SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER

K113429 · Nipro Medical Corporation · FOZ · Mar 12, 2012 · General Hospital

Device Facts

• Record ID: K113429
• Device Name: SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
• Applicant: Nipro Medical Corporation
• Product Code: FOZ · General Hospital
• Decision Date: Mar 12, 2012
• Decision: SESE
• Submission Type: Special
• 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 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 Story

SafeTouch PSV is a winged infusion set (25 gauge x 3/4 inch needle) featuring an integrated safety mechanism to prevent accidental needlesticks. Device connects to PVC tubing and a female luer connector. Includes an optional particulate matter filter. Used by clinicians for intravenous fluid administration or blood sampling. Safety mechanism requires manual activation by the clinician after use. Device is single-use. Benefits include reduced risk of needlestick injuries to healthcare personnel and prevention of particulate matter infusion.

Clinical Evidence

Bench testing only. No clinical testing performed.

Technological Characteristics

Winged needle (25G x 3/4"), DEHP-free PVC tubing, female luer connector, optional particulate matter filter. Manual safety mechanism. Sterilization method not specified.

Indications for Use

Indicated for patients requiring intravenous fluid administration or blood sampling via vascular access. Device includes an active safety mechanism for clinician use to prevent accidental needlesticks.

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

• NIPRO SafeTouch Scalp Vein Set and Blood Collection Needle (K011297)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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:

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.

#### 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.

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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.

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## 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.

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#### 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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

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# Indications for Use

510(k) Number:_

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

Indications for 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 or to sample blood. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.

## (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

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