PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606

K041919 · Clinico · FPA · Oct 4, 2004 · General Hospital

Device Facts

• Record ID: K041919
• Device Name: PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606
• Applicant: Clinico
• Product Code: FPA · General Hospital
• Decision Date: Oct 4, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Perfudrop® Air M-P with Needle is an intravascular administration set to administer IV fluids and pharmaceuticals from a container to a patient's vascular system through a needle inserted into a vein. The device includes a drip chamber with a 15 μm filter and a spike to penetrate and connect the tubing to an I. V. bag or other infusion fluid container, tubing, flow regulator and a connector to connect the needle to the set. The administration set is for use under gravity and pressure conditions. The set is not intended nor indicated for use with blood or blood products.

Device Story

Perfudrop® Air M-P is a disposable, single-use intravascular administration set; facilitates delivery of IV fluids/pharmaceuticals from container to patient vascular system via needle. Components include spike for container access, drip chamber with 15 μm filter, tubing, flow regulator, and needle connector. Operates under gravity or pressure conditions. Used in clinical settings by healthcare professionals. Output is controlled fluid delivery to patient vein; assists in therapeutic fluid/drug administration.

Clinical Evidence

No clinical data; substantial equivalence based on design and technological characteristics conforming to ISO standards.

Technological Characteristics

Disposable intravascular administration set; includes drip chamber with 15 μm filter, spike, tubing, flow regulator, and needle. Design conforms to ISO 8536-4 (set) and ISO 7864 (hypodermic needle). Sterile. Non-electronic/mechanical device.

Indications for Use

Indicated for patients requiring IV fluid or pharmaceutical administration via a needle inserted into a vein. Not indicated for use with blood or blood products.

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

• Gemini IV Administration Sets (K022209)

Submission Summary (Full Text)

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### Medical Produkte

# 510(k) Notification

## Section E. Summary as required by section 807.92 (c)

| Submitter: | Clinico GmbH | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--|
| | Robert-Koch-Strasse 5 | | |
| | D-36251 Bad Hersfeld | | |
| | Phone | (01149) 6621 - 1680 | |
| | FAX | (01149) 6621 - 168111 | |
| Contact: | Dr. Reinhard Hopf | | |
| | Manager Regulatory Affairs | | |
| | Phone | (01149) 6621 - 168480 | |
| | FAX | (01149) 6621 - 168111 | |
| | Email | [e-mail] | |
| Date: | 07 / 07 / 2004 | | |
| Name of Device: | Perfudrop® Air M-P With Needle | | |
| Common name: | Intravascular administration set | | |
| Classification<br>name of device: | | a) Product code: FPA | |
| | b) Regulation number: 880.5440 | | |
| Predicate device: | Gemini IV Administration Sets, | | |
| | | Alaris (Premarket notification K022209) | |
| Description of the<br>set: | The Perfudrop® Air M-P intravascular administration<br>set (model no. 48451606) is a disposable, single-use<br>Intravascular administration set intended for use<br>under gravity and pressure conditions as well. The<br>intravascular administration set uses a needle<br>attached to the set. | | |
| | The design of the intravascular administration set is<br>according to the requirements of ISO 8536-4.<br>The design of the sterile hypodermic needle is<br>according to the requirements of ISO 7864. | | |

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| innovative | |
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| Medical Produkte | |

| Intended use of the device: | Perfudrop® Air M-P with needle is an intravascular<br>administration set to administer IV fluids and<br>pharmaceuticals from a container to a patient's vascular<br>system through a needle inserted into a vein. The device<br>includes a drip chamber with a 15 μm filter and a spike to<br>penetrate and connect the tubing to an I. V. bag or other<br>infusion fluid container, tubing, flow regulator and a<br>connector to connect the needle to the set. |
|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The administration set is for use under gravity and pressure<br>conditions. |
| | The set is not intended nor indicated for use with blood or<br>blood products. |
| Comparison of the<br>Technological<br>Features of the New<br>Device and<br>Predicate Device: | The administration set "Perfudrop® Air M-P with needle"<br>is substantially similar to the lawfully marketed predicated<br>device. Both sets are intended for administration of IV<br>fluids and pharmaceuticals from a container to a<br>patient's vascular system. |

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OCT 4 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Reinhard Hopf Manager Regulatory Affairs Clinico GmbH Robert-Koch-Strasse 5 D-36251 Bad Hersfeld

Re: K041919

Trade/Device Name: Perfudrop® Air M-P with Sterile Hypodermic Needle 20 G. Model 48451606 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 12, 2004 Received: July 30, 2004

Dear Dr. Hopf:

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 - Dr. Hopf

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 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/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.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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#### Indications for Use Statement

510(k) Number (if known): K041919

Device Name: Perfudrop® Air With Sterile Hypodermic Needle 20 G

Indications For Use:

Perfudrop® Air M-P with Needle is an intravascular administration set to administer IV fluids and pharmaceuticals from a container to a patient's vascular system through a needle inserted into a vein.

The administration set is for use under gravity and pressure conditions. The set is not intended nor indicated for use with blood or blood products.

| 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 OF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Anesthesiology. General Hospital, Infection Control, Dental Device

510(k) Number