← Product Code [FMK](/submissions/SU/subpart-e%E2%80%94surgical-devices/FMK) · K221839 # Lancet (K221839) _Hebei Xinle Sci&Tech Co., Ltd. · FMK · Sep 19, 2022 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FMK/K221839 ## Device Facts - **Applicant:** Hebei Xinle Sci&Tech Co., Ltd. - **Product Code:** [FMK](/submissions/SU/subpart-e%E2%80%94surgical-devices/FMK.md) - **Decision Date:** Sep 19, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4850 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use It is intended for capillary blood sampling. ## Device Story Single-use, sterile, manual blood lancet; features integral sharps injury prevention mechanism to prevent reuse and needle stick injuries. Device consists of shell, trigger, needle connector, back cap, spring, needle, and protective cap. Available in 21G, 28G, and 30G needle gauges. Operated manually by user to puncture skin for capillary blood collection. Safety mechanism ensures needle retraction or shielding post-use. Intended for over-the-counter use. ## Clinical Evidence No clinical data. Bench testing only. Simulated clinical use study performed on 600 samples per FDA guidance and ISO 23908 to verify sharps injury prevention. Biocompatibility testing conducted per ISO 10993-5, -10, -11, and ASTM F756-17. Performance testing verified compliance with ISO 7864 and ISO 9626. ## Technological Characteristics Materials: Shell (PP), Trigger/Protective Cap (PS), Needle Connector/Back Cap (PE), Needle (Stainless Steel). Energy: Manual spring-actuated. Dimensions: 21G, 28G, 30G gauges. Sterilization: Radiation (SAL 10^-6). Standards: ISO 7864, ISO 9626, ISO 23908, ISO 10993 series, ASTM F756-17. ## Regulatory Identification The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes. ## Special Controls *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. ## Predicate Devices - Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet ([K192666](/device/K192666.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) K221839 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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: - 1. Date of Preparation: 06/21/2022 - 2. 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 - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person) 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 - 6. 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. - 7. 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: #### 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 <85> Bacterial Endotoxins Test - > USP-NF<71> Sterility Tests - > USP-NF<151> 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 - 8. Clinical Test Conclusion No clinical study is included in this submission. - 9. 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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FMK/K221839](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FMK/K221839) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com