(129 days)
Not Found
No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies focus on physical and biological safety, not algorithmic performance.
No.
The device is described as a "Blood Collection Needle" or "Blood Collection Set," intended for "multiple collections of venous blood." Its primary function is to draw blood, which is a diagnostic or procedural step, not a therapeutic intervention. The "safety shield" is to prevent injury, not to provide therapy.
No
The device description indicates that these are blood collection needles and sets, used for collecting venous blood. They are instruments for obtaining samples, not for analyzing or diagnosing conditions.
No
The device description clearly outlines physical components made of materials like PP, Polyisoprene rubber, SUS304, ABS, and PVC, and describes their physical structure (needles, hubs, holders, tubing, etc.). There is no mention of software as a component or function.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is solely for the collection of venous blood. It does not mention any subsequent analysis or testing of the collected blood for diagnostic purposes.
- Device Description: The description focuses on the physical components and materials of the blood collection devices themselves. There is no mention of reagents, assays, or any components designed to perform a diagnostic test on the blood sample.
- Performance Studies: The performance studies described are related to the safety and physical characteristics of the blood collection devices (biocompatibility, physical/mechanical/chemical testing, sharps injury protection, simulated clinical use). There are no studies related to the accuracy or performance of a diagnostic test.
- Predicate Device: The predicate device is also described as "Blood Collecting Needle, Safety Blood Collecting Needle, etc.", which are devices for blood collection, not for in vitro diagnostic testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens, including blood, to provide information for diagnostic, monitoring, or compatibility purposes. These devices typically involve reagents, instruments, or systems that perform tests on the sample.
This device is a blood collection device, which is a tool used to obtain a sample for potential subsequent in vitro diagnostic testing, but it is not an IVD device itself.
N/A
Intended Use / 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 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.
Product codes
JKA
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.
(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.
(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.
(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.
(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.
(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.
(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.
(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, holder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
The subject device was tested/analyzed according to the following standards to ensure its effectiveness and safety:
(1) Biocompatibility: The products are considered blood path, indirect for a duration of less than 24 hours. Biocompatibility was assessed according to ISO 10993-4:2017-04, ANSI AAMI ISO 10993-5:2009/(R)2014, ANSI AAMI ISO 10993-10:2010/(R)2014, and ISO 10993-11:2017-09. Key results include no cytotoxicity, no irritation to skin, no significant evidence of sterilization, no systemic toxicity, no hemolysis, and no pyrogen.
(2) Physical, Mechanical, Chemical testing performed on the subjective device: Performance safety and effectiveness according to ISO 7864:2016-08-01 (Sterile Hypodermic Needles For Single Use Requirements And Test Methods), ISO 9626:2016-08-01 (Stainless Steel Needle Tubing For The Manufacture Of Medical Devices - Requirements And Test Methods), and ISO 80369-7:2016-10-15 (Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular Or Hypodermic Applications).
(3) Additional performance safety and effectiveness: Risk Management Report to ISO 14971:2019 and Sharps Injury Protection Test Report to ISO 23908:2011.
Simulated Clinical Use Study:
A simulated clinical use study was performed 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1675 Blood specimen collection device.
(a)
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.(b)
Classification. Class II.
0
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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.
3
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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: 086-13651929266
- 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
| 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:
6
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
| 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 | ||
| 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
Needle with Holder for
| 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
| 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
| 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 | ||
| 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,
8
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
Set with Holder for Single
| 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
9
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
Item | Subjective Device | Predicate Device
(K172763) | Remark |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Classification | Product Code: JKA
Class: II | Product Code: JKA
Class: II | Same |
| Indications for
Use | The Blood Collection
Needle/ The Blood
Collection Needle with
Holder/ The Blood
Collection Set/ 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 Blood Collection
Needle/ The Blood
Collection Needle with
Holder/The Blood
Collection Set/ The Blood
Collection Set with Holder
is intended to be used with
vacuum blood collection
tube for multiple collections
of venous blood. | Same |
| | The Safety Blood
Collection Needle/ The
Safety Blood Collection
Needle with Holder/The | The Safety Blood
Collection Needle/ The
Safety Blood Collection
Needle with Holder/The | Same |
| Comparison
Item | Subjective Device | Predicate Device
(K172763) | Remark |
| Materials of
Different Device
Parts | Safety Blood Collection
Set/ 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. | Safety Blood Collection
Set/ The Safety Blood
Collection Set with Holder
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. | |
| | Needle Cap (PP) | Protective cover of
Patient-end Needle/
Protective cover of
Non-Patient-end Needle
(PP) | Same |
| | Needle Sleeve
(Polyisoprene Rubber) | Rubber Sleeve (Natural
Rubber) | Different
(Comment #1) |
| | Needle Hub (PP) | Patient-end Needle Hub/
Non-Patient end Hub (PP) | Same |
| | Needle Tube (SUS304) | Patient-end Needle/
Non-Patient end Needle
(Stainless Steel) | Same |
| | Needle Hub with
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
(ABS) | Same |
| | Needle Hub-Male (PP) | Conical Fitting (ABS) | Different
(Comment #2) |
| | Needle Cover (PP) | Protective Cover (PP) | Same |
| | Safety Shield (PP) | Safety Shield (PP) | Same |
| Gauge Size and
Needle Length | 18G, 20G, 21G, 22G, 23G,
25G | 18G~23G, 25G | |
| | Needle Length:
1 1/2", 3/4" | Needle Length:
5/8", 3/4", 1", 1 1/4", 1
1/2", 1 3/4", 2" | Different
(Comment #3) |
| Operate Mode | Manual | Manual | Same |
| Sterile Method | EO sterilized | EO sterilized | Same |
| Comparison
Item | Subjective Device | Predicate Device
(K172763) | Remark |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Conforms to the
requirement of ISO 10993
series Standards | Conforms to the
requirement of ISO 10993
series Standards | Same |
| | No cytotoxicity | No cytotoxicity | Same |
| | No irritation to skin | No irritation to skin | Same |
| | No significant evidence of
sterilization | No significant evidence of
sterilization | Same |
| | No systemic toxicity | No systemic toxicity | Same |
| | No hemolysis | No hemolysis | Same |
| | No pyrogen | No pyrogen | Same |
| | | | |
| Performance
Safety &
Effectiveness | Conforms with the
requirements of ISO 7864
and ISO 9626 | Conforms with the
requirements of ISO 7864
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.
11
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:
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(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;
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. ANSI AAMI ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity;
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. ANSI AAMI ISO 10993-10:2010/(R)2014, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization;
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. ISO 10993-11: Third Edition 2017-09, Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity;
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(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.