(54 days)
The safety lancet is intended for capillary blood sampling.
Sterile safety lancet consists of outer shell, middle sleeve, needle holder, spring, upper shell, back cover, small cover, needle. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use and single person use only. The shelf-life of the product is 5 years. The device is for medical professionals and lay person use as an OTC use.
This document is a 510(k) Summary for a medical device called "MedtFine Safety Lancet". It details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the provided text for acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a "Characters comparison" table (Table 2) that includes performance parameters for both the proposed "MedtFine Safety Lancet" and the predicate device "Safety Lancet (K220370)". This table effectively serves as a comparison against acceptance criteria. The acceptance criterion for each performance characteristic is generally implied to be "same" or within the range of the predicate device, or "meet requirements."
| Acceptance Criteria (Implied from Predicate/Requirement) | Reported Device Performance (MedtFine Safety Lancet) | Comments (from document) |
|---|---|---|
| Product Code: FMK | FMK | Same |
| Indication for Use: Capillary blood sampling | The safety lancet is intended for capillary blood sampling. | Same |
| OTC Use | OTC use | Same |
| Specifications: Needle: 18G, 18G blade, 21G, 23G, 16G, 28G, 30G, 32G | Needle: 18G, 18G blade, 21G, 23G, 16G, 28G, 30G, 32G | Same, within range. |
| Safety protection features: Yes | Yes | Same |
| Reuse durability: Single use for single person | Single use for single person | Same |
| User environments: Home, clinical | Home, clinical | Same |
| Components and materials: (Specific to predicate; proposed device differs) | Outer shell: PP, Middle sleeve: ABS, Needle holder: PE, Spring: carbon steel, Upper Shell: PE, Back cover: PE, Small cover: PP, Needle: Stainless Steel | #1 (The proposed and predicate devices used different materials for manufacturing. The device structures kept the same. The performance testing and biocompatibility testing results demonstrated the proposed device met the requirements of various standards) |
| Sterilization: Radiation SAL=10-6 | Radiation SAL=10-6 | Same |
| Shelf life: 5 years | 5 years | Same |
| Activation force: 4~15N | 4~7N | Same, within range. |
| Puncture force: 18 | 18-26G: 0.6 | Same, meet requirements |
| Puncture depth (needle exposure length): 18 | 18 | Same |
| Biocompatibility: Meet requirements of ISO 10993 serial standards | Meet requirements of ISO 10993 serial standards | Same |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the non-clinical performance test set. It lists the types of tests performed (e.g., appearance, needle size, firmness, puncture force, safety performance, limits for acidity or alkalinity, resistance to corrosion, sharps injury protection, simulated clinical use study).
The data provenance (country of origin, retrospective/prospective) is also not mentioned. These studies are typically conducted by the manufacturer or a contracted testing lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a medical lancet. The ground truth for its performance characteristics (like puncture force, needle exposure length, etc.) is established through objective measurements against defined engineering and biological standards, not through expert consensus or clinical interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the device relies on objective non-clinical performance testing rather than subjective interpretation requiring adjudication among experts.
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
An MRMC study is not applicable for this device. This type of study is relevant for diagnostic imaging AI devices, whereas the MedtFine Safety Lancet is a mechanical medical device for blood sampling.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a mechanical blood lancet. Standalone performance refers to the accuracy of an AI algorithm operating without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the MedtFine Safety Lancet's performance is established through adherence to recognized international standards and validated testing methodologies. For example:
- Physical and performance characteristics: Measured values compared against specifications (e.g., needle size compared to stated gauge, puncture force measured against a defined range, exposure length measured).
- Sterility: Validated according to ISO 11137-2:2013, with a Sterility Assurance Level (SAL) of 10-6.
- Biocompatibility: Demonstrated by testing in compliance with ISO 10993-1.
- Sharps Injury Protection: Tested per ISO 23908 and an FDA Guidance document.
- Shelf-life: Validated under accelerated aging conditions per ASTM F1980-16.
- Package integrity: Tested against ASTM F4169-22, ASTM F88/F88-15, and ASTM F1929-23.
- Sterility (packaging): USP <71>
8. The sample size for the training set
This information is not applicable. The MedtFine Safety Lancet is a mechanical medical device, not an AI/ML-based device that requires a "training set." Its design and manufacturing are based on engineering principles and material science, not data-driven learning.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above (not an AI/ML device). The design and development process for such a device relies on established engineering specifications, material selection, and manufacturing processes, which are then validated through the performance and biocompatibility testing outlined.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 20, 2024
Ningbo Caremed Medical Products Co. Ltd. % Evan Hu Technical and Regulatory Director Shanghai Mind-link Consulting Co., Ltd. 377 Tianzhu Road, Jiading Shanghai, 201801, China
Re: K241848
Trade/Device Name: MedtFine Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: June 13, 2024 Received: June 27, 2024
Dear Evan Hu:
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 OS 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,
Digitally signed by Long H. Chen -Long H. Chen-S Date: 2024.08.20 13:09:43 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
MedtFine Safety Lancet
Indications for Use (Describe)
The 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
1. Preparation date: Jun 12, 2024
2. Submitter
Manufacturer: Ningbo Caremed Medical Products Co. Ltd. Address: No.79 Jiutang Road, South Side Hangzhou Bay New Zone, Ningbo 315336, China. Contact person: Cen Wei, General Manager, +86057458582551, wei-cen@caremed-nb.com Submission correspondent: Evan Hu, Technical and Regulatory Director, +86-18616124827, evan.ww.hu@outlook.com
3. Device
Trade name: MedtFine Safety Lancet Common name: Blood Lancet Regulation Name: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature Regulation: 21 CFR § 878.4850 Product code: FMK Classification: Class II Review Pannel: General & Plastic Surgery
4. Predicate device
Predicate device: K220370 Trade name: Safety Lancet (Model: XIII, XVII, XXI, XXIII, XXIV, XXV, XXVI) Common name: Blood Lancet Regulation Name: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature Regulation: 21 CFR § 878.4850 Product code: FMK Classification: Class II Review Pannel: General & Plastic Surgery
5. Device description
Sterile safety lancet consists of outer shell, middle sleeve, needle holder, spring, upper shell, back cover, small cover, needle. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation
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K241848
sterilization. It is intended for single use and single person use only. The shelf-life of the product is 5 years. The device is for medical professionals and lay person use as an OTC use.
| NO. | Gauge | Needle exposure length(±0.3mm) | Color |
|---|---|---|---|
| 1 | 18G | 1.8 | Orange |
| 2 | 18G | 2.2 | Rose red |
| 3 | 18G Blade | 3.0 | Deep green |
| 4 | 21G | 2.2 | Grass green |
| 5 | 21G | 2.4 | Light Blue |
| 6 | 23G | 2.2 | Deep blue |
| 7 | 26G | 1.8 | Yellow |
| 8 | 28G | 1.8 | Lake blue |
| 9 | 30G | 1.6 | Pink |
| 10 | 32G | 1.6 | Purple |
Table 1. Device specifications
6. Indications for use/Intended use
The safety lancet is intended for capillary blood sampling.
7. Comparison of technological characters between proposed and predicate devices
Table 2. Characters comparison
| Element ofComparison | MedtFine Safety Lancet | Safety Lancet(K220370) | Comment |
|---|---|---|---|
| Product Code | FMK | FMK | Same |
| Indication for Use | The safety lancet isintended for capillaryblood sampling. | The safety lancet isintendedfor capillary bloodsampling. | Same |
| OTC and Rx Use | OTC use | OTC use | Same |
| Element ofComparison | MedtFine Safety Lancet | Safety Lancet(K220370) | Comment |
| Specifications | Needle: 18G, 18G blade,21G, 23G, 16G, 28G,30G, 32GHouse Type: XXV (belowgraph) | Needle: 18G, 18G blade,21G, 23G, 16G, 28G, 30G,32GHouse Type: XIII, XVII, | Same,within range. |
| Safety protectionfeatures | Yes | Yes | Same |
| Reuse durability | Single use for singleperson | Single use for singleperson | Same |
| User environments | Home, clinical | Home, clinical | Same |
| Components andmaterials | Outer shell: PPMiddle sleeve: ABSNeedle holder: PESpring: carbon steelUpper Shell: PEBack cover: PESmall cover: PPNeedle: Stainless Steel | Needle core (containNeedle): PE, PPCalcium powder (mainingredient: calciumcarbonate)stainless steel (needle)silicone oil (needle)Housing, Button, Bottom,Protective cap, Small lid,Depth adjuster ring: ABS,PS | #1 |
| Sterilization | RadiationSAL=10-6 | RadiationSAL=10-6 | Same |
| Shelf life | 5 years | 5 years | Same |
| Activation force | 4~7N | 4~15N | Same, withinrange. |
| Puncture force | 18-26G: 0.6 | 18 | Same, meetrequirements |
| Puncture depth(needle exposurelength) | 18 | 18 | Same |
| Biocompatibility | Meet requirements of ISO10993 serial standards | Meet requirements of ISO10993 serial standards | Same |
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Comments:
#1: The proposed and predicate devices used different materials for manufacturing. The device structures kept the same. The performance testing and biocompatibility testing results demonstrated the proposed device met the requirements of various standards
8. Non-clinical testing
PERFORMANCE TESTING
The following tests were performed per ISO 9626:2016 and internal requirements to demonstrate substantial equivalence:
- Appearance -
- -Needle size
- Firmness of needle and plastic handle -
- Puncture force -
- Safety performance -
- Limits for acidity or alkalinity -
- -Resistance to corrosion
Besides, the following tests were performed to determine the safe usage of devices.
- Sharps injury protection per ISO 23908 -
- Simulated clinical use study per FDA Guidance: Medical Devices with Sharps Injury -Prevention Features
BIOCOMPATIBILITY TESTING:
The proposed device was tested in compliance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process", as the Externally Communicating Device, Blood Path Indirect, Limited Contact (< 24hrs).
The items listed below underwent testing in accordance with ISO 10993-1.
- -Cytotoxicity
- Intracutaneous Reactivity -
- -Sensitization
- -Systemic toxicity
- Hemolysis -
- Pyrogen -
- Endotoxin -
STERILE, PACKAGE AND SHELF-LIFE:
The sterilization process of the proposed device has been validated in compliance with ISO 11137-2:2013.
The Shelf-Life validation study was conducted under accelerated aging conditions in compliance with ASTM F1980-16 to verify the claimed shelf-life of 5 years.
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Package integrity testing under simulated shipping conditions was conducted to satisfy the requirements in ASTM F4169-22. All packaging was deemed acceptable for protection of product and sterility maintenance.
Sterile barrier testing was conducted in compliance with the following FDA recognized consensus standards.
- Cap removal force: ASTM F88/F88-15 -
- Dye penetration: ASTM F1929-23. -
- Sterility: USP <71>
9. Clinical testing
Not applicable for this submission.
10. Conclusion
The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use and technological characteristics.
§ 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.