(412 days)
Not Found
No
The device description and performance studies focus on the mechanical design and material properties of a safety hypodermic needle, with no mention of AI or ML.
No.
The device is a needle intended for aspiration and injection of fluids, designed to minimize needlestick injury, not to provide therapy itself.
No
Explanation: The device is a safety hypodermic needle used for aspiration and injection of fluids, which are therapeutic or procedural actions, not diagnostic ones. Its purpose is to deliver or remove fluids, not to gather information about a patient's health status.
No
The device description clearly details a physical hypodermic needle with a safety sheath, made of stainless steel and polypropylene. There is no mention of software as a component of the device itself.
Based on the provided text, the TERUMO SurGuard®3 SAFETY HYPODERMIC NEEDLE is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "in the aspiration and injection of fluids for medical purposes." This describes a device used directly on or in a patient for therapeutic or diagnostic procedures involving fluid transfer, not for testing samples in vitro (outside the body).
- Device Description: The description details a hypodermic needle designed for connecting to a syringe and features a safety mechanism to prevent needlestick injuries. This aligns with a device used for administering or withdrawing substances from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
Therefore, the TERUMO SurGuard®3 SAFETY HYPODERMIC NEEDLE is a medical device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TERUMO SurGuard®3 SAFETY HYPODERMIC NEEDLE is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Product codes
FMI
Device Description
The SurGuard®3 Safety Hypodermic Needle is a hypodermic single lumen needle, for single use consisting of stainless steel cannula that is sharpened at one end at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The SurGuard®3 Safety Hypodernic Needle is compatible for use with standard luer slip and luer lock syringes. The needles are packed in a hard blister made of thermoformable blister lidding paper. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheath-collar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the risk of accidental needlestick. The safety sheath is activated with a one-handed operation, using the finger, thumb, or surface activation.
The SurGuard®3 Safety Hypodermic Needle will be individually packaged and sterilized by ethylene oxide.
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
Not Found
Intended User / Care Setting
Not Found
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)
The design of the SurGuard®3 Safety Hypodermic Needle has been validated by Terumo Europe N.V. in accordance with the Design Control Requirements and recognized consensus standards that have been established for hypodermic needles under FDA product code FMI and 21CFR Section 880.5570:
ISO 7864:2016 "Sterile hypodermic needle for Single use"
ISO 9626: 2016 "Stainless steel needle tubing for the manufacturing of medical devices"
ISO 80369-7: 2017 "Small bore connectors for liquids & gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO 6009:2016 "Stainless steel needle tubing for the manufacturing of medical devices"
ISO 23908:2013 Sharps injury protection - Requirements and test methods - Sharps protection features for single-used hypodermic needles, catheters, introducers for catheters and needles used for blood sampling
USP Particulate matter
Biocompatibility: The SurGuard®3 Safety Hypodermic Needles are categorized following the definitions in ISO 10993-1:2020 as external communicating devices that can indirectly contact the blood path up to 24 hours (short term exposure). Considering FDA Guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing within a risk management process", the following biological endpoints are addressed: cytotoxicity, sensitization, intracutaneous reactivity, toxicity (acute systemic toxicity, material-induced pyrogenicity, bacterial endotoxins) and haemocompatibility.
Sterilization: The sterility of the SurGuard®3 Safety Hypodermic Needles is assured by using a validated sterilization method qualified in accordance with ISO 11135:2014 "Sterilization of Health Care Products – Ethylene oxide – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices". The physical validation of the sterilizer is conducted to verify the temperature and humidity in the sterilization load and the pressure in the sterilizer during the whole cycle. The biological validation is performed in accordance with ISO 11135:2014 Annex B "Conservative determination of lethal rate of the sterilization process - Overkill approach" part B.1.2.a "Half cycle approach". This resulted in a holding time of 120 min for the sterilization cycle to assure a SAL of at least 10° according to the requirements of ISO 11135:2014. The products can therefore be labelled sterile in accordance with EN 556-1:2001/AC1:2006 "Sterilization of medical devices - Requirements for medical devices to be labelled STERILE - Part 1: Requirements for terminally sterilized medical devices". In accordance with ISO 10993-7:2008/AC:2009: "Biological evaluation of medical devices - Part 7: Ethylene Oxide sterilization residual ethylene oxide level after aeration does not exceed 4 mg/device/day and the ethylene chlorohydrin level does not exceed 9 mg/device/day.
Accelerated aging is performed based on ASTM F1980: "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices".
Simulated shipping is performed per ASTM D4169-16: "Standard Practice for Performance Testing of Shipping Containers and Systems".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 22, 2022
Terumo Europe N.V. M.J. Aerts VP Regulatory & Vigilance Interleuvenlaan 40 Leuven, 3001 Belgium
Re: K212095
Trade/Device Name: SurGuard3 Safety Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: June 27, 2022 Received: June 27, 2022
Dear M.J. Aerts:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
CAPT Alan M. Stevens 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212095
Device Name SurGuard®3 SAFETY HYPODERMIC NEEDLE
Indications for Use (Describe)
The TERUMO SurGuard@3 SAFETY HYPODERMIC NEEDLE is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
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) |
he-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the Terumo company logo. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters "TE". The font is sans-serif and bold.
510(k) SUMMARY K212095
1. Submitter Information (807.92(a)(1))
| Prepared for: | TERUMO EUROPE N.V.
Interleuvenlaan 40,
3001 Leuven,
BELGIUM |
|-----------------------------|------------------------------------------------------------------------------------------------|
| Prepared by/Contact person: | Mrs. M.J. Aerts – VP Regulatory & Vigilance
Tel. (+32) 16 38 13 53
Fax (+32) 16 40 02 49 |
| Date prepared: | August 19, 2022 |
2. Device Name (807.92(a)(2))
| Proprietary Name: | SurGuard®3 Safety Hypodermic Needle |
|---|---|
| Common Name: | Hypodermic needle with safety sheath or needle with needle protection device |
| Classification Name: | Hypodermic Single Lumen Needle |
| Classification Panel: | General Hospital |
| Regulation: | 21 CFR §880.5570 |
| Product Code: | FMI |
| Classification: | Class II |
3. Predicate Devices (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is claimed:
-Primary Predicate Device: Terumo SurGuard®3 Safety Hypodermic Needle (K113422) manufactured by Terumo (Philippines) Corporation, 21 CFR §880.5570, Product Code: FMI, MEG
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Image /page/4/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word, creating a dynamic and recognizable brand mark.
-Predicate Device: Terumo SurGuard®3 Safety Hypodermic Needle (K122249) manufactured by Terumo (Philippines) Corporation, 21 CFR §880.5570, Product Code: FMI, MEG
4. Reason for 510(k) Submission
This premarket notification [510(k)] is being submitted for the SurGuard®3 Safety Hypodermic Needle to provide supporting information that the proposed device is safe and effective and substantially equivalent to the following devices:
Primary Predicate Device: Terumo SurGuard®3 Safety Hypodermic Needle (K113422) manufactured by Terumo (Philippines) Corporation.
Predicate Device: Terumo SurGuard®3 Safety Hypodermic Needle (K122249) manufactured by Terumo (Philippines) Corporation
5. Device Description (807.92(a)(4))
Principle of Operation Technology
The SurGuard®3 Safety Hypodermic Needle is operated manually or by manual process.
Design/Construction
The SurGuard®3 Safety Hypodermic Needle is a hypodermic single lumen needle, for single use consisting of stainless steel cannula that is sharpened at one end at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The SurGuard®3 Safety Hypodernic Needle is compatible for use with standard luer slip and luer lock syringes. The needles are packed in a hard blister made of thermoformable blister lidding paper. This device features a hinged safety sheath attached to the needle hub. The safety sheath contains two locking mechanisms, the tooth-cannula and sheath-collar which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the risk of accidental needlestick. The safety sheath is activated with a one-handed operation, using the finger, thumb, or surface activation.
The SurGuard®3 Safety Hypodermic Needle will be individually packaged and sterilized by ethylene oxide.
Specifications
The following table shows the product codes, needle gauge and needle length.
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Image /page/5/Picture/0 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters "TE". The font is sans-serif and bold. The logo is simple and modern.
Table 5.2 Product Specifications
| PRODUCT CODE | NEEDLE
GAUGE | NEEDLE LENGTH | NEEDLE
BEVEL | CANNULA WALL |
|--------------|-----------------|---------------|-----------------|--------------|
| SG3-1925RB | 19 G (1.1 mm) | 1" (25 mm) | Long bevel | Thin wall |
| SG3-1938RB | 19 G (1.1 mm) | 1 ½" (38 mm) | Long bevel | Thin wall |
| SG3-2138RB | 21 G (0.8 mm) | 1 ½" (38 mm) | Long bevel | Thin wall |
| SG3-2516RB | 25 G (0.5 mm) | 5/8" (16 mm) | Long bevel | Thin wall |
6. Indications for Use (807.92(a)(5))
The TERUMO SurGuard®3 SAFETY HYPODERMIC NEEDLE is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer lock syringes. Additionally, after withdrawal of the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Note: The indications for use are identical to the following predicate devices:
- Primary Predicate Device: Terumo SurGuard®3 Safety Hypodermic Needle (K113422) manufactured by Terumo (Philippines) Corporation.
- Predicate Device: Terumo SurGuard®3 Safety Hypodernic Needle (K122249) manufactured by Terumo -(Philippines) Corporation
7. Substantial Equivalence Comparison (807.92(a)(6))
SurGuard® 3 SAFETY HYPODERMC NEEDLE, the subject of this 510(k), is substantially equivalent in intended use, description/specifications, technology/principles of operformance to the following predicate devices:
- Primary Predicate Device: Terumo SurGuard®3 Safety Hypodermic Needle (K113422) manufactured by Terumo (Philippines) Corporation.
- Predicate Device: Terumo SurGuard®3 Safety Hypodermic Needle (K122249) manufactured by Terumo -(Philippines) Corporation
The similarities and differences are summarized in table 5.3.
Table 5.3 Device Comparison Table
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Image /page/6/Picture/0 description: The image shows the logo for Terumo, a medical device company. The logo consists of a red arc above the word "TERUMO" in green. The red arc is curved and positioned above the left side of the word. The word "TERUMO" is written in a bold, sans-serif font.
| Characteristics | Subject Device:
SurGuard®3 Safety
Hypodermic Needle
(Terumo Europe, Belgium)
(K212095) | Primary Predicate device:
Terumo SurGuard®3 Safety
Hypodermic Needle
(Terumo (Philippines)
Corporation (Philippines))
(K113422) | Predicate device:
Terumo SurGuard®3 Safety
Hypodermic Needle
(Terumo (Philippines) Corporation
(Philippines))
(K122249) | Comments |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Manufacturer | Terumo Europe N.V. | Terumo (Philippines) Corporation | Terumo (Philippines) Corporation | Unchanged |
| Indications for Use* | The TERUMO SurGuard® 3
SAFETY HYPODERMIC
NEEDLE is intended for use in
the aspiration and injection of
fluids for medical purposes. The
Terumo Safety Hypodermic
Needle is compatible for use with
standard luer slip and luer lock
syringes. Additionally, after
withdrawal of the needle from the
body, the attached needle safety
sheath can be manually activated
to cover the needle immediately
after use to minimize risk of
accidental needlestick. | The TERUMO SurGuard® 3
SAFETY HYPODERMIC NEEDLE
is intended for use in the
aspiration and injection of fluids
for medical purposes. The Terumo
Safety Hypodermic Needle is
compatible for use with standard
luer slip and luer lock syringes.
Additionally, after withdrawal of
the needle from the body, the
attached needle safety sheath can
be manually activated to cover the
needle immediately after use to
minimize risk of accidental
needlestick. | The TERUMO SurGuard® 3 SAFETY
HYPODERMIC NEEDLE is intended for
use in the aspiration and injection of
fluids for medical purposes. The Terumo
Safety Hypodermic Needle is
compatible for use with standard luer
slip and luer lock syringes. Additionally,
after withdrawal of the needle from the
body, the attached needle safety sheath
can be manually activated to cover the
needle immediately after use to
minimize risk of accidental needlestick. | Unchanged |
| Materials | Cannula - Stainless Steel
Hub - Polypropylene/Masterbatch
Protector - Polypropylene
Adhesive - Epoxy Glue
Collar - Polypropylene
Sheath - Polypropylene
Lubricant - Polydimethylsiloxane | Cannula - Stainless Steel
Hub - Polypropylene/Masterbatch
Protector - Polypropylene
Adhesive - Epoxy Glue
Collar - Polypropylene
Sheath - Polypropylene
Lubricant - Polydimethylsiloxane | Cannula - Stainless Steel
Hub -Polypropylene/Masterbatch
Protector - Polypropylene
Adhesive - Epoxy Glue
Collar - Polypropylene
Sheath - Polypropylene
Lubricant - Polydimethylsiloxane | Unchanged |
| Design/
Constructions | The device consists of a
hypodermic needle with a hinged
safety sheath attached to the
connector hub. | The device consists of a
hypodermic needle with a hinged
safety sheath attached to the
connector hub. | The device consists of a hypodermic
needle with a hinged safety sheath
attached to the connector hub. | Unchanged |
| Characteristics | Subject Device:
SurGuard®3 Safety
Hypodermic Needle
(Terumo Europe, Belgium)
(K212095) | Primary Predicate device:
Terumo SurGuard®3 Safety
Hypodermic Needle
(Terumo (Philippines)
Corporation (Philippines))
(K113422) | Predicate device:
Terumo SurGuard®3 Safety
Hypodermic Needle
(Terumo (Philippines) Corporation
(Philippines))
(K122249) | Comments |
| Specifications | 19G x 1" (1.1 x 25 mm)
19G x 1 ½" (1.1 x 38 mm)
21G x 1 ½" (0.8 x 38 mm)
25G x 5/8" (0.5 x 16 mm) | 19G x 1" (1.1 x 25 mm)
19G x 1 ½" (1.1 x 38 mm)
21G x 1 ½" (0.8 x 38 mm) | 25G x 5/8" (0.5 x 16 mm) | Unchanged |
| Principle of
Operation | Manual | Manual | Manual | Unchanged |
| Unit packaging | Hard blister pack consisting of
blister lid coated paper and
thermoformable plastic film | Soft blister pack consisting of
blister lid coated paper and
thermoformable plastic film | Soft blister pack consisting of blister lid
coated paper and thermoformable
plastic film | Refer to
Substantial
Equivalence
Discussion |
| Sterilization | EO to SAL 10-6 | E-beam radiation to SAL 10-6 | E-beam radiation to SAL 10-6 | Refer to
Substantial
Equivalence
Discussion |
| Shelf life | 5 years | 5 years | 5 years | Unchanged |
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Image /page/7/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is curved upwards and to the right. The word "TERUMO" is in a bold, sans-serif font.
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Image /page/8/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green, block letters. The arc is positioned above and slightly to the left of the word, creating a sense of motion or direction.
Substantial Equivalence Discussion
SurGuard®3 Safety Hypodermic Needle is the same needle as the SurGuard®3 Safety Hypodermic Needles cleared in K113422 and K122249 given that:
- It has the same intended use and indications for use as the predicate devices ●
- It uses the same principles of operation ●
- It incorporates the same basic design ●
- It is manufactured from the same materials
- It is sterilized in accordance with validated methods ●
- It is sterilized to a Sterility Assurance Level (SAL) of 10-6 ●
- It has the same shelf life ●
The specifications of the subject device are the same of the ones already covered in K113422 and K122249.Terumo Europe buys SurGuard®3 Safety Hypodermic Needle in bulk from Terumo (Philippines) Corporation and then packs the product in a hard blister pack. Therefore, the difference is that the needle subject to this 510(k) file is packed in a hard blister pack consisting of blister lid coated paper and thermoformable plastic film instead of a soft blister pack, which is the case for the predicate devices. There is also a difference in the sterilization method (EO sterilization compared to E-beam sterilization) but the same sterility assurance level is achieved.
Based on the above explanation and supported by performance testing, it can be concluded that differences between the subject and the predicate devices do not impact safety and effectiveness.
Table 5.4 Product specifications
| | Subject Device: | Primary Predicate
(K113422) | Predicate device
(K122249) |
|---------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------|
| Product
Specifications | 19G x 1" (1.1 x 25 mm)
19G x 1 ½" (1.1 x 38 mm)
21G x 1 ½" (0.8 x 38 mm)
25G x 5/8" (0.5 x 16 mm) | 19G x 1" (1.1 x 25 mm)
19G x 1 ½" (1.1 x 38 mm)
21G x 1 ½" (0.8 x 38 mm) | 25G x 5/8" (0.5 x 16 mm) |
8. Non Clinical Test (807.92(b)(1))
Performance
The design of the SurGuard®3 Safety Hypodermic Needle has been validated by Terumo Europe N.V. in accordance with the Design Control Requirements and recognized consensus standards that have been established for hypodermic needles under FDA product code FMI and 21CFR Section 880.5570:
ISO 7864:2016 "Sterile hypodermic needle for Single use"
ISO 9626: 2016 "Stainless steel needle tubing for the manufacturing of medical devices"
9
Image /page/9/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green. The font is sans-serif and the letters are bold.
ISO 80369-7: 2017 "Small bore connectors for liquids & gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO 6009:2016 "Stainless steel needle tubing for the manufacturing of medical devices"
ISO 23908:2013 Sharps injury protection - Requirements and test methods - Sharps protection features for single-used hypodermic needles, catheters, introducers for catheters and needles used for blood sampling
USP Particulate matter
Biocompatibility
The SurGuard®3 Safety Hypodermic Needles are categorized following the definitions in ISO 10993-1:2020 as external communicating devices that can indirectly contact the blood path up to 24 hours (short term exposure). Considering FDA Guidance document: Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing within a risk management process", the following biological endpoints are addressed: cytotoxicity, sensitization, intracutaneous reactivity, toxicity (acute systemic toxicity, material-induced pyrogenicity, bacterial endotoxins) and haemocompatibility.
Sterilization
The sterility of the SurGuard®3 Safety Hypodermic Needles is assured by using a validated sterilization method qualified in accordance with ISO 11135:2014 "Sterilization of Health Care Products – Ethylene oxide – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices".
The physical validation of the sterilizer is conducted to verify the temperature and humidity in the sterilization load and the pressure in the sterilizer during the whole cycle.
The biological validation is performed in accordance with ISO 11135:2014 Annex B "Conservative determination of lethal rate of the sterilization process - Overkill approach" part B.1.2.a "Half cycle approach". This resulted in a holding time of 120 min for the sterilization cycle to assure a SAL of at least 10° according to the requirements of ISO 11135:2014.
The products can therefore be labelled sterile in accordance with EN 556-1:2001/AC1:2006 "Sterilization of medical devices - Requirements for medical devices to be labelled STERILE - Part 1: Requirements for terminally sterilized medical devices".
In accordance with ISO 10993-7:2008/AC:2009: "Biological evaluation of medical devices - Part 7: Ethylene Oxide sterilization residual ethylene oxide level after aeration does not exceed 4 mg/device/day and the ethylene chlorohydrin level does not exceed 9 mg/device/day.
10
Image /page/10/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green. The swoosh is curved and positioned above the left side of the word.
Accelerated aging is performed based on ASTM F1980: "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices".
Simulated shipping is performed per ASTM D4169-16: "Standard Practice for Performance Testing of Shipping Containers and Systems".
9. Clinical Test (807.92(b)(2))
This 510(k) does not include data from clinical tests.
10. Conclusion (807.92(b)(3))
In summary, the SurGuard®3 Safety Hypodermic Needle, manufactured by Terumo Europe, being the subject of this 510(k), is substantially equivalent in intended use, design, technology/principal of operation, materials, and performance to the following devices:
- Primary Predicate Device: Terumo SurGuard®3 Safety Hypodermic Needle -(K113422) manufactured by Terumo (Philippines) Corporation.
- -Predicate Device: Terumo SurGuard®3 Safety Hypodermic Needle (K122249) manufactured by Terumo (Philippines) Corporation
Differences between the devices do not raise any new issues of safety or effectiveness.