(565 days)
873487, 894106
K# 873487, K# 894106
No
The summary describes a standard water treatment system for dialysis and makes no mention of AI or ML.
No
The device is a water treatment system for kidney dialysis, which cleans water for use in dialysis. It is not directly treating a patient's medical condition but rather providing a purified resource for a therapeutic procedure.
No
The device description clearly states it is a "complete water treatment system for kidney dialysis," which is a treatment and support device, not a diagnostic one.
No
The device description explicitly states it is a "complete water treatment system," which implies hardware components are involved. The predicate devices are also described as "water treatment systems," further suggesting hardware. There is no mention of the device being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section, which is crucial for identifying an IVD, is listed as "Not Found".
- Device Description: The description clearly states the device is a "complete water treatment system for kidney dialysis". This is a system used to prepare water for a medical procedure performed on a patient, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
- Lack of IVD-related terms: There are no mentions of analyzing biological samples, diagnosing diseases, or other terms typically associated with IVDs.
The device is a water treatment system used in the context of kidney dialysis, which is a medical procedure.
N/A
Intended Use / Indications for Use
Mar Cor Services, Inc., requests that it's Complete Water Treatment System for Kidney Dialysis be granted substantial equivalence to other water treatment systems currently on the market.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Mar Cor Services, Inc., has developed a complete water treatment system for kidney dialysis. This system is equivalent to such other commercial water treatment systems as the Water Pure RO System (K# 873487) and the C.D. Medical, Inc., Drake Willock RO Water Treatment System (K# 894106), and other comparable water treatment systems.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
873487, 894106
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.
Not Found
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
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image is a black and white logo for a company called "LAR COR SERVICES, INC." The logo features a square with a diagonal line dividing it into two triangles. The top triangle has wavy lines, while the bottom triangle is solid black. The company name is printed in a bold, sans-serif font below the square.
14 28 1888 K 945 559
SUMMARY
Mar Cor Services, Inc., has developed a complete water treatment system for kidney dialysis. This system is equivalent to such other commercial water treatment systems as the Water Pure RO System (K# 873487) and the C.D. Medical, Inc., Drake Willock RO Water Treatment System (K# 894106), and other comparable water treatment systems.
Mar Cor Services, Inc., is confident that this water treatment system is comparable to existing water treatment systems for kidney dialysis, providing a system that, from the incoming water supply, treats the water through a number of system components and carries it to the point where it enters the individual kidney machines.
Through this 510(k) notification, Mar Cor Services, Inc., requests that it's Complete Water Treatment System for Kidney Dialysis be granted substantial equivalence to other water treatment systems currently on the market.
364 MAPLE AVENUE HARLEYSVILLE, PA 19438 215-256-9585 FAX-256-4551