ASPIRA PERITONEAL DRAINAGE SYSTEM

K110396 · C.R. Bard, Inc. · PNG · May 6, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110396
• Device Name: ASPIRA PERITONEAL DRAINAGE SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: PNG · Gastroenterology, Urology
• Decision Date: May 6, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aspira® Peritoneal Drainage System is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

Device Story

The Aspira® Peritoneal Drainage System provides a method for home-based relief of malignant ascites symptoms. The system consists of an indwelling peritoneal drainage catheter and a drainage bag. The catheter is placed to provide long-term access to the peritoneal cavity. Patients or caregivers perform intermittent drainage of accumulated fluid to alleviate symptoms such as dyspnea. The system includes a valve assembly, dressing kit, and luer/universal adapter to facilitate connection to various drainage methods, including wall suction, vacuum bottles, or syringes. By enabling regular, patient-managed fluid removal, the device reduces the need for repeated clinical procedures, thereby improving patient comfort and symptom management.

Clinical Evidence

Bench testing only. Verification and validation activities were performed to demonstrate compliance with predetermined performance specifications and relevant ISO/EN standards, including biocompatibility (ISO 10993), sterilization (ISO 11135, ISO 10993-7), and mechanical integrity (ISO 594, EN 1617, EN 1618).

Technological Characteristics

Catheter-based drainage system. Components include peritoneal catheter, drainage bag, valve assembly, and luer/universal adapter. Materials evaluated per ISO 10993-1. Sterilization via ethylene oxide (ISO 11135, ISO 10993-7). Fittings comply with ISO 594-1/2. Packaging validated per ISO 11607-1/2. System is non-electronic/mechanical.

Indications for Use

Indicated for intermittent drainage of recurrent and symptomatic malignant ascites in patients requiring long-term peritoneal cavity access to relieve symptoms like dyspnea.

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

• Aspira® Peritoneal Drainage System (K081288)

Submission Summary (Full Text)

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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 stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

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

July 18, 2017

C.R. Bard, Inc. Henry Boland Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, UT 84116

Re: K110396

> Trade/Device Name: Aspira® Peritoneal Drainage System Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: PNG Dated: April 6, 2011 Received: April 8, 2011

Dear Henry Boland:

This letter corrects our substantially equivalent letter of May 6, 2011.

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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Page 2 - Henry Boland

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Benjamin R. Fisher -S

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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Bard Access Systems, Inc. Aspira* Peritoneal Drainage Syslem Special 510(k) Premarket Notification

## Indications for Use Statement

510(k) Number (if known): K10396

Device Name: Aspira® Peritoneal Drainage System

Indications for Use:

The Aspira® Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symonomalic malignant asciles. The catheter is intended for long-term access of the perionely in order is intended is intended for long-term
access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter
for intermittent drainage for intermittent drainage.

The Aspira® Dressing Kit is indicated for dressing of a catheter and exit site.

The Aspira® Luer/Universal Adapter is intended to provide access to the Aspira® Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacum bottle, syringe or other suction, water
drainage system, glass vacuum bottle, syringe or other appropriate method.

The Aspira® Valve Assembly altaches to the Aspira® Drainage Catheter. The Aspira® Repair of the Aspira" Aspira" Drainage Catheter. The Aspira
Repair Kit is for the repair of the Aspira" Drainage Catheter and replacement of the Aspira® Valve Assembly.

Prescription Use X Over-The-Counter Use (Part 21 CFR 801 Subpart D) AND/OR (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)

Helena Sauer

of Reproductiv

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K110396

Bard Access Systems, Inc. Aspira® Peritoneal Drainage System Special 510(k) Premarket Notification -Page 16-01-02-PAGE I OF 3

### 510(k) Summary 21 CFR 807.92

MAY

## Aspira* Peritoneal Drainage System

| General<br>Provisions | Submitter Name:<br>Submitter Address: | Bard Access Systems, Inc.<br>605 North 5600 West<br>Salt Lake City, UT 84116 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Henry Boland<br>Regulatory Affairs Specialist<br>[e-mail]<br>801.522.5000 ext. 5428<br>801.522.5425 fax |
| | Date of Preparation: | 9 February 2011 |
| Subject Device | Trade Name: | Aspira* Peritoneal Drainage System |
| | Classification Name: | Peritoneal Dialysis System and Accessories<br>21 CFR 876.5630 - Class II<br>FJS - Peritoneal dialysis system and accessories |
| Predicate<br>Device | Trade Name: | Aspira* Peritoneal Drainage System |
| | Classification Name: | Peritoneal Dialysis System and Accessories<br>21 CFR 876.5630 - Class II<br>FJS - Peritoneal dialysis system and accessories |
| | Premarket Notification: | K081288, concurrence date 18 July 2008 |
| | Manufacturer. | Bard Access Systems, Inc. |
| Device<br>Description | The Aspira* Peritoneal Drainage System provides patients with a convenient<br>method to relieve malignant ascites symptoms at home. The primary<br>components of the Aspira* Peritoneal Drainage System are the Aspira*<br>Peritoneal Drainage Catheter and the Aspira* Drainage Bag. The Aspira*<br>Peritoneal Drainage System. | |
| Intended Use | The Aspira* Peritoneal Drainage System is intended for long-term access of the<br>peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms<br>associated with malignant ascites. | |
| Indications for<br>Use | The Aspira* Peritoneal Drainage System is indicated for intermittent drainage of<br>recurrent and symptomatic malignant ascites. The catheter is intended for long-<br>term access of the peritoneal cavity in order to relieve symptoms such as dyspnea<br>or other symptoms associated with malignant ascites. | |
| Technological<br>Characteristics | Technological characteristics of the subject Aspira* Peritoneal Drainage System<br>are equivalent with respect to the basic catheter design and function to those of<br>the predicate devices. Differences do not raise any new questions regarding<br>safety and effectiveness. | |
| Safety &<br>Performance<br>Tests | Verification and validation activities were designed and performed to<br>demonstrate that the subject Aspira* Peritoneal Drainage System met<br>predetermined performance specifications. The following guidance<br>documents and standards in conjunction with in-house protocols were used to<br>determine appropriate methods for evaluating the performance of the device: | |
| | ISO 10993-1:2009 | Biological Evaluation of Medical Devices Part 1:<br>Evaluation and Testing |
| | ISO 10993-7:2008 | Biological Evaluation of Medical Devices Part 7:<br>Ethylene Oxide Sterilization Residuals |
| | ISO 594-1:1986 | Conical Fittings with 6% (Luer) Taper for Syringes,<br>Needles and Certain Other Medical Equipment -<br>Part 1: General Requirements |
| | ISO-594-2:1998 | Conical Fittings with 6% (Luer) Taper for Syringes,<br>Needles and Certain Other Medical Equipment -<br>Part 2: Lock Fittings |
| | EN 1617:1997 | Sterile Drainage Catheters and Accessory Devices<br>for Single Use |
| | EN 1618:1997 | Catheters Other Than Intravascular Catheters -<br>Test Methods for Common Properties |
| | ISO 11607-1,2:2006 | Packaging for Terminally Sterilized Medical Devices |
| | ISTA -1G:2005<br>BS EN 550:1994 | International Safe Transit Authority Procedure 1G<br>Sterilization of Medical Devices - Validation and<br>Routine Control of Ethylene Oxide Sterilization |
| | ISO 11135-1:2007 | Sterilization of health care products- Ethylene<br>Oxide - Validation and Routine Control of<br>Sterilization Processes for Medical Devices |
| | AAMI TIR 19:1998 | Guidance for ANSI/AAMI/ISO 10993-7:1995,<br>Biological Evaluation of Medical Devices - Part 7:<br>Ethylene Oxide Sterilization Residuals - Replaces<br>AAMI ST29 and AAMI ST30; Cited as relevant<br>guidance to FDA-recognized standard |
| Summary of<br>Substantial<br>Equivalence | Based on the indications for use, technological characteristics, safety, a<br>performance testing, the subject Aspira* Peritoneal Drainage System n<br>the pre-determined requirements under 21 CFR 820.30, Design Control<br>demonstrates that the subject device is substantially equivalent to the<br>predicate device. | |

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#### Bard Access Systems, Inc. Aspira* Peritoneal Drainage System Special 510(k) Premarket Notification

The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device.

* Aspira is the trademark and/or registered trademark of C.R. Bard, Inc. or an affiliate.