(102 days)
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.
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.
This document is a 510(k) Premarket Notification for RenalSoft version 2.0. The device is a "Renal Therapy Clinical Data Management Software" and is substantially equivalent to a predicate device, Renal Link (K990953).
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet all design requirements. | "Validation and verification testing was successful in demonstrating that all design requirements have been met." |
| Demonstrate substantial equivalence to the predicate device. | "Bench testing was performed on RenalSoft to support substantial equivalence to the predicate device..." |
| Device operates as intended. | "...as well as demonstrating that the device operates as intended..." |
| Device is safe and efficacious. | "...and is safe and efficacious." |
| Not raise any new safety and effectiveness issues compared to predicate. | "The proposed product does not raise any new safety and effectiveness issues when compared to the predicate product." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for any test set related to clinical performance. The "Clinical Data" section explicitly states "NA" (Not Applicable). The study mentioned is "Bench testing," which typically refers to internal engineering or software testing, not clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since there is no mention of a clinical test set or clinical data, there is no information provided on experts used to establish ground truth or their qualifications.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
With no clinical test set or expert evaluation, no adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. The device (RenalSoft) is described as a "data repository and data query/reporting system" and a "clinical tool that organizes dialysis therapy data to facilitate clinician decision-making and patient care." It explicitly 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." Therefore, it's not an AI-assisted diagnostic or decision-making tool in the way an MRMC study would typically evaluate improvements in human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a data management system, not an algorithm that performs a standalone diagnostic or interpretive task. Therefore, a standalone performance study in the context of an algorithm's diagnostic accuracy was not performed or is not applicable. The "bench testing" mentioned assessed its functional operation, not clinical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the nature of the device as a data management system, there is no concept of "ground truth" related to a diagnostic or clinical outcome. The "ground truth" for this type of software would revolve around whether the data is correctly stored, retrieved, and presented according to its design requirements and specifications. The document implies that the "ground truth" for the bench testing was the pre-defined design requirements and expected operational behavior.
8. The Sample Size for the Training Set:
The device is a data management system, not a machine learning model that requires a "training set" in the conventional sense of AI. Therefore, a training set size is not applicable and not provided.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI/ML model, this question is not applicable to the RenalSoft device.
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RenalSoft version 2.0
510(k) Premarket Notification
Page 1 of 2
Section 5 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| 510(K) SUMMARYSEP 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 andaccessories per 21 CFR 876.5630 |
| Equivalent Predicate: | Renal Link (K990953) |
| Device Description: | RenalSoft is designed specifically fornephrology and offers an electronic alternative tothe paper medical chart, in accordance with localregulations. RenalSoft provides thefunctions of a data repository and data query/reporting system. RenalSoft is a clinicaltool that organizes dialysis therapy data to facilitateclinician decision-making and patient care. |
| Intended Use: | Renal Soft is designed specifically for nephrologyand offers an electronic alternative to the papermedical chart. RenalSoft provides the functions ofa data repository and data query/reporting system.This software is not intended to be a substitute forgood clinical management practices nor does itsoperation create decisions or treatment pathways. |
| Summary of the TechnologicalCharacteristics Compared toThe Predicate Device: | The general design of RenalSoftis identical to the Renal Therapy Clinical DataManagement Software product cleared underK990953. The proposed product does not raise anynew safety and effectiveness issues whencompared to the predicate product. |
| Clinical Data: | NA |
| Conclusions Drawn: | Validation and verification testing was successfulin demonstrating that all design requirements havebeen met. Bench testing was performed onRenalSoft to support substantialequivalence to the predicate device, as well asdemonstrating that the device operates as intendedand is safe and efficacious. |
| Additional InformationRequested by FDA: | None to date |
Baxter Confidential
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RenalSoft version 2.0
510(k) Premarket Notification
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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
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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
§ 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.