(122 days)
The Syringe with or without needle is intended for dispensing/administering fluids, and collecting/ sampling of fluid in medical practice.
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 Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
| 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 | - |
This is a 510(k) premarket notification for general hospital devices (syringes and needles), not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device evaluation are not applicable.
Here's the information that can be extracted relevant to acceptance criteria and device performance:
Acceptance Criteria and Device Performance for Syringes and Needles
This document describes a 510(k) submission for conventional medical devices (syringes and needles), not an AI/ML medical device. As such, the acceptance criteria are based on compliance with established international standards for these types of devices, rather than performance metrics like sensitivity, specificity, or AUC typically used for AI/ML.
1. Table of Acceptance Criteria and the Reported Device Performance:
| Device | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Syringe (with/without needle) | Performance: Conforms to ISO 7886-1 and ISO 7864 Biocompatibility: Conforms to ISO 10993 Sterility: EtO Sterilization Nozzle: Luer Slip Gradations Legibility: Legible Barrel Transparency: Transparent and clear Labeling: Meet FDA requirements | Performance: "Conforms to ISO 7886-1 and ISO 7864" Biocompatibility: "Conforms to ISO 10993" Sterility: "EtO Sterilization" (All reported to be equivalent to predicate device) |
| Insulin Syringe (U-100) with fixed needle | Performance: Conforms to ISO 8537 Biocompatibility: Conforms to ISO 10993 Sterility: EtO Sterilization Nozzle: Fixed Gradations Legibility: Legible Barrel Transparency: Transparent and clear Labeling: Meet FDA requirements | Performance: "Conforms to ISO 8537" Biocompatibility: "Conforms to ISO 10993" Sterility: "EtO Sterilization" (All reported to be equivalent to predicate device) |
| Hypodermic Needle for single use | Performance: Conforms to ISO 7864 Biocompatibility: Conforms to ISO 10993 Sterility: EtO Sterilization Nozzle: Female 6% luer conical socket Labeling: Meet FDA requirements | Performance: "Conforms to ISO 7864" Biocompatibility: "Conforms to ISO 10993" Sterility: "EtO Sterilization" (All reported to be equivalent to predicate device) |
| General Acceptance (all devices) | Physical properties: Meet design specifications (e.g., nominal capacity, needle gauge, material properties) | Bench tests conducted to verify compliance with design specifications and standards. (Results state "the proposed devices comply with the following standards...") |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a non-clinical bench testing summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document. The document mentions "Bench tests were conducted," implying laboratory testing on a sample of devices, but the exact number of units tested is not provided.
- Data Provenance: The tests were "Bench tests" which typically means laboratory-controlled testing. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical data, as this is a non-clinical submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For this type of device (syringes and needles), "ground truth" is established by adherence to engineering performance standards (ISO standards) and material specifications, verified through objective bench testing. It does not involve expert interpretation or clinical ground truth as would be relevant for an AI/ML diagnostic device.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is described because there is no subjective interpretation or clinical assessment involved in establishing ground truth for these physical devices. Compliance is determined by objective measurements against established standard parameters.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This submission is for physical medical devices (syringes and needles), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" for these devices is defined by international consensus standards (ISO 8537, ISO 7886-1, ISO 594-1, ISO 594-2, ISO 7864, ISO 10993) and the design specifications of the device (e.g., nominal capacity, material composition, transparency, legibility of gradations). These are objective, measurable criteria.
8. The sample size for the training set:
- Not applicable. This submission is for physical medical devices, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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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
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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
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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 | - |
.
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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 Syringes510(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 polyisopreneThis 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, withfixed needle510(K) #: K090929 |
| Intended Use | Insulin syringe (U-100) with fixedneedle is a device intended formedical purposes for the manualaspiration of U-100 insulin, and forthe injection of U-100 insulin intoparts of the body below the surfaceskin. | Sterile Insulin Syringe for single use, withfixed needle is a device intended for medicalpurpose 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 |
| LubricantComposition | Dowcorning 360 (used on internalsurface of barrel)Dowcorning 4159 (used on needletip) | Dowcorning 360 (used on internal surface ofbarrel)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 polyisopreneThis compoment is not made withnatural rubber latex. | Santoprene TPE (Natural color) |
| Lubricant | Dowcorning 360 (barrel internalsurface)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 Hypoint510(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 |
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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.
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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.
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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
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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
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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
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Page 2 of 3
Indications for Use
510(k) Number (if known): _ |< | | 0 6 9 7
Device Name: Hypodermic Needle for single use
Indications for Use:
The Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.
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)
Rild C. Chy 7/13/14
(Division Sign-Off)
് vision of Anesthesiology, General Hospital .fection Control, Dental Devices
510(k) Number: K110697
Page 3 of 3
§ 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).