(181 days)
BD Microtainer® Contact-Activated Lancet, K822209
Not Found
No
The device description details a mechanical lancet for blood sampling and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is described as a "puncture device to obtain micro blood samples" and is used for diagnostic purposes (pricking a finger to draw blood for testing), not for treating a disease or condition.
No
Explanation: The device is a puncture device used to obtain blood samples for diagnostic assays, but it does not perform the diagnosis itself. Its function is to facilitate the collection of samples for testing.
No
The device description clearly describes a physical, mechanical device (lancet) used to puncture skin, not a software application.
Based on the provided text, 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) to provide information for the diagnosis, treatment, or prevention of disease.
- SurgiLance's Function: The SurgiLance is a puncture device used to obtain a blood sample. It is a tool for collecting the specimen, not for analyzing it or performing a diagnostic test on it.
- Role in the Diagnostic Process: The text clearly states that the blood sample obtained by the SurgiLance is then tested for an array of diagnostic assays. This indicates that the diagnostic testing happens after the blood is collected using the lancet.
Think of it this way: A syringe used to draw blood is not an IVD, but the test kit used to analyze that blood for a specific condition is an IVD. The SurgiLance falls into the category of a sample 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.
Product codes
FMK
Device Description
The MediPurpose SurgiLance® Safety Lancets 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. Point-of-Care (POC) tests currently using micro-sample quantities of whole blood include glucose, cholesterol, HIV, Hepatitis, A1C, Allergies, Lactate, HgB, H.Pvlori. Creatinine, Mono, PT, D-Dimer, Anemia, Thyroid, Triglycerides, Ketones, Prostate, IgE. Chagas and more. 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 ergonomic 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 is 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 push the lancet down against 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.
The SurgiLance® Safety Lancet comes in six models: two low flow, one medium flow, one medium-high flow, and two high flows. The six models are differentiated by their casing color.
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 sharps prevention feature was fully tested to the FDA's quidance document as demonstrated in the performance testing.
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.
BD Microtainer® Contact-Activated Lancet, K822209
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
MediPurpose Pte. Ltd. Abbreviated 510(k) - K101145 - SurgiLance® Safety Lancet
510(k) Summary - Revised September 27, 2010
| Owner's Information: | MediPurpose Pte. Ltd.
3850 Holcomb Bridge Road, Suite 350
Norcross, GA 30092 |
|----------------------------------------|------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant
Regulatory Resources Group, Inc. |
| 510(k) Number: | K101145 OCT 21 2010 |
| Date Prepared: | September 2010 |
| Trade/Proprietary Name: | SurgiLance® Safety Lancets |
| Common Name: | Blood Lancets |
| Class: | I - Lancet with Sharps Prevention Feature |
| Legally Marketed
Predicate Devices: | BD Microtainer® Contact-Activated Lancet, K822209 |
Device Description:
The MediPurpose SurgiLance® Safety Lancets 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. Point-of-Care (POC) tests currently using micro-sample quantities of whole blood include glucose, cholesterol, HIV, Hepatitis, A1C, Allergies, Lactate, HgB, H.Pvlori. Creatinine, Mono, PT, D-Dimer, Anemia, Thyroid, Triglycerides, Ketones, Prostate, IgE. Chagas and more. 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 ergonomic 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 is 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 push the lancet down against 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.
The SurgiLance® Safety Lancet comes in six models: two low flow, one medium flow, one medium-high flow, and two high flows. The six models are differentiated by their casing color.
1
510(k) Summary - Revised September 27, 2010
Intended Use:
The Surgil ance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgilLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury.
Similarities and Differences of the Proposed Devices to the Predicate Devices:
Similarities
The Surgil ance® Safety Lancet has the same basic technology characteristics for a lancet with sharps injury prevention. It is intended for piercing the skin, as the predicate devices, and the indications for use are the same. The materials are comparable in that the needles and blades all use medical grade stainless steel and the housings are made of plastics.
Differences
The SurgiLance® Safety Lancet utilizes some of the same materials, specifically the use of medical grade stainless steel for the lancet needles and blades but may use different types or grades of plastics for the housings, caps, and triggers. All the materials are known biocompatible materials that have been used in lancets or other similar medical devices.
Conclusion:
The SurgiLance® Safety Lancet has the same principles of operation, intended use, and technological characteristics as the predicate devices. The sharps prevention feature was fully tested to the FDA's quidance document as demonstrated in the performance testing.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with its wings spread, clutching a caduceus, which is a traditional symbol of medicine. The seal is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MediPurpose Pte, Ltd. % Regulatory Resources Group, Inc. Ms. Julie Stephens 111 Laurel Ridge Drive Alpharetta, Georgia 30004
OCT 21 2018
Re: K101145
Trade/Device Name: SurgiLance® Safety Lancet Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: FMK Dated: September 16, 2010 Received: September 17, 2010
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. 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
3
Page 2 - Ms. Julie Stephens
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourccsfor You/Industry/default.htm.
Sincerely yours.
For Dottore
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Revised - September 2010
510(k) Number (if known): K101145
Device Name: SurgiLance® Safety Lancet
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.
FDA CDRH DMC
SEP 1 7 2018
AND/OR
Received
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP Order for nxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101145
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