0.2 U BACTERIAL FILTER

K974661 · Sims Deltec, Inc. · FPB · Feb 11, 1998 · General Hospital

Device Facts

• Record ID: K974661
• Device Name: 0.2 U BACTERIAL FILTER
• Applicant: Sims Deltec, Inc.
• Product Code: FPB · General Hospital
• Decision Date: Feb 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The 0.2 µ Bacterial Filter can be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications.

Device Story

The 0.2 µ Bacterial Filter is an add-on, air-eliminating, circular filter with a center vent and standard female/male luer connections. It is designed to be integrated into existing intravenous administration or extension sets. The device functions by physically trapping particulate matter as fluids or medications pass through the internal filter membrane. It is intended for use in clinical settings where fluid delivery devices are employed. By removing particulates, the device aims to prevent the infusion of contaminants into the patient. The device is operated by healthcare professionals during standard fluid administration procedures.

Clinical Evidence

No clinical data. Substantial equivalence was established through bench testing, including functional performance testing and biocompatibility assessment. Clinical studies were deemed unnecessary due to the device's similarity in materials, design, and function to existing commercially available filters.

Technological Characteristics

Circular air-eliminating filter; 0.2 μ pore size; 4.3 cm² filtration surface area; plastic housing (1.22 in x 1.85 in); standard female/male luer lock connections. Passive mechanical filtration. No software or energy source.

Indications for Use

Indicated for use with administration or extension sets to remove particulate matter during fluid or medication administration. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Extension Set with microbore tubing and 0.2 μ filter (SIMS Deltec, Inc.)
• Disposable I.V. Filter (0.2 μ) (The Medi-Dose® Group)

Submission Summary (Full Text)

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K974661

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

### 0.2 u Bacterial Filter

FEB | | 1998

December 12, 1997

#### GENERAL INFORMATION L

| Applicant's Name and Address: | SIMS Deltec, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa J. Stone<br>Manager, Regulatory Affairs<br>Tel. [phone] |
| Common/Usual Name: | 0.2 μ Bacterial Filter |
| Proprietary Name: | 0.2 μ Bacterial Filter |
| Equivalence Device Comparison: | Extension Set with microbore tubing and 0.2 μ filter<br>(manufactured by SIMS Deltec, Inc.)<br><br>Disposable I.V. Filter (0.2 μ)<br>(manufactured by The Medi-Dose® Group) |

#### II. DEVICE DESCRIPTION

The purpose of this submission is to offer an 0.2 u Bacterial Filter with standard luer connections for use with administration sets or extension sets used with fluid delivery devices. The subject device is intended to be "added-on" to an administration set or extension set.

The filter is an air-eliminating filter and is circular in shape with a center vent. The inlet of the filter is a standard female luer and the outlet of the filter is a standard male luer. The filter membranes are enclosed within a plastic case which is approximately 1.22 in. (width) x 1.85 in. (length).

#### INTENDED USE OF DEVICE III.

The 0.2 µ Bacterial Filter can be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications.

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## 510(k) Summary of Safety and Effectiveness Page 2 of 2

#### IV. DEVICE COMPARISON

| | 0.2 μ Bacterial Filter | Extension Set with<br>microbore tubing and<br>0.2 μ filter | Disposable I.V. Filter<br>(0.2 μ) |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | The Medi-Dose® Group |
| INDICATION FOR USE | The 0.2 μ Bacterial Filter<br>can be used with<br>administration sets or<br>extension sets for removal<br>of particulate matter<br>during the administration<br>of fluids or medications. | The Extension Set with<br>microbore tubing attaches<br>to the Micro Medication<br>Reservoir for the<br>administration of fluids or<br>medications with the<br>CADD-Micro® pump. | – |
| FILTER SIZE | 0.2 μ | 0.2 μ | 0.2 μ |
| FILTRATION<br>SURFACE AREA | $4.3 cm^2$ | $0.3 in^2$ | – |
| ADD-ON FILTER WITH<br>LUER LOCK<br>CONNECTION(S) | YES | NO | YES |

#### V. SUMMARY OF STUDIES

#### A. Functional Testing

Functional testing was performed on the filter to establish its operating parameters.

Biocompatibility testing was conducted on the filter.

#### B. Clinical Studies

Clinical studies were not deemed necessary regarding the filter due to its similarity in materials, design and function to current commercially available filters and extension sets with in-line filters.

#### C. Conclusions Drawn from the Studies

The results of the testing indicated that the filter functions according to specification and the filter meets the biocompatibility requirements. Therefore, the filter is considered acceptable for human use.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa J. Stone Manager, Regulatory Affairs Sims Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112

FEB 11 1998

K974661 Re : 0.2 μ Bacterial Filter Trade Name: Requlatory Class: II Product Code: FPB December 12, 1997 Dated: December 15, 1997 Received:

Dear Ms. Stone:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially.equivalent determination assumes compliance with-------the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Stone

through 542 of the Act for devices under the Electronic chrough 542 or the nec-ros-rovisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deborizoof substantial equivalence of your device to a legally rinding of bubbeanelar equiredults in a classification for your markets production of mits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy b. Ulatowski

Timoth Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K974661

510(k) Number (if known):

Device Name: 0.2 u Bacterial Filter

Indications for Use:

"The 0.2 µ Bacterial Filter can be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paboux Cassante

(Division Sign-C Division of Dental, In n Control, and . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . and General Hospital 510(k) Number -

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use