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 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.

AI/ML Overview

The provided text is a 510(k) summary for the "Asept Peritoneal Drainage System." It focuses on demonstrating substantial equivalence to a predicate device through in vitro testing, rather than presenting a study to prove acceptance criteria for an AI/ML powered device.

Therefore, many of the requested sections related to acceptance criteria, ground truth, expert involvement, and AI performance metrics are not applicable to this document. The device described is a physical medical device (a drainage system) and not a software algorithm that would have "acceptance criteria" in the way associated with AI/ML performance.

Here's a breakdown of what can be extracted and what is not applicable:

1. A table of acceptance criteria and the reported device performance:

Since this is a physical device submission focused on in vitro testing to demonstrate substantial equivalence, the "acceptance criteria" are implied by the standards and the performance of the predicate device. The document states:

Acceptance Criteria (Implied by standard and predicate)	Reported Device Performance
Leakage performance (per BS EN 1618-1997)	Met
Flow rate performance (per BS EN 1618-1997)	Met
Tensile strength performance (per BS EN 1618-1997)	Met
Corrosion resistance (per BS EN 1618-1997)	Met
Biocompatibility (per ISO 10993)	Met (or identical to legally marketed devices)

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

Sample size: Not explicitly stated for each in vitro test, but implied to be sufficient for the tests mentioned by the standard BS EN 1618-1997.
Data provenance: Not applicable. The testing was in vitro (laboratory-based) on the device itself, not on patient data.

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):

Not Applicable: This pertains to clinical studies or expert review of data, neither of which were performed. The "ground truth" for in vitro testing is defined by the physical or chemical properties measured.

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

Not Applicable: Adjudication is a process for resolving discrepancies in expert ratings or clinical outcomes, which did not occur here.

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:

Not Applicable: This is an AI/ML specific study type, and the device is a physical drainage system.

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

Not Applicable: This refers to AI/ML algorithm performance.

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

In vitro measurements: The ground truth for the in vitro tests (leakage, flow rate, tensile strength, corrosion, biocompatibility) would be based on the established scientific and engineering principles, measurement instruments, and reference standards defined by the BS EN 1618-1997 and ISO 10993 standards.

8. The sample size for the training set:

Not Applicable: There is no "training set" as this is not an AI/ML device.

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

Not Applicable: There is no "training set" as this is not an AI/ML device.

Summary of what the document does say about meeting criteria:

The document states, "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." It also mentions, "Materials used in the Asept Peritoneal Drainage System meet the requirements of ISO 10993 or Identical to legally marketed devices."

The key takeaway is that the device demonstrated safety and effectiveness through in vitro testing and comparison to legally marketed predicate devices, not through clinical trials or AI/ML performance studies.

Summary

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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 (800) 633-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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:

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.

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.