(123 days)
No
The summary describes an automated peritoneal dialysis system and a remote data transfer/programming portal. There is no mention of AI, ML, or any features that would typically involve these technologies, such as image processing, predictive analytics, or automated decision-making based on complex data patterns. The Sharesource portal explicitly states it is not intended to be a substitute for good clinical management practices and does not create decisions or treatment pathways.
Yes
The device is intended for the treatment of adult renal failure patients undergoing peritoneal dialysis, which makes it a therapeutic device.
No
The device is described as an "Automated PD System" intended for "automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis." While it allows for review and analysis of historical treatment data, its primary function is therapeutic, not diagnostic.
No
The device description clearly states "The Amia Automated PD System with Sharesource (hereafter "Amia/Sharesource System") device is intended for automatic control of dialysate solution exchanges...". This indicates a hardware component (the cycler) is integral to the system, even though Sharesource is a software accessory.
Based on the provided text, the Amia Automated PD System with Sharesource is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis. This is a therapeutic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the mechanical and software aspects of controlling fluid exchanges for treatment. It does not mention any analysis of biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The Sharesource component is a software accessory for remote communication and data transfer related to the treatment, not for in vitro diagnostic testing.
Therefore, the Amia Automated PD System with Sharesource falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
Amia Automated PD System:
The Amia Automated PD 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 Amia Automated PD System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.
Sharesource:
The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment data to a central database to aid in the review, analysis, and evaluation of patients' historical treatment results. This system is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
Product codes
FKX
Device Description
The Amia Automated PD System with Sharesource (hereafter "Amia/Sharesource System") device is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis therapy. The system automatically cycles peritoneal dialysis fluid in the amounts and at the times prescribed by a clinician familiar and well informed about peritoneal dialysis. The clinician may use the optional Sharesource software accessory to remotely communicate with the Amia Automated PD System. Sharesource will allow the transfer of treatment data originating from the treatment device to the clinician for review of patient historical treatment results. It will also allow the clinician to adjust the device settings of the Amia Automated PD System remotely. Changes to device program by the physician require the patient to review and accept the changes prior to the change of the device program on the cycler. If the patient does not accept the changes, the device will not accept the modified program. The Amia Automated PD System with Sharesource does not include any real-time remote monitoring or real-time remote programming capabilities. A device description is included in Section 11 of this submission.
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, healthcare professionals
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 was tested to verify conformance with the design specifications and applicable industry standards and to verify compatibility and functionality with Sharesource. Complete system verification testing was performed to ensure that the device functions as intended and met all requirements.
In addition, Human Factors evaluations for the Amia Automated PD System and the Sharesource software were conducted in simulated environments to ensure user needs and intended uses were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2015
DEKA Research and Development Corp. Roger A. Leroux Director of Regulatory and Clinical 340 Commercial Street Manchester, NH 03101
Re: K151525
Trade/Device Name: Amia Automated PD System with Sharesource Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: August 9, 2015 Received: September 10, 2015
Dear Roger A. 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.
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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 (reporting of medical device-related 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE
510(k) Number (if known): K151525
Device Name: Amia Automated PD System with Sharesource
Amia Automated PD System:
The Amia Automated PD 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 Amia Automated PD System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.
Sharesource:
The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment data to a central database to aid in the review, analysis, and evaluation of patients' historical treatment results. This system is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
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5. 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR 807.92.
Submitter's Information
| 510(k) Sponsor: | DEKA Research & Development
340 Commercial Street
Manchester, NH 03101 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Roger A. Leroux
Director, Regulatory and Clinical Affairs
DEKA Research & Development Corporation
Phone: (603) 669-5139
Fax: (603) 624-0573
rleroux @dekaresearch.com |
Device Information
| Common/Usual Name: | Automated peritoneal dialysis (APD) cycler |
|---|---|
| Trade/Proprietary Name: | Amia Automated PD System with Sharesource |
| Classification Name: | Peritoneal dialysis system and accessories (21 CFR 876.5630) |
| Device Classification: | II |
| Product Code: | FKX |
| Device Panel: | Gastroenterology/Urology |
Predicate Device(s)
The Amia Automated PD System is substantially equivalent to the Amia Automated PD System, which was previously cleared under application K124018. The HomeChoice PRO Automated Personal Cycler previously cleared under K102936 is also included as a reference predicate. The Sharesource software is substantially equivalent to Baxter Healthcare Corporation's RenalSoft v.2.0, which was previously cleared under K061515. The PDK accessory for the Amia Automated PD System (K124018) is also included as a reference predicate.
Device Description
The Amia Automated PD System with Sharesource (hereafter "Amia/Sharesource System") device is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis therapy. The system automatically cycles peritoneal dialysis fluid in the amounts and at the times prescribed by a clinician familiar and well informed about peritoneal dialysis. The clinician may use the optional Sharesource software
4
accessory to remotely communicate with the Amia Automated PD System. Sharesource will allow the transfer of treatment data originating from the treatment device to the clinician for review of patient historical treatment results. It will also allow the clinician to adjust the device settings of the Amia Automated PD System remotely. Changes to device program by the physician require the patient to review and accept the changes prior to the change of the device program on the cycler. If the patient does not accept the changes, the device will not accept the modified program. The Amia Automated PD System with Sharesource does not include any real-time remote monitoring or real-time remote programming capabilities. A device description is included in Section 11 of this submission.
Indications for Use
Amia Automated PD System:
The Amia Automated PD 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 Amia Automated PD System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.
Sharesource:
The Sharesource portal is intended for use by healthcare professionals to remotely communicate new or modified treatment parameters with compatible dialysis instruments and transfer completed treatment data to a central database to aid in the review, analysis, and evaluation of patients' historical treatment results. This system is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways.
Technological Characteristics
The Amia/Sharesource System has similar technological characteristics as compared to the predicate device(s). Risk analysis has been completed and potential hazards associated with the modifications have been identified and mitigated. All potential risks were deemed acceptable after mitigation.
Performance Data
The device was tested to verify conformance with the design specifications and applicable industry standards and to verify compatibility and functionality with Sharesource. Complete system verification testing was performed to ensure that the device functions as intended and met all requirements.
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In addition, Human Factors evaluations for the Amia Automated PD System and the Sharesource software were conducted in simulated environments to ensure user needs and intended uses were met.
Conclusion
Based on demonstrable evidence, the device modifications described within this submission do not affect the intended use, the fundamental technology or operating principles of the device, nor do any material changes raise safety or effectiveness issues with regard to the Amia Automated PD System with Sharesource. DEKA finds the Amia Automated PD System with Sharesource to be substantially equivalent to the predicate device(s).