TRUEdraw Lancing Device, Mini Lancing Device

K221072 · Trividia Health · QRL · Oct 18, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221072
• Device Name: TRUEdraw Lancing Device, Mini Lancing Device
• Applicant: Trividia Health
• Product Code: QRL · General, Plastic Surgery
• Decision Date: Oct 18, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2

Intended Use

The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm. The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm. The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting. The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Device Story

Reusable blood lancet holder; uses disposable sterile lancets to obtain capillary blood samples. Operates via mechanical, spring-driven mechanism; user loads lancet by pulling back device body; fires via trigger button. Used in home setting by patient; not for multi-patient healthcare use. Provides hygienic blood collection for diagnostic testing. Benefits patient by enabling convenient, manual blood sampling for glucose or other capillary blood tests.

Clinical Evidence

No clinical data. Bench testing only. Verification included mechanical performance, material characteristics, product life, shock testing, and compatibility with general-use lancets. Cleaning and disinfection validation performed for 1,095 cycles using Super Sani-Cloth Wipes, demonstrating durability for 3 years of daily use.

Technological Characteristics

Mechanical, spring-driven lancing device. Materials: plastics (body/internal components), metal (internal springs). Features: 5-level depth adjustment via nozzle/cap rotation, trigger-button firing, and lancet retraction. Designed for single-patient, multiple-use. Compatible with standard disposable sterile lancets. No software or electronic components.

Indications for Use

Indicated for single-patient home use to collect capillary blood samples from the fingertip or forearm for testing purposes, using a disposable sterile lancet.

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.

Predicate Devices

• Accu-Chek Softclix Blood Lancing Device (K214022)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

10/18/2022

Trividia Health Jacqueline Davis Global Regulatory Affairs Specialist IV 2400 N.W. 55th Court Fort Lauderdale, Florida 33309

Re: K221072

Trade/Device Name: TRUEdraw Lancing Device, Mini Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: September 20, 2022 Received: September 21, 2022

Dear Jacqueline Davis:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K221072

Device Name

TRUEdraw Lancing Device; Mini Lancing Device

Indications for Use (Describe)

The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygjenic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is 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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# K221072 - TRUEdraw Lancing Device; Mini Lancing Device 510(k) Summary

| Contact Details | 21 CFR 807.92(a)(1) |
|-----------------------------------|----------------------------------------------------------------|
| Applicant Name | Trividia Health |
| Applicant Address | 2400 N.W. 55th Court<br>Ft. Lauderdale, FL 33309 United States |
| Applicant Contact Telephone | [phone] |
| Applicant Contact | Ms. Jacqueline Davis |
| Applicant Contact Email | [e-mail] |
| Device Name | 21 CFR 807.92(a)(2) |
| Device Trade Name | TRUEdraw Lancing Device; Mini Lancing Device |
| Common Name | Lancing device |
| Classification Name | Multiple Use Blood Lancet For Single Patient Use Only |
| Regulation Number | 878.4850(c) |
| Product Code | QRL |
| Legally Marketed Predicate Device | 21 CFR 807.92(a)(3) |
| Predicate # | K214022 |
| Predicate Trade Name | Accu-Chek Softclix Blood Lancing Device |
| Product Code | ORL |

### Device Description Summary

The TRUEdraw Lancing Device/ Mini Lancing Device is a reusable blood lancet holder intended to be used in conjunction with a sterile, single-use blood lancet for obtaining a capillary blood sample for testing purposes from the fingertip and from alternative sites, such as the forearm. TRUEdraw Lancing Device/ Mini Lancing Device is intended for multiple use by a single patient.

# Intended Use/Indications for Use

The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

### Indications for Use Comparison 21 CFR 807.92(a)(5)

The indications for use of the subject devices are the same as the predicate with the exception that the subject devices are indicated for the forearm as an alternative site and the alternative sites for the predicate devices include the palm, upper arm, and forearm.

#### Technological Comparison 21 CFR 807.92(a)(6)

The subject devices have the same technological characteristics as the predicate device in terms of design and general type of materials used, principle of operation, usage, features, and function.

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| | Subject Devices | Predicate Device |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TRUEdraw Lancing Device;<br>Mini Lancing Device | Accu-Chek Softclix Lancing Device<br>(cleared as part of the Accu-Chek<br>Softclix Blood<br>Lancing System under K214022) |
| Description | The TRUEdraw/ Mini Lancing<br>Device is a reusable lancet base<br>that uses compatible single-use,<br>sterile lancets to obtain a drop of<br>blood from a fingertip or<br>alternative site (forearm) using the<br>clear end cap. | The Accu-Chek Softclix Lancing<br>Device uses compatible Accu-Chek<br>Softclix Lancets to obtain a drop of<br>blood from a fingertip or<br>alternative sites using the Accu-Chek<br>Softclix Alternative Site Testing<br>(AST) Cap. |
| Intended Use/ Indications<br>for Use | For use with a disposable sterile<br>lancet for the hygienic collection<br>of capillary blood for testing<br>purposes from the side of a<br>fingertip and from the forearm.<br><br>For use only on a single patient<br>in a home setting.<br><br>Not suitable for use by<br>healthcare professionals with<br>multiple patients in a healthcare<br>setting. | For the hygienic collection of<br>capillary blood for testing purposes<br>from the side of a fingertip and from<br>alternative sites, such as the palm,<br>the upper arm, and the forearm.<br><br>For use only on a single patient in a<br>home setting.<br><br>Not suitable for use by healthcare<br>professionals with multiple patients in<br>a healthcare setting. |
| Prescription/over-the-<br>counter use | Over-the-counter | Over-the-counter |
| Where Device Used | Home | Home |
| Number of uses | Multiple uses by a single patient | Lancing device: multiple uses by a<br>single patient |
| Anatomical<br>sites | Fingertip<br>Forearm | Fingertip<br>Ball of the hand (palm)<br>Upper arm<br>Lower arm (forearm) |
| Principle of operation | Mechanical, spring-driven | Mechanical, spring-driven |
| Materials | Plastics (body, internal<br>components), metal (internal<br>springs) | Plastics (body, internal components),<br>metal (internal springs) |
| Depth<br>adjustment | 5 levels by twisting nozzle/end<br>cap (finer adjustments can be<br>made by setting the indicator<br>arrow between the numbers) | 11 levels by twisting cap |
| Load and<br>firing | Load lancet by pulling back on<br>the lance body when the lancet is<br>inserted. Fire by pressing the<br>trigger button. | Load lancet by pressing priming<br>button when lancet is inserted. Fire<br>by pressing the release button. |
| Lancet retracted after use | Yes | Yes |

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| Alternative site cap | Yes |
|----------------------|-----|
| | Yes |

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Nonclinical bench testing was performed per the special controls in 21 CFR 878.4850(c). This included design verification & validation testing to ensure that the lancet blade can be manually changed with every use, that the structure and materials are consistent with the intended use and address the risk of sharp object injuries and blood borne pathogen transmission, and mechanical performance testing to demonstrate that the device will withstand the forces encountered during use.

| Description | Tests Performed | Results |
|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanical performance<br>verification for TRUEdraw<br>lancing device | - Materials and mechanical<br>characteristics<br>- Operation of the lancing device<br>- Product life and shock conditions<br>- Cosmetic attributes | - Pass<br>- Pass<br>- Pass<br>- Pass<br>- Pass |
| Mechanical performance<br>verification for mini lancing<br>device | - Materials and mechanical<br>characteristics<br>- Operation of the lancing device<br>- Product life and shock conditions<br>- Cosmetic attributes | - Pass<br>- Pass<br>- Pass<br>- Pass<br>- Pass |
| Compatibility with commonly<br>available general use lancets | - Critical dimensions (lancet body<br>diameter, exposed needle length,<br>body length)<br>- Fit | - Pass<br>- Pass |
| Cleaning and disinfection<br>validation - TRUEdraw lancing<br>device and alternate site cap | 1,095 cleaning and disinfecting cycles using<br>Super Sani-Cloth Wipes. | Pass. The TRUEdraw lancing<br>device and alternate site cap<br>may be cleaned and disinfected<br>with Super Sani-Cloth Wipes<br>once-daily for 3-years. |
| Cleaning and disinfection<br>validation - mini lancing<br>device and alternate site cap | 1,095 cleaning and disinfecting cycles using<br>Super Sani-Cloth Wipes. | Pass. The mini lancing device<br>and alternate site cap may be<br>cleaned and disinfected with<br>Super Sani-Cloth Wipes once-<br>daily for 3-years. |

Clinical testing is not applicable.

# Conclusion

The results of nonclinical testing demonstrate that the subject devices are as safe, as effective, and perform as well as or better than the predicate device identified above.