(88 days)
Flex-Neck™ Coiled Medigroup, Swan Neck™ Coiled Kendall, Tenckhoff Kendall, Jejunal Gatherer Kendall
Not Found
No
The description focuses solely on the physical design and materials of a peritoneal catheter and its implantation method. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
{"explanation": "A therapeutic device is one that treats or prevents a disease or condition. This device, a peritoneal catheter, is described as providing 'access for passage of dialysate during chronic peritoneal dialysis (PD)'. While it is part of a therapeutic process (dialysis), the catheter itself is a delivery/access device and not directly applying therapy to the patient. It does not treat or prevent disease, but rather facilitates a process that does. It provides access for the dialysate, which is the therapeutic agent, but is not the therapy itself."}
No.
The device is a peritoneal catheter intended to provide access for passage of dialysate during chronic peritoneal dialysis. It is a long-term implantable device used for treatment, not for diagnosis.
No
The device description clearly describes a physical, implantable catheter made of silicone with Dacron cuffs and a specific design for fluid flow, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access for the passage of dialysate during chronic peritoneal dialysis. This is a therapeutic procedure, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a catheter designed for implantation into the body to facilitate fluid exchange. It is a medical device used for treatment, not for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
Therefore, the Ash Advantage™ Peritoneal Catheter is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
78 FJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneum, abdominal musculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Flex-Neck™ Coiled Medigroup, Swan Neck™ Coiled Kendall, Tenckhoff Kendall, Jejunal Gatherer Kendall
Reference Device(s)
Blake™ Drain Johnson & Johnson
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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.
1
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.
2
Comparison Table
| | Characteristics Compared | New Device
Ash Advantage™
Peritoneal Catheter | Predicate Device
Flex-Neck™ Coiled
Medigroup | Predicate Device
Swan Neck™
Coiled
Kendall | Predicate Device
Tenckhoff
Kendall | Predicate Device
Jejunal Gatherer
Kendall | Predicate Device
Blake™ Drain
Johnson &
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 to
post distal (deep) cuff] | variable
24.0 cm to 30.0 cm
(trans-abdominal tube) | variable
29 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 of
intraperitoneal portion] | 30.0 cm
(includes both
fluted sections) | 32.0 cm | 34.0 cm | 34.0 cm | 5.1 cm diameter
discs: | 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) cuff
location relative to distal
cuff | 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 relative
to implantation site | any place between
lateral and caudal
30° - 90° bend | any place between
lateral and caudal
30° - 90° bend | Caudal 60°
nominal | 0-15° straight to
slight lateral | downward caudally | N/A |
" 1
、
3
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
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
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.
(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 | |
|---|---|
| ---------------------- | -- |
| | (Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices |
| -- | ---------------------------------------------------------------------------------------------- |
|---|
| 510(k) Number | |
|---|---|
| --------------- | -- |
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