(87 days)
Not Found
No
The description focuses on mechanical aspects of a lancet for blood sampling and does not mention any AI or ML components or functions.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is for capillary blood sampling, a diagnostic procedure, not a therapeutic one.
No
The device is a lancet used for capillary blood sampling. It collects blood, but does not analyze it or make a diagnosis.
No
The device description clearly indicates it is a physical lancet used for capillary blood sampling, which 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 "capillary blood sampling." This describes the collection of a sample, not the testing or analysis of that sample.
- Device Description: The description focuses on the physical characteristics and safety mechanisms of a lancet, which is a tool for obtaining a blood sample. It does not mention any components or functions related to analyzing or diagnosing conditions from the blood.
- Lack of IVD-related information: There is no mention of reagents, assays, analytical methods, or any other elements typically associated with in vitro diagnostic devices.
IVD devices are used to examine specimens (like blood) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's purpose is solely to obtain the specimen.
N/A
Intended Use / Indications for Use
It is intended for capillary blood sampling.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The propose device, Lancet, which is intended for capillary blood sampling. The safety protection mechanism is to prevent the reuse of products and protection against needle stick injury. The proposed devices are provided sterile, single use.
The proposed devices are divided into several models. In addition, the proposed devices are available in different specifications of needle gauge (21G, 28G and 30G) to allow to collect capillary blood sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed devices met all design specifications as was Substantially Equivalent (SE) to the predicate device. The tests performed on the relevant device configurations include:
Biocompatibility tests was conducted on the lancet, include in vitro cytotoxicity test (ISO 10993-5), skin sensitization Test (ISO 10993-10), Intracutaneous Reactivity Test (ISO 10993-10), Acute Toxicity Test (ISO 10993-11), Pyrogen Test (ISO 10993-11) and Hemolysis Test (ASTM F756-17).
A simulated clinical use study was performed on 600 device samples each for the 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 requirements.
The bench testing performed verifies that the proposed device is as effective, and performs as well as the legally marketed predicate device in terms of critical performance characteristics. These tests are as follow.
- Limits of Acidity or Alkalinity Test
- Limits for Extractable Metals Test
- Surface Finish and Visual Appearance Test
- Dimensions Test Record
- Test Records for Resistance to Corrosion
- Penetration Force Test
- Puncture Depth Test
- Bond Between Needle Connector and Needle Test
The test results demonstrated that the proposed device complies with the following standards and guidance.
- ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO11137-2:2006, Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose
- ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems
- USP Bacterial Endotoxins Test
- USP-NF Sterility Tests
- USP-NF Pyrogen Test
- Simulated Use Study Sharps Injury Prevention Feature FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005
- Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" dated April 23, 2020
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
September 19, 2022
Image /page/0/Picture/1 description: The image shows the logo for 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Hebei Xinle Sci&Tech Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.Box 120-119 Shanghai, 200120 China
Re: K221839
Trade/Device Name: Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood lancets Regulatory Class: Class II Product Code: FMK Dated: June 21, 2022 Received: June 24, 2022
Dear Diana Hong:
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,
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Lancet
Indications for Use (Describe) It is intended for capillary blood sampling.
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
Tab # 6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 06/21/2022
-
- Sponsor Identification
Hebei Xinle Sci&Tech Co., Ltd
No.2, Xingye Street, Xinle City, 050700 Shijiazhuang City, Hebei Province, PEOPLE'S REPUBLIC OF CHINA Establishment Registration Number: 3014498762
Contact Person: Jianxun Tian Position: Regulatory Affairs Manager Tel: +86- 311-88581058 Fax: +86- 311-88655819 Email: tianjianxun@hbxinle.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +8621 2281-5850 Fax: 360 925-3199 Email: info@mid-link.net
Identification of Proposed Device 4.
Trade Name: Lancet Common Name: Blood Lancet
Regulatory Information
4
Classification Name: Single Use Only Blood Lancet with an Integral Sharps Injury Prevention Feature Classification: II Product Code: FMK Regulation Number: 21 CFR 878.4850 Review Panel: General & Plastic Surgery
Indications for Use: It is intended for capillary blood sampling.
Device Description
The propose device, Lancet, which is intended for capillary blood sampling. The safety protection mechanism is to prevent the reuse of products and protection against needle stick injury. The proposed devices are provided sterile, single use.
The proposed devices are divided into several models. In addition, the proposed devices are available in different specifications of needle gauge (21G, 28G and 30G) to allow to collect capillary blood sample.
-
ડ. Identification of Predicate Devices
510(k) Number: K192666 Product Name: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet Regulation number: 21 CFR 878.4850 Product Code: FMK -
- Comparison of Technological Characteristics
Table 1 Comparison of Technology Characteristics
| ITEM | Proposed Device | Predicate Device K192666 | Remark |
|---|---|---|---|
| Product Code | FMK | FMK | Same |
| Regulation Number | 21 CFR 878.4850 | 21 CFR 878.4850 | |
| Class | II | II | |
| Prescription/ | |||
| Over-The-Counter Use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Indications for Use | It is intended for capillary blood | ||
| sampling. | It is intended for capillary blood | ||
| sampling. | Same | ||
| Safety Protection | |||
| Features | Yes | Yes | Same |
| Operate mode | Manual | Manual | Same |
2 / 5
5
| Single Use | Yes | Yes | Same |
|---|---|---|---|
| Configuration | Shell, Trigger, Needle Connector, | ||
| Back Cap, Spring, Needle, Protective | |||
| Cap | Shell, Trigger, Needle Connector, | ||
| Back Cap, Spring, Needle, | |||
| Protective Cap | Same | ||
| Materials of Parts in | |||
| Contact with Human | |||
| Body | Shell (PP) | ||
| Trigger, Protective Cap (PS) | |||
| Needle Connector, Back Cap (PE) | |||
| Needle (Stainless Steel) | Needle (Stainless Steel) | ||
| Other Parts: Plastics Materials | Similar | ||
| Analysis 1 | |||
| Label/Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | Same |
| Needle Gauge | 21G, 28G, 30G | 21G, 23G, 26G, 28G, 30G | Similar |
| Analysis 2 | |||
| Performance | Comply with | ||
| ISO 9626 | |||
| ISO 7864 | Comply with | ||
| ISO 9626 | |||
| ISO 7864 | Same | ||
| Biocompatibility | In Vitro Cytotoxicity | ||
| Skin Sensitization | |||
| Intracutaneous | |||
| Reactivity | |||
| Acute Systemic Toxicity | |||
| Hemolytic Properties | |||
| Pyrogen Test | Conform with ISO 10993 | ||
| Standards | Same | ||
| Sterilization | Method | ||
| SAL | |||
| Endotoxin Limit | Radiation Sterilization | ||
| 10-6 | |||
| 20 EU per device | Same |
Analysis 1 –Materials of Parts in Contact with Human Body
Some parts' materials of proposed device maybe are different with predicate device. However, the biocompatibility test for proposed device has been tested and the results comply with the requirements of ISO 10993.
Analysis 2- Needle Gauge
6
The needle gauge between the proposed device and predicate device is different. The needle gauge of predicate device covers the scope of needle gauge of proposed device.
-
- Non-Clinical Test Summary
Non clinical tests were conducted to verify that the proposed devices met all design specifications as was Substantially Equivalent (SE) to the predicate device. The tests performed on the relevant device configurations include:
- Non-Clinical Test Summary
Biocompatibility test
Biocompatibility tests was conducted on the lancet, include in vitro cytotoxicity test (ISO 10993-5), skin sensitization Test (ISO 10993-10), Intracutaneous Reactivity Test (ISO 10993-10), Acute Toxicity Test (ISO 10993-11), Pyrogen Test (ISO 10993-11) and Hemolysis Test (ASTM F756-17).
Simulated Clinical Use
A simulated clinical use study was performed on 600 device samples each for the 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 requirements.
Bench test
The bench testing performed verifies that the proposed device is as effective, and performs as well as the legally marketed predicate device in terms of critical performance characteristics. These tests are as follow.
-
Limits of Acidity or Alkalinity Test
-
Limits for Extractable Metals Test
-
Surface Finish and Visual Appearance Test
-
Dimensions Test Record
-
Test Records for Resistance to Corrosion
-
Penetration Force Test
-
Puncture Depth Test
-
Bond Between Needle Connector and Needle Test
The test results demonstrated that the proposed device complies with the following standards and guidance.
- V ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices ->
7
Requirements and test methods
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
ISO11137-2:2006, Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose
- A ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
-
ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
-
ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems
-
USP Bacterial Endotoxins Test
-
USP-NF Sterility Tests
-
USP-NF Pyrogen Test
-
Simulated Use Study Sharps Injury Prevention Feature FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005
-
Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" dated April 23, 2020
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion