Safety Lancet

K223208 · Suzhou Zhenwu Medical Co., Ltd. · FMK · Feb 10, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K223208
• Device Name: Safety Lancet
• Applicant: Suzhou Zhenwu Medical Co., Ltd.
• Product Code: FMK · General, Plastic Surgery
• Decision Date: Feb 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The safety lancet is intended for capillary blood sampling.

Device Story

Safety lancet for capillary blood sampling; single-use, disposable device. Comprises needle core, protective cap, plug, trigger, spring, outer case, and end cap. Operation: user pulls off protective cap, triggers device to puncture skin; needle automatically retracts into housing post-activation to prevent accidental needle sticks. Used in clinical or home settings by patients or healthcare providers. Benefits: provides safe, sterile blood sampling while minimizing sharps injury risk.

Clinical Evidence

No clinical testing performed. Evidence consists of bench testing and simulated clinical use testing on 500 samples per FDA guidance for sharps injury prevention features. Testing verified cap removal force, needle firmness, drop resistance, puncture force, and safety feature activation.

Technological Characteristics

Materials: PE (needle core), SUS304 (needle), ABS (housing/trigger), TPE (plug), SWC (spring). Sterilization: Gamma radiation (SAL 10^-6). Dimensions: 18G-30G needles, 1.2-2.4mm penetration depth. Standards: ISO 7864:2016 (puncture force/needle firmness), ISO 9626:2016 (tubing), ISO 23908:2011 (sharps injury prevention), ISO 10993 (biocompatibility), ISO 11137 (sterilization).

Indications for Use

Indicated for capillary blood sampling in adults and pediatrics. If user is under 18, must be used by an adult or under adult supervision.

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

• Tianjin Huahong Safety Lancet (K220370)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of 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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

February 10, 2023

Suzhou Zhenwu Medical Co., Ltd. % Evan Hu Marketing & Technical Manager Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai. 201114 China

Re: K223208

Trade/Device Name: Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: January 19, 2023 Received: January 19, 2023

Dear Evan Hu:

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

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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 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 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 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, PhD 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K223208

Device Name Safety Lancet

Indications for Use (Describe)

The safety lancet 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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# K223208 510(K) SUMMARY

## 1. Preparation date: 1/27/2023

## 2. Submitter

Manufacturer: Suzhou Zhenwu Medical Co., Ltd. Address: No.248, Chijiawan Road, Beishe Town, Fenhu Development Area, Wujiang District, Suzhou City, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA Contact person: Kai Xu, General Manager, Tel: [phone], [e-mail] Submission correspondent: Evan Hu, 86-18616124827, [e-mail]

## 3. Device

Trading name: Safety Lancet Common name: Safety Lancet Classification Name: Single Use Only Blood Lancet With an Integral Sharps Injury Prevention Feature Classification: Class II Product code: FMK

## 4. Predicate device

Predicate device: Tianjin Huahong Safety Lancet– K220370

## 5. Device description

The safety lancet consists of needle core, protective cap, plug, trigger, spring, outer case and end cap. The sterile part of the safety 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.

The safety lancet is intended for capillary blood sampling. The device was designed to minimize the risk from accidental needle sticks with a used needle by application of a sharp injury prevention feature. The needle tip back into the safety lancet body automatically after launch and cannot be reused. The safety lancet can be disposed safely.

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Image /page/4/Picture/0 description: The image shows a diagram of a device being assembled in four steps. In the first step, a rectangular piece is being placed on top of a cylindrical device. In the second step, the rectangular piece is being pushed down into the cylindrical device. In the third step, a small object is being inserted into the rectangular piece. In the fourth step, the device is fully assembled.

Figure 1. Schematic diagram of the working principle

| No. | Gauge | Needle Diameter(mm) | | Exposed Needle Length(mm) | | Color |
|-----|-----------|---------------------|-------|---------------------------|-----------|--------------|
| | | ODMIN | ODMAX | Length | Tolerance | |
| 1 | 30G | 0.298 | 0.320 | 1.2 | $\pm$ 0.3 | peacock blue |
| 2 | 30G | 0.298 | 0.320 | 1.6 | $\pm$ 0.3 | peacock blue |
| 3 | 30G | 0.298 | 0.320 | 1.8 | $\pm$ 0.3 | peacock blue |
| 4 | 28G | 0.349 | 0.370 | 1.8 | $\pm$ 0.3 | purple |
| 5 | 26G | 0.440 | 0.470 | 1.8 | $\pm$ 0.3 | yellow |
| 6 | 23G | 0.600 | 0.673 | 1.8 | $\pm$ 0.3 | Orange |
| 7 | 23G | 0.600 | 0.673 | 2.2 | $\pm$ 0.3 | Orange |
| 8 | 23G | 0.600 | 0.673 | 2.4 | $\pm$ 0.3 | Orange |
| 9 | 21G | 0.800 | 0.830 | 1.8 | $\pm$ 0.3 | Blue |
| 10 | 21G | 0.800 | 0.830 | 2.0 | $\pm$ 0.3 | Blue |
| 11 | 21G | 0.800 | 0.830 | 2.2 | $\pm$ 0.3 | Blue |
| 12 | 21G | 0.800 | 0.830 | 2.4 | $\pm$ 0.3 | Blue |
| 13 | 21G Blade | 0.800 | 0.830 | 2.0 | $\pm$ 0.3 | Bottle green |
| 14 | 21G Blade | 0.800 | 0.830 | 2.2 | $\pm$ 0.3 | Bottle green |
| 15 | 21G Blade | 0.800 | 0.830 | 2.4 | $\pm$ 0.3 | Bottle green |
| 16 | 18G | 1.200 | 1.300 | 2.0 | $\pm$ 0.3 | Rose |
| 17 | 18G | 1.200 | 1.300 | 2.2 | $\pm$ 0.3 | Rose |
| 18 | 18G | 1.200 | 1.300 | 2.4 | $\pm$ 0.3 | Rose |
| 19 | 18G Blade | 1.200 | 1.300 | 2.0 | $\pm$ 0.3 | Light green |
| 20 | 18G Blade | 1.200 | 1.300 | 2.2 | $\pm$ 0.3 | Light green |
| 21 | 18G Blade | 1.200 | 1.300 | 2.4 | $\pm$ 0.3 | Light green |

Table 1. Device models

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## 6. Indications for use/Intended use

The safety lancet is intended for capillary blood sampling.

## 7. Comparison of technological characters between proposed and predicate devices

| Characters | Proposed device<br>(K223208-Safety Lancet) | Predicate device<br>(K220370-Safety Lancet) | Remark |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Product code | FMK | FMK | Same |
| Regulation No. | 21 CFR 878.4850 | 21 CFR 878.4850 | Same |
| Classification | Class II | Class II | Same |
| Indications for use | The safety lancet is intended<br>for capillary blood sampling. | The safety lancet is intended<br>for capillary blood sampling. | Same |
| Intended<br>population | Adults and pediatrics. If user<br>is under the age of 18, the<br>safety lancet must be used by<br>an adult or under the<br>supervision of an adult. | Adults and pediatrics. | Same |
| Type of use | over-the-counter | over-the-counter | Same |
| Configuration and<br>materials | Needle core: PE<br>Needle: SUS304<br>Outer case, End case, Tigger:<br>ABS<br>Plug: TPE<br>Spring: SWC | Needle core: PE, PP, Calcium<br>powder<br>Needle: stainless steel,<br>silicone oil<br>Housing, Button, Bottom,<br>Protective cap, Small lid,<br>Depth adjuster ring: ABS,PS | Similar<br>#1 |
| Needle Gauge | Normal: 30G, 28G, 26G, 23G,<br>21G, 18G<br>Blade: 21G, 18G | Normal: 30G, 28G, 26G,<br>23G, 21G | Similar<br>#2 |
| Sterilization and<br>SAL | Sterilized by gamma<br>radiation<br>SAL = $10^{-6}$ | Sterilized by gamma<br>radiation<br>SAL = $10^{-6}$ | Same |
| Single-use | Single use on one patient, no<br>more than one use | Single use on one patient,<br>no more than one use | Same |
| Sharp injury<br>protection<br>function | The puncture function can<br>be only used after the cap<br>was pulled off | The puncture function can<br>be only used after the cap<br>was twisted off | Similar<br>#3 |
| | | | |
| Safety feature | Lancet retracts into body of device after activation.<br>The force to activate the safety feature: round 8.8N<br>Test access to the sharp: the needle shall not touch the sphere. | Lancet retracts into body of device after activation.<br>The force to activate the safety feature: 4-15N<br>Test access to the sharp: the needle shall not touch the sphere. | Same |
| Exposed needle<br>length/penetration<br>depth (max) | 1.2~2.4 mm<br>30G: 1.2, 1.6, 1.8 mm<br>28G: 1.8 mm<br>26G: 1.8 mm<br>23G: 1.8, 2.2, 2.4 mm<br>21G: 1.8, 2.0, 2.2, 2.4 mm<br>21G(Blade): 2.0, 2.2, 2.4 mm<br>18G: 2.0, 2.2, 2.4 mm<br>18G(Blade): 2.0, 2.2, 2.4 mm | 1.0~3.0 mm<br>30G: 1.0, 1.6 mm<br>28G: 1.8 mm<br>26G: 1.8 mm<br>23G: 1.8 mm<br>21G: 2.2, 2.8, 3.0mm | Similar<br>#4 |
| Cap removal | Pull off<br>Force: 3~9N | Twist off<br>Force: Not revealed | Different<br>#5 |
| Shelf-life | 5 years | 5 years | Same |
| Biocompatibility | No cytotoxicity<br>No irritation<br>No skin sensitization<br>No acute systemic toxicity<br>No pyrogens | No cytotoxicity<br>No irritation<br>No skin sensitization<br>No acute systemic toxicity<br>No thermogenic reaction | Same |

Table 2. Characters comparison

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## Similar #1

The safety lancet typically comprises three components, housing, needle, and spring. The component of the housing is mainly plastic. The component of the needle is stainless steel, and the spring consists of steel. Although the proposed and predicate devices use different materials, the types of components are unchanged. Besides, the performance testing reports, and biocompatibility testing reports show all the testing items meet requirements. This difference on materials has a minimal impact on the performance of the products.

In conclusion, the proposed device and predicate device are substantially equivalent.

#### Similar #2

The proposed device has six types of gauges, more than the predicate device, like 30G normal needle and 21G blade needle. Meanwhile, the proposed device has a new type-blade beveled needle tip. The differences between the blade and regular beveled tip are the beveled angle

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and beveled face number; the blade beveled tip has a smaller bevel angle than the regular one, but more beveled faces. The needle length of the proposed device is included in the length range of the predicate device. The performance testing (e.g., needle removal force, puncture force testing) results demonstrated that the proposed device can be used safely and effectively.

In conclusion, the proposed device and predicate device are substantially equivalent.

#### Similar #3

The different methods to remove the protective cap will not affect sharps injury protection. The related report has verified the sharps injury protection function of the device. The needle tip is molded in plastic housing to ensure sterility. The different ways of activating the safety lancet do not influence the performance.

In conclusion, the proposed device and predicate device are substantially equivalent.

#### Similar #4

The exposed needle length/depth falls within the range of the Predicate device. The performance testing report verifies the proposed device's sharps injury protection function.

In conclusion, the proposed device and predicate device are substantially equivalent.

## Different #5

The cap removal type is different. Unlike the predicate device twisting off the cap, the proposed device pulls off the cap. The cap removal force testing demonstrates the proposed device meets the internal requirements 3°9N; these requirements are similar to other cleared lancets.

In conclusion, the proposed device and predicate device are substantially equivalent.

## 8. Non-clinical testing results

## (1) Physical performance testing

The proposed device's physical performance was tested to evaluate the overall nonclinical performance. Results demonstrated the device's safety and effectiveness by the following main items.

- । Cap removal force testing.

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Cap removal force testing was conducted in compliance with the manufacturer's internal requirements 3~9 N to ensure that end users could easily remove the cap without getting hurt.

- -Needle removal force/Firmness
Needle removal force testing was conducted in compliance with the requirements of ISO 7864:2016 to ensure the needle's firmness by bonding with the hub.

- -Drop testing.
Drop testing was conducted in compliance with the requirements of IEC 60068-2-32:1993, that the needle tip would not be exposed when it was dropped from a table with a fixed height.

- -Puncture force testing.
Puncture force testing was conducted in compliance with the requirements of ISO 7864:2016. The force was as low as possible to ensure the needle easily punctured the patients' skin.

- -Safety Feature testing.
The safety features were verified in compliance with the requirements of ISO 23908:2011 and Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features Document Issued on: August 9,2005, to ensure end users' safe use.

Other physical performance testing was conducted in compliance with the following standards.

- (a) ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Device.
- (b) ISO 7864:2016 Sterile hypodermic needles for single use requirements and test methods

## (2) Sterility and Shelf-life

- (a) ISO 11737-1:2018, Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products.
- (b) ISO 11737-2:2019, Sterilization of health care products Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- (c) ISO 11137-1:2006, Radiation of medical devices part 1: Requirements for the development, validation and routine control of the sterilization process of medical devices.
- (d) ISO 11137-2:2013, Radiation sterilization of medical devices part 2: Determination of sterilization dose.
- (e) ISO11137-3: 2017, Radiation sterilization of medical devices part 3: Dosage guidelines.
- (f) ISO 11607-1:2019, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
- (g) ASTM F1980: Standard for Accelerated Aging of Sterile Barrier Systems and Medical Devices
- (h) ASTM D4169-16, Standard Practice For Performance Testing Of Shipping Containers And

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Systems

- (i) USP <71> Sterility Test
#### (3) Biocompatibility testing

- (a) ISO10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- (b) ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- (c) ISO 10993-10:2010, Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization.
- (d) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
- (e) USP <85> Bacterial Endotoxins Test
- (f) USP <788>Particulate matter in injection
- (g) USP <161>Medical Devices-Bacterial endotoxin and pyrogen tests

## (4) Simulated clinical use testing

A simulated clinical use study was conducted on 500 device samples in compliance with the Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features Document Issued on: August 9, 2005. Results demonstrated the device's effectiveness and safety in a simulated clinical condition.

## 9. Clinical testing

No clinical testing is available for this device.

#### 10. Conclusion

The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use and technological characteristics.