The IMM™ Hypodermic Needle Set consists of a conventional stainless steel needle, needle hub, extension tubing, clamp, and standard female 6% luer conical fitting for connection to a device contains a male luer fitting.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the IMM Hypodermic Needle Set. It details the device, its intended use, and a summary of performance. However, this document does not describe a study involving AI or machine learning.

Instead, it refers to:

Functional and performance tests demonstrating compliance with voluntary standards (ISO 594, ISO 7864).
Biocompatibility tests meeting requirements per ISO 10993.

Therefore, many of the requested categories related to AI studies (such as sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance with AI, etc.) cannot be answered from the provided text.

Here's the information that can be extracted:

Acceptance Criteria and Device Performance (Non-AI Study)

Acceptance Criteria Category	Specific Standard/Requirement Met	Reported Device Performance
Functional & Performance	ISO 594 (Luer conical fittings)	Meets specific requirements
	ISO 7864 (Sterile hypodermic needles for single use)	Meets specific requirements
Biocompatibility	ISO 10993 ("Limited exposure, indirect blood path, external communicating device")	Meets requirements

Information Not Applicable/Available for an AI Study:

Since this is a submission for a traditional medical device (hypodermic needle set) and not an AI/ML powered device, the following points are not applicable or cannot be answered from the provided document:

Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated against engineering and biological standards, not a clinical test set in the context of AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI test set is not relevant here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI study. The "ground truth" here involved physical and chemical properties assessed against established international standards.
The sample size for the training set: Not applicable. There is no training set for an AI model.
How the ground truth for the training set was established: Not applicable. There is no training set for an AI model.

Summary

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K070801

MAY 2 4 2007

PAGE 1 of 2

Pre-market Notification for IMM Hypodermic Needle Set

IMM Hypodermic Needle Set

510(k) Summary of Safety and Effectiveness

1. Submitter's Name:

INNOVATIVE MEDICAL MAUFACTURING COMPANY 107, 181 Lane, Sect. 1 Yong Jane Road Chunan, Miaoli, 350 TAIWAN (ROC)

Contact: J. P. Lee, General Manager

2. Name of Device

Common/Usual Name:	Hypodermic Needle Set
Proprietary Name:	IMMTM Hypodermic Needle Set
Classification Name:	Needle, hypodermic, single lumen

3. Predicate Device

Trade Name	510(k) Number	Decision Date
Nipro Scalp Vein Set	K955053	01/04/1996
SURFLO Winged Infusion Set	K771204	07/14/1977

4. Device Description

5. Indication for Use

The IMM™ Hypodermic Needle Set is to be used for sampling blood from or infusing fluid into body system underneath the skin.

6. Technological Characteristics

The IMMTM Hypodermic Needle Set has a conventional stainless steel needle, needle hub, extension tubing, clamp, female luer fitting with an end cap. The end cap can be removed to allow for connection of the female luer fitting to a device contains a male luer fitting for sampling or administering fluid.

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1000 - 1000

and the state of the state

. . . .

1000

7. Performance Summary

: 上一篇:

. . . . . . . .

陆儿

2007 - 100 - 100 - 100 - 100

The functional and performance tests demonstrated that the IMM™ Hypodermic Needle Set meets specific requirements established in voluntary standards: ISO 594, and ISO 7864. Biocompatibility tests indicated that the device meets the requirements per ISO 10993 for "Iimited exposure, indirect blood path, external communicating device".

and the comments of the comments of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innovative Medical Manufacturing Company C/O Mr. Joseph J. Chang, PhD, P.E. Innomedtech LLC 7128 Staffordshire Street Houston, Texas 77030

MAY 2 4 2007

Re: K070801

Trade/Device Name: IMM™ Hypodermic Needle Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 16, 2007 Received: March 23, 2007

Dear Dr. Chang:

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.

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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. 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 (QS) 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), please contact the Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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Ko70801

510(k) Number (if known):

Device Name: IMM™ Hypodermic Needle Set

Indications For Use:

The IMM Hypodermic Needle Set is to be used for sampling blood from or infusing fluid into body system underneath the skin.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chas D. mint

(k) Number _ Kong841

i Sign-Off) of Anesthesiology, General Hospital, tion Control, Dental Devices

Page 1 of

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.