(62 days)
Not Found
No
The device description and performance studies focus on conventional mechanical and material properties, with no mention of AI or ML.
No
The device is used for sampling blood or infusing fluid, which are diagnostic or procedural functions, not therapeutic treatment of a disease or condition.
No
Explanation: The device is intended for sampling blood or infusing fluid, which are procedures, not diagnostic interpretations. It does not analyze or interpret data to provide a diagnosis.
No
The device description explicitly lists physical components like a stainless steel needle, needle hub, extension tubing, clamp, and luer fitting, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "sampling blood from or infusing fluid into body system underneath the skin." This describes a device used for direct interaction with the patient's body for collection or delivery, not for testing samples outside the body.
- Device Description: The description details components of a needle and tubing set for accessing the circulatory system. This aligns with a medical device used for patient care, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any process that would be performed in vitro (in glass or outside the living organism).
IVD devices are specifically designed for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to collect or deliver substances to or from the body, which is a different category of medical device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
underneath the skin.
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)
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".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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.
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
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:
and the state of the state
:
. . . .
1000
:
:
7. Performance Summary
: 上一篇:
. . . . . . . .
:
陆儿
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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
2
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.
3
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
4
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
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