(264 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical aspects of blood collection needles and sets, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a blood collection needle and set, intended for collecting venous blood, which is a diagnostic or procedural function, not a therapeutic one.
No
Explanation: The device is a blood collection needle/set, which is used to collect blood samples. It does not perform any analysis or interpretation of the collected blood, nor does it provide any diagnostic information itself.
No
The device description and performance studies clearly indicate that the device is a physical blood collection needle and related accessories, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for the collection of venous blood. They are a means to obtain a sample.
- Device Description: The description focuses on the physical mechanism of blood flow from the vein into a collection tube. It describes a physical channel and the action of differential pressure.
- Lack of Diagnostic Function: There is no mention of the device being used to perform a test on the blood sample, or to provide any diagnostic information about the patient's condition. IVD devices are used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Performance Studies: The performance studies described focus on the physical, mechanical, chemical, and safety aspects of the blood collection process and the device itself, not on the analytical performance of a diagnostic test.
These devices are accessories used in the process of obtaining a sample that may then be used in an IVD test, but they are not IVD devices themselves.
N/A
Intended Use / Indications for Use
The Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
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 Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
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 Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collecting Set is intended to be used with vacuum blood collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
JKA, FMI
Device Description
The proposed devices are blood collection devices form a channel between patient's vein and the vacuum blood collection tube. The patient-end needle is punctured into vein, and non-patient end needle will penetrate into vacuum blood collection tube, blood will flow into blood collection tube under the action of differential pressure. The proposed devices are divided into several types and available in different specifications, see following table
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
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)
Non clinical tests were conducted to verify that the proposed devices met all design specifications. The test include following items
Physical, Mechanical, Chemical testing performed on the proposed device:
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, Surface finish, Cleanliness, Limits for acidity and alkalinity, Size designation, Dimensions, Stiffness, Resistance to breakage, Resistance to corrosion.
Sterile Barrier Packaging Testing performed on the proposed device:
Seal strength, Dye penetration.
Sterilization and Shelf Life Testing performed on the proposed device:
EO residue, ECH residue, Bacteria Endotoxin Limit, Shelf Life Evaluation were performed on aging samples to verify the claimed shelf life of the device.
Biocompatibility testing include in vitro cytotoxicity test (ISO 10993-5), skin sensitization test (ISO 10993-10), irritation sensitivity (ISO 10993-10), Acute Toxicity Test (ISO 10993-11), pyrogen test (ISO 10993-11) and Hemolysis Test (ASTM F756-17).
Simulated Clinical Study: A simulated clinical study was performed on proposed device according to FDA 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 devices. The results demonstrated that the proposed device met the pre-established criteria.
Safety Feature Test: The safety feature test was performed on both proposed device and predicate device to determine safety feature. The results demonstrated that the proposed devices did not show a significant difference from predicate devices.
No clinical study is included in this submission.
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
August 26, 2020
Zhejiang Kindly Medical Devices Co.,Ltd % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.Box 120-119 Shanghai, Zhejiang 325025 China
Re: K172763
Trade/Device 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: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA
Dear Diana Hong:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 4, 2018. Specifically, FDA is updating this SE Letter to update the product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Vacant, OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices, Paval Patel, (240) 402-6029, payal.patel(@fda.hhs.gov.
Sincerely,
Sapana Patel -S
for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices
1
Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Image /page/2/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.
June 4, 2018
Zhejiang kindly medical devices Co., Ltd % Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CHINA
Re: K172763
Trade/Device 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: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: April 28, 2018 Received: May 4, 2018
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. 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.
3
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Tina Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K172763
Device Name
Blood Collecting Needle, Safety Blood Collecting Needle, With Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder
Indications for Use (Describe)
The Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
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 Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
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 Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
The Safety Blood Collecting Set is intended to be used with vacuum blood collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
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 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.
Type of Use (Select one or both, as applicable)
| ☑ Requisition Use (Part 21 CFR 601 Subpart D) | ☐ Over-The-Counter Use (21 CFR 601 Subpart G) |
|---|---|
| --------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
5
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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6
Exhibit #2 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K172763
-
- Date of Preparation: 04/28/2018
-
- Sponsor Identification
Zhejiang kindly medical devices Co., Ltd.
No.758, 5th Binhai Road, Binhai Industrial Park, Longwan District, 325025 Wenzhou, Zhejiang Province, PRC.
Establishment Registration Number: Not yet registered
Contact Person: Yong Zhang Position: General Manager Tel: +86-577-86960616 Fax: +86-577-86374972 Email: zjkdl@kdlchina.com
- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
7
K172763
Identification of Proposed Device 4.
Trade 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
Common Name: Blood Collecting Needle and Set
Regulatory Information
Classification Name: Needle, Hypodermic, Single Lumen Classification: II; Product Code: FMI: Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital;
Indications for Use:
The Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
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 Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
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 Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
8
The Safety Blood Collecting Set is intended to be used with vacuumblood 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 Collecting Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.
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.
Device Description
The proposed devices are blood collection devices form a channel between patient's vein and the vacuum blood collection tube. The patient-end needle is punctured into vein, and non-patient end needle will penetrate into vacuum blood collection tube, blood will flow into blood collection tube under the action of differential pressure. The proposed devices are divided into several types and available in different specifications, see following table
| Device Name | Ref No. | Needle
Gauge | Needle Length |
|--------------------------------------------|---------|-----------------|--------------------------------------------|
| Blood Collecting Needle | 04-11 | 18G23G | 1", 1 1/4", 1 1/2" |23G | 1", 1 1/4", 1 1/2" |
| Blood Collecting Needle | 04-13 | 18G
| Blood Collecting Needle | 04-31 | 19G, 25G | 5/8", 3/4", 1", 1 1/4", 1 1/2", 1 3/4", 2" |
| Safety Blood Collecting Needle | 04-12 | 18G23G | 1", 1 1/4", 1 1/2" |23G | 1", 1 1/4", 1 1/2" |
| Safety Blood Collecting Needle | 04-32 | 19G, 25G | 5/8", 3/4", 1", 1 1/4", 1 1/2", 1 3/4", 2" |
| Blood Collecting Needle with Holder | 04-14 | 18G
| Blood Collecting Needle with Holder | 04-16 | 18G23G | 1", 1 1/4", 1 1/2" |23G | 1", 1 1/4", 1 1/2" |
| Blood Collecting Needle with Holder | 04-33 | 19G, 25G | 5/8", 3/4", 1", 1 1/4", 1 1/2", 1 3/4", 2" |
| Safety Blood Collecting Needle with Holder | 04-15 | 18G
| Safety Blood Collecting Needle with Holder | 04-34 | 19G, 25G | 5/8", 3/4", 1", 1 1/4", 1 1/2", 1 3/4", 2" |
| Blood Collecting Set | 04-21 | 19G, 25G | 5/8", 3/4", 1" |
| Safety Blood Collecting Set | 04-22 | 19G, 25G | 5/8", 3/4", 1" |
| Blood Collecting Set with Holder | 04-23 | 19G, 25G | 5/8", 3/4", 1" |
| Safety Blood Collecting Set with Holder | 04-24 | 19G, 25G | 5/8", 3/4", 1" |
9
5. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K982541 Product Name: VACUTAINER® Brand ECLIPSE™ Blood Collection Needle
Predicate Device 2 510(k) Number: K965202 Product Name: VACUTAINER® Brand Safety-Lok Blood Collection Set
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6. Technological Characteristics
| ITEM | Proposed Device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| K982541 | K965202 | ||
| Class | II | II | II |
| Indications for Use | The Blood Collecting Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. | ||
| 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 Collecting Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. 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 Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The Safety Blood Collecting Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety | The VACUTAINER® Brand ECLIPSETM Blood Collection Needle is a sterile, multiple sample, single-use device for blood collection. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needle sticks. | The VACUTAINER® Brand Safety-Lok™ Blood Collection Set is a winged blood collection needle and flexible tubing for venipuncture to collect blood specimens from patients. The Safety-Lok™ Blood Collection Set also contains a needle safety shield which minimizes the possibility of needlesticks if manually activated following blood collection. The VACUTAINER® Brand Safety-Lok™ Blood Collection Set is also recommended for use in patients with small veins | |
| shield is intended to aid in the protection against | |||
| accidental needle stick injury. | |||
| 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 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. | |||
| Configuration | |||
| and material | Patient-end Needle (Stainless Steel) | Protective Cover of Needle | Protective Cover of Patient-end Needle |
| Protective Cover of Patient-end Needle (PP) | Needle | Patient-end Needle | |
| Patient-end Needle Hub (PP) | Needle Hub | Needle Handle | |
| Non-patient end Needle Hub (ABS) | Rubber Sleeve | Double Wing | |
| Non-patient end Needle (Stainless Steel) | Safety Shield | Flexible Tube | |
| Rubber Sleeve (Natural Rubber) | Conical Fitting Connector | ||
| Protective Cover of Non-patient end Needle (PP) | Conical Fitting | ||
| Double Wing (PVC) | Non-patient end Needle | ||
| Flexible Tube (PVC) | Rubber Sleeve | ||
| Conical Fitting Connector (ABS) | Protective Cover of Non Patient end | ||
| Needle | |||
| Conical Fitting (ABS) | Safety Shield | ||
| Safety Shield (PP) | |||
| Needle Holder (PP) | |||
| Operate mode | Manual | Same | Same |
| Specification | 18G, 19G, 20G, 21G, 22G, 23G, 25G | Similar | Similar |
| 5/8", 3/4", 1", 1 1/4", 1 1/2", 1 3/4", 2" | |||
| Safety | |||
| Mechanism | The safety shield is intended to prevent needle | ||
| sticks | Same | Same |
11
12
| K172763 |
|---|
| Label/Labeling | Conform with Part 801 | Same | Same |
|---|---|---|---|
| Sterilization | EO sterilized | ||
| SAL: $10^{-6}$ | |||
| Endotoxin Limit: 20 EU per device | Same | Same | |
| Single Use | Single Use | Same | Same |
| Biocompatibility | In Vitro Cytotoxicity | Conform with ISO 10993 Standards | Conform with ISO 10993 Standard |
| Skin Sensitization | |||
| Intracutaneous Reactivity | |||
| Acute Systemic Toxicity | |||
| Hemolytic Properties | |||
| Pyrogen |
The proposed devices Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Neede with Holder are similar to the predicate device design, Indications for use, sterilization, method of operation and technological characteristics. The proposed devices Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder are similar to the predicate device design, Indications for use, sterilization, method of operation and technological characteristics. The difference in configuration between proposed devices is that the proposed devices have the additional configuration of the needle holder. In addition the proposed devices are available in a series of specification will be selected by physician per patients' condition. These two differ intended use, therefore, the proposed devices can be determined substantially equivalence to predicate devices.
13
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed devices met all design specifications. The test include following items
Physical, Mechanical, Chemical testing performed on the proposed device:
| Cleanliness | Clause 4.3 of ISO 7864:2016 |
|---|---|
| Limits for acidity or alkalinity | Clause 4.4 of ISO 7864:2016 |
| Limits for extractable metals | Clause 4.5 of ISO 7864:2016 |
| Size designation | Clause 4.6 of ISO 7864:2016 |
| Colour coding | Clause 4.7 of ISO 7864:2016 |
| Needle hub | Clause 4.8 of ISO 7864:2016 |
| Needle Cap | Clause 4.9 of ISO 7864:2016 |
| Needle tube | Clause 4.10 of ISO 7864:2016 |
| Needle point | Clause 4.11 of ISO 7864:2016 |
| Bond between hub and needle tube | Clause 4.12 of ISO 7864:2016 |
| Patency of lumen | Clause 4.13 of ISO 7864:2016 |
| Surface finish | Clause 5.2 of ISO 9626:2016 |
| Cleanliness | Clause 5.3 of ISO 9626:2016 |
| Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 |
| Size designation | Clause 5.5 of ISO 9626:2016 |
| Dimensions | Clause 5.6 of ISO 9626:2016 |
| Stiffness | Clause 5.8 of ISO 9626:2016 |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 |
| Resistance to corrosion | Clause 5.10 of ISO 9626:2016 |
Sterile Barrier Packaging Testing performed on the proposed device:
| Seal strength | ASTM F88/F88-15 |
|---|---|
| Dye penetration | ASTM F1929-15 |
Sterilization and Shelf Life Testing performed on the proposed device:
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 38-NF 33 |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests |
14
were performed on aging samples to verify the claimed shelf life of the device
Biocompatibility testing include in vitro cytotoxicity test (ISO 10993-5), skin sensitization test (ISO 10993-10), irritation sensitivity (ISO 10993-10), Acute Toxicity Test (ISO 10993-11), pyrogen test (ISO 10993-11) and Hemolysis Test (ASTM F756-17).
Simulated Clinical Study
A simulated clinical study was performed on proposed device according to FDA 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 devices. The results demonstrated that the proposed device met the pre-established criteria.
Safety Feature Test
The safety feature test was performed on both proposed device and predicate device to determine safety feature. The results demonstrated that the proposed devices did not show a significant difference from predicate devices.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.