SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216

K061115 · Gvs Spa · FPA · Jun 30, 2006 · General Hospital

Device Facts

• Record ID: K061115
• Device Name: SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216
• Applicant: Gvs Spa
• Product Code: FPA · General Hospital
• Decision Date: Jun 30, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. Environment of use: Hospital, Emergency Medical Services settings, wherever I.V. fluid administration may be indicated.

Device Story

Speedflow I.V. Administration Set with Easydrop Flow Regulator functions as a sterile fluid pathway for gravity-fed I.V. therapy. Device includes tubing, connectors, accessories, and an Easydrop flow regulator allowing manual adjustment of fluid volume (drops/cc). Used in hospitals and emergency settings by clinicians to deliver fluids. Provides extended fluid path; incorporates 0.2um or 1.2um filters for particulate/microbial retention. Benefits patient by enabling controlled, sterile fluid administration.

Clinical Evidence

Bench testing only. Validated for sterility (ISO 11137, SAL 10^-6), biocompatibility (ISO 10993-3, -5, -10, -11), and pyrogenicity (LAL test ≤0.25 EU/ml). Bacterial retention testing confirmed >99.9% removal of Brevundimonas diminuta (0.2um filter) and ≥99.9% removal of Candida Albicans (1.2um filter). Shelf life validated to 5 years per EN 868-5.

Technological Characteristics

Tubing set with integrated Easydrop flow regulator and 0.2um or 1.2um filters. Gravity-fed operation. Materials validated for biocompatibility per ISO 10993. Sterilization via validated process (max 40 kGy).

Indications for Use

Indicated for patients requiring I.V. therapy where an extended fluid path is necessary. Suitable for use in hospital and emergency medical settings.

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

• B. Braun; Filterflow Filtered Extension Sets
• Amsino: I.V. Administration Sets
• Leventon; I.V. Extension Sets with I.V. Flow Regulators

Submission Summary (Full Text)

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## 5. 510(k) Summary

JUN 3 0 2006

Summary Prepared: 28 Dec 2005 Common Name: Speedflow I.V. Set with Easydrop Flow Regulator Classification Name: Intravascular Administration Sets Product Code: FPA Panel: General Hospital and Personal Use Device Classification: II

Substantially Equivalent to: B. Braun; Filterflow Filtered Extension Sets Amsino: I.V. Administration Sets Leventon; I.V. Extension Sets with I.V. Flow Regulators

Description: The GVS Speedflow I.V. Administration Set with Easydrop Flow Regulator consists of a tubing set with a 0.2um or a 1.2um filter, various connectors and accessories and an Easydrop flow regulator and is used as a fluid pathway for I.V. administration. A choice can be made on the volume of fluid by easily adjusting the drops/cc setting on the Easydrop Flow Regulator. GVS will offer custom sets to meet customer requirements and specifications.

Indicated as a single use, sterile device for use in gravity fed I.V. therapy when an Intended Use: extended fluid path is required for administration.

Risk Analysis Method-1SO 14971 was used for the Risk Analysis. The specific risks associated with this device were:

| Identified Risk | Mitigation Measure |
|-------------------------|--------------------|
| Device Malfunction | Bench Testing |
| Adverse Tissue Reaction | Biocompatibility |
| Infection | Sterilization |
| Improper Use | Labeling |

Device Characteristics: In order to validate critical parameters of the product required to reduce risk, the following were performed:

Device Malfunction = Bench tests Leak testing on filter and sets. Joint strength testing, Flowrate testing (drops/minute), Filter Integrity testing

GVS S.p.A. Via Roma, 50 40069 - Zola Predosa (BOLOGNA) - Italia

Tel. [phone] Fax [phone] e-mail: [e-mail] www.gvs.com

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K061115

5. 510(k) Summary - continued

## Adverse Tissue Reaction = Biocompatibility

ISO 10993-10. Sensitization, ISO 10993-11, Acute Systemic Injection, ISO 10993-3, Haemocompatibility; ISO 10993-5, Cytotoxicity MEM Elution; ISO 10993-10, Intracutaneous Injection

## Infection = Sterilization

Sterility Testing: According to ISO 11137, the product has been validated to a maximum dose of 40 kGy's, with a sterility assurance level of 10-6.

Shelf Life Testing: A validation was performed according to EN 868-5 resulting in a 5 year shelf life.

Pyrogen Testing: Sets were tested by the LAL test method and were found to be ≤0.25 EU/ml.

Bacterial Retention Testing: Per industry recommendations,

The 0.2um was tested and found to remove >99.9% of the challenged organism, Brevundimonas diminuta.

The 1.2 µm was tested and found to remove ≥99.9% of the challenged organism, Candida Albicans.

Summary: The intended use, materials, and test results show that the GVS Speedflow I.V. Set with Easydrop Flow Regulator is substantially equivalent to predicate devices.

Tel. [phone] Fax [phone] e-mail: [e-mail] www.gvs.com

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JUN 3 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GVS SPA C/O Ms. Dawn I. Moore Consultant 20171 Bowens Road Manchester, Michigan 48158-9600

Re: K061115

Trade/Device Name: I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 19, 2006 Received: April 21, 2006

Dear Ms. Moore:

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. Moore

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

unmi UDIT

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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## Indications for Use

| 510(k) Number (if known): | K061115 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Name: | I.V. Administration Sets |
| Indications For Use: | |
| Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration. Environment of use: Hospital, Emergency Medical Services settings, wherever I.V. fluid administration may be indicated. | |
| Prescription Use | X |
| OR | Over-The-Counter Use ______ |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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