(125 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical function and safety features of a blood lancet, with no mention of AI or ML.
No.
The device is used for obtaining a capillary blood sample for diagnostic purposes, not for treating a condition, disease, or injury.
No
The device is described as a blood lancet used to obtain a blood sample, which is then used for diagnostic purposes. The lancet itself is not performing the diagnostic function; it is a tool for sample collection.
No
The device description clearly states it is a physical lancet comprised of a needle encased in a plastic housing, indicating it is a hardware device.
Based on the provided information, the SafetiCET Safety Lancet is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for obtaining capillary blood sample." This describes a device used to collect a sample, not to perform a diagnostic test on the sample.
- Device Description: The description focuses on the mechanism for puncturing the skin and collecting blood. It doesn't mention any components or functions related to analyzing the blood sample or providing diagnostic information.
- Lack of Diagnostic Function: The device's purpose is to facilitate the collection of a sample that will be used for diagnostic purposes, but the device itself does not perform the diagnostic test.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The SafetiCET Safety Lancet is a tool for obtaining the specimen, not for performing the diagnostic analysis.
N/A
Intended Use / Indications for Use
The device is designed for obtaining capillary blood sample.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The SafetiCET 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 needle 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 SafetiCET Safety Lancet is a sterile device and the sterilization is done using the Gamma Irradiation means.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 tests and comparison tests on the device quality confirmed the safety and effectiveness of the device.
The following performance testing was done on the subject device and compared against that of the predicate device:
- Sterilization testing and Validation
- Penetration depth test
- Twist break force test
- Drop test
- Joint strength of needle-to-needle holder test
- Joint strength of top cover to housing test
- Puncture resistance test
- Needle retraction test
- Mechanical properties test of material
The results of measuring penetration depth of the subject device are in the same range of the needle length of the predicate device. There is no significant difference in technological characteristics between the subject device and 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.
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
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10/24/2022
NSP Tech Pte Ltd Hc Tan Operations Manager 10 Admiralty Street, Northlink Building, #02-06 Singapore, 757695 Singapore
Re: K221783
Trade/Device Name: SafetiCET (SC-150);SafetiCET (SC-180);SafetiCET (SC-220);SafetiCET (SC-250);SafetiCET (SC-250B) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: August 29, 2022 Received: September 1, 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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
2
Indications for Use
510(k) Number (if known) K221783
Device Name SafetiCET Safety Lancet
| Indications for Use (Describe) | The device is designed for obtaining capillary blood sample. |
|---|---|
| -------------------------------- | -------------------------------------------------------------- |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary SafetiCET Blood Lancet
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 |
| : hockchoon.tan@nsptech.com.sg |
| Establishment registration number | ||
|---|---|---|
3008337059
Date prepared
: 21st October 2022
2. DEVICE
| Trade Name | : | SafetiCET Safety Lancet |
|---|---|---|
| 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 |
| Device 510K number | : | K221783 |
PREDICATE DEVICE 3.
VeriFine Safety Lancet Regulatory Class II Product Code FMK General & Plastic Surgery Predicate device 510K number: K221368
DEVICE DESCRIPTION: 4.
The SafetiCET 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 needle 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.
4
NSP Tech Premarket Notification 510(k) Submission Under 21 CFR § 807.87 for SafetiCET
510(k) Summary SafetiCET Blood Lancet
The SafetiCET Safety Lancet is a sterile device and the sterilization is done using the Gamma Irradiation means.
5. INTENDED USE
The device is used for obtaining capillary blood sample.
6. INDICATION FOR USE STATEMENT
The device is designed for obtaining capillary blood sample.
7. SUBSTANTIAL EQUIVALENCE COMPARISON
TABLE OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
| SafetiCET Safety Lancet | VeriFine Safety Lancet | |
|---|---|---|
| 510 (k) Number | K221783 | K 221368 |
| Classification | Class II | Class II |
| Product Code | FMK | FMK |
| Intended Use | The device is designed for | |
| obtaining capillary blood sample. | It is intended for capillary blood | |
| sampling. | ||
| Indication For | ||
| Use | The device is designed for | |
| obtaining capillary blood samples. | It is intended for capillary blood | |
| sampling. | ||
| Manufacturer | NSP Tech Pte Ltd | Promisemed Hangzhou Meditech |
| Co., Ltd. | ||
| Sterilizer | Grandten | Not known |
| Needle Gauge | 21G, 23G, and 28G | 18G, 21G, 23G, 25G, 26G, 28G, |
| 30G |
5
510(k) Summary SafetiCET Blood Lancet
| SafetiCET Safety Lancet | VeriFine Safety Lancet | |
|---|---|---|
| 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 | Not known | |
| Use | Single-Use only | Single-Use only |
| Bio | ||
| compatibility | ISO 10993 series | ISO 10993 series |
| Shelf Life | 5 years | Not mentioned |
8. TECHNOLOGICAL CHARACTERISTICS COMPARISON
The SafetiCET Safety Lancet has similarities with the predicate device in areas such as Intended Use, Indications For Use, Sterilization means.
The results of measuring penetration depth of the subject device are in the same range of the needle length of the predicate device. There is no significant difference in technological characteristics between the subject device and the predicate device.
Performance tests and comparison tests on the device quality confirmed the safety and effectiveness of the device.
In summary, the subject device and predicate device are said to have same technological characteristics.
6
510(k) Summary SafetiCET Blood Lancet
9. PRODUCT SAFETY AND EFFECTIVENESS DATA
| Product Safety
Design and
Effectiveness | The housing of the device encases the Needle and device has a
protective cap attached to the housing. This combination prevents any
needle stick issue with user or patient before the device is activated.
The safety relating to needle stick issue is further enhanced with the
needle encapsulated by a plastic molded over it when residing in the
housing of the device. This encapsulation is only removed when the
protective cap is detached from the housing with a force known as the
Twist Break Force preparing the device for activation and use. The
encapsulation of the needle also allows it to remain sterile after the
device has undergone sterilization process. This prevents any
inadvertent pathogen contamination or contact to user or patient before
use.
The device is activated by pushing the device on the blood collection
area of the patient. Once activated, the needle is pushed out of the
housing by the Trigger Spring. After the device has performed the
piercing or penetration operation, the Return Spring pushes the needle
back into the housing preventing any needlestick issue. The Trigger
Spring helps in attaining the effectiveness of the device in providing the
penetration operation essential for the 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
operation principle of capillary blood sample collection. The device is
first placed on the blood collection area of the patient and using contact
activation means, the automatic mechanism is activated with the
needle coming out of the device housing to make the piercing or
penetration operation. After the penetration operation is completed, the
needle automatically retracts into the housing. Because of the
construction of the mechanism, the needle cannot be pushed out of the
housing for a second round of penetration preventing the device from
being reused. After use, the device is to be discarded in a suitable
biohazard container.
The blood collection operation is controlled for its depth of the
penetration. This is done by the design of the parts operating in the
device. Hence, the device is checked for Penetration Depth as part of
its performance assessment.
The protective cap is able to break the encapsulation of the needle
when the twisting force is applied on the cap. This twisting force also
allows the cap to be detached from the housing preparing the device
for the penetration operation. Here, the Twist Break Force is measured
as part of device performance assessment. |
7
510(k) Summary SafetiCET Blood Lancet
10. PERFORMANCE TESTING SUMMARY
The following performance testing done on the subject device is compared against that of the predicate device.
- Sterilization testing and Validation ●
- . Penetration depth test
- Twist break force test ●
- Drop test
- Joint strength of needle-to-needle holder test ●
- Joint strength of top cover to housing test ●
- Puncture resistance test ●
- Needle retraction test ●
- Mechanical properties test of material
11. CONCLUSION
The comparison and evaluation of the device features, intended use, indication for use statement, 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. From the evaluation above, we can deem that the Safety Lancet is substantially equivalent to the predicate device.