Disposable Sterile Lancet

K222055 · Tianjin Rilifine Medical Device Co., Ltd. · FMK · Nov 15, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222055
• Device Name: Disposable Sterile Lancet
• Applicant: Tianjin Rilifine Medical Device Co., Ltd.
• Product Code: FMK · General, Plastic Surgery
• Decision Date: Nov 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2

Intended Use

It is intended for capillary blood sampling.

Device Story

Disposable Sterile Lancet is a single-use, pressure-activated device designed for capillary blood sampling. It consists of a housing, fire button, springs, and a stainless steel needle. Operated by healthcare personnel or patients, the device is pressed against the skin to trigger the needle, which automatically retracts into the housing after use to prevent sharps injuries. The device is provided sterile via radiation. It is used in clinical or home settings to obtain blood samples for diagnostic testing. The device provides a safe, disposable mechanism for skin puncture, reducing the risk of accidental needlestick injuries compared to manual lancets.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against design specifications including appearance, dimensions, puncture depth, launch performance, and needle firmness. Biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity, pyrogenicity) performed per ISO 10993 standards. Sterility validated per ISO 11137.

Technological Characteristics

Single-use, pressure-activated blood lancet. Materials: stainless steel needle, ABS/PP plastic housing. Needle lengths: 0.7mm to 3.0mm. Sterilization: radiation (SAL 10^-6). Shelf life: 5 years. Mechanical actuation via internal springs.

Indications for Use

Indicated for capillary blood sampling in healthcare personnel, patients, and lay users.

Regulatory Classification

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)

Submission Summary (Full Text)

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### 11/15/2022

Tianjin Rilifine Medical Device Co., Ltd. Qiusheng Jiang Manager No 32, Jingguan Road, Yixingbu, Beichen District Tianiin. 300402 China

Re: K222055

Trade/Device Name: Disposable Sterile Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: October 20, 2022 Received: October 21, 2022

#### Dear Qiusheng Jiang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Carr -S

for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222055

Device Name Disposable Sterile 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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# K222055

# 510(K) SUMMARY

(In accordance with 21 CFR 807.92)

## 1.0 Submitter's Information

| Name: | Tianjin Rilifine Medical Device Co., Ltd. |
|----------------------|----------------------------------------------------------------------------|
| Address: | No 32, Jingguan Road, Yixingbu, Beichen District<br>Tianjin, 300402, CHINA |
| Phone Number: | 86-22-23233999 |
| Contact: | Mr. Qiusheng Jiang |
| Date of Preparation: | July 5, 2022 |

### 2.0 Device Information

| Device Name: | Disposable Sterile Lancet |
|----------------------|-----------------------------------------------------------------------------------|
| Common Name: | Rilifine Safety Lancet |
| Classification Name: | Single Use Only Blood Lancet With An Integral Sharps<br>Injury Prevention Feature |

### 3.0 Classification

| Product Code: | FMK |
|--------------------|---------------------------|
| Regulation Number: | 21 CFR 878.4850 |
| Classification: | II |
| Review Panel: | General & Plastic Surgery |

### 4.0 Predicate Device Information

| Manufacturer: | Promisemed Hangzhou Meditech Co., Ltd. |
|----------------|---------------------------------------------------------------------------------|
| Device: | Promisemed Blood Lancet, VeriFine Safety Lancet,<br>VeriFine Mini-Safety Lancet |
| 510(k) Number: | K192666 |
| Classification | I |
| Product Code | FMK |

### 5.0 Intended Use

It is intended for capillary blood sampling.

## 6.0 Device Description

Disposable Sterile Lancet is Class II Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature bearing the product code FMK (21CFR878.4850).

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The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples.

The intended users include healthcare personnel, patients and lay users.

The Disposable Sterile Lancet consist of protective cap, housing, bottom, fire button, connection ring, springs (ejection spring and fire spring), and core of lancet (including needle).

The sterile part of the lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10° by radiation sterilization. It is intended for single use only. The shelf life of the product is 5 years.

### 7.0 Comparison of Technological Characteristics with Predicate Device

| Item | Subject Device | Predicate Device<br>(K192666) | Comparison<br>Result |
|---------------------------------|----------------------------------------------------|------------------------------------------------------------------------------------------|----------------------|
| Manufacturer | Tianjin Rilifine Medical<br>Device Co., Ltd. | Promisemed Hangzhou<br>Meditech Co., Ltd. | -- |
| 510K number | -- | K192666 | -- |
| Product name | Disposable Sterile Lancet | Promisemed Blood<br>Lancet,<br>VeriFine Safety Lancet,<br>VeriFine Mini-Safety<br>Lancet | -- |
| Classification | II | I | See Note 1 |
| Product Code | FMK | FMK | Same |
| Regulation<br>Number | 21 CFR 878.4850 | 21 CFR 878.4800 | See Note 1 |
| Intended Use | It is intended for<br>capillary blood<br>sampling. | It is intended for<br>capillary blood<br>sampling. | Same |
| Single Use | Single Use | Single Use | Same |
| Feature | Safety protection | Safety protection | Same |
| Principles of<br>operation | Pressure activated | Pressure activated | Same |
| Sterilization<br>method and SAL | Sterilized by radiation<br>SAL=10-6 | Sterilized by radiation<br>SAL=10-6 | Same |
| Shelf life | 5 years | 5 years | Same |

The following table is the summary of the technological characteristics, biocompatibility of the proposed subject device and predicate device.

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| | Item | Subject Device | Predicate Device<br>(K192666) | Comparison<br>Result |
|-------------------|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------|
| Bio-compatibility | Materials of parts<br>in contact with<br>human body | Needle: stainless steel<br>Other parts: plastic<br>materials, such as ABS, PP<br>etc. | Needle: stainless steel<br>Other parts: plastic<br>materials | Similar, See<br>note 2 |
| | Needle length | 0.7mm, 0.8mm, 0.9mm,<br>1.0mm, 1.1mm, 1.2mm,<br>1.3mm, 1.4mm, 1.5mm,<br>1.6mm, 1.7mm, 1.8mm,<br>1.9mm, 2.0mm, 2.1mm,<br>2.2mm, 2.3mm, 2.4mm,<br>2.5mm, 2.6mm, 2.7mm,<br>2.8mm, 2.9mm, and<br>3.0mm | 1.2mm, 1.4mm, 1.6mm,<br>1.8mm, 2.0mm, 2.2mm,<br>2.4mm, 2.6mm, 2.8mm | Similar, see<br>note 3 |
| | Primary<br>Skin<br>Irritation | Under the condition of<br>study not an irritant | Under the condition of<br>study not an irritant | Same |
| | Dermal<br>Sensitization | Under the conditions of the<br>study not a sensitizer | Under the conditions of the<br>study not a sensitizer | Same |
| | Cytotoxicity | Under the conditions of the<br>study, no cytotoxic potential | Under the conditions of the<br>study, no cytotoxic potential | Same |

Note 1: The classification and regulation number are different because FDA issued the final order about reclassification of Blood Lancet Nov 22, 2021.

Note 2: The raw materials of the proposed devices may be different from the predicate device. However, all the materials are known biocompatible materials that have been used in lancets or other similar medical devices.

Note 3: The length for the proposed device is wider than the predicate device K192666. Concerning the differences to the predicate devices, testing is done to the representative length of the proposed device, which are the extreme conditions for the device, that is length of 0.7mm (to review whether the length is long enough to get the required penetration), and length of 3.0mm (to review whether the length is too long to affect the retraction of the needle-tip after the product is activated). And based on the testing report, it is showed that the performance and safety feature for the products are not affected.

There are no significant differences between the two products and are identical in terms of intended use, design and technological characteristics.

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# 8.0 Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

- ISO 11137-1 First edition 2006-04-15, Sterilization of health care products -. Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
- ISO 11137-2 Third edition 2013-06-01, Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-23 First edition 2021-01,Biological evaluation of medical devices -● Part 23: Tests for irritation

Performance testing verified that the proposed device is as safe, as effective and performs as well as the legally marketed predicate device in terms of critical performance characteristics as follows:

| Items | | Acceptance Criteria | Results |
|-------------|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Appearance | Product Appearance | No obvious foreign body, fracture, unformed defects etc. | Meet the requirements |
| | Needle-tip | No obvious burrs, curved hooks, oil stains etc. Lancet should be well assembled, no obvious dislocation at the fitting of the shell | Meet the requirements |
| Dimensions | Diameter of needle core | Product dimensions shall be consistent to the drawings | Meet the requirements |
| | Length of exposed needle-tip | The length of exposed needle-tip shall be consistent to the drawings. | Meet the requirements |
| Performance | Puncture Depth | Using A4 printing paper for simulated testing and meet the requirements | Meet the requirements |
| | Launch performance | The operation of Fire should be smooth, after launching, | Meet the requirements |

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| | | the tip of the needle should<br>be automatically retracted<br>into the housing | |
|-----------|----------|--------------------------------------------------------------------------------|-----------------------|
| | Firmness | Needle should connect<br>firmly with plastic handle | Meet the requirements |
| Sterility | | The sterility for the device<br>shall be at SAL of 10-6 | Meet the requirements |

Biocompatibility testing as per ISO 10993 standards:

| Item | Subject device | Result |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------|--------|
| Cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Irritation | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |
| Sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Acute systemic toxicity | Under the condition of this study, not an acute systemic cytotoxic potential | Pass |
| Pyrogenicity | Under the condition of this study, no pyrogenicity reaction | Pass |

# 9.0 Clinical Test

No clinical study is included in this submission.

# 10. Comparison to the Predicate Device and Conclusion

The conclusion drawn from the nonclinical tests demonstrate that the subject device Disposable Sterile Lancet has the same indication for use and has similar design features and technological characteristic as the predicate device, and the proposed device is as safe, as effective and performs as well as the legally marketed predicate device K192666.