The SafeTouch PSV Winged Infusion Set with/without filter is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously or to sample blood. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.

Device Description

The SafeTouch PSV winged Infusion Set with/without filter consists of a winged needle (25 gauge x 3/4 inch) with an integrated safety mechanism connected to PVC tubing and a female luer connector with cap. The tubing material is DEHP-free PVC and the filter has been added to prevent the flow of particulate matter.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Nipro SafeTouch PSV winged Infusion Set with/without filter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Implied)	Reported Device Performance
Appearance	Acceptable visual inspection; free from defects.	Not explicitly stated, but results are included and deemed safe and effective.
Dimensional	Conformance to design specifications.	Not explicitly stated, but results are included and deemed safe and effective.
Package Integrity Testing	Maintain sterile barrier and component integrity.	Not explicitly stated, but results are included and deemed safe and effective.
Penetration force (puncture resistance)	Meet specified force requirements for needle insertion.	Not explicitly stated, but results are included and deemed safe and effective.
Pull force of connections	Meet specified force requirements to prevent accidental disconnection.	Not explicitly stated, but results are included and deemed safe and effective.
Safety Mechanism Deactivation force	Meet specified force for clinicians to activate safely.	Not explicitly stated, but results are included and deemed safe and effective.
Needle Clogging Test	Demonstrate resistance to clogging during use.	Not explicitly stated, but results are included and deemed safe and effective.
Leakage of product	Prevent fluid leakage.	Not explicitly stated, but results are included and deemed safe and effective.
Luer Cap Separation	Maintain secure connection but allow for intentional separation.	Not explicitly stated, but results are included and deemed safe and effective.
Connector Taper Leakage	Prevent leakage at tapered connections.	Not explicitly stated, but results are included and deemed safe and effective.
Internal/external surface of cannula	Smooth and free from defects to ensure safe insertion and flow.	Not explicitly stated, but results are included and deemed safe and effective.
Cannula Elasticity	Exhibit appropriate flexibility and resilience.	Not explicitly stated, but results are included and deemed safe and effective.
Cannula Bending Strength	Withstand bending forces without kinking or breaking.	Not explicitly stated, but results are included and deemed safe and effective.
Product Air Tightness	Prevent air ingress/egress.	Not explicitly stated, but results are included and deemed safe and effective.

Note: The document states that "The results and conclusions of these tests are included in this submission," and concludes that the device is "safe and effective when used as intended," implying that the device met the acceptance criteria for all listed tests. Specific numerical acceptance criteria and performance values are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided summary.
Data Provenance: The tests conducted are "Non-clinical tests," implying bench testing. The country of origin for this testing is not specified, but the applicant (Nipro Medical Corporation) is located in Miami, FL, USA. The data is retrospective in the sense that it was generated for the purpose of the 510(k) submission, not as a continuous monitoring process.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. This was bench testing, not a study requiring expert clinical assessment for ground truth.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable, as this was bench testing.

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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical testing was required or performed in support of this 510k submission." This is not an AI-based device, so a human-reader improvement metric is irrelevant.

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

Not applicable. This device is a medical instrument (infusion set), not an algorithm or AI system. Its performance is evaluated through physical and functional bench tests.

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

The "ground truth" for the bench tests would be the pre-defined engineering specifications, industry standards, and established test methodologies for medical devices of this type. It's based on engineering validated criteria rather than clinical ground truth (like pathology or outcomes data).

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

K113429

Image /page/0/Picture/1 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized, abstract symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. Below "NIPRO" is the text "MEDICAL CORPORATION" in a smaller, sans-serif font. The entire logo is black and white.

3150 NW 107th Avenue Miami FL 33172 Tel: 305.599.7174 Fax: 305.592.4621

MAR 1 2 2012

510(k) Summary SafeTouch PSV winged Infusion Set with/without filter

807.92(a)(1)

Applicant:
Establishment Reg.:

Nipro Medical Corporation 1056186

Contact Person:

Jessica Oswald Regulatory Affairs Specialist

Date of summary preparation: November 4, 2011

807.92(a)(2)

Trade Name: SafeTouch PSV winged Infusion Set with/without filter Common Name: Safety Scalp Vein Set Classification Name: catheter,intravascular,therapeutic,short-term less than 30 days Regulation Number: 21 CFR 880.5200 Panel: 80 Product Code: FOZ

807.92(a)(3)

Legally marketed substantial equivalent device: K011297 - NIPRO SafeTouch Scalp Vein Set and Blood Collection Needle

807.92(a)(4)

Description of device:

807.92(a)(5)

Indications for Use:

This device is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously or to sample blood. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.

807.92(a){6)

Comparison of technological characteristics:

The Nipro SafeTouch Scalp Vein Set with/without filter is identical to the predicate device, in terms of:

basic scientific technology, .
. design,
. Intended Use and
. Operational technique.

{1}------------------------------------------------

The differences between the proposed device and the predicate device are:

Physical characteristics/components addition of the particulate matter filter .
Material Characteristics change to DEHP-Free tubing .

807.92(b)(1)

Non-clinical tests submitted:

Performance testing was conducted to verify that the device is safe and effective for its intended use. Those tests include appearance, dimensional, package integrity testing and functional testing to include: Penetration force (puncture resistance testing), Pull force of connections, Safety Mechanism Deactivation force, Needle Clogging Test, Leakage of product, Luer Cap Separation, Connector Taper Leakage, Internal/external surface of cannula, Cannula Elasticity, Cannula Bending Strength and Product Air Tightness. The results and conclusions of these tests are included in this submission.

807.92(b)(2)

Clinical tests submitted:

Substantial equivalence was proven through bench testing. No clinical testing was required or performed in support of this 510k submission.

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 SafeTouch PSV performs equivalent to the predicate device and is safe and effective when used as intended.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

Ms. Jessica Oswald Regulatory Affairs Specialist Nipro Medical Corporation 3150 NW 107th Avenue Miami, Florida 33172

MAR 1 2 2012

Re: K113429

Trade/Device Name: SafeTouch PSV winged Infusion Set with/without filter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: March 6, 2012 Received: March 7, 2012

Dear Ms. Oswald:

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}------------------------------------------------

Page 2- Ms. Oswald

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number:_

Device Name: SafeTouch PSV winged Infusion Set with/without filter

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use
AND/OR
(21 CFR 801 Subpart C)

(Division Sign-Off)
3/12/2012

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K113429

SafeTouch PSV winged Infusion Set with/without filter

-4.1-

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).