(105 days)
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.
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.
This document describes the performance testing conducted for the Unistik® TinyTouch and Unistik® Heelstik sterile single-use heel incision safety lancets.
1. Table of Acceptance Criteria and Reported Device Performance
Because this is a 510(k) summary for a medical device that appears to be a blood lancet, the "acceptance criteria" are implied to be established specifications and standards for similar devices, ensuring safety and effectiveness. The reported device performance is consistently listed as "Meets acceptance criteria/ Pass" for all tests. Specific numerical acceptance criteria are not provided in this summary.
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Unistik® TinyTouch Specific Tests (from Table 7.1) | ||
| Sterility tab removal force | Defined specification | Meets acceptance criteria/ Pass |
| Button actuation force | Defined specification | Meets acceptance criteria/ Pass |
| Trigger interlock resistance force | Defined specification | Meets acceptance criteria/ Pass |
| Side load function test | Defined specification | Meets acceptance criteria/ Pass |
| Incision profile - depth of cut | Defined specification | Meets acceptance criteria/ Pass |
| Incision profile - length of cut | Defined specification | Meets acceptance criteria/ Pass |
| Simulated storage conditions (8 hr storage at 60°C/0% RH, -20°C/0% RH) | Defined specification | Meets acceptance criteria/ Pass |
| Simulated contact conditions (cleaned/wiped with 70% isopropyl alcohol) | Defined specification | Meets acceptance criteria/ Pass |
| Drop test | Defined specification | Meets acceptance criteria/ Pass |
| Sterile barrier integrity test | Defined specification | Meets acceptance criteria/ Pass |
| Shipping test report | Defined specification | Meets acceptance criteria/ Pass |
| Unistik® Heelstik Specific Tests (from Table 7.2) | ||
| Appearance | Defined specification | Meets acceptance criteria/ Pass |
| Blood collection function | Defined specification | Meets acceptance criteria/ Pass |
| Assembly status | Defined specification | Meets acceptance criteria/ Pass |
| Dimension | Defined specification | Meets acceptance criteria/ Pass |
| Resistance to corrosion | Defined specification | Meets acceptance criteria/ Pass |
| Acidity or Alkalinity | Defined specification | Meets acceptance criteria/ Pass |
| Extractable Metals | Defined specification | Meets acceptance criteria/ Pass |
| Structural integrity | Defined specification | Meets acceptance criteria/ Pass |
| Resistance to re-use | Defined specification | Meets acceptance criteria/ Pass |
| Incision profile - depth and length | Defined specification | Meets acceptance criteria/ Pass |
| Drop test | Defined specification | Meets acceptance criteria/ Pass |
| Packaging test after accelerated aging | Defined specification | Meets acceptance criteria/ Pass |
| Performance test after accelerated aging | Defined specification | Meets acceptance criteria/ Pass |
| Simulated clinical study | Defined specification | Meets acceptance criteria/ Pass |
| General Tests and Standards (for both devices) | ||
| Biocompatibility (per ISO 10993-1) | Compliance with ISO 10993-1 | Met |
| Sterilization (per ISO 11137) to achieve SAL 10^-6 | Compliance with ISO 11137 | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific bench test (e.g., number of devices tested for button actuation force). However, it indicates that "Design verification testing... has been carried out to evaluate the performance of the devices against defined acceptance criteria." The tests appear to be laboratory-based bench evaluations.
The data provenance is not explicitly stated in terms of country of origin, but Owen Mumford Ltd is based in the United Kingdom. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For bench testing of a physical medical device like a lancet, the "ground truth" is typically established by engineering specifications, validated test methods, and compliance with recognized standards. This generally does not involve expert consensus in the same way as, for example, image interpretation. The testing would have been performed by qualified technicians and engineers following established protocols. The document does not specify human experts for establishing ground truth for these types of tests.
4. Adjudication Method for the Test Set
Not applicable for this type of bench testing. The results are objective measurements against predefined engineering specifications and pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a 510(k) submission for a blood lancet, not an AI or imaging device that would typically undergo an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The performance data presented refers to the standalone performance of the physical devices themselves through various bench tests (e.g., incision profile, button actuation force, drop test). There is no "algorithm" in the context of an AI device.
7. The Type of Ground Truth Used
The ground truth for the performance tests is based on engineering specifications, predefined acceptance criteria, and compliance with international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11137 for sterilization). For example, "incision profile - depth of cut" would have a specific numerical range as an acceptance criterion.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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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
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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
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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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SECTION 5.0
510(k) SUMMARY
1. Submitter
| Prepared by: | Owen Mumford LtdTel: +44(0)1993 812021Fax: +44(0)1993 813466 |
|---|---|
| Prepared for: | Owner/ OperatorOwen Mumford LtdBrook HillWoodstockOxfordshireOX20 1TUUnited KingdomEstablishment Registration Number: 3003348846 |
| Contact Person: | Darren MansellRegulatory Affairs ManagerOwen Mumford Ltd,Tel: +44(0)1993 812021Fax: +44(0)1993 813466Email: darren.mansell@owenmumford.com |
| Date Prepared: | 03 November 2022 |
| 2. Device | |
| Name of Device: | Unistik® TinyTouch Sterile Single-Use Heel Incision Safety LancetsUnistik® Heelstik Sterile Single-Use Heel Incision Safety Lancets |
| Common Name: | Blood lancets |
| Classification Name: | Single use only blood lancet with an integral sharps injury preventionfeature |
| Regulatory Class: | II |
| Product Code: | FMK |
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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.
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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 IncisionSafety Lancets –K210745. | Submission Device -Unistik® TinyTouch Heel IncisionSafety Lancets |
|---|---|---|
| Intended Use | The SteriHeel Safety Lancetis a heel incision device toobtain capillary bloodsamples from newborns,premature babies andtoddlersThe SteriHeel Safety Lancethas a sharps preventionfeature to protect the userfrom needlestick injuries. | Unchanged from the predicatedevice. |
| Use environment | Clinical | Unchanged from the predicatedevice. |
| Operating principle | Trigger button-activated,spring-powered automaticsweeping blade incision andblade lockout | Unchanged from the predicatedevice. |
| Design/ construction | Stainless steel blademoulded into a plastic holdercomponent, which in turn isassembled into a mouldedplastic outer housing with apre-loaded steel spring. | Unchanged from the predicatedevice. |
| Integral sharps injury preventionfeature? | Yes | Unchanged from the predicatedevice |
| Single-use? | Yes | Unchanged from the predicatedevice |
| Table 6.1 - Comparison of the Unistik® TinyTouch submission device | |||
|---|---|---|---|
| to the SteriHeel predicate device |
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| Device Characteristic | Predicate Device:SteriHeel Heel IncisionSafety Lancets –K210745. | Submission Device –Unistik® TinyTouch Heel IncisionSafety Lancets |
|---|---|---|
| Sterility | Sterile | Unchanged from the predicatedevice |
| Sterilisation method | Irradiation | Unchanged from the predicatedevice |
| Components and Materials | Plastic external and internalcomponents, stainless steelneedle and steel spring | Unchanged from the predicatedevice, but likely that plastic andsteel specifications used differ frompredicate |
| Package | Laminate pulp board cartons | Unchanged from the predicatedevice. |
| Incision dimensions | DepthLength:0.651.40mm | Substantially equivalent to thepredicate device – the incisiondimensions are within the rangeachieved by the predicate deviceDepthLength:Preemie – 0.851.75mmFull Term – 1.00*2.50mm |
| 0.85*1.75mm | ||
| 1.00*2.50mm | ||
| 1.14*2.80mm | ||
| 2.00*3.00mm | ||
| Device Characteristic | Predicate Device:SteriHeel Heel IncisionSafety Lancets –K210745. | Submission Device -Unistik® Heelstik Heel IncisionSafety Lancets |
| Intended Use | The SteriHeel Safety Lancetis a heel incision device toobtain capillary bloodsamples from newborns,premature babies andtoddlersThe SteriHeel Safety Lancethas a sharps preventionfeature to protect the userfrom needlestick injuries. | Unchanged from the predicatedevice. |
| Use environment | Clinical | Unchanged from the predicatedevice. |
| Operating principle | Trigger button-activated,spring-powered automaticsweeping blade incision andblade lockout | Unchanged from the predicatedevice. |
| Design/ construction | Stainless steel blademoulded into a plastic holdercomponent, which in turn isassembled into a mouldedplastic outer housing with apre-loaded steel spring. | Unchanged from the predicatedevice. |
| Integral sharps injury preventionfeature? | Yes | Unchanged from the predicatedevice |
| Single-use? | Yes | Unchanged from the predicatedevice |
| Sterility | Sterile | Unchanged from the predicatedevice |
| Sterilisation method | Irradiation | Unchanged from the predicatedevice |
| Device Characteristic | Predicate Device:SteriHeel Heel IncisionSafety Lancets -K210745. | Submission Device -Unistik® Heelstik Heel IncisionSafety Lancets |
| Components and Materials | Plastic external and internalcomponents, stainless steelneedle and steel spring | Unchanged from the predicatedevice, but likely that plastic andsteel specifications used differ frompredicate |
| Package | Laminate pulp board cartons | Unchanged from the predicatedevice. |
| Incision dimensions | Substantially equivalent to thepredicate device – the incisiondimensions are within the rangeachieved by the predicate device | |
| Depth*Length: | Depth*Length: | |
| 0.65*1.40mm | Micro Preemie 0.65mm*1.5mm | |
| 0.85*1.75mm | Preemie 0.85*1.75 | |
| 1.00*2.50mm | Full Term 1.0*2.5 | |
| 1.142.80mm2.003.00mm | Toddler 1.5*2.8 |
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Table 6.2 – Comparison of the Unistik® Heelstik submission device
to
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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 at60°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
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| 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.
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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.
§ 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.