(230 days)
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.
The TERUMO® 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.
Here's an analysis of the acceptance criteria and supporting studies for the TERUMO® SURFLO® I.V. Catheter, based on the provided 510(k) summary:
This device is not an AI device, therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, training set details) are not applicable. The provided document details a traditional medical device submission for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TERUMO® SURFLO® I.V. Catheter are based on conformity to recognized consensus ISO standards and specific internal performance tests. The reported performance indicates that the device Meets Standard or Meets acceptance criteria for all tests.
| Test Category | Specific Test | Standard/Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO Standards | Force at break | ISO 10555-1 | Meets standard |
| Corrosion resistance | ISO 10555-1 | Meets standard | |
| Liquid leakage under pressure | ISO 10555-1 | Meets standard | |
| Air leakage into hub 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 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 | |
| Internal Tests | Cannula and needle hub fitting force | Acceptance criteria | Meets acceptance criteria |
| Catheter tube and catheter hub fitting force | Acceptance criteria | Meets acceptance criteria | |
| Catheter tube and catheter hub leakage | Acceptance criteria | Meets acceptance criteria | |
| Catheter tube and needle fitting force | Acceptance criteria | Meets acceptance criteria | |
| Flashback | Acceptance criteria | Meets acceptance criteria | |
| Needle and needle hub leakage | Acceptance criteria | Meets acceptance criteria | |
| Needle heel and catheter tip distance | Acceptance criteria | Meets acceptance criteria | |
| Needle penetration | Acceptance criteria | Meets acceptance criteria |
Biocompatibility Tests:
| Test | Reported Performance |
|---|---|
| Cytotoxicity | Biocompatible |
| Sensitization | Biocompatible |
| Intracutaneous reactivity | Biocompatible |
| Systemic toxicity (Acute) | Biocompatible |
| Pyrogenicity | Biocompatible |
| Subchronic toxicity (subacute toxicity) | Biocompatible |
| Hemocompatibility | Biocompatible |
| Genotoxicity | Biocompatible |
| Implantation | Biocompatible |
| Physicochemical Characterization | Biocompatible |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of units tested) for the performance tests. It states that "Performance testing was conducted to ensure the safety and effectiveness... and demonstrate substantial equivalence to the predicate device."
The data provenance is from the manufacturer, Terumo (Philippines) Corporation, and the tests were performed on the new device, comparing it to the legally marketed predicate device (K891087) manufactured by Terumo Medical Corporation, Elkton, Maryland. These are considered prospective tests performed on the device being submitted for clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the device is a physical medical instrument (intravascular catheter), not an AI/software device that relies on expert interpretation for ground truth. The "ground truth" for this device's performance is objective measurements against established engineering and biological standards.
4. Adjudication Method for the Test Set
This information is not applicable because the performance tests involve objective measurements and comparisons against established standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and AI assistance can impact their performance. This is not relevant for an intravascular catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone performance test in the context of an algorithm's performance was not done. The "standalone" performance here refers to the device's physical and biological characteristics as it would be used, independent of human interaction other than proper insertion and operation.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Established consensus standards: International Organization for Standardization (ISO) standards (e.g., ISO 10555 series, ISO 594 series, ISO 11137 for sterilization, ISO 10993-1 for biocompatibility).
- Predefined acceptance criteria: Internal specifications for physical properties and functionality (e.g., fitting forces, leakage, flashback, needle penetration).
- Demonstrated performance of a legally marketed predicate device: The new device's performance is compared to that of the predicate device (K891087) to establish substantial equivalence.
8. The Sample Size for the Training Set
This is not applicable. This submission is for a physical medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this type of device.
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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. (+63) 49 541 2111 Fax (+63) 49 541 2121
Date prepared : September 26, 2013
Contact Person : Phillip Michael Lester
Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 Phone#: (410)392-7321 Fax#: (410)398-6079 E-mail: philmichael.lester@terumomedical.com
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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.
015
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、
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・・ _
| Product Code | CatheterGauge | Color Code | Catheter length | Catheter OD (ID) | Flow rate | LumenVolume* |
|---|---|---|---|---|---|---|
| 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 underpressure | ISO 10555-1 | Meets standard |
| Air leakage into hubassembly during aspiration | ISO 10555-1 | Meets standard |
| Vent fitting | ISO 10555-5 | Meets standard |
| Flow rate | ISO 10555-5 | Meets standard |
| Strength of union betweenneedle 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 | |
| RadiopaqueMedium | 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
i
.
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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§ 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).