(28 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of a blood lancet, with no mention of AI or ML.
No.
A therapeutic device is used to treat a disease, condition, or injury, whereas this device is used for diagnostic purposes (blood sampling).
No
Explanation: The device is intended for capillary blood sampling, which is a collection activity, not a diagnostic one. Diagnostic devices interpret collected data to determine a medical condition.
No
The device description clearly describes physical, mechanical components (lancets, needles, springs) and the performance studies focus on bench testing of these physical characteristics. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for capillary blood sampling." This describes the collection of a sample, not the testing or analysis of the sample.
- Device Description: The description details a device for puncturing the skin to obtain a blood specimen. It does not mention any components or functions related to analyzing or testing the blood.
- Lack of IVD-related information: The document does not mention any aspects typically associated with IVDs, such as reagents, assays, analytical methods, or interpretation of results.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is used in vivo (on the body) to obtain the specimen.
N/A
Intended Use / Indications for Use
It is intended for capillary blood sampling.
Product codes (comma separated list FDA assigned to the subject device)
FMK, QRK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare provider or patient self
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)
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*
(* 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
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
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.
1
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
2
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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3
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
4
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
(K192666) | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Promisemed Hangzhou
Meditech Co., Ltd | Significant
Differences |
| Trade Name | Promisemed® Blood
Lancet | Promisemed® Blood
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
Lancet Without An
Integral Sharps Injury
Prevention Feature | Lancet, Blood | Different1 |
| Intended
Use/Indications for
Use | It is intended for
capillary blood sampling. | It is intended for capillary
blood sampling. | Same |
| Biocompatibility | Biocompatibility
established | Biocompatibility
established | Same |
| Structure | Stainless steel needle
encapsulated with a
plastic body and cap,
the cap is twisted off to
expose the needle for
use. | Stainless steel needle
encapsulated with a
plastic body and cap, the
cap is twisted off to
expose the needle for
use. | Same |
| Material | Needle: Stainless steel
Body and Cap:
polyethylene | Needle: Stainless steel
Body and Cap:
polyethylene | Same |
| Single use | Yes | Yes | Same |
| Sterilization | Gamma | Gamma | Same |
| Labeling | Labeling requirement
listed in blood lancet
reclassification final
order (86 FR 66180) such
as hand washing
instruction and warning
statement are
supplemented. | No include hand washing
instruction and warning
statement listed in blood
lancet reclassification
final order (86 FR 66180). | Different
The difference
does not affect
the
effectiveness
and safety of
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
(K192666) | Significant
Differences |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Promisemed Hangzhou
Meditech Co., Ltd | |
| Trade Name | VeriFine Safety Lancet
VeriFine Mini-Safety
Lancet | VeriFine Safety Lancet
VeriFine Mini-Safety
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
Lancet With An Integral
Sharps Injury Prevention
Feature | Lancet, Blood | Different¹ |
| Intended
Use/Indications for
Use | It is intended for
capillary blood sampling. | It is intended for
capillary blood sampling. | Same |
| Direction for use | 1. Rotate the twisting
cap less than half a
round
2. Pull out the twisting
cap
3. Place the device on
the puncture site and
push to start
4. Discard lancet into a
sharp container
5. Press lightly on the
finger toward the
puncture site to obtain
adequate blood sample | 1. Rotate the twisting
cap less than half a
round
2. Pull out the twisting
cap
3. Place the device on
the puncture site and
push to start
4. Discard lancet into a
sharp container
5. Press lightly on the
finger toward the
puncture site to obtain
adequate blood sample | Same |
| Gauge | 18G,21G,23G,25G,
26G,28G,30G | 18G,21G,23G,25G,
26G,28G,30G | Same |
| Needle Length (mm) | 1.2, 1.4, 1.6, 1.8, 2.0,
2.2, 2.4, 2.6, 2.8 | 1.2, 1.4, 1.6, 1.8, 2.0,
2.2, 2.4, 2.6, 2.8 | Same |
| Biocompatibility | Biocompatibility
established | Biocompatibility
established | Same |
| Structure/Design | VeriFine Safety Lancet
and VeriFine Mini-Safety
Lancet are spring-loaded
lancet.
VeriFine Safety lancet/
VeriFine Mini-Safety
Lancet 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 | VeriFine Safety Lancet
and VeriFine Mini-Safety
Lancet are spring-loaded
lancet.
VeriFine Safety lancet/
VeriFine Mini-Safety
Lancet 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 | Same |
| | needle into the skin and
the second withdraws
the needle back into the
shield. | needle into the skin and
the second withdraws
the needle back into the
shield. | |
| Material | Needle: Stainless steel | Needle: Stainless steel | Same |
| | Spring: Galvanized steel
wire | Spring: Galvanized steel
wire | |
| | Shield, hub and Safety:
ABS | Shield, hub and Safety:
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
listed in blood lancet | No include hand washing
instruction and warning | Different |
| | reclassification final
order (86 FR 66180) such
as hand washing | statement listed in blood
lancet reclassification
final order (86 FR | The difference
does not affect
the |
| | instruction and warning
statement are
supplemented. | 66180). | effectiveness
and safety of
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.