(58 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or functionalities.
No.
The device is for capillary blood sampling, which is a diagnostic procedure, not a therapeutic one. It facilitates obtaining a sample for diagnosis rather than directly treating a condition.
No
This device is a lancet used for capillary blood sampling, which is a collection method, not a diagnostic process itself. It facilitates the collection of blood, which may then be used for diagnostic tests, but the lancet itself does not perform any diagnostic function.
No
The device description explicitly lists physical components (Outer cover, Press carrier, Blade holder, blade) and describes mechanical functions (elastic force to puncture, blade shrinking back, blade firing). It also mentions sterilization and physical performance testing, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Heel Incision Safety Lancet is a device used to collect a sample (capillary blood). It is a tool for obtaining the specimen, not for analyzing it or providing diagnostic information itself.
- Intended Use: The intended use clearly states it's for "capillary blood sampling." This is a sample collection function, not a diagnostic function.
While the blood collected using this device might be used in an IVD test, the lancet itself is a sample collection device, not an IVD.
N/A
Intended Use / Indications for Use
Heel Incision Safety Lancet is intended for capillary blood sampling from the heel of newborns, preemies and toddlers.
Product codes
FMK
Device Description
Heel Incision Safety Lancet is comprised of Outer cover, Press carrier and Blade holder (include the blade). The press carrier provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired after press the press carrier. The blade holder is to protect the blade from triggering before use and form a sterile barrier to maintain the blade sterile. The device was sterilized by Radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heel
Indicated Patient Age Range
newborns, preemies and toddlers
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
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests: Cytotoxicity, Skin Sensitization, Intracutaneous reactivity, Acute systemic toxicity.
Non-clinical data: The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include: Appearance and type, Dimensions of product, Puncture function, Safety performance and Single-use function, Cutting depth and cutting width, Hardness, Surface roughness, Corrosion resistance and Sharpness, Assembly state, Cleanness and Sterility.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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February 26, 2025
SteriLance Medical (Suzhou) Inc. Susan Sun Official Correspondent No.168 PuTuoShan Road, New District Suzhou, Suzhou 215153 China
Re: K244036
Trade/Device Name: Heel Incision Safety Lancet (SteriHeel 2) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: December 23, 2024 Received: December 30, 2024
Dear Susan Sun:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for James H. Jang -S. The date of the signature is 2025.02.26, and the time is 22:12:13 -05'00'.
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
3
Indications for Use
510(k) Number (if known) K244036
Device Name
Heel Incision Safety Lancet (SteriHeel 2)
Indications for Use (Describe)
Heel Incision Safety Lancet is intended for capillary blood sampling from the heel of newborns, preemies and toddlers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary - K244036
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2024/12/16
1. Submission sponsor
Name: SteriLance Medical (Suzhou) Inc. Address: No.168 PuTuoShan Road, New District, 215153 Suzhou, Jiangsu, P. R. China Contact person: Susan Sun Title: Quality Manager E-mail: registration@sterilance.com Tel: 86-0512-65799308 Ext 8301
| Trade/Device Name | Heel Incision Safety Lancet |
|---|---|
| Model | SteriHeel 2 |
| Common Name | Blood Lancet |
| Regulatory Class | Class II |
| Classification | 21CFR 878.4850 / Single Use Only Blood Lancet With An |
| Integral Sharps Injury Prevention Feature / FMK | |
| Submission type | Traditional 510(K) |
Subject Device Information 2.
3. Predicate Device
SteriLance Medical (Suzhou) Inc., Heel Incision Safety Lancet, under K210745.
Device Description 4.
Heel Incision Safety Lancet is comprised of Outer cover, Press carrier and Blade holder (include the blade). The press carrier provides an elastic force to puncture and ensure the blade can shrink back to the covers. The blade can be fired after press the press carrier. The blade holder is to protect the blade from triggering before use and form a sterile barrier to maintain the blade sterile. The device was sterilized by Radiation.
5. Intended use & Indication for use
Heel Incision Safety Lancet is intended for the collection of capillary blood from the heel of newborn, preemie, and toddler.
Comparison to the Predicate Device 6.
| Features | Subject Device: Heel Incision | Predicate Device: Heel Incision | Comparison |
|---|---|---|---|
| Safety Lancet | Safety Lancet (K210745) |
5
| Product
| Code | FMK | FMK | Same |
|---|---|---|---|
| Regulation | |||
| Number | 21 CFR § 878.4850 | 21 CFR 878.4850 | Same |
| Classification | Class II | Class II | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| Indications for | |||
| Use | Heel Incision Safety Lancet is | ||
| intended for the collection of | |||
| capillary blood from the heel of | |||
| newborn, preemie, | |||
| and toddler. | Heel Incision Safety Lancet is | ||
| intended for the collection of | |||
| capillary blood from the heel of | |||
| newborn, preemie, | |||
| and toddler. | Same | ||
| Applicable | |||
| user | Newborn, preemie, and toddler | Newborn, preemie, and toddler | Same |
| Reuse | |||
| durability | Single use | Single use | Same |
| Sterilization | |||
| method and | |||
| SAL | Sterilized by Radiation SAL=10-6 | Sterilized by Radiation SAL=10-6 | Same |
| Component | 1. Outer cover, |
- Press carrier
- Blade holder (include the
blade) | 1. Triggering button - Safety button/Screw button
- Spring
- Cam
- Lancet core
- Shell
- Blade
- Swing arm | Different1 |
| Incision
length and
depth | DepthLength:
0.651.40mm,
0.851.75mm
1.002.50mm,
2.003.00mm | DepthLength:
0.651.40mm,
0.851.75mm
1.002.50mm,
1.142.80mm,
2.00*3.00mm | Different2 |
| Materials of
parts in
contact with
human body | Blade: Stainless steel
Outer cover: ABS
Press carrier: POM
Blade holder: PE | Blade: Stainless steel
Shell: ABS
Triggering button: ABS
Safety button: ABS | Different1 |
Different1: The components and raw materials of proposed devices may be different from the predicate devices. However, all the materials are known biocompatible materials that have been used in heel incision safety lancets or other similar medical devices.
Different2: The Incision length and depth difference does not raise any safety and effectiveness
6
K244036
questions. The incision length and depth was verified in the performance test report.
7. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Intracutaneous reactivity
- Acute systemic toxicity
Non-clinical data
The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- Appearance and type
- Dimensions of product
- Puncture function, Safety performance and Single-use function
- Cutting depth and cutting width
- Hardness, Surface roughness, Corrosion resistance and Sharpness
- Assembly state, Cleanness and Sterility
8. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.