(81 days)
The device is used to obtain capillary blood samples from the heel of newborn and neonatal infants in the healthcare setting by qualified healthcare providers.
The SafetiHeel Safety Lancet is single use only blood lancet used to puncture the skin to obtain a drop of blood for diagnostic purposes. It is a disposable blood lancet intended for a single use and the device is comprised of a blade encased in a housing made with plastic material commonly used for medical devices. The mechanism of the device includes an integral sharps injury prevention feature which allows the device to be used only once and then renders it inoperable and incapable of further use. The SafetiHeel Safety Lancet is a sterile device and the sterilization is done using the Gamma Irradiation means. The SafetiHeel device is marketed under model numbers SH-065, SH-100 and SH-150. The device is also marketed under trade names such as MediHeel and Novaplus in the USA market. The models for the MediHeel include model number 1003, 1004, 1005 and 1006. For the Novaplus device, the model numbers are 10041 and 10051.
The document provided describes the SafetiHeel, MediHeel, and Novaplus blood lancets, which are intended for obtaining capillary blood samples from the heel of newborn and neonatal infants. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the "Predicate Device (specification)" column, and the reported device performance is indicated in the "SafetiHeel performance," "MediHeel performance," and "Novaplus performance" columns.
SafetiHeel Device Performance
| Test | Model | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (SafetiHeel) | Meets Criteria? |
|---|---|---|---|---|
| Cutting Depth Test | (mm) | (mm) | ||
| SH-065 | 0.65 to 0.85 | 0.63 to 0.80 | Yes (close) | |
| SH-085 | 1.00 to 1.20 | 1.04 to 1.19 | Yes | |
| SH-100 | 1.40 to 1.60 | 1.42 to 1.59 | Yes | |
| SH-150 | 1.60 to 1.80 | 1.66 to 1.79 | Yes | |
| Trigger Force Test | (grams) | (grams) | ||
| SH-065 | 450 to 750 | 475 to 575 | Yes | |
| SH-085 | 450 to 750 | 494 to 578 | Yes | |
| SH-100 | 450 to 750 | 496 to 565 | Yes | |
| SH-150 | 450 to 750 | 494 to 586 | Yes | |
| Blade Retraction Test | All Models | Blade must retract into housing after incision. | All tested samples retracted the blade. | Yes |
MediHeel Device Performance
| Test | Predicate Device Model | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (MediHeel) | MediHeel Model | Meets Criteria? |
|---|---|---|---|---|---|
| Cutting Depth Test | (mm) | (mm) | |||
| SH-065 | 0.65 to 0.85 | 0.67 to 0.81 | 1003 | Yes | |
| SH-085 | 1.00 to 1.20 | 1.05 to 1.16 | 1004 | Yes | |
| SH-100 | 1.40 to 1.60 | 1.45 to 1.58 | 1005 | Yes | |
| SH-150 | 1.60 to 1.80 | 1.65 to 1.75 | 1006 | Yes | |
| Trigger Force Test | (grams) | (grams) | |||
| SH-065 | 450 to 750 | 475 to 588 | 1003 | Yes | |
| SH-085 | 450 to 750 | 496 to 591 | 1004 | Yes | |
| SH-100 | 450 to 750 | 488 to 585 | 1005 | Yes | |
| SH-150 | 450 to 750 | 492 to 596 | 1006 | Yes | |
| Blade Retraction Test | All Models | Blade must retract into housing after incision. | All tested samples retracted the blade. | All Models | Yes |
Novaplus Device Performance
| Test | Predicate Device Model | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (Novaplus) | Novaplus Model | Meets Criteria? |
|---|---|---|---|---|---|
| Cutting Depth Test | (mm) | (mm) | |||
| SH-085 | 1.00 to 1.20 | 1.06 to 1.15 | 10041 | Yes | |
| SH-100 | 1.40 to 1.60 | 1.44 to 1.57 | 10051 | Yes | |
| Trigger Force Test | (grams) | (grams) | |||
| SH-085 | 450 to 750 | 492 to 597 | 10041 | Yes | |
| SH-100 | 450 to 750 | 486 to 589 | 10051 | Yes | |
| Blade Retraction Test | All Models | Blade must retract into housing after incision. | All tested samples retracted the blade. | All Models | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the test set beyond stating that "The samples of all the models tested show..." for the Blade Retraction Test, and presenting ranges for Cutting Depth and Trigger Force. This implies that multiple units were tested for each model.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests described (physical performance tests on the devices themselves), it is highly likely these were prospective laboratory or engineering tests conducted on manufactured devices, rather than clinical studies involving human patients or existing datasets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of performance testing described. The "ground truth" for these physical performance tests (cutting depth, trigger force, blade retraction) is established by direct measurement against known engineering specifications, not by expert interpretation.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies when establishing ground truth for diagnostic decisions. The tests here are physical measurements of device specifications.
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
This is not applicable. The device is a physical blood lancet, not an AI-powered diagnostic or assistance tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical blood lancet, not an algorithm.
7. The type of ground truth used
The ground truth for these performance tests is based on engineering specifications and direct physical measurements. Specifically:
- Cutting Depth: Measured depth of blade protrusion.
- Trigger Force: Measured force required to activate the blade.
- Blade Retraction: Visual and/or mechanical confirmation of the blade returning into the housing.
- Sterility: Adherence to established sterility assurance levels (SAL) based on ISO standards.
8. The sample size for the training set
This information is not applicable. The device is a physical product, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, there is no training set for this type of device.
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August 22, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
NSP Tech Pte Ltd HC Tan Operations Manager 10 Admiralty Street, #02-06 Northlink Building Singapore, 757695 Singapore
Re: K221604
Trade/Device Name: SafetiHeel, MediHeel, Novaplus Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: August 2, 2022 Received: August 5, 2022
Dear Hc Tan:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
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,
Colin Chen Acting 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) K221604
Device Name
SafetiHEEL Safety Lancet, MediHEEL Safety Heelstick, Novaplus Safety Heelstick
Indications for Use (Describe)
The device is used to obtain capillary blood samples from the heel of newborn and neonatal infants in the healthcare setting by qualified healthcare providers.
| 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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SUBMITTER: 1.
Applicant Name:
NSP Tech Pte Ltd 10 Admiralty Street, Northlink Building, #02-06 Singapore 757695
Contact Person:
Name: HC Tan Phone: (65)98180450 Fax: (65)67476533 Email: hockchoon.tan@nsptech.com.sg
| Establishment registration number | : 3008337059 |
|---|---|
| Date prepared | : March 20, 2022 |
2. DEVICE
| Trade Name | : | SafetiHeel, MediHeel, Novaplus |
|---|---|---|
| Common Name | : | Blood Lancet |
| Regulatory Class | : | Class II (special controls) |
| Classification Name | : | Single Use Only Blood Lancet with an Integral Sharps InjuryPrevention Feature |
| Product Code | : | FMK |
| Regulation Number | : | 21 CFR § 878.4850 (special controls) |
| Review Panel | : | General & Plastic Surgery |
PREDICATE DEVICE 3.
The predicate device used for the study shall be the predecessor device which is also the preamendments device of the Safety Lancet. The latter is currently registered under Class I with listing FDA device listing number, D117836.
Regulatory Class: Class I
Product Code: FMK
Review Panel: General & Plastic Surgery
FDA Device Listing Number: D117836
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4. DEVICE DESCRIPTION:
The SafetiHeel Safety Lancet is single use only blood lancet used to puncture the skin to obtain a drop of blood for diagnostic purposes. It is a disposable blood lancet intended for a single use and the device is comprised of a blade encased in a housing made with plastic material commonly used for medical devices. The mechanism of the device includes an integral sharps injury prevention feature which allows the device to be used only once and then renders it inoperable and incapable of further use.
The SafetiHeel Safety Lancet is a sterile device and the sterilization is done using the Gamma Irradiation means.
The SafetiHeel device is marketed under model numbers SH-065, SH-100 and SH-150. The device is also marketed under trade names such as MediHeel and Novaplus in the USA market. The models for the MediHeel include model number 1003, 1004, 1005 and 1006. For the Novaplus device, the model numbers are 10041 and 10051.
INTENDED USE 5.
The device is used to obtain capillary blood samples from the heel of newborn and neonatal infants in the healthcare setting by qualified healthcare providers.
INDICATION FOR USE STATEMENT 6.
The device is used to obtain capillary blood samples from the heel of newborn and neonatal infants in the healthcare setting by qualified healthcare providers.
SUBSTANTIAL EQUIVALENCE COMPARISON 7.
In the comparison below, the subject device refers to the SafetiHeel and its private brand devices, MediHeel and Novaplus devices while the predicate device refers to the preamendments device SafetiHeel lancet under FDA listing number D117836.
| Similarities/Differences | |||
|---|---|---|---|
| Item | SafetiHeel | Predicate Device | MediHeel andNovaplus |
| FDA DeviceListing Number | D117836 | ||
| Classification | Class II | Class I | Class I |
| Product Code | FMK | FMK | FMK |
| Similarities/Differences | |||
| Item | SafetiHeel | Predicate Device | MediHeel andNovaplus |
| Intended Use | The device is used toobtain capillary bloodsamples from the heelof newborn andneonatal infants in thehealthcare setting byqualified healthcareproviders. | The device is used toobtain capillary bloodsamples from the heelof newborn andneonatal infants inthe healthcare setting byqualifiedhealthcare providers. | The device is used toobtain capillary bloodsamples from the heelof newborn andneonatal infants in thehealthcare setting byqualified healthcareproviders. |
| Indication ForUse | The device is used toobtain capillary bloodsamples from the heelof newborn andneonatal infants in thehealthcare setting byqualified healthcareproviders. | The device is used toobtain capillary bloodsamples from the heelof newborn andneonatal infants inthe healthcare setting byqualifiedhealthcare providers. | The device is used toobtain capillary bloodsamples from the heelof newborn andneonatal infants in thehealthcare setting byqualified healthcareproviders. |
| Manufacturer | NSP Tech Pte Ltd | NSP Tech Pte Ltd | NSP Tech Pte Ltd |
| Sterilizer | GrandTen Sdn Bhd | GrandTen Sdn Bhd | GrandTen Sdn Bhd |
| Appearance | |||
| Similarities/Differences | |||
| Item | SafetiHeel | Predicate Device | MediHeel andNovaplus |
| ProductConfiguration | HousingProtective CapBlade HolderSlider TopCoverRollerSlider LeftSlider RightWasherBladeTrigger SpringReturn Spring | HousingProtective CapBlade HolderSlider TopCoverRollerSlider LeftSlider RightWasherBladeTrigger SpringReturn Spring | HousingProtective CapBlade HolderSlider TopCoverRollerSlider LeftSlider RightWasherBladeTrigger SpringReturn Spring |
| Sterilization | Gamma Radiationsterilization | Gamma Radiationsterilization | Gamma Radiationsterilization |
| Sterility | Meet the SterilityAssurance Level of10-6 as per therequirement ofISO 11137-1:2006 | Meet the SterilityAssurance Level of10-6 as per therequirement ofISO 11137-1:2006 | Meet the SterilityAssurance Level of10-6 as per therequirement of ISO11137-1:2006 |
| Use | Single-Use only | Single-Use only | Single-Use only |
| Bio compatibility | ISO 10993 series | ISO 10993 series | ISO 10993 series |
| Shelf Life | 5 years | 5 years | 5 years |
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8. TECHNOLOGICAL CHARACTERISTICS COMPARISON
The subject device SafetiHeel and her private brand devices under names MediHeel and Novaplus has similarities with the predicate device in areas such as Intended Use, Indication For Use, Product Configuration, Material used for its key components and Safety Features. For sterilization, both the subject and predicate device uses the Gamma Radiation Sterilization method with attaining the Sterility Assurance Level (SAL) of 10-6.
In summary, the subject device and predicate device are said to have same technological characteristics.
PERFORMANCE TEST COMPARISON 9.
| Test | Model | Predicate Device(specification) | SafetiHeelperformance |
|---|---|---|---|
| Cutting Depth Test –ability of the blade to keepwithin cutting depth rangewhen the device isactivated | SH-065 | 0.65 to 0.85 mm | 0.63 to 0.80 mm |
| SH-085 | 1.00 to 1.20 mm | 1.04 to 1.19 mm | |
| SH-100 | 1.40 to 1.60 mm | 1.42 to 1.59 mm | |
| SH-150 | 1.60 to 1.80 mm | 1.66 to 1.79 mm | |
| Trigger Force Test –force required to push theblade out of the housing ofthe device for incisionoperation activation | SH-065 | 450 to 750 grams | 475 to 575 grams |
| SH-085 | 450 to 750 grams | 494 to 578 grams | |
| SH-100 | 450 to 750 grams | 496 to 565 grams | |
| SH-150 | 450 to 750 grams | 494 to 586 grams |
● Comparison between SafetiHeel and predicate device
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| Test | Model | Predicate Device(specification) | SafetiHeelperformance |
|---|---|---|---|
| Blade Retraction Test– the ability of the blade toretract into the housing ofthe device aftercompleting incisionoperation | SH-065 | The blade of thedevice must retract intothe housing of thedevice after it hascompleted the incisionoperation | The samples of all themodels tested show thedevices retracting theblade into the housingafter completing theincision operation. |
| SH-085 | |||
| SH-100 | |||
| SH-150 |
Comparison between MediHeel and predicate device ●
| Test | PredicateDeviceModel | Predicate Device(specification) | MediHeelperformance | MediHeelModel |
|---|---|---|---|---|
| Cutting Depth Test -ability of the blade tokeep within cuttingdepth range when thedevice is activated | SH-065 | 0.65 to 0.85 mm | 0.67 to 0.81 mm | 1003 |
| SH-085 | 1.00 to 1.20 mm | 1.05 to 1.16 mm | 1004 | |
| SH-100 | 1.40 to 1.60 mm | 1.45 to 1.58mm | 1005 | |
| SH-150 | 1.60 to 1.80 mm | 1.65 to 1.75 mm | 1006 | |
| Trigger Force Test -force required to pushthe blade out of thehousing of the devicefor incision operationactivation | SH-065 | 450 to 750 grams | 475 to 588 grams | 1003 |
| SH-085 | 450 to 750 grams | 496 to 591 grams | 1004 | |
| SH-100 | 450 to 750 grams | 488 to 585 grams | 1005 | |
| SH-150 | 450 to 750 grams | 492 to 596 grams | 1006 |
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| Test | Model | Predicate Device(specification) | MediHeelperformance | MediHeelModel |
|---|---|---|---|---|
| Blade Retraction Test- the ability of theblade to retract into thehousing of the deviceafter completingincision operation | SH-065 | The blade of thedevice must retractinto the housing ofthe device after ithas completed theincision operation | The samples of allthe models testedshow the devicesretracting the bladeinto the housingafter completing theincision operation. | 1003 |
| SH-085 | 1004 | |||
| SH-100 | 1005 | |||
| SH-150 | 1006 |
Comparison between Novaplus and predicate device .
| Test | PredicateDeviceModel | Predicate Device(specification) | Novaplusperformance | NovaplusModel |
|---|---|---|---|---|
| Cutting Depth Test –ability of the blade tokeep within cuttingdepth range when thedevice is activated | SH-085 | 1.00 to 1.20 mm | 1.06 to 1.15 mm | 10041 |
| SH-100 | 1.40 to 1.60 mm | 1.44 to 1.57 mm | 10051 | |
| Trigger Force Test -force required to pushthe blade out of thehousing of the devicefor incision operationactivation | SH-085 | 450 to 750 grams | 492 to 597 grams | 10041 |
| SH-100 | 450 to 750 grams | 486 to 589 grams | 10051 | |
| Blade RetractionTest- the ability of theblade to retract intothe housing of thedevice aftercompleting incisionoperation | SH-085 | The blade of thedevice must retractinto the housing ofthe device after it hascompleted theincision operation | The samples of allthe models testedshow the devicesretracting the bladeinto the housing aftercompleting theincision operation. | 10041 |
| SH-100 | The blade of thedevice must retractinto the housing ofthe device after it hascompleted theincision operation | 10051 |
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10. SYNOPSIS OF PERFORMANCE STUDY RESULTS
Performance Test result done on the subject device is compared against the specification of the predicate device in the areas of Cutting Depth and Trigger Force Test.
| • Cutting Depth Test- ability of theblade to keepwithin cuttingdepth range whenthe device isactivated | The subject device is able to push out the Blade whenactivated and the blade incise within the range of cuttingdepth as per the specification of the predicate device. |
|---|---|
| • Trigger Force Test- force required topush the bladeout of the housingof the device forincision operationactivation | The Trigger Force applied on the subject device falls withinthe specification of the predicate device with the blade beingpushed out for the incision operation. |
| • Blade RetractionTest- the ability of theblade to retract intothe housing of thedevice aftercompleting incisionoperation | The subject device is able to retract the Blade into its housingafter it have completed the incision operation. |
| • SterilizationTesting | Sterilization is done for the subject device with reference toISO 11137-1:2006 Sterilization of health care products –Radiation – Part 1: Requirements for development,validation and routine control of a sterilization process formedical devices and ISO 11737-1: 2006 with ISO 11737-2:2009 to attain a Sterility Assurance Level of 10-6.Dose mapping is carried out with planes representing theminimum and maximum dose location for the subject device.The latter is checked for its sterility after it has undergone thesterilization process. |
| Product SafetyDesign andEffectiveness | The housing of the device encases the Blade preventing any needlestick issue with user or patient before the device is activated. Thedevice also has a protective cap assembled to the housing of thedevice. This prevents any inadvertent contact with the blade by theuser or patient before use. |
| Once the device is activated by pushing the device onto the heel of thepatient, the blade is pushed out of the housing by the Trigger Spring.After the device has performed the incision operation, the ReturnSpring will now push the blade back into the housing avoiding theoccurrence of needlestick issue. The Trigger Spring helps in attainingthe effectiveness of the device in providing the penetration operationessential for the incision and blood sample collection. The ReturnSpring helps in accomplishing the safety of the device by ensuring thatthe needle retracts into the housing after the penetration operation iscompleted. | |
| Test Principle | Both the subject device and the predicate device adopt the same testprinciple of incising the heel of the newborn and neonatal infants forcapillary blood sample collection. The device is first placed on the heelthe patient and using contact activation means, the automatic incisionmechanism is activated with the blade coming out of the devicehousing to make the incision. After the incision operation is completed,the blade will automatically retract into the housing. Because of theconstruction of the mechanism, the blade cannot be pushed out of thehousing for a second round of incision preventing the device from beingreused. After use, the device is to be discarded in a suitable biohazardcontainer. |
| The incision on the heel for the blood sampling operation is controlledfor its depth of the incision. This is done by the design of the partsoperating in the device. Hence, the device is checked for Cutting Depthas part of its performance assessment. | |
| The pushing out of the blade is controlled by the Trigger Springencased in the housing of the device. Here, the Trigger Force ismeasured as part of device performance assessment. |
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Result of the performance tests show the subject device meeting the specification of the predicate device in the Cutting depth and Trigger Force requirement. The subject device is also able to demonstrate its Sharps Injury Prevention feature through the result of the Blade Retraction Test. This shows the subject device's substantive equivalence to the predicate device in the area of device performance.
The result of the sterilization validation process shows that the subject device attaining the requirement of Sterility Assurance Level (SAL) of 10-6 similar to the predicate device.
11. PRODUCT SAFETY AND EFFECTIVENESS DATA
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12. SUBSTANTIAL EQUIVALENCE
The comparison and evaluation of the device features, intended use, indication for use statement, product configuration, safety and effectiveness, materials and performance tests demonstrate substantial equivalence between the subject device and the predicate device. For the Safety and Effectiveness test, the subject device provides same safety and effective performance as the predicate device. The physical dimension, appearance, key component, sterilization, packaging used for the subject device are also the same as those of the predicate device.
13. CONCLUSION
From the evaluation above, we can deem that the SafetiHeel , MediHeel and Novaplus are 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.