(81 days)
D117836
Not Found
No
The device description and performance studies focus on mechanical components and physical properties, with no mention of AI or ML.
No
The device is used to obtain capillary blood samples for diagnostic purposes, not to treat a condition or disease.
No
The device is a lancet used to obtain blood samples "for diagnostic purposes," but it is not a diagnostic device itself. It is a tool for sample collection, not for diagnosing conditions.
No
The device description clearly details a physical lancet with a blade, housing, and mechanical components for skin puncture and sharps injury prevention. It is a hardware device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to obtain a capillary blood sample. It does not perform any diagnostic testing on the blood sample itself.
- Device Description: The device is a lancet used for skin puncture to get a blood drop. It's a tool for sample collection, not for analyzing the sample.
- Performance Studies: The performance studies focus on the physical characteristics of the lancet (cutting depth, trigger force, blade retraction, sterilization) and its ability to safely and effectively collect a blood sample. There are no studies related to the analysis of the blood or any diagnostic results.
An IVD device is used to examine specimens derived from the human body (like blood) to provide information for diagnostic, monitoring, or compatibility purposes. This device's function stops at the point of obtaining the sample. The diagnostic testing would be performed separately on the collected blood sample using a different IVD device or method.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heel
Indicated Patient Age Range
newborn and neonatal infants
Intended User / Care Setting
qualified healthcare providers / healthcare setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Cuting Depth Test - ability of the blade to keep within cutting depth range when the device is activated. The subject device is able to push out the Blade when activated and the blade incise within the range of cutting depth as per the specification of the predicate device.
Trigger Force Test - force required to push the blade out of the housing of the device for incision operation activation. The Trigger Force applied on the subject device falls within the specification of the predicate device with the blade being pushed out for the incision operation.
Blade Retraction Test - the ability of the blade to retract into the housing of the device after completing incision operation. The subject device is able to retract the Blade into its housing after it have completed the incision operation.
Sterilization Testing - Sterilization is done for the subject device with reference to ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical 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 the minimum and maximum dose location for the subject device. The latter is checked for its sterility after it has undergone the sterilization process.
Product Safety Design and Effectiveness - The housing of the device encases the Blade preventing any needle stick issue with user or patient before the device is activated. The device also has a protective cap assembled to the housing of the device. This prevents any inadvertent contact with the blade by the user or patient before use. Once the device is activated by pushing the device onto the heel of the patient, the blade is pushed out of the housing by the Trigger Spring. After the device has performed the incision operation, the Return Spring will now push the blade back into the housing avoiding the occurrence of needlestick issue. The Trigger Spring helps in attaining the effectiveness of the device in providing the penetration operation essential for the incision and blood sample collection. The Return Spring helps in accomplishing the safety of the device by ensuring that the needle retracts into the housing after the penetration operation is completed.
The 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
D117836
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
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
2
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 Injury |
| Prevention 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
4
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 and |
| Novaplus | |||
| FDA Device | |||
| Listing Number | D117836 | ||
| Classification | Class II | Class I | Class I |
| Product Code | FMK | FMK | FMK |
| Similarities/Differences | |||
| Item | SafetiHeel | Predicate Device | MediHeel and |
| Novaplus | |||
| Intended Use | 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 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 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 | 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 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 device is used to | ||
| obtain capillary blood | |||
| samples from the heel | |||
| of newborn and | |||
| neonatal infants in the | |||
| healthcare setting by | |||
| qualified healthcare | |||
| providers. | |||
| 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 and |
| Novaplus | |||
| Product | |||
| Configuration | Housing | ||
| Protective Cap | |||
| Blade Holder | |||
| Slider Top | |||
| Cover | |||
| Roller | |||
| Slider Left | |||
| Slider Right | |||
| Washer | |||
| Blade | |||
| Trigger Spring | |||
| Return Spring | Housing | ||
| Protective Cap | |||
| Blade Holder | |||
| Slider Top | |||
| Cover | |||
| Roller | |||
| Slider Left | |||
| Slider Right | |||
| Washer | |||
| Blade | |||
| Trigger Spring | |||
| Return Spring | Housing | ||
| Protective Cap | |||
| Blade Holder | |||
| Slider Top | |||
| Cover | |||
| Roller | |||
| Slider Left | |||
| Slider Right | |||
| Washer | |||
| Blade | |||
| Trigger Spring | |||
| Return Spring | |||
| Sterilization | Gamma Radiation | ||
| sterilization | Gamma Radiation | ||
| sterilization | Gamma Radiation | ||
| sterilization | |||
| Sterility | Meet the Sterility | ||
| Assurance Level of | |||
| 10-6 as per the | |||
| requirement of | |||
| ISO 11137-1:2006 | Meet the Sterility | ||
| Assurance Level of | |||
| 10-6 as per the | |||
| requirement of | |||
| ISO 11137-1:2006 | Meet the Sterility | ||
| Assurance Level of | |||
| 10-6 as per the | |||
| requirement of ISO | |||
| 11137-1:2006 | |||
| 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 |
5
6
7
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) | SafetiHeel
performance |
|--------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------------------|---------------------------|
| Cutting Depth Test –
ability of the blade to keep
within cutting depth range
when the device is
activated | 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 the
blade out of the housing of
the device for incision
operation 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
8
| Test | Model | Predicate Device
(specification) | SafetiHeel
performance |
|-----------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Blade Retraction Test
– the ability of the blade to
retract into the housing of
the device after
completing incision
operation | SH-065 | The blade of the
device must retract into
the housing of the
device after it has
completed the incision
operation | The samples of all the
models tested show the
devices retracting the
blade into the housing
after completing the
incision operation. |
| | SH-085 | | |
| | SH-100 | | |
| | SH-150 | | |
Comparison between MediHeel and predicate device ●
| Test | Predicate
Device
Model | Predicate Device
(specification) | MediHeel
performance | MediHeel
Model |
|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------------|-------------------------|-------------------|
| Cutting Depth Test -
ability of the blade to
keep within cutting
depth range when the
device 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 push
the blade out of the
housing of the device
for incision operation
activation | 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 |
9
| Test | Model | Predicate Device
(specification) | MediHeel
performance | MediHeel
Model |
|------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Blade Retraction Test
- the ability of the
blade to retract into the
housing of the device
after completing
incision operation | SH-065 | The blade of the
device must retract
into the housing of
the device after it
has completed the
incision operation | The samples of all
the models tested
show the devices
retracting the blade
into the housing
after completing the
incision operation. | 1003 |
| | SH-085 | | | 1004 |
| | SH-100 | | | 1005 |
| | SH-150 | | | 1006 |
Comparison between Novaplus and predicate device .
| Test | Predicate
Device
Model | Predicate Device
(specification) | Novaplus
performance | Novaplus
Model |
|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Cutting Depth Test –
ability of the blade to
keep within cutting
depth range when the
device 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 push
the blade out of the
housing of the device
for incision operation
activation | SH-085 | 450 to 750 grams | 492 to 597 grams | 10041 |
| | SH-100 | 450 to 750 grams | 486 to 589 grams | 10051 |
| Blade Retraction
Test- the ability of the
blade to retract into
the housing of the
device after
completing incision
operation | SH-085 | The blade of the
device must retract
into the housing of
the device after it has
completed the
incision operation | The samples of all
the models tested
show the devices
retracting the blade
into the housing after
completing the
incision operation. | 10041 |
| | SH-100 | The blade of the
device must retract
into the housing of
the device after it has
completed the
incision 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 the
blade to keep
within cutting
depth range when
the device is
activated | The subject device is able to push out the Blade when
activated and the blade incise within the range of cutting
depth as per the specification of the predicate device. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Trigger Force Test - force required to
push the blade
out of the housing
of the device for
incision operation
activation | The Trigger Force applied on the subject device falls within
the specification of the predicate device with the blade being
pushed out for the incision operation. |
| • Blade Retraction
Test - the ability of the
blade to retract into
the housing of the
device after
completing incision
operation | The subject device is able to retract the Blade into its housing
after it have completed the incision operation. |
| • Sterilization
Testing | Sterilization is done for the subject device with reference to
ISO 11137-1:2006 Sterilization of health care products –
Radiation – Part 1: Requirements for development,
validation and routine control of a sterilization process for
medical 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 the
minimum and maximum dose location for the subject device.
The latter is checked for its sterility after it has undergone the
sterilization process. |
| Product Safety
Design and
Effectiveness | The housing of the device encases the Blade preventing any needle
stick issue with user or patient before the device is activated. The
device also has a protective cap assembled to the housing of the
device. This prevents any inadvertent contact with the blade by the
user or patient before use. |
| | Once the device is activated by pushing the device onto the heel of the
patient, the blade is pushed out of the housing by the Trigger Spring.
After the device has performed the incision operation, the Return
Spring will now push the blade back into the housing avoiding the
occurrence of needlestick issue. The Trigger Spring helps in attaining
the effectiveness of the device in providing the penetration operation
essential for the incision and blood sample collection. The Return
Spring helps in accomplishing the safety of the device by ensuring that
the needle retracts into the housing after the penetration operation is
completed. |
| Test Principle | Both the subject device and the predicate device adopt the same test
principle of incising the heel of the newborn and neonatal infants for
capillary blood sample collection. The device is first placed on the heel
the patient and using contact activation means, the automatic incision
mechanism is activated with the blade coming out of the device
housing to make the incision. After the incision operation is completed,
the blade will automatically retract into the housing. Because of the
construction of the mechanism, the blade cannot be pushed out of the
housing for a second round of incision preventing the device from being
reused. After use, the device is to be discarded in a suitable biohazard
container. |
| | The incision on the heel for the blood sampling operation is controlled
for its depth of the incision. This is done by the design of the parts
operating in the device. Hence, the device is checked for Cutting Depth
as part of its performance assessment. |
| | The pushing out of the blade is controlled by the Trigger Spring
encased in the housing of the device. Here, the Trigger Force is
measured 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.