(142 days)
No
The summary describes a physical medical device (a catheter) and its mechanical properties and intended use. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
Explanation: The device is a peritoneal dialysis catheter ("PD Cath") indicated for long-term peritoneal access for peritoneal dialysis, which is a therapeutic treatment to remove waste products from the blood when the kidneys are no longer able to do so effectively.
No
The device is described as a catheter for peritoneal dialysis, which is a treatment, not a diagnostic procedure.
No
The device description clearly describes a physical catheter made of silicone with a Dacron cuff, indicating it is a hardware medical device, not software-only.
Based on the provided information, the PD Cath is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "attaining long term peritoneal access for peritoneal dialysis via the peritoneum." This involves a medical procedure performed on a patient's body, not the examination of samples taken from the body.
- Device Description: The device is a "radiopaque silicone, single lumen catheter used to insert and remove peritoneal fluid." This describes a medical device used for fluid exchange within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (in glass, or outside the living organism) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PD Cath does not fit this description.
N/A
Intended Use / Indications for Use
The PD Cath is indicated for use in attaining long term peritoneal access for peritoneal dialysis via the peritoneum. The catheter is intended for implantation dwell time of greater than 30 days.
Product codes
FJS
Device Description
The PD Cath is a radiopaque silicone, single lumen catheter used to insert and The fixed Dacron cuff allows for tissue ingrowth for remove peritoneal fluid. long-term placement. A flexible silicone overtube is permanently bonded to the lumen passages and the cuff to insulate the cuff from forces applied to the external or internal lumens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneum
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)
Information submitted in this premarket notification includes in vitro performance data for the PD Cath including flow rate and tensile strength that is substantially equivalent to the legally marketed devices. Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for peritoneal dialysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
MAR 29 2006
510(k) Summary
-
- SPONSOR
Med-Conduit Inc. 18 Derby Lane Tyngsboro, MA 01879
- SPONSOR
Contact: Gerald G. Bousquet, M.D.
Date Prepared:
-
- DEVICE NAME
| Proprietary Name: | PD Cath |
|---|---|
| Common/Usual Name: | Skin Port Catheter |
| Classification Name: | Long-Term PD Catheter |
| Classification: |
-
- PREDICATE DEVICES
Dermaport™ Access Device -- K894131
- PREDICATE DEVICES
Missouri Catheter-K874650
-
- DEVICE DESCRIPTION
The PD Cath is a radiopaque silicone, single lumen catheter used to insert and The fixed Dacron cuff allows for tissue ingrowth for remove peritoneal fluid. long-term placement. A flexible silicone overtube is permanently bonded to the lumen passages and the cuff to insulate the cuff from forces applied to the external or internal lumens.
- DEVICE DESCRIPTION
-
INTENDED USE ડ.
The PD Cath is indicated for use in attaining long term peritoneal access for peritoneal dialysis via the peritoneum. The catheter is intended for implantation dwell time of greater than 30 days.
1
K053123 Pzg
SUBSTANTIAL EQUIVALENCE 6.
The PD Cath is substantially equivalent to a combination of its predicate devices in terms of intended use, design, material type, performance, and method of sterilization.
- Performance Testing 7.
Information submitted in this premarket notification includes in vitro performance data for the PD Cath including flow rate and tensile strength that is substantially equivalent to the legally marketed devices.
Clinical data was not deemed necessary since in vitro testing was sufficient to demonstrate safety and efficacy by way of comparison to legally marketed predicate device intended for peritoneal dialysis.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2006
Gerald G. Bousquet, M.D. Med-Conduit, Inc. 18 Derby Lane TYNGSBORO MA 01879
Re: K053123
Trade/Device Name: PD Cath/Skin Port Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FJS Dated: February 7, 2006 Received: February 16, 2006
Dear Dr. Bousquet:
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 (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 (Act) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Scetion 510(k) This leter will anow you to begin harketing your manence of your device of your device to a legally premarket nothleation. The I DA muning of our 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), please If you desire specific advice for your do roo of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entitled, "Association on your responsibilities under the Act from the 807.97). I ou may obtain outce general michel and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KOS 3123
Indications for Use
510(k) Number (if known): K053123
PD Cath/Skin port Device Name:
Indications For Use: The PD Cath is indicated for use in attaining long term peritoneal The I D Oath 15 Indivated a your and ener is intended for access for porkonous and greater than 30 days.
Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Slagman
(Division Sign-Off) Division of Reproductive, Abo and Radiological Devi 510(k) Number
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