(30 days)
No
The device description and performance studies focus on the mechanical and material properties of a standard insulin syringe, with no mention of AI or ML technologies.
No
The device is an insulin syringe, which is used for injection of medication, not for therapeutic treatment itself.
No
Explanation: The device is an insulin syringe, used for the injection of medication, not for diagnosing a condition or disease.
No
The device description clearly outlines a physical medical device (insulin syringe) with components like a barrel, needle, plunger, and cap. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for injection of U100 insulin only." This describes a device used to administer a substance into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a syringe, which is a tool for injection. It doesn't mention any components or functions related to analyzing biological samples (like blood, urine, etc.).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples
- Detecting or measuring substances in samples
- Providing diagnostic information
- Reagents or test kits
The device is clearly described as a syringe for administering insulin, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / Indications for Use
For the injection of U100 insulin. The Easy.Touch disposable sterile insulin syringes are intended for injection of U100 insulin only.
Product codes
FMF
Device Description
The Easy Touch insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston svringes. This premarket notification is for additional needle gauges and lengths as compared to our previous submission, K091472.
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)
Bench tests were performed. Bench testing included biocompatibility, merhanical testing, sterility testing including EO residues. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K10217.8
2 2010 SEP
510(K) Summary, K10
1
MHC Medical Products 100 Commerce Blvd Loveland, OH 54140 Ph: 513 354-2694 Fax: 800.861.1906 Contact person: John Edmiston Date prepared: July 16, 2010
- Trade Name: Easy. Touch Insulin Syringe 1. Common Name: Insulin syringe Classification Name: Syringe, piston, product code FMF, Regulation: 880.5860 Class of device: Class II.
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : 2. Feel-ject Insulin Syringe made by Feel Tech (Korea) K070917 and Easy.Touch Insulin Syringe, K091474, MHC Medical Products.
- Description of device: The Easy Touch insulin syringe consists of a calibrated hollow 3. barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston svringes. This premarket notification is for additional needle gauges and lengths as compared to our previous submission, K091472.
- Intended use: For the injection of U100 insulin. 4.
- Technological characteristics: The Easy•Touch Insulin Syringes and the predicate 5. devices have identical technological characteristics and perform the same way as common piston syringes. These syringes are EO sterilized.
- Performance: Bench tests were performed. Bench testing included biocompatibility, 6. merhanical testing, sterility testing including EO residues. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
1
Exhibit 6. Truthful and Accuracy Statement as required per 21CFR807.87(k).
I certify that, in my capacity as Vice-president of MHC Medical Products, I believe, to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate, and that no material fact has been omitted.
Jutland
:
John Edmiston July 16, 2010
. .
ਾ
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MHC Medical Products C/O Mr. Daniel Kamm Kamm & Associates 8870 Ravello Court Naples, Florida 34114
2 2010 SEP
Re: K102178
Trade/Device Name: Easy-Touch Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 19, 2010 Received: August 13, 2010
Dear Mr. Kamm:
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.
3
Page 2- Mr. Kamm
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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Nh for
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
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Indications for Use
510(k) Number (if known):
Easy.Touch Insulin Syringe Device Name:
Indications For Use:
The Easy•Touch disposable sterile insulin syringes are intended for injection of U100 insulin only.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _X (21 CFR 807 Subpart C)
(Please do not write Below This Line-Continue on Another Page if NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rih C. Chaym 9/1/10
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: __ 10211