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

• K Number: K022110
• Device Name: KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS INFUSION SETS.
• Manufacturer: KAWASUMI LABORATORIES, INC.
• Date Cleared: 2002-09-12 ( 76 days)
• Product Code: LJT FMI
• Regulation Number: 880.5965

Intended 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 Description

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.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly describe a mechanical, passive safety device. There is no mention of any computational or data-driven components that would suggest AI/ML.

Therapeutic

No
The device is described as an accessory device intended to minimize accidental needle stick injuries by shielding port access needles, not to treat a disease or condition.

Diagnostic

No
Explanation: This device is described as an accessory device intended to minimize accidental needle stick injuries by shielding needles. It does not collect or analyze medical data to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is manufactured from "polymeric material" and is a physical accessory that shields a needle. There is no mention of software components or functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to "minimize accidental needle stick injuries when used as an active safety device to shield port access needles." This is a physical safety function related to handling needles, not a diagnostic test performed on samples taken from the body.
• Device Description: The description details a physical protector made of polymeric material that encloses a needle. This aligns with a physical safety device, not a diagnostic test.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in samples
  • Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device is clearly described as an accessory device for physical protection during needle handling.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

FMI, LJT

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Portex Point-Lok Sharps Safety Device

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

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

Summary

0

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

3

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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