Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single

K212019 · Jiangsu Micsafe Medical Technology Co., Ltd. · JKA · Nov 4, 2021 · Clinical Chemistry

Device Facts

• Record ID: K212019
• Device Name: Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single
• Applicant: Jiangsu Micsafe Medical Technology Co., Ltd.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Nov 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. The Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

Device Story

Single-use venous blood collection system; includes needles, sets, and optional holders. Input: venous blood via vacuum collection tubes. Operation: manual insertion of needle into vein; vacuum draws blood into collection tube. Safety versions feature integrated shield to prevent needle stick injuries. Used in clinical settings by healthcare professionals. Output: collected venous blood sample. Benefits: facilitates safe, efficient blood collection; reduces risk of sharps injury to clinicians.

Clinical Evidence

No clinical testing performed. Bench testing included biocompatibility (ISO 10993), physical/mechanical/chemical testing (ISO 7864, ISO 9626, ISO 80369-7), and a simulated clinical use study per FDA guidance for sharps injury prevention features. All results met pre-established criteria.

Technological Characteristics

Materials: PP, Polyisoprene rubber, SUS304, ABS, PVC. Standards: ISO 10993 (biocompatibility), ISO 7864 (hypodermic needles), ISO 9626 (stainless steel tubing), ISO 80369-7 (small-bore connectors), ISO 23908 (sharps injury protection), ISO 14971 (risk management). Manual operation. EO sterilized (SAL 10^-6). Single-use. Various gauge (18G-25G) and length (3/4", 1 1/2") configurations.

Indications for Use

Indicated for use with vacuum blood collection tubes for multiple collections of venous blood in patients requiring blood sampling. Safety versions include a shield to aid in protection against accidental needle stick injury.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder (K172763)

Submission Summary (Full Text)

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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: the Department of Health & Human Services seal 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 written out to the right of the square.

November 4, 2021

Jiangsu Micsafe Medical Technology Co., Ltd Tony Yang General Manager Xituan Industrial Park, Dafeng District Yancheng, Jiangsu 224125 China

Re: K212019

Trade/Device Name: Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: September 24, 2021 Received: October 6, 2021

Dear Tony Yang:

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.

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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 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,

For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology 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) K212019

#### Device Name

Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single

Indications for Use (Describe)

(1) Blood Collection Needle for Single Use

The Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

(2) Safety Blood Collection Needle for Single Use

The Safety Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

(3) Blood Collection Needle with Holder for Single Use

The Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

(4) Safety Blood Collection Needle with Holder for Single Use

The Safety Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

(5) Blood Collection Set for Single Use

The Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

(6) Safety Blood Collection Set for Single Use

The Safety Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

(7) Blood Collection Set with Holder for Single Use

The Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

(8) Safety Blood Collection Set with Holder for Single Use

The Safety Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of two red squares stacked on top of two blue squares on the left side. To the right of the squares is the text "Micsafe" in a bold, sans-serif font, with a small registered trademark symbol above the "e". Below "Micsafe" is the word "med" in a smaller, lighter font.

### 510(k) Summary K212019

(As required by 21 CFR 807.92(a))

### 1. Submitter Information

- . Company: Jiangsu Micsafe Medical Technology Co., Ltd
- . Address: Xituan Industrial Park, Dafeng District, Yancheng City,

Jiangsu Province, 224125, China

- . Phone: [phone]
- Contact: Tony Yang, General Manager
- . Date: November 3, 2021

#### 2. Device Information

- Trade/Device Name: Blood Collection Needle for Single Use
Safety Blood Collection Needle for Single Use

Blood Collection Needle with Holder for Single Use

Safety Blood Collection Needle with Holder for Single Use

Blood Collection Set for Single Use

Safety Blood Collection Set for Single Use

Blood Collection Set with Holder for Single Use

Safety Blood Collection Set with Holder for Single Use

- . Common Name: Blood Collection Tubes, Vials, Systems, Serum Separators
- Classification: .

Regulation Name: Blood specimen collection device Review Panel: Clinical Chemistry Product Code: JKA Submission Type: 510(k) Regulation Number: 21 CFR 862.1675 Device Class: II Type of Use: Prescription use only

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Image /page/5/Picture/1 description: The image contains the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top two squares in red and the bottom two in blue. To the right of the square is the text "Micsafe" in bold, black letters, with a small red accent on the "i". Below "Micsafe" is the word "med" in a smaller, lighter font.

### 3. Predicate Device Information

Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder [510(k) Number: K172763; submitted by Zhejiang kindly medical devices Co., Ltd.]

> Regulation Name: Blood specimen collection device Review Panel: Clinical Chemistry Product Code: JKA Submission Type: 510(k) Regulation Number: 21 CFR 862.1675 Device Class: II Type of Use: Prescription use only

#### 4. Device Description

The subject devices are single use, EtO sterilized with a shelf-life of 5 years. Blood collection needles and holders are intended to be used with a vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

#### (1) Blood Collection Needle for Single Use

This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube and needle sleeve.

| Blood Collection Needle<br>for Single Use | Specification of Needle | Length of Needle |
|-------------------------------------------|-------------------------|------------------|
| | 18G | 1 1/2" |
| | 20G | 1 1/2" |
| | 21G | 1 1/2" |
| | 22G | 1 1/2" |
| | 23G | 1 1/2" |

#### Device Models:

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Image /page/6/Picture/1 description: The image shows the logo for Micsafe med. The logo consists of a red and blue cross symbol on the left, followed by the text "Micsafe" in bold, black font. Below "Micsafe" is the word "med" in a smaller, lighter font. To the right of the word "Micsafe" is the registered trademark symbol.

(2) Safety Blood Collection Needle for Single Use

This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle

cap, needle hub with safety shield, needle tube, needle sleeve.

Device Models:

| Safety Blood Collection<br>Needle for Single Use | Specification of Needle | Length of Needle |
|--------------------------------------------------|-------------------------|------------------|
| | 21G | 1 1/2" |
| 22G | 1 1/2" | |

(3) Blood Collection Needle with Holder for Single Use

This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, needle sleeve, holder.

#### Device Models:

| | Specification of Needle | Length of Needle |
|-------------------------------------------------------|-------------------------|------------------|
| | 18G | 1 1/2" |
| Blood Collection Needle<br>with Holder for Single Use | 20G | 1 1/2" |
| | 21G | 1 1/2" |
| | 22G | 1 1/2" |
| | 23G | 1 1/2" |

(4) Safety Blood Collection Needle with Holder for Single Use

This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle

cap, needle hub with safety shield, needle tube, needle sleeve, holder.

#### Device Models:

| Safety Blood Collection<br>Needle with Holder for<br>Single Use | Specification of Needle | Length of Needle |
|-----------------------------------------------------------------|-------------------------|------------------|
| | 21G | 1 1/2" |
| | 22G | 1 1/2" |

### (5) Blood Collection Set for Single Use

The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, tubing, butterfly wings, needle sleeve.

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Image /page/7/Picture/1 description: The image shows the logo for Micsafe med. The logo consists of a red and blue square pattern on the left, followed by the word "Micsafe" in bold, black letters. Below "Micsafe" is the word "med" in a smaller, lighter font. There is a registered trademark symbol to the right of the word "Micsafe".

Device Models:

| Blood Collection Set for<br>Single Use | Specification of Needle | Length of Needle |
|----------------------------------------|-------------------------|------------------|
| | 20G | 3/4" |
| | 21G | 3/4" |
| | 22G | 3/4" |
| | 23G | 3/4" |
| | 25G | 3/4" |

(6) Safety Blood Collection Set for Single Use

The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, safety shield, needle tube, tube, tubing, butterfly wings, needle sleeve.

Device Models:

| Safety Blood Collection<br>Set for Single Use | Specification of Needle | Length of Needle |
|-----------------------------------------------|-------------------------|------------------|
| | 20G | 3/4" |
| | 21G | 3/4" |
| | 22G | 3/4" |
| | 23G | 3/4" |
| 25G | 3/4" | |

#### (7) Blood Collection Set with Holder for Single Use

The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, tubing, butterfly wings, needle sleeve, holder.

Device Models:

| | Specification of Needle | Length of Needle |
|----------------------------------------------------|-------------------------|------------------|
| Blood Collection Set with<br>Holder for Single Use | 20G | 3/4" |
| | 21G | 3/4" |
| | 22G | 3/4" |
| | 23G | 3/4" |
| | 25G | 3/4" |

(8) Safety Blood Collection Set with Holder for Single Use

The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, safety shield, needle tube, tubing, butterfly wings, needle sleeve,

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Image /page/8/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a blue and red square symbol on the left, followed by the text "Micsafe" in bold, black letters. Below "Micsafe" is the word "med" in a smaller, lighter font. The logo appears to be for a medical company or product.

holder.

### Device Models:

| Safety Blood Collection<br>Set with Holder for Single<br>Use | Specification of Needle | Length of Needle |
|--------------------------------------------------------------|-------------------------|------------------|
| | 20G | 3/4" |
| | 21G | 3/4" |
| | 22G | 3/4" |
| | 23G | 3/4" |
| | 25G | 3/4" |

#### 5. Indications for Use

- (1) Blood Collection Needle for Single Use
The Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

#### (2) Safety Blood Collection Needle for Single Use

The Safety Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

#### (3) Blood Collection Needle with Holder for Single Use

The Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

#### (4) Safety Blood Collection Needle with Holder for Single Use

The Safety Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

(5) Blood Collection Set for Single Use

The Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube

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Image /page/9/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the text "Micsafe" in a bold, sans-serif font, with the "i" in "Micsafe" being red. Below "Micsafe" is the text "med" in a smaller, sans-serif font.

for multiple collections of venous blood.

(6) Safety Blood Collection Set for Single Use

The Safety Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

(7) Blood Collection Set with Holder for Single Use

The Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

(8) Safety Blood Collection Set with Holder for Single Use

The Safety Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

| Comparison<br>Item | Subjective Device | Predicate Device<br>(K172763) | Remark |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Classification | Product Code: JKA<br>Class: II | Product Code: JKA<br>Class: II | Same |
| Indications for<br>Use | The Blood Collection<br>Needle/ The Blood<br>Collection Needle with<br>Holder/ The Blood<br>Collection Set/ The Blood<br>Collection Set with Holder<br>for Single Use is intended<br>to be used with vacuum<br>blood collection tube for<br>multiple collections of<br>venous blood. | The Blood Collection<br>Needle/ The Blood<br>Collection Needle with<br>Holder/The Blood<br>Collection Set/ The Blood<br>Collection Set with Holder<br>is intended to be used with<br>vacuum blood collection<br>tube for multiple collections<br>of venous blood. | Same |
| | The Safety Blood<br>Collection Needle/ The<br>Safety Blood Collection<br>Needle with Holder/The | The Safety Blood<br>Collection Needle/ The<br>Safety Blood Collection<br>Needle with Holder/The | Same |
| Comparison<br>Item | Subjective Device | Predicate Device<br>(K172763) | Remark |
| Materials of<br>Different Device<br>Parts | Safety Blood Collection<br>Set/ The Safety Blood<br>Collection Set with Holder<br>for Single Use is intended<br>to be used with vacuum<br>blood collection tube for<br>multiple collections of<br>venous blood. The safety<br>shield is intended to aid in<br>the protection against<br>accidental needle stick<br>injury. | Safety Blood Collection<br>Set/ The Safety Blood<br>Collection Set with Holder<br>is intended to be used with<br>vacuum blood collection<br>tube for multiple collections<br>of venous blood. The safety<br>shield is intended to aid in<br>the protection against<br>accidental needle stick<br>injury. | |
| | Needle Cap (PP) | Protective cover of<br>Patient-end Needle/<br>Protective cover of<br>Non-Patient-end Needle<br>(PP) | Same |
| | Needle Sleeve<br>(Polyisoprene Rubber) | Rubber Sleeve (Natural<br>Rubber) | Different<br>(Comment #1) |
| | Needle Hub (PP) | Patient-end Needle Hub/<br>Non-Patient end Hub (PP) | Same |
| | Needle Tube (SUS304) | Patient-end Needle/<br>Non-Patient end Needle<br>(Stainless Steel) | Same |
| | Needle Hub with<br>Safety-Shield (PP) | Safety-Shield (PP) | Same |
| | Holder (PP) | Needle Holder (PP) | Same |
| | Butterfly Wings (PVC) | Double Wing (PVC) | Same |
| | Tubing (PVC) | Flexible Tube (PVC) | Same |
| | Needle Hub-Female (ABS) | Conical Fitting Connector<br>(ABS) | Same |
| | Needle Hub-Male (PP) | Conical Fitting (ABS) | Different<br>(Comment #2) |
| | Needle Cover (PP) | Protective Cover (PP) | Same |
| | Safety Shield (PP) | Safety Shield (PP) | Same |
| Gauge Size and<br>Needle Length | 18G, 20G, 21G, 22G, 23G,<br>25G | 18G~23G, 25G | |
| | Needle Length:<br>1 1/2", 3/4" | Needle Length:<br>5/8", 3/4", 1", 1 1/4", 1<br>1/2", 1 3/4", 2" | Different<br>(Comment #3) |
| Operate Mode | Manual | Manual | Same |
| Sterile Method | EO sterilized | EO sterilized | Same |
| Comparison<br>Item | Subjective Device | Predicate Device<br>(K172763) | Remark |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Conforms to the<br>requirement of ISO 10993<br>series Standards | Conforms to the<br>requirement of ISO 10993<br>series Standards | Same |
| | No cytotoxicity | No cytotoxicity | Same |
| | No irritation to skin | No irritation to skin | Same |
| | No significant evidence of<br>sterilization | No significant evidence of<br>sterilization | Same |
| | No systemic toxicity | No systemic toxicity | Same |
| | No hemolysis | No hemolysis | Same |
| | No pyrogen | No pyrogen | Same |
| | | | |
| Performance<br>Safety &<br>Effectiveness | Conforms with the<br>requirements of ISO 7864<br>and ISO 9626 | Conforms with the<br>requirements of ISO 7864<br>and ISO 9626 | Same |

#### 6. Comparison of Technological Characteristics with the Predicate Device

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Image /page/10/Picture/1 description: The image contains the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top left square being red, the top right square being white, the bottom left square being blue, and the bottom right square being white. To the right of the square is the text "Micsafe" in bold, black font, with a registered trademark symbol in the upper right corner. Below "Micsafe" is the text "med" in a smaller, lighter font.

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Image /page/11/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square symbol on the left, followed by the text "Micsafe" in black, with a red dot over the "i". Below "Micsafe" is the word "med" in a smaller font size. A registered trademark symbol is located to the right of the word "safe".

#### Discussion

The subject devices are similar to the predicate device K172763 in design, indications for use, sterilization, method of operation and technological characteristics. The biocompatibility of both devices has been ensured by relevant ISO 10993 standards, which ensures that the subject device will be as safe for use as the predicate device.

#### Comment #1

The difference between subject device and predicate device is the materials of rubber sleeve. However, the biocompatibility test for the subject device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantial equivalence on safety and effectiveness.

#### Comment #2

The difference between subject device and predicate device is the materials of needle hub-male. However, the biocompatibility test for the subject device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect

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Image /page/12/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square pattern on the left, followed by the text "Micsafe" in a bold, sans-serif font. The word "med" is written in a smaller font below "Micsafe". There is also a registered trademark symbol to the right of the word "Micsafe".

substantial equivalence on safety and effectiveness.

#### Comment #3

In addition, the needle gauge and length of between the subjective device and predicate device is different. However, the difference is just in dimension. Different gauge and length device will be selected by the end user. This difference does not affect raise new or different questions of safety or effectiveness. Both the subject and the predicate device were tested to the same performance standards (ISO 7864 and ISO 9626).

#### Discussion of Test Performed 7.

#### 7.1. Clinical Tests

Clinical testing was not performed for the subject device as part of the submission.

#### 7.2. Non-Clinical Tests

The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:

- (1) Biocompatibility
The products are considered blood path, indirect for a duration of less than 24 hours, the biocompatibility is according to:

- . ISO 10993-4: Third Edition 2017-04. Biological Evaluation Of Medical Devices - Part 4: Selection Of Tests For Interactions With Blood;
- . ANSI AAMI ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity;
- . ANSI AAMI ISO 10993-10:2010/(R)2014, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization;
- . ISO 10993-11: Third Edition 2017-09, Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity;
- (2) Physical, Mechanical, Chemical testing performed on the subjective device:

Performance safety and effectiveness according to ISO 7864 Fourth Edition 2016-08-01,

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Image /page/13/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top left square being red, the top right square being red, the bottom left square being blue, and the bottom right square being blue. To the right of the square is the text "Micsafe" in a bold, sans-serif font, with the word "med" below it in a smaller font. There is a registered trademark symbol to the right of the word "Micsafe".

Sterile Hypodermic Needles For Single Use Requirements And Test Methods:

- . Cleanliness
- . Limits for acidity or alkalinity
- . Limits for extractable metals
- Size designation
- Colour coding
- Needle hub
- . Needle cap
- . Needle tube
- . Needle point
- Bond between hub and needle tube
- . Patency of lumen

Performance safety and effectiveness according to ISO 9626 Second Edition 2016-08-01,

Stainless Steel Needle Tubing For The Manufacture Of Medical Devices - Requirements And

Test Methods:

- . Limits for acidity or alkalinity
- Surface finish and visual appearance
- Cleanliness
- Size designation
- . Dimensions
- . Stiffness
- . Resistance to breakage
- Resistance to corrosion

Performance safety and effectiveness according to ISO 80369-7 First Edition 2016-10-15,

Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7:

Connectors For Intravascular Or Hypodermic Applications:

- Leakage by pressure decay
- Positive pressure liquid leakage

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Image /page/14/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the text "Micsafe" in bold, black letters, with a registered trademark symbol in the upper right corner. Below "Micsafe" is the text "med" in a smaller, lighter font.

- Sub-atmospheric pressure air leakage
- . Stress cracking
- . Resistance to separation from axial load
- . Resistance to separation from unscrewing
- Resistance to overriding
- (3) Additional performance safety and effectiveness for the Blood Collection Needle for Single Use/ Safety Blood Collection Needle for Single Use/ Blood Collection Needle with Holder for Single Use/ Safety Blood Collection Needle with Holder for Single Use/ Blood Collection Set for Single Use/ Safety Blood Collection Set for Single Use/ Blood Collection Set with Holder for Single Use/ Safety Blood Collection Set with Holder for Single Use:
- . Risk Management Report to ISO 14971: 2019
- Sharps Injury Protection Test Report to ISO 23908: 2011

#### 7.3. Simulated Clinical Use Study

A simulated clinical use study was performed on proposed device according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

#### 8. Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the comparison above and the non-clinical bench testing conducted, the subject device is determined to be Substantiality Equivalent (SE) to the predicate devices cleared under K172763 with respect to the indications for use, target populations, treatment method, and technological characteristics.