(235 days)
Not Found
No
The document describes a mechanical safety syringe and does not mention any AI or ML components or functionalities.
No
The device is described as a "general purpose injection of fluids into, or withdrawal of fluids from the body," which are diagnostic or procedural functions, not therapeutic.
No
The device is described as a safety syringe for injecting or withdrawing fluids, and for preventing needle stick injuries. These are therapeutic or general purpose medical functions, not diagnostic ones.
No
The device description clearly states it is a "Safety Syringe" consisting of a "calibrated hollow barrel and a movable plunger," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general purpose injection of fluids into, or withdrawal of fluids from the body, below the surface of the skin". This describes a device used for direct interaction with the patient's body, not for testing samples in vitro (outside the body).
- Device Description: The description of a "calibrated hollow barrel and a movable plunger" with a connection for a hypodermic needle is consistent with a syringe used for administering or withdrawing substances from a living organism.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device's primary intended use is general purpose injection of fluids into, or withdrawal of fluids from the body, below the surface of the skin except for phlebotomy. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
The Safety Syringe per (21 CFR § 880.5860) is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. Size variations are listed below.
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
BD Spring Based Syringe (K011103)
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).
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§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
KO53519
510(k) SUMMARY
AUG 1 1 2006
1. Submitter's Identification:
Wuxi Yushou Medical Appliances Co., Ltd. 215#XiGang Road, DongbeiTang WuXi City - JiangSu - 214191 - China Telephone (262) 636-8957 Facsimile (262) 636-9760 Contact Timothy Llewellyn
September 19, 2005 - Updated August 9, 2006 Date Prepared:
2. Device Name:
| Trade/ Proprietary Name | Safety Syringe |
|---|---|
| Common Name | Syringe |
| Classification Name | Syringe, Antistick |
| Class | Class II, per 21 CFR § 880.5860 |
| Product Code | MEG |
3. Predicate Device(s):
BD Spring Based Syringe (K011103)
4. Description and Intended Use:
The Safety Syringe per (21 CFR § 880.5860) is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. Size variations are listed below.
The device's primary intended use is general purpose injection of fluids into, or withdrawal of fluids from the body, below the surface of the skin except for phlebotomy. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
1
510(k) SUMMARY (cont'd.)
Following are the size variations.
Syringes Sizes 1cc 3cc ର୍ଚ୍ଚ ୧୯୯ 10cc Pre-Tipped Syringes 1cc – 27g x 3/8" 1cc — 27g x ½" 1cc - 26 g x 3/8" 1cc - 25 g x 5/8" 1cc - 22 g x 1 1/2" 3cc - 25 g x 5/8" 3cc - 25 g x 1" 3cc - 23 g x 1" 3cc - 22 g x 3/4" 3cc - 22 g x 1" 3cc - 22 g x 1 1/2" 3cc - 21 g x 1" 3cc - 21 g x 1 1/2" 3cc - 20 g x 1" 3cc - 20 g x 1 1/2" 10cc - 21 g x 1" 10cc - 20 g x 1" Needles Sizes 27g x 1/2" 25g x 5/8" 25g x 1" 25g x 1 1/2" 23g x 1" 22g × 1" 22g x 1 1/2" 20g x 1 " 20g x 1 1/2" 18g x 1" 18g x 1 1/2"
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2006
Wuxi Yushou Medical Appliances Company, Limited C/O Mr. Gary Pond CEO Inter-Med, Incorporated 2200 Northwestern Avenue Racine, Wisconsin 53404
Re: K053519
Trade/Device Name: Safety Syringes 1 cc, 3 cc, 5 cc, and 10 cc Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: July 17, 2006 Received: July 20, 2006
Dear Mr. Pond:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are 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 devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Eederal Register.
3
Page 2 - Mr. Pond
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices complies with other moun mat 1 Dr. I has mass any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: agenctes. - Tournitus compry - 1 CFR Part 807); labeling (21 CFR Part 801); good manufacturing registration and moming (a 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 devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices 510(t) promance technologicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), rr you desire specific acritics 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 may overn 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/industry/support/index.html.
Sincerely yours,
Sylite H. Michael Omd.
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
INDICATIONS FOR USE
510(k) Number (if known): 4053519
Device Name: Safety Syringe - - - - - - - - - -
Indications for Use:
The device's primary intended use is general purpose injection of fluids into, or withdrawal of fluids from The devices primary intended as gonelar por phlebotomy. Its secondary intended use is to retract the body, below the sunated of the bith oxespention of and aid in the prevention of accidental needle stick injuries.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence f CDRH, Office of Device Evaluation (ODE)
Anton D, m
: ... Jn-Off) on of Anesthesiology, General Hospital. :on Control, Dental Devices
Page 1 of 1
Number: K053514