(177 days)
Not Found
No
The description focuses on automated control of dialysis parameters based on physician prescriptions and recorded volumes, with no mention of AI/ML terms or functionalities like learning, adaptation, or complex pattern recognition beyond programmed logic.
Yes
The device is described as treating renal failure patients undergoing peritoneal dialysis, which is a therapeutic intervention.
No
This device is described as an automated personal cycler for peritoneal dialysis, which is a treatment system. It controls the exchange of dialysate solution and records volumes, but it does not perform diagnostic functions like identifying or characterizing a disease.
No
The device description explicitly states it is a "peritoneal dialysis system" and a "cycler" which performs physical actions like heating and pumping solutions, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis." This describes a therapeutic device used directly on a patient for treatment, not a device used to examine specimens taken from the body to provide diagnostic information.
- Device Description: The description further elaborates on the device's function, which involves heating, pumping, and controlling the flow of dialysate solution within the patient's peritoneal cavity. This is a direct treatment process.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the provision of diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
Product codes
FKX
Device Description
The HomeChoice/HomeChoice PRO Automated Personal Cycler is used for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis therapy. The HomeChoice/HomeChoice PRO cycler automates peritoneal dialysis by heating the dialysis solution, pumping the solution to and from the patient, controlling dwell times, accounting for volumes of the solution according to a physician prescribed therapy and recording the ultrafiltration volume produced by the therapy.
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
pediatric and adult
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)
The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. It is further verified for system compatibility with the devices with which it communicates. Device hardware is certified to applicable safety standards.
Full system validation and software verification testing was performed to ensure that the modifications to the HomeChoice/HomeChoice PRO Automated Personal Cycler function as intended and that the modifications did not negatively impact the overall system. Testing included:
- · Software validation and verification testing
- · Electromagnetic compatibility (EMC) testing
- · Electrical safety testing
- · Human Factors Testing
The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria.
Electromagnetic compatibility testing (EMC) was conducted according to the IEC 60601-1-2. The modified HomeChoice/HomeChoice PRO device, outlined in this submission, meets the requirements of IEC 60601-1-2.
Electrical safety testing was conducted according to IEC 60601-1. The modified HomeChoice/HomeChoice PRO device, outlined in this submission, meets the requirements of IEC 60601-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K102936
Page 1 of 3
MAR 3 0 2011
5. 510(K) SUMMARY
DATE PREPARED
September 30, 2010 .
OWNER
Baxter Healthcare Corporation
CONTACT PERSON
| Name: | David E. Curtin |
|---|---|
| Address (street, suite #): | 1620 Waukegan Road |
| Address (City, state, zip code): | McGaw Park, IL 60085 |
| Title: | Director, Global Regulatory Affairs |
| Telephone: | (847) 473-6079 |
| Fax: | (847) 785-5116 |
| Email: | Dave_Curtin@baxter.com |
DEVICE NAME
HomeChoice/HomeChoice PRO Automated Personal Cycler
COMMON NAME
Automated Peritoneal Dialysis (APD) Cycler
CLASSIFICATION NAME
: ·
Peritoneal dialysis system and accessories per 21 CFR 876.5630
PREDICATE DEVICE
| K053512 | HomeChoice/HomeChoice PRO Automated Personal Cycler |
|---|---|
| K012988 | HomeChoice/HomeChoice PRO Automated Personal Cycler |
| K923065 | HomeChoice/HomeChoice PRO Automated Personal Cycler |
1
DEVICE DESCRIPTION
The HomeChoice/HomeChoice PRO Automated Personal Cycler is used for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis therapy. The HomeChoice/HomeChoice PRO cycler automates peritoneal dialysis by heating the dialysis solution, pumping the solution to and from the patient, controlling dwell times, accounting for volumes of the solution according to a physician prescribed therapy and recording the ultrafiltration volume produced by the therapy.
STATEMENT OF INTENDED USE
The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
TECHNOLOGICAL CHARACTERISTICS
The HomeChoice/HomeChoice PRO Automated Personal Cycler with Version 10.4 software intended use and general technological characteristics remain the same as the HomeChoice Automated Personal Cycler predicate device cleared under K053512. K012988 and K923065. It has the same fluid heating, pumping and measurement controls as the predicate device as well as the same safety and effectiveness features, design and materials of construction.
The HomeChoice/HomeChoice PRO Automated Personal Cycler with Version 10.4 software is substantially equivalent to the predicate device.
ASSESSMENT OF NON-CLINICAL DATA
The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. It is further verified for system compatibility with the devices with which it communicates. Device hardware is certified to applicable safety standards.
Full system validation and software verification testing was performed to ensure that the modifications to the HomeChoice/HomeChoice PRO Automated Personal Cycler function as intended and that the modifications did not negatively impact the overall system. Testing included:
2
K102936
Page 3 of
- · Software validation and verification testing
- · Electromagnetic compatibility (EMC) testing
- · Electrical safety testing
- · Human Factors Testing
The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria.
Electromagnetic compatibility testing (EMC) was conducted according to the IEC 60601-1-2. The modified HomeChoice/HomeChoice PRO device, outlined in this submission, meets the requirements of IEC 60601-1-2.
Electrical safety testing was conducted according to IEC 60601-1. The modified HomeChoice/HomeChoice PRO device, outlined in this submission, meets the requirements of IEC 60601-1.
ASSESSMENT OF CLINICAL DATA
Not Applicable
CONCLUSION
Based upon the results of non-clinical testing, the modified HomeChoice/HomeChoice PRO device is safe and effective, and performs equivalently to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Baxter Healthcare Corporation c/o Lisa Skeens, Ph.D Vice President, Global Regulatory Affairs 1620 Waukegan Road MCGAW PARK, IL 60085
MAR 3 0 2011
Re: K102936
Trade/Device Name: HomeChoice / HomeChoice PRO Automated Personal Cycler Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: 'September 30, 2010 Received: October 4, 2010
Dear Dr. Skeens:
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. Please note: CDRH does not evaluate information related to contract liability · warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting of medical device-related
4
Page 2
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
5
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: HomeChoice/HomeChoice Pro Automated Personal Cycler
Indication(s) for Use:
The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
| Prescription Use: | Over-the-Counter Use: |
|---|---|
| 21 CFR 801 Subpart D | 21 CFR Subpart C |
lozu Mzhy