(116 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of a simple lancet, with no mention of computational analysis or learning algorithms.
No
The device is intended to obtain a capillary blood specimen for in-vitro diagnostic (IVD) assays, not to treat a medical condition.
No
The device is a safety lancet used to obtain a capillary blood specimen. It is explicitly stated that the blood specimen is "for the purposes of performing in-vitro diagnostic (IVD) assays," indicating it is a tool for specimen collection, not a diagnostic device itself.
No
The device description clearly details physical components like needles, plastic housings, and springs, indicating it is a hardware device, not software-only.
Based on the provided text, the device itself is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to diagnose, monitor, or screen for diseases or conditions.
- Device Function: The device described is a safety lancet. Its function is to obtain a capillary blood specimen. It does not perform any diagnostic test on that specimen.
- Intended Use/Indications: The text explicitly states the lancets are intended "to obtain a capillary blood specimen" for the purpose of "performing in-vitro diagnostic (IVD) assays." This clearly positions the lancet as a tool used in conjunction with IVD assays, not as an IVD itself.
Think of it this way: A syringe is used to collect a blood sample, but the syringe itself is not an IVD. The IVD is the test performed on the blood sample collected by the syringe. Similarly, the lancet collects the blood sample, and the IVD is the test performed on the blood sample collected by the lancet.
N/A
Intended Use / Indications for Use
The single-use safety lancets are hand-held disposable devices intended to achieve a controlled skin puncture, typically on the fingertip, to obtain a capillary blood specimen.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
This submission covers the following devices:
- . Unistik® 3, sterile single-use safety lancets
- . Unistik® 3 Value, sterile single-use safety lancets
- . Abbott SF® sterile single-use safety lancets
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are hand-held disposable devices intended to be used to achieve a controlled skin puncture on the fingertip, in order to obtain a capillary blood specimen. The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.g. for blood glucose monitoring in patients with diabetes.
The Unistik® 3 safety lancets are available in five different variants, each with a different needle gauge (18G, 21G, 23G, 28G, 30G) to facilitate appropriate blood flow rates from the skin puncture. There are two high flow variants (18G, 21G) one medium flow variant (23G) and two low flow variants (28G, 30G). The Unistik® 3 Value devices are identical to the equivalent gauge of Unistik® 3 devices, except for the colour of the plastic body housings. The Unistik® 3 Value devices all have a vanilla body housing colour, whereas the Unistik® 3 devices have a different colour for each gauge.
In the remainder of this submission, the Unistik® 3 safety lancets and Unistik® 3 Value safety lancets will both be referred to as "the Unistik® 3 safety lancets."
The Abbott SF sterile single-use safety lancets are available in a single configuration only (28G needle).
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are designed for prescription and over-the-counter use and to be used by self-testing patients, caregivers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for care-givers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female, right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime.
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are sterile single-use devices with integral sharps protection whereby the lancet needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the device automatically self-disables after a single use, thus preventing any hazards of re-use.
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are used by first twisting off the end cap, the needle tip is then exposed but remains safely shielded within the device housing. The user then presses the end face of the device against the sampling site, then activates the device by pressing the release button on the side of the lancet needle is then automatically propelled forward by the internal pre-loaded spring to lance the skin and also automatically retracted by the spring back inside the device housing, where it is then automatically locked to prevent re-use. After firing, the locked position of the needle tip inside the device ensures that it remains safely shielded, and the device can be safely disposed of into an appropriate sharps receptacle.
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets consist of a stainless steel lancet needle moulded into a plastic lancet holder component. which in turn is assembled into a moulded plastic outer housing with a pre-loaded steel spring for propelling the lancet holder forward when the device is activated and subsequently automatically retracting it. After retraction, the lancet holder is automatically locked into the device such that the device cannot be re-used and the needle tip is safely shielded.
The lancet needles are moulded into the lancet holder component such that the needle tip is sealed by complete encapsulation in overmoulded plastic. The complete lancet holder component is then sterilised by gamma irradiation, so after irradiation the sterility of the needle tip is maintained by encapsulation within the plastic. The sterile seal is only broken when the user twists off and removes the lancet cap immediately before use. The needle tip is the exposed needle length after the cap is removed, and this is the only part of the needle that will penetrate the patient's skin during use. Therefore, the encapsulation of the needle tip by plastic overmoulding performs the function of primary packaging, whereby a sterile seal is maintained until the point of use.
The purpose of this 510(k) application is to obtain both prescription-only clearance and overcounter clearance for the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile singleuse safety lancets. The intended use for the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets remains the same as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing patients, caregivers and healthcare professionals. Home and clinical.
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)
Bench Testing:
- Test: Integrity of device, Requirement: Internal test specification, Results: Meets specification
- Test: Test firing protocol, Requirement: Internal test specification, Results: Meets specification
- Test: Environmental testing, Requirement: Internal test specification, Results: Meets specification
- Test: Cap removal torque and needle retention, Requirement: Internal test specification, Results: Meets specification
- Test: Needle penetration measurement, Requirement: Internal test specification, Results: Meets specification
- Test: Drop test, Requirement: Internal test specification, Results: Meets specification
All additional performance tests met the acceptance criteria. The results from these tests demonstrate that the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are safe and effective when used as intended.
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.
SurgiLance® Safety Lancet, under 510k number K101145.
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
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August 12, 2022
Owen Mumford Ltd Darren Mansell Regulatory Affairs Manager Brook Hill Woodstock. Oxfordshire OX20 1TU United Kingdom
Re: K221126
Trade/Device Name: Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: July 8, 2022 Received: July 12, 2022
Dear Darren Mansell:
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/cfpm/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 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 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).
Sincerelv.
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) K221126
Device Name
Unistik® 3, sterile single-use safety lancets Unistik® 3 Value, sterile single-use safety lancets Abbott SF sterile single-use safety lancets
Indications for Use (Describe)
The single-use safety lancets are hand-held disposable devices intended to achieve a controlled skin puncture, typically on the fingertip, to obtain a capillary blood specimen.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
1. Submitter
| Prepared by: | Owen Mumford Ltd
Tel: +44(0)1993 812021
Fax: +44(0)1993 813466 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared for: | Owner/ Operator
Owen Mumford Ltd
Brook Hill
Woodstock
Oxfordshire
OX20 1TU
United Kingdom
Establishment Registration Number: 3003348846 |
| Contact Person: | Darren Mansell
Regulatory Affairs Manager
Owen Mumford Ltd,
Tel: +44(0)1993 812021
Fax: +44(0)1993 813466
Email: darren.mansell@owenmumford.com |
| Date Prepared: | 08 July 2022 |
| 2. Device | |
| Name of Device: | Unistik® 3, sterile single-use safety lancets, |
| | Unistik® 3 Value, sterile single-use safety lancets, |
| | Abbott SF sterile single-use safety lancets |
| Common Name: | Blood lancets |
| Classification Name:
feature | Single use only blood lancet with an integral sharps injury prevention feature |
| Regulatory Class: | II |
| Product Code: | FMK |
| 3. Predicate Devices | |
| Predicate Device Name: | SurgiLance® Safety Lancet, under 510k number K101145. |
(Cleared for: Prescription Use and Over-The-Counter Use)
4
4. Description of The Device
This submission covers the following devices:
- . Unistik® 3, sterile single-use safety lancets
- . Unistik® 3 Value, sterile single-use safety lancets
- . Abbott SF® sterile single-use safety lancets
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are hand-held disposable devices intended to be used to achieve a controlled skin puncture on the fingertip, in order to obtain a capillary blood specimen. The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.g. for blood glucose monitoring in patients with diabetes.
The Unistik® 3 safety lancets are available in five different variants, each with a different needle gauge (18G, 21G, 23G, 28G, 30G) to facilitate appropriate blood flow rates from the skin puncture. There are two high flow variants (18G, 21G) one medium flow variant (23G) and two low flow variants (28G, 30G). The Unistik® 3 Value devices are identical to the equivalent gauge of Unistik® 3 devices, except for the colour of the plastic body housings. The Unistik® 3 Value devices all have a vanilla body housing colour, whereas the Unistik® 3 devices have a different colour for each gauge.
In the remainder of this submission, the Unistik® 3 safety lancets and Unistik® 3 Value safety lancets will both be referred to as "the Unistik® 3 safety lancets."
The Abbott SF sterile single-use safety lancets are available in a single configuration only (28G needle).
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are designed for prescription and over-the-counter use and to be used by self-testing patients, caregivers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for care-givers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female, right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime.
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are sterile single-use devices with integral sharps protection whereby the lancet needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the device automatically self-disables after a single use, thus preventing any hazards of re-use.
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are used by first twisting off the end cap, the needle tip is then exposed but remains safely shielded within the device housing. The user then presses the end face of the device against the sampling site, then activates the device by pressing the release button on the side of the lancet needle is then automatically propelled forward by the internal pre-loaded spring to lance the skin and also automatically retracted by the spring back inside the device housing, where it is then automatically locked to prevent re-use. After firing, the locked position of the needle tip inside the device ensures that it remains safely shielded, and the device can be safely disposed of into an appropriate sharps receptacle.
5
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets consist of a stainless steel lancet needle moulded into a plastic lancet holder component. which in turn is assembled into a moulded plastic outer housing with a pre-loaded steel spring for propelling the lancet holder forward when the device is activated and subsequently automatically retracting it. After retraction, the lancet holder is automatically locked into the device such that the device cannot be re-used and the needle tip is safely shielded.
The lancet needles are moulded into the lancet holder component such that the needle tip is sealed by complete encapsulation in overmoulded plastic. The complete lancet holder component is then sterilised by gamma irradiation, so after irradiation the sterility of the needle tip is maintained by encapsulation within the plastic. The sterile seal is only broken when the user twists off and removes the lancet cap immediately before use. The needle tip is the exposed needle length after the cap is removed, and this is the only part of the needle that will penetrate the patient's skin during use. Therefore, the encapsulation of the needle tip by plastic overmoulding performs the function of primary packaging, whereby a sterile seal is maintained until the point of use.
The purpose of this 510(k) application is to obtain both prescription-only clearance and overcounter clearance for the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile singleuse safety lancets. The intended use for the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets remains the same as the predicate device.
5. Indications for Use
The single-use safety lancets are hand-held disposable devices intended to be used to achieve a controlled skin puncture, typically on the fingertip, to obtain a capillary blood specimen.
6
6. Technological Characteristics
The Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are substantially equivalent to the predicate device, the SurgiLance® Safety Lancet.
A comparison of the intended uses and technological characteristics of the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets to the predicate SurgiLance® devices is summarised in the table below.
| Device Characteristic | Predicate Device: SurgiLance® Safety Lancets – K101145. | Submission Device - Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets | |
|---|---|---|---|
| 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. | Equivalent to the predicate device | |
| Use environment | Home and clinical | Home and clinical | |
| Operating principle | Contact-activated spring-powered automatic lancing and needle retraction. | Manually activated (side fire button) spring-powered automatic lancing and needle retraction. | |
| Design/ construction | Stainless steel lancet needle moulded into a plastic lancet holder component, which in turn is assembled into a moulded plastic outer housing with a pre-loaded steel spring | Unchanged from the predicate device with the exception of an addition of a plastic tab functioning as a firing button which is incorporated into the external plastic outer housing. | |
| Integral sharps injury prevention feature? | Yes | Unchanged from the predicate device | |
| Device Characteristic | Predicate Device: | ||
| SurgiLance® Safety | |||
| Lancets – K101145. | Submission Device - | ||
| Unistik® 3 sterile single-use | |||
| safety lancets and Abbott SF | |||
| sterile single-use safety lancets | |||
| Single-use? | Yes | Unchanged from the predicate | |
| device | |||
| Sterility | Sterile | Unchanged from the predicate | |
| device | |||
| Components and Materials | Plastic external and internal | ||
| components, stainless steel | |||
| needle and steel spring | Unchanged from the predicate | ||
| device, but likely that plastic and | |||
| steel specifications used differ from | |||
| predicate. | |||
| Package | Laminate pulp board cartons | Unchanged from the predicate | |
| device. | |||
| Needle | |||
| Specifications | Needle | ||
| Gauges | |||
| (SWG) | 18G, 21G | Unistik 3: 18G, 21G, 23G, 28G, | |
| 30G | |||
| Abbott SF: 28G | |||
| The predicate device is available in | |||
| 18G and 21G variants only, | |||
| therefore the Unistik® 3 sterile | |||
| single-use safety lancets and | |||
| Abbott SF sterile single-use safety | |||
| lancets represent an extended | |||
| range of higher gauges (smaller | |||
| needle diameters) compared to the | |||
| predicate. | |||
| Device Characteristic | Predicate Device: | ||
| SurgiLance® Safety | |||
| Lancets – K101145. | Submission Device - | ||
| Unistik® 3 sterile single-use | |||
| safety lancets and Abbott SF | |||
| sterile single-use safety lancets | |||
| Lancing | |||
| Depths (mm) | 1.8 mm & 2.3 mm (18G) | ||
| 1.0 mm, 1.8 mm, 2.2 mm & | |||
| 2.8 mm (21G) | Unistik 3: 1.4mm, 1.5mm. 1.8mm, | ||
| 2.0mm | |||
| Abbott SF: 1.4mm | |||
| The Unistik® 3 sterile single-use | |||
| safety lancets and Abbott SF sterile | |||
| single-use safety lancets lancing | |||
| depth range falls within the range | |||
| offered by the predicate device, i.e. | |||
| 1.4 mm - 2.0 mm compared to the | |||
| predicate range of | |||
| 1.0 mm - 2.8 mm. | |||
| Needle Tip | |||
| Configuration | Not known. | 2-facet chisel - 1.8 mm (18G) | |
| 3-facet - 2.0 mm (21G) | |||
| 3-facet - 1.8 mm (23G) | |||
| 3-facet - 1.8 mm (28G) | |||
| 3-facet - 1.5 mm (30G) | |||
| Sterilisation | |||
| method | Not known. | 20-40 kGy Cobalt 60 gamma | |
| radiation validated to achieve a | |||
| sterility assurance level (SAL) of 10-6 |
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Table 6.1: Comparison of Characteristics between Submission Devices and Predicate Device
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7. Performance Data
Non-clinical performance data:
Design verification testing of the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets has been carried out to evaluate the performance of the devices against defined acceptance criteria.
The following table provides a summary of the relevant design verification testing.
Bench Testing:
| Test | Requirement | Results |
|---|---|---|
| Integrity of device | Internal test specification | Meets specification |
| Test firing protocol | Internal test specification | Meets specification |
| Environmental testing | Internal test specification | Meets specification |
| Cap removal torque and needle | ||
| retention | Internal test specification | Meets specification |
| Needle penetration measurement | Internal test specification | Meets specification |
| Drop test | Internal test specification | Meets specification |
Table 7.1: Summary of the performance tests
Additionally, performance testing other than the above was conducted on the devices. The devices comply with the acceptance criteria established based on the specifications of the devices. All additional performance tests met the acceptance criteria.
The results from these tests demonstrate that the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets are safe and effective when used as intended.
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Biocompatibility:
Biocompatibility evidence per ISO 10993-1 is available for some of the materials of the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets.
Sterilisation:
The sterility of the devices is assured using a sterilisation method validated in accordance with ISO 11137 "Medical Devices – Validation and Routine Control of Radiation Sterilisation". Through the sterilisation methods used, all devices are sterilised to provide a Sterility Assurance Level (SAL) of 10-6.
8. Conclusion
In summary, the differences between the Unistik® 3 sterile single-use safety lancets and Abbott SF sterile single-use safety lancets and the predicate device have no impact on safety and effectiveness and the products are therefore substantially equivalent to the predicate device.