(167 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or data-driven performance metrics.
No.
The device is described as being used for the collection of capillary blood, which is a diagnostic procedure, not a therapeutic treatment.
No
Explanation: The device is a "Heel Incision Safety Lancet" used for the collection of capillary blood. It is explicitly stated that the device is "designed to be used in collecting the blood sample," not for analyzing or diagnosing anything from the collected blood sample.
No
The device description explicitly lists multiple physical components (covers, button, plug, slider, rod, holder, spring, blade) and describes mechanical actions (spring providing elastic force, blade firing). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the collection of capillary blood from the heel". This describes a device used to obtain a biological sample.
- Device Description: The description focuses on the mechanical components and function of the lancet for puncturing the skin and collecting blood.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze the collected blood sample or provide any diagnostic information. IVD devices are used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening.
This device is a medical device used for sample collection, which is a pre-analytical step in some diagnostic processes, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
Heel Incision Safety Lancet is comprised of top upper cover, bottom cover, button, safety plug, slider, rod, holder, spring, blade. The spring provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired when the spring is under pressure. The safety plug is to protect the blade from triggering before use.
Heel Incision Safety Lancet is single use, sterile medical devices designed to be used in collecting the blood sample. Heel Incision Safety Lancet is intended to be used by professionals.
Heel Incision Safety Lancets are sterile and non-toxic. The product is intended for prescription (Rx) only.
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, preemie, and toddler
Intended User / Care Setting
professionals
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 Testing: The bench testing performed verifies that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device in terms of critical performance characteristics.
Items tested include: Material of blade, Appearance, Dimensions of product, Blade corrosion resistance, Force to activate Safety Screw button, Trigger force, Safety overriding and unlocking force after activation, Sterility, Limits acidity and alkalinity, Total heavy metal, Incision depth and length, Safety self-locking, Safety plug pullout, Shooting performance, Accidental access to sharp once in safe mode.
Results: F type stainless steel materials, The surface has no burr and scratch, The height of product(mm): 32±1.5, The width of product(mm): :35±1.5, No blemishes, Compared with equivalent devices, there was no statistical difference (for Force to activate Safety Screw button, Trigger force, and Safety overriding and unlocking force after activation), Sterile, Meet the requirement (for Limits acidity and alkalinity, and Total heavy metal), All models have been tested within tolerances, There were no failures observed in a test run of 500 devices (for Safety self-locking, Safety plug pullout, Shooting performance, and Accidental access to sharp once in safe mode).
Biocompatibility: The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process".
Tests include: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous reactivity, Acute Systemic Toxicity Test, Material mediated pyrogenicity, In vitro Hemolytic.
Test results: No Cytotoxicity, No Skin sensitization, No irritation, No Acute Systemic Toxicity, Absence of pyrogens, No Hemolytic.
No clinical tests were performed.
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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August 26, 2021
SteriLance Medical (Suzhou) Inc. % Joyce Yang, Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K210745
Trade/Device Name: Heel Incision Safety Lancet Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: Class I Product Code: FMK Dated: July 8, 2021 Received: July 26, 2021
Dear Joyce Yang:
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/cfpm/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.
1
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210745
Device Name Heel Incision Safety Lancet
Indications for Use (Describe)
Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 201 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR Part 330) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
510(k) Number: K210745
Date of Summary prepare: August 11, 2021
1. Submission Sponsor
| Applicant Name | SteriLance Medical(Suzhou) Inc. |
|---|---|
| Address | No.168 PuTuoShan Road, New |
| District,215153 Suzhou, Jiangsu, P.R.China | |
| Contact person | Yuan Jie |
| Phone | +86-512-65799308 |
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan |
| Times Square, Nanshan District, Shenzhen | |
| Post Code | 518000 |
| Phone No. | +86-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Heel Incision Safety Lancet |
| Common name: | Lancet, Blood |
| Regulation name: | Manual Surgical Instrument for General Use |
| Review Panel: | General & Plastic Surgery |
| Product Code: | FMK |
| Device Class: | I |
| Regulation Number: | 21 CFR 878.4800 |
4. Legally Marketed Predicate Device
| Trade Name | Promisemed Heel Blood Lancet |
|---|---|
| Regulation number | 21 CFR 878.4800 |
| Regulation class | I |
| Regulation name | Manual Surgical Instrument for General Use |
| 510(k) Number | K193009 |
| Product Code | FMK |
| Manufacturer | Promisemed Hangzhou Meditech Co., Ltd. |
4
Device Description 5.
Heel Incision Safety Lancet is comprised of top upper cover, bottom cover, button, safety plug, slider, rod, holder, spring, blade. The spring provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired when the spring is under pressure. The safety plug is to protect the blade from triggering before use.
Heel Incision Safety Lancet is single use, sterile medical devices designed to be used in collecting the blood sample. Heel Incision Safety Lancet is intended to be used by professionals.
Heel Incision Safety Lancets are sterile and non-toxic. The product is intended for prescription (Rx) only.
6. Intended Use/ Indications for Use
Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler. The lancet has equipped with safety protection features.
| Comparison
item | Subject Device: Heel Incision
Safety Lancet | Predicate Device: Promisemed
Heel Blood Lancet (K193009) |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Code | FMK | FMK |
| Regulation
Number | 21 CFR § 878.4800 | 21 CFR § 878.4800 |
| Classificatio
n | Class I | Class I |
| Type of use | Prescription Use | Prescription Use |
| Intended
use &
Indication
s for Use | Heel Incision Safety Lancet is
intended for the collection of capillary
blood from the heel of newborn,
preemie, and toddler. The lancet has
equipped with safety protection
features. | It is intended for collection of capillary
blood from the heel of newborn and
premature babies. The lancet has
equipped with safety protection
features. |
| Applicable
user | Newborn, preemie,and toddler | Newborn, preemie |
| Safety
protection
features | Yes | Yes |
| Reuse
durability | Single use | Single use |
| Sterilization
method and
SAL | Sterilized by Radiation
SAL=10-6 | Sterilized by ethylene oxide
SAL=10-6 |
7. Technological characteristics comparison
5
| Comparison
item | Subject Device: Heel Incision
Safety Lancet | Predicate Device: Promisemed
Heel Blood Lancet (K193009) |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Self life | 5 Years | 5 Years |
| Incision
length and
depth | DepthLength:
0.651.40mm,
0.851.75mm,
1.002.50mm,
1.142.80mm,
2.003.00mm | DepthLength:
0.651.50mm,
0.851.75mm,
1.002.50mm,
1.50*3.00mm |
| Component | 1. Triggering button
2. Safety button/Screw button
3. Spring
4. Cam
5. Lancet core
6. Shell
7. Blade
8. Swing arm | 1. Top upper cover
2. Bottom cover
3. Button
4. Safety plug
5. Slider
6. Rod
7. Holder
8. Spring
9. blade |
| Materials of
parts in
contact with
human body | Blade: 304 stainless steel
Shell: ABS
Triggering button: ABS
Safety button: ABS | Blade: 304 stainless steel
Shell: ABS
Triggering button: ABS
Safety button: ABS |
The subject device and the predicate device have the same intended use, similar technology characteristics, and similar ingredients. The differences will not cause safety and effectiveness problems for proposed device, and does not affect the equality.
8. Summary of non-clinical testing
*Performance Testing
The bench testing performed verifies that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device in terms of critical performance characteristics . These tests are as follow.
| Items | Results |
|---|---|
| Material of blade | F type stainless steel materials |
| Appearance | The surface has no burr and scratch |
| Dimensions of product | The height of product(mm): 32±1.5 |
| The width of product(mm): :35±1.5 | |
| Blade corrosion resistance | No blemishes |
| Force to activate Safety Screw button | Compared with equivalent devices, there was |
6
| Items | Results | |
|---|---|---|
| Trigger force | Compared with equivalent devices, there was | |
| no statistical difference | ||
| Safety overriding and unlocking force | ||
| after activation | Compared with equivalent devices, there was | |
| no statistical difference | ||
| Sterility | Sterile | |
| Limits acidity and alkalinity | Meet the requirement | |
| Total heavy metal | Meet the requirement | |
| Incision depth and length | All models have been tested within tolerances | |
| Safety self-locking | There were no failures observed in a test run | |
| of 500 devices | ||
| Safety plug pullout | There were no failures observed in a test run | |
| of 500 devices | ||
| Shooting performance | There were no failures observed in a test run | |
| of 500 devices | ||
| Accidental access to sharp once in | ||
| safe mode | There were no failures observed in a test run | |
| of 500 devices |
*Biocompatibility
The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process". The tests include the following tests:
| Item | Test method | Test results |
|---|---|---|
| In Vitro Cytotoxicity | ISO 10993-5: 2009 | No Cytotoxicity |
| Skin Sensitization | ISO 10993-10: 2010 | No Skin sensitization |
| Intracutaneous reactivity | ISO 10993-10: 2010 | No irritation |
| Acute Systemic Toxicity Test | ISO 10993-11: 2017 | No Acute Systemic Toxicity |
| Material mediated | USP | Absence of pyrogens |
7
K210745
| pyrogenicity | ||
|---|---|---|
| In vitro Hemolytic | ASTM F756-17 | No Hemolytic |
9. Brief discussion of clinical tests
No clinical tests were performed.
10. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Heel Incision Safety Lancets are as safe and effective, and performs as well as or better than the legally marketed predicate device cleared under K193009.