(232 days)
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No
The description focuses on the material and physical design of a peritoneal dialysis catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a peritoneal dialysis catheter, which is used for peritoneal dialysis therapy in patients suitable for end-stage renal disease. Peritoneal dialysis is a medical treatment used to remove waste products from the blood when the kidneys are no longer able to do so adequately. Therefore, it serves a therapeutic purpose.
No
Explanation: The Flex-Neck™ PD Catheter is used for providing peritoneal access for fluid infusion and drainage in peritoneal dialysis therapy. It is an implanted device for delivering therapy, not for diagnosing conditions.
No
The device description clearly describes a physical catheter made of silicone with Dacron cuffs and multiple holes, which is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Flex-Neck™ PD Catheter is described as a physical implantable device made of silicone with Dacron® cuffs and holes. Its function is to provide access to the peritoneal cavity for fluid infusion and drainage during peritoneal dialysis.
- Intended Use: The intended use is for peritoneal dialysis therapy, which involves the exchange of fluids within the body, not the analysis of specimens taken from the body.
The device is a medical device used in vivo (within the body) for a therapeutic purpose (peritoneal dialysis), not an in vitro diagnostic device used for testing specimens outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
78 FJS
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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
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.
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.
| Characteristics
Compared | Subject Device
Flex-Neck™
PD Catheter | Predicate Device
Swan Neck™ Coiled | Predicate Device
Tenckhoff |
|----------------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------|------------------------------------|
| 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) cuff
location | 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 to
distal cuff | Varies | Varies | Varies |
| 11. Exit site direction
(location) choices
relative toimplantation
site | Any place between
lateral and caudal
30 - 90° bend | Caudal 60 nominal | 0-15 straight to
slight 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:
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.
(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)