(25 days)
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 intended to be used by a single patient and should not be shared. (HH-X-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, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T)
The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T)
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, main body and protective cap. 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 obtain a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM, PC and PS Resin. And the spring is made of carbon steel. The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first. For Model HH-XIII-T, the service life of the Lancing Device is 10 years or 5000 times of normal use, whichever comes first. The Lancing Device is provided non-sterile.
The provided text is a 510(k) summary for a medical device (Lancet and Lancing Device). This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than extensive clinical studies or AI/software performance evaluations. Therefore, many of the requested details related to "AI performance," "expert ground truth," "MRMC studies," and "training sets" are not applicable to this document.
However, I can extract the relevant acceptance criteria and study information provided for this medical device based on the document's content.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of quantitative acceptance criteria and corresponding performance metrics for the device in the format common for AI/software devices. Instead, it generally states that the device "met the performance criteria outlined" and that "all verification and validation tests passed without deviations." The performance evaluation for this device category (lancets and lancing devices) would typically involve mechanical, sterilization, biocompatibility, and functional tests.
Here's an interpretation of the implied acceptance criteria and reported performance based on the "Non-Clinical Testing" section:
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Performance | Device meets all established performance specifications (e.g., proper piercing, blood collection, retraction, durability). | "The testing confirmed that the lancet and lancing device meet the performance criteria outlined." |
| Sterilization | Sterility Assurance Level (SAL) of $10^{-6}$ for lancets sterilized by radiation. | "No Change" from predicate, implying adherence to this SAL. |
| Biocompatibility | New material (PE) is biocompatible and non-toxic (as per ISO 10993-1). | "The results confirmed that the material is nontoxic and safe for use in its intended application." |
| Simulated Clinical Use | Safety mechanism meets pre-established criteria (as per FDA Guidance and ISO 23908). | "The results demonstrated that the proposed device met the pre-established criteria." |
| Durability (Lancing Device) | Service life of 5 years or 5000 uses (or 10 years/5000 uses for model HH-XIII-T). | "The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first." (Specifically mentions HH-XIII-T). |
| Sharp Injury Prevention | Device design prevents sharp injuries after use. | "Lancet retracted after use to prevent sharp injure" (Comparison table), confirming this feature. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the Simulated Clinical Use study, 640 device samples were used for both the Lancet and the Lancing Device. Other performance and biocompatibility tests would have their own sample sizes, but these are not explicitly stated in this summary for each specific test (e.g., mechanical tests, needle integrity, etc.).
- Data Provenance: The studies were conducted by Tianjin Huahong Technology Co., Ltd. (China). The data origin is thus China. The studies described are prospective tests performed on the new device, not retrospective data analysis.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. This device is a mechanical medical device, not an AI/software device that requires expert radiological or clinical interpretation to establish ground truth for performance evaluation in the way AI algorithms do. The "ground truth" for this device's acceptance is based on engineering specifications, physical measurements, biological safety tests (biocompatibility), and functional performance tests against established standards.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI/software performance study relying on human interpretation, there is no "adjudication" in the sense of reconciling expert opinions. Performance is assessed against quantitative engineering specifications and standard test methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document is for a mechanical medical device (lancet and lancing device), not an Artificial Intelligence (AI) or software device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or discussed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. Performance is evaluated through physical and functional testing of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for showing the device meets acceptance criteria is based on:
- Engineering Specifications/Standards: Performance criteria outlined in internal specifications and relevant international standards (e.g., ISO 23908 for sharps injury prevention, ISO 10993-1 for biocompatibility).
- Physical Measurements: E.g., needle length range, gauge range.
- Functional Testing: Demonstrating the device performs its intended action (capillary blood sampling, proper retraction).
- Biocompatibility Testing: Laboratory results confirming non-toxicity and safety of materials.
- Safety Mechanism Testing: Verification that sharps injury prevention features work as intended.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for a training set.
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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
November 15, 2024
Tianjin Huahong Technology Co., Ltd. Ningning Wang Registered Engineer A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone(Air Port Industrial Park) Tianjin, 300308 China
Re: K243306
Trade/Device Name: Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VIII, IX); Lancing device (HH-X-T. HH-XV-T. HH-XVI-T. HH-XVI-T. HH-XVIII-T. HH-XIX. HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: ORL, ORK Dated: October 17, 2024 Received: October 21, 2024
Dear Ningning Wang:
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 (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 available 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
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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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,
Digitally signed by Long H. Chen
Long H. Chen -S-5
Date: 2024.11.15 10:06:41 -05'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
| Device Name | Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX);Lancing device (HH-X-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, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) |
|---|---|
| Indications for Use (Describe) | |
| 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 intended to be used by a single patient and should not be shared. (HH-X-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, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T)The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T) |
| 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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510(k) summary
l Submitter
Tianjin Huahong Technology Co., Ltd. A01, Plant B, No.278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park), 300308 Tianjin, China
Establishment Registration Number: 3009498536
Contact person: Ms. Ningning Wang Registered Engineer Tel.: +86-13021381776 E-mail: ningning.wang@hh-technology.com
Preparation date: October 17, 2024
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: | K220475 |
|---|---|
| Trade name: | Lancet, Lancing device |
| Classification: | Class II |
| Product Code: | QRL, QRK |
| Manufacturer: | Tianjin Huahong Technology Co., Ltd. |
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.
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The Lancet is composed three components: needle, main body and protective cap. 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 obtain a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM, PC and PS Resin. And the spring is made of carbon steel.
The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first.
For Model HH-XIII-T, the service life of the Lancing Device is 10 years or 5000 times of normal use, whichever comes first.
The Lancing Device is provided non-sterile.
V Indication for use
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 intended to be used by a sinqle patient and should not be shared. (HH-X-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, HH-XXV-T, HH-XXVI-T, HH-XXVII-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T) The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T).
VI Comparison of technological characteristics with the predicate devices The comparison and discussion between the Proposed device and the predicate devices are listed in below table 1&2:
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| Item | Predicate device(K220475) | Proposed device | Comments onSimilarities/Differences | Safety/EffectivenessStatement |
|---|---|---|---|---|
| Product name | Lancet | No Change | N/A | No new concerns.The product name remainsunchanged |
| Product Code | QRL and QRK | No Change | N/A | No new concerns.The product code remainsthe same, reflecting nochange in devicefunctionality. |
| Regulation No. | 21 CFR § 878.4850 | No Change | N/A | No new concerns.The regulation numberremains consistent. |
| Class | II | No Change | N/A | No new concerns.The device remains in ClassII, indicating no change inrisk level. |
| Prescription/over-the-counter use | Over-The-Counter Use | No Change | N/A | No new concerns.The over-the-counter useremains consistent. |
| Indication for use | The lancet is intended forcapillary blood sampling. | No Change | N/A | No new concerns.The Indication for useremains consistent. |
| Applicable user | Healthcare professional or layperson | No Change | N/A | No new concerns.The applicable user remainsconsistent. |
| Reuse durability | Single use | No Change | N/A | No new concerns.The single use remainsconsistent. |
| Sterilization methodand SAL | Sterilized by RadiationSAL=10-6 | No Change | N/A | No new concerns.The sterilization method andSAL remains consistent. |
| Manufacturingaspects | For the Lancet, stainless steelneedle is fed into an injectionmolding machine to over-moldplastic material (polyethylene(PE) and Ethylene Vinyl Acetate(EVA) and calcium powder)forming a body and cap,encapsulating the stainless steelneedles. | No Change | N/A | No new concerns.The manufacturing aspectsremains consistent. |
| Design andFunctionalityaspects | The Lancet comprises astainless steel needleencapsulated with a plastic bodyand cap, the cap is twisted off toexpose the needle for use | No Change | N/A | No new concerns.The design and functionalityaspects remains consistent. |
| 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) | 3.2±0.3mm (Model:IA、IB、IC、ID、IE、IK、IL、IM、IIA、IIB、III、VI、VII)2.1±0.3mm (Model: V)2.2±0.3mm (Model:VIII, IX ) | New three modelsof VII, VIII and IXwere added. | No new concerns.Model VII can only be usedin conjunction with ourcompany's HH-XXV-Tlancing device. After theperformance test and thematching test, the productcan be guaranteed to besafe and effective. Model VIIIcan only be used inconjunction with ourcompany's HH-XXIX-Tlancing device. After theperformance test and thematching test, the productcan be guaranteed to besafe and effective. Model IXcan only be used inconjunction with ourcompany's HH-XXX-Tlancing device. After the |
| performance test and thematching test, the productcan be guaranteed to besafe and effective. Model IXis a little smaller than modelVIII. | ||||
| 1.50±0.02mm (16G) | 1.50±0.02mm (16G) | |||
| 1.20±0.01mm (18G) | 1.40±0.02mm (17G) | |||
| 1.07±0.01mm (19G) | 1.20±0.01mm (18G) | |||
| 0.91±0.01mm (20G) | 1.07±0.01mm (19G) | |||
| 0.82±0.01mm (21G) | 0.91±0.01mm (20G) | |||
| 0.72±0.01mm (22G) | 0.82±0.01mm (21G) | |||
| 0.64±0.01mm (23G) | 0.72±0.01mm (22G) | New three size of | No new concerns. | |
| Gauge range | 0.57±0.01mm (24G) | 0.64±0.01mm (23G) | 17G, 35G and 37Gwere added. | The added sizes are withinthe original approved sizes. |
| 0.51±0.01mm (25G) | 0.57±0.01mm (24G) | |||
| 0.46±0.01mm (26G) | 0.51±0.01mm (25G) | |||
| 0.41±0.01mm (27G) | 0.46±0.01mm (26G) | |||
| 0.36±0.01mm (28G) | 0.41±0.01mm (27G) | |||
| 0.34±0.01mm (29G) | 0.36±0.01mm (28G) | |||
| 0.31±0.01mm (30G) | 0.34±0.01mm (29G) | |||
| 0.26±0.01mm (31G) | 0.31±0.01mm (30G) | |||
| 0.24±0.01mm (32G) | 0.26±0.01mm (31G) | |||
| 0.21±0.01mm (33G) | 0.24±0.01mm (32G) | |||
| 0.19±0.01mm (34G) | 0.21±0.01mm (33G) | |||
| 0.17±0.01mm (36G) | 0.19±0.01mm (34G) | |||
| 0.15±0.01mm (38G) | 0.18±0.01mm (35G) | |||
| 0.17±0.01mm (36G) | ||||
| 0.16±0.01mm (37G) | ||||
| 0.15±0.01mm (38G) | ||||
| Shelf-life | 5 years | No Change | N/A | No new concerns.The shelf-life aspectsremains consistent. |
| Materials of parts incontact with humanbody | The Lancet has a needle that ismade of stainless steel and abody and a cap that are made ofpolyethylene and Ethylene VinylAcetate (EVA) and calciumpowder. | The Lancet has a needlethat is made of stainlesssteel and a body and acap that are made ofpolyethylene and EthyleneVinyl Acetate (EVA) andcalcium powder. | Material of bodyand a cap is addedthe PE which isonly contact intactskin. | No new concerns.The raw materials added thistime are the same as inK220475, all are PE, only thegrades are different, and thehuman body surface is incontact with the completeskin, reviewed geometricchanges per CDRH'sBiocompatibility Guidance,That these materials pose a |
| very low biocompatibility risk,and we have done theappropriate biological testsfor this purpose, and the testresults show that it meets therequirements. | ||||
| Biocompatibility | Conforms to the requirements ofISO 10993 series standards. | No Change | N/A | No new concerns.The biocompatibility remainsconsistent. |
| Performancerequirements | Remain no change | No Change | N/A | No new concerns.Performance requirementsremain unchanged, ensuringconsistent functionality. |
| Label/Labeling | Complied with 21 CFR part 801 | No Change | N/A | No new concerns.The labeling remainsconsistent. |
Table 1 General Comparison of Lancet
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| Table 2 General Comparison of Lancing device | ||||
|---|---|---|---|---|
| Item | Predicate device(K220475) | Proposed device | Comments onSimilarities/Differences | Safety/EffectivenessStatement |
| Product name | Lancing device | No Change | N/A | No new concerns.The product name remainsunchanged |
| Product Code | QRL | No Change | N/A | No new concerns.The product code remainsthe same, reflecting nochange in devicefunctionality. |
| Regulation No. | 21 CFR § 878.4850 | No Change | N/A | No new concerns.The regulation numberremains consistent. |
| Class | II | No Change | N/A | No new concerns.The device remains inClass II, indicating nochange in risk level. |
| Prescription/over-the-counter use | Over-The-Counter Use | No Change | N/A | No new concerns.The over-the-counter useremains consistent. |
| Indication for use | The Lancing Device is used withlancets to draw capillary bloodfrom the fingertip, for testingutilizing small amounts of blood.The Lancing Device is intended tobe used by a single patient andshould not be shared. | The Lancing Device is used withlancets to draw capillary bloodfrom the fingertip, for testingutilizing small amounts of blood.The Lancing Device is intended tobe used by a single patient andshould not be shared. (HH-X-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, HH-XXV-T, HH-XXVI-T, HH-XXVII-T, HH-XXVIII-T, HH-XXIX-T,HH-XXX-T, HH-XIII-T)The Lancing Device is used withlancets to draw capillary bloodfrom the fingertip, palm (at thebase of the thumb) or forearm, fortesting utilizing small amounts ofblood. The Lancing Device isintended to be used by a singlepatient and should not be shared.(HH-XXVII-T) | Increase inIndication for Use(add palm andforearm) of thenew model HH-XXVII-T | No new concerns becausethe additional intended usesite of HH-XXVII-T (palmand forearm) was coveredby the predicatedevice(K113332) of ourpredicate device (K220475) |
| Puncture device toobtain micro bloodsamples | Yes | No Change | N/A | No new concerns.The function is the same. |
| Lancet retractedafter use to preventsharp injure | Yes | No Change | N/A | No new concerns.The prevent sharp injure isthe same. |
| Device penetrationdepth range | 0.85 | 0.85 | New six models ofHH-XXV-T, HH-XXVI-T, HH-XXVII-T, HH-XXVIII-T,HH-XXIX-T, andHH-XXX-T wereadded. | No new concerns.The newly added modelsare only changed inappearance anddimensions compared toK220475. |
| Mechanical loadingand firing function | Cocking barrel with releasingbutton | No Change | N/A | No new concerns. |
| The mechanical loadingand firing function remainsconsistent. | ||||
| Materials | ABS, POM, PC | ABS, POM, PC and PS | Increase in rawmaterial PS | No new concerns.This addition of rawmaterial PS will only comeinto contact with completeskin on the surface of thehuman body, reviewedgeometric changes perCDRH's BiocompatibilityGuidance, That thesematerials pose a very lowbiocompatibility riskbecause they have a longhistory of safe use in legallymarketed medical devicesthat contact intact skin. |
| Reuse durability | ReusableSingle Patient Use Only | No Change | N/A | No new concerns.The reuse durabilityremains consistent. |
| Sterilization methodand SAL | NA | NA | N/A | N/A |
| Performancerequirements | Remain no change | No Change | N/A | No new concerns.Performance requirementsremain unchanged,ensuring consistentfunctionality. |
| Label/Labeling | Complied with 21 CFR part 801 | No Change | N/A | No new concerns.The labeling remainsconsistent. |
Table 2 General Comparison of Lancing device
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VII Non-Clinical Testing
To support substantial equivalence to the predicate device, Tianjin Huahong Technology Co., Ltd. completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met.
Verification and Validation Activities - Design Changes:
Sizes and model: Additional sizes ranging and model were introduced to meet clinical needs.
Material: The lancet body and cap material was changed to include PE to improve manufacturing efficiency. The new material was tested and found to be biocompatible and non-toxic as per ISO 10993-1.
Testing Performed:
Performance Testing: The lancet and lancing device underwent performance testing (reports HH-JS-RP-2024-03 and HH-JS-RP-2024-04), The testing confirmed that the lancet and lancing device meet the performance criteria outlined.
Biocompatibility Testing: The new PE material was tested for In Vitro cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, and pyrogenicity according to ISO 10993-1 standards. The results confirmed that the material is nontoxic and safe for use in its intended application.
Simulated Clinical Use
A simulated clinical use study was performed on 640 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.
Test Results:
All verification and validation tests passed without deviations, confirming that the lancet and lancing device meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device.
Conclusions:
Based on the results of the non-clinical verification and validation activities, it can be concluded that the modified lancet and lancing device are substantially equivalent to
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the predicate device K220475. The changes, including the addition of new needle sizes and the material change, have been thoroughly evaluated and verified to meet all applicable performance and safety standards. Therefore, the device is as safe and effective as the predicate device for its intended use, and no new risks have been introduced.
VIII Clinical Testing
No clinical study is included in this submission.
Conclusion when compared to the predicate devices have been successfully evaluated through appropriate safety and performance testing which demonstrates that the proposed device, when compared to the predicate device, does not raise any new questions of safety and effectiveness. Therefore, the proposed device have been determined to be substantially equivalent to the predicate devices.
§ 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.