(177 days)
Not Found
No
The device description and intended use are purely mechanical components for blood collection. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
No
The device is described as a blood collection device used for diagnostic purposes (collecting venous blood) and does not treat or alleviate any medical condition.
No
The device is described as a "blood collection device" intended for the "collection of venous blood" and does not perform any diagnostic function such as analyzing blood or identifying medical conditions.
No
The device description clearly outlines physical components such as needles, tubes, holders, and safety shields, indicating it is a hardware medical device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of these devices is solely for the collection of venous blood. They are designed to create a channel between the patient's vein and a vacuum blood collection tube.
- Device Description: The descriptions detail the physical components of the blood collection devices (needles, tubes, holders, safety shields). They facilitate the physical act of drawing blood.
- Lack of Diagnostic Function: An IVD device is intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. These blood collection devices do not perform any analysis or testing of the blood itself. They are simply tools for obtaining the specimen.
- Performance Studies: The performance studies mentioned are bench tests and biocompatibility tests, which are relevant to the physical function and safety of a blood collection device, not the diagnostic performance of an IVD.
- Predicate Devices: The predicate devices listed are also blood collection needles and sets, which are not typically classified as IVDs.
In summary, these devices are accessories used in the process of collecting a sample that may later be used for in vitro diagnostic testing, but they themselves do not perform any diagnostic function. They are classified as medical devices, but not specifically as IVD devices.
N/A
Intended Use / Indications for Use
The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collection Set 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 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.
The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collection Needle 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 Safety Blood Collection Needle 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.
The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The proposed devices are blood collection devices form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood.
The Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Flexible tube, Connector Luer adapter and Holder.
The Safety Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield to aid in the protection against accidental needle stick injury. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Safety sheath, Flexible tube, Connector, Luer adapter and Holder.
The Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle hub, Luer adapter and Holder.
The Safety Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cannula, Safety sheath, Needle hub, Luer adapter and Holder.
The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. The Pre-attached Holder is designed to aid in protection against accidental non-patient needle injury and blood splatter. It is provided sterile and single use. The proposed devices are composed of Needle cannula, Safety sheath, Needle hub, Luer adapter and Holder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous blood collection (vein puncture)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
No clinical study is included in this submission as the device does not require clinical studies to determine substantial equivalence with the predicate device.
Bench Test:
- ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
- ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
- ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- USP 41-NF 36:2018 Bacterial Endotoxins Test
- Simulated Use Study Sharps Injury Prevention Feature FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005
- USP Particular Matter in Injections
Biocompatibility Tests:
- In vitro cytotoxicity test (ISO 10993-5)
- Skin sensitization test (ISO 10993-10)
- Irritation sensitivity (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11)
- Pyrogen (USP )
- Hemolysis Test (ASTM F756-2017)
- Complement Activation Test (ISO 10993-4)
- Partial Thromboplastin Time Study (ISO 10993-4)
- Platelet Leukocyte Count Study (ISO 10993-4)
Key results: The test results demonstrated that the proposed device complies with the listed standards and guidance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 7, 2023
Yangzhou Medline Industry Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K230080
Trade/Device Name: Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood Collection Needle, Blood Collection Needle with Holder, Safety Blood Collection Needle, Safety Blood Collection Needle with Holder, Luer Adapter with Holder Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA
Dated: June 7, 2023 Received: June 7, 2023
Dear Diana Hong:
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
David Walloschek
David Wolloscheck, Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K230080
Device Name
Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood Collection Needle, Blood Collection Needle with Holder, Safety Blood Collection Needle with Holder, Luer Adapter with Holder
Indications for Use (Describe)
The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collection Set 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 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.
The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collection Needle 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 Safety Blood Collection Needle 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.
The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.
| 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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4
510(k) Summary K230080
-
- Sponsor Identification
Yangzhou Medline Industry Co., Ltd.
No. 108, Jinshan Road, Economic Development Zone Yangzhou, China 225000
Establishment Registration Number: 3017180772
Contact Person: Hu Tingting Position: General Office Director Tel: 0514-87525616 Fax: 0514-87525631 Email: office@cnmedical.net
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Xingqi Wang (Alternative Contact Person)
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
- Date of Preparation: 07/07/2023
5
4. Subject Device
Trade Name: Blood Collection Set,
- Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood Collection Needle, Blood Collection Needle with Holder, Safety Blood Collection Needle, Safety Blood Collection Needle with Holder, Luer Adapter with Holder
Common Name: Blood Collection Systems
Regulatory Information
Classification Name: Blood specimen collection device Classification: Class II Product Code: JKA Regulation Number: 21CFR 862.1675
5. Identification of Predicate Devices
Predicate Device 510(k) Number: K172763 Product Name: 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 Regulation number: 862.1675 Product Code: JKA
6. Device Description
The proposed devices are blood collection devices form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood.
The Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for 2 / 10
6
multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Flexible tube, Connector Luer adapter and Holder.
The Safety Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield to aid in the protection against accidental needle stick injury. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Safety sheath, Flexible tube, Connector, Luer adapter and Holder.
The Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle hub, Luer adapter and Holder.
The Safety Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cannula, Safety sheath, Needle hub, Luer adapter and Holder.
The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. The Pre-attached Holder is designed to aid in protection against accidental non-patient needle injury and blood splatter. It is provided sterile and single use. The proposed devices are composed of Needle cannula, Safety sheath, Needle hub, Luer adapter and Holder.
7
7. Indication for Use:
The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collection Set 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 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.
The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collection Needle 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 Safety Blood Collection Needle 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.
The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.
8
Comparison of Technological Characteristics 8.
| ITEM | Proposed Device | Predicate Device
K172763 | Remark |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | JKA | JKA | Same |
| Regulation
Number | 21CFR 862.1675 | 21CFR 862.1675 | Same |
| Classification | II | II | Same |
| Indications
for Use | The Blood Collection Needle is
intended to be used with vacuum
blood collection tube for multiple
collections of venous blood. | The Blood Collecting Needle is
intended to be used with vacuum
blood collection tube for multiple
collections of venous blood. | Analysis 1 |
| | The Safety Blood Collection Needle
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 Safety Blood Collecting
Needle 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 is intended to be used with
vacuum blood collection tube for
multiple collections of venous
blood. | The Blood Collecting Needle with
Holder is intended to be used with
vacuum blood collection tube for
multiple collections of venous
blood. | |
| | The Safety Blood Collection Needle
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. | The Safety Blood Collecting
Needle 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. | |
| | The Blood Collection Set is
intended to be used with vacuum | The Blood Collecting Set is
intended to be used with vacuum
blood collection tube for multipla | |
| Table 1 Comparison of Technology Characteristics |
|---|
9
| blood collection tube for multiple
| collections of venous blood. | collections of venous blood. |
|---|---|
| The Safety Blood Collection Set 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 Safety Blood Collecting Set 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 is intended to be used with | |
| vacuum blood collection tube for | |
| multiple collections of venous | |
| blood. | The Blood Collecting Set with |
| Holder is intended to be used with | |
| vacuum blood collection tube for | |
| multiple collections of venous | |
| blood. | |
| 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. | The Safety Blood Collecting 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. | |
| The Luer adapter with Holder is | |
| intended to be used with vein | |
| puncture needle and vacuum blood | |
| collection tube for multiple | |
| collections of venous blood. |
10
| Configuration
and material | Blood Collection Needle
with/without Holder, Safety Blood Collection Needle with/without
Holder:
Needle cap (PP)
Needle tube (Stainless Steel
SUS304)
Needle Hub (PP)
Needle Holder (PP)
Non-patient end needle tube
(Stainless Steel SUS304)
Connector base (ABS)
Rubber sleeve (Gather Isoprene
Rubber)
Safety Sheath(PP)
Non-patient end needle cap (PP)
Blood Collection Set with/without
Holder, Safety Blood Collection
Set with/without Holder:
Needle cap (PVC)
Needle tube (Stainless Steel
SUS304)
Needle Wing (PVC)
Flexible Tube (PVC)
Needle Hub (ABS)
Connect base (ABS)
Non-patient end needle tube
(Stainless Steel SUS304)
Rubber sleeve (Gather Isoprene
Rubber)
Non-patient end needle cap (PP)
Safety Sheath(PP)
Needle Holder (PP) | Patient-end Needle (Stainless Steel)
Protective Cover of Patient-end
Needle (PP)
Patient-end Needle Hub (PP)
Non-patient end Needle Hub (ABS)
Non-patient end Needle (Stainless
Steel)
Rubber Sleeve (Natural Rubber)
Protective Cover of Non-patient
end Needle (PP)
Double Wing (PVC)
Flexible Tube (PVC)
Conical Fitting Connector (ABS)
Conical Fitting (ABS)
Safety Shield (PP)
Needle Holder (PP) | Analysis 2 |
| ------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------ |
|---|
11
510(k) Summary
| Luer adapter with Holder | |||
|---|---|---|---|
| Connect base (ABS) | |||
| Non-patient end needle tube | |||
| (Stainless Steel SUS304) | |||
| Rubber sleeve (Gather Isoprene Rubber) | |||
| Needle Holder (PP) | |||
| Operate mode | Manual | Manual | Same |
| Needle Gauge | |||
| and Length | 21G, 22G, 23G, 25G | ||
| 5/8", 3/4", 1/2", 1", 1 1/4", 1 1/2" | 18G, 19G, 20G, 21G, 22G, 23G, 25G | ||
| 5/8", 3/4", 1", 1 1/4", 1 1/2", 1 3/4", | |||
| 2" | Analysis 3 | ||
| Safety | |||
| Mechanism | The safety shield is intended to | ||
| prevent needle sticks | The safety shield is intended to | ||
| prevent needle sticks | Same | ||
| Label/ | |||
| Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | Same |
| Sterilization | EO sterilized | EO sterilized | Same |
| SAL: 10-6 | SAL: 10-6 | ||
| Endotoxin Limit: 20 EU per device | Endotoxin Limit: 20 EU per device | ||
| Single Use | Single Use | Single Use | Same |
| Biocompatibility | In Vitro Cytotoxicity | In Vitro Cytotoxicity | Same |
| Skin Sensitization | Skin Sensitization | ||
| Intracutaneous Reactivity | Intracutaneous Reactivity | ||
| Acute Systemic Toxicity | Acute Systemic Toxicity | ||
| Hemolytic Properties | |||
| Pyrogen | Hemolytic Properties | ||
| Pyrogen |
Analysis 1- Indications for Use
The Indications for Use between proposed device and predicate device is similar. Because the needle holder is used as part of the predicate device, the proposed device is an independent needle holder, the Luer adapter with Holder, but the Indications for Use are the same. Therefore, this difference is not determined to affect substantially equivalence on safety and effectiveness.
Analysis 2 -Configuration and material
The configuration difference between proposed device and predicate device is only the description of component. They have same configuration. The difference in the description of component does not affect the indications for use. In addition, the material of rubber sleeve from proposed device is different with predicate device. However, the biocompatibility test for proposed device has been tested and the results
12
comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantially equivalence on safety and effectiveness.
Analysis 3 -Needle Gauge and Length
The needle gauge and length of between the proposed device is different. However, this difference is just in dimension. Different gauge and length device will be selected by the end user. In addition, needles were tested according to ISO 7864:2016 and ISO 9626:2016 standards, and the results met the requirements of the standards. Therefore, this difference does not affect raise new or different questions of safety or effectiveness
-
- Non-Clinical Test Conclusion
The test results demonstrated that the proposed device complies with the following standards and guidance. The following tests were conducted as applicable to the subject devices:
- Non-Clinical Test Conclusion
Bench Test
- ▶ ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- V ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- ► ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
- ► ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- レ ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- レ ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- レ ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
- ▶ ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials ▶
- ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by > Dye Penetration
- USP 41-NF 36:2018 Bacterial Endotoxins Test レ
- ▶ Simulated Use Study Sharps Injury Prevention Feature FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005
- ▶ USP Particular Matter in Injections
13
Biocompatibility
The subject device is classified as externally communicating medical device with circulating blood contact for limited exposure.
Biocompatibility tests was conducted on the subject device, include in vitro cytotoxicity test (ISO 10993-5), skin sensitization test (ISO 10993-10), and irritation sensitivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Pyrogen (USP ), Hemolysis Test (ASTM F756-2017), Complement Activation Test (ISO 10993-4), Partial Thromboplastin Time Study (ISO 10993-4) and Platelet Leukocyte Count Study (ISO 10993-4).
-
- Clinical Test Conclusion
No clinical study is included in this submission as the device does not require clinical studies to determine substantial equivalence with the predicate device
- Clinical Test Conclusion
-
- Conclusion
It can be concluded that the differences between the subject devices, Blood collection Set with/without holder, Safety Blood Collection set with/without holder, Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without holder and Luer Adapter with Holder, and the 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 and Safety Blood Collecting Set, do not raise any new or different questions of safety or effectiveness. The subject devices are substantially equivalent to the predicate devices cleared under K172763 with respect to the indications for use, target population, treatment method, and technological characteristics.
- Conclusion