(30 days)
No
The device description and intended use focus on mechanical components for fluid drainage and do not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to relieve symptoms associated with pleural effusion, such as dyspnea and chest discomfort, by draining accumulated pleural fluid, which is a therapeutic action.
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 outlines multiple hardware components including a catheter, drainage bag, luer adapter, and valve assembly. There is no mention of software as a primary or standalone component.
Based on the provided information, the AspiraTM Pleural Drainage System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the drainage of pleural fluid to relieve symptoms. This is a therapeutic intervention, not a diagnostic one. IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system for physically removing fluid from the body. It involves a catheter implanted in the chest cavity and a drainage bag. This is a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on the properties of the fluid. The focus is entirely on the mechanical removal of the fluid.
Therefore, the AspiraTM Pleural Drainage System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AspiraTM 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 AspiraTM Drainage Bag is indicated for use only with the Aspira™ Drainage Catheter for intermittent drainage.
The AspiraTM Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira™ Luer Adapter is intended to provide access to the Aspira™ Drainage Catheter. It is used to drain fluid using standard wall suction, 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.
Product codes
DWM
Device Description
The Aspira™ Pleural Drainage System is designed for long-term intermittent drainage of recurrent and symptomatic pleural effusions. The primary components of the system are the AspiraTM Pleural Drainage Catheter and the Aspira™ Drainage Bag.
The Aspira™ Pleural Drainage Catheter is a long-term indwelling silicone catheter used to drain accumulated fluid from the pleural cavity to relieve symptoms associated with pleural effusion. The fenestrated catheter is implanted in the patient's chest cavity enabling the patient or caregiver to perform intermittent drainage of their pleural effusion at home.
The Aspira™ Drainage Bag is used to collect pleural fluid by gravity. The drainage bag attaches to the implanted catheter and is activated using an in-line silicone pump.
The AspiraTM Luer Adapter is designed to access the AspiraTM Drainage Catheter. The luer adapter is connected to wall suction or a syringe to perform intermittent drainage or catheter maintenance.
The Aspira™ Valve assembly attaches to the proximal end of the Aspira™ Pleural Drainage Catheter to prevent fluid or air exchange through the catheter when not in use.
The Aspira™ Pleural Drainage System provides patients with a convenient method to relieve pleural effusion symptoms at home.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pleural cavity, chest cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient or caregiver, 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 testing was performed according to the protocols developed based on listed standards. The Aspira™ Pleural Drainage System met performance criteria of the safety and effectiveness tests performed and demonstrates substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K971753, K010642, K011831, K051084, K052436
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ko71095
Section 5 510(k) Summary 21 CFR 807.92(a)
MAY 1 8 2007
5.1 General Information
| Submitter Name: | Bard Access Systems, Inc. (BAS) |
|---|---|
| [Wholly owned Subsidiary of C. R. Bard, Inc.] | |
| Address: | 5425 West Amelia Earhart Drive |
| Salt Lake City, Utah 84116 | |
| Telephone Number: | (801) 595-0700 ext. 7175 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | JiHyun Kim |
| Date of Preparation: | January 31, 2007 |
| Registration Number: | 1720496 |
| Additional Registration Numbers: | |
| C. R. Bard: | 2212754 |
5.2 Subject Device Information
| Device Name: | Aspira™ Pleural Drainage System |
|---|---|
| Trade Name: | Aspira™ |
| Common/Usual Name: | Patient Care Suction Apparatus |
| Classification Name: | Patient Care Suction Apparatus |
| 21 CFR 870.5050, Class II | |
| 74 DWM - Patient Care Suction Apparatus | |
| Classification Panel: | Cardiovascular devices |
5.3 Predicate Device Information
| Device Name: | Denver® PLEURX® Pleural Catheter Kit and Denver®
PLEURX® Home Drainage Kit |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Denver® PLEURX® |
| Common/Usual Name: | Patient Care Suction Apparatus |
| Classification Name: | Patient Care Suction Apparatus
21 CFR 870.5050 - Class II
74 DWM -Patient Care Suction Apparatus |
| Classification Panel: | Cardiovascular devices |
| 510(k) Clearance: | K971753, concurrence date June 27, 1997.
K010642, concurrence date March 20, 2001
K011831, concurrence date June 28, 2001
K051084, concurrence date June 13, 2005
K052436, concurrence date October 6, 2005 |
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5.4 Intended Use
The AspiraTM 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.
5.5 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 AspiraTM Drainage Bag is indicated for use only with the Aspira™ Drainage Catheter for intermittent drainage.
The AspiraTM Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira™ Luer Adapter is intended to provide access to the Aspira™ Drainage Catheter. It is used to drain fluid using standard wall suction, 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.
5.6 Device Description
The Aspira™ Pleural Drainage System is designed for long-term intermittent drainage of recurrent and symptomatic pleural effusions. The primary components of the system are the AspiraTM Pleural Drainage Catheter and the Aspira™ Drainage Bag.
The Aspira™ Pleural Drainage Catheter is a long-term indwelling silicone catheter used to drain accumulated fluid from the pleural cavity to relieve symptoms associated with pleural effusion. The fenestrated catheter is implanted in the patient's chest cavity enabling the patient or caregiver to perform intermittent drainage of their pleural effusion at home.
The Aspira™ Drainage Bag is used to collect pleural fluid by gravity. The drainage bag attaches to the implanted catheter and is activated using an in-line silicone pump.
The AspiraTM Luer Adapter is designed to access the AspiraTM Drainage Catheter. The luer adapter is connected to wall suction or a syringe to perform intermittent drainage or catheter maintenance.
The Aspira™ Valve assembly attaches to the proximal end of the Aspira™ Pleural Drainage Catheter to prevent fluid or air exchange through the catheter when not in use.
The Aspira™ Pleural Drainage System provides patients with a convenient method to relieve pleural effusion symptoms at home.
2
5.7 Technological Comparison to Predicate Device
The technological characteristics of the Aspira™ Pleural Drainage System is substantially equivalent to the predicate device, Denver® PLEURX® Pleural Catheter Kit and Home Drainage Kit, in terms of intended use, application, user population, basic design, performance and labeling.
5.8 510(k) Substantial Equivalence Decision Tree
New device is compared to Marketed Device?
-
Yes. Aspira™ Pleural Drainage System was compared to the legally marketed predicate device, Denver® PLEURX®.
Does the new device have the same indication statement and intended use as the predicate?
-
Yes. The Indications for Use and the intended use are the same as that of the predicate with minor verbiage changes.
Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)?
- A No. The differences do not alter the intended use of the device.
Does the new device have the same technological characteristics (e.g. design, materials, etc.)?
- a Not in all regards. The principles of operation and basic design are the same as the predicate device. The main differences of the Aspira™ Pleural Drainage system hour the Denver® PLEURX® are a pump chamber initiating pleural fluid flow and a drainage bag collecting pleural fluid drained by gravity.
Could the new characteristics affect safety or effectiveness?
- A Yes. The design changes may affect safety or effectiveness of the device.
Do the new characteristics raise new types of safety or effectiveness questions?
- No. Safety and effectiveness questions are the same as for the predicate device. A
Do accepted scientific methods exist for assessing effects of the new characteristics? > Yes. The device performance was evaluated based on the following standards.
| BS EN 1617 | Sterile drainage catheters and accessory devices for single use |
|---|---|
| BS EN 1618 | Catheters Other Than Intravascular Catheters - Test Methods for Common Properties |
| BS EN ISO 14630 | Non-Active Surgical Implants – General Requirements |
| ISO 10993-1 | Biological Evaluation of Medical Devices Part 1: Evaluation and Testing |
| ISO 10993-7 | Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals |
| ASTM F 640-79 | Standard Test methods for Radiopacity of Plastics for Medical Use |
3
| ISO 594-1 | Conical Fittings with 6% (Luer) Taper for Syringes, Needles
and Certain Other Medical Equipment - Part 1: General
Requirements |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 594-2 | Conical Fittings with 6% (Luer) Taper for Syringes, Needles
and Certain Other Medical Equipment – Part 2: Lock Fittings |
| ISO 8669-2 | Urine Collection Bags Part 2 |
| AAMI ISO 14538 | Biological Evaluation of Medical Devices - Establishment of
Permissible Limits for Sterilization and process Residues
Using Health -Based Risk Assessment |
| BS EN 550 | Sterilization of Medical Devices - Validation and Routine
Control of Ethylene Oxide Sterilization |
| ISO 11135 | Medical Devices - Validation and Routine Control of
Ethylene Oxide Sterilization |
| ISO 11737-1 | Sterilization of Medical Devices -- Microbiological Methods -
Part 1: Estimation of Population of Microorganisms on
Products |
| ISO 14971-1 | Medical Devices - Risk Management - Part 1: Application of
Risk Analysis |
Are performance data available to assess effects of new characteristics?
-
Yes. Verification testing was performed according to the protocols developed based on the standards listed above.
Performance data demonstrate equivalence?
- A Yes. The Aspira™ Pleural Drainage System met performance criteria of the safety and effectiveness tests performed and, based on FDA's decision tree, is substantially equivalent to the predicate device Denver® PLEURX Pleural Catheter Kit and Home Drainage Kit covered by K971753, K010642, K011831, K051084, K052436.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2007
Bard Access Systems, Incorporated C/O Mr. Bradley J. Bonnette Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K071095
Trade/Device Name: Aspira™ Pleural Drainage System Regulation Number: 870.5050 Regulation Name: Patient Care Suction Appartus Regulatory Class: II Product Code: DWM Dated: April 17, 2007 Received: April 18, 2007
Dear Mr. Bonnette:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
5
Page 2 -Mr. Bonnette
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sutte y. Michau Om.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Section 4 Indications for Use
510(k) Number (if known):
Device Name: Aspira™ Pleural Drainage System
Indications for Use:
The Aspiral 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 Adapter is intended to provide access to the Aspira™ Drainage Catheter. It is used to drain fluid using standard wall suction, 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ിന്ന Sign-Off)
Nision of Anesthesiology, General Hospital, ് സ്ട്രീഗ് of Affesthoolorogy
510(k) Number: K071093
000010