An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.

Device Description

The Portex® Epidural Filter is a 0.2um (micron) filter used in epidural anesthesia for the filtration of aqueous drugs and is designed to help protect the patient from injected microorganisms or particulate matter. The Filter is comprised of a 0.2 um supported membrane enclosed in a modified acrylic leak proof transparent housing with male Lucr with a rotating Locking Hub and a female Luer Lock.

The filtration area is 5.25 cm², has a flow rate of ≥ 200ml/Min @ 45 psi and can withstand a pressure of ≥ 115 psi during bolus injections.

The priming volume of the filter is 0.8 ml and the hold up volume is 0.45 ml as determined by weight. The filter has a bubble point of ≥46psi. The filter has 100% bacterial retention.

AI/ML Overview

This document describes the Portex® Epidural Filter, a 0.2um filter for epidural anesthesia. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical data.

Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (from predicate or general standards)	Reported Performance (Portex® Epidural Filter)
Filtration Pore Size	0.22 micron (predicate)	0.2 micron
Filtration Area	Not explicitly stated for predicate in summary	5.25 cm²
Flow Rate	Not explicitly stated for predicate in summary	≥ 200ml/Min @ 45 psi
Pressure Withstand	Not explicitly stated for predicate in summary	≥ 115 psi (during bolus injections)
Priming Volume	Not explicitly stated for predicate in summary	0.8 ml
Hold Up Volume	Not explicitly stated for predicate in summary	0.45 ml
Bubble Point	Not explicitly stated for predicate in summary	≥ 46 psi
Bacterial Retention	Expected to be 100% (implied for filter function)	100%
Material Composition	Hydrophilic membrane in plastic housing (predicate)	Hydrophilic membrane in modified acrylic housing
Luer Lock Fittings	Male and female Luer lock fittings	Male Luer with rotating Locking Hub and female Luer Lock
ISO 594-1 Testing	Compliant	Data submitted
ISO 594-2 Testing	Compliant	Data submitted
Dimensional Characteristics	Assumed comparable to predicate	Data submitted

Sample Size Used for the Test Set and Data Provenance:
- The document states "Data submitted" for various non-clinical tests (dimensional, flow rate, bubble point, ISO 594-1 and ISO 594-2 testing, bacterial retention).
- Specific sample sizes for each test are not provided in this summary.
- Data Provenance: The nature of these tests (e.g., laboratory testing of device samples) indicates prospective testing performed for the purpose of this submission, likely conducted by the manufacturer, Smiths Medical ASD, Inc., located in Keene, NH, USA. There is no mention of country of origin for the data itself, but it originates from the manufacturer's testing.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This device is a physical filter, and its performance is evaluated through objective, quantitative non-clinical laboratory tests (e.g., flow rate measurement, bacterial retention testing) based on established engineering and medical device standards (e.g., ISO standards). Expert consensus for "ground truth" as typically understood in diagnostic AI/image analysis is not relevant here. The ground truth for these tests is the objective measurement of the filter's physical and functional properties.
Adjudication Method for the Test Set:
- Not applicable. As the "ground truth" is established via objective laboratory measurements, there is no need for expert adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a physical medical device (anesthesia conduction filter), not a diagnostic algorithm or image analysis tool, so MRMC studies involving human readers or AI assistance are not relevant. Clinical data was explicitly stated as "Not required."
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The Type of Ground Truth Used:
- The ground truth for the performance was established through objective laboratory testing and measurements based on scientific and engineering principles (e.g., measuring flow rates, bubble points, determining bacterial retention through microbial challenge tests, and adherence to ISO standards for Luer fittings). Comparisons were made against the technological characteristics of a legally marketed predicate device and implied industry standards for filter performance.
The Sample Size for the Training Set:
- Not applicable. This is a hardware device (filter), not a machine learning algorithm. Therefore, there is no "training set."
How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for a hardware device, this question is not relevant.

Summary

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KO83451

MAR 4 2009

SECTION 5, 510(k) Summary

Company Information:

Smiths Medical ASD, Inc. 10 Bowman Dr. Keene, NH 03431 (603) 352-3812, prompt 4, ext 2923 Contact: Cynthia Engelhardt Regulatory Affairs Specialist

Summary Prepared: March 3, 2009

Product Name:

Trade Name: Portex® Epidural Filter

Common Name: Epidural Filter

Classification Name: Filter, Conduction, Anesthetic (Class II, Product Code BSN)

Predicate Device(s):

Unknown, B. Braun Medial Inc. 0.22 Micron Flat Epidural Filter

Device Description:

The filtration area is 5.25 cm², has a flow rate of ≥ 200ml/Min @ 45 psi and can withstand a pressure of ≥ 115 psi during bolus injections.

The priming volume of the filter is 0.8 ml and the hold up volume is 0.45 ml as determined by weight. The filter has a bubble point of ≥46psi. The filter has 100% bacterial retention.

Indications for Use:

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Technological Characteristics:

The design of the proposed filter is similar to the predicate device. Both are a round flat filter with male and female Lucr lock fittings. Both of the devices are a hydrophilic membrane enclosed in a plastic housing. The proposed is comprised of a 0.2micron filter and the predicate of a 0.22 micron filter.

All statements and representations set forth herein regarding or related to "substantially equivalent" or "substantial equivalence" are in the limited context of the definition and purpose of substantial equivalence in the Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations of the Food and Drug Administration, and are not made in the context of, for any purpose related to, or as an admission against interest under, any other laws or regulations, including patent laws (whether in the context of patent infringement or otherwise).

Non-Clinical Data:

Data submitted demonstrates that the epidural filter performs equivalently to the predicate device. Data submitted covers; dimensional characteristics, flow rate, bubble point, ISO 594-1 and ISO 594-2 testing and bacterial retention,

Clinical Data:

Not required.

Conclusion:

The proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SMITHS MEDICAL ASD, INC.

Lomakin & Co. 03/03/1007

Cynthia Engelhardt Regulatory Affairs Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 stripes forming its body and wing. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

4 2009 MAR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cynthia Engelhardt Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431

Re: K083451

Trade/Device Name: Epidural Filter Regulation Number: 21 CFR 868.5130 Regulation Name: Anesthesia Conduction Filter Regulatory Class: II Product Code: BSN Dated: February 26, 2009 Received: February 27, 2009

Dear Ms. Engelhardt:

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 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 - Ms. Engelhardt

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 (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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sigitte Y. Mchaw Dins.

Ginette Y. Michaud, M.D. Acting 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 Statement

Indications for Use

510(k) Number (if known): |< 0 8 3 4 S /

Device Name: Epidural Filter

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﺸﻔ (Division Sign-Off)

Division of Anesthesiology, General Hospital nfection Control, Dental Devices

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o 10(k) Number:

Regulation Number and Section

§ 868.5130 Anesthesia conduction filter.

(a)
Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.(b)
Classification. Class II (performance standards).