Intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated during removal. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.

Device Description

The Luther Safety Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials, The Luther Safety Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. It is supplied sterile for single use only.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Luther Safety Huber Needle Set," submitted by Luther Needlesafe Products, Inc. It details the device's characteristics and its substantial equivalence to a predicate device, as required for FDA clearance.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study:

Key Observation: The provided document is a 510(k) summary, which is a pre-market notification to the FDA. Its purpose is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. It does not contain a detailed study report with specific acceptance criteria, sample sizes, ground truth establishment, or performance metrics in the way you've requested. The focus is on comparing the new device's technological characteristics to the predicate device.

Therefore, I will answer your questions based only on the information available in the provided text. Many of your questions cannot be answered with the given document.

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" and "reported device performance" in the context of a detailed study proving performance against those criteria is not explicitly present in this 510(k) summary.

The document indicates that the new device (Low Profile Luther Safety Huber) has substantially equivalent technological characteristics to its predicate device (Luther Safety Huber Needle Set, K021565). This "substantial equivalence" is the primary "acceptance criterion" for 510(k) clearance, rather than specific performance metrics against pre-defined targets.

The changes in the new device are minor: "Overall height of device is lower" and "Clear body of device allows user to check insertion." The document states:

"The old and the new design have similar technological characteristics and are equivalent."

"There is no change in the following items:

Indications for Use

Patient contact or fluid path materials

Safety activation feature

Instructions for Use

Sizes and options for gauge, length and needless Y site"

Therefore, the "device performance" reported is its equivalence to the predicate device, implying it performs no worse and maintains the safety and effectiveness of the previously cleared device.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) summary):

Acceptance Criteria (Inferred from 510(k))	Reported Device Performance (Inferred from 510(k))
Substantial Equivalence to Predicate Device (K021565)	"The old and the new design have similar technological characteristics and are equivalent."
No change in Indications for Use	"There is no change in... Indications for Use"
No change in Patient Contact or Fluid Path Materials	"There is no change in... Patient contact or fluid path materials"
No change in Safety Activation Feature	"There is no change in... Safety activation feature" (Implies the safety feature performs identically to the predicate device in preventing needlesticks)
Device aids in the prevention of accidental needle sticks (as per Indications for Use)	Inherits this performance characteristic through "substantial equivalence" to the predicate, which presumably demonstrated this through its original clearance.

Study Details Not Present in the Document:

The provided 510(k) summary does not contain information about a specific study that quantifies device performance against detailed acceptance criteria in the way your questions imply (e.g., sample sizes, ground truth, experts, MRMC studies, standalone algorithm performance).

Here's why each of your specific points cannot be fully addressed by this document:

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. 510(k) summaries of this nature typically do not include detailed study designs or data provenance. The assessment is usually based on design comparisons and existing predicate device data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable/Not provided. This document does not describe a study involving human experts establishing ground truth for performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical Huber needle set, not an AI or imaging diagnostic device. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is purely mechanical.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided. The "ground truth" for a 510(k) for a simple mechanical device like this is typically a comparison to the predicate device's mechanical specifications, design, and intended use, rather than clinical outcomes or expert consensus on diagnostic tasks. The claim of "aiding in the prevention of accidental needle sticks" would have been established for the original predicate device through appropriate testing (e.g., simulated use, sharps injury rates if applicable, but details are not in this document).
The sample size for the training set: Not applicable/Not provided. This is not an AI or machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) pre-market notification. It demonstrates "substantial equivalence" between a new medical device (Low Profile Luther Safety Huber Needle Set) and a predicate device (Luther Safety Huber Needle Set, K021565). This is the "study" that proves the device meets the "acceptance criteria" of being equally safe and effective as the predicate. The document, by its nature, does not contain the detailed study methodologies, performance metrics, sample sizes, or ground truth establishment typically found in a clinical or performance study report for diagnostic or complex AI devices.

Summary

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Attachment A: Revised

MAR 2 6 2004

Luther Needlesafe Products, Inc.

3199 Airport Loop Drive, Unit E Costa Mesa, CA 92626 Phone 714-434-4561 FAX 714-434-1557

510(k) Summary

Submitted by: Luther Needlesafe Products, Inc. 3199 Airport Loop Drive, Unit E Costa Mesa, California 92626-3414 Phone: 714-434-1564 Fax: 714-434-1557

Contact Person: Greq Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax 949-552-2821

Device Name:

Classification Name: Classification: Product Code: Requlation Number: Proprietarv Name: Common Name:

Set, Administration, Intravascular Class II FPA 21 CFR 880.5440 Luther Safety Huber Needle Set Safety Huber Needle and Administration Set

Predicate Device:

Luther Safety Huber Needle Set K021565

Device Description:

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It is supplied sterile for single use only.

Indications for Use:

The Luther Safety Huber Needle Set is a device intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated during removal. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.

Summary of the technological characteristics of this device compared to the predicate, original, device:

The old and the new design have similar technological characteristics and are equivalent.

There is no change in the following items:

Indications for Use Patient contact or fluid path materials Safety activation feature Instructions for Use Sizes and options for gauge, length and needless Y site

There are changes in following items:

Overall height of device is lower Clear body of device allows user to check insertion

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2004

Luther Needlesafe Products, Incorporated C/O Mr. Greg Holland Consultant Regulatory Specialist, Incorporated 3722 Avenue Sausalito Irvine, California 92606

Re: K040527

Trade/Device Name: Low Profile Luther Safety Huber Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 27, 2004 Received: March 1, 2004

Dear Mr. Holland:

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 vour 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 -Mr. Holland

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. or the Act of any I each s requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF er rett in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic 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 premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-5618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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Page

510(k) Number (if known):_ Koyo≤27

Device Name:_Low Profile Luther Safety Huber

Indications For Use:

Intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually subcularleodo implanted to feature is activated, the device is designed to aid in the prevention of accidental needle sticks.

(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 OR (Optional Format 1-2-96)

Vick Hubbard for Anthony Wilson, B.C.
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control. Dental Devices

510(k) Number: KO

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.