(244 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, sterilization, and safety features, with no mention of AI or ML.
No
The device is a pen needle used for injecting drugs, which is a delivery mechanism, not a therapeutic agent itself.
No
The device is a pen needle intended for the injection of drugs, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, sterile, single-use needle with a plastic hub and safety features, indicating it is a hardware medical device, not software only.
Based on the provided information, the Promisemed X-safety pen needle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for use with needle based injector for the injection of drugs." This describes a device used to deliver medication into the body, which is an in vivo (within a living organism) application, not an in vitro (in glass, i.e., outside the body) diagnostic test.
- Device Description: The description focuses on the physical characteristics of a needle designed for injection, including safety features to prevent needle stick injuries. This aligns with an injection device, not a device used to analyze samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. The performance studies listed are related to the physical and functional properties of a needle for injection, not diagnostic accuracy.
Therefore, the Promisemed X-safety pen needle is a medical device used for drug delivery, not an IVD.
N/A
Intended Use / Indications for Use
Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
X-Safety Pen Needle is a single-use, double-ended, sterile needles for needlebased injection systems (NISs) that fulfil the specifications of ISO 11608-1.
This device is constructed as a double-ended, stainless steel needle of various sizes that is with a threaded plastic hub.
The device includes needle shielding safety features (at both patient-end and cartridge-end or at patient-end only) to reduce the risk of needle stick injury and its container can be provided as short or long type.
It is packaged in a sealed sterility barrier, and the needle is lubricated.
This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control.
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)
The bench testing performed verifies that the performance of the subject devices is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- ISO 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- · ISO11608-2: Needle-based injection systems for medical use -Requirements and test methods — Part 2: Needles
- · ISO 7864: Sterile hypodermic needles for single use Requirements and test methods
- · ISO 23908: Sharps injury protection Requirements and test methods
- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
Biocompatibility
- ISO 10993-1:2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- · ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity
- · ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Subacute systemic toxicity
- ASTM F756-13 Standard Practice for Assessment of Hemolytic Properties of Materials
- USP42-NF37 pyrogen test
- USP39 NF34 Endotoxin test (LAL)
- · Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
- Sterility, Shipping, and Shelf-Life
- ISO 11135:2014, Sterilization of health-care products Ethylene oxide - Requirements of the development, validation and routine control of a sterilization process for medical devices
- Package integrity testing, after environmental conditioning and . simulated transportation in accordance with ISTA-3A 2008, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- · Sterile Barrier Packaging Testing performed on the proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP38-NF33_C71
- Shelf life of 5 years is validated using ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Conclusion: Based on the information provided within this 510(k) submission, the proposed subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed 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
§ 880.5570 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 19, 2022
Promisemed Hangzhou Meditech Co., Ltd. % Wei Hsu Regulatory manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong China
Re: K220129
Trade/Device Name: Promisemed X-Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 24, 2022 Received: August 24, 2022
Dear Wei Hsu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220129
Device Name Promisemed X-Safety Pen Needle
Indications for Use (Describe)
Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Date Prepared 1
September 19, 2022
Submitter's Information 2
Name of Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
Address:
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou
City, 311121 Zhejiang, China
Contact Name:
Zearou Yang
Telephone No.:
+86 571 88772985
Fax No.:
+86 571 88772985
Email Address:
ന Trade Name, Common Name, Classification
Trade/Product Name: X-Safety Pen Needle Common Name: Hypodermic single lumen needle Classification name: Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: FMI
Identification of Predicate Device(s) ব K163578: EasyTouch Safety Pen Needle
4
Description of the Device ഗ
X-Safety Pen Needle is a single-use, double-ended, sterile needles for needlebased injection systems (NISs) that fulfil the specifications of ISO 11608-1.
This device is constructed as a double-ended, stainless steel needle of various sizes that is with a threaded plastic hub.
The device includes needle shielding safety features (at both patient-end and cartridge-end or at patient-end only) to reduce the risk of needle stick injury and its container can be provided as short or long type.
It is packaged in a sealed sterility barrier, and the needle is lubricated.
This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control.
6 Intended Use
Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs.
7 Similarities and Differences of the Proposed Device to the Predicate Device
Promisemed X-Safety Pen Needle is substantially equivalent in its technologies and functions to the EasyTouch Safety Pen Needle which cleared under premarket notification number K163578. The following are comparisons between subject device and the predicate device.
A detailed comparison to the predicate is provided in Table 1.
| | Subject Device | Predicate Device
(K163578) | |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Promisemed X-Safety Pen
Needle | EasyTouch Safety Pen
Needle | Comments |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | MHC Medical Products,
LLC. | |
| Device Class | Class II | Class II | Same |
| Product Code | FMI | FMI | Same |
| Regulation
number | 880.5570 | 880.5570 | Same |
| Regulation Name | Needle, Hypodermic,
Single Lumen | Needle, Hypodermic,
Single Lumen | Same |
| Intended Use/
Indications for
Use | Promisemed X-Safety Pen
Needle | The EasyTouch ™ Safety
Pen Needle | Same |
| | Needle is intended for use
with needle based
injector for the injection
of drugs. | 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 subject device
include needle
shielding safety
features (at both
patient end and
cartridge end or at
patient end only)
to reduce the risk
of needle stick
injury. |
| Operating
Principle | 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.
For safety features at
both patient end and
cartridge end: A second
shield covers the needle
tail when the needle is
removed from the
injector.
Once the sharps injury
prevention feature is
activated, it locks in
place and the product can
no longer be used again. | 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. | Different
An additional
protective design is
introduced in
subject device (for
safety features at
both patient end
and cartridge end)
which prevent
accidental needle
sticks at the
cartridge end upon
removal of the
needle from the
injector. |
| Gauge | 29G, 30G, 31G, 32G | 29G, 30G, 31G | Different
Subject device has
additional gauge
size (32G) than
predicate device. |
| Needle Length | 4mm, 5mm, 6mm, 8mm | 5mm, 6mm, 12.7mm | Different |
| | | | Subject device has shorter needle length than predicate device. |
| Material (Needle, Hub, Hub protector, Safety feature) | Needle Tube: 304
Stainless steel X5CrNi18-10 | Needle Tube: 304
Stainless steel needle | Same |
| | Needle Hub:
Polypropylene (PP) | Needle Hub:
Polypropylene (PP) | Same |
| | Container: Polypropylene (PP) | Hub protector:
Polypropylene (PP) | Same |
| | Trigger spring/Posterior spring: Stainless steel | Safety Feature:
Stainless steel spring | Same |
| | Lubricant: Silicon oil | Lubricant: Silicon oil | Same |
| Performance | Complied with ISO 9626, ISO 7864, ISO11608-1, ISO 11608-2 | Complied with ISO 9626, ISO 7864, ISO11608-1, ISO 11608-2 | Same |
| Sterilization | EO Sterilization | EO Sterilization | Same |
| | SAL:10-6 | SAL:10-6 | Same |
| Shelf Life | 5 years | 5 years | Same |
| Single use | Yes | Yes | Same |
| Biocompatibility | Complied with ISO10993 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 and Subacute Systemic Toxicity: No systemic toxicity
-Hemolysis: No evidence of hemolysis
-Pyrogen: Non-pyrogenic | Complied with ISO10993 series standards, and the following tests are performed and passed - 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
- Pyrogen: Non-pyrogenic | Same |
5
6
The Promisemed X-Safety Pen Needle has the same intended use and technological characteristics as the predicate device. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices.
The subject device has additional safety feature at the cartridge end which has been validated through ISO 23908. The subject device has wider gauge size and
7
shorter needle length than predicate device. The specification of needle length and gauze size fulfil the requirement of ISO 9626:2016 and ISO 7864:2016. The differences between the subject device and its predicate do not alter the intended use and do not raise new questions of safety and effectiveness.
8 Performance Testing Summary
The bench testing performed verifies that the performance of the subject devices is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- ISO 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- · ISO11608-2: Needle-based injection systems for medical use -Requirements and test methods — Part 2: Needles
- · ISO 7864: Sterile hypodermic needles for single use Requirements and test methods
- · ISO 23908: Sharps injury protection Requirements and test methods
- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
Biocompatibility
- ISO 10993-1:2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- · ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity
- · ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Subacute systemic toxicity
8
- ASTM F756-13 Standard Practice for Assessment of Hemolytic Properties of Materials
- USP42-NF37 pyrogen test
- USP39 NF34 Endotoxin test (LAL)
- · Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
- Sterility, Shipping, and Shelf-Life
- ISO 11135:2014, Sterilization of health-care products Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- Package integrity testing, after environmental conditioning and . simulated transportation in accordance with ISTA-3A 2008, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- · Sterile Barrier Packaging Testing performed on the proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP38-NF33_C71
- Shelf life of 5 years is validated using ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- Conclusion g
Based on the information provided within this 510(k) submission, the proposed subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.