(97 days)
Heel Stick 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.
The heel stick safety lancet is offered in various depth size (0.65mm, 0.85mm, 1.00mm, 1.50mm) and width size (1.50 mm, 1.75mm, 2.50 mm, 2.80 mm). It consists of blade base, blade, which is welded with the blade base, spring, top head, bottom, and pushing button. The top head and bottom are intended to provide physical protection to the blade, and PET blister along with the tyvek paper cover the primary sterile barrier system for the device. The product is individually primarily packaged and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years. Heel stick safety lancet is intended to be used by professionals. The product is intended for prescription (Rx) only.
This document describes the premarket notification (510(k)) for the "Heel Stick Safety Lancet (HHZ-II, HHZ-III)" and does not involve an AI or Machine Learning (ML) enabled device. Therefore, many of the typical acceptance criteria and study components requested in the prompt, such as data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable.
The acceptance criteria provided for this device concern its physical and performance characteristics as a manual surgical instrument, not an AI model.
Here's an attempt to answer the prompt based on the provided document, highlighting where the requested information is not relevant due to the nature of the device:
Device: Heel Stick Safety Lancet (HHZ-II, HHZ-III)
Device Type: Manual Surgical Instrument For General Use (Lancet)
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | The product color shall be correct, with the surface without burr and scratches | Meet the requirement |
| Cleanness | The product shall be cleaned | Meet the requirement |
| Dimension (HHZ-II) | length: 32.0mm±1.0mm; width: 11.5mm±0.5mm | Meet the requirement |
| Dimension (HHZ-III) | length: 36.65mm±0.5mm; width: 11.6±0.5mm | Meet the requirement |
| Firmness (Blade and blade base connection) | Blade and blade base shall be firmly connected. | Meet the requirement |
| Launch performance | Launch performance should be good, launch button press smoothly, no jam | Meet the requirement |
| Launch depth and Launch width | Launch depth and launch width shall meet the requirements. | Meet the requirement |
| Force to activate the safety feature | 4 - 10N | Meet the requirement |
| Testing access to the sharp in safe mode | The blade shall not touch the sphere. | Meet the requirement |
Biocompatibility Testing Acceptance and Results:
| Item | Acceptance Criteria (Test Results) | Reported Device Performance |
|---|---|---|
| In Vitro Cytotoxicity | No Cytotoxicity | No Cytotoxicity |
| Skin Sensitization | No Skin sensitization | No Skin sensitization |
| Intracutaneous reactivity | No irritation | No irritation |
| Acute Systemic Toxicity | No Acute Systemic Toxicity | No Acute Systemic Toxicity |
| Pyrogenicity | No thermogenic reaction | No thermogenic reaction |
2. Sample Size Used for the Test Set and Data Provenance
For the Simulated Clinical Use study to evaluate the safety mechanism:
- Sample Size: 600 device samples each for the HHZ-II and HHZ-III models (implicitly, 1200 samples total, though not explicitly stated as combined).
- Data Provenance: Not specified, but generally, bench testing and simulated clinical use for a medical device cleared via 510(k) are conducted by the manufacturer or their contracted laboratories to demonstrate compliance with standards. It's a prospective test of the device. Country of origin not specified for the test data, but the manufacturer is in China.
For the Non-Clinical (Bench) Testing (Appearance, Cleanness, Dimension, etc.):
- Sample Size: Not explicitly stated for each test, but standard quality control and performance testing typically involve a defined sample size from production batches.
- Data Provenance: Not specified, likely internal testing by the manufacturer.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable as the device is a manual lancet and the studies are performance/bench/biocompatibility tests, not studies involving expert adjudication of AI outputs or clinical interpretations. The "ground truth" for these tests is based on measurable physical properties and specified standards (e.g., ISO standards).
4. Adjudication Method for the Test Set
This is not applicable for the type of device and testing performed. Adjudication methods like "2+1" or "3+1" are typical for clinical studies involving human interpretation (e.g., for image reading in AI studies), not for mechanical device performance or biocompatibility testing. The "ground truth" (acceptance criteria) for the bench tests are against physical measurements and functional performance as per engineering specifications and relevant ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation or diagnostic tools to assess the impact of AI on human reader performance. The Heel Stick Safety Lancet is a manual instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This is not an AI/algorithm-based device. The "simulated clinical use" mentioned is a physical test of the device's safety mechanism, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests conducted on the Heel Stick Safety Lancet consisted of:
- Pre-defined engineering specifications and measurable physical properties: For criteria like appearance, cleanness, dimensions, firmness, launch performance, launch depth/width, activating force, and sharp access in safe mode.
- Compliance with international standards: Specifically, ISO 23908 for evaluating the safety mechanism and ISO 10993 series for biocompatibility.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical, manual medical device, not an AI/ML product that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no AI/ML training set for this device.
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May 17, 2022
Tianjin Huahong Technology Co., Ltd. % Stuart Situ. Director Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan District, Shanghai, 200072 China
Re: K220372
Trade/Device Name: Heel Stick Safety Lancet (HHZ-II, HHZ-III) Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class II Product Code: FMK Dated: January 28, 2022 Received: February 9, 2022
Dear Stuart Situ:
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.
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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 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,
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
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Indications for Use
Submission Number (if known)
Device Name
| Heel Stick Safety Lancet (HHZ-II, HHZ-III) |
|---|
| -------------------------------------------- |
Indications for Use (Describe)
Heel Stick 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 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) summary-K220372
l Submitter
Tianjin Huahong Technology Co., Ltd. A01, Plant B, No.278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park), 300308 Tianjin, China
Establishment Registration Number: 3009498536
Contact person: Ms. Ying Yuan Quality Manager Tel.: +86-18622179097 E-mail: ying.yuan@hh-technology.com
Submission Correspondent:
Ms. Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: stuart.situ@landlink-healthcare.com
Preparation date: Jan 28, 2022
II Proposed Device
| Trade Name of Device: | Heel Stick Safety Lancet (HHZ-II,HHZ-III) |
|---|---|
| Common name: | Single Use Only Blood Lancet With An Integral Sharps InjuryPrevention Feature |
| Regulation Number: | 21 CFR 878.4850 |
| Regulatory Class: | Class II |
| Product code: | FMK |
| Review Panel | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K210745 |
|---|---|
| Trade name: | Heel Incision Safety Lancet |
| Classification: | Class I |
| Product Code: | FMK |
| Manufacturer: | SteriLance Medical(Suzhou) Inc. |
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IV Device description
The heel stick safety lancet is offered in various depth size (0.65mm, 0.85mm, 1.00mm, 1.50mm) and width size (1.50 mm, 1.75mm, 2.50 mm, 2.80 mm).
It consists of blade base, blade, which is welded with the blade base, spring, top head, bottom, and pushing button. The top head and bottom are intended to provide physical protection to the blade, and PET blister along with the tyvek paper cover the primary sterile barrier system for the device. The product is individually primarily packaged and sterilized to a SAL of 10° by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.
Heel stick safety lancet is intended to be used by professionals. The product is intended for prescription (Rx) only.
V Indication for use
Heel Stick 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.
VI Comparison of technological characteristics with the predicate devices
The comparison and discussion between the subject device and the predicate devices are listed in below table 1:
| Item | Proposed device(K220372) | Predicate device(K210745) | Discussion |
|---|---|---|---|
| Product name | Heel Stick Safety Lancet(HHZ-II,HHZ-III) | Heel Incision Safety Lancet | Same |
| Product Code | FMK | FMK | Same |
| Regulation No. | 21 CFR § 878.4850 | 21 CFR § 878.4800 | Similar¹ |
| Class | II | I | Similar¹ |
| Prescription/over-the-counter use | Prescription Use | Prescription Use | Same |
| Indication foruse | Heel Stick Safety Lancet isintended for the collection ofcapillary blood from the heelof newborn, preemie, andtoddler. The lancet hasequipped with safetyprotection features | Heel Incision Safety Lancetis intended for thecollection of capillary bloodfrom the heel of newborn,preemie, and toddler. Thelancet has equipped withsafety protection features | Same |
| Applicableuser | Newborn, preemie, andtoddler | Newborn, preemie, andtoddler | Same |
| Safetyprotectionfeatures | Yes | Yes | Same |
| Reusedurability | Single use | Single use | Same |
| Sterilizationmethod andSAL | Sterilized by RadiationSAL=10-6 | Sterilized by RadiationSAL=10-6 | Same |
| Self-life | 5 years | 5 years | Same |
| Component | 1. Blade2. Blade base3. Top head4. Bottom5. Pushing button6. Spring | 1. Triggering button2. Safety button/Screwbutton3. Spring4. Cam5. Lancet core6. Shell7. Blade8. Swing arm | Similar2 |
| IncisionDepth*Width | 0.651.50 mm0.851.75 mm1.002.50 mm1.502.80 mm | 0.651.40 mm0.851.75 mm1.002.50 mm1.142.80 mm2.00*3.00 mm | Similar3 |
| Materials of | Blade: stainless steel | Blade:304 stainless steel | Same |
| parts in | Top head: ABS | Shell: ABS | |
| contact withhuman body | Bottom: ABS | Triggering button: ABS | |
| Pushing bottom: ABS | Safety button: ABS | ||
| Biocompatibil | Conforms to the | Conforms to the | Same |
| ity | requirements of ISO 10993 | requirements of ISO 10993 | |
| series standards. | series standards. | ||
| Label/Labeling | Complied with 21 CFR part | Complied with 21 CFR part | Same |
| 801 | 801 |
Table 1 General Comparison of Heel Stick Safety Lancet
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1 The classification and Regulation number are different because FDA issued the final order about Reclassification of Blood Lancets on 11/22/2021.
2 The component of proposed devices is different from the predicate devices. However, the performance test for proposed device has been conducted as same as predicate device. The Safety feature performance specification for predicate device is a little difference. However, the safety feature performance test for proposed device has been evaluated and the test result conforms to requirements of ISO 23908:2011 standards. Therefore, the difference on configuration and materials does not affect substantially equivalence.
3 The Incision depth and width of proposed devices is different from the predicate devices. However, the performance test for proposed device has been conducted as same as predicate device. And the depth and width of the proposed devices is covered by the predicated devices. Therefore, the difference on configuration and materials does not affect substantially equivalence.
VII Non-Clinical 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 | Acceptance criteria | Results |
|---|---|---|
| Appearance | The product color shall be correct, with the surface without burr and scratches | Meet the requirement |
| Cleanness | The product shall be cleaned | Meet the requirement |
| Dimension | HHZ-II : | Meet the |
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| length: 32.0mm±1.0mm; width:11.5mm±0.5mmHHZ-III :length: 36.65mm±0.5mm; width:11.6±0.5mm | requirement | |
|---|---|---|
| Firmness | Blade and blade base shall be firmly connected. | Meet the requirement |
| Launch performance | Launch performance should begood, launch button presssmoothly, no jam | Meet the requirement |
| Launch depth and Launchwidth | Launch depth and launch widthshall meet the requirements. | Meet the requirement |
| Force to activate thesafety feature | 4 - 10N | Meet the requirement |
| Testing access to thesharp in safe mode | The blade shall not touch thesphere. | Meet the requirement |
Biocompatibility Testing:
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 | ISO 10993-11: 2017 | No Acute Systemic Toxicity |
| Pyrogenicity | ISO 10993-11: 2017 | No thermogenic reaction |
Simulated Clinical Use
A simulated clinical use study was performed on 600 device samples each for the Heel Stick Safety Lancet according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
VIII Clinical Testing
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No clinical study is included in this submission.
IX Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.