RENAL LINK

K990953 · Baxter Healthcare Corp · KPF · Jun 18, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990953
• Device Name: RENAL LINK
• Applicant: Baxter Healthcare Corp
• Product Code: KPF · Gastroenterology, Urology
• Decision Date: Jun 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 query/reporting system.

Device Story

Renal Link is a clinical data management software system for nephrology. It functions as a digital repository for patient medical data, replacing traditional paper charts. The device enables healthcare providers to query and generate reports from stored clinical information. It is intended for use in clinical environments to assist in managing renal therapy data. By centralizing patient records, it facilitates data access and clinical decision-making for nephrology staff.

Clinical Evidence

No clinical data. Bench testing only; all software functions were tested and validated to meet required specifications.

Technological Characteristics

Software-based clinical data management system utilizing relational database technology. Operates as an accessory to medical devices. No specific hardware, energy source, or sterilization requirements described.

Indications for Use

Indicated for use in nephrology clinical settings as an electronic alternative to paper medical charts for data repository, query, and reporting functions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• cyberREN

Submission Summary (Full Text)

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K990953
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## 510(k) Summary

| Submitter's name: | David E. Curtin |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 1620 Waukegan Rd. MPRA-A2E<br>McGaw Park, IL 60085 |
| Phone: | [phone] |
| Fax: | [phone] |
| 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<br>Hemodialysis system and accessories, 21 CFR 876.5820 |
| Equivalent predicate: | cyberREN |
| Intended Use: | Renal Therapy Clinical Data Management Software (Renal<br>Link) is designed specifically for nephrology and offers an<br>alternative to the paper medical chart. Renal Link provides the<br>functions of a data repository and data querv/reporting system. |
| Summary of the<br>Technological<br>Characteristics<br>compared to the<br>predicate device | Renal Link Clinical Data Management Software (Renal Link)<br>is a software accessory to a medical device based on<br>relational database technology, the same technology<br>as that used by the predicate device. |
| Clinical data: | N/A |
| Conclusions drawn<br>From tests: | All functions of Renal Link have been tested and validated.<br>Based on the validation results, all functions meet their<br>respective required specifications. |

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K990953

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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

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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510(K) Number (if known):

K990953

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

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