RENALSOFT

K061515 · Baxter Healthcare Corp · KPF · Sep 11, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061515
• Device Name: RENALSOFT
• Applicant: Baxter Healthcare Corp
• Product Code: KPF · Gastroenterology, Urology
• Decision Date: Sep 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

RenalSoft is a clinical data management software for nephrology; serves as an electronic alternative to paper medical charts. Functions as a data repository and query/reporting system; organizes dialysis therapy data. Operated by clinicians to facilitate decision-making and patient care. Does not create treatment pathways or substitute for clinical judgment. Used in clinical settings to manage patient records.

Clinical Evidence

No clinical data. Bench testing was performed to verify design requirements and demonstrate that the device operates as intended.

Technological Characteristics

Software-based clinical data management system. Functions as a data repository and query/reporting tool. No hardware components described.

Indications for Use

Indicated for use in nephrology settings as an electronic medical record alternative for data repository and reporting functions. Not intended to substitute for clinical management or generate treatment pathways.

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

• Renal Link (K990953)

Submission Summary (Full Text)

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K061515

RenalSoft version 2.0
510(k) Premarket Notification

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Page 1 of 2
Section 5 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| | 510(K) SUMMARY<br>SEP 11 2006 |
|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name: | Michael C. Garcia |
| Address: | 1620 Waukegan Rd.<br>McGaw Park, IL 60085 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | David E. Curtin - [phone] |
| 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<br>accessories per 21 CFR 876.5630 |
| Equivalent Predicate: | Renal Link (K990953) |
| Device Description: | RenalSoft is designed specifically for<br>nephrology and offers an electronic alternative to<br>the paper medical chart, in accordance with local<br>regulations. RenalSoft provides the<br>functions of a data repository and data query/<br>reporting system. RenalSoft is a clinical<br>tool that organizes dialysis therapy data to facilitate<br>clinician decision-making and patient care. |
| Intended Use: | Renal Soft is designed specifically for nephrology<br>and offers an electronic alternative to the paper<br>medical chart. RenalSoft provides the functions of<br>a data repository and data query/reporting system.<br>This software is not intended to be a substitute for<br>good clinical management practices nor does its<br>operation create decisions or treatment pathways. |
| Summary of the Technological<br>Characteristics Compared to<br>The Predicate Device: | The general design of RenalSoft<br>is identical to the Renal Therapy Clinical Data<br>Management Software product cleared under<br>K990953. The proposed product does not raise any<br>new safety and effectiveness issues when<br>compared to the predicate product. |
| Clinical Data: | NA |
| Conclusions Drawn: | Validation and verification testing was successful<br>in demonstrating that all design requirements have<br>been met. Bench testing was performed on<br>RenalSoft to support substantial<br>equivalence to the predicate device, as well as<br>demonstrating that the device operates as intended<br>and is safe and efficacious. |
| Additional Information<br>Requested by FDA: | None to date |

Baxter Confidential

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K061515

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.

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ing and Promoting Public S.

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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 [phone] or [phone]

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)-

| | <i>Nancy Brogdon</i> |
|---------------|---------------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, and Radiological Devices |
| 510(k) Number | K061515 |

Baxter Confidential