(59 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI or ML.
No.
The device is used to obtain blood samples for diagnostic assays, which is a diagnostic purpose, not a therapeutic one.
No
The device is a "puncture device to obtain micro blood samples" or "needle or blade device used to prick a patient's finger to draw a micro-sample of blood". It collects blood for testing but does not perform any diagnostic function itself. The diagnostic assays are performed on the collected blood by other means.
No
The device description clearly details a physical, mechanical device (lancet) used to puncture skin, not a software application.
Based on the provided information, the SurgiLance® Safety Lancet is not an In Vitro Diagnostic (IVD) device itself.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnostic purposes.
- SurgiLance®'s Function: The SurgiLance® Safety Lancet is a tool used to obtain the blood sample. It is the means of collecting the specimen, not the device that performs the diagnostic test on the specimen.
- Intended Use: The intended use clearly states it's a "puncture device to obtain micro blood samples." It doesn't mention analyzing the blood or providing diagnostic information.
- Device Description: The description focuses on the mechanism for pricking the finger and collecting blood, not on any analytical capabilities.
- Lack of Diagnostic Metrics: The "Key Metrics" section is listed as "Not Applicable," which would not be the case for an IVD device that measures something in the sample.
While the blood sample obtained using the SurgiLance® Safety Lancet can be used for diagnostic assays (which are IVD tests), the lancet itself is a specimen collection device.
N/A
Intended Use / Indications for Use
The SurgiLance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgiLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury. Single patient use only.
Product codes
FMK
Device Description
The SurgiLance® Safety Lancet is a needle or blade device used to prick a patient's finger to draw a micro-sample of blood which can then be tested for an array of diagnostic assays. Lancets are commonly used in hospitals, clinics, physician offices, laboratories, OB/GYN practices, oncology departments, emergency medical services, nursing homes and blood banks. The outside plastic casing is designed to be erqonomic for the user and compatible with the test site, usually a human finger. The device is available with either a needle or blade, each with different depths of penetration, to provide optimal blood flow for different applications and skin types. The SurgiLance® Safety Lancet comes in seven (7) models: two low flow, two medium flow, and three high flows. The seven models are differentiated by their casing color.
SurgiLance® Safety Lancets are safely retracted and concealed before and after use. The user simply removes the protective cap, places the red raised platform end onto the patient's test site, and gently pushes the lancet down aqainst the test site to activate the lancet mechanism. Once the lancet is used, it is rendered inoperative, providing added safety for patient and clinician. The device is discarded in a sharps container after use. SurgiLance Safety Lancets are provided sterile and are single patient use only. They are sterilized using irradiation (R) sterilization method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, clinics, physician offices, laboratories, OB/GYN practices, oncology departments, emergency medical services, nursing homes and blood banks.
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 biocompatibility risk assessment was completed as directed by FDA quidance under ISO 10993-1 biocompatibility requirements. Cytotoxicity, Sensitization, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, and Hemolysis testing was completed to demonstrate that the known biocompatible materials maintained compliance through manufacturing and sterilization. Performance and safety testing completed for the Surgil.ance® Safety Lancet included tests for drop testing, trigger force and reverse safety, penetration and depth force measurements, and simulated use testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 22, 2022
MediPurpose Pte. Ltd. % Ms. Julie Stephens President Regulatory Resources Group, Inc. 111 Laurel Ridge Drive Alpharetta, Georgia 30004
Re: K222224
Trade/Device Name: SurgiLance® Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: July 25, 2022 Received: July 25, 2022
Dear Ms. Stephens:
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
1
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 (OS) 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 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,
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) K222224
Device Name SurgiLance® Safety Lancet
Indications for Use (Describe)
The SurgiLance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgiLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury. Single patient use only.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
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3
MediPurpose Pte. Ltd. Traditional 510(k) - SurgiLance® Safety Lancet
510(k) Summary - 510(k) # K222224
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.
| Submitted By: | MediPurpose Pte. Ltd.
10 Anson Road, No. 12-08 International Plaza
Singapore, Central Singapore 079903 SINGAPORE | US Agent: |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| | | MediPurpose, Inc. |
| | | 3883 Rogers Bridge Rd NW-Suite 501 |
| | | Duluth, GA 30097 USA |
| | | Phone: (404) 855-3655 |
| MediPurpose Contact: | Adeline Yi - adelineyi@medipurpose.com | |
| Consultant Contact: | Julie Stephens - jstephens@regresourcesgroup.com
Regulatory Resources Group, Inc. - Phone: (678) 513-0693
111 Laurel Ridge Dr, Alpharetta, GA 30004 USA | |
| Date Submitted: | September 21, 2022 | |
Device Name and Classification:
| Trade/Proprietary Name: | SurgiLance® Safety Lancet |
|---|---|
| Common Name: | Blood Lancet with Sharps Prevention Feature |
| Classification Name: | Blood Lancets - Single use only blood lancet with an integral sharps injury prevention feature |
| Regulation Number: | 21 CFR 878.4850 |
| Class: | II |
| Product Code: | FMK |
Legally Marketed Predicate Device:
Primary Predicate: MediPurpose SurgiLance® Safety Lancet, 510(k) # K101145 Additional Predicate: BD Autolancet [Microtainer® Lancet], 510(k) # K822209
Device Description:
The SurgiLance® Safety Lancet is a needle or blade device used to prick a patient's finger to draw a micro-sample of blood which can then be tested for an array of diagnostic assays. Lancets are commonly used in hospitals, clinics, physician offices, laboratories, OB/GYN practices, oncology departments, emergency medical services, nursing homes and blood banks. The outside plastic casing is designed to be erqonomic for the user and compatible with the test site, usually a human finger. The device is available with either a needle or blade, each with different depths of penetration, to provide optimal blood flow for different applications and skin types. The SurgiLance® Safety Lancet comes in seven (7) models: two low flow, two medium flow, and three high flows. The seven models are differentiated by their casing color.
SurgiLance® Safety Lancets are safely retracted and concealed before and after use. The user simply removes the protective cap, places the red raised platform end onto the patient's test site, and gently pushes the lancet down aqainst the test site to activate the lancet mechanism. Once the lancet is used, it is rendered inoperative, providing added safety for patient and clinician. The device is discarded in a sharps container after use. SurgiLance Safety Lancets are provided sterile and are single patient use only. They are sterilized using irradiation (R) sterilization method.
4
MediPurpose Pte. Ltd. Traditional 510(k) - SurgiLance® Safety Lancet
510(k) Summary - 510(k) # K222224
Indications for Use:
The SurgilLance® Safety Lancet is a puncture device to obtain micro blood samples. The Surgil.ance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury. Single patient use only.
The Indications for Use statement for the SurgiLance® Safety Lancet did not change from the cleared 510(k) # K101145. SurgiLance Safety Lancets [Proposed Device and Primary Predicate Device].
Technological Characteristics:
SurgiLance® Safety Lancets [Proposed Device] did not change technological characteristics or material specifications from the cleared 510(k) # K101145 [Primary Predicate Device]. The SurgiLance Safety Lancets are substantially equivalent to the BD Microtainer lancets [Additional Predicate Device] as they have the same basic technology characteristics for piercing the skin with a needle or blade to draw a micro-sample of blood and include a sharps injury prevention feature. The materials are comparable in that the needles and blades all use medical grade stainless steel and the housings are made of medical grade plastics.
| Comparison of Technological Characteristics to the Predicate Devices | |||||
|---|---|---|---|---|---|
| -- | -- | ---------------------------------------------------------------------- | -- | -- | -- |
| Proposed Device
510(k) #: Pending | Primary Predicate Device
510(k) #: K101145 | Additional Predicate Device
510(k) #: K822209 |
|------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------|
| SurgiLance® Safety Lancet | SurgiLance® Safety Lancet | BD Microtainer® Contact-
Activated Lancet |
| FMK; 21 CFR 878.4850; Class II
[New Classification] | FMK; 21 CFR 878.4400;
Class I | FMK; 21 CFR 878.4400; Class I |
| Materials | | |
| Needles -Stainless steels
Blades - Stainless steels
Housing/Case, Holder, Cap -
Plastics | Same - No changes | Needles - Surgical steels
Blades - Surgical steels
Housing/Case, Holder, Cap -
Plastics |
| Mechanical Specifications | | |
| Low Flow - Needle - G28 & G21
Medium Flow - Needle - G21
High Flow - Blade - G21 & G18 | Same - No changes | Low Flow - Needle - G30
Medium Flow - Needle - G21
High Flow - Blade 1.5mm/G16.5 |
| Labeled Cut Profiles: Cut Depths (mm) and Blood Flow | | |
| Low Flow - 1.7& 1.0 depths
Medium Flow - 1.8 & 2.2 depths
High Flow - 2.8, 1.8 & 2.3
depths | Same - No changes | Low Flow - 1.5 depth (single
drop)
Medium Flow - 1.8 depth
High Flow - 2.0 depth |
5
MediPurpose Pte. Ltd. Traditional 510(k) - SurgiLance® Safety Lancet
| Proposed Device
510(k) #: Pending | Primary Predicate Device
510(k) #: K101145 | Additional Predicate Device
510(k) #: K822209 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety Features | | |
| • Single use only with an integral
sharps injury prevention
feature.
• Needle/blade is not exposed
except when lancet is
activated.
• The needle/blade retracts back
into the housing at the end of
the incision motion; the trigger
mechanism is disabled and
locks the needle/blade in the
housing. | Same - No changes | • Single use only with an
integral sharps injury
prevention feature.
• Needle/blade is not exposed
except when lancet is
activated.
• The needle/blade retracts back
into the housing at the end of
the incision motion; the trigger
mechanism is disabled and
locks the needle/blade in the
housing. |
510(k) Summary - 510(k) # K222224
Summary of Testing:
The biocompatibility risk assessment was completed as directed by FDA quidance under ISO 10993-1 biocompatibility requirements. Cytotoxicity, Sensitization, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, and Hemolysis testing was completed to demonstrate that the known biocompatible materials maintained compliance through manufacturing and sterilization. Performance and safety testing completed for the Surgil.ance® Safety Lancet included tests for drop testing, trigger force and reverse safety, penetration and depth force measurements, and simulated use testing.
Substantial Equivalence Conclusions:
SurgiLance® Safety Lancets have the same principles of operation, intended use, and technological characteristics including the materials used, mechanical specifications, cutting profiles, and sharps injury prevention features as the predicate devices. The sharps prevention feature was fully tested to the FDA's guidance document as demonstrated in the performance testing.