(118 days)
Not Found
No
The summary describes a simple mechanical lancing device and lancet for capillary blood sampling. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The performance studies focus on sterilization, biocompatibility, and mechanical function.
No.
The device is used to collect blood samples, which is for diagnostic purposes, not for treating a disease or condition.
No
The device is used to collect capillary blood samples, which is a step in the diagnostic process but not a diagnostic act in itself. It is explicitly stated that the device is "intended for capillary blood sampling" and "for testing utilizing small amounts of blood," but it does not perform the testing or provide any diagnostic information.
No
The device description clearly outlines physical components (lancet and lancing device) and discusses sterilization and biocompatibility testing, 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 clearly stated as "capillary blood sampling." This is a device used to collect a sample, not to test or analyze the sample itself.
- Device Description: The description focuses on the physical characteristics of the lancet and lancing device and their function in obtaining blood. There is no mention of any components or processes related to analyzing the blood sample.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on biological samples to provide information about a patient's health. This device's function stops at the point of sample collection.
While the collected blood sample will likely be used for an IVD test, the lancet and lancing device themselves are considered medical devices for sample collection, not IVDs.
N/A
Intended Use / Indications for Use
Disposable Sterile Lancet: The 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 single patient use only and should not be shared with anyone else, even a family member.
Product codes (comma separated list FDA assigned to the subject device)
QRL, QRK
Device Description
Disposable Sterile Lancet is Class II Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature bearing the product code ORK (21CFR 878.4850), and The Disposable Sterile Lancet and lancing device is Class II Multiple Use Blood Lancet For Single Patient Use Only bearing the product code QRL (21CFR878.4850).
The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples. And the lancing device is intended for capillary blood sampling with Disposable Sterile Lancet. The lancet can be used independently, or used together with lancing device.
The intended users include healthcare personnel, patients and lay users.
The lancet is provided sterile. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf life of the lancet is 5 years.
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 personnel, patients and lay users.
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- . ISO 11137-1 First edition 2006-04-15, Sterilization of health care products -Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
- ISO 11137-2 Third edition 2013-06-01, Sterilization of health care products -. Radiation - Part 2: Establishing the sterilization dose
- . ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests . For In Vitro Cytotoxicity
- ISO 10993-23 First edition 2021-01,Biological evaluation of medical devices -Part 23: Tests for irritation
Performance testing verified that the proposed device is as effective and performs as well as the legally marketed predicate device in terms of critical performance characteristics:
Appearance:
Product Appearance: No obvious foreign body, fracture, unformed defects etc. - Meet the requirements
Needle-tip: No obvious burrs, curved hooks, oil stains etc. Lancet should be well assembled, no obvious dislocation at the fitting of the shell - Meet the requirements
Dimensions:
Diameter of needle core: Product dimensions shall be consistent to the drawings - Meet the requirements
Length of exposed needle-tip: The length of exposed needle-tip shall be consistent to the drawings. - Meet the requirements
Performance:
Puncture Force: 17-20G≤4N; 21-25G
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
11/21/2022
Tianjin Rilifine Medical Device Co., Ltd. Mr. Qiusheng Jiang Manager No 32, Jingguan Road, Yixingbu, Beichen District Tianjin, 300402 China
Re: K222246
Trade/Device Name: Disposable Sterile Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood lancets Regulatory Class: Class II Product Code: QRL, QRK Dated: September 26, 2022 Received: September 27, 2022
Dear Mr. Jiang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr -S
for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K22246
Device Name
Disposable Sterile Lancet; lancing device
Indications for Use (Describe) Disposable Sterile Lancet: The 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 single patient use only and should not be shared with anyone else, even a family member.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
(In accordance with 21 CFR 807.92)
1.0 Submitter's Information
| Name: | Tianjin Rilifine Medical Device Co., Ltd. | ||
|---|---|---|---|
| Address: | No 32, Jingguan Road, Yixingbu, Beichen District | ||
| Tianjin, 300402, CHINA | |||
| Phone Number: | 86-22-23233999 | ||
| Primary Submitter: | Mr. Qiusheng Jiang | ||
| Title | Co-founder and Manager | ||
| Email: | henry@rilifine.com | ||
| Secondary Submitter: | Ms. Belinda Wang | ||
| Title: | Regulatory manager | ||
| Email: | belindaw@126.com | ||
| Date of Preparation: | Nov 17, 2022 |
2.0 Device Information
| Device Name: | Disposable Sterile Lancet; Lancing device |
|---|---|
| Common Name: | Rilifine Blood Lancet, lancing device |
| Classification Name: | Single Use Only Blood Lancet Without An Integral Sharps |
| Injury Prevention Feature | |
| Multiple Use Blood Lancet For Single Patient Use Only |
3.0 Classification
| Product Code: | QRK, QRL |
|---|---|
| Regulation Number: | 21 CFR 878.4850 |
| Classification: | II |
| Review Panel: | General & Plastic Surgery |
4.0 Predicate Device Information
| Manufacturer: | Tianjin Huahong Technology Co., Ltd. |
|---|---|
| Device: | Lancet, lancing device |
| 510(k) Number: | K220475 |
| Classification | II |
| Product Code | QRL, QRK |
5.0 Intended Use
4
Disposable Sterile Lancet: The 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 single patient use only and should not be shared with anyone else, even a family member.
6.0 Device Description
Disposable Sterile Lancet is Class II Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature bearing the product code ORK (21CFR 878.4850), and The Disposable Sterile Lancet and lancing device is Class II Multiple Use Blood Lancet For Single Patient Use Only bearing the product code QRL (21CFR878.4850).
The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples. And the lancing device is intended for capillary blood sampling with Disposable Sterile Lancet. The lancet can be used independently, or used together with lancing device.
The intended users include healthcare personnel, patients and lay users.
The lancet is provided sterile. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf life of the lancet is 5 years.
7.0 Comparison of Technological Characteristics with Predicate Device
following table is the summary of the technological characteristics, The biocompatibility of the proposed subject device and predicate device.
| Item | Subject Device | Predicate Device
(K220475) | Comparison
Result | |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Manufacturer | Tianjin Rilifine Medical
Device Co., Ltd. | Tianjin Huahong
Technology Co., Ltd. | -- | |
| 510K number | -- | K220475 | -- | |
| Product name | Disposable Sterile Lancet
Lancing device | Lancet,
Lancing Device | -- | |
| Classification | II | II | Same | |
| Product Code | QRK, QRL | QRK, QRL | Same | |
| Regulation Number | 21 CFR 878.4850 | 21 CFR 878.4850 | Same | |
| Item | Subject Device | Predicate Device
(K220475) | Comparison
Result | |
| Intended Use | Disposable Sterile Lancet:
The 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 single patient
use only and should not be
shared with anyone else,
even a family member. | Lancet:
Lancet is intended for
capillary blood
sampling.
Lancing device:
The lancing device is
used with lancet to draw
capillary blood from
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. | Same | |
| Single Use | The disposable sterile
lancet is single Use, and
the lancing device is
reusable, but single patient
use only | The disposable sterile
lancet is single Use, and the
lancing device is reusable,
single patient use only | Same | |
| technical
specifica-
tions | Needle
gauge | 21G (0.82±0.01mm)
23G (0.64±0.01mm)
26G (0.46±0.01mm)
28G (0.36±0.01mm)
30G (0.31±0.01mm)
31G (0.26±0.01mm)
32G (0.24±0.01mm)
33G (0.21±0.01mm) | 16G (1.50±0.02mm)
18G (0.20±0.01mm)
19G (1.07±0.01mm)
20G (0.91±0.01mm)
21G (0.82±0.01mm)
22G (0.72±0.01mm)
23G (0.64±0.01mm)
24G (0.57±0.01mm)
25G (0.51±0.01mm)
26G (0.46±0.01mm)
27G (0.41±0.01mm)
28G (0.36±0.01mm)
29G (0.34±0.01mm)
30G (0.31±0.01mm)
31G (0.26±0.01mm)
32G (0.24±0.01mm)
33G (0.21±0.01mm)
34G (0.19±0.01mm) | Similar, See
note 1 |
| | Exposed
needle | Normally the length of
exposed needle tip is | 3.2±0.3mm (Model: IA, IB,
IC, ID, IE, IK, IL, IM, IIA, | |
| Item | Subject Device | Predicate Device
(K220475) | Comparison
Result | |
| | Which can also vary per
customer requirements
from 0.7mm to 3.5mm
(±0.3mm). | | | |
| Puncture
Force | 17-20G≤4N
21-25G≤1.5N
26-38G