Lancing device (HH-XV-T)

K253706 · Tianjin Huahong Technology Co., Ltd. · QRL · Dec 9, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K253706
• Device Name: Lancing device (HH-XV-T)
• Applicant: Tianjin Huahong Technology Co., Ltd.
• Product Code: QRL · General, Plastic Surgery
• Decision Date: Dec 9, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4850
• Device Class: Class 2

Intended Use

Without Clear Cap configuration: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. With Clear Cap configuration: The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.

Device Story

Lancing device (HH-XV-T) used to obtain capillary blood samples for diagnostic testing; spring-driven mechanism fires lancet into skin; device features two configurations: without clear cap (fingertip only) and with clear cap (fingertip, palm, or forearm). Device is reusable, intended for single-patient use only; operated by patient. User loads lancet, cocks spring-loaded barrel, and presses release button to trigger puncture. Device includes safety feature to retract lancet after use to prevent sharps injury. Healthcare providers use blood samples for diagnostic testing; device benefits patient by enabling convenient, small-volume blood collection for home monitoring. Device is cleaned/disinfected using Super Sani-Cloth or Discide Ultra Disinfecting Wipes.

Clinical Evidence

Bench testing only. Included injection process verification, performance testing, simulated transportation, accelerated aging, cleaning/disinfection validation, and simulated clinical use study (500 samples) per FDA guidance on sharps injury prevention. No clinical testing required.

Technological Characteristics

Materials: ABS, POM, PC, PS; spring: carbon steel. Principle: spring-driven mechanical firing. Dimensions: 107mm length, 18.3mm tail diameter. Connectivity: None (mechanical). Sterilization: Non-sterile. Software: None.

Indications for Use

Indicated for single-patient use to obtain capillary blood samples from the fingertip (without clear cap) or fingertip, palm, or forearm (with clear cap) for diagnostic testing.

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

• Lancet, Lancing device (K243306)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

Tianjin Huahong Technology Co., Ltd.
Ningning Wang
Registered Engineer
A01, Plant B, # 278, Hangkong Rd.
Tianjin Pilot Free Trade Zone(Air Port Industrial Park)
Tianjin, 300308
China

December 9, 2025

Re: K253706
Trade/Device Name: Lancing device (HH-XV-T)
Regulation Number: 21 CFR 878.4850
Regulation Name: Blood Lancets
Regulatory Class: Class II
Product Code: QRL
Dated: November 24, 2025
Received: November 24, 2025

Dear Ningning Wang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253706 - Ningning Wang
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

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K253706 - Ningning Wang
Page 3

Sincerely,

Colin K. Chen -S

Digitally signed by
Colin K. Chen -S
Date: 2025.12.09
14:32:12 -05'00'

Colin Kejing Chen, Ph.D.
Acting Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253706 | |
| Device Name Lancing device (Model: HH-XV-T) | |
| Indications for Use (Describe) Without Clear Cap configuration: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. With Clear Cap configuration: The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. | |
| Type of Use (Select one or both, as applicable) ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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K253706 510(k) Summary

# 510(k) summary

## I Submitter

Tianjin Huahong Technology Co., Ltd.
A01, Plant B, No.278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park), 300308 Tianjin, China

Establishment Registration Number: 3009498536

Contact person: Ms. Ningning Wang
Registered Engineer
Tel.: [phone]
E-mail: [e-mail]

Preparation date: November 24, 2025

## II Proposed Device

Trade Name of Device: Lancing device
Common name: Multiple Use Blood Lancet For Single Patient Use Only
Regulation Number: 21 CFR 878.4850
Regulatory Class: Class II
Product code: QRL
Review Panel: General & Plastic Surgery

## III Predicate Devices

510(k) Number: K243306
Trade name: Lancet, Lancing device
Classification: Class II
Product Code: QRL, QRK
Manufacturer: Tianjin Huahong Technology Co., Ltd.

## IV Device description

Model: HH-XV-T

Along with a lancet, the lancing device is used to obtain a capillary blood sample.
The body and the active parts of the lancing device are made of ABS, POM, PC and PS. And the spring is made of carbon steel.

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K253706 510(k) Summary

The device is available in two configurations:
- Without clear cap: Fingertip use only
- With clear cap: Fingertip, palm (base of thumb), and forearm

The device is provided non-sterile and is intended for single-patient reuse, with a service life of no less than 3000 times.

## V Indication for use

### Without Clear cap configuration:

The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.

### With Clear cap configuration:

The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.

### Summary of Modification:

This Special 510(k) includes an expanded Indication for Use for model HH-XV-T (addition of palm and forearm) and an additional disinfection method (Discide® Ultra Disinfecting Wipes).

## VI Comparison of technological characteristics with the predicate devices

The comparison and discussion between the proposed device and the predicate devices are listed in below table 1:

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K253706 510(k) Summary

Table 1 Substantial Equivalence Comparison

| Item | Predicate device
Model: HH-XXVII-T
Model: HH-XV-T
(K243306) | Proposed device
Model: HH-XV-T
(K253706) | Comments |
| --- | --- | --- | --- |
| Product name | Lancing device | Lancing device | Same |
| Product Code | QRL | QRL | Same |
| Regulation No. | 21 CFR § 878.4850 | 21 CFR § 878.4850 | Same |
| Class | II | II | Same |
| Prescription/over-the-counter use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Indication for use | Model HH-XV-T: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.
Model HH-XXVII-T: The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be | Without Clear Cap configuration: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.
With Clear Cap configuration: The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. | Same |

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K253706
510(k) Summary

| | | used by a single patient and should not be shared. | | |
| --- | --- | --- | --- | --- |
| Puncture device to obtain micro blood samples | | Yes | Yes | Same |
| Lancet retracted after use to prevent sharp injure | | Yes | Yes | Same |
| Materials | | ABS, POM, PC and PS | ABS, POM, PC and PS | Same |
| Reuse durability | | Reusable
Single Patient Use Only | Reusable
Single Patient Use Only | Same |
| Disinfection Method | | Super Sani-Cloth | Super Sani-Cloth or Discide® Ultra Disinfecting Wipes | Different 1 |
| Label/Labeling | | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Main performance parameters | Penetration Depth | 0.50~1.70±0.30mm (Model: HH-XV-T) | 0.50~1.70±0.30mm (Model: HH-XV-T, Without Clear Cap) | Same |
| | | 3.2±0.30mm (Model: HH-XXVII-T, With AST Cap) | 3.2±0.30mm (Model: HH-XV-T, With Clear Cap) | Same |

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K253706
510(k) Summary

| Dimension | model | Total Length L1(± 2mm) | Tail end diameter r D1(± 1mm) | Middle diameter r D2(± 1mm) | Diameter of needle outlet D3(± 0.5mm) | Inner diameter of the needle fixed carriage D4(± 0.5mm) |
| --- | --- | --- | --- | --- | --- | --- |
| | HH-XV-T | 107 | 18.3 | 16.6 | 3.0 | 6.1 |
| | | | | | | |
| model | Total Length L1(± 2mm) | Tail end diameter D1(± 1mm) | Middle diameter D2(± 1mm) | Diameter of needle outlet D3(± 0.5mm) | Inner diameter of the needle fixed carriage D4(± 0.5mm) |
| --- | --- | --- | --- | --- | --- |
| HH-XV-T | 107 | 18.3 | 16.6 | 3.0 | 6.1 |

Same

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K253706
510(k) Summary

| | | model | Total Length L1(± 2mm) | Tail end diameter D1(± 1mm) | Middle diameter D2(± 1mm) | Diameter of needle outlet D3(± 0.5mm) | Inner diameter of the needle fixed carriage D4(± 0.5mm) | model | Total Length L1(± 2mm) | Tail end diameter D1(± 1mm) | Middle diameter D2(± 1mm) | Diameter of needle outlet D3(± 0.5mm) | Inner diameter of the needle fixed carriage D4(± 0.5mm) | Differential 2 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | HH-XXVII-T | 105 | 14.7 | 17 | 4 | 6 | HH-XV-T | 107 | 18.3 | 16.6 | 3.0 | 6.1 | |
| | Mechanical loading and firing function | Cocking barrel with releasing button | | | | | | Cocking barrel with releasing button | | | | | | same |
| Explanation of differences: Different 1: The additional disinfectant (Discide® Ultra Disinfecting Wipes) has been validated for compatibility and efficacy. Material compatibility testing and simulated use cleaning were conducted, confirming no adverse impact on device performance, material integrity, or user safety. Therefore, this change does not raise new questions of safety or effectiveness. Different 2: | | | | | | | | | | | | | | |

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K253706
510(k) Summary

The dimensional differences between the predicate model HH-XXVII-T and the proposed model HH-XV-T (e.g., overall length, diameters, and geometric contours) represent minor structural variations that do not affect the lancing device's fundamental technology, spring-driven firing mechanism, applied force, or blood-sampling performance. Verification testing confirmed that these dimensional differences do not impact usability, ergonomics, or functional safety, and therefore do not raise new questions of safety or effectiveness.

## Discussion:

1. The expanded Indications for Use do not introduce any changes to the device's technological characteristics, including penetration depth, structural dimensions, firing mechanism, or applied force. The device operates with the same spring-driven lancet actuation mechanism, and all key performance characteristics remain unchanged.

2. The additional disinfecting wipe, Discide® Ultra, is an EPA-registered intermediate-level disinfectant with the same active ingredient categories (quaternary ammonium compounds and isopropyl alcohol) as the previously used Super Sani-Cloth®. Both wipes are approved for use on medical devices and effective against bloodborne pathogens, including HIV-1, HBV, and HCV. Validation testing confirmed material compatibility and demonstrated that the introduction of the new wipe does not affect safety, device performance, or user instructions.

Therefore, the proposed device does not raise new questions of safety or effectiveness compared to the predicate.

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K253706
510(k) Summary

# VII Non-Clinical Testing

Non-clinical verification and validation testing was conducted to support substantial equivalence of the modified device to the predicate device (K243306). All testing was performed using the same or equivalent protocols and acceptance criteria previously reviewed and cleared for the predicate.

# Design Verification and Validation

Testing included, but was not limited to:

- Injection process verification report
- Performance test report
- Match Test Report
- Simulated Transportation Test report
- Accelerated aging test report
- After accelerate aging- Performance test report
- Cleaning and Disinfection Validation
- Simulated Clinical Use Testing Study Protocol and Report

# 1. Indication for Use Expansion

Testing included penetration depth verification, performance testing, and simulated-use validation on models. All testing followed the same protocols and acceptance criteria as the predicate device (K243306).

Results confirmed that the modified device meets its design specifications, and no new safety or effectiveness concerns were identified.

# 2. Disinfection Method Update

Cleaning and disinfection validation was conducted to evaluate the addition of Discide® Ultra Disinfecting Wipes as an alternative disinfectant. The evaluation consisted of repeated cleaning/disinfection cycles followed by visual examination and functional performance checks.

The results demonstrated no material degradation, no functional changes, and no negative impact on device usability or performance.

Therefore, the addition of the new disinfectant does not introduce new risks and does not raise new questions of safety or effectiveness.

# 3. Simulated Clinical Use

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K253706 510(k) Summary

A simulated clinical use study was conducted using 500 device samples in accordance with the FDA Guidance “Medical Devices with Sharps Injury Prevention Features” (2005).

The device met all pre-established criteria for safety mechanism performance and user operation.

No use-related hazards or adverse events were identified.

## VIII Clinical Testing

No clinical testing was required for this submission.

## IX Conclusion

The proposed device and the predicate device have the same intended use and fundamental scientific technology.

All design changes—including the expanded Indication for Use and the additional disinfection method—have been fully verified and validated. Results demonstrate that the modified device:

- Meets all design input and performance requirements
- Does not introduce new safety or effectiveness concerns
- Is substantially equivalent to the predicate device (K243306)

Therefore, the proposed device is as safe and effective as the predicate device for its intended use.

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