Medifun Safety Lancet ( MSL1 series)

K241750 · Medifun Corporation · FMK · Aug 15, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K241750
• Device Name: Medifun Safety Lancet ( MSL1 series)
• Applicant: Medifun Corporation
• Product Code: FMK · General, Plastic Surgery
• Decision Date: Aug 15, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2

Intended Use

Safety lancet is intended for capillary blood sampling.

Device Story

Single-use, sterile, radiation-sterilized safety lancet; obtains capillary blood samples from fingertip. Comprises needle seat, main body, release platform, spring, and protective cap. User removes protective cap, presses device against skin to trigger spring-loaded needle puncture; puncture mechanism automatically retracts needle post-use to prevent reuse and accidental sharps injury. Used in clinical or home settings by healthcare professionals or lay users. Provides blood sample for diagnostic testing; aids in clinical decision-making by facilitating blood collection. Benefits patient through safe, single-use design minimizing infection risk and sharps exposure.

Clinical Evidence

Bench testing only. Evaluated appearance, dimensions, needle protrusion, launch performance, puncture force, disposable mechanism, safety feature (retraction), structural strength, drop/compression resistance, corrosion resistance, and chemical properties (pH, extractable metals). Biocompatibility testing included cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity. Simulated clinical use study performed on 500 samples per FDA guidance for sharps injury prevention features; all pre-established criteria met.

Technological Characteristics

Materials: stainless steel needle, plastic body. Energy: mechanical spring-loaded actuation. Form factor: handheld, single-use lancet with 6 models (MSL1-30, 28, 26, 23, 21, 18). Sterilization: radiation (SAL 10^-6). Biocompatibility: ISO 10993 compliant. Mechanical features: integral sharps injury prevention (automatic needle retraction).

Indications for Use

Indicated for capillary blood sampling in patients requiring blood collection. Intended for use by healthcare personnel, patients, and lay persons.

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

• Safety Lancet (8 models: XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) (K220370)

Submission Summary (Full Text)

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August 15, 2024

Medifun Corporation % Mandy Lin Regulatory Affairs Consultant Voler Biotech Consulting CO., Ltd 6F .- 17, No. 14, Ln. 609, Sec. 5, Chongxin Rd., Sanchong Dist New Taipei City, 241407 Taiwan

Re: K241750

Trade/Device Name: Medifun Safety Lancet ( MSL1 series) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: June 18, 2024 Received: June 18, 2024

Dear Mandy Lin:

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 (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/cdrb/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"

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(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 OS regulation requires device manufacturers to review and approve changes to device design and production (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 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-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 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.

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-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 [phone] or 301-796-7100).

Sincerely,

Digitally signed by Long H. Chen Long H. Chen -S -s Date: 2024.08.15 07:57:15 -04'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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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) K241750

Device Name Medifun Safety Lancet ( MSL1 series)

Indications for Use (Describe) Safety lancet is intended for capillary blood sampling.

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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# 510(k) SUMMARY

### 1. Submission Information

| Submitter: | Medifun Corporation |
|--------------------|--------------------------------------------------------|
| | 4F-1, 4F-9, 4F-10, No.99, Jingke S. Rd., Nantun Dist., |
| | Taichung City 408, Taiwan (R.O.C.) |
| Submitter contact: | Aaron Chen |
| | Tel: [phone] |
| | E-mail: [e-mail] |

### 2. Device Name and Classification

| Product Name: | Medifun Safety Lancet ( MSL1 series ) |
|-----------------------|-----------------------------------------------------------------------------------|
| Classification Name: | Single Use Only Blood Lancet With An Integral<br>Sharps Injury Prevention Feature |
| Common or Usual Name: | Blood lancets |
| Regulation Number: | 21 CFR 878.4850 |
| Product Code: | FMK |

### 3. Predicate Device(s)

| Product Name: | Safety Lancet (8 models: XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) (K220370) |
|-----------------------|-----------------------------------------------------------------------------------|
| Common or Usual Name: | Blood lancets |
| Regulation Number: | 21 CFR 878.4850 |
| Product Code: | FMK |

### 4. Device Description

The Medifun Safety Lancet (MSL1 series) is designed to obtain capillary blood samples from the fingertip.

The intended users include healthcare personnel, patients, and lay persons. According to the needle and color differences, the safety lancets have 6 models : MSL1-30, MSL1-28, MSL1-26, MSL1-23, MSL1-21, and MSL1-18. The safety lancets consist of the needle seat, main body, release platform, spring, and protective сар.

The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 106 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.

The lancets contain a safety feature. After use, the puncture mechanism retracts,

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rendering it unusable for a second time.

## 5. Indications for Use

Safety lancet is intended for capillary blood sampling.

### 6. Comparison to the Predicate Device

| | Proposed Device | Predicate Device<br>K220370 | Differences |
|--------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Item | Medifun Safety<br>Lancet (MSL1 series) | Safety Lancet (8<br>models: XIII, XVII,<br>XXI, XXII, XXIII,<br>XXIV, XXV, XXVI) | NA |
| Classification | 2<br>(21CFR878.4850) | 2<br>(21CFR878.4850) | Same |
| Product Code | FMK | FMK | Same |
| Indications for Use | Safety lancet is<br>intended for<br>capillary blood<br>sampling. | The safety lancet is<br>intended for capillary<br>blood sampling. | Same |
| Safety protection<br>features | Yes | Yes | Same |
| Reuse durability | Single use | Single use | Same |
| Sterilization method<br>and SAL | Sterilized by<br>Radiation<br>SAL=10-6 | Sterilized by<br>Radiation<br>SAL=10-6 | Same |
| Self-life | 5 years | 5 years | Same |
| Materials of<br>parts in<br>contact with<br>human body | Needle: stainless steel<br>Other parts: plastic<br>materials | Needle core (contain<br>Needle): PE, PP,<br>Calcium Powder<br>(main ingredient:<br>calcium carbonate),<br>stainless steel<br>(needle), silicone oil<br>(needle);<br>Housing, Button, | Similar1 |
| | Proposed Device | Predicate Device<br>K220370 | Differences |
| Item | Medifun Safety<br>Lancet (MSL1 series) | Safety Lancet (8<br>models: XIII, XVII,<br>XXI, XXII, XXIII,<br>XXIV, XXV, XXVI) | NA |
| | | Bottom, Protective<br>cap, Small lid,<br>Depth adjuster ring:<br>ABS, PS | |

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1 The Medifun safety lancet shares many of the same technological characteristics as the predicate device. The subject device's raw materials may differ from the predicate device. However, all the materials are known biocompatible materials that have been used in lancets or other similar medical devices.

### 7. Performance Data

### Non-clinical tests were performed on the proposed device.

The following performance data were provided in support of the substantial equivalence determination.

| Item | Acceptance Criteria | Result |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Appearance | Consistent with the drawings.<br>There should be no damage, dirt, or holes and the<br>protective cap must not be pulled open. | Meet the<br>requirement |
| Dimension | Consistent with the drawings. | Meet the<br>requirement |
| Firmness | The needle must remain firmly attached to the plastic<br>part of the needle seat. | Meet the<br>requirement |
| Needle<br>protrusion<br>length | Use calipers to measure and meet the requirements. | Meet the<br>requirement |
| Launch<br>performance | It must be able to fire smoothly, and there should be<br>no abnormal rebound noise after firing. | Meet the<br>requirement |
| Puncture force | The needle tip of the needle should have good<br>puncture ability. | Meet the<br>requirement |
| Disposable | The safety lancet is only allowed to be puncture once,<br>and it becomes invalid and cannot be fired again after | Meet the<br>requirement |

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| | it has been punctured. | |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Safety Feature | The downward firing force <2 kg<br>After firing, the needle tip must retract and the needle<br>must not touch the surface of the balloon. | Meet the<br>requirement |
| Protective cap<br>pull test | It must be possible to smoothly open the protective<br>cap within a full cycle. | Meet the<br>requirement |
| Structural<br>strength | The combined force between the protective cap of the<br>needle seat and the main body must be greater than 2.5<br>kg. | Meet the<br>requirement |
| Drop test | Perform a puncturing test after a fall, it must be able to<br>puncture normally. | Meet the<br>requirement |
| Compression<br>test | After pressing down the protective cap, it must be able<br>to rebound. There should be no shrinkage or jamming. | Meet the<br>requirement |
| Resistance to<br>corrosion | The corrosion resistance of the needle of the lancet<br>shall show no evidence of corrosion. | Meet the<br>requirement |
| Acidity or<br>Alkalinity | The pH value of an extract prepared refers to ISO<br>9626 Annex A shall be within one pH unit of that of<br>the control fluid. | Meet the<br>requirement |
| Limits for<br>Extractable<br>Metals | When corrected for the metal content of the control<br>fluid, contain not greater than a combined total of 5<br>mg/l of lead, tin, zinc and iron. The cadmium content<br>of the extract shall, when corrected for the cadmium<br>content of the control fluid, be lower than 0.1 mg/l | Meet the<br>requirement |

# Biocompatibility Testing:

The tests include the following tests:

- In Vitro Cytotoxicity
- Skin Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Pyrogenicity

### Simulated Clinical Use

A simulated clinical use study was performed on 500 device samples for the Safety Lancet according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005, to evaluate

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#### 510(k) Summary

the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

### Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristics as the predicate device. Performance testing data demonstrates that the proposed device is as safe and effective as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.