(155 days)
Medifun Lancing Device, Model No. LD-E1 is a reusable lancing device for the single user. Itshould be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
Medifun Lancing Device, Model No. LD-E1 is a mechanical blood lancet holder. It is used with a single use sterile lancet to puncture the skin for collecting capillary whole blood sampled from the fingertip or alternate sites. Medifun Lancing Device LD-E1 can be adjusted for 6 levels of depth. This device is for single user only.
This 510(k) summary is for a lancing device, which is a mechanical device used to obtain blood samples. The document focuses on showing substantial equivalence to existing predicate devices, primarily through non-clinical bench testing. It does not involve AI or human-in-the-loop performance studies. Therefore, many of the requested categories related to such studies are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1, ISO 10993-5 (In vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization), ISO 10993-23 (Skin Irritation) standards. | Non-clinical bench testing specifically for ISO 10993-5, ISO 10993-23, and ISO 10993-10. |
| Cleaning Validation | Successful validation of cleaning procedures. | Non-clinical bench testing for cleaning validation. |
| Risk Management | Adheres to ISO 14971:2019 standard. | Risk management activities performed according to ISO 14971:2019. |
| Mechanical Design & Functionality | Meets specified requirements (e.g., 6 levels of depth adjustment from 0.5mm-1.7mm, 'lancet retract after use'). | Non-clinical bench testing including "Specification and functional tests" and "mechanical design verification and validation testing." |
| Substantial Equivalence (Overall) | The device is deemed substantially equivalent to predicate devices in intended use, technology, operation principle, and similar technical characteristics, with all verification tests meeting required acceptance criteria. | Comparative analysis with predicate devices (RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device K221062) and comprehensive non-clinical bench testing. The document states that "all tests were verified to meet the required acceptance criteria." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is primarily non-clinical bench testing. Therefore, details about sample size (e.g., number of devices tested for mechanical properties) and data provenance (country of origin, retrospective/prospective) for these bench tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the studies were non-clinical bench tests; there was no "test set" requiring expert ground truth in the clinical sense.
4. Adjudication method for the test set
This is not applicable for the same reasons as point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a mechanical lancing device, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical lancing device, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" would be established by the criteria defined in the respective ISO standards (e.g., ISO 10993 for biocompatibility) and the device's own internal specifications for functional performance. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The sample size for the training set
This is not applicable. There is no concept of a "training set" for a mechanical lancing device as there are no algorithms being trained.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
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November 22, 2023
Medifun Corporation Tyra Chiu Regulatory Consultant VOLER Biotech Consulting Co., Ltd. IF. No 3-1. Ln. 58. Hejiang St., Zhongshan Dist, Taipei, 104 Taiwan
Re: K231797
Trade/Device Name: Medifun Lancing Device, Model No. LD-E1 Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: August 25, 2023 Received: September 5, 2023
Dear Tyra Chiu:
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" (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).
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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 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,
Mark Mark
Trumbore -S -S -S -S -S Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231797
Device Name Medifun Lancing Device, Model No. LD-E1
Indications for Use (Describe)
Medifun Lancing Device, Model No. LD-E1 is a reusable lancing device for the single user. Itshould be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
| 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) |
ounter Use (21 CFR 801 Suppart C)
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510(k) Summary
May 09, 2023 Date
| Manufacturer/ | Medifun Corporation |
|---|---|
| 510(k) Owner | 4F-1, 4F-9, 4F-10, No.99, Jingke S. Rd., Nantun Dist., Taichung City408, Taiwan (R.O.C.) |
| Contact Person | Aaron Chen |
| Device Trade Name | Medifun Lancing Device, Model No. LD-E1 |
| Common Name | Multiple Use Blood Lancet For SinglePatient Use Only |
| Classification Name | Multiple Use Blood Lancet For SinglePatient Use Only |
| Device Class | II |
| Classification Panel | General & Plastic Surgery |
| Regelation Number | 21 CFR 878.4850 |
| Product Code | QRL |
| Device Descriptionand TechnologyCharacteristics | Medifun Lancing Device, Model No. LD-E1 is a mechanical blood lancetholder. It is used with a single use sterile lancet to puncture the skin forcollecting capillary whole blood sampled from the fingertip or alternatesites. Medifun Lancing Device LD-E1 can be adjusted for 6 levels ofdepth. This device is for single user only. |
| Indications for Use | Medifun Lancing Device, Model No. LD-E1 is a reusable lancing devicefor the single user. Itshould be used with the proper sterile lancet for thecapillary blood sampling. It could automatically inject the lancet into andretract it from the fingertip to obtain a capillary blood sample for glucosemonitoring or other test that require one or two drops of blood. A depthadjustable cap allows the best depth of skin penetration for each individualuser. Alternative site testing (palm or forearm) can be performed byinstalling the clear cap on the lancing device. |
| Predicate Device(s) | RIGHTEST Lancing Device GD500, GE Lancing Device,iGlucose Lancing Device, submitted by BionimeCorporationK221062 |
Discussion on Non-clinical bench testing was performed to ensure predetermined Performance Data criteria were met and the special controls were satisfied. This includes Non-Clinical Tests mechanical design verification and validation testing in order to ensure the risks were appropriately managed in addition to, verifying that the
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device continued to meet the specified requirements. The following nonclinical tests were conducted to evaluate the safety and performance of the subject device and provide evidence to support the verification and validation:
- ISO 10993-5 In vitro Cytotoxicity -
- ISO 10993-23 Skin Irritation -
- ISO 10993-10 Skin Sensitization -
- cleaning validation -
- Risk management according to ISO 14971:2019. -
- Specification and functional tests -
The subject device has same indications for use, technology, and Substantial Equivalence operation principle as well as similar technical characteristics with the predicate device. Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The verification tests demonstrate that the differences in the device do not affect the intended use of the device or raise any unsolved issues. There are no significant differences between subject device and the predicate device(s). We conclude that subject device is substantially equivalent to predicate devices.
- Based on the information provided in this premarket notification, we Conclusion believe the proposed Medifun Lancing Device, Model No. LD-E1 and its predicate device are substantially equivalent in their intended use, both devices share similar design and technology characteristics.
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Summary of Comparison and Technological Characteristics
| Proposed Device | Predicate Device | Substantial Equivalence Comparison | |
|---|---|---|---|
| Device Name | Medifun Lancing Device , Model No. LD-E1 | RIGHTEST Lancing Device GD500,GE Lancing Device and iGlucoseLancing Device | - |
| 510(k) # | - | K221062 | - |
| Product code | QRL | QRL | Identical |
| Classification | Class II | Class II | Identical |
| Intended Use | Medifun Lancing Device, Model No. LD-E1 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of | RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the | Identical |
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| skin penetration for each individual user.Alternative site testing (palm or forearm)can be performed by installing the clearcap on the lancing device. | best depth of skin penetration for eachindividual user. Alternative site testing(palm or forearm) can be performed byinstalling the clear cap on the lancingdevice.GE Lancing Device is a reusable lancingdevice for the single user. It should beused with the proper sterile lancet for thecapillary blood sampling. It couldautomatically inject the lancet into andretract it from the fingertip to obtain acapillary blood sample for glucosemonitoring or other test that require oneor two drops of blood. A depth adjustablecap allows the best depth of skinpenetration for each individual user.Alternative site testing(palm or forearm) can be performed byinstalling the clear cap on the lancing |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| device. | |||
|---|---|---|---|
| iGlucose Lancing Device is a reusable | |||
| lancing device for the single user. It | |||
| should be used with the proper sterile | |||
| lancet for the capillary blood sampling. It | |||
| could automatically inject the lancet into | |||
| and retract it from the fingertip to obtain | |||
| a capillary blood sample for glucose | |||
| monitoring or other test that require one | |||
| or two drops of blood. A depth adjustable | |||
| cap allows the best depth of skin | |||
| penetration for each individual user. | |||
| OTC/ Prescription Use | OTC | OTC | Identical |
| Operation Principle | Mechanical puncture device to obtain micro | Mechanical puncture device to obtain | Identical |
| blood samples | micro blood samples | ||
| Materials of construction | ABS plastic, Polyoxymethylene, SUS304 | - | Different |
| stainless-steel springs | |||
| Depth Adjustment | 6 different depths, 0.5mm-1.7 mm | 7 different depths, 0.5 mm- 1.7 mm. | Similar |
| Loading and Firing | Mechanical, Spring-driven | Mechanical, Spring-driven | Identical |
| Sharps Injury Prevention | Lancet retract after use | Lancet retract after use | Identical |
| Device Sterility | Non-sterile | Non-sterile | Identical |
| Number of Use | multiple use for single patient only | multiple use for single patient only | Identical |
| Biocompatibility | ISO 10993-1,ISO 10993-5,ISO 10993-10ISO 10993-23 | ISO 10993-1,ISO 10993-5,ISO 10993-10 | Identical |
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§ 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.