(102 days)
Not Found
No
The summary explicitly states the software is a data repository and query/reporting system and is not intended to create decisions or treatment pathways, which are common applications of AI/ML in medical devices. There is no mention of AI, ML, or related terms.
No
Explanation: The device is described as a data repository and data query/reporting system for organizing dialysis therapy data, primarily to facilitate clinician decision-making. It explicitly states it "is not intended to be a substitute for good clinical management practices nor does its operation create decisions or treatment pathways." This indicates it does not directly treat or diagnose, but rather assists in data management.
No
Explanation: The description states that "This software is not intended to be a substitute for good clinical management practices nor does its operation create decisions or treatment pathways." It functions as a data repository and query system, organizing data to facilitate decision-making but not making decisions or providing diagnoses itself.
Yes
The device description explicitly states "RenalSoft is a clinical tool that organizes dialysis therapy data" and "offers an electronic alternative to the paper medical chart". The summary focuses on data management and reporting functions, with no mention of hardware components or interaction with physical medical devices beyond potentially receiving data. The performance studies mention "bench testing" but this is likely related to software functionality and not hardware performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states that RenalSoft is a data repository and query/reporting system for nephrology. It is an electronic alternative to a paper medical chart and is not intended to create decisions or treatment pathways. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. RenalSoft does not perform this function.
- Device Description: The description reinforces that it's a clinical tool for organizing dialysis therapy data to facilitate clinician decision-making and patient care. This is a data management and presentation tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, RenalSoft falls under the category of a clinical information system or electronic health record (EHR) system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Renal Soft is designed specifically for nephrology and offers an electronic alternative to the paper medical chart. RenalSoft provides the functions of a data repository and data queryroperating by course its operation create decisions or treatment pathways. This software is not intended to be a substitute for good clinical management practices nor does its operation create decisions or treatment pathways.
Product codes (comma separated list FDA assigned to the subject device)
KPF, FKP
Device Description
RenalSoft is designed specifically for nephrology and offers an electronic alternative to the paper medical chart, in accordance with local regulations. RenalSoft provides the functions of a data repository and data query/ reporting system. RenalSoft is a clinical tool that organizes dialysis therapy data to facilitate clinician decision-making and patient care.
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)
Validation and verification testing was successful in demonstrating that all design requirements have been met. Bench testing was performed on RenalSoft to support substantial equivalence to the predicate device, as well as demonstrating that the device operates as intended and is safe and efficacious.
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.
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
§ 876.5630 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
RenalSoft version 2.0
510(k) Premarket Notification
Page 1 of 2
Section 5 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | 510(K) SUMMARY
SEP 11 2006 |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name: | Michael C. Garcia |
| Address: | 1620 Waukegan Rd.
McGaw Park, IL 60085 |
| Phone: | (847) 473-6896 |
| Fax: | (847) 785-5116 |
| Contact: | David E. Curtin - (847) 473-6079 |
| Date Prepared: | 05/22/2006 |
| Trade Name: | RenalSoft |
| Common Name: | RenalSoft |
| Classification Name: | Hemodialysis system and accessories per 21 CFR 876.5620, and Peritoneal dialysis system and
accessories per 21 CFR 876.5630 |
| Equivalent Predicate: | Renal Link (K990953) |
| Device Description: | RenalSoft is designed specifically for
nephrology and offers an electronic alternative to
the paper medical chart, in accordance with local
regulations. RenalSoft provides the
functions of a data repository and data query/
reporting system. RenalSoft is a clinical
tool that organizes dialysis therapy data to facilitate
clinician decision-making and patient care. |
| Intended Use: | Renal Soft is designed specifically for nephrology
and offers an electronic alternative to the paper
medical chart. RenalSoft provides the functions of
a data repository and data query/reporting system.
This software is not intended to be a substitute for
good clinical management practices nor does its
operation create decisions or treatment pathways. |
| Summary of the Technological
Characteristics Compared to
The Predicate Device: | The general design of RenalSoft
is identical to the Renal Therapy Clinical Data
Management Software product cleared under
K990953. The proposed product does not raise any
new safety and effectiveness issues when
compared to the predicate product. |
| Clinical Data: | NA |
| Conclusions Drawn: | Validation and verification testing was successful
in demonstrating that all design requirements have
been met. Bench testing was performed on
RenalSoft to support substantial
equivalence to the predicate device, as well as
demonstrating that the device operates as intended
and is safe and efficacious. |
| Additional Information
Requested by FDA: | None to date |
Baxter Confidential
1
RenalSoft version 2.0
510(k) Premarket Notification
2
SEP 1 1 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
David E. Curtin, R.A.C. Associate Director, Global Regulatory Affairs Baxter Healthcare Corporation Renal Division, MPGR-A2E 1620 Waukegan Road MCGAW PARK IL 60085
Re: K061515
Trade/Device Name: RenalSoft Regulation Number: 21 CFR $876.5630 Regulation Name: Peritoneal dialysis system and accessories Product Code: KPF Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Product Code: FKP Regulatory Class: II Dated: May 31, 2006 Received: June 12, 2006
Dear Mr. Curtin:
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.
Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 1906-2006. The letters FDA are in a bold, stylized font in the center of the logo. The word "Centennial" is written in a cursive font below the letters FDA. The text "U.S. Food and Drug Administration" is written around the top of the circle, and the text "Protecting and Promoting Your Health" is written around the bottom of the circle.
ing and Promoting Public S.
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Page 2 -
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K061575
Device Name: RenalSoft
Indications For Use: RenalSoft
Renal Soft is designed specifically for nephrology and offers an electronic alternative to the paper medical chart. RenalSoft provides the functions of a data repository and data mo paper mountar vans. This software is not intended to be a substitute for good clinical queryroperating by course its operation create decisions or treatment pathways.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| ------------------ | -- | ---- | ---------------------- | -- |
(Per 21 CFR 801.109)-
| Nancy Brogdon | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K061515 |
Baxter Confidential