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.

Device Description

The Amia Automated PD System is used for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis therapy. The Amia device automatically cycles peritoneal dialysis fluid in the amounts and time prescribed by a clinician.

AI/ML Overview

The provided text describes the Amia Automated PD System and its substantial equivalence to a predicate device, the Voyager Peritoneal Dialysis System (K103220). The document focuses on regulatory compliance and performance testing to demonstrate safety and effectiveness for a 510(k) submission.

Here's an analysis of the acceptance criteria and the study information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Stated Method of Evaluation / Standard	Reported Device Performance
Software Validation & Regression Testing	Software validation and regression testing	"Complete system validation and software regression testing was performed to ensure that the device functions as intended and met all software requirements."
Biocompatibility	ISO 10993-1, -4, -5, -7, -10, -11, -12	"Biocompatibility testing to ISO 10993-1; -4, -5, -7, 10, -11 and -12 . […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Sterilization	Sterilization Testing	"Sterilization Testing […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Ethylene Oxide Sterilization Residuals	ISO 10993-7	"Ethylene Oxide Sterilization Residual testing to ISO 10993-7 […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	"Electromagnetic compatibility (EMC) testing to IEC 60601-1-2 . […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Electrical Safety	IEC 60601-1	"Electrical safety testing to IEC 60601-1 […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
General Requirements for Safety (PEMS)	IEC 60601-1-4 (Programmable electrical medical system)	"General requirements for safety, Programmable electrical medical system-IEC 60601-1-4 […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Usability	Medical electrical equipment General requirements for safety Collateral Standard: Usability	"Medical electrical equipment General requirements for safety Collateral Standard: . Usability […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Degrees of Protection Provided by Enclosures	IEC 60529	"Degrees of Protection Provided by Enclosures - IEC 60529 […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Assessment of Hemolytic Properties	ASTM F756-08 (Standard Practice for Assessment of Hemolytic Properties of Materials)	"Standard Practice for Assessment of Hemolytic Properties of Materials ASTM F756-08 . […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Performance Testing of Shipping Containers	ASTM D4169 (Standard Practice for Performance Testing of Shipping Containers and Systems)	"Standard Practice for Performance Testing of Shipping Containers and Systems ASTM D4169 […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Packaged-Products Basic Requirements	ISTA 2A (Packaged-Products 150 1b (68 kg) or Less Basic Requirements)	"Packaged-Products 150 1b (68 kg) or Less Basic Requirements ISTA 2A . […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Pyrogen Test	USP 32 (USP Rabbit Test)	"Pyrogen test (USP Rabbit Test) USP 32 . . […Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.]"
Functional Performance	Design specifications	"It is in conformance with the design specifications and applicable industry standards for software development. […]. Complete system validation and software regression testing was performed to ensure that the device functions as intended and met all software requirements. Performance testing - All performance requirements were tested under simulated and actual environmental conditions using worst case scenarios to confirm compliance to the stated requirements." "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; therefore, DEKA finds it to be substantially equivalent to the predicate device."
System Compatibility		"It was further verified for system compatibility with the devices with which it communicates."
Risk Analysis	Internal risk assessment process	"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."

Based on the provided text, the following information is NOT available:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "worst case scenarios" for performance testing but does not provide specific sample sizes for any test sets, nor does it specify data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

There is no mention of experts or ground truth establishment for any test sets. The testing described is primarily engineering and regulatory compliance, not clinical performance requiring expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication methods are mentioned as this type of study was not conducted.

5. 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

No MRMC study was conducted or mentioned. This device is an automated cycler, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The tests described ("system validation and software regression testing", "performance testing") represent standalone algorithm/device performance, ensuring the device functions as intended based on its design specifications and relevant standards. However, it's not "algorithm only" in the sense of a medical AI diagnostic algorithm, but rather the functional performance of the APD cycler.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the engineering and regulatory tests performed, the "ground truth" is implied by adherence to established industry standards (e.g., ISO, IEC, ASTM, USP) and the device's own design specifications. There's no clinical "ground truth" like pathology or outcomes data discussed for the validation of the device itself, as this is a device for fluid exchange, not diagnosis or clinical outcome prediction.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning. The device is an automated cycler, not a machine learning model that requires training data.

9. How the ground truth for the training set was established

Not applicable, as no machine learning training set is discussed.

Summary

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JUN 1 4 2013

4. 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(formerly the Voyager Peritoneal Dialysis System)
Classification Name:	Peritoneal dialysis system and accessories (21 CFR 876.5630)
Device Classification:	II
Product Code:	FKX
Device Panel:	Gastroenterology/Urology

Predicate Device

The Amia Automated PD System is substantially equivalent to the Voyager Peritoneal Dialysis System, which was previously cleared under application K 103220.

Device Description

Indications for Use

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.

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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.

Technological Characteristics

The Amia device has the same technological characteristics as compared to its predicate device. 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 Amia device has been evaluated for substantial equivalence to its predicate device.

It is in conformance with the design specifications and applicable industry standards for software development. It was further verified for system compatibility with the devices with which it communicates. Complete system validation and software regression testing was performed to ensure that the device functions as intended and met all software requirements.

Standards testing included:

. Software validation and regression testing
Biocompatibility testing to ISO 10993-1; -4, -5, -7, 10, -11 and -12 .
. Sterilization Testing
. Ethylene Oxide Sterilization Residual testing to ISO 10993-7
Electromagnetic compatibility (EMC) testing to IEC 60601-1-2 .
. Electrical safety testing to IEC 60601-1
. General requirements for safety, Programmable electrical medical system-IEC 60601-1-4
Medical electrical equipment General requirements for safety Collateral Standard: . Usability
. Degrees of Protection Provided by Enclosures - IEC 60529
Standard Practice for Assessment of Hemolytic Properties of Materials ASTM F756-08 .
Standard Practice for Performance Testing of Shipping Containers and Systems ASTM ◆ D4169

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Packaged-Products 150 1b (68 kg) or Less Basic Requirements ISTA 2A .
Pyrogen test (USP Rabbit Test) USP 32 . .

Standards testing results demonstrated that all applicable sections of the identified standards were in conformance to pre-determined acceptance criteria.

Performance testing - All performance requirements were tested under simulated and actual environmental conditions using worst case scenarios to confirm compliance to the stated requirements.

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; therefore, DEKA finds it to be substantially equivalent to the predicate device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2013

DEKA Research & Development Corp. % Mr. Roger Leroux Director of Regulatory and Clinical Affairs 340 Commercial Street MANCHESTER NH 03101

Re: K124018

Trade/Device Name: Amia Automated PD System Regulation Number: 21 CFR§ 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: FKX Dated: May 23, 2013 Received: May 30, 2013

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-Drugand 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 (reporting of

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Page 2 - Mr. Roger Leroux

medical device-related 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/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,

HerbertP.Lerner-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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3. INDICATIONS FOR USE

K124018 510(k) Number (if known):

Device Name: Amia Automated PD System

Indications for Use:

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.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

K124018

Amia Automated PD System - Special 510(k) Section 3. Indications for Use

Dacember 26, 2012 510(k) Page 1

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.