(156 days)
No
The device description and performance studies focus on mechanical and biological properties, with no mention of AI/ML or data processing beyond basic measurements.
No.
The device is used to obtain capillary blood samples for testing, not to treat a medical condition or disease.
No
The device, a disposable safety lancet, is used to obtain capillary blood samples for testing purposes, not to diagnose conditions itself. Diagnosis occurs after the blood sample has been analyzed.
No
The device description clearly outlines physical components like a needle/blade, spring, press button, and shell parts, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain capillary blood samples." This is a step before any diagnostic testing is performed. The device itself does not perform any diagnostic function on the blood sample.
- Device Description: The description focuses on the mechanism for puncturing the skin and collecting a blood sample. It does not mention any components or processes related to analyzing the blood or providing a diagnostic result.
- Lack of Diagnostic Function: An IVD device is specifically designed to perform tests on samples (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This lancet simply collects the sample.
While the blood collected by this lancet will likely be used for in vitro diagnostic testing, the lancet itself is a sample collection device, not an IVD.
N/A
Intended Use / Indications for Use
The disposable safety lancet is used to obtain capillary blood samples. The device has an integral sharps injury prevention feature
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The disposable safety lancet is sterile, single use, spring loaded and designed to draw a capillary blood sample. The device is mainly comprised of a single use needle/blade attached to a needle core by injection molding and then assembled with spring, press button, depth adjusting ring (optional) and shell parts, which also forming an integral sharps injury prevention feature. The device is used to puncture the skin to obtain a drop of blood for testing purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
Flex 3 model is the only adjustable lancet, and all other models (Press, Press Plus, Press2, Press2 Plus, Lite3) are provided at various single depths.
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
The device is intended to be used by professionals and individuals.
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 following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- O Cytotoxicity
- Skin Sensitization O
- Intracutaneous reactivity O
- O Acute systemic toxicity
- Pyrogen O
- Hemocompatibility O
Non-clinical data
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:
- 0 Appearance and type, Cleanliness
- Basic Dimensions
- O Needle Diameter, sharpness and triggering depth
- Safety, Single-use and adjustment function
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.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
10/28/2022
SteriLance Medical (Suzhou) Inc. Susan Sun Quality Manager No.168 PuTuoShan Road, New District, Suzhou. Jiangsu 215153 China
Re: K221521
Trade/Device Name: Disposable Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: September 30, 2022 Received: October 3, 2022
Dear Susan Sun:
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/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.
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
1
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 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,
for 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) K221521
Device Name Disposable Safety Lancet
Indications for Use (Describe)
The disposable safety lancet is used to obtain capillary blood samples. The device has an integral sharps injury prevention feature
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
K221521 510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2022/10/25
1. Submission sponsor
Name: SteriLance Medical (Suzhou) Inc. Address: No.168 PuTuoShan Road, New District,215153 Suzhou, Jiangsu, P. R. China Contact person: Susan Sun Title: Deputy Quality Manager E-mail: registration1@sterilance.com Tel: 86-0512-65799308 Ext 8301
| Trade/Device Name | Disposable Safety Lancet |
|---|---|
| Model | Press, Press Plus, Press2, Press2 Plus, Lite3, Flex3 |
| Common Name | Blood Lancet |
| Regulatory Class | Class II |
| Classification | 21CFR 878.4850 / Single Use Only Blood Lancet With An |
| Integral Sharps Injury Prevention Feature / FMK | |
| Submission type | Traditional 510(K) |
Subject Device Information 2.
Predicate Device 3.
Promisemed Hangzhou Meditech Co., Ltd., Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet under K192666.
Reference device: MediPurpose Pte. Ltd., The Surgilance® Safety Lancet under K101145.
Device Description 4.
The disposable safety lancet is sterile, single use, spring loaded and designed to draw a capillary blood sample. The device is mainly comprised of a single use needle/blade attached to a needle core by injection molding and then assembled with spring, press button, depth adjusting ring (optional) and shell parts, which also forming an integral sharps injury prevention feature. The device is used to puncture the skin to obtain a drop of blood for testing purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
Flex 3 model is the only adjustable lancet, and all other models (Press, Press Plus, Press2, Press2 Plus, Lite3) are provided at various single depths.
The device is intended to be used by professionals and individuals.
Intended use & Indication for use 5.
4
The disposable safety lancet is used to obtain capillary blood samples. The device has an integral sharps injury prevention feature
| Features | Subject Device: | Predicate Device: VeriFine | Comparison |
|---|---|---|---|
| Disposable Safety Lancet | Safety Lancet (K192666) | ||
| Product | FMK | FMK | Same |
| Code | |||
| Regulation | 21 CFR § 878.4850 | 21 CFR § 878.4850 | Same |
| Number | |||
| Classification | Class II | Class II | Same |
| Type of use | OTC | OTC | Same |
| Indications for | |||
| Use | The disposable safety lancet | ||
| is used to obtain capillary | |||
| blood samples. The device | |||
| has an integral sharps injury | |||
| prevention feature | It is intended for capillary | ||
| blood sampling. | Similar | ||
| Reuse | Single use | Single use | Same |
| durability | |||
| Sterilization | Sterilized by Radiation | Sterilized by Radiation | Same |
| method and | |||
| SAL | SAL=10-6 | SAL=10-6 | |
| Gauge | 17;18;21;23;26;28;30 | 21;23;26;28;30;31;32 | Different |
| There are some differences in the | |||
| smaller gauge specification | |||
| compared with the predicate device. | |||
| The comparative Performance | |||
| testing can demonstrate the safety | |||
| and performance of the subject | |||
| device. | |||
| Penetration | |||
| depth (mm) | 1.2, 1.5, 1.8, 2.0, 2.2, 2.3, | ||
| 2.4, 2.8 | 1.6, 1.8, 2.0, 2.2, 2.3, 2.4 | Different. | |
| More wide range of penetration | |||
| depth in the device will not cause | |||
| new safety and effectiveness | |||
| concerns raised. The comparative | |||
| Penetration testing can demonstrate | |||
| the safety and performance of the | |||
| subject device. | |||
| Component | Needle | ||
| Shell | |||
| Press button | |||
| Protective cap | Needle | ||
| Shell | |||
| Press button | |||
| Protective cap | Same | ||
| Materials of | |||
| parts in | |||
| contact with | |||
| human body | Needle:304 stainless steel | Needle:304 stainless steel | Same |
Comparison to the Predicate Device 6.
5
Comparison to Reference Device
| Features | Subject Device:
Disposable Safety
Lancet | Reference Device: The
Surgilance® Safety
Lancet (K101145) | Comparison |
|---------------------------|------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------|
| Penetration
depth (mm) | 1.2, 1.5, 1.8, 2.0, 2.2,
2.3, 2.4, 2.8 | 1.0, 1.8, 2.2, 2.3, 2.8, | Different.
The range of penetration depth is within the
reference device. |
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- O Cytotoxicity
- Skin Sensitization O
- Intracutaneous reactivity O
- O Acute systemic toxicity
- Pyrogen O
- Hemocompatibility O
Non-clinical data
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:
- 0 Appearance and type, Cleanliness
- Basic Dimensions
- O Needle Diameter, sharpness and triggering depth
- Safety, Single-use and adjustment function
8. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.