(131 days)
No
The device description and performance studies focus on the physical characteristics, sterility, and biocompatibility of a simple blood lancet, with no mention of AI or ML capabilities.
No
Explanation: This device is used for obtaining blood samples, not for treating a condition or disease.
No
The device is a blood lancet, a tool used to obtain blood samples. While blood samples can be used for diagnostic purposes, the lancet itself is a collection tool, not a device that performs a diagnosis. Its intended use is to "obtain a drop of capillary blood," which is a sample collection function.
No
The device description clearly states it is a physical medical device consisting of a needle sheath, hub, and needle, and is used for capillary blood sampling. It is a hardware component.
Based on the provided information, the MedtFine Blood Lancet is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. Examples include blood glucose meters, pregnancy tests, or tests for infectious diseases.
- The MedtFine Blood Lancet's intended use is to obtain a blood sample. It is a tool for collecting the specimen, not for analyzing it or providing diagnostic information itself.
- The device description clearly states it's a "small medical device used for capillary blood sampling." It's a physical instrument for making a puncture.
While the blood obtained using the lancet might be used with an IVD device (like a blood glucose meter), the lancet itself is not the IVD. It's a sample collection tool.
N/A
Intended Use / Indications for Use
MedtFine Blood Lancet is intended for use together with a lancing device of skin to obtain a drop of capillary blood from fingertip or from alternative sites.
Product codes (comma separated list FDA assigned to the subject device)
QRK
Device Description
MedtFine Blood Lancet is a small medical device used for capillary blood sampling. It is similar to a small scalpel with a double-edged needle used to make punctures, such as a fingerstick, to obtain small blood specimens.
The device consists of a needle sheath, a hub, and a needle and provided sterility that is sterilized by gamma radiation. The device has three types listed in table 1 with recognized color.
The device is an over-the-counter instrument equipped with a lancing device that patients mostly use during blood monitoring. However, in this case, it doesn't contain a lancing device, only the lancet. The proposed device is a universal device that can be fitted with most common marked lancing devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip or from alternative sites
Indicated Patient Age Range
Child older than 2 years
Adolescent
Adult
Intended User / Care Setting
patients mostly use during blood monitoring.
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 tests were performed in conformance with the following standards:
- Physical performance testing according to ISO 9626:2016, ISO 7864-2016, ISO 11608-1:2014, and ISO 11608-2.
- Sterility testing according to ISO 11737-1:2018, ISO 11737-2:2019, ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2006, ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1980, ASTM F1929: 2015, ASTM D4169-16, and USP .
- Biocompatibility testing according to ISO10993-1:2018, ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, USP , USP , and USP .
- Biocompatibility testing results showed no hemolysis, no cytotoxicity, no irritation, no skin sensitization, no acute systemic toxicity, and no pyrogens.
- Population evaluation testing was conducted to support the wider intended population.
- Visual checking results meet all requirements of ISO 9626, ISO 7864, and internal requirements.
- Performance and usability testing showed no impact of slightly longer needle length, as exposed needle length is tuned by the lancing device.
- Penetration force of the proposed device is lower, making it easier to puncture skin with less pain.
No clinical testing is available for this 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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
September 21, 2022
Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Shanghai Carelife International Trading Co. Ltd. % Evan Hu Marketing & Technical Manager Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, Shanghai 201114 China
Re: K221383
Trade/Device Name: MedtFine Blood Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK Dated: August 18, 2022 Received: August 23, 2022
Dear Evan Hu:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Colin Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221383
Device Name MedtFine Blood Lancet
Indications for Use (Describe)
MedtFine Blood Lancet is intended for use together with a lancing device of skin to obtain a drop of capillary blood from fingertip or from alternative sites.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K221383 510(K) SUMMARY
1. Preparation date: 9/16/2022
2. Submitter
Manufacturer: Shanghai Carelife International Trading Co. Ltd. Address: 1707 Yinqiao Bldg.,58 Jinxin Rd.201206 Shanghai, PEOPLE'S REPUBLIC OF CHINA person: Xiaoying, Quality Contact zxy@shanghaicarelife.com Submission correspondent: Evan Hu, 86-18616124827, Evan.hu@mind-link.net
3. Device
Trading name: MedtFine Blood Lancet Common name: Sterile Blood Lancet Classification Name: Single Use Only Blood Lancet Without an Integral Sharps Injury Prevention Feature Classification: Class II Product code: QRK
4. Predicate device
Primary predicate device: Promisemed Blood Lancet - K192666 Reference device: Accu-Chek Softclix Blood Lancing System - K214022
5. Device description
MedtFine Blood Lancet is a small medical device used for capillary blood sampling. It is similar to a small scalpel with a double-edged needle used to make punctures, such as a fingerstick, to obtain small blood specimens.
The device consists of a needle sheath, a hub, and a needle and provided sterility that is sterilized by gamma radiation. The device has three types listed in table 1 with recognized color.
The device is an over-the-counter instrument equipped with a lancing device that patients mostly use during blood monitoring. However, in this case, it doesn't contain a lancing device, only the lancet. The proposed device is a universal device that can be fitted with most common marked lancing devices.
4
Table 1. Device models
| Gauge Size | Designated metric size | Color |
|---|---|---|
| 28G | 0.36 | Green-Blue |
| 30G | 0.30 | Grey-Blue |
| 33G | 0.20 | Transparent |
-
- Indications for use/Intended use
MedtFine Blood Lancet is intended for use together with a lancing device for puncture of skin to obtain a drop of capillary blood from fingertip or from alternative sites.
- Indications for use/Intended use
-
- Comparison of technological characters between proposed and predicate devices
| Characters | Proposed device
(K221383- MedtFine Blood Lancet) | Primary predicate
device
(K192666-Promisemed
Blood Lancet) | Reference device
(K214022- Accu-Chek
Softclix Blood Lancing
System) | Remark | Type of use | over-the-counter | over-the-counter | over-the-counter | Same |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------------------------------|-----------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Product code | QRK | FMK | QRL, QRK | #1 | Configuration
and materials | Needle sheath: PE
Hub: PP
Needle: SUS 304 | Cap: PE
Body: PE
Needle: SUS | Cap
Body
Needle | #6 |
| Regulation No. | 21 CFR 878.4850 | 21 CFR 878.4800 | 21 CFR 878.4850 | #2 | Needle Gauge | 28G, 30G, 33G | 21G, 26G, 28G, 30G | 28G | #7 |
| Classification | Class II | Class I | Class II | #3 | Sterility | Sterilized by gamma
radiation
SAL = $10^{-6}$ | Sterilized by gamma
radiation
SAL = $10^{-6}$ | Sterilized by gamma
radiation
SAL = $10^{-6}$ | Same |
| Intended use | MedtFine Blood Lancet is
intended for use together
with a lancing device for
puncture of skin to obtain
a drop of capillary blood
from fingertip or from
alternative sites. | It is intended for
capillary blood
sampling. | The Accu-Chek Softclix
Blood Lancing System is
intended for the hygienic
collection of capillary
blood for testing
purposes from the side of
a fingertip and from
alternative sites, such as
the palm, the upper arm,
and the forearm. | #4 | Single-use | Single use on one patient,
no more than one use | Single use on one
patient, no more than
one use | Single use on one patient,
no more than one use | Same |
| Indications for
use | | | Accu-Chek Softclix
Lancets:
The sterile, single-use
lancets are to be used
with the reusable lancing
device that is to be
cleaned and disinfected
between each use, and
then the lancets are to be
disposed of. | #5 | Sharp injury
protection | No sharp injury protection
function | No sharp injury
protection function | Lancets are covered by a
sterile barrier cap until
twisted off before use.
Until firing, the lancet is
contained within the
lancing device housing.
Immediately after firing,
the lancet is
automatically retracted
back into housing. An
ejector sleeve can then
be pulled forward for
contactless disposal of
the lancet | #8 |
| Intended
population | Child older than 2 years
Adolescent
Adult | Adult | Not known | #9 | | | | | |
| Visual
inspection | (a) Smooth, clean,
free from contamination
(b) No color fading
(c) Sharp edge, free
from burrs, hook, and
blunt.
(d) Straight, no
slanting
Meet visual checking
requirements of ISO 9626,
ISO 7864, and internal
requirements | Meet visual checking
requirements of ISO
9626 and ISO 7864 | Not known | #10 | | | | | |
| Needle
dimension- | 33G: 3.47 mm
30G: 3.52 mm | 21G: 3mm
26G: 3mm
28G: 3mm | Not known | #11 | | | | | |
Table 2. Characters comparison
5
6
| exposed needle
| length | 28G: 3.25 mm | 30G: 3mm | ||
|---|---|---|---|---|
| Needle | ||||
| dimension-OD | 33G: 0.20 mm | |||
| 30G: 0.32 mm | ||||
| 28G: 0.36 mm | ||||
| Meet needle outer | ||||
| dimension requirements | ||||
| of ISO 9626 | Meet needle outer | |||
| dimension | ||||
| requirements of ISO | ||||
| 9626 | Not known | Same | ||
| Chemical | ||||
| Characters | Limits for acidity or | |||
| alkalinity | ||||
| 33G: 0.31 | ||||
| 30G: 0.29 | ||||
| 28G: 0.34 | ||||
| Meet requirements of ISO | ||||
| 7864 | Meet requirements of | |||
| ISO 7864 | Not known | Same | ||
| Needle bond | ||||
| force | 33G: 12.15 N | |||
| 30G: 15.87 N | ||||
| 28G: 15.39 N | ||||
| Meet requirements of ISO | ||||
| 7864 | Meet requirements of | |||
| ISO 7864 | Not known | Same | ||
| Resistance to | ||||
| corrosion | No corrosion in NaCl | |||
| solution for 7 hours | ||||
| Meet corrosion resistance | ||||
| requirements of ISO 9626 | Meet corrosion | |||
| resistance | ||||
| requirements of ISO | ||||
| 9626 | Not known | Same | ||
| Lancing device | ||||
| compatibility | As a universal device, it is | |||
| compatible with various | ||||
| commercially marketed | ||||
| lancing devices verified in | ||||
| usability testing. | It claims to be | |||
| compatible with | ||||
| lancing devices. | It claims to be compatible | |||
| with the Accu-Chek | ||||
| Softclix Blood Lancing | ||||
| System | Same | |||
| Penetrate | ||||
| force/puncture | ||||
| force | 33G: 0.388 N | |||
| 30G: 0.543 N | ||||
| 28G: 0.545 N | ||||
| Meet requirements of ISO | ||||
| 7864 | 30G: 0.656 N | |||
| 28G: 0.751 N | ||||
| Meet requirements of | ||||
| ISO 7864 | Not Known | #12 | ||
| Biocompatibility | No hemolysis | |||
| No cytotoxicity | ||||
| No irritation and no skin | ||||
| sensitization | ||||
| No acute systemic toxicity | ||||
| No pyrogens | No cytotoxicity | |||
| No irritation and no | ||||
| skin sensitization | Not Known | #13 |
#1, #2 and #3:
Single-use only blood lancet without an integral sharps injury prevention feature was once a Class I device exempted from 510(k) registration. However, the regulation was last amended, and the device is reclassified to Class II, effective on 12/03/2021. The device is given the
7
product code QRK under regulation 21 CFR part878.4850. So, the differences are administrative differences, which cannot affect the device's safety and effectiveness.
The reference device is a combination device that consists of a lancet and a lancing device. In this case, only the lancet is used to be compared. So, there is no difference in product code, requlation number, and classification.
In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.
#4 and #5
There is no difference of intended use and indication for use between the proposed device and the primary predicate device. They are both intended to equip with a lancing device and then puncture the skin to obtain capillary blood.
However, the reference device is a combination system, and only the lancet is compared. For this view, there is also no difference.
In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.
#6:
The configurations are different. The proposed device has a removable needle sheath (or called a cap). The user could directly remove the needle sheath and load it to a lancing device. However, the primary and reference devices have an integrity structure, which means the cap, body, and needle are over-molded together from an injection machine. The user should twist the cap to expose the needle and the load to a lancing device. The differences are rising from the different manufacturing processes. So, the process validation and device performance testing are run to verify the device's effectiveness.
The materials used are different. Due to the integrity structure, the primary predicate and reference devices only use PE to make the cap and body. However, the proposed device uses PE to make the sheath (cap) and PP to make the hub (cap) due to two separated manufacturing processes and late assembly. So, biocompatibility testing is run to verify the device's safety.
The proposed device uses SUS 304 to make a needle; however, the predicate device does not reveal the exact stainless-steel grade. The difference between different SUS grades is their performance. So, performance testing is conducted to verify the device's effectiveness.
In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.
#7:
The proposed device has three types of gauge, more than the primary and reference device. The primary predicate device has four types, according to their official website, and the reference device only has one type. So, all proposed device types' performance testing is run to verify the device's effectiveness.
8
In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.
#8:
Unlike the reference device, the proposed and predicate devices do not claim sharp injury protection features, meaning they don't contain the sharp injury prevention structure. It cannot affect safety and effectiveness.
#9: The intended population of the proposed device is wider than the primary predicate device. So, the manufacturer conducts population evaluation testing, and the results support the intended population, demonstrating substantial equivalence.
#10: The proposed device uses an additional internal requirement to conduct the device's visual checking to confirm no deficiencies in visual appearance. The internal requirements are derived from the visual checking sections of ISO 9626 and ISO 78664. The visual checking results meet all requirements, so there is no significant difference compared with the predicate device, demonstrating substantial equivalence.
#11: The needle length of the proposed device is slightly longer than the predicate device. Testings of performance and usability show no impact of a slightly longer needle on device properties because the exposed needle length is tuned by the lancing device, not the lancet itself, demonstrating the substantial equivalence.
#12: The proposed device's penetrate force (puncture force) is lower than the primary predicate device, meaning that the proposed device lancet is easier to puncture into the patient's skin, resulting in a less painful feeling for patients. Results show that the proposed device is comparable to the predicate device in the penetrate force, demonstrating substantial equivalence.
#13: The proposed device conducts six items of biocompatibility testing, but the predicate device only conducts three items. Results show that the proposed device is as safe as the proposed device, demonstrating substantial equivalence.
-
- Non-clinical testing results
The non-clinical tests of this proposed device are tested in conformance with the following standards.
- Non-clinical testing results
-
(1) Physical performance testing
-
(a) ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Device.
-
(b) ISO 7864-2016 Sterile hypodermic needles for single use requirements and test methods
9
- (c) ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods - Part 1: Needle-based injection systems
- (d) ISO 11608-2 Needle-based injection system s for medical use — Requirements and test methods — Part 2: Double-ended pen needles
- (2) Sterility
- (a) ISO 11737-1:2018, Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products.
- (b) ISO 11737-2:2019 Sterilization of health care products Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- (c) ISO 11137-1:2006, Radiation sterilization of medical devices part 1: Requirements for the development, validation and routine control of the sterilization process of medical devices.
- (d) ISO 11137-2:2013, Radiation sterilization of medical devices part 2: Determination of sterilization dose.
- (e) ISO11137-3 : 2006 Radiation sterilization of medical devices part 3: Dosage guidelines.
- (f) ISO 11607-1:2019, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
- (q) ISO 11607-2:2019, Packaqing for terminally sterilized medical devices--Part 2: Validation requirements for forming, sealing and assembly processes
- (h) ASTM F1980: Standard for Accelerated Aging of Sterile Barrier Systems and Medical Devices
- (i) ASTM F1929: 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- (j) ASTM D4169-16 Standard Practice For Performance Testing Of Shipping Containers And Systems
- (k) USP Sterility Test
- (3) Biocompatibility testing
- (a) ISO10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- (b) ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood.
- (c) ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- (d) ISO 10993-10:2010, Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization.
- (e) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
- (f) USP Bacterial Endotoxins Test
- (q) USP Particulate matter in injection
10
- (h) USP Medical Devices-Bacterial endotoxin and pyrogen tests
9. Clinical testing
No clinical testing is available for this device.
10. Conclusion
The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use and technological characteristics.