AMIA AUTOMATED PD SYSTEM

K124018 · Deka Research & Development Corp. · FKX · Jun 14, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K124018
• Device Name: AMIA AUTOMATED PD SYSTEM
• Applicant: Deka Research & Development Corp.
• Product Code: FKX · Gastroenterology, Urology
• Decision Date: Jun 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Amia Automated PD System automates dialysate solution exchanges for adult renal failure patients. Device cycles peritoneal dialysis fluid based on clinician-prescribed amounts and timing. Used in clinical or home settings under physician responsibility. System ensures precise fluid management; replaces manual exchange processes; reduces burden on patients/caregivers. Healthcare providers program therapy parameters; device executes cycles; monitors performance. Benefits include consistent therapy delivery and automated fluid control.

Clinical Evidence

No clinical data. Evidence consists of bench testing, software validation, regression testing, biocompatibility (ISO 10993), sterilization, EMC (IEC 60601-1-2), electrical safety (IEC 60601-1), and usability testing. Performance requirements verified under simulated and worst-case environmental conditions.

Technological Characteristics

Automated peritoneal dialysis cycler. Materials comply with ISO 10993. Standards: ISO 10993-1, -4, -5, -7, -11, -12; IEC 60601-1; IEC 60601-1-2; IEC 60601-1-4; IEC 60529; ASTM F756-08; ASTM D4169; ISTA 2A; USP 32. Programmable electrical medical system. Sterilization via Ethylene Oxide.

Indications for Use

Indicated for adult patients with renal failure undergoing peritoneal dialysis. Must be prescribed and performed under physician supervision.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Voyager Peritoneal Dialysis System (K103220)

Submission Summary (Full Text)

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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: [phone] |
| | Fax: [phone] |
| | [e-mail] |

### Device Information

| Common/Usual Name: | Automated peritoneal dialysis (APD) cycler |
|------------------------|---------------------------------------------------------------------------------------------------------|
| | Trade/Proprietary Name: Amia Automated PD System<br>(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

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.

### 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

J

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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 [phone] or [phone] 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