FREEDOM TRAVELLER

K964825 · Impact Case Technologies, Inc. · MLW · May 19, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964825
• Device Name: FREEDOM TRAVELLER
• Applicant: Impact Case Technologies, Inc.
• Product Code: MLW · Gastroenterology, Urology
• Decision Date: May 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For kidney patients who are on continuous ambulatory peritoneal dialysis. To heat the dialysate to within one degree of 98.6. (body temperature) As a preferred alternative to heating the dialysate using a commercial heating pad or microwave oven. The solution is heated in it's original packaging. The solution (dialysate) can be heated when travelling - utilizing the car cigarette lighter. adapter.

Device Story

Freedom Traveller is a portable heating device for dialysate solution bags used by patients on continuous ambulatory peritoneal dialysis (CAPD). Device warms dialysate solution within original packaging to approximately 98.6°F. Designed for travel use; powered via vehicle cigarette lighter adapter. Serves as alternative to heating pads or microwave ovens. Patient-operated; provides consistent temperature control to improve comfort during peritoneal dialysis exchanges.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Portable heating unit; powered by vehicle cigarette lighter adapter (12V DC). Designed to accommodate standard dialysate solution packaging. Temperature regulation mechanism maintains output within 1°F of 98.6°F.

Indications for Use

Indicated for kidney patients undergoing continuous ambulatory peritoneal dialysis (CAPD) requiring dialysate warming to body temperature (98.6°F).

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 19 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mrs. Angela Hamlen
President
Impact Case Technologies, Incorporated
20 Steelcase Road, West,
Unit 6 & 7
Markham, Ontario,
Canada

Re: K964825
Trade Name: Freedom Traveller
Regulatory Class: II
Product Code: MLW
Dated: February 14, 1997
Received: February 25, 1997

Dear Mrs. Hamlen:

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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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

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Page 2 - Mrs. Hamlen

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 vitro 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 at [phone].

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K964825

Device Name: Freedom Traveller

Indications For Use: For kidney patients who are on continuous ambulatory peritoneal dialysis. To heat the dialysate to within one degree of 98.6. (body temperature)

As a preferred alternative to heating the dialysate using a commercial heating pad or microwave oven.

The solution is heated in it's original packaging.

The solution (dialysate) can be heated when travelling - utilizing the car cigarette lighter.

adapter.

(Handwritten: G. A. H. H. H.)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Patents & Accounts
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K964825

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over the Counter Use ☐

(Optional Format 1-2-96)

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