(315 days)
No
The 510(k) summary describes a mechanical drainage system and does not mention any AI or ML components or functionalities.
Yes.
The device is indicated for the "intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites" and for "palliation of symptoms" related to this condition, which directly addresses a medical condition and symptoms.
No
This device is designed for the drainage of accumulated fluid, specifically ascites, from the peritoneal cavity for symptomatic relief, not for diagnosing conditions.
No
The device description explicitly states the primary components are a physical catheter and a drainage kit, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes.
- Device Function: The ASEPT Peritoneal Drainage System is a device used to drain accumulated fluid from the peritoneal cavity. It is a therapeutic device, not a diagnostic one. It is used to manage symptoms (ascites) rather than to diagnose a condition by analyzing a sample.
- Intended Use: The intended use clearly states it is for "intermittent, long-term drainage" and "palliation of symptoms." This is a treatment function, not a diagnostic one.
- Device Description: The description focuses on the physical components and their function in draining fluid from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing bodily fluids, using reagents, or providing diagnostic information based on the drained fluid.
Therefore, the ASEPT Peritoneal Drainage System falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ASEPT Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites.
The use of the ASEPT Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The ASEPT Peritoneal Catheter is indicated for adults only.
Product codes
PNG
Device Description
The ASEPT Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
Indicated Patient Age Range
adults only.
Intended User / Care Setting
Home or in the hospital.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed on the ASEPT Peritoneal Catheter and replacement valve to demonstrate substantial equivalence. The performance testing requirements were determined by the predicate and reference devices and assessment of risk.
No clinical tests were conducted for this submission. The modified indications for use statement was supported using a clinical literature review. The literature review demonstrates that peritoneal drainage catheters have a history of safety and efficacy in non-malignant refractory ascites and that the incidence of device related complications is more closely related to patient specific health status and preferences than the underlying cause (malignant vs non-malignant) of ascites.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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May 2, 2023
PFM Medical, Inc. Jessica Jho Director of Regulatory Affairs 1916 Palomar Oaks Way, Suite 150 Carlsbad, California 92008
Re: K221779
Trade/Device Name: ASEPT® Peritoneal Drainage System Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: Class II Product Code: PNG Dated: March 30, 2023 Received: March 31, 2023
Dear Jessica Jho:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kits have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kits. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gema Gonzalez -S
Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221779
Device Name ASEPT® Peritoneal Drainage System
Indications for Use (Describe)
The ASEPT Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites.
The use of the ASEPT Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-iugular intrahepatic portosystemic shunt or LVP. The ASEPT Peritoneal Catheter is indicated for adults only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER | PFM Medical, Inc
1916 Palomar Oaks Way, Suite 150
Carlsbad, CA 92008, USA |
|-----|-------------------------------------------------------|-------------------------------------------------------------------------------------------|
| | Contact Person: | Jessica Jho
Director, Regulatory Affairs
PFM Medical, Inc
JJho@pfmmedicalusa.com |
| | Date Summary Prepared: | May 1, 2023 |
| II. | DEVICE | |
| | Trade or Proprietary Name
Common Name | ASEPT® Peritoneal Drainage System
Peritoneal catheter, long term, indwelling |
| | Device Class
Regulation Number
FDA Product Code | Class II
21 CFR §876.5630
PNG. Peritoneal. Drainage Catheter for Refractory |
III. LEGALLY MARGETED PREDICATE DEVICES
| Predicate Device | ||
|---|---|---|
| 510(k) | Product Name | Clearance Date |
| K093796 | ASEPT Peritoneal Drainage System | February 26, 2010 |
| Reference Device | ||
| 510(k) | Product Name | Clearance Date |
| K201155 | PleurX Peritoneal Catheter System | October 21, 2020 |
Ascites, Long-Term Indwelling
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IV. DEVICE DESCRIPTION
The ASEPT Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital.
V. INTENDED USE
The intended use of an indwelling peritoneal drainage catheter is for drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
VI. INDICATIONS FOR USE
The ASEPT Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites.
The use of the ASEPT Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The ASEPT Peritoneal Catheter is indicated for adults only.
VII. TECHNICAL COMPARISON TO PREDICATE
The technological design features of the subject device including intended use, design, materials, drainage function and method, and fundamental scientific technology, were compared to the predicate device and it was demonstrated that they are substantially equivalent.
PERFORMANCE DATA VIII.
Bench testing was performed on the ASEPT Peritoneal Catheter and replacement valve to demonstrate substantial equivalence. The performance testing requirements were determined by the predicate and reference devices and assessment of risk.
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IX. SUMMARY OF CLINICAL TESTS REFERENCED
No clinical tests were conducted for this submission. The modified indications for use statement was supported using a clinical literature review. The literature review demonstrates that peritoneal drainage catheters have a history of safety and efficacy in non-malignant refractory ascites and that the incidence of device related complications is more closely related to patient specific health status and preferences than the underlying cause (malignant vs non-malignant) of ascites.
X. CONCLUSION
Based on the information provided in this 510(k) submission, it has been determined that the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device.