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.

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.

AI/ML Overview

This device is a Peritoneal Dialysis (PD) System, not an AI/ML device, therefore most of the requested information (sample sizes, ground truth establishment, MRMC studies, etc.) is not applicable. The document assesses the device's conformance to design specifications and industry standards rather than its performance in an AI/ML context.

Here's an overview of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Reported Device Performance
Design Specifications	Met: The Voyager Peritoneal Dialysis System has been evaluated for conformance to its design specifications. Full system validation and software regression testing were performed to ensure the device functions as intended and that all design requirements have been met.
Applicable Industry Standards for Software Development	Met: The device has been evaluated for conformance to applicable industry standards for software development.
System Compatibility	Met: The device is verified for system compatibility with the devices with which it communicates.
Hardware Certification	Met: Device hardware is certified to applicable safety standards.
Electromagnetic Compatibility (EMC)	Met: EMC testing was conducted according to IEC 60601-1-2. The device was found to meet the requirements defined in that document.
Electrical Safety	Met: Electrical safety testing was conducted according to IEC 60601-1. The device was found to meet the requirements put forth in that document.
Human Factors	Met: Human factors testing was performed. The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria.
Overall Functionality	Met: Full system validation and software regression testing were performed to ensure that the device functions as intended. Bench testing, simulated use testing, and human factors testing were performed 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. The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria. Validation and Verification testing was successful in demonstrating that all design requirements have been met.

Study Information (Based on the context of a non-AI medical device submission):

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of data for an AI/ML model. Instead, the testing described refers to verification and validation activities for a physical medical device and its software.
- The provenance of data (e.g., country of origin, retrospective/prospective) is not applicable or provided, as the studies are focused on product-based engineering assessments (bench testing, simulated use testing, human factors testing, etc.) rather than clinical data analysis for an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the device is not an AI/ML diagnostic tool requiring expert-established ground truth from a "test set" of cases. The validation relies on engineering and regulatory standards.
- The document implies that "a physician who is familiar and well informed about peritoneal dialysis" is responsible for prescribing and performing therapies using the device, but this is for clinical use, not for establishing ground truth for a test set.
Adjudication method for the test set:
- Not applicable, as there is no "test set" in the context of an AI/ML model for which adjudication would be needed.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic or decision-support tool. Therefore, MRMC studies evaluating improvement in human readers with AI assistance were not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is a physical medical device with integrated software, not a standalone AI algorithm. The performance evaluation is of the complete system ("algorithm only" performance is not a relevant concept for this device type).
The type of ground truth used:
- For this device, "ground truth" is established by adherence to predefined engineering specifications, regulatory standards (e.g., IEC 60601-1-2, IEC 60601-1), functional requirements, and the successful outcome of various performance tests (software validation, EMC, electrical safety, human factors, bench testing, simulated use testing). There is no "pathology" or "outcomes data" in the AI/ML sense for ground truth.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device that learns from data. The software is developed and validated, not trained.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.

Summary

{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

{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

Regulation Number and Section

§ 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.