(270 days)
No
The summary describes an automated system for controlling dialysate exchanges based on prescribed parameters, with no mention of AI or ML technologies.
Yes
The device is used for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis, which is a therapeutic intervention.
No
The device is used for treatment (peritoneal dialysis), not for diagnosing a condition.
No
The device description explicitly states it is a "System" used for "automatic control of dialysate solution exchanges," implying the presence of hardware components (like pumps, valves, sensors) to physically manage the fluid flow, which is not characteristic of a software-only device. The performance studies also mention "Bench testing, simulated use testing, and human factors testing" on the "Voyager Peritoneal Dialysis System," further suggesting a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The description of the Voyager Peritoneal Dialysis System clearly states it is used for "automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis." This involves directly treating the patient by cycling fluid within their body, not analyzing a sample taken from the body.
- The intended use is therapeutic, not diagnostic. The purpose is to treat renal failure, not to diagnose a condition or provide information about a patient's health status based on a sample.
The device is a therapeutic medical device used for a specific treatment procedure.
N/A
Intended Use / Indications for Use
The Voyager Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis. All therapies using the Voyager Peritoneal Dialysis System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.
Product codes (comma separated list FDA assigned to the subject device)
FKX
Device Description
The Voyager Peritoneal Dialysis (PD) System is used for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis therapy. The Voyager Peritoneal Dialysis (PD) System automatically cycles peritoneal dialysis fluid in the amounts and time prescribed by a clinician.
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
Adult
Intended User / Care Setting
Physician / 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 Voyager Peritoneal Dialysis System 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 regression testing was performed to ensure that the device functions as intended. Testing included:
- Software validation and regression 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 device was found to meet the requirements defined in that document. Electrical safety testing was conducted according to IEC 60601-1. The device was found to meet the requirements put forth in that document.
Validation and Verification testing was successful in demonstrating that all design requirements have been met. Bench testing, simulated use testing, and human factors testing were performed on the Voyager Peritoneal Dialysis System to support substantial equivalence to the predicate device and demonstrate that the device performs as intended and is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APPENDIX 12 - 510(K) SUMMARY
Voyager Peritoneal Dialysis (PD) System
JUL 2 9 2011
Applicant
DEKA Research & Development Corporation 340 Commercial Street Manchester, NH 03101-1129
Contact Information
| Name: | Roger Leroux, Director of Regulatory and Clinical Affairs |
|---|---|
| Telephone: | (603) 669-5139 |
| E-mail: | rleroux@dekaresearch.com |
| Date Prepared: | October 29, 2010 |
Device
| Proprietary Name: | Voyager Peritoneal Dialysis (PD) System |
|---|---|
| Common/Usual Name: | Automated Peritoneal Dialysis (ADP) Cycler |
| Classification: | Peritoneal dialysis system and accessories per 21 CFR 876.5630 |
| Device Class | II |
| Product Code: | FKX |
Predicate Devices
The Voyager Peritoneal Dialysis (PD) System is substantially equivalent to the HomeChoice Automated Personal Cycler, which was previously cleared under applications K053512, K012988, and originally K923065. The Voyager System has the same intended use (with the exception that it is not intended for pediatric use) and similar technological characteristics.
The Voyager device is also substantially equivalent to the Fresenius Liberty Cycler and Disposable Cycler Set which was cleared under application K043363.
Device Description
The Voyager Peritoneal Dialysis (PD) System is used for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis therapy. The Voyager Peritoneal Dialysis (PD) System automatically cycles peritoneal dialysis fluid in the amounts and time prescribed by a clinician.
1
KI03220
Indications for Use
The Voyager Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis
All therapies using the Voyager Peritoneal Dialysis System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.
Assessment of Non-clinical Data
The Voyager Peritoneal Dialysis System 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 regression testing was performed to ensure that the device functions as intended. Testing included:
- Software validation and regression 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 device was found to meet the requirements defined in that document.
Electrical safety testing was conducted according to IEC 60601-1. The device was found to meet the requirements put forth in that document.
Assessment of Clinical Data
Not applicable
Conclusion
Validation and Verification testing was successful in demonstrating that all design requirements have been met. Bench testing, simulated use testing, and human factors
2
K103220
testing were performed on the Voyager Peritoneal Dialysis System to support substantial equivalence to the predicate device and demonstrate that the device performs as intended and is as safe and effective as 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 eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Roger A. Leroux Director of Regulatory and Clinical Affairs DEKA Research & Development Corporation 340 Commercial Street MANCHESTER NH 03101
JUL 2 9 2011
Re: K103220
Trade/Device Name: Voyager Peritoneal Dialysis (PD) System Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: July 19, 2011 Received: July 20, 2011
Dear Mr. Leroux:
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 (OS) 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/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.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Hichard Levens 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
510(k) Number (if known): K/032220
Device Name: Voyager Peritoneal Dialysis (PD) System
Indications for Use:
The Voyager Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis.
All therapies using the Voyager Peritoneal Dialysis System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.
Prescription Use
Use
AND/OR
Over-The-Counter
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Hal Kem
(Division Sign-Off)
Division of Reproductive,, Gastro-Renal, and
Urological Devices
510(k) Number K103220
Voyager Peritoneal Dialysis System - 510(k) Section 4 - Indications For Use
October 29, 2010