SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER

K132153 · Nipro Medical Corporation · FOZ · Dec 5, 2013 · General Hospital

Device Facts

• Record ID: K132153
• Device Name: SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
• Applicant: Nipro Medical Corporation
• Product Code: FOZ · General Hospital
• Decision Date: Dec 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. Secondly it is designed with an active share that requires physical action by the clinician to prevent accidental needlesticks.

Device Story

Winged infusion set (25 gauge x 3/4 inch needle) with integrated safety mechanism, PVC tubing, and female luer connector; optional filter included to prevent particulate matter flow. Used by clinicians in clinical settings for intravenous fluid administration. Device features active safety mechanism requiring manual clinician activation to prevent accidental needlesticks. Output is fluid delivery to patient vascular system. Benefits include safe, controlled intravenous access and reduced risk of sharps injury to healthcare personnel.

Clinical Evidence

Bench testing only. No clinical testing performed.

Technological Characteristics

Winged needle (25G x 3/4"), PVC tubing, female luer connector, optional particulate filter. Active safety mechanism for needle shielding. Single-use, sterile, intravascular device.

Indications for Use

Indicated for patients requiring intravenous fluid administration via an indwelling vascular access device. For use by clinicians.

Regulatory Classification

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.

Predicate Devices

• SafeTouch PSV Winged Infusion Set with or without filter (K113429)

Submission Summary (Full Text)

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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 in black and white.

3150 NW 107th Avenue Miami FL 33172 Tel: [phone] Fax: [phone]

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

Regulatory Affairs Specialist

#### 807.92(a){1)

| Applicant: | Nipro Medical Corporation |
|---------------------|-----------------------------------|
| | 3150 NW 107th Ave. Doral FL 33172 |
| Establishment Reg.: | 1056186 |
| Contact Person: | Jessica Oswald-McLeod |

Date of summary preparation: June 24, 2013

#### 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: K113429 - SafeTouch PSV Winged Infusion Set with or without filter

#### 807.92(a)(4)

#### Description of device:

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. An optional filter has been added to prevent the flow of particulate matter.

## 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. 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 all aspects except the indications for use. We have removed the indication of blood sampling.

#### 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

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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.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized graphic of a human figure.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

#### December 5, 2013

Nipro Medical Corporation Ms. Jessica Oswald-McLeod Regulatory Affairs Specialist 3150 NW 107th Avenue Miami. FL 33172

Re: K132153

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: November 1, 2013 Received: November 6, 2013

Dear Ms. 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.

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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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kwame O. Ulmer -S

for

Erin 1. Keith, M.S. 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

510(k) Number (if known) K132153

#### Device Name

SafeTouch PSV winged Infusion Set with/without filter

#### Indications for Use (Describe)

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. Secondly it is designed with an active share that requires physical action by the clinician to prevent accidental needlesticks.

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

> 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.

Image /page/4/Figure/11 description: The image shows a document with the header "FOR FDA USE ONLY". It indicates the concurrence of the Center for Devices and Radiological Health (CDRH). The document includes a digital signature by Richard C. Chapman, dated December 4, 2013, at 17:28:59 with a time zone offset of -05'00'.

FORM FDA 3881 (9/13)

PSC Publishing Sers sees ( 101) 44 3-6740

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