(84 days)
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Not Found
No
The 510(k) summary describes a simple, single-use medical device (scalp vein set and hypodermic needles) for fluid administration and blood sampling. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
The device, a Scalp Vein Set, is used for administering fluids or sampling blood, which are diagnostic and supportive functions, not primarily therapeutic.
No
The device, a Scalp Vein Set and hypodermic needles, is intended for administering fluids or sampling/withdrawing fluids from the body. It does not analyze or interpret data to identify health conditions or diseases, which is the function of a diagnostic device.
No
The device description clearly indicates physical medical devices (Scalp Vein Set and sterile hypodermic needles) intended for insertion into the body and handling fluids. There is no mention of software as the primary or sole component.
Based on the provided information, neither the Scalp Vein Set nor the Sterile Hypodermic Needles are IVDs.
Here's why:
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside the body (in vitro).
- Device Intended Use:
- The Scalp Vein Set is intended for insertion into the patient's vascular system to administer fluids or sample blood. This is an in vivo (within the body) use.
- The Sterile Hypodermic Needles are intended for use to inject or withdraw fluids from the body. This is also an in vivo use.
Both devices are used directly on or within the patient's body, not for testing specimens outside the body. Therefore, they do not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
Scalp Vein Set: intended to be used for insertion into the patient's vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.
Sterile hypodermic needles for single use: intended for use to inject or withdraw fluids from the body.
Product codes
FMI, FOZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion.
MAR 2 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shandong Qiaopai Group Company, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 53313
Re: K073705
Trade/Device Name: Scalp Vein Set for Single Use Sterile Hypodermic Needles for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI, FOZ Dated: March 8, 2008 Received: March 10, 2008
Dear Mr. Job:
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.
1
Page 2 - Mr. Job
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 (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). 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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Image /page/2/Picture/0 description: The image shows the logo for QIAOPAI GROUP. The logo consists of a circular symbol with Chinese characters inside, followed by the text "QIAOPAI GROUP" in capital letters. The symbol appears to be a registered trademark symbol.
Indications for Use
510(k) Number (if known):
Device Name: Scalp Vein Set for single use
Indications for Use:
Scalp Vein Set: intended to be used for insertion into the patient's vascular system (single use only) as an in-dwelling device to administer fluids intravenously or to sample blood.
| Scalp vein set for single use | |
|---|---|
| Specification | |
| mm | Length of outside(l) |
| mm | |
| 0.45 (26G) | 16±1.5 |
| 0.5 (25G) | 18±1.5 |
| 0.55 (24G) | 18±1.5 |
| 0.6 (23G) | 23±1.5 |
| 0.7 (22G) | 23±1.5 |
| 0.8 (21G) | 26±1.5 |
| 0.9 (20G) | 28±1.5 |
Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
8/102
Cinthony D, m
Oivision Sign-Off) vision of Anesthesiology, General Hospital fection Control, Dental Devices
K473745 510(k) Number: _
Page 1 of 2
3
® QIAOPAI GROUP
Indications for Use
510(k) Number (if known):
Device Name: Sterile hypodermic needles for single use
Indications for Use:
Sterile hypodermic needles for single use: intended for use to inject or withdraw fluids from the body.
| Sterile Hypodermic needle for single use | |
|---|---|
| Specification mm | Length of outside(l) mm |
| 0.45(26G) | 13±1.0 |
| 0. 5(25G) | 18±1.0 |
| 0.6(23G) | 25±1.5 |
| 0.7(22G) | 30±1.5 |
| 0.8(21G) | 36±1.5 |
| 0.9(20G) | 36±1.5 |
| 1.1(19G) | 36±1.5 |
| 1.2(18G) | 36±1.5 |
| 1.6(16G) | 36±1.5 |
Prescription Use V Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2 - End of Section -
Dimmer antin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
9/102