Nipro SafeTouch IV Catheter

K161681 · Nipro Medical Corporation · FOZ · Mar 8, 2017 · General Hospital

Device Facts

• Record ID: K161681
• Device Name: Nipro SafeTouch IV Catheter
• Applicant: Nipro Medical Corporation
• Product Code: FOZ · General Hospital
• Decision Date: Mar 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Nipro SafeTouch IV Catheter is an over-the-needle, radiopaque polyurethane catheter; features passive safety mechanism engaging upon removal from patient to prevent accidental needlestick injuries. Available in 16-24 gauges, lengths 3/4"–2", with or without wings. Used by clinicians for short-term venous or arterial access; enables infusion of fluids/blood components. Compatible with power injectors up to 300psi. Device is single-use, sterile (EtO), and color-coded for gauge identification. Passive safety mechanism reduces risk of sharps injury to healthcare providers during catheter removal.

Clinical Evidence

No clinical data provided. Bench testing only. Performance validated via simulated clinical study of safety mechanism (zero failures), dimensional/performance testing, biocompatibility (ISO 10993), sterilization validation (ISO 11135), and shelf-life testing (ASTM F1980).

Technological Characteristics

Materials: Polyurethane (PUR), Polypropylene (PP), Polycarbonate (PC), Stainless Steel. Passive safety mechanism. Sterilization: Ethylene Oxide (ISO 11135). Biocompatibility: ISO 10993. Packaging: ISO 11607-2. Shelf-life: 5 years (ASTM F1980). Connectivity: None. Energy source: None.

Indications for Use

Indicated for patients requiring short-term vascular access for the infusion of fluids and/or blood components via an intravascular catheter.

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

• B Braun Introcan Safety IV Cath (K020785)

Submission Summary (Full Text)

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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 [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" (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 [phone] or [phone] 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)

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

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 Corporation<br>3150 NW 107th Ave.<br>Miami FL 33172<br>Tel: [phone] |
|---------------------|----------------------------------------------------------------------------------------|
| Establishment Reg.: | 1056186 |
| Contact Person: | Jessica Oswald-McLeod<br>Director, 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:

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.

#### 807.92(a)(5)

Indications for Use:

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

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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:<br>1. FEP, PP, ABS, chrome-<br>nickel steel<br>2. PUR, PP, ABS, chrome-<br>nickel steel |
| Design: Operational mode | Mechanical - Manually<br>operated IV catheter with a<br>passive safety mechanism | Same |
| Design: Physical<br>characteristics | Safety IV Catheter, with<br>passive anti-stick safety<br>mechanism. | Same |
| Design: Device<br>Configurations | 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 IV<br>Catheter is a passive anti-<br>needle stick intra-vascular<br>catheter that is inserted into<br>the patient's vascular system<br>for short term use for the<br>infusion of fluids, and/or<br>blood components. 16-24<br>gauge catheters may be used<br>with power injectors for<br>which the maximum pressure<br>setting is 300psi | Passive anti-needle stick<br>device for venous or arterial<br>access for the infusion of<br>fluids, drugs, and/or blood<br>components. 14-22 gauge<br>catheters may be used with<br>power injectors for which<br>the maximum pressure<br>setting is 300psi |
| Sterilization and Expiry<br>dating | Method: Ethylene Oxide<br>Shelf-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.
- 3. Air leakage (internal test method)
- 4. Flow rate (internal test method)
- 5. Safety mechanism performance (simulated clinical study)
- Package integrity/microbial barrier (ISO 11607-2) 6.
- 7. 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.
- 10. Eto residuals (ISO 10993-7)
- 11. Transportation tests (ASTM-d4169-09)
- 12. 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
- 13. Pyrogen testing (USP 35-NF30:2012, <85>)
- 14. 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.