(112 days)
No reference devices were used in this submission.
No
The summary describes a mechanical drainage system and does not mention any AI or ML components or functionalities.
Yes.
The device is intended to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites, which is a therapeutic purpose.
No
The device is intended for drainage to relieve symptoms, not for diagnosing a condition.
No
The device description and performance studies clearly indicate that the Aspira Peritoneal Drainage System is comprised of physical components like catheters, bags, bottles, and valve assemblies, not just software.
Based on the provided information, the Aspira Peritoneal Drainage System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites." This describes a therapeutic intervention (draining fluid to alleviate symptoms), not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on the physical components used for drainage (catheter, bags, bottle).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic purposes. The Aspira system is designed to remove fluid from the body for symptomatic relief.
N/A
Intended Use / Indications for 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.
•Aspira Drainage Catheter: The Aspira Dramage catheter is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieves symptoms such as dyspnea or other symptoms associated with malignant ascites.
• Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for internittent drainage.
•Aspira Drainage Bottle: The Aspira Drainage Bottle is indicated for use only with the Aspira Valve Assembly for intermittent drainage.
• Aspira Dressing Kit: The Aspira Dressing Kit is indicated for dressing of the drainage catheter and exit site.
•Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with Aspira, PleurX® and Rocket® catheters.
• Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method. · Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe,or other appropriate method.
Product codes (comma separated list FDA assigned to the subject device)
PNG
Device Description
The Aspira Peritoneal Drainage System provides patients with a convenient method to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites at home. The primary components of the Aspira Peritoneal Drainage System are the Aspira Peritoneal Drainage Catheter, the Aspira Drainage Bag, and the Aspira Drainage Bottle.
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
Not Found
Intended User / Care Setting
Not Found
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)
Performance Testing-Bench
Aspira Valve – Compatibility with Competitive Drainage Catheters (Aspira, Asept®, PleurX® and Rocket® catheters)
Catheter Leak Test - Negative Pressure
Tensile Strength – Valve Assembly to Catheter
Design Validation - Insertion Forces
Aspira Drainage Bottle
1000 mL Fluid Pull
Leak Test
Barb to Tubing Tensile
Tubing to Connector Tensile
Tubing Impact Resistance
Human Factors Engineering/User Engineering
Simulated Use
Drainage Speed Control
Bottle Emptying
Bottle Activation Force
Bottle Activation Method
Drainage Time
Indication of FullFlow
Intuitiveness of Status
Handle Reseal Ability
Grip Comfort when Empty
Grip Comfort when Full
IFU Understandability for Lay Users
Ease of Use
Vacuum Loss
Fluid Leak
The results of the testing demonstrated that the subject Aspira Peritoneal Drainage System met the predetermined acceptance criteria applicable to the safety and efficacy of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2021
Merit Medical Systems, Inc. Jennifer Webb Regulatory Affairs Manager 1600 West Merit Parkway South Jordan, Utah 84095
Re: K212675
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: November 16, 2021 Received: November 18, 2021
Dear Jennifer Webb:
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 kit 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 kit/tray. 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,
Glenn B Bell, Ph.D. Director THT3A1: Renal. Gastrointestinal. Obesity and Transplantation Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212675
Device Name
Aspira Peritoneal Drainage System
Indications for Use (Describe)
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.
•Aspira Drainage Catheter: The Aspira Dramage catheter is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieves symptoms such as dyspnea or other symptoms associated with malignant ascites.
• Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for internittent drainage.
•Aspira Drainage Bottle: The Aspira Drainage Bottle is indicated for use only with the Aspira Valve Assembly for intermittent drainage.
• Aspira Dressing Kit: The Aspira Dressing Kit is indicated for dressing of the drainage catheter and exit site.
•Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with Aspira, PleurX® and Rocket® catheters.
• Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method. · Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe,or other appropriate method.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems Inc.
1600 West Merit Parkway
South Jordan UT 84095
(801) 208-4247
Jennifer Webb
20 Aug 2021
1721504 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Aspira Peritoneal Drainage System
Tunneled drainage catheter system
Peritoneal Dialysis System and Accessories
Ascites, Long-Term Indwelling
2
PNG
876.5630
Gastroenterology/Urology |
| Predicate
Device | Trade Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel:
Premarket Notification:
Manufacturer: | Aspira Peritoneal Drainage System
Peritoneal Dialysis System and Accessories
Ascites, Long-Term Indwelling
2
PNG
876.5630
Gastroenterology/Urology
K110396
Merit Medical Systems, Inc.
This predicate has not been subject to a design-related recall. |
| Reference
Device | No reference devices were used in this submission. | |
| Device
Description | The Aspira Peritoneal Drainage System provides patients with a
convenient method to relieve symptoms such as dyspnea or other
symptoms associated with malignant ascites at home. The primary
components of the Aspira Peritoneal Drainage System are the Aspira
Peritoneal Drainage Catheter, the Aspira Drainage Bag, and the Aspira
Drainage Bottle. | |
| 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. | |
| Indications for
Use | Aspira Drainage Catheter: The Aspira Drainage catheter is indicated for intermittent 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 or other symptoms associated with malignant ascites. Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for intermittent drainage. Aspira Drainage Bottle: The Aspira Drainage Bottle is indicated for use only with the Aspira Valve Assembly for intermittent drainage. Aspira Dressing Kit: The Aspira Dressing Kit is indicated for dressing of the drainage catheter and exit site. Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with silicone catheters with inner diameters between 0.103" - 0.116" such as Aspira, Asept®, PleurX® and Rocket® catheters. Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method. Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method. The Indications for Use statement for the subject Aspira Peritoneal Drainage System device is not identical to the predicate device; however, the differences do not alter the intended therapeutic use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites. | |
| Technological characteristics of the subject Aspira Peritoneal Drainage System are equivalent with respect to the basic catheter design and function to those of the predicate devices. Differences do not raise any new questions regarding safety and effectiveness. | | |
| Comparison to
Predicate
Device | The design and technological characteristics of the subject device are substantially equivalent to those of the predicate device. The subject device has the same materials and use as the predicate device. The main difference between the subject and the predicate device is the expanded scope of the indications to expand the compatibility of the Aspira Valve/Repair Kit portion of the Aspira Peritoneal Drainage System with competitive drainage catheters as well as the introduction of the Aspira Drainage Bottle as an alternative to the Aspira Drainage Bag. | |
| | At a high level, the subject and predicate devices are based on the following same technological elements: Same Clinical Use Same Intended Use | |
| Comparison to
Predicate
Device (Cont.) | Same Overall Device Design Same Sterilization Methods Same Labeling and Packaging Same Fundamental Technology/Principle of Operation The following differences exist between the subject and predicate devices: Expanded Indications for use to include: Compatibility of the Merit Aspira replacement valve used in the Aspira Repair Kit with competitive drainage catheters (Asept®, PleurX® and Rocket®catheters). Use of the Aspira Drainage Bottle as an alternative to the Aspira Drainage Bag. | |
| | The following performance data were provided in support of the substantial equivalence determination. | |
| | Performance Testing-Bench Aspira Valve – Compatibility with Competitive Drainage Catheters (Aspira, Asept®, PleurX® and Rocket® catheters) Catheter Leak Test - Negative Pressure Tensile Strength – Valve Assembly to Catheter Design Validation - Insertion Forces Aspira Drainage Bottle 1000 mL Fluid Pull Leak Test Barb to Tubing Tensile Tubing to Connector Tensile Tubing Impact Resistance | |
4
- Same Materials ●
5
- o Human Factors Engineering/User Engineering o Simulated Use
- · Drainage Speed Control
- · Bottle Emptying
- · Bottle Activation Force
- Bottle Activation Method
- · Drainage Time
- Indication of FullFlow
- Intuitiveness of Status
- Handle Reseal Ability
- Grip Comfort when Empty
- Grip Comfort when Full
- IFU Understandability for Lay Users
- Ease of Use
- Vacuum Loss
- Fluid Leak
The results of the testing demonstrated that the subject Aspira Peritoneal Drainage System met the predetermined acceptance criteria applicable to the safety and efficacy of the device.
Safety & Performance Testing
6