The Promisemed Blood Lancet, VeriFine Safety Lancet, and VeriFine Mini-Safety Lancet are sterile, single-use instruments for capillary blood sampling. The Promisemed Blood Lancet is a manual, non-mechanical, scalpel-like device. The VeriFine Safety and Mini-Safety lancets are spring-loaded devices; activation occurs by pressing the device against the skin. Upon activation, a spring drives the needle into the skin, and a second spring retracts the needle into the device body to prevent sharps injury. These devices are used in clinical or home settings by healthcare providers or patients. The output is a small blood specimen obtained via skin puncture. The device design allows for various needle gauges to accommodate different blood volume requirements. The safety mechanism reduces the risk of accidental needle sticks.
Clinical Evidence
Bench testing only. Testing included visual inspection, needle dimensions, chemical properties, bond strength, corrosion resistance, locking function, spring elasticity, percussive function, and penetration force. Biocompatibility was established per ISO 10993-1, -5, and -10. Sterility and shelf-life (5 years) were validated per ISO 11137, ISO 11737, and ASTM F1980-07.
Indicated for capillary blood sampling in patients requiring small blood specimens, suitable for use by healthcare providers or patients for self-testing.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
*Single use only blood lancet without an integral sharps injury prevention feature* —(1)*Identification.* A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
*Multiple use blood lancet for single patient use only* —(1)*Identification.* A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
*Multiple use blood lancet for multiple patient use* —(1)*Identification.* A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class III (premarket approval).(3)
*Date PMA or notice of completion of a PDP is required:* A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
K222801 — Safety Lancet · Sarstedt AG & CO KG · Jan 25, 2023
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 9, 2022
Promisemed Hangzhou Meditech Co., Ltd. % Wei Hsu Regulatory Manager Vee Care (Asia) Limited 1 7th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong Hong Kong
Re: K221368
Trade/Device Name: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK, QRK Dated: April 29, 2022 Received: May 12, 2022
Dear Wei Hsu:
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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
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
510(k) Number (if known) K221368
Device Name Promisemed Blood Lancet VeriFine Safety Lancet VeriFine Mini-Safety Lancet
Indications for Use (Describe) It 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
#### Date Prepared 1
May 9, 2022
#### Submitter's Information 2
### Submission Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China.
Contact: Zearou Yang
Telephone No.: +86 571 88772985
Fax No.:+86 571 88772985
Email: zearou.yang@promisemed.ca
#### ന Trade Name, Common Name, Classification
### Trade/Product Name:
Promisemed Blood Lancet
VeriFine Safety Lancet
VeriFine Mini-Safety Lancet
Common Name: Blood Lancet
## Classification name:
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Regulation Number: 21 CFR 878.4850
Device Class: Class II
Product Code: FMK, QRK
#### ব ldentification of Predicate Device(s)
K192666: Promisemed Blood Lancet
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VeriFine Safety Lancet
VeriFine Mini-Safety Lancet
### 5 Description of the Device
Promosemed Blood Lancet is a sterile, handheld, sharply-pointed, nonmechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.
VeriFine Safety lancet and VeriFine Mini-Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Both single-use Promisemed Blood Lancet and VeriFine Safety Lancet/VeriFine Mini-Safety Lancet offers different gauge (needle diameter) options, to allow to choose the lancet which meets blood volume needs.
#### Intended Use 6
It is intended for capillary blood sampling.
### 7 Similarities and Differences of the Proposed Devices to the Predicate Devices
Promisemed Blood Lancet and VeriFine Safety Lancet/ VeriFine Mini-Safety Lancet are substantially equivalent to the predicate devices, K192666, in that these devices have same intended use and technological characteristics. The basic technological and operating principles are the same. The differences between the subject device and predicate device do not affect the intended use or raise new questions of safety and effectiveness.
A detailed comparison to the predicate is provided in Table 1 and Table 2.
{5}------------------------------------------------
| | Subject Device | Predicate Device<br>(K192666) | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Manufacturer | Promisemed Hangzhou<br>Meditech Co., Ltd | Promisemed Hangzhou<br>Meditech Co., Ltd | Significant<br>Differences |
| Trade Name | Promisemed® Blood<br>Lancet | Promisemed® Blood<br>Lancet | |
| Device Class | Class II | Class I (Exempt) | Different1 |
| Product Code | QRK | FMK | Different1 |
| Regulation number | 878.8450 | 878.4800 | Different1 |
| Regulation Name | Single Use Only Blood<br>Lancet Without An<br>Integral Sharps Injury<br>Prevention Feature | Lancet, Blood | Different1 |
| Intended<br>Use/Indications for<br>Use | It is intended for<br>capillary blood sampling. | It is intended for capillary<br>blood sampling. | Same |
| Biocompatibility | Biocompatibility<br>established | Biocompatibility<br>established | Same |
| Structure | Stainless steel needle<br>encapsulated with a<br>plastic body and cap,<br>the cap is twisted off to<br>expose the needle for<br>use. | Stainless steel needle<br>encapsulated with a<br>plastic body and cap, the<br>cap is twisted off to<br>expose the needle for<br>use. | Same |
| Material | Needle: Stainless steel<br>Body and Cap:<br>polyethylene | Needle: Stainless steel<br>Body and Cap:<br>polyethylene | Same |
| Single use | Yes | Yes | Same |
| Sterilization | Gamma | Gamma | Same |
| Labeling | Labeling requirement<br>listed in blood lancet<br>reclassification final<br>order (86 FR 66180) such<br>as hand washing<br>instruction and warning<br>statement are<br>supplemented. | No include hand washing<br>instruction and warning<br>statement listed in blood<br>lancet reclassification<br>final order (86 FR 66180). | Different<br>The difference<br>does not affect<br>the<br>effectiveness<br>and safety of<br>the device. |
Table 1: Device Comparison Chart for Promisemed Blood Lancet
Note 1: In response to blood lancet reclassification.
# Table 2: Device Comparison Chart for VeriFine Safety Lancet/ VeriFine Mini-Safety Lancet
| | Subject Device | Predicate Device<br>(K192666) | Significant<br>Differences |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Manufacturer | Promisemed Hangzhou<br>Meditech Co., Ltd | Promisemed Hangzhou<br>Meditech Co., Ltd | |
| Trade Name | VeriFine Safety Lancet<br>VeriFine Mini-Safety<br>Lancet | VeriFine Safety Lancet<br>VeriFine Mini-Safety<br>Lancet | |
| Device Class | Class II | Class I (Exempt) | Different¹ |
| Product Code | FMK | FMK | Same |
| Regulation number | 878.8450 | 878.4800 | Different¹ |
| Regulation Name | Single Use Only Blood<br>Lancet With An Integral<br>Sharps Injury Prevention<br>Feature | Lancet, Blood | Different¹ |
| Intended<br>Use/Indications for<br>Use | It is intended for<br>capillary blood sampling. | It is intended for<br>capillary blood sampling. | Same |
| Direction for use | 1. Rotate the twisting<br>cap less than half a<br>round<br>2. Pull out the twisting<br>cap<br>3. Place the device on<br>the puncture site and<br>push to start<br>4. Discard lancet into a<br>sharp container<br>5. Press lightly on the<br>finger toward the<br>puncture site to obtain<br>adequate blood sample | 1. Rotate the twisting<br>cap less than half a<br>round<br>2. Pull out the twisting<br>cap<br>3. Place the device on<br>the puncture site and<br>push to start<br>4. Discard lancet into a<br>sharp container<br>5. Press lightly on the<br>finger toward the<br>puncture site to obtain<br>adequate blood sample | Same |
| Gauge | 18G,21G,23G,25G,<br>26G,28G,30G | 18G,21G,23G,25G,<br>26G,28G,30G | Same |
| Needle Length (mm) | 1.2, 1.4, 1.6, 1.8, 2.0,<br>2.2, 2.4, 2.6, 2.8 | 1.2, 1.4, 1.6, 1.8, 2.0,<br>2.2, 2.4, 2.6, 2.8 | Same |
| Biocompatibility | Biocompatibility<br>established | Biocompatibility<br>established | Same |
| Structure/Design | VeriFine Safety Lancet<br>and VeriFine Mini-Safety<br>Lancet are spring-loaded<br>lancet.<br><br>VeriFine Safety lancet/<br>VeriFine Mini-Safety<br>Lancet are activated<br>when you press the<br>device against your<br>finger.<br><br>Once activated the<br>needle retracts into the<br>body of the device which<br>reduces the risk of<br>injury as the result if an<br>exposed needle. The | VeriFine Safety Lancet<br>and VeriFine Mini-Safety<br>Lancet are spring-loaded<br>lancet.<br><br>VeriFine Safety lancet/<br>VeriFine Mini-Safety<br>Lancet are activated<br>when you press the<br>device against your<br>finger.<br><br>Once activated the<br>needle retracts into the<br>body of the device which<br>reduces the risk of injury<br>as the result if an<br>exposed needle. The | Same |
| | needle into the skin and<br>the second withdraws<br>the needle back into the<br>shield. | needle into the skin and<br>the second withdraws<br>the needle back into the<br>shield. | |
| Material | Needle: Stainless steel | Needle: Stainless steel | Same |
| | Spring: Galvanized steel<br>wire | Spring: Galvanized steel<br>wire | |
| | Shield, hub and Safety:<br>ABS | Shield, hub and Safety:<br>ABS | |
| | Trigger POM | Trigger POM | |
| | Lancet body, cap: PE | Lancet body, cap: PE | |
| Single use | Yes | Yes | Same |
| Sterilization | Gamma | Gamma | Same |
| Labeling | Labeling requirement<br>listed in blood lancet | No include hand washing<br>instruction and warning | Different |
| | reclassification final<br>order (86 FR 66180) such<br>as hand washing | statement listed in blood<br>lancet reclassification<br>final order (86 FR | The difference<br>does not affect<br>the |
| | instruction and warning<br>statement are<br>supplemented. | 66180). | effectiveness<br>and safety of<br>the device. |
{6}------------------------------------------------
{7}------------------------------------------------
Note 1: In response to blood lancet reclassification.
#### 8 Performance Testing Summary
The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- · Visual Inspection
- Needle Dimensions
- Chemical properties
- Bond between lancet body and needle
- Resistance to corrosion of the needle
- · Lancing device compatibility test (Promisemed Blood Lancet only)
- Locking function
- Spring elasticity*
- Percussive function*
- Penetrate force*
{8}------------------------------------------------
(* VeriFine Safety Lancet and VeriFine Mini-Safety Lancet only)
- Biocompatibility
- a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process
- b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- c. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- Sterility and Shelf-Life
- -ISO 11137-1:2006, Sterilization of Health Care Products Radiation -Part 1: Requirements for Development, Validation and Routine control of a sterilization process for medical devices
- -ISO 11737-1:2006, Sterilization of Health Care Products -Microbiological Methods - Part 1: Determination of Population of Microorganisms on products
- -ISO 11737-2:2009, Sterilization of Medical Devices Microbiological Methods - Part 2: Tests of Sterility Performed in the Definition, validation and maintenance of a sterilization process
- Shelf life of 5 years is validated using ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
### Conclusion の
Promisemed Blood Lancet and VeriFine Safety Lancet/VeriFine Mini-Safety Lancet has the same intended use and technological characteristics as the predicate. The labeling changes made to subject device do not raise any new or different questions of safety or effectiveness. The proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed predicate device.
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