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.

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.

AI/ML Overview

This is a 510(k) premarket notification for the Aspira™ Pleural Drainage System, seeking substantial equivalence to a predicate device. As such, the submission primarily focuses on comparing the new device's technological characteristics to the predicate and demonstrating that any differences do not raise new questions of safety or effectiveness and can be assessed using accepted scientific methods.

Therefore, the document does not describe an independent study to prove the device meets acceptance criteria in the way a clinical trial or performance study for a novel device would. Instead, it relies on demonstrating that the device meets established engineering and biocompatibility standards, and that its performance is equivalent to a previously cleared predicate device.

Here's an analysis of the provided text with respect to your request:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table with explicit "acceptance criteria" alongside specific "reported device performance" metrics as would be seen in a clinical study for diagnostic accuracy or treatment efficacy. Instead, the acceptance criteria are implicit in the adherence to various established standards, and the "reported device performance" is a general statement of compliance.

Acceptance Criteria (Implicit)	Reported Device Performance
Adherence to relevant medical device standards:	"The Aspira™ Pleural Drainage System met performance criteria of the safety and effectiveness tests performed..." This indicates that the device successfully passed verification testing against all listed standards.
- BS EN 1617 (Sterile drainage catheters and accessory devices)
- BS EN 1618 (Catheters other than intravascular catheters - test methods)
- BS EN ISO 14630 (Non-Active Surgical Implants – General Requirements)
- ISO 10993-1 (Biological Evaluation Part 1)	Biocompatibility testing successfully completed.
- ISO 10993-7 (Biological Evaluation Part 7: EtO Sterilization Residuals)	EtO residuals within permissible limits.
- ASTM F 640-79 (Radiopacity)	Radiopacity confirmed.
- ISO 594-1 & -2 (Luer fittings)	Luer fittings meet specified requirements.
- ISO 8669-2 (Urine Collection Bags Part 2 - relevant for drainage bag)	Drainage bag performance consistent with similar device standards.
- AAMI ISO 14538 (Biological Evaluation - Sterilization/Process Residues)	Permissible limits met for residues.
- BS EN 550 / ISO 11135 (EtO Sterilization Validation)	Sterilization process validated.
- ISO 11737-1 (Microbiological Methods - Microorganism Estimation)	Microbiological control measures are effective.
- ISO 14971-1 (Risk Management)	Risk management plan in place and risks adequately mitigated.
Substantial equivalence to predicate device	"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..."
No new safety or effectiveness questions raised	"No. The design changes may affect safety or effectiveness of the device. [...] No. Safety and effectiveness questions are the same as for the predicate device."
Effectiveness of design changes assessed by accepted scientific methods	"Yes. The device performance was evaluated based on the following standards." (Followed by the list of standards)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not specify a "test set" in the context of clinical data (e.g., patient cases). The "verification testing" mentioned would typically involve a predefined number of units of the device components being tested according to the referenced engineering and biocompatibility standards. For instance, for material testing, a certain number of samples are taken from a batch. For sterilization validation, an overkill method often involves a defined number of sterility tests.

Sample size: Not specified for individual tests, but implied to be sufficient for meeting the requirements of each listed standard.
Data provenance: Not explicitly stated, but as a submission to the US FDA by a US-based company (Bard Access Systems, Salt Lake City, Utah), the testing would typically be conducted under GLP/GCP-like conditions, likely in the US or in qualified international labs following these standards. The nature of these tests (engineering, sterilization, biocompatibility) doesn't typically involve "country of origin of data" or "retrospective/prospective" in the same way clinical patient data would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The "test set" here refers to physical components of the device and its manufacturing processes, not patient data requiring expert interpretation for ground truth. Ground truth for these types of tests is established by objective measurements against predefined engineering, chemical, and biological specifications outlined in the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretation of clinical data. For engineering and biocompatibility testing, results are typically considered objective (e.g., pass/fail based on quantitative measurements) and do not require adjudication.

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

This is not applicable. This submission concerns a physical medical device (drainage system) and not an AI or imaging diagnostic product. Therefore, no MRMC study or AI assistance evaluation was performed or required.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. This device is a physical medical device. It does not involve algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance evaluation of this device is adherence to validated engineering specifications, biocompatibility requirements, and sterilization efficacy demonstrated through standardized laboratory testing. For example:

Engineering Tests: Measurements of tensile strength, burst pressure, flow rates, luer lock integrity, radiopacity, etc., are compared against predefined limits in the respective standards.
Biocompatibility: In vitro and in vivo tests (e.g., cytotoxicity, irritation, sensitization, systemic toxicity) are performed, and results are compared against established biological safety criteria.
Sterilization: Sterility assurance level (SAL) is confirmed through ethylene oxide sterilization validation, which involves biological indicators and direct product sterility testing.
Residuals: Levels of ethylene oxide residuals are measured against pre-established permissible limits.

These are objective, quantitative measures based on scientific standards, not subjective expert interpretations of patient data.

8. The sample size for the training set

This is not applicable. This submission is for a physical medical device, not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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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 Apparatus21 CFR 870.5050 - Class II74 DWM -Patient Care Suction Apparatus
Classification Panel:	Cardiovascular devices
510(k) Clearance:	K971753, concurrence date June 27, 1997.K010642, concurrence date March 20, 2001K011831, concurrence date June 28, 2001K051084, concurrence date June 13, 2005K052436, concurrence date October 6, 2005

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5.4 Intended Use

5.5 Indications for Use

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™ 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.

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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

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ISO 594-1	Conical Fittings with 6% (Luer) Taper for Syringes, Needlesand Certain Other Medical Equipment - Part 1: GeneralRequirements
ISO 594-2	Conical Fittings with 6% (Luer) Taper for Syringes, Needlesand 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 ofPermissible Limits for Sterilization and process ResiduesUsing Health -Based Risk Assessment
BS EN 550	Sterilization of Medical Devices - Validation and RoutineControl of Ethylene Oxide Sterilization
ISO 11135	Medical Devices - Validation and Routine Control ofEthylene Oxide Sterilization
ISO 11737-1	Sterilization of Medical Devices -- Microbiological Methods -Part 1: Estimation of Population of Microorganisms onProducts
ISO 14971-1	Medical Devices - Risk Management - Part 1: Application ofRisk 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.

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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.

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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

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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)

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Nision of Anesthesiology, General Hospital, ് സ്ട്രീഗ് of Affesthoolorogy

510(k) Number: K071093

000010

Regulation Number and Section

§ 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).