectus	within the rectus	N/A
10.	Proximal (superficial) cufflocation relative to distalcuff	6.0 cm(standard adult)	6.0 cm(standard adult)	5.2 cm(standard)	6.0 cm(standard)	6.22 cm(standard)	N/A
11.	Exit site direction(location), choices relativeto implantation site	any place betweenlateral and caudal30° - 90° bend	any place betweenlateral and caudal30° - 90° bend	Caudal 60°nominal	0-15° straight toslight lateral	downward caudally	N/A

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Image /page/3/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" arranged around the circumference. Inside the circle is a stylized symbol resembling an abstract human figure or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

Mr. John A. Navis President Mediaroup. Inc. 615 Enterprise Street Aurora, IL 60504-8138 Re: K991042 Ash Advantage™ Peritoneal Catheter Dated: March 26, 1999 Received: March 29, 1999 Requlatory Class: II 21 CFR §876.5630/Procode: 78 FJS

Dear Mr. Navis:

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 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, 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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compilance at (301) 594-4613. 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 requlation 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

(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)
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Over-The-Counter Use
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	(Division Sign-Off)Division of Reproductive, Abdominal, ENT,and Radiological Devices
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510(k) Number
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Page 4 of 17

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.