(86 days)
Not Found
No
The document describes a mechanical drainage system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for relieving symptoms associated with pleural effusion, which positions it as a therapeutic device.
No
The device is intended for long-term intermittent drainage of pleural fluid to relieve symptoms, not for diagnosing a condition.
No
The device description clearly lists physical components like a catheter and drainage bag, indicating it is a hardware-based system.
Based on the provided information, the Aspira* Pleural Drainage System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the drainage of pleural fluid from the pleural cavity to relieve symptoms. This is a physical intervention on the body, not a test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: The description focuses on a catheter and drainage bag, which are used for fluid removal, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, or the drained pleural fluid itself for diagnostic purposes), reagents, or any process related to determining the state of health or disease based on in vitro examination.
The device is a medical device used for a therapeutic procedure (draining fluid), not a diagnostic test.
N/A
Intended Use / Indications for Use
The Aspira* Pleural Drainage System is intended for long-term intermittent drainage of pleural fluid accumulated in the pleural cavity for the purpose of relieving symptoms associated with pleural effusion.
The Aspira* Pleural Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.
The Aspira* Drainage Bag is indicated for use only with the Aspira* Drainage Catheter 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 vacuum bottle, syringe or other appropriate method.
The Aspira* Valve Assembly attaches to the 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)
DWM
Device Description
The Aspira* Pleural Drainage System provides patients with a convenient method to relieve pleural effusion symptoms at home. The primary components of the Aspira* Pleural Drainage System are the Aspira* Pleural Drainage Catheter and the Aspira* Drainage Bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pleural 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)
Verification and validation activities were designed and performed to demonstrate that the subject Aspira* Pleural Drainage System met predetermined performance specifications. 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
§ 870.5050 Patient care suction apparatus.
(a)
Identification. A patient care suction apparatus is a device used with an intrathoracic catheter to withdraw fluid from the chest during the recovery period following surgery.(b)
Classification. Class II (performance standards).
0
Bard Access Systems, Inc. Aspira* Pleural Drainage System Special 510(k) Premarket Notification
Page 16 of 92
.
MAY 1 1 2011
510(k) Summary 21 CFR 807.92
Aspira* Pleural 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* Pleural Drainage System |
| | Classification Name: | Patient Care Suction Apparatus
21 CFR 870.5050 - Class II
DWM - Patient care suction apparatus |
| Predicate
Device | Trade Name: | Aspira* Pleural Drainage System |
| | Classification Name: | Patient Care Suction Apparatus
21 CFR 870.5050 - Class II
DWM - Patient care suction apparatus |
| | Premarket Notification: | K071095, concurrence date 18 May 2007 |
| | Manufacturer: | Bard Access Systems, Inc. |
| Device
Description | The Aspira* Pleural Drainage System provides patients with a convenient
method to relieve pleural effusion symptoms at home. The primary
components of the Aspira* Pleural Drainage System are the Aspira* Pleural
Drainage Catheter and the Aspira* Drainage Bag. | |
| Intended Use | The Aspira* Pleural Drainage System is intended for long-term intermittent
drainage of pleural fluid accumulated in the pleural cavity for the purpose of
relieving symptoms associated with pleural effusion. | |
| Indications for
Use | The Aspira* Pleural Drainage System is indicated for intermittent drainage of
recurrent and symptomatic pleural effusions. The catheter is intended for long-term
access to the pleural cavity in order to relieve symptoms such as dyspnea and
chest discomfort associated with malignant pleural effusion and other recurrent
effusions. | |
| | | |
| The Aspira* Drainage Bag is indicated for use only with the Aspira* Drainage
Catheter 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 vacuum bottle, syringe or other appropriate method. | | |
| The Aspira* Valve Assembly attaches to the Aspira* Drainage Catheter. The
Aspira* Repair Kit is for the repair of the Aspira* Drainage Catheter and
replacement of the Aspira* Valve Assembly. | | |
| Technological
Characteristics | Technological characteristics of the subject Aspira* Pleural 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* Pleural 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 | International Safe Transit Authority Procedure 1G |
| | BS EN 550:1994 | 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
ANSI/AAMI/ISO 10993-7 |
| | The subject device met all pre-determined acceptance criteria and
demonstrated substantial equivalence as compared to the predicate device. | |
| Summary of
Substantial
Equivalence | Based on the indications for use, technological characteristics, safety, and
performance testing, the subject Aspira* Pleural Drainage System meets the
pre-determined requirements under 21 CFR 820.30, Design Controls, and
demonstrates that the subject device is substantially equivalent to the
predicate device. | |
1
·
2
- Aspira is the trademark and/or registered trademark of C.R. Bard, Inc. or an affiliate.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines that suggest wings and a body. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle, with the bird symbol placed centrally within the circle's right side.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
MAY 1 1 2011
Mr. Henry Boland Regulatory Affairs Specialist C.R. Bard, Incorporated 605 North 5600 West Salt Lake City, Utah 84116
Re: K110409
Trade/Device Name: Aspira Pleural Drainage System Regulation Number: 21 CFR 870.5050 Regulation Name: Patient Care Suction Apparatus Regulatory Class: II Product Code: DWM Dated: April 8, 2011 Received: April 11, 2011
Dear Mr. Boland:
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.
4
Page 2- Mr. Boland
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Bard Access Systems, Inc. Aspira* Pleural Drainage System Special 510(k) Premarket Notification
Indications for Use Statement
510(k) Number (if known):
Device Name: Aspira® Pleural Drainage System
Indications for Use:
The Aspira® Pleural Drainage System is indicated for intermittent drainage of recurrent and symptomatic pleural effusions. The catheter is intended for long-term access to the pleural cavity in order to relieve symptoms such as dyspnea and chest discomfort associated with malignant pleural effusion and other recurrent effusions.
The Aspira® Drainage Bag is indicated for use only with the Aspira® Drainage Catheter 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 vacuum bottle, syringe or other appropriate method.
The Aspira® Valve Assembly attaches to the 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 × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
L. Schulthess
(Division Sign-Off) )ivision of Anesthesiology, General Hospital ifection Control, Dental Devices
510(k) Number: K110409