(178 days)
The Safety Sliding Blood Collection Set is intention into a patient's vascular system for blood collection or short term (up to 2 hours) IV administration, by a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.
Components of the subject device include: (1) Needle cap, (2) Butterfly wings, (3) Safety shield, (4) Needle, (5) Flexible tube, (6) Female luer (adapter), (7) Male luer hub, (8) Puncture needle, (9) Rubber sleeve, (10) Puncture needle protect cover, (11) Holder, (12) Protective cap.
The subject device has three configurations: with Holder, with Holder, without Male Adapter. Each configuration has all of the (1) - (6) components mentioned above. The difference between the three configurations is that they have only one or more of the (7) – (12) components mentioned above. The proposed device is available various needle size and flexible tube length. The range of needle size is from 25G (0.5mm) to 20G (0.9mm). The range of flexible tube length is from 10cm (4") to 30cm (12").
The subject device has sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature.
The subject device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
No DEHP, BPA and Natural Rubber Latex are added in the proposed device.
The provided document describes the Jiangsu Caina Medical Co., Ltd.'s "Safety Sliding Blood Collection Set" (K232781) and its substantial equivalence to a predicate device (K980414), but it does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.
The document primarily focuses on:
- Regulatory Clearance: Announcing FDA clearance (510(k)) based on substantial equivalence.
- Indications for Use: Describing the intended purpose of the device.
- Device Description: Outlining the components and configurations.
- Comparison to Predicate Device: Detailing similarities and differences between the subject device and the predicate.
- Non-Clinical Testing: Listing the international standards and specific tests conducted (e.g., biocompatibility, sterility, seal integrity, sharps injury protection) to support the substantial equivalence claim.
Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving their fulfillment based on this document.
The document explicitly states:
- 10. Clinical Test Conclusion: "Clinical studies are not required to demonstrate substantial equivalence to the predicate device." This indicates that the regulatory clearance was based on non-clinical data and comparison to an existing device, rather than a clinical trial with specific performance acceptance criteria.
The "Non-Clinical Testing" section lists various tests performed (e.g., ISO, ASTM standards, extraction force, simulated clinical study for safety feature, sharps injury protection testing). These tests would have their own internal pass/fail criteria as defined by the respective standards or the manufacturer's internal specifications. However, these specific criteria and the detailed results demonstrating achievement are not provided in this publicly available 510(k) summary.
§ 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.