The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.

Device Description

The GRIPPER PLUS™ Needle is similar in design to the current GRIPPER® Needle, with the incorporation of a passive needle stick protection feature. The protection feature is made of a base and arm with a hinge on one end. As the needle is removed from a portal the hinge allows the needle to be pulled back and locked into the capture well in the base. There is an audible "click" when the needle is captured. The device is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The needle tip is fully protected after deployment of the needle stick protection feature and will not disengage with normal handling such that the needle tip becomes exposed.

The needle will be offered in various needle gauges and lengths, and with or without a slit-septum injection site cap.

AI/ML Overview

The provided document describes the GRIPPER PLUS™ Needle, a medical device designed to protect against needlestick injuries. Below is an analysis of its acceptance criteria and the study used to demonstrate compliance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GRIPPER PLUS™ Needle are primarily functional, focusing on the successful activation of the needle-stick protection feature and the biocompatibility of its components.

Acceptance Criteria	Reported Device Performance
Needle-stick protection feature activation	Successfully activated during all attempts in simulated use testing.
Protection against exposure to bloodborne pathogens	Designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.
Needle tip fully protected and will not disengage	Needle tip is fully protected after deployment and will not disengage with normal handling.
Function according to specifications	Functions according to specifications.
Biocompatibility of device components	Materials used in the device are biocompatible.
Acceptable for its intended use	Evaluated by healthcare professionals in simulated use and found acceptable for its intended use.

2. Sample Size and Data Provenance for Test Set

Sample Size: The document does not explicitly state a numerical sample size for the "simulated use test." Instead, it mentions that the device was "evaluated by health care professionals during a simulated use test."
Data Provenance: The testing was "in-vitro testing and simulated use testing." The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was conducted to U.S. standards. The study was retrospective in the sense that the testing was performed to support the 510(k) submission after the device's design.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Number of Experts: The document states the device was "evaluated by health care professionals." It does not specify the exact number of professionals involved.
Qualifications of Experts: The qualifications are broadly stated as "health care professionals." Specific expertise (e.g., years of experience, specific medical field) is not detailed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The assessment appears to be based on the direct observation and feedback from the "health care professionals" during the simulated use test, where the protection feature "successfully activated during all attempts."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study was performed or cited. The document does not mention any comparison of human readers' performance with and without AI assistance, as AI is not a component of this device.

6. Standalone Performance Study

Yes, a standalone study was performed. The "functional testing" and "simulated use testing" evaluated the device's inherent performance. The key finding from this standalone testing was that the device's protection feature "successfully activated during all attempts."

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria was primarily based on:

Functional performance standards: The device's ability to activate its safety mechanism and protect the needle tip.
Expert evaluation/observation: Healthcare professionals' assessment of the device's acceptability in simulated use.
Biocompatibility testing: Laboratory results confirming material safety.

8. Sample Size for the Training Set

This device is a mechanical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.

9. How Ground Truth for Training Set Was Established

Not applicable, as this is not an AI/machine learning device.

Summary

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AUG 1 3 2002

K021999

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

GRIPPER PLUSTM Needle

June 18, 2002

I. GENERAL INFORMATION

Applicant's Name and Address:	Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Lisa J. StoneManager, Regulatory Affairs
Common/Usual Name:	Administration Set
Proprietary Name:	GRIPPER PLUS™ Needle
Equivalence Device Comparison:	GRIPPER® Needle(manufactured by Deltec, Inc.)Huber Plus Safety Infusion Set(manufactured by NowMedical)

II. DEVICE DESCRIPTION

The needle will be offered in various needle gauges and lengths, and with or without a slit-septum injection site cap.

Ш. INTENDED USE OF THE DEVICE

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DEVICE COMPARISON IV.

	GRIPPER PLUSTMNeedle	Huber Plus SafetyInfusion Set	GRIPPER® Needle
MANUFACTURER	Deltec, Inc.	NowMedical	Deltec, Inc.
INDICATIONS FORUSE	The GRIPPER PLUSTMNeedle is indicated forthe administration into orwithdrawal of fluids fromimplanted ports. It isdesigned to help protectagainst exposure tobloodborne pathogenscaused by accidentalneedlestick injuries.	To be used withimplanted vascular ports.	Intended for theadministration into orwithdrawal of fluids fromimplanted ports.
NONCORING NEEDLE	YES	YES	YES
NEEDLE-STICKPREVENTIONFEATURE	YES	YES	NO
NEEDLE GAUGES	222019	222019	222019
NEEDLE LENGTHS(inches)	0.6250.751.01.25	0.50.751.01.251.5	0.6250.751.01.25
NEEDLE MATERIAL	Stainless Steel	Stainless Steel	Stainless Steel
TUBING DIMENSIONS(Nominal)
I.D.O.D.Length	0.047 in.0.103 in.8.0 in.	0.046 in.0.091 in.9 in.	0.047 in.0.103 in.8.0 in.
TUBING MATERIAL	PVC plasticized withTOTM	PVC (non-DEHP)	PVC plasticized withTOTM
AVAILABLE WITH ORWITHOUT INJECTIONSITE	YES	YES	YES

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V. SUMMARY OF STUDIES

Functional Testing A.

In-vitro testing and simulated use testing was conducted in accordance with the FDA "Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features," dated March 1995.

Biocompatibility testing was conducted on the device components.

B. Clinical Studies

Clinical studies were not deemed necessary regarding the GRIPPER PLUSTM Needles due to their similarity in materials, design and function to the current GRIPPER® Needle and Huber Plus Safety Infusion Set. The device was evaluated by health care professionals during a simulated use test and was found to be acceptable for its intended use.

ﺰ Conclusion Drawn from the Studies

The results of the testing indicated that the GRIPPER PLUS™ Needles function according to specifications and the materials used in the device are biocompatible. Simulated use testing indicated that the device's protection feature successfully activated during all attempts. Therefore, this product is considered acceptable for human use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human figures or silhouettes, arranged in a row, with their heads slightly overlapping.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2002

Mr. Edward W. Numainville Vice President, RA/OA SIMS Deltec. Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112

Re: K021999

Trade/Device Name: GRIPPER PLUSTM Needle Regulation Number: 880.5440 and 880.5570 Regulation Name: Intravascular Administration Set and Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FPA and FMI Dated: June 18, 2002 Received: June 19, 2002

Dear Ms. Numainville:

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. Numainville

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.

JSAWintAronson for.

Timothy 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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Ko2,1999

510(k) Number (if known):

Device Name: GRIPPER PLUS™ Needle

Indications for Use:

"The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries."

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

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

510(k) Number: K021999

000038

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.