(168 days)
For kidney patients who are on continuous ambulatory peritoneal dialysis. To heat the cialysate to within one degree of 98.6.(body temperature) As a preferred alternative to heating the dialysate using a commercial heating pad on microwave oven. The solution is heated in it's original packaging, The solution (dialysate) can be heated when travelling the car cigarette lighter adapter.
Not Found
I'm sorry, but the provided text does not contain enough information to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Freedom Traveller," which is used to heat dialysate for kidney patients.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size for test or training sets.
- Information on expert ground truth establishment or adjudication methods.
- Any multi-reader multi-case (MRMC) study results or effect sizes.
- Standalone algorithm performance.
- Specific types of ground truth used.
The only technical detail provided regarding performance is in the "Indications For Use" section, stating: "To heat the dialysate to within one degree of 98.6 (body temperature)." This is an indication for use, not an acceptance criterion with associated study data.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a partial view of a seal or emblem, likely from a government or organizational context. The right side of the image features a stylized graphic, possibly representing an eagle or a similar symbol, rendered in a minimalist, abstract style with thick, curved lines. To the left, there's a portion of text arranged in a circular pattern, suggesting it's part of the seal's border, with the words 'DEPARTMENT OF HEALTH & HUMAN' visible.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 1997
Mrs. Angela Hamlen ·President Impact Case Technologies, Incorporated 20 Steelcase Road, West, Unit 6 & 7 Markham, Ontario, Canada
K964825 Re : Freedom Traveller Trade Name: Regulatory Class: 11 Product Code: MLW February 14, 1997 Dated: 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, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Fitle 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 requlation 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
{1}------------------------------------------------
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one 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 at (301) 443-6597.
Sincerely yours,
-
- Mildred
Timothy A. Ulatowski Diredtor Division of Dental, Infection Control
and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Page1_________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): _ K964825
Oevice Name: Freedom Traveller
For kidney patients who are on continuous ambulatory peritoneal Indications I-or Use: dialysis. To heat the cialysate to within one degree of 98.6.(body temperature)
As a preferred alternative to heating the dialysate using a commercial heating pad on microwave oven.
The solution is heated in it's original packaging,
The solution (dialysate) can be heated when travelling the car cigarette lighter
adapter.
Ged And
Angela Hamlow
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Patricia Accente
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number X964825
Prescription Use (Pac 21 CFR 801 109)
Over The-Counter Use_____
(Optional Format 1-2-96)
§ 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.