KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.

K022110 · Kawasumi Laboratories, Inc. · LJT · Sep 12, 2002 · General Hospital

Device Facts

• Record ID: K022110
• Device Name: KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.
• Applicant: Kawasumi Laboratories, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Sep 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2

Indications for Use

The Antineedle Stick Protector is a non-sterile, single use accessory device intended to minimize accidental needle stick injuries when used as an active safety device to shield port access needles.

Device Story

Antineedle Stick Protector is a non-sterile, single-use accessory device for port access infusion sets. Device consists of two rectangular polymeric sides connected by a hinge. Clinician positions protector over port access wings; activates by snapping hinged sides closed to enclose and shield needle. Unlike predicate device, which requires needle removal from patient before insertion into safety device, this protector is folded over and closed around needle during removal from patient. Output is a shielded needle tip, reducing risk of accidental needlestick injuries to healthcare providers.

Clinical Evidence

Bench testing only. A successful simulated use study was conducted to determine the device's acceptability for minimizing accidental needlestick injuries.

Technological Characteristics

Non-sterile, single-use accessory device; polymeric material construction; hinged, two-sided rectangular form factor; mechanical activation (manual snapping).

Indications for Use

Indicated for use as an active safety device to shield port access needles to minimize accidental needle stick injuries.

Regulatory Classification

Identification

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

• Portex Point-Lok Sharps Safety Device

Submission Summary (Full Text)

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SEP 12 2002

# EXHIBIT 17

K022110

## 510(k) SUMMARY

### 1. Submitter

Kawasumi laboratories, Inc. 3-28-15 Minami-Ohi Shinagawa-Ku, Tokyo 140 Japan Phone: [phone] Fax: Contact: Mr. S. Suwa

### Authorized Contact

Kawasumi Laboratories America, Inc. 5905 C Hampton Oaks Parkway Tampa, Fl 33610 Phone: [phone] Fax: Contact: Mr. Jack Pavlo

- 2. Name of Device: Antineedle Stick Protector for Use with Port Access Infusion Sets
Common Name: Needle stick protector

- 3. Predicate Device: Portex Point-Lok Sharps Safety Device
- 4. Description of the Device: The Antineedle Stick Protector is a non-sterile, single use, active accessory device manufactured from polymeric material. The protector has two rectangular sides connected by a hinge. It is positioned over the port access wings, and is activated by snapping closed the hinged sides that will enclose and shield the port access infusion set needle within the protector.
- 5. Intended Use: The Antineedle Stick Protector is a non-sterile, single use accessory device intended to minimize accidental needle stick injuries when used an an active safety device to shield port access needles.
- 6. Technological Characteristics: The Antineedle Stick Protector is shaped differently than the predicate device and is activated in a different manner to achieve the same result. That is, the Antineedle Stick Protector is folded over and closed around the entire needle as it is removed from the patient. Use of the predicate device requires that the needle first be removed from the patient, and then the tip of the needle subsequently will be pushed into the device. In both devices, the needle tip is protected inside the device after use.
- 7. Performance Data: Kawasumi Laboratories has conducted a successful simulated use study to determine the acceptability of this device for use to minimize accidental needlestick injuries. Kawasumi Laboratories believes the successful simulated use study shows the device is suitable for its intended use and is substantially equivalent to the predicate device.
- 8. Conclusions: The device is as safe as the predicate device and performs as well as the predicate device.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three curved lines that resemble human profiles facing to the right, with the lines becoming progressively smaller from top to bottom.

SEP 1 2 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jack Pavlo Manager, Technical Affairs Kawasumi Laboratories, Incorporated 1800 Massachusetts Avenue N. W. Suite 200 Washington, D.C. 20036

Re: K022110

Trade/Device Name: Antineedle Stick Protector for use Port Access Infusion Sets Regulation Number: 880.5570 and 880.5965 Regulation Name: Hypodermic Single Lumen Needle and Subcutaneous Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: FMI and LJT Dated: June 27, 2002 Received: June 28, 2002

Dear Ms. Pavlo:

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.

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.

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Page 2 - Mr. Pavlo

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timoth A. Ulatowski 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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K022,110

#### EXHIBIT 15

Page of

510(k) NUMBER (IF KNOWN):

DEVICE NAME: Antineedle Stick Protector for use with Port Access Infusion Sets INDICATIONS FOR USE:

> The Antineedle Stick Protector is a non-sterile, single use accessory device intended to minimize accidental needle stick injuries when used as an active safety device to shield port access needles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

scription Use 21 CFR 801.109) OR

Over-The-Countar-Use (Optional Format

Patricia Cuscente

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

510(k) Number: K022110

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