(120 days)
No
The description focuses on the physical components and intended use of a peritoneal dialysis catheter, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
The device is a peritoneal dialysis catheter, which is used for chronic peritoneal dialysis in adults. Dialysis is a medical treatment that performs the function of kidneys in filtering waste products from the blood, making it a therapeutic intervention.
No
Explanation: The device is a peritoneal dialysis catheter, used for the delivery of treatment in peritoneal dialysis. It is not designed to diagnose a condition or disease.
No
The device description clearly outlines physical components made of silicone rubber and titanium, and the performance studies focus on physical properties and biocompatibility, 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 clearly states the device is for "peritoneal dialysis in adults." This is a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a catheter designed for implantation into the peritoneal cavity to facilitate fluid exchange for dialysis. This is a medical device used for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
Therefore, the "X" Series PD Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The "X" Series PD Catheter is indicated for peritoneal dialysis in adults. It is intended for use in patients who are poor candidates for conventional peritoneal dialysis catheters and are candidates for presternal insertion.
The "X" Series Catheter is indicated for chronic peritoneal dialysis.
The extended length of the "X" Series Catheter makes it especially applicable for peritoneal dialysis patients when it is necessary to locate the skin exit site remote from the usual lower abdominal region. The catheter may be particularly indicated in patients with obesity, floppy abdominal skin folds, urinary or fecal incontinence, chronic yeast intertrigo, intestinal stomas, or in patients who desire to take deep tub baths.
Product codes (comma separated list FDA assigned to the subject device)
FJS
Device Description
The "X" Series PD Catheter is comprised of a silicone rubber, coiled tip, single polyester cuff abdominal catheter segment that is joined with a titanium double bared connector to a silicone rubber, double polyester cuff subcutaneous extension catheter possessing a preformed tubing arc bend between the two cuffs. The abdominal catheter segment is implanted into the peritoneal cavity. The attached subcutaneous extension piece allows remote location of the catheter skin exit site away from the lower abdominal region.
The catheter will be sold in two kit configurations, as the catheter only with a female luer, clamp, and male luer end cap and titanium connector. The catheter set will also include the addition of a dilator/sheath introducer, guidewire, scalpel, introducer needle, tunneling tool, gauze pads and syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity, lower abdominal region
Indicated Patient Age Range
adults
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)
Performance Testing:
- Air Leakage Liquid Leakage Gravity Flow Force at Break Pull Force Testing Priming Volume Effects of Site Care Agents Cuff Shear Testing Tip Separation Force
Biocompatibility:
Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993. All materials have been cleared under past approved 510K's.
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.
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.
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5 2012 SEP
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Section 5 510(k) SUMMARY Traditional 510K Submitter Information: Submitter: MEDCOMP® 1499 Delp Drive Harleysville, PA 19438 (215) 256-4201 Telephone (215) 256-9191 Fax Contact: Rosanna Severini, Compliance Director Date Prepared: August 10, 2012 "X" Series PD Catheter Device Name: Common Name: Peritoneal Dialysis Catheter Classification Name: Peritoneal Dialysis Catheter & Accessories C.F.R. Section: 876.5630 Classification Panel: Gastroenterology and Urology Class: II. 78 FJS Predicate Devices: K071167, Flex-Neck® ExxTended™ PD Catheter & Accessories, concurrence date Primary:
August 31, 2007. Class II CFR §876.5630 K950042, Swan Neck Presternal Peritoneal Dialysis Catheter, concurrence date December 15, 1995. Class II CFR $876.5630 K915490, Peritoneal Dialysis Catheter, concurrence date February 2, 1994. Class II CFR §876.5630 Secondary: K113487: Hemo-Cath K110424: CT Power Injectable implantable Infusion Port
Device Description:
The "X" Series PD Catheter is comprised of a silicone rubber, coiled tip, single polyester cuff abdominal catheter segment that is joined with a titanium double bared connector to a silicone rubber, double polyester cuff subcutaneous extension catheter possessing a preformed tubing arc bend between the two cuffs. The abdominal catheter segment is implanted into the peritoneal cavity. The attached subcutaneous extension piece allows remote location of the catheter skin exit site away from the lower abdominal region.
The catheter will be sold in two kit configurations, as the catheter only with a female luer, clamp, and male luer end cap and titanium connector. The catheter set will also include the addition of a dilator/sheath introducer, guidewire, scalpel, introducer needle, tunneling tool, gauze pads and syringe.
Intended Used:
The "X" Series PD Catheter is indicated for peritoneal dialysis in adults. It is intended for use in patients who are poor candidates for conventional peritoneal dialysis catheters and are candidates for presternal insertion.
Indications for Use:
The "X" Series Catheter is indicated for chronic peritoneal dialysis.
1
K12 1383
The extended length of the “X” Series Catheter makes it especially applicable for peritoneal dialysis
patients when it is necessary to locate the skin exit site remote from the usual lower abdominal
region. The catheter may be particularly indicated in patients with obesity, floppy abdominal skin
folds, urinary or fecal incontinence, chronic yeast intertrigo, intestinal stomas, or in patients who
desire to take deep tub baths.
Comparison to Predicate Devices:
The "X" PD Series Catheter is substantially equivalent to the predicate devices in terms of intended use, materials, anatomical location, basic design, performance, labeling, manufacturing process and method of sterilization.
Performance Standards:
Performance standards have not been established by the FDA under section 514 of the Federal Food, Drug and Cosmetic Act.
Performance Testing:
- Air Leakage Liquid Leakage Gravity Flow Force at Break Pull Force Testing Priming Volume Effects of Site Care Agents Cuff Shear Testing Tip Separation Force
Biocompatibility:
Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993. All materials have been cleared under past approved 510K's.
Technological Characteristics:
The principles of operation are the same as the predicate devices. There are no new questions raised regarding the safety or effectiveness of the device.
Summary of Substantial Equivalence:
The proposed device meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP -5 2012
Ms. Rosanna Severini Compliance Director Medcomp (Medical Components) 1499 Delp Drive HARLEYSVILLE PA 19438
Re: K121383
Trade/Device Name: "X" Series PD Catheter Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FJS Dated: August 24, 2012 Received: August 24, 2012
Dear Ms. Severini:
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 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
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 and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hulda Reimer
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K/2/383
"X" Series PD Catheter __ Device Name:
Indications for Use:
The "X" Series Catheter is indicated for chronic peritoneal dialysis.
The extended length of the "X" Series Catheter makes it especially applicable for peritoneal dialysis patients when it is necessary to locate the skin exit site remote from the usual lower abdominal region. The catheter may be particularly indicated in patients with obesity, floppy abdominal skin folds, urinary or fecal incontinence, chronic yeast intertrigo, intestinal stomas, or in patients who desire to take deep tub baths.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Lehman
vision Sign-Off ision of Reproductive, Gastro-Renal, and rological Devices 510(k) Number
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