(591 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, and the safety feature is described as an automatic physical mechanism, not involving computational analysis or learning. There is no mention of AI or ML terms, image processing, or data sets for training/testing.
No.
The device, a pen needle, is intended for drug delivery rather than directly treating a disease or condition. While essential for administering therapeutic drugs, it is a delivery mechanism, not a therapeutic agent itself.
No
The device is a pen needle intended for drug injection, not for diagnosing a condition or disease.
No
The device description clearly outlines a physical medical device (pen needle with a safety shield) and the performance studies focus on physical and mechanical properties, biocompatibility, and sterility, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of drugs (insulin and exenatide) via subcutaneous injection using a pen injector. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description focuses on the mechanical aspects of the needle and safety shield for injection, not on analyzing samples from the body to provide diagnostic information.
- Lack of Diagnostic Function: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such analysis.
The EasyTouch™ Safety Pen Needle is a drug delivery device with a safety feature to prevent needlesticks.
N/A
Intended Use / Indications for Use
The EasyTouch™ Safety Pen Needle is intended for use with pen injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
EasyTouch™ Safety Pen Needle is designed to be used with pen injectors for subcutaneous injections of a desired dose of drugs approved for delivery using a pen needle. The EasyTouch™ Safety Pen Needle is sterile (Ethylene Oxide sterilization procedure), and non-pyrogenic. It is a disposable, single use device. Additionally, the EasyTouch™ Safety Pen Needle is designed to reduce the occurrence of accidental needle sticks by providing a sheath that locks of the needle after use. Prior to injection, the end user will attach the EasyTouch™ Safety Pen Needle to an injector pen. The protective sheath will hide the needle from the user prior to use. Upon application of the needle to the sheath will retract to allow for the needle to enter the body. After the injection is complete, and the needle is removed from the skin, the protective sheath will automatically extend over the needle and lock into place. The EasyTouch™ Safety Pen Needle should be removed from the pen and discarded properly.
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)
Non-clinical testing: Bench Tests were performed. Bench Testing included:
- a. Performance of a Risk Analysis to guide the bench testing regimens.
- b. Biocompatibility per the ISO10993 series of biocompatibility tests: In- Vitro Cytotoxicity report, ISO 10993-5 Skin Sensitization test report ISO-10993-10 Intracutaneous study , ISO-10993-10 Systemic Toxicity test report, ISO-10993-11 Pyrogen test report , ISO-10993-11 All tests passed.
- ﻥ Mechanical testing: To establish proper functioning of the safety feature, testing was performed to evaluate the function of the safety feature in a simulated clinical environment utilizing both professional health care workers and non-clinician pen users using gloved hands. Reference: FDA Guidance Document: Guidance for Industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features Document Issued on: August 9, 2005
- ð. Pen injector compatibility testing was performed to show that the pen needle works properly with multiple brands of pen injectors. Validation basis ISO11608-1 and ISO11608-2
- e. Sterility testing including EO residues. A sterility assurance level of 10⁻⁶ has been demonstrated. We use Ethylene oxide sterilization whereas the predicate device uses gamma sterilization. The SAL levels for both methods are the same.
- f. Packaging and shelf life testing: Accelerated packaging testing was performed to assure a 5 year shelf life: Packaging integrity, packaging permeability, compression resistance, resistance to bacteria.
- Testing was performed to assure compliance with ISO 7864, Sterile hypodermic needles for single oo use -- Requirements and test methods.
- h. Testing was performed to assure compliance with ISO 9626, Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods
Clinical testing: Clinical testing was not required (per FDA guidance) to establish substantial equivalence. However SIMULATED CLINICAL TESTING was performed to meet the requirements of the FDA Guidance on Sharps Injury Prevention (2005) (see above)
Conclusion: Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate device BD Autoshield™ Pen Needle, K06007.
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.
BD Autoshield™ Pen Needle, K060007
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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
August 3, 2018
MHC Medical Products, LLC. % Daniel Kamm Kamm & Associates 8870 Ravello Ct. Naples, Florida 34114
Re: K163578
Trade/Device Name: EasyTouch™ Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 3, 2018 Received: July 6, 2018
Dear Daniel 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.
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Image /page/1/Picture/6 description: The image shows a signature and a name. The name is "Tina Kiang-S". The signature is a stylized, looping design to the left of the name.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K163578
Device Name EasyTouch™ Safety Pen Needle
Indications for Use (Describe)
The EasyTouch™ Safety Pen Needle is intended for use with pen injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the shield also serves to hide the needle before and after injection.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K163578 MHC Medical Products 8695 Seward Rd. Fairfield, OH 45011 Tel: 877-358-4342 Contact Person: Sean O'Keefe Date Prepared: August 1, 2018
1. Identification of the Proposed Device:
Trade Name: EasyTouch™ Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI
-
- Identification of the Predicate Device: BD Autoshield™ Pen Needle, K060007. Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI
-
- Description of Device: EasyTouch™ Safety Pen Needle is designed to be used with pen injectors for subcutaneous injections of a desired dose of drugs approved for delivery using a pen needle. The EasyTouch™ Safety Pen Needle is sterile (Ethylene Oxide sterilization procedure), and non-pyrogenic. It is a disposable, single use device. Additionally, the EasyTouch™ Safety Pen Needle is designed to reduce the occurrence of accidental needle sticks by providing a sheath that locks of the needle after use. Prior to injection, the end user will attach the EasyTouch™ Safety Pen Needle to an injector pen. The protective sheath will hide the needle from the user prior to use. Upon application of the needle to the sheath will retract to allow for the needle to enter the body. After the injection is complete, and the needle is removed from the skin, the protective sheath will automatically extend over the needle and lock into place. The EasyTouch™ Safety Pen Needle should be removed from the pen and discarded properly.
-
- Intended Use/Indications for Use: The EasyTouch™ Safety Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exenatide. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
-
- Technical Characteristics: EasyTouch™ Safety Pen Needles and the predicate devices have identical technological characteristics and perform the same way as common pen needles. The EasyTouch™ Safety Pen Needle and the predicate device both include safety features that are identical in function and performance. A detailed comparison table follows:
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Comparison Table
| BD Autoshield™ Pen Needle, K060007 | EasyTouch™ Safety Pen Needle | |
|---|---|---|
| Indications for Use | The BD AutoShield™ Pen Needle is | |
| intended for use with pen injector devices | ||
| for the injection of drugs, including insulin | ||
| and exenatide. Additionally, the attached | ||
| safety shield automatically locks in place | ||
| and reduces the occurrence of accidental | ||
| needle sticks from the patient end of the | ||
| needle. The shield also serves to hide the | ||
| needle before and after injection. | The EasyTouch™ Safety Pen Needle is | |
| intended for use with pen injector devices | ||
| for the injection of drugs, including insulin | ||
| and exenatide. Additionally, the attached | ||
| safety shield automatically locks in place and | ||
| reduces the occurrence of accidental needle | ||
| sticks from the patient end of the needle. The | ||
| shield also serves to hide the needle before | ||
| and after injection. SAME. | ||
| USE | OTC | SAME |
| Principle of | ||
| operation | Serves as a single use pen needle. The | |
| device is removed from its packaging and | ||
| screwed into a pen injector device. The | ||
| patient then injects the medicine by first | ||
| setting the dose on the pen, and then | ||
| inserting the needle into the skin and then | ||
| pressing the button on the pen. After the | ||
| injection the needle automatically retracts | ||
| into a shielded housing, thus preventing | ||
| an accidental needle stick. | SAME | |
| Interface with pen | ||
| injector (e.g. luer | ||
| taper or others), | Employs standardized dimensions and luer | |
| taper per ISO 11608, Needle-based | ||
| injection systems for medical use – | ||
| Requirements and test methods —The | ||
| dimensions of the attachment part of the | ||
| needle shall be such that the needle fits | ||
| and functions with pen injectors which are | ||
| in accordance with ISO 11608-1. | ||
| Unscrewing torque of the needle: | ||
| 0.06~0.08 N.m. The standard 6% luer | ||
| taper is employed to help ensure a leak | ||
| free connection to the syringe or pen | ||
| assembly. | SAME | |
| Material | ||
| information: Hub, | ||
| Hub protector, | ||
| Safety feature | ||
| Needle | Hub: Polypropylene | |
| Hub Protector: Polypropylene | ||
| Safety Feature: Stainless steel spring | ||
| Needle: 304 Stainless steel needle with | ||
| silicone lubricant | Hub: Polypropylene | |
| Hub Protector: Polypropylene | ||
| Safety Feature: Stainless steel spring | ||
| Needle: 304 Stainless steel needle with | ||
| silicone lubricant | ||
| SAME | ||
| Sizes/Lengths | 29G, 30G, and 31G | |
| 5 mm, 8 mm, 12.7 mm lengths | 29G: 3/16" (5mm) and 5/16" (8mm) | |
| (29G only). This is a subset of the predicate. | ||
| Sterilization | SAL: 10⁻⁶ | |
| Gamma Sterilized | SAL: 10⁻⁶ SAME | |
| Ethylene Oxide EQUIVALENT | ||
| See discussion below. | ||
| Shelf life | 5 Years | 5 Years SAME |
| Single use | YES | YES SAME |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 |
| BD Autoshield™ Pen Needle, K060007 | EasyTouch™ Safety Pen Needle | |
| series standards, (presumed, not stated in | ||
| 510(k) summary) | series standards, and the following tests are | |
| performed, | ||
| ● Cytotoxicity: No cytotoxicity | ||
| ● Skin Irritation: No evidence of skin | ||
| irritation | ||
| ● Skin Sensitization: No evidence of | ||
| sensitization | ||
| ● Acute Systemic Toxicity: No systemic | ||
| toxicity | ||
| ● Hemolysis: No evidence of hemolysis | ||
| SAME | ||
| Photo | Image: BD Autoshield Pen Needle | Image: EasyTouch Safety Pen Needle |
| SIMILARITY IS OBVIOUS |
5
6. Non-clinical testing: Bench Tests were performed. Bench Testing included:
- a. Performance of a Risk Analysis to guide the bench testing regimens.
- b. Biocompatibility per the ISO10993 series of biocompatibility tests: In- Vitro Cytotoxicity report, ISO 10993-5 Skin Sensitization test report ISO-10993-10 Intracutaneous study , ISO-10993-10 Systemic Toxicity test report, ISO-10993-11 Pyrogen test report , ISO-10993-11 All tests passed.
- ﻥ Mechanical testing: To establish proper functioning of the safety feature, testing was performed to evaluate the function of the safety feature in a simulated clinical environment utilizing both professional health care workers and non-clinician pen users using gloved hands. Reference: FDA Guidance Document: Guidance for Industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features Document Issued on: August 9, 2005
- ರ. Pen injector compatibility testing was performed to show that the pen needle works properly with multiple brands of pen injectors. Validation basis ISO11608-1 and ISO11608-2
- e. Sterility testing including EO residues. A sterility assurance level of 10* has been demonstrated. We use Ethylene oxide sterilization whereas the predicate device uses gamma sterilization. The SAL levels for both methods are the same.
- f. Packaging and shelf life testing: Accelerated packaging testing was performed to assure a 5 year shelf life: Packaging integrity, packaging permeability, compression resistance, resistance to bacteria.
- Testing was performed to assure compliance with ISO 7864, Sterile hypodermic needles for single oo use -- Requirements and test methods.
6
- h. Testing was performed to assure compliance with ISO 9626, Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods
-
- Clinical testing: Clinical testing was not required (per FDA guidance) to establish substantial equivalence. However SIMULATED CLINICAL TESTING was performed to meet the requirements of the FDA Guidance on Sharps Injury Prevention (2005) (see above)
-
- Conclusion: Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate device BD Autoshield™ Pen Needle, K06007.