(51 days)
The Unistik® Touch is a puncture device to obtain micro blood samples. Unistik Touch has a sharps prevention feature to protect the user from a needlestick injury.
The Unistik® Touch contact-activated safety lancets are hand-held disposable devices intended for performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism. Unistik® Touch 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® Touch contact-activated safety lancets are available in five different variants of needle gauge as follows: Needle gauge 16G, Penetration Depth 2.0 mm Needle gauge 21G, Penetration Depth 2.0 mm Needle gauge 23G, Penetration Depth 2.0 mm Needle gauge 28G, Penetration Depth 1.8 mm Needle gauge 30G, Penetration Depth 1.5 mm The Unistik® Touch contact-activated safety lancets are intended for prescription and over-the-counter use and to be used by self-testing patients, care-givers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for caregivers 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. Unistik® Touch contact-activated safety lancets 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. Furthermore, the devices automatically self-disable after a single use, thus preventing any hazards of re-use. The Unistik® Touch contact-activated safety lancets achieve their intended purpose of performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism 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 Unistik® Touch Single-Use Safety Lancets were evaluated through a series of non-clinical performance studies, primarily bench testing and a simulated clinical use study.
1. Table of acceptance criteria and the reported device performance:
| Items | Acceptance criteria | Results |
|---|---|---|
| Appearance | The surface shall be free of burrs and no scratches shall be visible | Pass |
| Dimension | Product dimensions shall be consistent to the drawings | Pass |
| Cleanness | No dust, no grease, no hair, no dirt | Pass |
| Firmness | Needle should connect firmly with plastic handle | Pass |
| Resistance to corrosion | Needle of lancet shall show no evidence of corrosion. | Pass |
| Acidity or Alkalinity | The pH value of an extract prepared refers to ISO 9626 Annex A shall be within one pH unit of that of the control fluid. | Pass |
| Limits for Extractable Metals | When corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l. | Pass |
| Puncture depth | Use calipers to measure and meet the requirements. | Pass |
| Launch performance | Launch performance should be good, launch button press smoothly, no jam | Pass |
| Puncture force | The needle tip of the needle should have good puncture ability. | Pass |
| Lubricant | No lubricant shall be visible. | Pass |
| Disposable | Safety lancet should be single use, and should not be operational after use | Pass |
| Drop Test | The needle tip shall not be exposed after dropping the device vertically from a height of 1.2m | Pass |
| Safety Feature | The force to activate the safety feature: 4 - 15N. Test access to the needle: the needle shall not touch the sphere. | Pass |
2. Sample size used for the test set and the data provenance:
- Simulated Clinical Use Study: 500 device samples were used.
- Data Provenance: The document does not specify the country of origin of the data, nor whether it was retrospective or prospective, beyond stating it was a "simulated clinical use study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The studies described are non-clinical, primarily bench testing, and a simulated clinical use study. The performance criteria are objective measurements against established standards (e.g., ISO, FDA guidance).
4. Adjudication method for the test set:
- This information is not applicable and not provided. The studies involved objective measurements against predefined acceptance criteria rather than subjective expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a blood lancet, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's inherent functional performance without human interaction regarding its analytical functions (e.g., accurate puncture depth, safety mechanism activation). This was assessed through the various bench tests.
7. The type of ground truth used:
- The ground truth for the bench testing was based on objective, verifiable measurements and physical characteristics outlined in the acceptance criteria (e.g., freedom from burrs, adherence to dimensions, pH values, metal content, puncture depth measurements, force to activate safety features).
- For the simulated clinical use study, the ground truth was based on demonstrating that the device "met the pre-established criteria" for its safety mechanism, as evaluated against FDA Guidance and ISO 23908.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, this is a physical medical device and does not involve a training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 7, 2022
Owen Mumford Ltd Darren Mansell Regulatory Affairs Manager Brook Hill Woodstock, Oxfordshire OX20 1TU United Kingdom
Re: K222111
Trade/Device Name: Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: July 11, 2022 Received: July 18, 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 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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SECTION 4.0
INDICATIONS FOR USE STATEMENT
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K222111
Device Name Unistik® Touch
Indications for Use (Describe)
The Unistik® Touch is a puncture device to obtain micro blood samples. Unistik Touch has a sharps prevention feature to protect the user from a needlestick injury.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5.0
510(k) SUMMARY
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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: | JULY 11, 2022 |
| 2. Device | |
| Name of Device: | Unistik® Touch Sterile Single-Use Contact-Activated Safety Lancets |
| Common Name: | Blood lancets |
| Classification Name:feature | Single use only blood lancet with an integral sharps injury prevention |
| Regulatory Class: | II |
| Product Code: | FMK |
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3. Predicate Devices
Predicate Device Names:
SurgiLance® Safety Lancet
The Unistik® Touch sterile single-use contact activated safety lancets are substantially equivalent in device description, function and basic composition of materials to the predicate device, SurqiLance® Safety Lancet, under 510k number K101145.
4. Description of The Device
The Unistik® Touch contact-activated safety lancets are hand-held disposable devices intended for performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism.
Unistik® Touch 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® Touch contact-activated safety lancets are available in five different variants of needle gauge as follows:
Needle gauge 16G, Penetration Depth 2.0 mm Needle gauge 21G, Penetration Depth 2.0 mm Needle gauge 23G, Penetration Depth 2.0 mm Needle gauge 28G, Penetration Depth 1.8 mm Needle gauge 30G, Penetration Depth 1.5 mm
The Unistik® Touch contact-activated safety lancets are intended for prescription and over-thecounter use and to be used by self-testing patients, care-givers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the fingertip, in order for caregivers 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.
Unistik® Touch contact-activated safety lancets 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. Furthermore, the devices automatically self-disable after a single use, thus preventing any hazards of re-use.
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The Unistik® Touch contact-activated safety lancets achieve their intended purpose of performing controlled skin punctures of the fingertips in adults and children, by means of a needle lancing mechanism 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.
5. Indications for Use
The Unistik® Touch is a puncture device to obtain micro blood samples. Unistik Touch has a sharps prevention feature to protect the user from a needlestick injury.
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6. Technological Characteristics
The Unistik® Touch contact-activated safety lancets are substantially equivalent to the predicate device, the SurgiLance® Safety Lancet.
Table 6.1 below summarise a comparison of the intended uses and technological characteristics of the Unistik® Touch device to the respective predicate.
| Device Characteristic | Predicate Device:SurgiLance® SafetyLancets - K101 145. | Submission Device -Unistik® Touch Safety Lancets |
|---|---|---|
| Intended Use | The SurgiLance® SafetyLancet is a skin puncturedevice to obtain micro bloodsamples.The SurgiLance® SafetyLancet has a sharpsprevention feature to protectthe user from needlestickinjuries. | Unchanged from the predicatedevice. |
| Use environment | Home and clinical | Unchanged from the predicatedevice. |
| Operating principle | Contact-activated spring-powered automatic lancingand needle retraction. | Unchanged from the predicatedevice. |
| Design/ construction | Stainless steel lancet needlemoulded into a plastic lancetholder component, which inturn is assembled into amoulded plastic outerhousing with a pre-loadedsteel 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 |
| Device Characteristic | Predicate Device:SurgiLance® SafetyLancets - K101 145. | Submission Device -Unistik® Touch Safety Lancets |
| 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. |
| Needle Gauges (SWG) | 18G, 21G | 16G, 21G, 23G, 28G, 30GThe predicate device is available in18G and 21G variants only,whereas the Unistik® Touchdevices represent an extendedrange of gauges compared to thepredicate (16G - 30G). |
| Lancing Depths (mm) | 1.8 mm & 2.3 mm (18G)1.0 mm, 1.8 mm, 2.2 mm &2.8 mm (21G) | 2.0 mm (16G, 21G and 23G)1.8 mm (28G)1.5 mm (30G)Substantially equivalent to thepredicate device - the Unistik®Touch lancing depth range fallswithin the range offered by thepredicate device, i.e. 1.0 mm - 2.0mm compared to the predicaterange of 1.0 mm - 2.8 mm. |
Table 6.1 – Comparison of the Unistik® Touch submission device to the SurgiLance® predicate device
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7. Performance Data
Non-clinical performance data:
Design verification testing of the Unistik® Touch 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:
The bench testing performed verifies that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device, in terms of critical performance characteristics. These tests are as follow.
| Items | Acceptance criteria | Results |
|---|---|---|
| Appearance | The surface shall be free of burrsand no scratches shall be visible | Pass |
| Dimension | Product dimensions shall be consistent to the drawings | Pass |
| Cleanness | No dust, no grease, no hair, no dirt | Pass |
| Firmness | Needle should connect firmly withplastic handle | Pass |
| Resistance to corrosion | Needle of lancet shall show no evidence of corrosion. | Pass |
| Acidity or Alkalinity | The pH value of an extract prepared refers to ISO 9626Annex A shall be within one pH unit of thatof the control fluid. | Pass |
| Limits for Extractable Metals | When corrected for the metals content of the control fluid,contain not greater than a combined total of 5 mg/l of lead,tin, zinc and iron. The cadmium content of the extract shall,when corrected for the cadmium content of the controlfluid, be lower than 0.1 mg/l. | Pass |
| Puncture depth | Use calipers to measure and meetthe requirements. | Pass |
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| Launchperformance | Launch performance should be good, launch button presssmoothly, no jam | Pass |
|---|---|---|
| Puncture force | The needle tip of the needle shouldhave good puncture ability. | Pass |
| Lubricant | No lubricant shall be visible. | Pass |
| Disposable | Safety lancet should be single use, and should not beoperational after use | Pass |
| Drop Test | The needle tip shall not be exposed after dropping thedevice vertically from a height of 1.2m | Pass |
| Safety Feature | The force to activate the safety feature: 4 - 15NTest access to the needle: theneedle shall not touch the sphere. | Pass |
The results from these tests demonstrate that the Unistik® Touch devices are safe and effective when used as intended.
Biocompatibility:
Biocompatibility evidence per ISO 10993-1 is available, to demonstrate the device is safe for its intended use.
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.
Simulated Clinical Use:
A simulated clinical use study was performed on 500 device samples each for the Safety Lancet according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
8. Conclusion
In summary, the differences between the Unistik® Touch 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.