(58 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, and there is no mention of AI or ML.
No
The device is described as a safety lancet intended for capillary blood sampling, which is a diagnostic procedure, not a therapeutic treatment.
No
A safety lancet is used to obtain blood samples, not to diagnose a condition. Diagnostic devices analyze samples or data to determine the presence or nature of a disease.
No
The device description clearly outlines physical components (needle seat, main body, release platform, spring, protective cap, needle tip) and mentions sterilization and mechanical features, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "capillary blood sampling." This is a device used to obtain a sample, not to perform a diagnostic test on the sample.
- Device Description: The description focuses on the mechanical aspects of the lancet for puncturing the skin and collecting blood. It does not describe any components or functions related to analyzing the blood sample for diagnostic purposes.
- Lack of Diagnostic Function: The device's sole purpose is to facilitate the collection of a blood sample. It does not perform any analysis or provide any diagnostic information about the blood itself.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This safety lancet is a tool for sample collection, which is a step that might precede an IVD test, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
Safety lancet is intended for capillary blood sampling.
Product codes (comma separated list FDA assigned to the subject device)
FMK
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 cap. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 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, rendering it unusable for a second time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for capillary blood sampling)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel, patients, and lay persons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed on the proposed device. The following performance data were provided in support of the substantial equivalence determination: Appearance, Dimension, Firmness, Needle protrusion length, Launch performance, Puncture force, Disposable, Safety Feature, Protective cap pull test, Structural strength, Drop test, Compression test, Resistance to corrosion, Acidity or Alkalinity, Limits for Extractable Metals. All tests met the requirements.
Biocompatibility Testing: 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 the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
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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"
1
(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 (1-800-638-2041 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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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: +886-4-2350-1991 | |
| E-mail: aaron.chen@medifun.com.tw |
2. Device Name and Classification
| Product Name: | Medifun Safety Lancet ( MSL1 series ) |
|---|---|
| Classification Name: | Single Use Only Blood Lancet With An Integral |
| 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,
5
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
K220370 | Differences |
|--------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Item | Medifun Safety
Lancet (MSL1 series) | Safety Lancet (8
models: XIII, XVII,
XXI, XXII, XXIII,
XXIV, XXV, XXVI) | NA |
| Classification | 2
(21CFR878.4850) | 2
(21CFR878.4850) | Same |
| Product Code | FMK | FMK | Same |
| Indications for Use | Safety lancet is
intended for
capillary blood
sampling. | The safety lancet is
intended for capillary
blood sampling. | Same |
| Safety protection
features | Yes | Yes | Same |
| Reuse durability | Single use | Single use | Same |
| Sterilization method
and SAL | Sterilized by
Radiation
SAL=10-6 | Sterilized by
Radiation
SAL=10-6 | Same |
| Self-life | 5 years | 5 years | Same |
| Materials of
parts in
contact with
human body | Needle: stainless steel
Other parts: plastic
materials | Needle core (contain
Needle): PE, PP,
Calcium Powder
(main ingredient:
calcium carbonate),
stainless steel
(needle), silicone oil
(needle);
Housing, Button, | Similar1 |
| | Proposed Device | Predicate Device
K220370 | Differences |
| Item | Medifun Safety
Lancet (MSL1 series) | Safety Lancet (8
models: XIII, XVII,
XXI, XXII, XXIII,
XXIV, XXV, XXVI) | NA |
| | | Bottom, Protective
cap, Small lid,
Depth adjuster ring:
ABS, PS | |
6
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. | |
| There should be no damage, dirt, or holes and the | ||
| protective cap must not be pulled open. | Meet the | |
| requirement | ||
| Dimension | Consistent with the drawings. | Meet the |
| requirement | ||
| Firmness | The needle must remain firmly attached to the plastic | |
| part of the needle seat. | Meet the | |
| requirement | ||
| Needle | ||
| protrusion | ||
| length | Use calipers to measure and meet the requirements. | Meet the |
| requirement | ||
| Launch | ||
| performance | It must be able to fire smoothly, and there should be | |
| no abnormal rebound noise after firing. | Meet the | |
| requirement | ||
| Puncture force | The needle tip of the needle should have good | |
| puncture ability. | Meet the | |
| requirement | ||
| Disposable | The safety lancet is only allowed to be puncture once, | |
| and it becomes invalid and cannot be fired again after | Meet the | |
| requirement |
7
| it has been punctured. | ||
|---|---|---|
| Safety Feature | The downward firing force |