(110 days)
No
The device description and intended use clearly define a mechanical device for blood sampling with a sharps prevention feature. There is no mention of any computational or data-driven processes that would indicate the use of AI or ML.
No
The device is intended for capillary blood sampling, a diagnostic procedure, not for treating a disease or condition.
No
Explanation: The device is a blood lancet used for obtaining capillary blood samples, not for analyzing or diagnosing medical conditions from those samples. Its purpose is solely for sample collection.
No
The device description clearly describes a physical, hand-held device with a needle or blade, plastic housing, and a spring-loaded mechanism. It is a hardware device for capillary blood sampling.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. The key is that the device is used on the sample to provide diagnostic information.
- Function of these devices: These lancets are used to obtain a sample (capillary blood). They are not used to perform any diagnostic test on that sample. Their function is purely for specimen collection.
Therefore, while these lancets are essential for obtaining the sample needed for many IVD tests (like blood glucose monitoring), they themselves are not IVDs. They are considered medical devices for specimen collection.
N/A
Intended Use / Indications for Use
OneTouch® Delica® Safety is a single use blood lancet with sharps prevention feature to protect the user from a needlestick injury and that is intended for capillary blood sampling from a fingertip.
HemoCue® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Plus Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Capiject® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Newborn is single use and intended for capillary blood sampling from a heel for newborn. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Preemie is single use and intended for capillary blood sampling from a heel for preemie. Sharps prevention feature protects the user from needlestick injury.
Product codes
FMK
Device Description
The Single Use Blood Lancets are hand-held, sterile, needle or blade-like devices with a pull-off or twistoff cap and integral sharps injury prevention feature for controlled skin puncture to obtain a capillary blood specimen; typically at the fingertip or heel of the patient. The housing of the devices are made of plastic and have a spring-loaded mechanism which enables the tip of the needle or blade to puncture the fingertip or heel to a predetermined depth, whereby blood is subsequently squeezed out of the puncture site. These devices are made available in various needle and blade sizes which are distinguished by their different colors. Until activation, the lancet is contained within its housing (holder). Immediately after use, the needle or blade is automatically retracted back into its holder until the device is disposed of in an appropriate manner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip and Heel.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
To demonstrate safety and effectiveness of the Single Use Blood Lancets and to show substantial equivalence to the predicate device, Asahi Polyslider completed the following verification and validation activities, including non-clinical tests. Results confirm that the design inputs and performance specifications for the subject devices are met. The Single Use Blood Lancets passed all required testing in accordance with internal requirements, national standards, and international standards shown below, supporting their safety and effectiveness and substantial equivalence to the predicate device:
- Materials of Construction Specifications met
- Visual, Physical and Dimensional Verification – Specifications met
- Functional Testing – Specifications met
- Performance Testing – Specifications met
- Cytotoxicity Testing per ISO 10993-5 – Passed
- Sensitization Testing per ISO 10993-10 – Passed
- Irritation per ISO 10993-10 - Passed
- Sterilization Validation per ISO 11137-1/-2 – Demonstrates SAL 10°
- Product Sterility per ISO 11737-1 – Demonstrates product is free of microorganisms
- Shelf-life Testing per ASTM F1980 – Supports a shelf-life of 5 years
- Transportation Testing per ASTM 4169 – Demonstrates package integrity is maintained
- Risk Analysis per ISO 14971 – Hazards identified, ranked and risk mitigation measures implemented
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
11/02/2022
Asahi Polyslider Co., Ltd. % Stuart Goldman Sr. Consultant, RA/OA Emergo by UL 2500 Bee Cave Road Bldg. 1. Suite 300 Austin, Texas 78746
Re: K222084
Trade/Device Name: OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class II Product Code: FMK Dated: September 26, 2022 Received: September 29, 2022
Dear Stuart Goldman:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device 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) K222084
Device Name
OneTouch® Delica® Safety, HemoCue® Safety Lancet, Assure® Lance, Assure® Lance Plus
Indications for Use (Describe)
OneTouch® Delica® Safety is a single use blood lancet with sharps prevention feature to protect the user from a needlestick injury and that is intended for capillary blood sampling from a fingertip.
HemoCue® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Plus Safety Lancets are single use and intended for capillary blood sampling from a fingertin. Sharps prevention feature protects the user from needlestick injury.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K222084
Device Name
Capiject® Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie
Indications for Use (Describe)
Capiject@ Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Newborn is single use and intended for capillary blood sampling from a heel for newborn. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Preemie is single use and intended for capillary blood sampling from a heel for preemie. Sharps prevention feature protects the user from needlestick injury.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary Single Use Blood Lancets K222084
1. Submission Sponsor
Asahi Polyslider Company, Ltd. 860-2 Misaki, Maniwa Okayama 719-3226 Japan Yoshitaka Akagi Sr. Manager, Quality Assurance 0867-42-1171
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Stuart R. Goldman Sr. Consultant (512) 327-9997
3. Date Prepared
November 2, 2022
4. Device Identification
Trade/Proprietary Name:
Single Use Blood Lancets
| (OneTouch® Delica® Safety, HemoCue® Safety Lancet, Assure® Lance Safety | |
|---|---|
| Lancets, Assure® Lance Plus Safety Lancets, Capiject® Safety Lancet, Heel | |
| Lancet Newborn and Heel Lancet Preemie) | |
| Common/Usual Name: | Blood lancets |
| Classification Name: | Blood lancets |
| Regulation Number: | 878.4850 |
| Product Code: | FMK |
| Class: | II |
| Classification Panel: | General & Plastic Surgery |
5. Legally Marketed Predicate and Reverence Devices
| Predicate Device | |
|---|---|
| Device name: | SurgiLance® Safety Lance |
| 510(k) number: | K101145 |
| Manufacturer: | MediPurpose |
5
| Reference Devices | |
|---|---|
| Device name: | OneTouch® Delica® Plus Lancing System |
| 510(k) number: | K221546 |
| Manufacturer: | Asahi Polyslider |
| Device name: | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety |
| Lancet | |
| 510(k) number: | K192666 |
| Manufacturer: | Promisemed Hangzhou Meditech |
| Device name: | Accu-Chek Safe-T-Pro Uno Lancing Device |
| 510(k) number: | K220364 |
| Manufacturer: | Roche Diabetes Care |
6. Indication for Use Statements
| OneTouch® Delica® Safety | OneTouch® Delica® Safety is a single use blood lancet with sharps prevention feature to protect the user from a needlestick injury and that is intended for capillary blood sampling from a fingertip.
OTC |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| HemoCue® Safety Lancet | HemoCue® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
OTC |
| Assure® Lance | Assure® Lance Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
OTC |
| Assure® Lance Plus | Assure® Lance Plus Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
OTC |
| Capiject® Safety Lancet | Capiject Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Rx |
| Heel Lancet Newborn | Heel Lancet Newborn is single use and intended for capillary blood sampling from a heel for newborn. Sharps prevention feature protects the user from needlestick injury.
Rx |
| Heel Lancet Preemie | Heel Lancet Preemie is single use and intended for capillary blood sampling from a heel for preemie. Sharps prevention feature protects the user from needlestick injury.
Rx |
7. Device Description
The Single Use Blood Lancets are hand-held, sterile, needle or blade-like devices with a pull-off or twistoff cap and integral sharps injury prevention feature for controlled skin puncture to obtain a capillary blood specimen; typically at the fingertip or heel of the patient. The housing of the devices are made of plastic and have a spring-loaded mechanism which enables the tip of the needle or blade to puncture the
6
fingertip or heel to a predetermined depth, whereby blood is subsequently squeezed out of the puncture site. These devices are made available in various needle and blade sizes which are distinguished by their different colors. Until activation, the lancet is contained within its housing (holder). Immediately after use, the needle or blade is automatically retracted back into its holder until the device is disposed of in an appropriate manner.
8. Substantial Equivalence Discussion
Table 5-1 compares the Single Use Blood Lancets to the predicate device with respect to its intended use, and technological characteristics, forming the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
| Attribute | Subject Device | Predicate Device | Reference Device for
Lancet Penetration
Depth |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Manufacturer | Asahi Polyslider | MediPurpose | Roche |
| 510(k) # | Pending | K101145 | K220364 |
| Product Codes | FMK | FMK | FMK |
| Device Name | Single Use Blood Lancets | SurgiLance® Safety Lancets | Accu-Chek Safe-T-Pro
Uno Lancing Device |
| Device
Description | The needle or blade lancet
is used to prick a test site
to draw a sample of blood
for testing purposes. Once
fired, the needle or blade is
safely retracted into its
plastic housing that acts as
a sharps prevention
feature until the device is
disposed. The device is
provided single use and
sterile. | The needle or blade lancet is used
to prick a test site to draw a
sample of blood for testing
purposes. Once fired, the needle
or blade is safely retracted into its
plastic housing that acts as a
sharps prevention feature until the
device is disposed. The device is
provided single use and sterile. | |
| Intended Use | For the hygienic collection
of capillary blood for
testing purposes. | For the hygienic collection of
capillary blood for testing
purposes. | |
| Type of Use | Rx and OTC | Rx and OTC | |
| Mechanism of
Action | Spring-loaded mechanism
which enables the tip of
the sterile lancet to
puncture to a
predetermined depth. | Same as subject devices. | |
| Attribute | Subject Device | Predicate Device | Reference Device for
Lancet Penetration
Depth |
| Load and Firing | Loading / priming the
device is not required.
Press release button or
trigger to activate lancet
mechanism or press device
down against test site to
activate lancet mechanism. | Loading / priming the device is not
required. Press device down
against test site to activate lancet
mechanism. | |
| Lancet Sizes /
Dimensions | 30G (needle) / Ø 0.32mm
28G (needle) / Ø 0.4mm
25G (needle) / Ø 0.5mm
23G (needle) / Ø 0.65mm
21G (needle) / Ø 0.8mm
1.5mm (blade)
1.75mm (blade)
2.50mm (blade) | 28G (needle)
21G (needle)
18G (blade) | 28G (needle) |
| Lancet Sizes /
Penetration
Depth | 30G (needle) / 0.7, 1.5mm
28G (needle) / 1.0, 1.25mm
25G (needle) / 1.1, 2.0mm
23G (needle) / 2.0, 2.25mm
21G (needle) / 1.80mm
1.5mm / 1.00, 1.5, 2.0mm
1.75mm / 0.85mm
2.50mm / 1.00mm | 28G (needle) / 1.7mm
21G (needle) / 1.0, 1.8, 2.2, 2.8mm
18G (blade) / 1.8, 2.3mm | 28G (needle) / 1.5mm |
| Needle | Stainless Steel. | Stainless Steel. | |
| Housing | Polymer. | Polymer. | |
| Anatomical
Site(s) | Fingertip and Heel. | Fingertip. | |
| Sharps Injury
Prevention | Yes, automatic retraction
of the needle/blade into
plastic device housing. | Yes, automatic retraction of the
needle/blade into plastic device
housing. | |
| Sterile | Yes (gamma radiation). | Yes (gamma radiation). | |
| Single-Use | Yes. | Yes. | |
| Shelf-Life | 5 years. | 4 years. | |
Table 5-1 – Substantial Equivalence Comparison of Blood Lancets to Predicate Device
7
9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of the Single Use Blood Lancets and to show substantial equivalence to the predicate device, Asahi Polyslider completed the following verification and validation
8
activities, including non-clinical tests. Results confirm that the design inputs and performance specifications for the subject devices are met. The Single Use Blood Lancets passed all required testing in accordance with internal requirements, national standards, and international standards shown below, supporting their safety and effectiveness and substantial equivalence to the predicate device:
- Materials of Construction Specifications met ●
- . Visual, Physical and Dimensional Verification – Specifications met
- . Functional Testing – Specifications met
- Performance Testing – Specifications met
- . Cytotoxicity Testing per ISO 10993-5 – Passed
- Sensitization Testing per ISO 10993-10 – Passed
- Irritation per ISO 10993-10 - Passed
- . Sterilization Validation per ISO 11137-1/-2 – Demonstrates SAL 10°
- Product Sterility per ISO 11737-1 – Demonstrates product is free of microorganisms
- . Shelf-life Testing per ASTM F1980 – Supports a shelf-life of 5 years
- . Transportation Testing per ASTM 4169 – Demonstrates package integrity is maintained
- Risk Analysis per ISO 14971 – Hazards identified, ranked and risk mitigation measures implemented
10. Substantial Equivalence Conclusion
The Single Use Blood Lancets have intended use as the SurgiLance® Safety Lancets and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the subject device is as safe and effective as the predicate device. The Single Use Blood Lancets are substantially equivalent to the predicate device.