(138 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is used to collect blood samples for diagnostic testing, not for treatment.
No
The device is intended for capillary blood sampling, which is a step in collecting a sample, but it does not analyze the sample or provide any diagnostic information itself.
No
The device description explicitly details physical components made of materials like stainless steel, PE, EVA, calcium powder, ABS, POM, PC Resin, and carbon steel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for capillary blood sampling. This is a method of obtaining a sample, not a diagnostic test itself.
- Device Description: The description focuses on the physical components and function of the lancet and lancing device for puncturing the skin to get blood. It doesn't describe any components or processes for analyzing the blood sample.
- Lack of Diagnostic Function: An IVD device is designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function stops at obtaining the sample.
- Predicate Devices: The predicate devices listed (K192666 Promosemed Blood Lancet and K113332 On Call® Lancing Device) are also devices for blood sampling, not diagnostic testing.
While the blood obtained using this device can be used for IVD testing (e.g., with a blood glucose meter), the lancet and lancing device themselves are not performing the diagnostic function. They are tools for sample collection.
N/A
Intended Use / Indications for Use
Lancet: Lancet is intended for capillary blood sampling.
Lancing Device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.
Product codes
QRL, QRK
Device Description
Lancet
The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip.
The Lancet is composed three components: needle (made of stainless steel and silicone oil), main body and protective cap (both made of PE, EVA and calcium powder). Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years.
Lancing Device
Along with a lancet, the lancing device is used to collect a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM and PC Resin. And the spring is made of carbon steel.
The service life of lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) is no more than 3000 times or 3 years. The service life of lancing device (HH-XVII-T) is no more than 5000 times or 5 years. The Lancing Device is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professional or lay person / Over-The-Counter Use
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
Bench testing was performed to verify the proposed device is safe, effective, and performs well compared to the predicate device. Tests included appearance, dimension, needle diameter, cleanness, firmness, resistance to corrosion, acidity or alkalinity, extractable metals, puncture force, lubricant, and matching. All results met the requirements.
Biocompatibility evaluations were conducted according to the 2020 FDA Guidance document Use of International Standard ISO 10993-1. The tests performed were In Vitro Cytotoxicity (ISO 10993-5: 2009), Skin Sensitization (ISO 10993-10: 2010), Intracutaneous reactivity (ISO 10993-10: 2010), Acute Systemic Toxicity (ISO 10993-11: 2017), and Pyrogenicity (ISO 10993-11: 2017). All biocompatibility tests showed positive results (No Cytotoxicity, No Skin sensitization, No irritation, No Acute Systemic Toxicity, no thermogenic reaction).
A simulated clinical use study was performed on 500 device samples each for the Lancet and Lancing Device 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. The study evaluated the safety mechanism of the proposed device, and the results demonstrated that the proposed device met the pre-established criteria.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and the word "Administration" in a smaller font.
July 6, 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: K220475
Trade/Device Name: Lancet (I, II, III, V, V); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL, QRK Dated: June 6, 2022 Received: June 6, 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/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.
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); 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.
Colin Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220475
Device Name Lancet (I, II, III, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)
Indications for Use (Describe) Lancet: Lancet is intended for capillary blood sampling.
Lancing Device:
The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.
| 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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3
510(k) summary-K220475
| 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.: +86-15302127671 E-mail: ying.yuan@hh-technology.com
Preparation date: Feb 15, 2022
II Proposed Device
| Trade Name of Device: | Lancet, Lancing device |
|---|---|
| Common name: | Multiple Use Blood Lancet For Single Patient Use Only |
| Regulation Number: | 21 CFR 878.4850 |
| Regulatory Class: | Class II |
| Product code: | QRL and QRK |
| Review Panel | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K192666 |
|---|---|
| Trade name: | Promosemed Blood Lancet |
| Classification: | Class II |
| Product Code: | FMK |
| Manufacturer | Promisemed Hangzhou Meditech Co., Ltd. |
| 510(k) Number: | K113332 |
| Trade name: | On Call® Lancing Device |
| Classification: | Class II |
| Product Code: | FMK |
| Manufacturer | ACON Laboratories, Inc. |
4
IV Device description
Lancet
The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip.
The Lancet is composed three components: needle (made of stainless steel and silicone oil), main body and protective cap (both made of PE, EVA and calcium powder). Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years.
Lancing Device
Along with a lancet, the lancing device is used to collect a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM and PC Resin. And the spring is made of carbon steel.
The service life of lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) is no more than 3000 times or 3 years. The service life of lancing device (HH-XVII-T) is no more than 5000 times or 5 years. The Lancing Device is provided non-sterile.
V Indication for use
Lancet
Lancet is intended for capillary blood sampling.
Lancing Device
The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared.
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&2:
| Table 1 General Comparison of Lancet | |||
|---|---|---|---|
| Item | Proposed device | Predicate device | Discussion |
| (K220475) | (K192666) | ||
| Product | |||
| name | Lancet | Promosemed Blood Lancet | Same |
| Product | |||
| Code | QRL and QRK | FMK | Different¹ |
| Regulation | |||
| No. | 21 CFR § 878.4850 | 21 CFR § 878.4850 | Same |
| Class | II | II | Same |
| Prescription/ | |||
| over-the-counter use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Indication for | |||
| use | It is intended for capillary | ||
| blood sampling | It is intended for capillary | ||
| blood sampling | Same | ||
| Applicable | |||
| user | Healthcare professional or | ||
| lay person | Healthcare professional or | ||
| lay person | 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 | ||
| Manufacturing aspects | For the Lancet, stainless | ||
| steel needle is fed into an | |||
| injection molding machine to | |||
| over-mold plastic material | |||
| (polyethylene (PE) and | |||
| Ethylene Vinyl Acetate (EVA) | |||
| and calcium powder) forming | |||
| a body and cap, | |||
| encapsulating the stainless | |||
| steel needles. | For the Promisemed Blood | ||
| Lancet, stainless steel | |||
| needle is fed into an | |||
| injection molding machine | |||
| to over-mold plastic | |||
| material (polyethylene) | |||
| forming a body and cap, | |||
| encapsulating the stainless | |||
| steel needles. | Same | ||
| Design and | |||
| Functionality | |||
| aspects | The Lancet comprises a | ||
| stainless steel needle | |||
| encapsulated with a plastic | |||
| body and cap, the cap is | |||
| twisted off to expose the | The Promisemed Blood | ||
| Lancet comprises a | |||
| stainless steel needle | |||
| encapsulated with a plastic | |||
| body and cap the cap is | Same | ||
| needle for use | twisted off to expose the needle for use | ||
| Needle length range | 3.2±0.3mm (Model: IA、IB、IC、ID、IE、IK、IL、IM、IIA、IIB、III、VI) | ||
| 2.1±0.3mm (Model: V) | unknown | Different² | |
| Gauge range | 1.50±0.02mm (16G) | ||
| 1.20±0.01mm (18G) | |||
| 1.07±0.01mm (19G) | |||
| 0.91±0.01mm (20G) | |||
| 0.82±0.01mm (21G) | |||
| 0.72±0.01mm (22G) | |||
| 0.64±0.01mm (23G) | |||
| 0.57±0.01mm (24G) | |||
| 0.51±0.01mm (25G) | |||
| 0.46±0.01mm (26G) | |||
| 0.41±0.01mm (27G) | |||
| 0.36±0.01mm (28G) | |||
| 0.34±0.01mm (29G) | |||
| 0.31±0.01mm (30G) | |||
| 0.26±0.01mm (31G) | |||
| 0.24±0.01mm (32G) | |||
| 0.21±0.01mm (33G) | |||
| 0.19±0.01mm (34G) | unknown | ||
| Shelf-life | 5 years | 5 years | Same |
| Materials of parts in contact with human body | The Lancet has a needle that is made of stainless steel and silicone oil. The body and cap are made of polyethylene (PE) and Ethylene Vinyl Acetate (EVA) | The Promisemed Blood Lancet has a needle that is made of stainless steel and a body and a cap that are made of polyethylene (PE) | Similar² |
| and calcium powder. | |||
| Biocompatibil | |||
| ity | Conforms to the | ||
| requirements of ISO 10993 | |||
| series standards. | Conforms to the | ||
| requirements of ISO 10993 | |||
| series standards. | Same | ||
| Label/Labelin | |||
| g | Complied with 21 CFR part | ||
| 801 | Complied with 21 CFR part | ||
| 801 | Same |
Table 1 General Comparison of Lancet
5
6
7
1 The product code is different because FDA issued the final order about Reclassification of Blood Lancets on 11/22/2021. Three new codes have been added of Blood Lancets. The product code QRL (Multiple Use Blood Lancet For Single Patient Use Only) and QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature) are closer to the purpose of our device.
2 The component and material of proposed devices is different from the predicate devices. However, all the materials are known biocompatible materials that have been used in lancets or other similar medical devices. After the comparison test of the I-type needle of our device and the predicate device, the result shows that the length of the exposed tip of this product (3.2±0.3mm) is similar to that of the predicate device, see the comparison test report (No.: VC-22032202). Model V (the length of the exposed tip is 2.1±0.3mm) can only be used in conjunction with the company's HH-XVIII-T lancing pen. After the performance test and the matching test, the product can be guaranteed to be safe and effective.
3 The needle length range or gauge range of the predicate device are unknown. There may be some differences between predicate device and proposed device. But the durability and strength of the needles were tested in a series of penetration tests using the proposed device, which shows positive result in these testing. Therefore, the differences do not raise concerns related to the device safety and effectiveness.
| Item | Proposed device
(K220475) | Predicate device
(K113332) | Discussion |
|----------------|------------------------------|-------------------------------|------------|
| Product name | Lancing device | Genteel Lancing device | Same |
| Product Code | QRL | FMK | Different1 |
| Regulation No. | 21 CFR § 878.4850 | 21 CFR § 878.4850 | Same |
Table 2 General Comparison of Lancing device
8
| Class | II | II | Same |
|---|---|---|---|
| Prescription/ | |||
| over-the-cou | |||
| nter use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Indication for | |||
| use | The Lancing Device is used | ||
| with lancets to draw capillary | |||
| blood from the fingertip, for | |||
| testing utilizing small | |||
| amounts of blood. The | |||
| Lancing Device is intended | |||
| to be used by a single | |||
| patient and should not be | |||
| shared. | The On Call® Lancing | ||
| Device is used with On | |||
| Call® disposable sterile | |||
| lancets to draw capillary | |||
| blood from the fingertip, | |||
| palm (at the base of the | |||
| thumb) or forearm, for | |||
| blood glucose testing or | |||
| other testing utilizing small | |||
| amounts of blood. The On | |||
| Call® Lancing Device is | |||
| intended to be used by a | |||
| single patient and should | |||
| not be shared. | Same | ||
| Puncture | |||
| device to | |||
| obtain micro | |||
| blood | |||
| samples | Yes | Yes | Same |
| Lancet | |||
| retracted | |||
| after use to | |||
| prevent | |||
| sharp injure | Yes | Yes | Same |
| Device | |||
| penetration | |||
| depth range | 0.85mm(±0.30mm)~2.20mm(± | ||
| 0.30mm) (Model: HH-X-T); | |||
| 0.60mm(±0.30mm)~2.00mm(± | |||
| 0.30mm) (Model HH-XIII-T、 | |||
| HH-XXII-T); | |||
| 0.50mm(±0.30mm)~1.70mm(± | |||
| 0.30mm) (Model HH-XV-T); | |||
| 0.60mm(±0.30mm)~1.95mm(± | unknown | Different4 | |
| 0.30mm) (Model HH-XVI-T、 | |||
| HH-XXI-T、HH-XXIII-T、 | |||
| HH-XXIV-T); | |||
| 0.60mm(±0.30mm)~1.80mm(± | |||
| 0.30mm) (Model HH-XVII-T、 | |||
| HH-XIX); | |||
| 0.60mm(±0.30mm)~2.10mm(± | |||
| 0.30mm) (Model HH-XVIII-T) | |||
| Mechanical | |||
| loading and | |||
| firing function | Cocking barrel with releasing | ||
| button | Cocking barrel with | ||
| releasing button | Same | ||
| Materials | ABS, POM and PC Resin | ABS | Similar5 |
| Reuse | |||
| durability | Reusable | ||
| Single Patient Use Only | Reusable | ||
| Single Patient Use Only | Same | ||
| Sterilization | |||
| method and | |||
| SAL | NA | NA | Same |
| Label/Labeling | Complied with 21 CFR part | ||
| 801 | Complied with 21 CFR part | ||
| 801 | Same |
9
4 The Device penetration depth range of the predicate device is unknown. Krleza et al.[1] recommended that if the recommended puncture site is finger, the recommended incision depth is up to 1.5mm for child aged 6 months to 8 years, and up to 2.4mm for child older than 8 years and adults; if the recommended puncture site is heel, the recommended incision depth is up to 0.85mm for premature neonates(up to 3kg), and up to 2.0mm for infants under 6 months of age. The puncture depth of the product ranges from 0.50mm ( ± 0.30mm) to 2.2mm ( ± 0.30mm) covers the requirements of recommended incision depth. Therefore, this differences in the subject and predicate device do not raise concerns related to device safety and effectiveness.
5 The raw materials of proposed devices may different from the predicate devices. However, all the materials are medical grade materials that have been used in lancets or other similar medical devices.
10
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 surface shall be free of burr and no scratches. | Meet the requirement |
| Dimension | Product dimensions shall be consistent to the drawings | Meet the requirement |
| Needle diameter | The diameter of the needle shall be consistent to the requirement | Meet the requirement |
| Cleanness | No dust, no grease, no hair, no dirt | Meet the requirement |
| Firmness | Needle should connect firmly with plastic handle: | Meet the requirement |
| Resistance to corrosion | Corrosion resistance of needle of lancet shall show no evidence of corrosion. | Meet the requirement |
| Acidity or Alkalinity | When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an extract prepared shall be within one pH unit of that of the control fluid. | Meet the requirement |
| Extractable Metals | When corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l. | Meet the requirement |
| Puncture force | The needle tip of the needle should have good puncture ability. | Meet the requirement |
| Lubricant | Visual, should not be visible droplets. | Meet the requirement |
| Matching | It should be well assembled with the lancing devices, with no dislocation in | Meet the requirement |
| the appearance coordination. |
11
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 500 device samples each for the Lancet and Lancing Device 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
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.