TD-5010 Lancing Device and TD-5084 Sterile Lancets
K221419 · Gostar Co., Ltd. · QRL · Jan 20, 2023 · General, Plastic Surgery
Device Facts
Record ID
K221419
Device Name
TD-5010 Lancing Device and TD-5084 Sterile Lancets
Applicant
Gostar Co., Ltd.
Product Code
QRL · General, Plastic Surgery
Decision Date
Jan 20, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4850
Device Class
Class 2
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.
Device Story
The TD-5010 Lancing Device is a spring-driven, reusable manual device used with single-use TD-5084 Sterile Lancets to obtain capillary blood samples. It is intended for single-patient home use. The device features an adjustable selector cap and an Alternative Site Testing (AST) cap, providing six levels of puncture depth (0.8mm to 2.4mm). The user loads a lancet into the holder, primes the device, and triggers the spring mechanism to puncture the skin. After use, the lancet is ejected to prevent reuse. The device is designed to be cleaned and disinfected between uses. The output is a drop of blood for diagnostic testing. The device benefits patients by providing a safe, controlled method for self-collection of blood samples for glucose or other diagnostic monitoring.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including mechanical performance (lancet cap twist/pull force, firmness force, drop testing, penetration depth, loading force), storage stability, and robustness testing against cleaning/disinfection cycles.
Technological Characteristics
Spring-driven manual lancing device. Materials: Housing and AST cap. Needle: 30G, 3-facet beveled. Puncture depth: 0.8mm to 2.4mm (6 settings). Sterilization: Gamma irradiation for lancets. Connectivity: None. Software: None.
Indications for Use
Indicated for single-patient home use to obtain capillary blood samples from the fingertip, palm, upper arm, or forearm for testing purposes.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*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.
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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
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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
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### 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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## 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<br>Taipei City, TAIWAN |
| Correspondent Contact | Pei-Fen Yang, Ph.D. |
| Title | President |
| Phone | +886-2-2298-1927 |
| E-mail | 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 |
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### 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.
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| | Predicate Device- K214022 | Candidate Device- K221419 | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Characteristic | Accu-Chek Softclix Blood Lancing | TD-5010 Lancing Device and | Remark |
| | System | TD-5084 Sterile Lancets | |
| Device<br>Description | • The Accu-Chek Softclix Lancing<br>Device uses compatible Accu-<br>Chek Softclix Lancets to obtain a<br>drop of blood from a fingertip or<br>alternative sites using the Accu-<br>Chek Softclix Alternative Site<br>Testing (AST) Cap.<br>• The sterile, single-use lancets are<br>to be used with the reusable<br>lancing device that is to be<br>cleaned and disinfected between<br>each use, and then the lancets are<br>to be disposed of.<br>• This system is for use only<br>on a single patient in a home<br>setting.<br>• This system is not suitable<br>for use by healthcare<br>professionals with multiple<br>patients in a healthcare<br>setting. | • The TD-5010 Lancing Device<br>uses compatible TD-5084<br>Sterile Lancets to obtain a drop<br>of blood from a fingertip or<br>alternative sites using the<br>Alternative Site Testing (AST)<br>Cap.<br>• The single-use TD-5084 Sterile<br>Lancets are to be used with the<br>reusable TD-5010 Lancing<br>Device that is to be cleaned and<br>disinfected between each use,<br>and then the TD- 5084 Sterile<br>Lancets are to be disposed of.<br>• For use only on a single patient<br>in a home setting. Not suitable<br>for use by healthcare<br>professionals with multiple<br>patients in a healthcare setting. | Identical |
| Intended Use | The Accu-Chek Softclix Blood<br>Lancing System is intended for the<br>hygienic collection of capillary blood<br>for testing purposes from the side of a<br>fingertip and from alternative sites,<br>such as the palm, the upper arm, and<br>the forearm.<br>The sterile, single-use lancets are to<br>be used with the reusable lancing<br>device that is to be cleaned and<br>disinfected between each use, and<br>then the lancets are to be disposed of.<br>This system is for use only on a<br>single patient in a home setting.<br>This system is not suitable for use by<br>healthcare professionals with<br>multiple patients in a healthcare<br>setting. | The TD-5010 Lancing Device and TD-<br>5084 Sterile Lancets are intended to<br>obtain capillary blood for testing<br>purposes from the side of a fingertip<br>and from alternative sites, such as the<br>palm, the upper arm, and the forearm.<br>The single-use TD-5084 Sterile<br>Lancets are to be used with the<br>reusable TD- 5010 Lancing Device<br>that is to be cleaned and disinfected<br>between each use, and then the TD-<br>5084 Sterile Lancets are to be disposed<br>of.<br>For use only on a single patient in a<br>home setting.<br>Not suitable for use by healthcare<br>professionals with multiple patients in<br>a healthcare setting. | Identical |
| Characteristic | Predicate Device- K214022<br>Accu-Chek Softclix Blood Lancing<br>System | Candidate Device- K221419<br>TD-5010 Lancing Device and<br>TD- 5084 Sterile Lancets | Remark |
| Mechanical<br>Loading | Spring-driven | Spring-driven | Identical |
| Lancet Sterility | Gamma irradiation | Gamma irradiation | Identical |
| Number of<br>Uses | Base (lancing device): multiple use<br>Lancet: single use | TD-5010 Lancing Device: multiple use<br>TD-5084 Sterile Lancets: single use | Identical |
| Anatomical<br>Sites | Fingertip<br>Ball of the hand (palm)<br>Upper arm<br>Lower arm (forearm) | Fingertip<br>Ball of the hand (palm)<br>Upper arm<br>Lower arm (forearm) | Identical |
| Sharps Injury<br>Prevention | Lancets are covered by a sterile barrier<br>cap until twisted off before use. Until<br>firing, the lancet is contained within<br>the lancing device housing.<br>Immediately after firing, the lancet is<br>automatically retracted back into<br>housing. An ejector sleeve can then be<br>pulled forward for contactless disposal<br>of the lancet. | The TD-5010 Lancing Device can be<br>reset to operate only after the used<br>lancet has been ejected which<br>prevents multiple punctures with a<br>used lancet. Ejection of used lancets<br>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
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| Characteristic | Predicate Device- K214022<br>Accu-Chek Softclix Blood Lancing System | Candidate Device- K221419<br>TD-5010 Lancing Device and<br>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<br>Depth and<br>Exposed<br>Needle<br>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
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### 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
- 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.
- 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.
- 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
{10}------------------------------------------------
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).
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
