(122 days)
Not Found
No
The 510(k) summary describes basic medical devices (syringes and needles) and does not mention any AI or ML capabilities. The performance studies are based on standard bench tests and compliance with ISO standards, not AI/ML performance metrics.
No
A therapeutic device is one that treats or heals an illness or condition. This device is used for administering/dispensing fluids and collecting/sampling fluids, which are diagnostic or procedural functions, not therapeutic.
No
The devices described (Syringe, Insulin Syringe, Hypodermic Needle) are intended for dispensing/administering fluids and collecting/sampling fluids, and injecting substances. Their stated uses do not involve diagnosing a condition, but rather delivering or collecting substances for medical practice.
No
The device description clearly outlines physical components made of materials like PP/PE and SUS 304 Stainless Steel, and the performance studies involve bench tests on these physical devices. There is no mention of software as the primary or sole component.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described for the Syringe, Insulin Syringe, and Hypodermic Needle all involve administering or collecting fluids directly from or into the body, or for general purpose fluid injection/aspiration. This is a direct interaction with the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. They are used for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens in vitro. There is no mention of tests, reagents, or equipment used to analyze samples outside the body.
The devices described are medical devices used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Syringe (with or without needle): The Syringe with or without needle is intended for dispensing/administering fluids, and collecting/ sampling of fluid in medical practice.
Insulin syringe (U-100) with fixed needle: The insulin syringe (U-100) with fixed needle is a device intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of U-100 insulin into parts of the body below the surface skin.
Hypodermic Needle for single use: The 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, FMF, FMI
Device Description
Syringe: Syringe is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Nozzel: Luer Slip. Nominal Capacity / Gauge: 1ml、2ml、3ml、5ml、10ml、20ml、30ml、50ml. Material: PP/PE. Remark: With or Without Needle.
Insulin Syringe: Insulin syringe (U-100) with fixed needle is a device intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of U-100 insulin into parts of the body below the surface skin. Nozzel: Fixed. Nominal Capacity / Gauge: 0.3ml、0.5ml、1ml. Material: PP/PE. Remark: With Fixed Needle.
Hypodermic Needle: Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. Nozzel: Female 6% Luer Conical Socket. Nominal Capacity / Gauge: 16G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G. Material: SUS 304 Stainless Steel / PP.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Insulin syringe (U-100) with fixed needle: parts of the body below the surface 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)
Bench tests were conducted to verify that the proposed devices meet all design specifications as are Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed devices comply with the following standards: ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin. ISO 7886 Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use. ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirement. ISO 594-2: 1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings. ISO 7864:1993 Sterile hypodermic needles for single use.
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
510(k) Summary
As Required by 21 CFR 807.92
JUL 1 4 2011
The assigned 510(k) Number is : ______________________________________________________________________________________________________________________________________________
- Date Prepared: Dec, 17, 2010
2. Sponsor Infromation:
Tiger Medical Products Ltd. Liulin Tower, Suit 1910, 1 Huaihai Zhong Road Shanghai 200021, China
Contact Person:
David Wang RA Manager Fiona Fu Regulatory Assistant Tiger Medical Products Ltd. Phone Number: 86-21-6386 6300 Fax Number: 86-21-6386 5086 E-mail: davidwang@tigermedicalgroup.com
3. Submission Correspondent
David Wang RA Manager Fiona Fu Regulatory Assistant Tiger Medical Products Ltd. Phone Number: 86-21-6386 6300 Fax Number: 86-21-6386 5086 E-mail: davidwang@tigermedicalgroup.com
4. Device Name and Classification:
1) Syringe (with/without needle)
a. Classification Name: Syringe,Piston
b. Regulation Number: 880.5860
c. Product code: FMF
d. Class: Il
e. Review Panel: General Hospital
2) Insulin syringe (U-100) with fixed needle
f. Classification Name: Syringe,Piston
1
g. Regulation Number: 880.5860 h. Product Code: FMF i. Class: II j. Review Panel: General Hospital
3) Hypodermic Needle for single use
k. Classification Name: Needle, Hypodermic, Single Lumen
- Regulation Number: 880.5570
m. Product code: FMI
n. Class: II
o. Review Panel: General Hospital
5. Predicate Device Identification:
a. K number: K980987 Trade Name: Becton Dickinson Single Use Hypodermic Syringes
b. K number: K090929
Trade Name: Sterile Insulin Syringe for single use, with fixed needle
c. K number: K070440
Trade Name: BD Hypoint
6. Device Description
2
Premarked Notification 510(k) Submisssion- 510(K) Summar
:
| Device Name | Intended Use | Nozzel | Nominal Capacity / Gauge | Material | Remark |
|---|---|---|---|---|---|
| Syringe | Syringe is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. | Luer Slip | 1ml、2ml、3ml、5ml、10ml、20ml、30ml、50ml | PP/PE | With or Without Needle |
| Insulin Syringe | Insulin syringe (U-100) with fixed needle is a device intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of U-100 insulin into parts of the body below the surface skin. | Fixed | 0.3ml、0.5ml、1ml | PP/PE | With Fixed Needle |
| Hypodermic Needle | Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | Female 6% Luer Conical Socket | 16G, 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | SUS 304 Stainless Steel / PP | - |
.
3
7. Summary of Comparison in Technological Charateristics
Through comparions between the applicant devices with the predicate devices (see comparison chart in Executive Summary), we belive the applicant devices are substantially equivalent with the predicate devices.
Technology Comparison to Predicate Device:
| Item | Syringe (with/without needle) | Becton Dickinson Single Use Hypodermic Syringes
510(K) #: (K980987) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Syringe is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. | The Becton Dickinson Syringes product line consists of single use disposable syringes intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical. |
| Syringe Volume | Nominal capacity: 1,2,3,5,10,20,30,50ml (Luer Slip);
2,3,5,10,20,30,50ml (Luer Lock) | Various sizes |
| Needle Gauge | Various sizes | Various sizes |
| Needle Hub Type | Female 6% Luer | Female 6% Luer |
| Gradations Legibility | Legible | Legible |
| Lubricant Composition | Dowcorning 360 silicone (barrelinternal surface)
Dowcorning 4159 silicone (needle tip) | Unknown |
| Barrel Transparency | Transparent and clear | Transparent and clear |
| Labeling and Labels | Meet FDA requirements | Meet FDA requirements |
| Plunger Material | PP/PE | Same |
| Barrel Material | PP | Same |
| Piston Material | Kraton IR-307 polyisoprene
This component is not made with natural rubber latex. | Unknown |
| lubricant for the syringe Material | Dowcorning 360 (barrel internal surface)
Dowcorning 4159 (needle tip) | Unknown |
| Ink on the Barrel Material | Teikuko PPE 911 | Unknown |
| Performance | Conforms to ISO 7886-1 and ISO 7864 | Conforms to ISO 7886-1 and ISO 7864 |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 |
| Sterility | EtO Sterilization | EtO Sterilization |
| Item | Insulin syringe with fixed needle | Sterile Insulin Syringe for single use, with
fixed needle
510(K) #: K090929 |
| Intended Use | Insulin syringe (U-100) with fixed
needle is a device intended for
medical purposes for the manual
aspiration of U-100 insulin, and for
the injection of U-100 insulin into
parts of the body below the surface
skin. | Sterile Insulin Syringe for single use, with
fixed needle is a device intended for medical
purpose for the manual injection of insulin. |
| Specific Drug Use | U-100 Insulin | Insulin |
| Nominal Capacity | 0.3ml、0.5ml、1ml | 0.3ml、0.5ml、1ml |
| Needle Hub Type | Fixed | Fixed |
| Gradations Legibility | Legible | Legible |
| Lubricant
Composition | Dowcorning 360 (used on internal
surface of barrel)
Dowcorning 4159 (used on needle
tip) | Dowcorning 360 (used on internal surface of
barrel)
Dowcorning 4159 (used on needle tip) |
| Barrel Transparency | Transparent and clear | Transparent and clear |
| Labeling and Labels | Meets the FDA requirements | Meets the FDA requirements |
| Needle | SUS 304 stainless steel | 304 Stainless Steel |
| Plunger | PE/PP | Medical Grade Polypropylene |
| Barrel | PP | Medical Grade Polypropylene |
| Piston | Kraton IR-307 polyisoprene
This compoment is not made with
natural rubber latex. | Santoprene TPE (Natural color) |
| Lubricant | Dowcorning 360 (barrel internal
surface)
Dowcorning 4159 (needle tip) | Polydimethylsioxane (12500 cp) |
| Ink on the Barrel | Teikuko PPE 911 | 50% SSPPNK-911 |
| | | 50% PPE-911 |
| Performance | Conforms to ISO 8537 | Conforms to ISO 8537 |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 |
| Sterility | EtO Sterilization | EtO Sterilization |
| Item | Hypodermic Needle for single use | BD Hypoint
510(K) #: K070440 |
| Intended Use | The Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration | The BD HypointTM Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. |
| Needle Gauge | Various sizes | Various sizes |
| Needle Hub Type | Female 6% luer conical socket | Female 6% luer conical socket |
| Labeling and Labels | Meet FDA requirements | Meet FDA requirements |
| Needle Material | SUS 304 stainless steel | Unknown |
| Needle Hub Material | PP | Same |
| Needle Sheath Material | PP | Same |
| Lubricant Material | Dowcorning 4159 | Unknown |
| Performance | Conforms to ISO 7864 | Conforms to ISO 7864 |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 |
| Sterility | EtO Sterilization | EtO Sterilization |
4
5
8. Non-Clinical Test Summary
Bench tests were conducted to verify that the proposed devices meet all design specifications as are Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed devices comply with the following standards: ISO 8537:2007 Sterile single-use syringes, with or without needle, for insulin.
ISO 7886 Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use
ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirement
ISO 594-2: 1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings
ISO 7864:1993 Sterile hypodermic needles for single use.
9. Substantially Equivalent Conclusion
The subject device and predicate device have the same classification information, intended use, sterilization specifications, performance, biocompatibility, chemical specifications, physical and mechanical specifications. Both devices meet requirements of ISO 10993, ISO 7886-1, ISO 7864 and ISO 8537. Even if there is some difference in component material (lubricant, ink, piston), we believe such difference has no adverse effect on safety and efficacy of the subject device, and we can be sure of substantial equivalence between subject device and predicate device.
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized bird or eagle, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. David Wang Tiger Medical Products, Limited 1 Huaihai Zhong Road Liu Lin Tower, Suite 1910 Shanghai, China 200021
JUL 1 4 2011
Re: K110697
Trade/Device Name: Syringe (With or Without Needles), Insulin Syringe (U-100) With Fixed Needles, Hypodermic Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: June 28, 2011 Received: June 28, 2011
Dear Mr. Wang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
7
Page 2 -- Mr. Wang
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/MedicalDevices/Safety/Reporta Problem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Anthony D. Norton
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): _ K (10697
Syringe (with or without needle) Device Name: __
Indications for Use:
The Syringe with or without needle is intended for dispensing/administering fluids, and collecting/ sampling of fluid in medical practice.
Prescription Use (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)
Jivision of Anesthesiology, General Hospital nfection Control, Dental Devices
් 10 (k) Number:
Page 1 of 3
9
Indications for Use
K110697 510(k) Number (if known):
Device Name: Insulin syringe (U-100) with fixed needle
Indications for Use:
The insulin syringe (U-100) with fixed needle is a device intended for medical purposes for the manual aspiration of U-100 insulin, and for the injection of U-100 insulin into parts of the body below the surface skin.
The proposed device of Insulin Syringe (U-100) with fixed needle is available in 0.3ml, 0.5ml, and 1ml in volume.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use V AND/OR (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)
7/1/14
Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
:10(k) Number: K110697
10
Page 2 of 3
Indications for Use
510(k) Number (if known): _ |