(88 days)
Not Found
Not Found
No
The summary explicitly states the device is based on relational database technology and does not mention AI, ML, or related terms.
No.
The "Intended Use" section states that Renal Link is "Clinical Data Management Software" designed for "data repository and data query/reporting system," which manages clinical data rather than directly providing therapy.
No
The device is described as clinical data management software that functions as a data repository and data query/reporting system for nephrology, offering an alternative to paper medical charts. It does not perform any diagnostic functions.
Yes
The device is explicitly described as "Clinical Data Management Software" and a "software accessory to a medical device," with no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "Renal Therapy Clinical Data Management Software" that acts as a "data repository and data query/reporting system" for nephrology. This focuses on managing and reporting clinical data, not on performing tests on samples taken from the human body to provide diagnostic information.
- Device Description: It's described as a "software accessory to a medical device based on relational database technology." This further reinforces its role as a data management tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic results based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This software's function is to manage and report existing clinical data, which is a different purpose.
N/A
Intended Use / Indications for Use
Renal Therapy Clinical Data Management Software (Renal Link) is designed specifically for nephrology and offers an alternative to the paper medical chart. Renal Link provides the functions of a data repository and data querv/reporting system.
Renal Therapy Clinical Data Management Software is designed specifically for nephrology and offers an electronic alternative to the paper medical chart. Renal Link provides the functions of a data repository and data query/reporting system.
Product codes (comma separated list FDA assigned to the subject device)
21 CFR 876.5630, 21 CFR 876.5820
Device Description
Renal Link Clinical Data Management Software (Renal Link) is a software accessory to a medical device based on relational database technology, the same technology as that used by the predicate device.
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)
All functions of Renal Link have been tested and validated. Based on the validation results, all functions meet their respective required specifications.
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.
cyberREN
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
K990953
P. 1/2
510(k) Summary
| Submitter's name: | David E. Curtin |
|---|---|
| Address: | 1620 Waukegan Rd. MPRA-A2E |
| McGaw Park, IL 60085 | |
| Phone: | (847) 473-6079 |
| Fax: | (847) 473-6952 |
| Contact: | Robert L. Wilkinson or David E. Curtin |
| Date Prepared: | March 4, 1999 |
| Trade name: | Renal Link |
| Common name: | Baxter's Renal Therapy Clinical Data Management Software |
| Classification Name: | Peritoneal dialysis system and accessories, 21 CFR 876.5630 |
| Hemodialysis system and accessories, 21 CFR 876.5820 | |
| Equivalent predicate: | cyberREN |
| Intended Use: | Renal Therapy Clinical Data Management Software (Renal |
| Link) is designed specifically for nephrology and offers an | |
| alternative to the paper medical chart. Renal Link provides the | |
| functions of a data repository and data querv/reporting system. | |
| Summary of the | |
| Technological | |
| Characteristics | |
| compared to the | |
| predicate device | Renal Link Clinical Data Management Software (Renal Link) |
| is a software accessory to a medical device based on | |
| relational database technology, the same technology | |
| as that used by the predicate device. | |
| Clinical data: | N/A |
| Conclusions drawn | |
| From tests: | All functions of Renal Link have been tested and validated. |
| Based on the validation results, all functions meet their | |
| respective required specifications. |
1
p. 2/2
Additional Information Requested by FDA: None
Official Correspondent:
Robert L. Wilkinson Director, Regulatory Affairs Renal Division
Prepared by:
David L. Curtin,`
3-19-99
David E. Curtin, RAC Date
David E. Curtin, RAC Manager, Regulatory Affairs Renal Division Baxter Healthcare Corporation
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/2 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the logo is a stylized image of an eagle or other bird with its wings spread. The logo is black and white.
JUN 18 1999
Mr. David E. Curtin, R.A.C. Manager, Regulatory Affairs Renal Division Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, IL 60085
Re: Kaadasa
Renal Therapy Clinical Data Management Software (Renal Link®) Dated: March 19, 1999 Received: March 22, 1999 Regulatory Class: Il 21 CFR $876.5630/78 KPF 21 CFR $876,5820/78 FKP
Dear Mr. Curtin:
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 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requiring may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 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 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 and additionally 809.10 for in vilro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(K) Number (if known):
Renal Therapy Clinical Data Management Software Device Name:
Indications for Use: Renal Therapy Clinical Data Management Software is designed specifically for nephrology and offers an electronic alternative to the paper medical chart. Renal Link provides the functions of a data repository and data query/reporting system.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter Use_
Division Sign-Off) of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
(Optional Format 1/2/96
g:\510(k)\RenalLink\indicuse-1
23