TERUMO SURFLO I.V. CATHETER

K133280 · Terumo (Philippines) Corporation · FOZ · Jun 12, 2014 · General Hospital

Device Facts

• Record ID: K133280
• Device Name: TERUMO SURFLO I.V. CATHETER
• Applicant: Terumo (Philippines) Corporation
• Product Code: FOZ · General Hospital
• Decision Date: Jun 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TERUMO® SURFLO® I.V. Catheter is inserted into the patient's vascular system for short term use (less than 30 days) to withdraw blood samples, monitor blood pressure, or administer fluids intravenously.

Device Story

The TERUMO® SURFLO® I.V. Catheter is a manually operated, over-the-needle peripheral catheter. It consists of a catheter assembly (catheter, caulking pin, hub) and a needle assembly (needle, hub, filter cap, filter). The device is inserted into the patient's vascular system; the stainless steel cannula provides rigidity during placement and is withdrawn immediately after insertion. The catheter is made of radio-opaque ETFE. The needle assembly includes a membrane filter to prevent blood leakage during the procedure. It is used in clinical settings by healthcare professionals to facilitate intravenous therapy, blood withdrawal, or hemodynamic monitoring. The device benefits patients by providing a reliable, short-term vascular access point for necessary medical interventions.

Clinical Evidence

Bench testing only. Performance testing verified compliance with ISO 10555-1, ISO 10555-5, and ISO 594-1 standards, including force at break, corrosion resistance, leakage (liquid/air), flow rate, and mechanical strength. Biocompatibility testing was conducted per ISO 10993-1 and FDA G95-1, covering cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, subchronic toxicity, hemocompatibility, genotoxicity, and implantation. All tests met acceptance criteria.

Technological Characteristics

Over-the-needle peripheral catheter. Materials: ETFE catheter (with barium sulfate), stainless steel cannula/pin, polypropylene hub, polycarbonate needle hub, reactive silicone lubricant. Available in 14-24G diameters and 19-64mm lengths. Manual operation. Sterilized via E-beam radiation (SAL 10^-6). Complies with ISO 10555-1, ISO 10555-5, and ISO 594-1.

Indications for Use

Indicated for patients requiring short-term (less than 30 days) vascular access for blood sampling, blood pressure monitoring, or intravenous fluid administration.

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

• TERUMO® SURFLO® I.V. Catheter (K891087)

Submission Summary (Full Text)

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# K133280

# JUN 1 2 2014

## 510(k) SUMMARY

#### A. SUBMITTER INFORMATION (807.92(a)(1))

: TERUMO (PHILIPPINES) CORPORATION Prepared for 124 East Main Avenue, Laguna Technopark, Binan, Laguna,Philippines

Prepared by : Ma. Cristina Faderagao - Supervisor, Regulatory Affairs Tel. [phone] Fax [phone]

Date prepared : September 26, 2013

Contact Person : Phillip Michael Lester

Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 Phone#: [phone] Fax#: [phone] E-mail: [e-mail]

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#### B. DEVICE NAME (807.92(a)(2))

#### Proprietary Name

TERUMO® SURFLO® I.V. Catheter or similar proprietary name

#### Classification Name

Intravascular Catheter (880.5200)

Product Code: FOZ

Panel: General Hospital

Classification: Class II

#### Common Name

Intravascular catheter

#### C. PREDICATE DEVICE (807.92(a)(3))

The legally marketed device to which substantial equivalence is claimed is the TERUMO® SURFLO® I.V. Catheter (K891087), manufactured by Terumo Medical Corporation, Elkton, Maryland.

#### D. REASON FOR 510(K) SUBMISSION

This premarket notification (510(k)) is being submitted for the TERUMO® SURFLO® I.V. Catheter, an intravascular device, manufactured by Terumo (Philippines) Corporation, as a new device.

### E. INTENDED USE (807.92(a)(5))

TERUMO® SURFLO® I.V. Catheter is inserted into the patient's vascular system for short term use (less than 30 days) to withdraw blood samples, monitor blood pressure, or administer fluids intravenously.

Note: This intended use is substantially equivalent to the predicate device, TERUMO® SURFLO® I.V. Catheter (K891087).

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## F. DEVICE DESCRIPTION (807.92(a)(4))

(Summary of Technological Characteristics)

#### Principle of Operation and Technology

The TERUMO® SURFLO® I.V. Catheter is manually operated.

#### Design/Construction

The SURFLO® I.V. Catheter is a device consisting of a catheter assembly (catheter, caulking pin, and catheter hub) and needle assembly (needle, needle hub, filter cap and filter).

The device is an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque plastic with a hub that is inserted into the patient's vascular system for short term (<30days) use to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line.

#### Material

The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The needle assembly contains a plug and membrane filter which prevents blood leakage.

The catheter that is advanced into the vessel is made of ethylene tetrafluoro ethylene, which is the same as TERUMO® SURFLO® I.V. Catheter (K891087), manufactured by Terumo Medical Corporation, Elkton, Maryland.

#### Specifications

The TERUMO® SURFLO® I.V. Catheter will be individually packaged by case unit and sterilized by electron beam. It is available in 14, 16, 18, 20, 22 and 24 gauge catheters diameters and 19, 25, 32, 51, and 64 mm catheter lengths.

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| Product Code | Catheter<br>Gauge | Color Code | Catheter length | Catheter OD (ID) | Flow rate | Lumen<br>Volume* |
|--------------|-------------------|------------|-----------------|------------------|------------|------------------|
| SR-OX1464CA | 14G | Orange | 2½" (64mm) | 2.15mm (1.73mm) | 300 mL/min | 120 µL |
| SR-OX1451CA | 14G | Orange | 2" (51mm) | 2.15mm (1.73mm) | 305 mL/min | 120 µL |
| SR-OX1664CA | 16G | Gray | 2½" (64mm) | 1.70mm (1.30mm) | 180 mL/min | 68 µL |
| SR-OX1651CA | 16G | Gray | 2" (51mm) | 1.70mm (1.30mm) | 190 mL/min | 68 µL |
| SR-OX1632CA | 16G | Gray | 1¼" (32mm) | 1.70mm (1.30mm) | 200 mL/min | 68 µL |
| SR-OX1864CA | 18G | Green | 2½" (64mm) | 1.30mm (0.96mm) | 85 mL/min | 23 µL |
| SR-OX1851CA | 18G | Green | 2" (51mm) | 1.30mm (0.96mm) | 90 mL/min | 23 µL |
| SR-OX1832CA | 18G | Green | 1¼" (32mm) | 1.30mm (0.96mm) | 100 mL/min | 23 µL |
| SR-OX2051CA | 20G | Pink | 2" (51mm) | 1.10mm (0.78mm) | 55 mL/min | 16 µL |
| SR-OX2032CA | 20G | Pink | 1¼" (32mm) | 1.10mm (0.78mm) | 60 mL/min | 15 µL |
| SR-OX2025CA | 20G | Pink | 1" (25mm) | 1.10mm (0.78mm) | 65 mL/min | 12 µL |
| SR-OX2225CA | 22G | Blue | 1" (25mm) | 0.85mm (0.62mm) | 35 mL/min | 7 µL |
| SR-OX2419CA | 24G | Yellow | 3/4" (19mm) | 0.67mm (0.47mm) | 15 mL/min | 3 µL |

*Catheter only

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#### G. NON CLINICAL TESTS (807.92(b)(1))

#### Performance

Performance testing was conducted to ensure the safety and effectiveness of the TERUMO® SURFLO® I.V. Catheter throughout the shelf life, verify conformity to the applicable part of ISO standards, and demonstrate substantial equivalence to the predicate device, as mentioned in the table below.

No new issues of safety and effectiveness were raised with the testing performed. Performance testing demonstrates that the TERUMO® SURFLO® I.V. Catheter conforms to the recognized consensus ISO standards, is substantially equivalent to the predicate devices, and acceptable for clinical use throughout the shelf life.

The following performance tests were performed on TERUMO® SURFLO® I.V. Catheter, manufactured by Terumo (Philippines) Corporation, and the predicate:

| Test | Standard | Result |
|---------------------------------------------------------|-------------|----------------|
| Force at break | ISO 10555-1 | Meets standard |
| Corrosion resistance | ISO 10555-1 | Meets standard |
| Liquid leakage under<br>pressure | ISO 10555-1 | Meets standard |
| Air leakage into hub<br>assembly during aspiration | ISO 10555-1 | Meets standard |
| Vent fitting | ISO 10555-5 | Meets standard |
| Flow rate | ISO 10555-5 | Meets standard |
| Strength of union between<br>needle hub and needle tube | ISO 10555-5 | Meets standard |
| Gauging | ISO 594-1 | Meets standard |
| Liquid leakage | ISO 594-1 | Meets standard |
| Air leakage | ISO 594-1 | Meets standard |
| Separation force | ISO 594-1 | Meets standard |
| Stress cracking | ISO 594-1 | Meets standard |

No deviations from recognized consensus ISO standards were identified in the testing to standards.

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> Performance testing other than to the above ISO Standards was also performed on the device. The device complies with the acceptance criteria for each test:

| Performance Test | Results |
|----------------------------------------------|---------------------------|
| Cannula and needle hub fitting force | Meets acceptance criteria |
| Catheter tube and catheter hub fitting force | Meets acceptance criteria |
| Catheter tube and catheter hub leakage | Meets acceptance criteria |
| Catheter tube and needle fitting force | Meets acceptance criteria |
| Flashback | Meets acceptance criteria |
| Needle and needle hub leakage | Meets acceptance criteria |
| Needle heel and catheter tip distance | Meets acceptance criteria |
| Needle penetration | Meets acceptance criteria |

#### Biocompatibility

The TERUMO® SURFLO® I.V. Catheter is classified as:

- -Catheter and lubricant: Externally Communicating Device, Circulating Blood, Prolonged Exposure (24 hours to 30 days):
- Cannula with lubricant: Externally Communicating Device, Circulating -Blood, Short Term (<24 hours) Use, as the cannula is immediately withdrawn after insertion of the catheter into the vascular system; and
- Catheter hub and caulking pin: Externally Communicating Device, Blood -Path Indirect. Prolonged Exposure (24 hours to 30 days).

The device's body and blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained all throughout the shelf life of the product. Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.

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| Tests |
|-----------------------------------------|
| Cytotoxicity |
| Sensitization |
| Intracutaneous reactivity |
| Systemic toxicity (Acute) |
| Pyrogenicity |
| Subchronic toxicity (subacute toxicity) |
| Hemocompatibility |
| Genotoxicity |
| Implantation |
| Physicochemical |
| Characterization |

### H. ADDITIONAL SAFETY INFORMATION

The sterility of the device is assured using a sterilization method validated in accordance with ANSI/AAMI/ISO 11137 - Medical Devices - Validation and Routine Control of Radiation Sterilization. The TERUMO® SURFLO® I.V. Catheter is sterilized to provide a Sterility Assurance Level (SAL) of 106.

#### I. SUBSTANTIAL EQUIVALENCE (807.92(a)(6)) ,

The TERUMO® SURFLO® I.V. Catheter, manufactured by Terumo (Philippines) Corporation, is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to TERUMO® SURFLO® I.V. Catheter (K891087), manufactured by Terumo Medical Corporation, Elkton, Maryland.

The table on the following page summarizes a comparison of the technological characteristics.

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| | Terumo (Philippines) Corporation | Terumo Medical Corporation |
|----------------------|--------------------------------------|---------------------------------------|
| Device | TERUMO® SURFLO® I.V. catheter | TERUMO® SURFLO® I.V. catheter |
| | (subject of this 510(k)) | (K891087) |
| | Inserted into patient's vascular | Inserted into patient's vascular |
| | system for short term use (less than | system for short term use (less than |
| Intended Use | 30 days) to withdraw blood samples, | 30 days) to withdraw blood samples, |
| | monitor blood pressure, or | monitor blood pressure, or administer |
| | administer fluids intravenously. | fluids intravenously (880.5200). |
| Operation | | |
| Principle | Manual | Manual |
| | a. catheter assembly (catheter, | a. catheter assembly (catheter, |
| Design / | caulking pin, and catheter hub) | caulking pin, and catheter hub) |
| Construction | b. needle assembly (needle, needle | b. needle assembly (needle, needle |
| | hub, filter cap and filter) | hub, filter cap and filter) |
| | Cannula - stainless steel | Cannula - stainless steel |
| | Catheter hub - polypropylene | Catheter hub – polypropylene |
| Material | Needle hub - polycarbonate | Needle hub - polycarbonate |
| | Caulking pin - stainless steel | Caulking pin - stainless steel |
| | Catheter- ETFE with barium sulfate | Catheter- ETFE with barium sulfate |
| | Lubricant - Reactive Silicone | Lubricant - Reactive Silicone |
| Radiopaque<br>Medium | Barium sulfate | Barium sulfate |
| Color Code | | |
| of Catheter | In accordance with ISO 10555-5 | In accordance with ISO 10555-5 |
| Hub | | |
| Package | Unit case | Unit case |
| Sterilization | E-beam radiation (validated in | EtO (validated in accordance with |
| | accordance with ISO 11137-1) | ISO 11135-1) |

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## J. CONCLUSION (807.92(b)(3))

In summary, the TERUMO® SURFLO® I.V. Catheter, manufactured by Terumo (Philippines) Corporation, is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to TERUMO® SURFLO® I.V. Catheter (K891087), manufactured by Terumo Medical Corporation, Elkton, Maryland.

There is no significant difference that raises any new issues of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another figure, representing health and human services.

Public Health Service

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

June 12, 2014

Terumo Medical Corporation C/O Mr. Phillip Lester Regulatory Affairs Specialist 950 Elkton Boulevard Elkton, MD 21921

Re: K133280

Trade/Device Name: Terumo Surflo I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Short-term Regulatory Class: II . . Product Code: FOZ Dated: May 16, 2014 Received: May 19, 2014

Dear Mr. Lester:

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 - Mr. Lester

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 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" (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 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 yours,

Mary S. Runner -S

Erin I. Keith, M.S. . Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### K133280

#### Device Name

TERUMO® SURFLO® I.V. Catheter or similar proprietary name

#### Indications for Use (Describe)

TERUMO® SURFLO® I. V. Catheter is inserted into the patient's vascular system for short term use (less than 30 days) to withdraw blood samples, monitor blood pressure, or administer fluids intravenously.

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.

#### FOR FDA USE ONLY

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

Digitally signed by Richard C. Chapman -S Date: 2014.06.12 11:24:54 -04'00'

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

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