The Nipro SafeTouch IV Catheter is a passive anti-needle stick intra-vascular catheter that is inserted into the patient's vascular system for short term use for the infusion of fluids, and/or blood components. 16-24 gauge catheters may be used with power injectors for which the maximum pressure setting is 300psi

Device Description

Nipro SafeTouch IV Catheter consists of an over-the-needle, catheter made of radiopaque polyurethane with a passive safety mechanism that will engage upon removal from the patient in order to prevent accidental needlestick injuries. The device is available in gauges 16-24 and in catheter lengths of ¾" – 2". It is also available with or without wings on the hub. Gauges are color coded for easy differentiation. Nipro SafeTouch IV Catheter is sterilized by Ethylene Oxide gas (EtO). It is packaged in a peel blister that ensures the sterility of the device until package is opened and labeled for single use only. A sleeve of SafeTouch Cath contains 5 units of blister packages. An inner box contains 10 sleeves (50 units). An outer box contains 40 inner boxes (3000 units). Its shelf life period is 5 years.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Nipro SafeTouch IV Catheter". Since it's a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove optimal performance against specific clinical acceptance criteria in the same way a new drug or novel high-risk device might.

Based on the provided information, the device is an Intravascular Catheter with a passive anti-needle stick safety mechanism. The acceptance criteria and supporting studies are focused on its non-clinical performance and a simulated clinical study for the safety mechanism.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are not explicitly stated with quantitative thresholds in the provided document beyond "All of the above tests were performed within the specifications of the standards listed above." The performance is reported as "passed with zero failures" for the simulated clinical study and "performs equivalent to the predicate device" for other tests.

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance
Mechanical/Physical	1. Disengagement force between components	Performed within specifications of internal test method
	2. Penetration force	Performed within specifications of internal test method
	3. Air leakage	Performed within specifications of internal test method
	4. Flow rate	Performed within specifications of internal test method
	8. Corrosion resistance (ISO 10555-1:1995)	Performed within specifications of ISO 10555-1:1995
Safety Mechanism	5. Safety mechanism performance (simulated clinical study)	Passed with zero failures
Sterilization & Packaging	6. Package integrity/microbial barrier (ISO 11607-2)	Performed within specifications of ISO 11607-2
	9. Sterilization validation (ISO 11135-1:2007, ISO 11135-2:2008)	Performed within specifications of ISO 11135-1/11135-2
	10. EtO residuals (ISO 10993-7)	Performed within specifications of ISO 10993-7
	11. Transportation tests (ASTM-d4169-09)	Performed within specifications of ASTM-d4169-09
	14. Shelf-life testing (ASTM F1980-07)	Performed within specifications of ASTM F1980-07
Biocompatibility	7. Chemical testing / acid, alkalinity and extractable metals (ISO 7864:1993)	Performed within specifications of ISO 7864:1993
	12. Biocompatibility (ISO 10993, various sub-parts)	Performed within specifications of ISO 10993
	13. Pyrogen testing (USP 35-NF30:2012, <85>)	Performed within specifications of USP 35-NF30:2012, <85>
	Particulate matter testing	Performed within specifications

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any of the non-clinical tests or for the "simulated clinical study" that evaluated the safety mechanism.
The provenance of the data (country of origin, retrospective/prospective) is not mentioned. These are likely internal laboratory tests conducted by Nipro Medical Corporation or a contracted testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. Since the tests are largely non-clinical engineering and laboratory tests, "experts" in the context of clinical interpretation or diagnostic decision-making are not relevant. The "ground truth" for these tests would be defined by the specifications of the relevant international standards (e.g., ISO, ASTM, USP).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is generally not applicable to the types of non-clinical, objective tests described here. Adjudication methods are typically used in clinical studies where subjective human interpretation of conditions or outcomes requires consensus.

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

No, an MRMC comparative effectiveness study was not done.
This device is an IV catheter, not an AI-assisted diagnostic tool or imaging device. There is no AI component, and therefore no assessment of human reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the device is an IV catheter, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is established by the specifications and requirements defined within the referenced international and national standards (e.g., ISO, ASTM, USP). The device performance is compared against these predefined physical, chemical, and biological limits or parameters.
For the "simulated clinical study" of the safety mechanism, the ground truth would be a binary outcome of successful activation/engagement of the safety mechanism as per its design specifications.

8. The sample size for the training set

This device is not an AI/machine learning device, so the concept of a "training set" is not applicable.

9. How the ground truth for the training set was established

This question is not applicable as the device does not involve a training set.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 8, 2017

Nipro Medical Corporation % Jessica Oswald-McLeod Director, Quality Assurance & Regulatory Affairs 3150 NW 107th Ave. Miami, Florida 33172

Re: K161681

Trade/Device Name: Nipro SafeTouch IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: June 14, 2016 Received: June 17, 2016

Dear Jessica Oswald-McLeod:

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.

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 (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Lori A. Wiggins -S

for 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K161681

Device Name Nipro SafeTouch IV Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary: Nipro SafeTouch IV Catheter K161681

807.92(a)(1)

Applicant:

Applicant:	Nipro Medical Corporation3150 NW 107th Ave.Miami FL 33172Tel: 305-599-7174
Establishment Reg.:	1056186
Contact Person:	Jessica Oswald-McLeodDirector, Quality Assurance & Regulatory Affairs

Date of summary preparation: March 7, 2017

807.92(a)(2)

Trade Name: Nipro SafeTouch IV Catheter Common Name: Safety IV Catheter Classification Name: catheter, intravascular Regulation Number: 21 CFR 880.5200 Panel: 80 Product Code: FOZ

807.92(a)(3)

Legally marketed substantial equivalent device: B Braun Introcan Safety IV Cath (K020785)

807.92(a)(4)

Description of device:

807.92(a)(5)

Indications for Use:

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807.92(a)(6)

Comparison of technological characteristics:

The catheter is substantially equivalent to the predicate device in the following technological characteristics:

Element of Comparison	Nipro SafeTouch IV Catheter	Predicate
Materials	PUR, PP, PC, Stainless Steel	Available in two materials:1. FEP, PP, ABS, chrome-nickel steel2. PUR, PP, ABS, chrome-nickel steel
Design: Operational mode	Mechanical - Manuallyoperated IV catheter with apassive safety mechanism	Same
Design: Physicalcharacteristics	Safety IV Catheter, withpassive anti-stick safetymechanism.	Same
Design: DeviceConfigurations	Available in both winged and non-winged Needle gauges 16-24 catheter lengths of ¾" – 2" Color coded hubs for easy identification distal end: Luer connector proximal end: Cannula and catheter	Same
Intended Use	The Nipro SafeTouch IVCatheter is a passive anti-needle stick intra-vascularcatheter that is inserted intothe patient's vascular systemfor short term use for theinfusion of fluids, and/orblood components. 16-24gauge catheters may be usedwith power injectors forwhich the maximum pressuresetting is 300psi	Passive anti-needle stickdevice for venous or arterialaccess for the infusion offluids, drugs, and/or bloodcomponents. 14-22 gaugecatheters may be used withpower injectors for whichthe maximum pressuresetting is 300psi
Sterilization and Expirydating	Method: Ethylene OxideShelf-life: 5 years	Same
Energy Source	NA	NA

Table 4: Comparison of technological characteristics

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Non-clinical tests submitted are for dimensional and performance, sterilization and biocompatibility:

1. Disengagement force between components (internal test method)
Penetration force (internal test method) 2.
1. Air leakage (internal test method)
1. Flow rate (internal test method)
1. Safety mechanism performance (simulated clinical study)
Package integrity/microbial barrier (ISO 11607-2) 6.
1. Chemical testing / acid, alkalinity and extractable metals (ISO 7864:1993)
Corrosion resistance (ISO 10555-1:1995) 8.
Sterilization validation (ISO 11135-1:2007, ISO 11135-2:2008) 9.
1. Eto residuals (ISO 10993-7)
1. Transportation tests (ASTM-d4169-09)
1. Biocompatibility (ISO 10993)
- a. Cytotoxicity: MEM Elution
- b. Sensitization: Kligman Maximization
- ﻥ Intracutaneous Irritation
- d. Acute Systemic Toxicity: Systemic Injection
- e. Rabbit Pyrogen
- f. Hemolysis –Rabbit Blood – direct and indirect contact
- Complement Activation SC5b9 g.
- h. Complement Activation - СЗа
- i. Dog Thrombogenicity
- j. ASTM Partial Thromboplastin Time
- Genotoxicity: Bacterial Reverse Mutation Study k.
- 1. Mouse Peripheral Blood Micronucleus Study
- m. Two Week Rat Study, Repeated Parenteral Administration of Two Extracts
- n. Genotoxicity: Mouse Lymphoma Assay
- o. ISO Muscle Implantation Study 2 Week
- p. LAL testing
- q. Particulate matter testing
1. Pyrogen testing (USP 35-NF30:2012, <85>)
1. Shelf-life testing (ASTM F1980-07)

All of the above tests were performed within the specifications of the standards listed above.

807.92(b)(2)

Clinical tests:

This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission.

A simulated clinical test was performed to evaluate the effectiveness of the safety mechanism. This test passed with zero failures.

807.92(b)(3)

Conclusions drawn from non-clinical and clinical tests:

The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Nipro SafeTouch IV Catheter performs equivalent to the predicate device when used as intended.

Regulation Number and Section

§ 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).