(81 days)
No
The summary describes a simple mechanical connector and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is a connector used to connect a catheter to a dialysate line, rather than directly treating a medical condition itself.
No
The device description states its use is to connect a peritoneal dialysis catheter to a dialysate line, which is a functional connection for treatment, not for diagnosing a condition.
No
The device description clearly states it is a physical connector made of titanium, used to connect a catheter to a dialysate line. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect a peritoneal dialysis catheter to a dialysate line. This is a physical connection for delivering fluid into and out of the body.
- Device Description: The description focuses on the physical nature of the connector (titanium, configuration, materials).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as part of a medical procedure.
N/A
Intended Use / Indications for Use
Peritoneal dialysis connectors are used to connect the peritoneal dialysis catheter to the dialysate line.
Product codes
78 FKO
Device Description
Peritoneal dialysis connectors are used to connect the peritoneal dialysis catherer to the dialysate line. Medigroup intends to market titanium connectors for use with their large diameter, low duromoter (Flex Neck™) cathere only. Those connectors have the same intended use, general configuration, and materials as titanium connectors marketed by Accurate Surgical Instruments.
Configuration: Two-piece connector
Connection Method: Main body with single, rounded barb; cap over the catheter end with screw lock onto main body
Material: Medical grade titanium
Sterilization Method: 100% ETO
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Functional testing has been performed to demonstrate mechanical integrity, including connector retention.
Key Metrics
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
Premarket Notification - Peritoneal Dialysis Catheter Connector Medigroup, Inc.
K974570
P191
FEB 2 7 1998510(k) Summary of Safety and Effectiveness
Device information
Classification Name: Peritoneal Dialysis Accessories Common Name: Peritoneal Dialysis Catheter Connector
Predicate Device
This dovice is substantially equivalent to titenium connectors legally marketed by Accurate Surgical Instruments. Reference 510(k) # K910787.
Device Description & Intended Use
Peritoneal dialysis connectors are used to connect the peritoneal dialysis catherer to the dialysate line. Medigroup intends to market titanium connectors for use with their large diameter, low duromoter (Flex Neck™) cathere only. Those connectors have the same intended use, general configuration, and materials as titanium connectors marketed by Accurate Surgical Instruments.
Comparison to Predicate Device
| | Accurate Surgical Instruments
Peritoneal Dialysis Catheter
Connector
K910787 | Medigroup Peritoneal Dialysis
Catheter Connector |
|----------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Configuration | Two-piece connector | Two-piece connector |
| Connection Method | Main body with single, rounded
barb; cap over the catheter end
with screw lock onto main body | Main body with single, rounded
barb; cap over the catheter end
with screw lock onto main body |
| Material | Medical grade titanium | Medical grade titanium |
| Sterilization Method | 100% ETO | 100% ETO |
Testing
Functional testing has been performed to demonstrate mechanical integrity, including connector retention.
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services. The seal features an abstract representation of a human profile in the center. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular pattern around the profile.
FEB 2 7 1998
Mr. John Navis President Medigroup, Inc. 615 Enterprise Street Aurora, IL 60504-8138
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K974570 Titanium Two-Piece Connector (for Peritoneal Dialysis Catheter) Dated: December 5, 1997 Received: December 8, 1997 Regulatory Class: II 21 CFR 876.5630/Procode: 78 FKO
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 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 Cometic 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 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 Resulations, Title 21. Parts 800 to 895. A substantially equives commes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 Resister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 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 predication 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 on the promotion 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/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INTENDED USE FORM
510(k) #
Device Name: Peritoneal Dialysis Catheter Connector
Indications for Use:
Peritoneal dialysis connectors are used to connect the peritoneal dialysis catheter to the dialysate line.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
Robert D Satting/
(Division Sign-Off)
Division of Reproductive. Abdominal ENT
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K971570