POLYPERF / POLYPERF SAFE

K063631 · Laboratoires Perouse · FPA · Oct 5, 2007 · General Hospital

Device Facts

• Record ID: K063631
• Device Name: POLYPERF / POLYPERF SAFE
• Applicant: Laboratoires Perouse
• Product Code: FPA · General Hospital
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

POLYPERF® / POLYPERF® Safe connecting lines are indicated for the administration into or withdrawal of fluids from implanted ports. POLYPERF® Safe is designed to help protect against exposure to blood caused by accidental needle stick injuries.

Device Story

POLYPERF and POLYPERF Safe are intravascular administration sets consisting of connecting lines with Huber needles. The device is used to access implanted ports for fluid administration or withdrawal. The POLYPERF Safe variant incorporates a safety mechanism designed to prevent accidental needle stick injuries and exposure to blood. The device is intended for use by healthcare professionals in clinical settings. The system facilitates secure connection to implanted ports; the safety feature provides protection for the clinician during and after needle removal. The device is a manual, non-powered accessory for vascular access.

Clinical Evidence

Clinical evaluation of the handiness and safety of use of Polyperf® Safe was performed. Biocompatibility and safety/functionality bench testing were also conducted to support the submission.

Technological Characteristics

Intravascular administration set consisting of connecting lines and Huber needles. Features include luer lock connectors, clamps, and optional injection sites. The Safe version includes an integrated safety mechanism for needle stick prevention. Materials are biocompatible. Device is non-powered and manual.

Indications for Use

Indicated for patients with implanted ports requiring administration or withdrawal of fluids. POLYPERF® Safe version includes features to reduce risk of accidental needle stick injuries during use.

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

• GRIPPER PLUS NEEDLE - DELTEC, INC - K021999
• GRIPPER NEEDLE - DELTEC, INC - K896346

Submission Summary (Full Text)

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510k Premarket Notification POLYPERF® / POLYPERF® Safe

Image /page/0/Picture/1 description: The image shows a logo with a stylized letter 'P' at the top, resembling a drop or a stylized leaf. Below the symbol, the word 'PEROUSE' is written in a bold, sans-serif font. Underneath 'PEROUSE', the word 'laboratoires' is written in a smaller, lighter font, suggesting that the logo represents a laboratory or a company named Perouse Laboratories.

Ko6363

## 510(k) Summary of Safety and EFFECTIVENESS

OCT 5 * 2007

As required by section 807.92(c)

| Submitter | Laboratoire PEROUSE Route du Manoir 60173 IVRY LE TEMPLE FRANCE<br>Phone [phone]<br>Fax [phone]<br>Website: www.perouse.com | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Marie-Noëlle EROUT – Quality Manager – e-mail marie-<br>[e-mail]<br>Regulatory contact: Idée Consulting (FRANCE)<br>Isabelle DRUBAIX e-mail : [e-mail] | |
| Preparation date | August 22, 2006 | |
| Trade Name | POLYPERF® / POLYPERF® Safe | |
| Common Name | Intravascular administration set | |
| Classification Name | set, administration, intravascular | |
| Legally marketed<br>predicate devices | GRIPPER PLUS NEEDLE -DELTEC, INC - K021999<br>GRIPPER NEEDLE - DELTEC, INC - K896346 | |
| Description | POLYPERF®<br>Connection lines with Huber<br>needle. Curved needle with<br>luer lock and clamp with<br>and without injection site. | POLYPERF® Safe<br>Safety Huber needle<br>with connecting line.<br>Prevention of ABE.<br>Easy to perform positive<br>Pressure. |
| | Image: connection lines with huber needle | Image: safety huber needle |

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510k Premarket Notification POLYPERF® / POLYPERF® Safe

Image /page/1/Picture/1 description: The image shows the logo for PEROUSE Laboratories. The logo consists of a stylized letter "P" in a circle above the word "PEROUSE" in bold, block letters. Below "PEROUSE" is the word "laboratories" in a smaller, sans-serif font.

| Intended Use | POLYPERF® / POLYPERF® Safe connecting lines are indicated for the<br>administration into or withdrawal of fluids from implanted ports.<br>POLYPERF® Safe is designed to help protect against exposure to blood<br>caused by accidental needle stick injuries. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance data | Performance data included with this submission<br>✓ Biocompatibility<br>✓ Safety and functionality testing<br>✓ Clinical evaluation of the handiness and the safety of use of<br>Polyperf® safe |
| Substantial equivalence | POLYPERF® / POLYPERF® Safe connecting lines are substantially<br>equivalent to their predicate devices in term of intended use and<br>technological characteristics (materials, design and functionality). |
| Conclusion | Performance data demonstrates safety, effectiveness and substantial<br>equivalence |

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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 caduceus symbol, which is a staff with two snakes coiled around it. Above the caduceus, the text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion. Below the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marie-Noëlle EROUT Quality and Regulatory Affairs Manager Laboratoires PEROUSE Route du Manoir 60173 Ivry Le Temple · FRANCE

OCT 5 " 2007

Re: K063631

Trade/Device Name: POLYPERF and POLYPERF® Safe Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FMI Dated: September 10, 2007 Received: September 13, 2007

Dear Ms. EROUT:

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. EROUT

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/industry/support/index.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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510k Premarket Notification POLYPERF® / POLYPERF® Safe

Image /page/4/Picture/1 description: The image shows a logo for PEROUSE laboratoires. The logo features a stylized letter 'P' in a dark, textured oval shape above the word "PEROUSE" in a bold, sans-serif font. Below "PEROUSE" is the word "laboratoires" in a smaller, sans-serif font.

## INDICATIONS FOR USE

510(k) Number (if known): Device Name: POLYPERF® / POLYPERF® Safe Indications for Use:

POLYPERF® / POLYPERF® Safe connecting lines are indicated for the administration into or withdrawal of fluids from implanted ports. POLYPERF® Safe is designed to help protect against exposure to blood caused by "accidental needle stick injuries."

Prescription Use Over-The-Counter Use > AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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Concurrence of CDRH, Affice of Deythe Evaluation (ODE)

Clem L. Bennett for ADW
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: KD6363/00012