K Number
K083451
Device Name
PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
Date Cleared
2009-03-04

(103 days)

Product Code
Regulation Number
868.5130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

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

Not Found

No
The device description and performance studies focus on the physical filtration properties of the device, with no mention of AI or ML.

Yes
The device is described as an "anesthesia conduction filter" used in "administering to a patient injections of local anesthetics" to minimize contamination, and specifically as a "0.2um (micron) filter used in epidural anesthesia for the filtration of aqueous drugs." These uses indicate it is part of a medical treatment process rather than a diagnostic tool.

No
The device is a microporous filter used to minimize particulate contamination during the administration of local anesthetics, which is a therapeutic function, not a diagnostic one.

No

The device description clearly details a physical filter with a membrane, housing, and Luer connections, indicating it is a hardware device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease, monitoring a condition, or screening for a risk factor.
  • Device Function: The described device, an anesthesia conduction filter, is used to filter fluids being injected directly into a patient's body during anesthesia. It's a physical barrier to remove particulate matter and microorganisms from the injected fluid.
  • Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It acts on the fluid before it enters the body.

Therefore, based on its intended use and function, the Portex® Epidural Filter is a medical device used for direct patient care, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

BSN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

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.

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.

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

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

§ 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).

0

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 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.

Indications for Use:

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.

1

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

2

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.

3

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): |