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.

AI/ML Overview

The provided document does not contain sufficient information to fully answer all aspects of your request regarding acceptance criteria and performance studies. Specifically, it offers very limited details on the "simulated use study."

However, based on the available text, here's what can be extracted:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Minimize accidental needlestick injuries (Intended Use)	Successful simulated use study to determine acceptability for minimizing accidental needlestick injuries.
Suitable for its intended use	Suitable for its intended use (based on successful simulated use study).
As safe as the predicate device	As safe as the predicate device.
Performs as well as the predicate device	Performs as well as the predicate device.

Missing Information: The document does not specify quantitative acceptance criteria (e.g., a specific percentage reduction in needlestick injuries, or a predefined pass/fail rate for the simulated use study). It only states that the study was "successful" and the device "is suitable."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: The study was a "simulated use study," implying it was conducted experimentally, likely in a controlled environment, rather than using retrospective or prospective clinical data from patients. The country of origin for the study is not explicitly stated, but the submitter is based in Tokyo, Japan, and the authorized contact is in Tampa, FL, USA.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document only mentions a "simulated use study" but provides no details on how "ground truth" or "acceptability" was specifically measured or by whom.
Adjudication method for the test set:
- Not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No. There is no mention of an MRMC study or any study involving human readers with or without AI assistance. The device is a physical safety mechanism, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This question is irrelevant as the device is not an algorithm or AI. It is a physical accessory. The "simulated use study" would inherently involve human interaction with the device.
The type of ground truth used:
- Based on "successful simulated use study to determine the acceptability of this device for use to minimize accidental needlestick injuries," the ground truth was likely related to performance in preventing simulated needlesticks or ease of use/functionality in preventing such injuries. The exact methodology for defining "ground truth" or "success" in this simulation is not detailed. It's not pathology, outcomes data, or expert consensus in the typical sense applied to diagnostic tools, but rather an assessment of functional safety.
The sample size for the training set:
- N/A. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set."
How the ground truth for the training set was established:
- N/A. As above, no training set for a physical device.

Summary

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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: 81-3-376-1151 81-3-376-3235 Fax: Contact: Mr. S. Suwa

Authorized Contact

Kawasumi Laboratories America, Inc. 5905 C Hampton Oaks Parkway Tampa, Fl 33610 Phone: 813-630-5554 813-630-2033 Fax: Contact: Mr. Jack Pavlo

1. Name of Device: Antineedle Stick Protector for Use with Port Access Infusion Sets
  Common Name: Needle stick protector
1. Predicate Device: Portex Point-Lok Sharps Safety Device
1. 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.
1. 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.
1. 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.
1. 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.
1. 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 (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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.