(249 days)
No
The device description and performance studies focus solely on the mechanical function and safety of a lancing device and lancets for obtaining blood samples. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is intended to obtain capillary blood for testing purposes, not to treat or cure a disease or condition.
No.
The device is a lancing device, which is used to obtain a sample of capillary blood. It does not perform any diagnostic function on the blood sample itself.
No
The device description explicitly details physical components (TD-5010 Lancing Device and AST Cap) and mechanical performance testing, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The TD-5010 Lancing Device and TD-5084 Sterile Lancets are used to obtain a sample of blood. They are a tool for collecting the sample, not for performing a diagnostic test on the sample itself.
- Intended Use: The intended use clearly states that the purpose is to "obtain capillary blood for testing purposes." This indicates that the testing is done separately, likely with an IVD device like a blood glucose meter.
While the blood obtained is used for diagnostic testing, the lancing device and lancets themselves are considered medical devices used for sample collection, not IVDs.
N/A
Intended Use / Indications for Use
The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain 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.
The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of.
For use only on a single patient in a home setting.
Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
Product codes
QRL, QRK
Device Description
The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets to obtain a drop of blood from a fingertip or alternative sites. The TD-5010 Lancing Device consists of two components:
(1)TD-5010 Lancing Device
(2) Alternative Site Testing (AST) Cap
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm, upper arm, forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For use only on a single patient in a home setting. Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
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
Mechanical performance test, Storage stability test, Robustness test.
Mechanical functions were verified between candidate device and predicate device by bench tests.
Storage stability test of candidate device was performed to ensure the safety and effectiveness were suitable for use over the shelf life of device.
Robustness test demonstrated that the TD-5010 Lancing Device was robust against cleaning and disinfection procedures after multiple cleaning and disinfection cycles using EPA-registered disinfecting wipes.
Clinical Testing is not applicable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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.
January 20, 2023
GOSTAR Co., Ltd. Pei-Fen Yang President 2F, No.65, Wuquan 7nd Rd. New Taipei City, Wugu District 248020 Taiwan
Re: K221419
Trade/Device Name: TD-5010 Lancing Device and TD-5084 Sterile Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL, QRK Dated: December 12, 2022 Received: December 14, 2022
Dear Pei-Fen Yang:
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,
Jessica Carr -S
for Long Chen, Ph.D. 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) K221419
Device Name
TD-5010 Lancing Device and TD-5084 Sterile Lancets
Indications for Use (Describe)
The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, and the forearm. The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of.
For use only on a single patient in a home setting.
Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
| 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
K221419
510(k) Summary
In accordance with the requirements of 21 CFR 807.92, this summary is being provided to serve as the basis for the substantial equivalence determination.
1. 510(k) Owner Information
| Correspondent | GOSTAR CO., LTD. |
|---|---|
| Address | 2F., No. 65, Wuquan 7th Rd., Wugu Dist., 248020 New |
| Taipei City, TAIWAN | |
| Correspondent Contact | Pei-Fen Yang, Ph.D. |
| Title | President |
| Phone | +886-2-2298-1927 |
| ra.cert@gostarmed.com | |
| Date Prepared | May 13, 2022 |
2. Candidate Device Information
| Proprietary Name | TD-5010 Lancing Device and TD-5084 Sterile Lancets |
|---|---|
| Common Name | Lancing device; Lancets |
| Classification Product Code | QRL |
| Subsequent Product Code | QRK |
| 510(k) Number | K221419 |
| Review Panel | General & Plastic Surgery |
| Classification | 2 |
| Regulation Number | 21 CFR 878.4850 |
3. Predicate Device Information
| Manufacturer | Roche Diabetes Care, Inc. |
|---|---|
| Proprietary Name | Accu-Chek Softclix Blood Lancing System |
| Classification Product Code | QRL |
| Subsequent Product Code | QRK |
| 510(k) Number | K214022 |
| Review Panel | General & Plastic Surgery |
| Classification | 2 |
| Regulation Number | 21 CFR 878.4850 |
4
4. Intended Use
The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain 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.
The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of.
For use only on a single patient in a home setting.
Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
5. Device Description Summary
The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets to obtain a drop of blood from a fingertip or alternative sites. The TD-5010 Lancing Device consists of two components:
(1)TD-5010 Lancing Device
(2) Alternative Site Testing (AST) Cap
6. Comparison to Predicate Device
- 6.1 Intended Use Comparison
The intended use of the candidate device is the same as the predicate device, including the testing sites and environment of use.
6.2 Technological Comparison
The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets are substantially equivalent to the predicate device in terms of technological characteristics, including their intended use, function and design.
5
| Predicate Device- K214022 | Candidate Device- K221419 | ||
|---|---|---|---|
| Characteristic | Accu-Chek Softclix Blood Lancing | TD-5010 Lancing Device and | Remark |
| System | TD-5084 Sterile Lancets | ||
| Device | |||
| Description | • The Accu-Chek Softclix Lancing | ||
| Device uses compatible Accu- | |||
| Chek Softclix Lancets to obtain a | |||
| drop of blood from a fingertip or | |||
| alternative sites using the Accu- | |||
| Chek Softclix Alternative Site | |||
| Testing (AST) Cap. | |||
| • 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. | |||
| • This system is for use only | |||
| on a single patient in a home | |||
| setting. | |||
| • This system is not suitable | |||
| for use by healthcare | |||
| professionals with multiple | |||
| patients in a healthcare | |||
| setting. | • The TD-5010 Lancing Device | ||
| uses compatible TD-5084 | |||
| Sterile Lancets to obtain a drop | |||
| of blood from a fingertip or | |||
| alternative sites using the | |||
| Alternative Site Testing (AST) | |||
| Cap. | |||
| • The single-use TD-5084 Sterile | |||
| Lancets are to be used with the | |||
| reusable TD-5010 Lancing | |||
| Device that is to be cleaned and | |||
| disinfected between each use, | |||
| and then the TD- 5084 Sterile | |||
| Lancets are to be disposed of. | |||
| • For use only on a single patient | |||
| in a home setting. Not suitable | |||
| for use by healthcare | |||
| professionals with multiple | |||
| patients in a healthcare setting. | Identical | ||
| Intended Use | 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. | |||
| 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. | |||
| This system is for use only on a | |||
| single patient in a home setting. | |||
| This system is not suitable for use by | |||
| healthcare professionals with | |||
| multiple patients in a healthcare | |||
| setting. | The TD-5010 Lancing Device and TD- | ||
| 5084 Sterile Lancets are intended to | |||
| obtain 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. | |||
| The single-use TD-5084 Sterile | |||
| Lancets are to be used with the | |||
| reusable TD- 5010 Lancing Device | |||
| that is to be cleaned and disinfected | |||
| between each use, and then the TD- | |||
| 5084 Sterile Lancets are to be disposed | |||
| of. | |||
| For use only on a single patient in a | |||
| home setting. | |||
| Not suitable for use by healthcare | |||
| professionals with multiple patients in | |||
| a healthcare setting. | Identical | ||
| Characteristic | Predicate Device- K214022 | ||
| Accu-Chek Softclix Blood Lancing | |||
| System | Candidate Device- K221419 | ||
| TD-5010 Lancing Device and | |||
| TD- 5084 Sterile Lancets | Remark | ||
| Mechanical | |||
| Loading | Spring-driven | Spring-driven | Identical |
| Lancet Sterility | Gamma irradiation | Gamma irradiation | Identical |
| Number of | |||
| Uses | Base (lancing device): multiple use | ||
| Lancet: single use | TD-5010 Lancing Device: multiple use | ||
| TD-5084 Sterile Lancets: single use | Identical | ||
| Anatomical | |||
| Sites | Fingertip | ||
| Ball of the hand (palm) | |||
| Upper arm | |||
| Lower arm (forearm) | Fingertip | ||
| Ball of the hand (palm) | |||
| Upper arm | |||
| Lower arm (forearm) | Identical | ||
| Sharps Injury | |||
| Prevention | 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. | The TD-5010 Lancing Device can be | ||
| reset to operate only after the used | |||
| lancet has been ejected which | |||
| prevents multiple punctures with a | |||
| used lancet. Ejection of used lancets | |||
| is done by sliding the ejector. | Identical | ||
| Type of Use | Over the counter use | Over the counter use | Identical |
Table 1. Similarities Between the Predicate and Candidate Device
6
7
| Characteristic | Predicate Device- K214022
Accu-Chek Softclix Blood Lancing System | Candidate Device- K221419
TD-5010 Lancing Device and
TD- 5084 Sterile Lancets | Remark | | | | | | | | | | | | | | | | | | | | | | | | |
|------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------|
| Appearance | Image: Accu-Chek Softclix Blood Lancing System and lancet | Image: TD-5010 Lancing Device and AST cap and TD-5084 Sterile Lancets | Difference 1 | | | | | | | | | | | | | | | | | | | | | | | | |
| Puncture
Depth and
Exposed
Needle
Length | Not publicly available | Segment Puncture depth (mm) Exposed needle length (mm) Segment 1 (Minimum penetration depth) $0.8 \pm 0.1$ $0.8 \pm 0.1$ Segment 2 $1.0 \pm 0.1$ $1.0 \pm 0.1$ Segment 3 $1.2 \pm 0.1$ $1.2 \pm 0.1$ Segment 4 $1.4 \pm 0.1$ $1.4 \pm 0.1$ Segment 5 $1.6 \pm 0.1$ $1.6 \pm 0.1$ Segment 6 $1.8 \pm 0.1$ $1.8 \pm 0.1$ AST Cap (Maximum penetration depth) $2.4 \pm 0.1$ $2.4 \pm 0.1$ | | | | | | | | | | | | | | | | | | | | | | | | | Difference 2 |
| Load | Load by pressing priming button when lancet is inserted | The TD-5084 Sterile Lancets can be loaded into TD-5010 lancing device by (1) installing the lancets into lancet holder of lancing device with enough loading force, or (2) inserting the lancets into lancet holder of lancing device then pulling the pulling cap of the TD-5010 lancing device with enough pulling force. | Difference 3 | | | | | | | | | | | | | | | | | | | | | | | | |
| Needle | 28G; beveled cut with 3 facets | 30G; beveled cut with 3 facets | Difference 4 | | | | | | | | | | | | | | | | | | | | | | | | |
Table 2. Differences Between the Predicate and Candidate Device
8
7. Discussion of Differences
7.1 Difference 1 (Appearance)
The user interfaces of candidate device include selector cap, AST cap, release button, pulling cap and ejector, the purposes of design are similar to predicate device. The mechanical performance test was performed to verify the lancets installation, loading, firing and ejection between candidate device and predicate device. All test results met acceptance criteria, which demonstrated that the different appearance design of candidate device could meet the same intended use as predicate device and didn't impact the safety and effectiveness.
The disinfection validation test and biocompatibility tests were performed to verify the housing materials of TD-5010 Lancing Device. The results demonstrated that the housing materials of TD-5010 Lancing Device would not affect the effectiveness of cleaning and disinfection, and biocompatibility.
The biocompatibility tests were performed to verify the materials of TD- 5084 Sterile Lancets. The results demonstrated that the materials of TD- 5084 Sterile Lancets would not affect the biocompatibility.
7.2 Difference 2 (Puncture Depth, Exposed Needle Length and Firmness Force)
The TD-5010 Lancing Device has 6 levels of puncture depth, which are adjustable by rotating the selector cap and installing the AST cap. The predicate device has 11 levels of puncture depth, which are adjustable by rotating the rotatable cap and AST cap.
The mechanical performance test was performed between candidate device and predicate device to verify the percussion of lancets for each puncture depth. The firmness force test was also performed in the accelerated and real-time aging tests of TD-5084 Sterile Lancets. According to the test results, puncture depths and exposed needle length of candidate device and predicate device both met its specifications, and the firmness force was within acceptance criteria in the accelerated and real-time aging tests. The puncture depth range and exposed needle length range of candidate device were similar to predicate device, and the needle of TD-5084 Sterile Lancets was verified to be firmly fixed in lancet housing at each time point of accelerated and real-time aging tests, which demonstrated that the safety and effectiveness of candidate device were substantially equivalent to predicate device.
7.3 Difference 3 (Load)
The TD-5084 Sterile Lancets can be loaded into TD-5010 Lancing Device by (1) installing the lancets into lancet holder of lancing device with enough loading force, or (2) inserting the lancets into lancet holder of lancing device then pulling the pulling cap of the TD-5010 lancing device with enough pulling force.
For predicate device, the lancets can be loaded into lancing device only by pressing the priming button.
The effectiveness of loading the lancets on lancing device was verified by measuring loading force and pulling force of TD-5010 Lancing Device. For predicate device, effectiveness of lancet loading was verified by measuring the pressing force of priming button.
All test results of lancets loading force on candidate device and predicate device met the acceptance criteria, which demonstrated that the safety and effectiveness of lancets loading (loading force and pulling force) of candidate device was substantially equivalent to predicate device.
7.4 Difference 4 (Needle)
The specification of TD-5084 Sterile Lancets (30G) is different from the lancets of predicate device (28G). In order to confirm the performance between the different lancet specifications, percussion of TD-5084 Sterile Lancets and predicate device was verified by measuring the puncture depth. The firmness force was also verified in the accelerated and real-time aging tests of TD-5084 Sterile Lancets.
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All test results met the acceptance criteria, which demonstrated that puncture depths of both the TD-5084 Sterile Lancets (30G) and predicate device (28G) met the specifications, and the needle of TD-5084 Sterile Lancets (30G) was firmly fixed in lancet housing at each time point of accelerated and real-time aging tests. The safety and effectiveness of candidate device were substantially equivalent to predicate device.
8. Non-Clinical Testing Summary and Conclusions
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8.1 Mechanical performance test
Mechanical functions were verified between candidate device and predicate device by bench tests. -
8.1.1. Lancet Cap Twist Force and Pulling Force Test
To ensure the lancet cap of TD-5084 Sterile Lancets can be easily and safely removed by end user. the study verified the twist force and pulling force of removing the lancet cap between predicate device and candidate device. All test results met acceptance criteria which demonstrated that lancet cap of candidate device can be removed by end user smoothly and safely. -
8.1.2. Firmness Force Test
The firmness force was measured by pulling up the needle from the lancet housing of candidate device to verify the needle was firmly fixed in lancet housing at each time point of accelerated and real-time aging tests. All test results met acceptance criteria, which demonstrated that the lancet needle of candidate device was firmly fixed in lancet housing during its claimed shelf life.
8.1.3. Drop testing
The appearance and performance of candidate device were verified after performing drop forces in order to ensure the candidate device met its intended use while conducting drop forces during operations. All test results met acceptance criteria, which demonstrated that lancing devices installed with lancets met its intended use after undergoing drop forces during operations.
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8.1.4. Measure Penetration Depth
The different gap dimensions of lancing device will allow the needle on the lancet exposure in different lengths to reach different penetration depths for obtaining blood drops. The penetration depths were verified and compared between candidate device and predicate device. All results met acceptance criteria which demonstrated that the candidate device met its intended use and its claimed specifications. -
8.1.5. Loading force and pulling force
The TD-5084 Sterile Lancets can be loaded into TD-5010 Lancing Device by: (1) installing the lancets into lancet holder of lancing device with enough loading force, or (2) pulling the pulling cap of the lancing device with enough pulling force.
This study measured the loading force and pulling force of the candidate device, and the pressing force of priming button for the predicate device.
All results met acceptance criteria, which demonstrated that the lancets can be effectively and smoothly loaded into lancing device by end users.
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8.2 Storage stability test
Storage stability test of candidate device was performed to ensure the safety and effectiveness were suitable for use over the shelf life of device. -
8.3 Robustness test
Robustness test demonstrated that the TD-5010 Lancing Device was robust against cleaning
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and disinfection procedures after multiple cleaning and disinfection cycles using EPAregistered disinfecting wipes.
Nonclinical tests were performed in accordance with 21 CFR 878.4850. Clinical Testing is not applicable. Risks are analyzed to confirm that all identified risks were effectively mitigated. There were no special concerns of safety and effectiveness identified.
9. Conclusions
According to results of nonclinical tests, the TD-5010 Lancing Device and TD-5084 Sterile Lancets have a substantially equivalent safety and effectiveness profile to the predicate device (K214022).