(59 days)
Facet Manatee Reuseable Lancet Base (Product Code MDM, 510(k) Exempt)
Not Found
No
The device description and performance studies focus solely on the mechanical function of a lancing device for obtaining blood samples. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is used to obtain a blood sample for diagnostic testing, not for treatment.
No
The device is a lancing device used to obtain a blood sample for diagnostic testing. It does not perform the diagnostic testing itself.
No
The device description explicitly states it is a "reusable lancet base" and a "spring-loaded mechanism," indicating a physical, mechanical device, not software. The performance studies also focus on "mechanical design verification and validation testing."
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the purpose is "obtaining a blood sample for diagnostic testing".
- Device Description: The device description further clarifies its use "to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients."
- Regulatory Classification: The predicate device is listed as "Facet Manatee Reuseable Lancet Base (Product Code MDM, 510(k) Exempt)". Product Code MDM is for "Lancet, Blood". Devices used to obtain blood samples for diagnostic testing are considered IVDs.
While the device itself doesn't perform the diagnostic test, it is an essential component in the process of obtaining the sample needed for the diagnostic test. Therefore, it falls under the category of an IVD accessory or component.
N/A
Intended Use / Indications for Use
The Facet Manatee Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adult), and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.
Product codes (comma separated list FDA assigned to the subject device)
QRL
Device Description
The Facet Manatee Reuseable Lancet Base is a reuseable blood sampling device used in conjunction with a standard or universal lancet blade to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
Biocompatibility testing has been conducted per ISO 10993 at a GLP testing facility.
The lancing device has been in commercial distribution in the United States for over 10 years. There have been no significant design changes over the life of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin puncture of a finger or alternate site (palm of the hand, upper arm, lower arm, thigh)
Indicated Patient Age Range
children, adolescents, and adults
Intended User / Care Setting
Home setting. This system is not suitable for use by healthcare professionals with multiple patients.
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)
Non-clinical bench testing was performed to ensure predetermined criteria were met and the special controls (21 CFR 878.4850) were satisfied. This includes mechanical design verification and validation testing in order to ensure the risks were appropriately managed in addition to verifying that the mechanical functions of the device are suitable for use over the shelf life of the device.
Clinical testing is not applicable as the risk analysis confirmed that all identified risks were addressed and mitigated appropriately. Residual risks after mitigation were acceptable. There were no special performance of safety concerns identified.
Nonclinical tests performed:
- Endcap Removal Force (Tensile strength tester)
- Endcap Attachment Force (Tensile strength tester)
- Depth of Puncture (Calibrated High Speed Video)
- Over-Charging Force (Tensile force gauge)
- Charging Force (Tensile force gauge)
- Lancet Insertion Force (Tensile force gauge)
- Depth Adjust Torque (Torque gauge)
- Button Activation Force (Tensile force gauge)
- Lancet Rotation (Torque gauge)
- Drop Test (Simulated Use after drop)
- Life Cycle Test (Simulated use)
- Chemical Test (Cleaning and disinfection studies)
- Storage Temperature Test (Simulated Use)
- Biocompatibility (Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute Systemic toxicity (materials mediated pyrogen))
In summary, the results of nonclinical testing demonstrate that the candidate device is substantially equivalent to the predicate device.
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.
Facet Manatee Reuseable Lancet Base (Product Code MDM, 510(k) Exempt)
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 for 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".
November 28, 2022
Facet Technologies LLC Mr. James Bonds Director Regulatory Affairs 3900 North. Commerce Drive. Atlanta, Georgia 30344-8149
Re: K223099
Trade/Device Name: Facet Manatee Reusable Lancing Base Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: September 30, 2022 Received: September 30, 2022
Dear Mr. Bonds:
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,
Jessica Carr -S
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) K223099
Device Name
Facet Manatee Reuseable Lancet Base
Indications for Use (Describe)
The Facet Manatee Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.
| 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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K223099
Facet Manatee Reuseable Lancet Base
510(k) Summary (Reference 21 CFR 807.92)
| Submitted by: | Facet Technologies, LLC
3900 North Commerce Drive
Atlanta, GA 30344-8149
Phone Number: (770) 590-6462
Fax Number: (770) 590-6412 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | James R. Bonds
Director Regulatory Affairs
JBonds@facetmed.com |
| Date of Preparation: | November 25, 2022 |
| Device Trade Name: | Facet Manatee Reuseable Lancet Base |
| Common Name: | Lancing Device |
| Classification Name: | Multiple use blood lancet base for single patient use only |
| Regulation: | 878.4850 |
| Product codes: | QRL (Multiple use blood lancet intended for use on a single
patient use only) |
| Product Classification: | II |
| Panel: | General & Plastic Surgery |
| Predicate Device: | Facet Manatee Reuseable Lancet Base (Product Code MDM,
510(k) Exempt) |
4
Device Description
The Facet Manatee Reuseable Lancet Base is a reuseable blood sampling device used in conjunction with a standard or universal lancet blade to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
Biocompatibility testing has been conducted per ISO 10993 at a GLP testing facility.
The lancing device has been in commercial distribution in the United States for over 10 years. There have been no significant design changes over the life of the device.
Indication for Use
The Facet Manatee Reuseable Lancet Base (commonly referred to as a lancing device) is a nonsterile reuseable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adult), and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.
Intended Use
The Facet Manatee Reuseable Lancet Base is intended to be used with a standard or universal lancet blade to perform a skin puncture of a finger or alternate site (palm of the hand, upper arm, lower arm, thigh) for collection of a droplet of capillary blood for subsequent diagnostic testing. This system is not suitable for use by healthcare professionals with multiple patients.
Technological Characteristics
The primary technological characteristics and intended use of the Facet Manatee Reuseable Lancet Base are substantially equivalent to other legally marketed universal lancets.
5
As indicated in Table 1, the Facet Manatee Reuseable Lancet Base is substantially equivalent to characteristics of the identified predicate device, the Facet Manatee Reuseable Lancet Base previously marketed as a 510(k) exempt device.
| Characteristic | Predicate Device | Subject Device |
|---|---|---|
| Indication for Use | The Facet Manatee | |
| Reuseable Lancet Base | ||
| (commonly referred to as | ||
| a lancing device) is a non- | ||
| sterile reuseable device | ||
| which provides a spring- | ||
| loaded mechanism to | ||
| quickly eject and retract a | ||
| single or regular version | ||
| lancet to effect a lancing | ||
| event for the purpose of | ||
| obtaining a blood sample | ||
| for diagnostic testing in | ||
| children, adolescents (use | ||
| on children and | ||
| adolescents should be by | ||
| or under supervision of an | ||
| adult), and adults in a | ||
| home setting. The device | ||
| is designed to be cleaned | ||
| and disinfected between | ||
| uses on a single patient. | Same | |
| Intended Use | The Facet Manatee | |
| Reuseable Lancet Base is | ||
| The Facet Manatee | ||
| Reuseable Lancet Base is | ||
| intended to be used with | ||
| a standard or universal | ||
| lancet blade to perform a | ||
| skin puncture of a finger | ||
| or alternate site (palm of | ||
| the hand, upper arm, | ||
| lower arm, thigh) for | ||
| collection of a droplet of | ||
| capillary blood for | ||
| subsequent diagnostic | ||
| testing. This system is | ||
| not suitable for use by | ||
| healthcare professionals | ||
| with multiple patients. | Same | |
| Characteristic | Predicate Device | Subject Device |
| Manufacturer | Facet Technologies, LLC | Same |
| 510(k) Number | N/A | K223099 |
| Product Code | MDM | QRL |
| Sterility | Non-sterile, can be cleaned | |
| and low-level disinfected | ||
| between uses | Same |
Comparison of Subject Device and Predicate Device Table 1:
6
Non-clinical Testing Summary and Conclusions
Non-clinical bench testing was performed to ensure predetermined criteria were met and the special controls (21 CFR 878.4850) were satisfied. This includes mechanical design verification and validation testing in order to ensure the risks were appropriately managed in addition to verifying that the mechanical functions of the device are suitable for use over the shelf life of the device.
Clinical testing is not applicable as the risk analysis confirmed that all identified risks were addressed and mitigated appropriately. Residual risks after mitigation were acceptable. There were no special performance of safety concerns identified.
| Property/Characteristic | Test Method | Importance | Reference |
|---|---|---|---|
| Endcap Removal Force | Tensile strength | ||
| tester | Ensure cap can be | ||
| removed easily to | |||
| insert lancet blade | N/A | ||
| Endcap Attachment | |||
| Force | Tensile strength | ||
| tester | Ensure cap will | ||
| remain on lancet | |||
| base during lancing | |||
| event | N/A | ||
| Depth of Puncture | Calibrated High | ||
| Speed Video | Ensure depth of | ||
| puncture is | |||
| repeatable for | |||
| various depth | |||
| settings | N/A | ||
| Over-Charging Force | Tensile force gauge | Ensure that device | |
| can be charged to | |||
| engage actuation | |||
| spring | N/A | ||
| Property/Characteristic | Test Method | Importance | Reference |
| Charging Force | Tensile force gauge | Ensure device can | |
| be charged to | |||
| engage actuation | |||
| spring | N/A | ||
| Lancet Insertion Force | Tensile force gauge | Ensure lancet can be | |
| easily inserted | N/A | ||
| Depth Adjust Torque | Torque gauge | Ensure that depth | |
| adjustment can be | |||
| easily adjusted and | |||
| that adjustment will | |||
| not change during | |||
| use | N/A | ||
| Button Activation Force | Tensile force gauge | Ensure activation | |
| force is within | |||
| specification | N/A | ||
| Lancet Rotation | Torque gauge | Ensure lancet does | |
| not rotate during | |||
| device actuation | N/A | ||
| Drop Test | Simulated Use after | ||
| drop | Ensure that device | ||
| can withstand a 1 | |||
| meter drop to a hard | |||
| surface and still | |||
| function | N/A | ||
| Life Cycle Test | Simulated use | Ensure device can | |
| withstand 3 years of | |||
| expected use | N/A | ||
| Chemical Test | Cleaning and | ||
| disinfection studies | Ensure device can | ||
| withstand | |||
| recommended | |||
| cleaning and | |||
| disinfection over | |||
| useful life | N/A | ||
| Storage Temperature | |||
| Test | Simulated Use | Ensure device can | |
| function after | |||
| exposure to heat and | |||
| cold cycles | N/A |
Table 2: Summary of Nonclinical Tests Performed
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8
| Property/Characteristic | Test Method | Importance | Reference |
|---|---|---|---|
| Biocompatibility | Cytotoxicity, | ||
| Sensitization, | |||
| Irritation or | |||
| Intracutaneous | |||
| reactivity, Acute | |||
| Systemic toxicity | |||
| (materials mediated | |||
| pyrogen) | Ensure material of | ||
| construction are | |||
| biocompatible for | |||
| their intended use | FDA Guidance Use | ||
| of International | |||
| Standard 10993-1, | |||
| "Biological evaluation | |||
| of medical devices - | |||
| Part 1: Evaluation | |||
| and testing within a | |||
| risk management | |||
| process", Sept. | |||
| 2020, | |||
| ISO 10993-1, ISO | |||
| 10993-5, ISO 0993- | |||
| 10, ISO 10993-11 |
In summary, the results of nonclinical testing demonstrate that the candidate device is substantially equivalent to the predicate device.
Conclusion
The intended use, technology, non-clinical testing, and functionality of the Facet Manatee Reuseable Lancet Base demonstrate a substantially equivalent safety and effectiveness profile to the predicate device and should perform as well as the predicate in the specified use conditions.