(262 days)
The proposed device, I.V. Catheter, is intended to be inserted in to a patient's vascular system for short term use (no more than 72 hours) to withdraw blood samples or administer fluid intravenously.
The proposed devices, I.V. Catheters, are sterile, single use devices intended to be inserted in to a patient's vascular system for short term use to withdraw blood samples or administer fluid intravenously.
The I.V. Catheter is a closed system, and further available in two combinations of configurations. All of them are sterilized by Ethylene Oxide to achieve a SAL of 106, and packed in a sterility maintenance package. The shelf life of the product is three years.
This document is a 510(k) summary for an I.V. Catheter (K142797) submitted by Jiangxi Sanxin Medtec Co., Ltd. It declares substantial equivalence (SE) to a predicate device (K083429).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by compliance with recognized international and ASTM standards. The reported device performance is that it complies with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM F88-09 (Seal Strength of Flexible Barrier Materials) | Device complies |
| ASTM F 1140-07 (Internal Pressurization Failure Resistance of Unrestrained Package) | Device complies |
| ASTM F1929-98(2004) (Detecting Seal Leaks by Dye Penetration) | Device complies |
| ISO 11135-1:2007 (Ethylene Oxide Sterilization) | Device complies (achieves SAL of 10^-6) |
| USP (Bacterial Endotoxin Limit) | Device complies |
| ISO 10993-3:2003 (Biological evaluation - Genotoxicity, carcinogenicity, reproductive toxicity) | Device complies (conforms to the requirements of ISO 10993 series Standards) |
| ISO 10993-4:2002 A1:2006 (Biological evaluation - Interactions with blood) | Device complies (conforms to the requirements of ISO 10993 series Standards) |
| ISO 10993-5:2009 (Biological Evaluation - In Vitro Cytotoxicity) | Device complies (conforms to the requirements of ISO 10993 series Standards) |
| ISO 10993-6:2007 (Biological evaluation - Local effects after implantation) | Device complies (conforms to the requirements of ISO 10993 series Standards) |
| ISO 10993-7:2008 (Biological evaluation - Ethylene Oxide Residues) | Device complies (conforms to the requirements of ISO 10993 series Standards) |
| ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization) | Device complies (conforms to the requirements of ISO 10993 series Standards) |
| ISO 10993-11:2006 (Biological evaluation - Systemic toxicity) | Device complies (conforms to the requirements of ISO 10993 series Standards) |
| ASTM F756-08 (Assessment of hemolytic properties of material) | Device complies |
| ISO 10555-1:1995/AMD.1:1999/AMD.2:2004(E) (Sterile, single-use intravascular catheters - General requirements) | Device complies |
| ISO10555-5: 1996/AMD.1:1999(E) (Sterile, single-use intravascular catheters - Over-needle peripheral catheters) | Device complies |
| ISO594-2:1998 (Conical fittings with 6 % (Luer) taper for syringes, needles) | Device complies |
| ISO9626:1991/AMD-1:2001 (Stainless steel needle tubing) | Device complies |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for each non-clinical test. The data provenance is indicated as "Non clinical tests were conducted to verify that the proposed device met all design specifications" (Page 5), suggesting these were performed by the manufacturer, Jiangxi Sanxin Medtec Co., Ltd. The country of origin for the device itself is China, and the tests were likely conducted there or by affiliated entities. The tests are prospective with respect to the submission, performed specifically to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes a 510(k) submission for a medical device (I.V. Catheter). The "tests" here are primarily engineering and biocompatibility evaluations against recognized standards, not diagnostic performance assessments requiring expert ground truth establishment in a clinical sense. Therefore, this information is not applicable and not provided in the document. The standards themselves represent expert consensus on performance requirements.
4. Adjudication method for the test set
Similarly to point 3, adjudication methods like 2+1 or 3+1 are typically for diagnostic studies where there's variability in interpretation or a need to resolve discrepancies. For the non-clinical tests listed (e.g., seal strength, sterilization, biocompatibility), the results are generally objective measurements against predefined criteria in the standards. Therefore, an adjudication method is not applicable and not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This document is for an I.V. Catheter, which is a physical medical device, not an AI software or a diagnostic imaging system. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
As this is a physical medical device and not an algorithm, a standalone performance study in the context of an algorithm is not applicable and not discussed in the document. The non-clinical tests represent the standalone performance of the physical device.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the specifications and limits set forth in the referenced ASTM and ISO international standards. For example, for sterility, the ground truth is "achieve a SAL of 10^-6". For biocompatibility, it's "conforms to the requirement of ISO 10993 series Standards." This is based on established scientific and engineering principles for medical device safety and performance.
8. The sample size for the training set
This document describes non-clinical testing of a physical medical device, not a machine learning algorithm. Therefore, the concept of a "training set" is not applicable and no information is provided.
9. How the ground truth for the training set was established
As there is no training set for a machine learning algorithm, this question is not applicable.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).