(403 days)
Not Found
No
The device description and performance studies indicate a manually operated, disposable infusion set with no mention of AI/ML capabilities or related data/training sets.
No
A therapeutic device is used to treat or cure a disease or condition. This device is indicated for venipuncture and intravenous administration of fluids, which are procedures, not treatments in themselves.
No
This device is designed for venipuncture and intravenous administration of fluids, which are treatment and administration functions, not diagnostic ones.
No
The device description clearly outlines physical components like a needle, wing, tubing, and connector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "venipuncture and intravenous administration of fluids". This is a procedure performed directly on a patient's body for therapeutic purposes (administering fluids).
- Device Description: The device is a physical instrument used for accessing a vein and delivering fluids. It does not involve the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in samples, or providing diagnostic information.
IVD devices are used to test samples (like blood, urine, tissue) outside of the body to provide information about a person's health. This device is used to directly interact with the patient's circulatory system for treatment.
N/A
Intended Use / Indications for Use
The Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Surflo Winged Infusion Set consists of a protector, needle, wing, tubing, connector, and connector cap. The connector is 6% female Luer. It is primarily made from medical grade PVC (the whole device uses TOTM as plasticizer instead of DEHP) and medical grade stainless steel.
The Surflo Winged Infusion Set is operated manually. The device is intended to be used by trained healthcare professionals in a healthcare facility.
The Surflo Winged Infusion Set is a disposable device intended for single use only. The device is packaged and sterilized by ethylene oxide gas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
any patient population with consideration given to patient size.
Intended User / Care Setting
trained healthcare professionals in a healthcare facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted to ensure the Surflo Winged Infusion Set met the predetermined specifications throughout the shelf life, verify conformity to the applicable parts of ISO and non-ISO standards, and demonstrate substantial equivalence to the predicate device. No new issues of safety and effectiveness were raised with the testing performed.
Performance tests included: Flow rate, Leak test, Wing to tubing connection strength (static pull force), Tubing to connector connection strength (static pull force), Needle to wing connection strength (static pull force), Needle curvature, Wing to tubing connection strength (dynamic pull force), Tubing to connector connection strength (dynamic pull force), Needle to wing connection strength (dynamic pull force), Wing-needle protector fit, Needle penetration resistance, Blockage test, Priming volume.
Performance testing demonstrates that the Surflo Winged Infusion Set conforms to the recognized consensus ISO and non-ISO standards, is substantially equivalent to the predicate device, and is acceptable for clinical use throughout the shelf life.
Biocompatibility tests included: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute System Toxicity, Pyrogenicity, Hemolysis, Subacute/Subchronic Toxicity for both non-aged and accelerated-aged devices. Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.
Sterility was assured using a sterilization method validated in accordance with ISO 11135:2014, with a Sterility Assurance Level (SAL) of 10-6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font and is placed above the rest of the text. The text is aligned to the right of the symbol.
June 23, 2023
Terumo Medical Products (Hangzhou) Co., Ltd. % Brian Byrd Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, New Jersey 08873
Re: K221411
Trade/Device Name: Surflo Winged Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: June 19, 2023 Received: June 20, 2023
Dear Brian Byrd:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221411
Device Name Surflo Winged Infusion Set
Indications for Use (Describe)
The Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size.
Type of Use (Select one or both, as applicable)
| Research Use Only (21 CFR 801.4; Subpart B) |
|---|
| For In-Vitro Use Only (21 CFR 801.4; Subpart I) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K221411 510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
Prepared by: Brian Byrd Regulatory Affairs Specialist Terumo Medical Corporation Tel. (908) 208-5226 Fax (410) 398-6079
Prepared for: Owner/Operator
Terumo Medical Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang CN 310018 Owner/Operator Number: 10033965
Manufacturer and Sterilization Facility (Applicant)
Terumo Medical Products (Hangzhou) Co., Ltd. M4-9-5, Hangzhou Economic & Technological Development Zone Hangzhou, Zhejiang CN 310018 Registration Number: 3004102031
Contact Person: Brian Byrd
Regulatory Affairs Specialist Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (908) 208-5226 Fax (410) 398-6079 E-mail: brian.byrd@terumomedical.com
June 20, 2023 Date prepared:
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B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | Surflo Winged Infusion Set |
|---|---|
| Common Name: | Intravascular Administration Set |
| Classification Name: | Intravascular Administration Set |
| Classification Panel: | General Hospital |
| Regulation: | 21 CFR 880.5440 |
| Product Code: | FPA |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device to which substantial equivalence is claimed is:
Primarv Predicate:
- . K 771204 - Surflo Winged Infusion Set, manufactured by Kofu Factory of Terumo Corporation.
D. REASON FOR 510(k) SUBMISSION
This Traditional 510(k) is being submitted for the Surflo Winged Infusion Set, an intravascular administration set manufactured by Terumo Medical Products (Hangzhou) Co., Ltd., for the purposes of establishing substantial equivalence to a legally marketed predicate device. The device design remains the same excluding the material of the Connector Cap, available needle lengths, and solvent for the tubing/connector. The remaining components including the needle are the same.
E. INDICATIONS FOR USE (807.92(a)(5))
The Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size.
F. DEVICE DESCRIPTION (807.92(a)(4))
The Surflo Winged Infusion Set consists of a protector, needle, wing, tubing, connector, and connector cap. The connector is 6% female Luer. It is primarily made from medical grade PVC
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(the whole device uses TOTM as plasticizer instead of DEHP) and medical grade stainless steel.
The Surflo Winged Infusion Set is operated manually. The device is intended to be used by trained healthcare professionals in a healthcare facility.
The Surflo Winged Infusion Set is available in different gauge sizes and tubing lengths. Table 5.1 shows the available product codes and their specifications.
| Product
code | Needle
gauge
(mm)* | Wall
thickness** | Needle
length
(inch) | Tubing
length
(mm) | Tubing
Inner / Outer
Diameter
(mm) | Priming
volume
(ml) | Wing
type*** |
|-----------------|--------------------------|---------------------|----------------------------|--------------------------|---------------------------------------------|---------------------------|-----------------|
| SV18BLK | 18G (1.20) | TW | 3/4 | 300 | 1.2/2.2 | 0.45±0.10 | C |
| SV19BLK | 19G (1.10) | TW | 3/4 | 300 | 1.2/2.2 | 0.45±0.10 | C |
| SV21BLK | 21G (0.80) | UTW | 3/4 | 300 | 1.1/2.1 | 0.41±0.08 | C |
| SV22BLK | 22G (0.70) | UTW | 3/4 | 300 | 1.1/2.1 | 0.41±0.08 | C |
| SV23BLK | 23G (0.65) | UTW | 3/4 | 300 | 1.1/2.1 | 0.40±0.08 | C |
| SV25BLK | 25G (0.50) | TW | 3/4 | 300 | 1.1/2.1 | 0.40±0.08 | C |
| SV19BLS | 19G (1.10) | TW | 3/4 | 90 | 1.2/2.2 | 0.21±0.08 | C |
| SV21BLS | 21G (0.80) | UTW | 3/4 | 90 | 1.1/2.1 | 0.20±0.08 | C |
| SV23BLS | 23G (0.65) | UTW | 3/4 | 90 | 1.1/2.1 | 0.20±0.08 | C |
| SV25BLS | 25G (0.50) | TW | 3/4 | 90 | 1.1/2.1 | 0.19±0.08 | C |
| SV25EL | 25G (0.50) | TW | 1/2 | 200 | 1.1/2.1 | 0.30±0.05 | D |
| SV27EL | 27G (0.40) | RW | 1/2 | 200 | 1.1/2.1 | 0.30±0.05 | D |
Table 5.1 Surflo Winged Infusion Set specifications
*Referred to as Needle I/OD in Performance Testing
**TW = Thin Wall, UTW = Ultra-Thin Wall, RW = Regular Wall
***Wing Type: See Figure 11.1 in Section 11 - Device Description for differences in dimensions
The Surflo Winged Infusion Set is a disposable device intended for single use only. The device is packaged and sterilized by ethylene oxide gas.
Mechanical Specifications applicable to the Surflo Winged Infusion Set:
| | Tensile stress strength when
100% elongated | Tensile fracture strength |
|------------------------|------------------------------------------------|---------------------------|
| PVC (TR-630T) [tubing] | 5.84±1.96 MPa | 17.3±4.9 MPa |
Table 5.2 Strength of material (body-contacting material)
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| PVC (R-500T) 【wing】 | $10.3\pm2.9$ MPa | $22.2\pm5.9$ MPa |
|---|---|---|
| Izod impact strength | ||
| PMMA 【connector】 | >68.6J/m |
Tubing elongation: 410~490%
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The Surflo Winged Infusion Set, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the Surflo Winged Infusion Set (K771204), manufactured by Kofu Factory of Terumo Corporation, Japan.
A comparison of the technological characteristics is summarized in the table below:
| Device
Characteristic | Subject Device: Surflo
Winged Infusion Set | Predicate: Surflo
Winged Infusion Set,
K771204 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Terumo Medical Products
(Hangzhou) Co., Ltd. | Terumo Corporation |
| Intended Use | The Surflo Winged
Infusion Set is a device
used to administer fluids
from a container to a
patient's vascular system
through a needle
inserted in a vein. | Same |
| Indications for
Use | The Surflo Winged Infusion
Set is indicated for
venipuncture and
intravenous administration of
fluids for up to 24 hours
using compatible/appropriate
disposable infusion devices
for medical purposes. It may
be used for any patient
population with
consideration given to
patient size. | The Surflo Winged
Infusion Set is a device
used to administer fluids
from a container to a
patient's vascular system
through a needle
inserted in a vein. The
product consists of a
needle with attached
tubing and connectors. |
| Operation
Principle | Manual | Same |
Table 5.3: Summary of Comparative Information
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| Device
Characteristic | Subject Device: Surflo
Winged Infusion Set | Predicate: Surflo
Winged Infusion Set,
K771204 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design /
Construction | • Needle, needle protector,
winged type hub, tubing,
connector, connector cap | Same |
| Materials | • Needle: stainless steel
• Needle protector:
Polyethylene
• Wing: PVC
• Tubing: PVC
• Connector: PMMA
• Connector cap:
Polypropylene | • Needle: Same
• Needle protector:
Same
• Wing: Same
• Tubing: Same
• Connector: Same
• Connector cap:
Polyethylene or
Polypropylene |
| Package | • Primary pack
• Shelf box
• Shipping carton | Same |
| Specifications | Needle Gauge:
18G, 19G, 21G, 22G, 23G,
25G, 27G
Needle Length (inch):
3/4", 1/2"
Tubing Length (mm):
300, 90, 200 | Needle Gauge:
18G, 19G, 21G, 22G,
23G, 25G, 27G
Needle Length (inch):
3/4", 1/4", 1/2", 1", 1 1/4"
Tubing Length (mm):
300, 90, 200 |
| Sterilization | Ethylene oxide (validated
in accordance with ISO
11135 to achieve SAL 10-6) | Same |
| Shelf Life | 3 years | Same |
Note:
- . The subject device needle lengths fall within the range of the predicate device's cleared needle lengths. Therefore, the product is substantially equivalent because no new needle lengths were introduced.
- . The indications for use of the K771204 cleared product is essentially the same as the subject device except for the inclusion of the patient population statement and
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duration for use. The patient population statement was added because the predicate does not identify the intended patient population. This statement aims to direct the user to be mindful of the patient size so the patient can be administered intravenous therapy safely. While the predicate did not specify duration for use, the duration for use was added to clarify the period where the product can be safely used. Although there are wording differences within the statements, the intended use for the subject and the predicate devices are the same.
The Surflo Winged Infusion Set, manufactured by Terumo Medical Products (Hangzhou) Co., Ltd., is substantially equivalent to K771204 Surflo Winged Infusion Set, manufactured by Kofu Factory of Terumo Corporation.
H. NON-CLINICAL TESTS (807.92(b)(1))
Performance
Performance testing was conducted to ensure the Surflo Winged Infusion Set met the predetermined specifications throughout the shelf life, verify conformity to the applicable parts of ISO and non-ISO standards, and demonstrate substantial equivalence to the predicate device. No new issues of safety and effectiveness were raised with the testing performed. The following performance tests were performed on the Surflo Winged Infusion Set:
Table 5.4: Performance Tests
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| Test | Standard |
|---|---|
| Flow rate | GB 18671-2009 Intravenous |
| needles for single use | |
| Leak test | JIS T 3222:2011 Sterile |
| winged intravenous devices | |
| Wing to tubing connection strength (static | |
| pull force) | ISO 8536-4:2019 Infusion |
| equipment for medical use – | |
| Part 4: Infusion sets for | |
| single use, gravity feed | |
| Tubing to connector connection strength | |
| (static pull force) | ISO 8536-4:2019 Infusion |
| equipment for medical use – | |
| Part 4: Infusion sets for | |
| single use, gravity feed | |
| Needle to wing connection strength (static | |
| pull force) | ISO 8536-4:2019 Infusion |
| equipment for medical use – | |
| Part 4: Infusion sets for | |
| single use, gravity feed | |
| Needle curvature | JIS T 3222:2011 Sterile |
| winged intravenous devices |
No deviations from recognized consensus ISO or non-ISO standards were identified in the testing to standards.
Additionally, performance testing other than to the above ISO and non-ISO Standards was performed on the device. The device complies with the acceptance criteria established based on the predicate device:
| Performance Test | Results |
|---|---|
| Wing to tubing connection strength (dynamic | |
| pull force) | Meets acceptance criteria |
| Tubing to connector connection strength | |
| (dynamic pull force) | Meets acceptance criteria |
| Needle to wing connection strength (dynamic | |
| pull force) | Meets acceptance criteria |
| Wing-needle protector fit | Meets acceptance criteria |
| Needle penetration resistance | Meets acceptance criteria |
| Blockage test | Meets acceptance criteria |
Table 5.5: Additional Performance Tests
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| Performance Test | Results |
|---|---|
| Priming volume | Meets acceptance criteria |
Performance testing demonstrates that the Surflo Winged Infusion Set conforms to the recognized consensus ISO and non-ISO standards, is substantially equivalent to the predicate device, and is acceptable for clinical use throughout the shelf life.
Biocompatibility
In accordance with ISO 10993-1, the Surflo Winged Infusion Set is classified as: Externally Communicating Device, Blood Path, Indirect, Prolonged Contact (>24 hours to 30 days). This classification was chosen as "worst case scenario," and is the same as the Surflo Winged Infusion Set, K771204. The finished device's patient contacting parts were tested in accordance with the tests recommended in FDA Guidance for Industry and Food and Drug Administration Staff – Use of International Standard ISO-10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. " The tests were performed on non-aged (time=0) and accelerated-aged devices to show that biocompatibility is maintained throughout the shelf life of the product. Table 5.6 provides a list of biocompatibility tests conducted on the Surflo Winged Infusion Set.
| Non-Aged, Sterile, Whole Device |
|---|
| Cytotoxicity |
| Sensitization |
| Intracutaneous Reactivity |
| Acute System Toxicity |
| Pyrogenicity |
| Hemolysis |
| Subacute/Subchronic Toxicity |
| Accelerated-Aged (3 Years), Sterile, Whole Device |
| Cytotoxicity |
| Sensitization |
| Intracutaneous Reactivity |
| Acute System Toxicity |
| Pyrogenicity |
| Hemolysis |
| Subacute/Subchronic Toxicity |
Table 5.6: Summary of ISO 10993 Biocompatibility Testing
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Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.
Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014, Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices. The Surflo Winged Infusion Set is sterilized to provide a Sterility Assurance Level (SAL) of 10-6.
I. CLINICAL TESTS (807.92(b)(2))
This 510(k) does not include data from clinical tests.
J. CONCLUSION (807.92(b)(3))
In summary, the Surflo Winged Infusion Set, subject of this 510(k), is Substantially Equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device K771204 – Surflo Winged Infusion Set manufactured by Kofu Factory of Terumo Corporation.