ASEPT PERITONEAL DRAINAGE SYSTEM

K093796 · Pfm Medical, Inc. · PNG · Feb 26, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K093796
• Device Name: ASEPT PERITONEAL DRAINAGE SYSTEM
• Applicant: Pfm Medical, Inc.
• Product Code: PNG · Gastroenterology, Urology
• Decision Date: Feb 26, 2010
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 876.5630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Asept Peritoneal Drainage System is indicated for periodic drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long term access of the peritoneal cavity in order to relieve symptoms such as dyspnea.

Device Story

Asept Peritoneal Drainage System is a tunneled, indwelling catheter system for draining accumulated abdominal fluid. System components include an indwelling peritoneal catheter and drainage kits. The catheter proximal end features a valve preventing fluid/air exchange until breached. The valve is breached by connecting the drainage catheter to wall suction, pleurovac, or vacuum bottles. Used in home or hospital settings; operated by patients or clinicians. Provides convenient, periodic relief of malignant ascites symptoms; enables long-term peritoneal access.

Clinical Evidence

No clinical data. Safety and effectiveness were demonstrated through in vitro bench testing, including leakage, flow rate, tensile strength, and corrosion testing in accordance with BS EN 1618-1997, and biocompatibility testing per ISO 10993.

Technological Characteristics

Tunneled, indwelling catheter system. Materials meet ISO 10993 requirements. Features a valve-based proximal end for fluid control. Performance testing conducted per BS EN 1618-1997. No electronic components or software.

Indications for Use

Indicated for patients with recurrent and symptomatic malignant ascites requiring periodic drainage and long-term peritoneal cavity access for symptom relief (e.g., 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

• Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits (K051711)
• Asept Pleural Drainage System (K093307)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

July 18, 2017

PFM Medical, Inc. Salvadore F. Palomares, RAC Director of Regulatory Affairs 2605 Temple Heights Drive, Suite A Oceanside, CA 92056

Re: K093796

> Trade/Device Name: Asept Peritoneal Drainage System Regulation Number: 21 CFR §876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: PNG Dated: December 10, 2010 Received: December 11, 2010

Dear Salvadore F. Palomares:

This letter corrects our substantially equivalent letter of February 26, 2010.

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 - Salvadore F. Palomares, RAC

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/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 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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K093796

181

510(k):

Kog3796

Device Name:

Indications for Use:

The Asept Peritoneal Drainage System is indicated

Asept Peritoneal Drainage System

for periodic drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long term access of the peritoneal cavity in order to relieve symptoms such as dyspnea.

Prescription Use × (Per 21 CFR 801 Subpart D)

AND/OR

Over the Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

.(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

్రాల

. ﺃ ー。

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K093796

181

## 510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

| Name: | PFM Medical, Inc |
|-----------------|-----------------------------|
| Address: | 2605 Temple Heights Drive |
| | Suite A |
| | Oceanside, CA 92056 |
| Contact Person: | SALVADORE F. PALOMARES, RAC |

FEB 2 6 2010

#### 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | |
|--------------------------------|------------------------------------------------------------|
| Trade Name: | Asept Peritoneal Drainage System |
| Common Name: | Catheter, Peritoneal, Long-Term Indwelling and Accessories |
| Classification: | FJS |
| Equivalent Devices: | |
| Manufacturer: | Denver Biomedical (Cardinal Health) |
| Name: | Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits |
| 510(k) #: | K051711 |
| Manufacturer: | PFM Medical |
| Name: | Asept Pleural Drainage System |
| 510(k) #: | K093307 |

#### Device Description:

The Asept Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen. The catheler is implanted in the patient's peritoneal cavity enabling the patient to perform periodic perioneal drainage at home or hospital. The primary components of the system are the Asept indwelling Peritoneal Catheter and the Asept Drainage Kit. The proximal end of the indwelling catheter has a valve that prevents fluid or air from moving in or out of the peritoneal space until the valve is breached. The valve can be breached by the Asept Peritoneal Drainage catheter connected to wall suction or pleurovac or vacuum bottles. The Asept Peritoneal Drainage System provides patients with a convenient way to relieve malignant ascites symploms at home.

#### Intended Use:

The Asept Periloneal Drainage System is indicated for periodic drainage of recurrent and symplomatic malignant asciles. The catheter is intended for long term access of the pentoneal cavity in order to relieve symptoms such as dyspnea.

#### Performance Data:

In vitro testing was performed on the Asept Peritoneal Drainage System to assure reliable design and performance in accordance with BS EN 1618-1997. Testing includes leakage, flow rate, tensile strength, and corrosion.

Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device.

#### Biocompatibility:

Materials used in the Asept Periloneal Drainage System meet the requirements of ISO 10993 or Identical to legally marketed devices.