(71 days)
Not Found
No
The device description and intended use clearly state the device's function is mechanical, and there are no mentions of AI, ML, or related concepts.
No
The devices listed (syringes and needles) are designed for administering or collecting fluids, which are typically diagnostic or drug delivery functions, not therapeutic treatments themselves.
No
The devices (syringes and needles) are described as being for dispensing, administering, collecting, sampling fluids, and injecting substances like insulin. Their function is mechanical, and they are used for therapeutic or procedural purposes, not for diagnosing conditions.
No
The device description and intended use clearly describe physical medical devices (syringes and needles) and their mechanical function, not software.
Based on the provided information, no, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended uses described are for dispensing/administering fluids, collecting/sampling fluids, and injecting insulin. These are all actions performed on or in the body, not on samples taken from the body for diagnostic purposes.
- Function is Mechanical: The description explicitly states the function of the hypodermic syringe is mechanical. IVDs typically involve chemical, biological, or immunological reactions to analyze samples.
- No Mention of Diagnostic Testing: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The devices described here are tools for delivering or collecting substances directly to or from the body.
N/A
Intended Use / Indications for Use
- Sterile Hypodermic Syringe for single use: The Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical.
- Sterile Insulin Syringe for single use, with fixed needle: The sterile Insulin Syringe for single use with fixed needle is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
- Sterile Hypodermic Needle for single use: The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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)
Laboratory testing was conducted to validate and verify that Double-Dove Syringes and Needle met all design specifications and was substantially equivalent to the predicate 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
§ 880.5860 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
JUN 1 2 2009 Chapter III 510(k) Summary
(As required by 21 CFR 807.92)
The assigned 510(k) Number is:
-
- Date Prepared: March 17, 2009
-
- Sponsor Information
Shanghai Double-Dove Industry Co.,Ltd
No.1888 Huhang Road FengXian Economic Zone Shanghai, 201400, China
Contact Person: Mr. Sanba Yang, Quality Manager Tel: +86-21-67104888 Fax: +86-21-67104666 E-Mail: Yangsbmaster@hotmail.com
3. Submission Correspondent
Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongshan Zhongxin Mansion No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China
- Device Name and Classification:
a. Sterile Hypodermic Syringe for single use
(1) Classification Name: Syringe, Piston
(2) Regulation Number: 880.5860
- (3) Product Code: FMF
- (4) Class: II
1
Kogor29
2
b. Sterile Insulin Syringe for single use, with fixed needle
(1) Classification Name: Syringe, Piston
(2) Regulation Number: 880.5860
(3) Product Code: FMF
(4) Class: II
(5) Review Panel: General Hospital
c. Sterile Hypodermic Needle for single use
(1) Classification Name: Needle, Hypodermic, Single Lumen
(2) Regulation Number: 880.5570
(3) Product Code: FMI ·
(4) Class: II
(5) Review Panel: General Hospital
5. Predicate Device Identification:
a. K number: K980987
Trade Name: Becton Dickinson Single Use Hypodermic Syringes
b. K number: K071630 Trade Name: TERUMO 31G ThinPro Insulin Syringe
c. K number: K070440 Trade Name: BD Hypoint
2
| Device Name | Intended Use | Nozzel | Volume | Material | Remark | |
|---|---|---|---|---|---|---|
| Sterile Hypodermic | ||||||
| Syringe for single use | The Sterile Hypodermic Syringe for Single | |||||
| Use is intended for dispensing/ | ||||||
| administering fluids, and collecting/ | ||||||
| sampling of fluid in medical practice. Their | ||||||
| function is mechanical. | Luer Slip | |||||
| Luer Lock | 1ml、3ml、5ml、10ml、20ml、 | |||||
| 30ml、50ml | Medical Grade | |||||
| Polypropylene | With or Without Needle | |||||
| Sterile Insulin | ||||||
| Syringe for single | ||||||
| use, with fixed needle | The sterile Insulin Syringe for single use | |||||
| with fixed needle is a device intended for | ||||||
| medical purposes for the manual aspiration | ||||||
| of insulin, and for the injection of insulin | ||||||
| into parts of the body below the surface | ||||||
| skin. | Fixed | 0.3ml、0.5ml、1ml | Medical Grade | |||
| Polypropylene | With Fixed Needle | |||||
| Sterile Hypodermic | ||||||
| Needle for single use | The Sterile Hypodermic Needle for single | |||||
| use is intended for use with syringes and | ||||||
| injection devices for general purpose fluid | ||||||
| injection/aspiration | Luer Slip | |||||
| Luer Lock | 0.312.7; 0.325; 0.33*12.7; | |||||
| 0.3312.7; 0.3325; | ||||||
| 0.412.7; 0.425; 0.45*16; | ||||||
| 0.4525; 0.516; 0.5*25; | ||||||
| 0.5516; 0.5525; 0.6*25; | ||||||
| 0.630; 0.725; 0.7*32; | ||||||
| 0.825; 0.838; 0.9*25; | ||||||
| 0.938; 1.125; 1.1*38; | ||||||
| 1.225; 1.238 | Stainless Steel |
i
.
III-3
3
4
Premarket Notification Submission - Chapter III 510(K) Summary Report No.: A2008-034-061
7. Test Conclusion
Laboratory testing was conducted to validate and verify that Double-Dove Syringes and Needle met all design specifications and was substantially equivalent to the predicate device.
8. Substantially Equivalent Conclusion:
The subject device, Double-Dove Syringes and Needle, is substantially equivalent to the predicate device.
4
Image /page/4/Picture/0 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" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Shanghai Double-Dove Industry Company, Limited C/O Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, No. 19, Lane 999, Zhongshan No.2 Road (S) Shanghai CHINA 200030
JUN 1 2 2009
Re: K090929
Trade/Device Name: Sterile Insulin Syringe for Single Sue Needle, with Fixed Needle Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 31, 2009 Received: April 2, 2009
Dear Ms. Hong:
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 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.
5
Page 2 - Ms. Hong
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Susan Roane
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection_Control_and_Dental_Devices_ Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number:
Device Name: Sterile Hypodermic Syringe for Single Use
Indications for Use:
The Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical.
Prescription Use V (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sta Carlsson
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090929
Page 1 of 3
7
Indication for Use
510(k) Number:
Device Name: Sterile Insulin Syringe for single sue needle, with fixed needle
Indications for Use:
The sterile Insulin Syringe for single use with fixed needle is a device is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin, and for the injection of insulin into parts of the body below the surface skin.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (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)
Adall
(Division Sign-on)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090939
Page 2 of
8
Indication for Use
510(k) Number:
Device Name: Sterile Hypodermic Needle for single use
Indications for Use:
The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
Prescription Use N (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090229
Page 3 of 3