(86 days)
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.
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.
This document describes the Aspira Pleural Drainage System*, a medical device designed for long-term intermittent drainage of pleural fluid. The submission is a Special 510(k) Premarket Notification (K110409) dated February 9, 2011, by Bard Access Systems, Inc. The purpose of this notification is to demonstrate the substantial equivalence of the modified device to a previously cleared predicate device (K071095).
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details the verification and validation activities conducted to demonstrate that the Aspira* Pleural Drainage System met predetermined performance specifications. The acceptance criteria are implicitly defined by the adherence to a set of recognized international standards and internal protocols. The "reported device performance" is a general statement that the device met all pre-determined acceptance criteria.
| Acceptance Criteria (Defined by adherence to standards and in-house protocols) | Reported Device Performance |
|---|---|
| Biocompatibility: Evaluation and testing according to ISO 10993-1:2009 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) | The subject device met all pre-determined acceptance criteria. |
| Ethylene Oxide Sterilization Residuals: Evaluation according to ISO 10993-7:2008 (Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals) and AAMI TIR 19:1998 (Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals). | The subject device met all pre-determined acceptance criteria. |
| Conical Fittings (Luer Taper): Adherence to ISO 594-1:1986 (General Requirements) and ISO 594-2:1998 (Lock Fittings) for syringes, needles, and certain other medical equipment. | The subject device met all pre-determined acceptance criteria. |
| Sterile Drainage Catheters and Accessory Devices: Compliance with EN 1617:1997 (Sterile Drainage Catheters and Accessory Devices for Single Use). | The subject device met all pre-determined acceptance criteria. |
| Catheter Common Properties (Other than Intravascular): Compliance with EN 1618:1997 (Catheters Other Than Intravascular Catheters – Test Methods for Common Properties). | The subject device met all pre-determined acceptance criteria. |
| Packaging for Terminally Sterilized Medical Devices: Compliance with ISO 11607-1,2:2006 (Packaging for Terminally Sterilized Medical Devices). | The subject device met all pre-determined acceptance criteria. |
| Shipping and Handling (Package Integrity): Adherence to ISTA -1G:2005 (International Safe Transit Authority Procedure 1G) for transportation simulation testing. | The subject device met all pre-determined acceptance criteria. |
| Sterilization Validation (Ethylene Oxide): Compliance with BS EN 550:1994 (Sterilization of Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization) and ISO 11135-1:2007 (Sterilization of health care products - Ethylene Oxide – Validation and Routine Control of Sterilization Processes for Medical Devices). | The subject device met all pre-determined acceptance criteria. |
| Product-specific performance specifications: Compliance with in-house protocols for various performance aspects (e.g., proper drainage function, valve integrity, repair kit effectiveness, adapter functionality). (These are not explicitly listed but implied by the statement "in-house protocols were used to determine appropriate methods for evaluating the performance of the device.") | The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample sizes used for the test set for any of the mentioned verification and validation activities. It also does not mention the data provenance (e.g., country of origin of the data, retrospective or prospective) as the studies are entirely non-clinical (engineering and biocompatibility testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The studies described are primarily engineering and biocompatibility tests, not clinical studies requiring expert consensus for ground truth. The "ground truth" for these tests would be the compliance with the specified international standards and internal performance specifications.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human readers or evaluators, which is not the case for the verification and validation activities described here. Compliance is determined against pre-defined engineering and biological criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study done. This device is a physical medical device (drainage system), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI system. It is a physical medical device.
7. The Type of Ground Truth Used
The ground truth used for these studies is:
- Compliance with established international standards: Such as ISO 10993, ISO 594, EN 1617, EN 1618, ISO 11607, ISTA -1G, BS EN 550, ISO 11135, and AAMI TIR 19.
- Adherence to in-house protocols and predetermined performance specifications: These would cover aspects like device functionality, integrity, and safety.
- Substantial equivalence to a predicate device (K071095): The ultimate ground truth is demonstrating that the modified device is as safe and effective as the previously cleared predicate device, based on the non-clinical tests.
8. The Sample Size for the Training Set
This information is not applicable. This device is not an AI/machine learning system that requires a "training set." The studies performed are for validating the physical properties and performance of a medical device.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this type of medical device submission.
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Bard Access Systems, Inc. Aspira* Pleural Drainage System Special 510(k) Premarket Notification
Page 16 of 92
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MAY 1 1 2011
510(k) Summary 21 CFR 807.92
Aspira* Pleural Drainage System
| GeneralProvisions | Submitter Name:Submitter Address: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 |
|---|---|---|
| Contact Person: | Henry BolandRegulatory Affairs Specialisthenry.boland@crbard.com801.522.5000 ext. 5428801.522.5425 fax | |
| Date of Preparation: | 9 February 2011 | |
| Subject Device | Trade Name: | Aspira* Pleural Drainage System |
| Classification Name: | Patient Care Suction Apparatus21 CFR 870.5050 - Class IIDWM - Patient care suction apparatus | |
| PredicateDevice | Trade Name: | Aspira* Pleural Drainage System |
| Classification Name: | Patient Care Suction Apparatus21 CFR 870.5050 - Class IIDWM - Patient care suction apparatus | |
| Premarket Notification: | K071095, concurrence date 18 May 2007 | |
| Manufacturer: | Bard Access Systems, Inc. | |
| DeviceDescription | The Aspira* Pleural Drainage System provides patients with a convenientmethod to relieve pleural effusion symptoms at home. The primarycomponents of the Aspira* Pleural Drainage System are the Aspira* PleuralDrainage Catheter and the Aspira* Drainage Bag. | |
| Intended Use | The Aspira* Pleural Drainage System is intended for long-term intermittentdrainage of pleural fluid accumulated in the pleural cavity for the purpose ofrelieving symptoms associated with pleural effusion. | |
| Indications forUse | The Aspira* Pleural Drainage System is indicated for intermittent drainage ofrecurrent and symptomatic pleural effusions. The catheter is intended for long-termaccess to the pleural cavity in order to relieve symptoms such as dyspnea andchest discomfort associated with malignant pleural effusion and other recurrenteffusions. | |
| The Aspira* Drainage Bag is indicated for use only with the Aspira* DrainageCatheter 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 sealdrainage system, glass vacuum bottle, syringe or other appropriate method. | ||
| The Aspira* Valve Assembly attaches to the Aspira* Drainage Catheter. TheAspira* Repair Kit is for the repair of the Aspira* Drainage Catheter andreplacement of the Aspira* Valve Assembly. | ||
| TechnologicalCharacteristics | Technological characteristics of the subject Aspira* Pleural Drainage System areequivalent with respect to the basic catheter design and function to those of thepredicate devices. Differences do not raise any new questions regarding safetyand effectiveness. | |
| Safety &PerformanceTests | Verification and validation activities were designed and performed todemonstrate that the subject Aspira* Pleural Drainage System metpredetermined performance specifications. The following guidancedocuments and standards in conjunction with in-house protocols were used todetermine 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 Devicesfor 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 andRoutine Control of Ethylene Oxide Sterilization | |
| ISO 11135-1:2007 | Sterilization of health care products- EthyleneOxide – Validation and Routine Control ofSterilization 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 - ReplacesAAMI ST29 and AAMI ST30; Cited as relevantguidance to FDA-recognized standardANSI/AAMI/ISO 10993-7 | |
| The subject device met all pre-determined acceptance criteria anddemonstrated substantial equivalence as compared to the predicate device. | ||
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, safety, andperformance testing, the subject Aspira* Pleural Drainage System meets thepre-determined requirements under 21 CFR 820.30, Design Controls, anddemonstrates that the subject device is substantially equivalent to thepredicate device. |
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- Aspira is the trademark and/or registered trademark of C.R. Bard, Inc. or an affiliate.
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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.
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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
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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
§ 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).