(105 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and bench testing, with no mention of AI or ML.
No.
The device is used to collect a blood sample, which is a diagnostic procedure, not a therapeutic one.
No
This device is a safety lancet used to collect blood samples, not to analyze or interpret them for diagnostic purposes. It is explicitly stated that the device is used to obtain capillary blood specimens "for IVD assays," indicating the diagnostic component is a separate activity performed on the collected sample.
No
The device description clearly states it is a physical, single-use device with integral sharps protection and a lancet blade or needle, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to collect a capillary blood sample. It is a tool for obtaining a specimen, not for performing a diagnostic test on that specimen.
- Device Description: The description focuses on the physical characteristics of the lancet and its safety features for blood collection. It explicitly states the devices are used to "obtain capillary blood specimens for IVD assays," indicating they are a precursor to an IVD assay, not the assay itself.
- Lack of Diagnostic Function: The device does not analyze the blood sample or provide any diagnostic information. Its function is solely to facilitate the collection of the sample.
While the collected blood sample is intended for use in IVD assays, the lancet itself is a specimen collection device, not an IVD.
N/A
Intended Use / Indications for Use
Unistik® Heelstik:
The Unistik® Heelstik heel incision safety lancets are single use devices used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers.
Unistik® TinyTouch:
The Unistik® TinyTouch heel incision safety lancets are single used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The submission devices are sterile single-use devices with integral sharps protection whereby the lancet blade or needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. The devices automatically self-disable after a single use, thus preventing any hazards of re-use.
The submission devices are intended for use by healthcare professionals only, for performing heel incisions on newborns, preemies, and toddlers to obtain capillary blood specimens for IVD assays. The product is intended for prescription (Rx) only use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heel
Indicated Patient Age Range
newborns, preemies, and toddlers
Intended User / Care Setting
healthcare professionals only, for performing heel incisions on newborns, preemies, and toddlers to obtain capillary blood specimens for IVD assays. The product is intended for prescription (Rx) only use. Use environment: 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)
Non-clinical performance data:
Design verification testing of the Unistik® TinyTouch and Unistik®Heelstik heel incision safety lancets has been carried out to evaluate the performance of the devices against defined acceptance criteria.
Bench Testing for Unistik® TinyTouch device:
- Sterility tab removal force: Meets acceptance criteria/ Pass
- Button actuation force: Meets acceptance criteria/ Pass
- Trigger interlock resistance force: Meets acceptance criteria/ Pass
- Side load function test: Meets acceptance criteria/ Pass
- Incision profile - depth of cut: Meets acceptance criteria/ Pass
- Incision profile - length of cut: Meets acceptance criteria/ Pass
- Simulated storage conditions (8 hour storage at 60°C/0% relative humidity, -20° C / 0% relative humidity): Meets acceptance criteria/ Pass
- Simulated contact conditions (cleaned/wiped with 70% isopropyl alcohol): Meets acceptance criteria/ Pass
- Drop test: Meets acceptance criteria/ Pass
- Sterile barrier integrity test: Meets acceptance criteria/ Pass
- Shipping test report: Meets acceptance criteria/ Pass
Bench Testing for Unistik® Heelstik device:
- Appearance: Meets acceptance criteria/ Pass
- Blood collection function: Meets acceptance criteria/ Pass
- Assembly status: Meets acceptance criteria/ Pass
- Dimension: Meets acceptance criteria/ Pass
- Resistance to corrosion: Meets acceptance criteria/ Pass
- Acidity or Alkalinity: Meets acceptance criteria/ Pass
- Extractable Metals: Meets acceptance criteria/ Pass
- Structural integrity: Meets acceptance criteria/ Pass
- Resistance to re-use: Meets acceptance criteria/ Pass
- Incision profile - depth and length: Meets acceptance criteria/ Pass
- Drop test: Meets acceptance criteria/ Pass
- Packaging test after accelerated aging: Meets acceptance criteria/ Pass
- Performance test after accelerated aging: Meets acceptance criteria/ Pass
- Simulated clinical study: Meets acceptance criteria/ Pass
All additional performance tests met the acceptance criteria.
The results from these tests demonstrate that the Unistik® TinyTouch and Unistik®Heelstik heel incision safety lancets are safe and effective when used as intended.
Biocompatibility:
Biocompatibility evidence per ISO 10993-1 is available for the materials of Unistik® TinyTouch and Unistik®Heelstik heel incision 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.
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.
SteriHeel Heel Incision Safety Lancet - K210745
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 of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
11/3/2022
Owen Mumford Ltd Darren Mansell Regulatory Affairs Manager Brook Hill Woodstock, Oxfordshire OX20 1TU United Kingdom
Re: K222168
Trade/Device Name: Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets -MicroPreemie, Preemie, Full-Term and Toddler Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: July 15, 2022 Received: July 21, 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/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
1
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,
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) K222168
Device Name Unistik® TinyTouch, Unistik® Heelstik
Indications for Use (Describe)
Unistik® Heelstik:
The Unistik® Heelstik heel incision safety lancets are single use devices used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers.
Unistik® TinyTouch:
The Unistik® TinyTouch heel incision safety lancets are single used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------- |
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3
SECTION 5.0
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: | 03 November 2022 |
| 2. Device | |
| Name of Device: | Unistik® TinyTouch Sterile Single-Use Heel Incision Safety Lancets
Unistik® Heelstik Sterile Single-Use Heel Incision Safety Lancets |
| Common Name: | Blood lancets |
| Classification Name: | Single use only blood lancet with an integral sharps injury prevention
feature |
| Regulatory Class: | II |
| Product Code: | FMK |
4
3. Predicate Devices
Predicate Device Names:
SteriHeel Heel Incision Safety Lancet -
The Unistik® TinyTouch sterile single-use heel incision safety lancets and Unistik® Heelstik sterile single-use heel incision safety lancets are substantially equivalent in device description, function, and basic composition of materials to the predicate device, the SteriHeel Heel Incision Safety Lancet under 510k number K210745.
4. Description of The Device
The submission devices are sterile single-use devices with integral sharps protection whereby the lancet blade or needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. The devices automatically self-disable after a single use, thus preventing any hazards of re-use.
The submission devices are intended for use by healthcare professionals only, for performing heel incisions on newborns, preemies, and toddlers to obtain capillary blood specimens for IVD assays. The product is intended for prescription (Rx) only use.
5. Indications for Use
The Unistik® Heelstik heel incision safety lancets are single use devices used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers.
The Unistik® TinyTouch heel incision safety lancets are single use devices used to collect a capillary blood sample from the heel of newborns, preemies, and toddlers.
5
6. Technological Characteristics
The Unistik® TinyTouch and Unistik® Heelstik sterile single-use heel incision safety lancets are substantially equivalent to the predicate device, the SteriHeel Heel Incision Safety Lancet.
Tables 6.1 and 6.2 below summarise a comparison of the intended uses and technological characteristics of the Unistik® TinyTouch and Unistik® Heelstik and Unistik® Touch devices to the predicates.
| Device Characteristic | Predicate Device:
SteriHeel Heel Incision
Safety Lancets –
K210745. | Submission Device -
Unistik® TinyTouch Heel Incision
Safety Lancets |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Intended Use | The SteriHeel Safety Lancet
is a heel incision device to
obtain capillary blood
samples from newborns,
premature babies and
toddlers
The SteriHeel Safety Lancet
has a sharps prevention
feature to protect the user
from needlestick injuries. | Unchanged from the predicate
device. |
| Use environment | Clinical | Unchanged from the predicate
device. |
| Operating principle | Trigger button-activated,
spring-powered automatic
sweeping blade incision and
blade lockout | Unchanged from the predicate
device. |
| Design/ construction | Stainless steel blade
moulded into a plastic holder
component, which in turn is
assembled into a moulded
plastic outer housing with a
pre-loaded steel spring. | Unchanged from the predicate
device. |
| Integral sharps injury prevention
feature? | Yes | Unchanged from the predicate
device |
| Single-use? | Yes | Unchanged from the predicate
device |
| Table 6.1 - Comparison of the Unistik® TinyTouch submission device | |||
|---|---|---|---|
| to the SteriHeel predicate device |
6
| Device Characteristic | Predicate Device:
SteriHeel Heel Incision
Safety Lancets –
K210745. | Submission Device –
Unistik® TinyTouch Heel Incision
Safety Lancets |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility | Sterile | Unchanged from the predicate
device |
| Sterilisation method | Irradiation | 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. |
| Incision dimensions | DepthLength:
0.651.40mm | Substantially equivalent to the
predicate device – the incision
dimensions are within the range
achieved by the predicate device
DepthLength:
Preemie – 0.851.75mm
Full Term – 1.002.50mm |
| | 0.851.75mm | |
| | 1.002.50mm | |
| | 1.142.80mm | |
| | 2.00*3.00mm | |
| Device Characteristic | Predicate Device:
SteriHeel Heel Incision
Safety Lancets –
K210745. | Submission Device -
Unistik® Heelstik Heel Incision
Safety Lancets |
| Intended Use | The SteriHeel Safety Lancet
is a heel incision device to
obtain capillary blood
samples from newborns,
premature babies and
toddlers
The SteriHeel Safety Lancet
has a sharps prevention
feature to protect the user
from needlestick injuries. | Unchanged from the predicate
device. |
| Use environment | Clinical | Unchanged from the predicate
device. |
| Operating principle | Trigger button-activated,
spring-powered automatic
sweeping blade incision and
blade lockout | Unchanged from the predicate
device. |
| Design/ construction | Stainless steel blade
moulded into a plastic holder
component, which in turn is
assembled into a moulded
plastic outer housing with a
pre-loaded steel spring. | Unchanged from the predicate
device. |
| Integral sharps injury prevention
feature? | Yes | Unchanged from the predicate
device |
| Single-use? | Yes | Unchanged from the predicate
device |
| Sterility | Sterile | Unchanged from the predicate
device |
| Sterilisation method | Irradiation | Unchanged from the predicate
device |
| Device Characteristic | Predicate Device:
SteriHeel Heel Incision
Safety Lancets -
K210745. | Submission Device -
Unistik® Heelstik Heel Incision
Safety Lancets |
| 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. |
| Incision dimensions | | Substantially equivalent to the
predicate device – the incision
dimensions are within the range
achieved by the predicate device |
| | DepthLength: | DepthLength: |
| | 0.651.40mm | Micro Preemie 0.65mm1.5mm |
| | 0.851.75mm | Preemie 0.851.75 |
| | 1.002.50mm | Full Term 1.02.5 |
| | 1.142.80mm
2.003.00mm | Toddler 1.5*2.8 |
7
Table 6.2 – Comparison of the Unistik® Heelstik submission device
to
8
9
7. Performance Data
Non-clinical performance data:
Design verification testing of the Unistik® TinyTouch and Unistik®Heelstik heel incision safety lancets has been carried out to evaluate the performance of the devices against defined acceptance criteria.
Bench Testing:
Tables 7.1 and 7.2 below provide a summary of the relevant bench testing for the Unistik® TinyTouch and Unistik®Heelstik devices respectively.
| Test | Results |
|---|---|
| Sterility tab removal force | Meets acceptance criteria/ Pass |
| Button actuation force | Meets acceptance criteria/ Pass |
| Trigger interlock resistance force | Meets acceptance criteria/ Pass |
| Side load function test | Meets acceptance criteria/ Pass |
| Incision profile - depth of cut | Meets acceptance criteria/ Pass |
| Incision profile - length of cut | Meets acceptance criteria/ Pass |
| Simulated storage conditions (8 hour storage at | |
| 60°C/0% relative humidity, -20° C / 0% relative humidity) | Meets acceptance criteria/ Pass |
| Simulated contact conditions (cleaned/wiped with 70% | |
| isopropyl alcohol) | Meets acceptance criteria/ Pass |
| Drop test | Meets acceptance criteria/ Pass |
| Sterile barrier integrity test | Meets acceptance criteria/ Pass |
| Shipping test report | Meets acceptance criteria/ Pass |
Table 7.1 - Summary of bench testing for the Unistik® TinyTouch device
10
| Test | Results |
|---|---|
| Appearance | Meets acceptance criteria/ Pass |
| Blood collection function | Meets acceptance criteria/ Pass |
| Assembly status | Meets acceptance criteria/ Pass |
| Dimension | Meets acceptance criteria/ Pass |
| Resistance to corrosion | Meets acceptance criteria/ Pass |
| Acidity or Alkalinity | Meets acceptance criteria/ Pass |
| Extractable Metals | Meets acceptance criteria/ Pass |
| Structural integrity | Meets acceptance criteria/ Pass |
| Resistance to re-use | Meets acceptance criteria/ Pass |
| Incision profile - depth and length | Meets acceptance criteria/ Pass |
| Drop test | Meets acceptance criteria/ Pass |
| Packaging test after accelerated aging | Meets acceptance criteria/ Pass |
| Performance test after accelerated aging | Meets acceptance criteria/ Pass |
| Simulated clinical study | Meets acceptance criteria/ Pass |
Table 7.2- :Summary of bench testing for the Unistik® Heelstik device
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® TinyTouch and Unistik®Heelstik heel incision safety lancets are safe and effective when used as intended.
11
Biocompatibility:
Biocompatibility evidence per ISO 10993-1 is available for the materials of Unistik® TinyTouch and Unistik®Heelstik heel incision 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® TinyTouch and Unistik® Heelstik heel incision safety lancets and the predicate device have no impact on safety and effectiveness and the products are therefore substantially equivalent to the predicate device.