(84 days)
Not Found
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 indicates a therapeutic purpose.
No
The device is described as a drainage system for symptomatic relief of malignant ascites, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly lists physical components like a catheter and drainage bag, indicating it is a hardware-based system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for draining fluid from the peritoneal cavity to relieve symptoms. This is a therapeutic procedure, not a diagnostic test performed on a sample outside the body.
- Device Description: The description focuses on the physical components used for drainage (catheter, bag, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The device is used to manage a symptom (ascites), not to diagnose the underlying cause or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
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 malignant ascites symptoms at home. The primary components of the Aspira* Peritoneal Drainage System are the Aspira* Peritoneal Drainage Catheter and the Aspira* Drainage Bag. The Aspira* Peritoneal Drainage System.
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
home
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)
Verification and validation activities were designed and performed to demonstrate that the subject Aspira* Peritoneal Drainage System met predetermined performance specifications.
Key Results: The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate 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.
Not Found
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/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.
1
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 (800) 638-2041 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/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 (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
2
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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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
Provisions | Submitter Name:
Submitter Address: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Henry Boland
Regulatory Affairs Specialist
henry.boland@crbard.com
801.522.5000 ext. 5428
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
21 CFR 876.5630 - Class II
FJS - Peritoneal dialysis system and accessories |
| Predicate
Device | Trade Name: | Aspira* Peritoneal Drainage System |
| | Classification Name: | Peritoneal Dialysis System and Accessories
21 CFR 876.5630 - Class II
FJS - Peritoneal dialysis system and accessories |
| | Premarket Notification: | K081288, concurrence date 18 July 2008 |
| | Manufacturer. | Bard Access Systems, Inc. |
| Device
Description | The Aspira* Peritoneal Drainage System provides patients with a convenient
method to relieve malignant ascites symptoms at home. The primary
components of the Aspira* Peritoneal Drainage System are the Aspira*
Peritoneal Drainage Catheter and the Aspira* Drainage Bag. The Aspira*
Peritoneal Drainage System. | |
| 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 | The Aspira* Peritoneal Drainage System 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. | |
| Technological
Characteristics | 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. | |
| Safety &
Performance
Tests | Verification and validation activities were designed and performed to
demonstrate that the subject Aspira* Peritoneal Drainage System met
predetermined performance specifications. The following guidance
documents and standards in conjunction with in-house protocols were used to
determine appropriate methods for evaluating the performance of the device: | |
| | ISO 10993-1:2009 | Biological Evaluation of Medical Devices Part 1:
Evaluation and Testing |
| | ISO 10993-7:2008 | Biological Evaluation of Medical Devices Part 7:
Ethylene Oxide Sterilization Residuals |
| | ISO 594-1:1986 | Conical Fittings with 6% (Luer) Taper for Syringes,
Needles and Certain Other Medical Equipment -
Part 1: General Requirements |
| | ISO-594-2:1998 | Conical Fittings with 6% (Luer) Taper for Syringes,
Needles and Certain Other Medical Equipment -
Part 2: Lock Fittings |
| | EN 1617:1997 | Sterile Drainage Catheters and Accessory Devices
for Single Use |
| | EN 1618:1997 | Catheters Other Than Intravascular Catheters -
Test Methods for Common Properties |
| | ISO 11607-1,2:2006 | Packaging for Terminally Sterilized Medical Devices |
| | ISTA -1G:2005
BS EN 550:1994 | International Safe Transit Authority Procedure 1G
Sterilization of Medical Devices - Validation and
Routine Control of Ethylene Oxide Sterilization |
| | ISO 11135-1:2007 | Sterilization of health care products- Ethylene
Oxide - Validation and Routine Control of
Sterilization Processes for Medical Devices |
| | AAMI TIR 19:1998 | Guidance for ANSI/AAMI/ISO 10993-7:1995,
Biological Evaluation of Medical Devices - Part 7:
Ethylene Oxide Sterilization Residuals - Replaces
AAMI ST29 and AAMI ST30; Cited as relevant
guidance to FDA-recognized standard |
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, safety, a
performance testing, the subject Aspira* Peritoneal Drainage System n
the pre-determined requirements under 21 CFR 820.30, Design Control
demonstrates that the subject device is substantially equivalent to the
predicate device. | |
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5
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.